S. Hrg. 111–910 

H1N1 FLU—2009 

HEARINGS 

BEFORE THE

COMMITTEE ON 

HOMELAND SECURITY AND 

GOVERNMENTAL AFFAIRS 

UNITED STATES SENATE 

OF THE

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

APRIL 29, 2009 

COORDINATING THE FEDERAL RESPONSE 

SEPTEMBER 21, 2009 

PROTECTING OUR COMMUNITY 

FIELD HEARING IN HARTFORD, CT 

OCTOBER 21, 2009 

MONITORING THE NATION’S RESPONSE 

NOVEMBER 17, 2009 

GETTING THE VACCINE TO WHERE IT IS MOST NEEDED 

Available via the World Wide Web: http://www.fdsys.gov 

Printed for the use of the 

Committee on Homeland Security and Governmental Affairs 

( 

H1N1 FLU—2009 

U.S. GOVERNMENT PRINTING OFFICE

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51–020 PDF 2011

S. Hrg. 111–910 

H1N1 FLU—2009 

HEARINGS 

BEFORE THE

COMMITTEE ON 

HOMELAND SECURITY AND 

GOVERNMENTAL AFFAIRS 

UNITED STATES SENATE 

OF THE

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

APRIL 29, 2009 

COORDINATING THE FEDERAL RESPONSE 

SEPTEMBER 21, 2009 

PROTECTING OUR COMMUNITY 

FIELD HEARING IN HARTFORD, CT 

OCTOBER 21, 2009 

MONITORING THE NATION’S RESPONSE 

NOVEMBER 17, 2009 

GETTING THE VACCINE TO WHERE IT IS MOST NEEDED 

Available via the World Wide Web: http://www.fdsys.gov 

Printed for the use of the 

Committee on Homeland Security and Governmental Affairs 

( 

(II) 

COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS 

MEMBERSHIP AS OF APRIL 29, 2009 

JOSEPH I. LIEBERMAN, Connecticut, Chairman 

CARL LEVIN, Michigan 

DANIEL K. AKAKA, Hawaii 

THOMAS R. CARPER, Delaware 

MARK L. PRYOR, Arkansas 

MARY L. LANDRIEU, Louisiana 

CLAIRE MCCASKILL, Missouri 

JON TESTER, Montana 

ROLAND W. BURRIS, Illinois 

MICHAEL F. BENNET, Colorado 

SUSAN M. COLLINS, Maine 

TOM COBURN, Oklahoma 

JOHN MCCAIN, Arizona 

GEORGE V. VOINOVICH, Ohio 

JOHN ENSIGN, Nevada 

LINDSEY GRAHAM, South Carolina 

COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS 

MEMBERSHIP AS OF OCTOBER 21, 2009 

JOSEPH I. LIEBERMAN, Connecticut, Chairman 

CARL LEVIN, Michigan 

DANIEL K. AKAKA, Hawaii 

THOMAS R. CARPER, Delaware 

MARK L. PRYOR, Arkansas 

MARY L. LANDRIEU, Louisiana 

CLAIRE MCCASKILL, Missouri 

JON TESTER, Montana 

ROLAND W. BURRIS, Illinois 

PAUL G. KIRK, JR., Massachusetts 

SUSAN M. COLLINS, Maine 

TOM COBURN, Oklahoma 

JOHN MCCAIN, Arizona 

GEORGE V. VOINOVICH, Ohio 

JOHN ENSIGN, Nevada 

LINDSEY GRAHAM, South Carolina 

ROBERT F. BENNETT, Utah 

MICHAEL L. ALEXANDER, Staff Director 

AARON M. FIROVED, Professional Staff Member 

CARLY A. STEIER, Research Assistant 

BRANDON L. MILHORN, Minority Staff Director and Chief Counsel 

ASHA A. MATHEW, Minority Senior Counsel 

PRISCILLA H. HANLEY, Minority Professional Staff Member 

TRINA DRIESSNACK TYRER, Chief Clerk 

PATRICIA R. HOGAN, Publications Clerk and GPO Detailee 

LAURA W. KILBRIDE, Hearing Clerk 

(III) 

C O N T E N T S 

Opening statements: Page 

Senator Lieberman ............................................................................. 1, 37, 79, 119 

Senator Collins.......................................................................................... 3, 82, 122 

Senator McCain............................................................................................... 14, 99 

Senator Tester............................................................................................... 18, 107 

Senator Voinovich ............................................................................................. 20 

Senator Pryor .................................................................................................... 22 

Senator Burris............................................................................................... 24, 105 

Senator Graham ............................................................................................... 25 

Senator Kirk................................................................................................ 102, 138 

Senator McCaskill....................................................................................... 110, 141 

Senator Carper ................................................................................................. 113 

Prepared statements: 

Senator Lieberman ..................................................................... 153, 195, 248, 337 

Senator Collins.................................................................................... 155, 252, 341 

Senator Burris .................................................................................................. 254 

Senator Kirk with attachment ........................................................................ 345 

WITNESSES 

Wednesday, April 29, 2009 

Hon. Janet A. Napolitano, Secretary, U.S. Department of Homeland Security . 5 

Anne Schuchat, M.D., Interim Deputy Director for Science and Public Health 

Program, Centers for Disease Control and Prevention, U.S. Department 

of Health and Human Services ........................................................................... 8 

ALPHABETICAL LIST OF WITNESSES

Napolitano, Hon. Janet A.: 

Testimony .......................................................................................................... 5 

Prepared statement .......................................................................................... 157 

Schuchat, Anne, M.D.: 

Testimony .......................................................................................................... 8 

Prepared statement .......................................................................................... 167 

APPENDIX 

Responses to post-hearing questions for the Record from: 

Secretary Napolitano with attachments ......................................................... 174 

Dr. Schuchat ..................................................................................................... 186 

Wayne Pacelle, President and CEO, Humane Society of the United States, 

statement for the Record ..................................................................................... 193 

Monday, September 21, 2009 

Rear Admiral Michael R. Milner, U.S. Public Health Service, Regional Health 

Administrator, Region I, U.S. Department of Health and Human Services ... 40 

Matthew L. Cartter, M.D., State Epidemiologist, Connecticut Department 

of Public Health .................................................................................................... 44 

Hon. Peter J. Boynton, Commissioner, Connecticut Department of Emergency 

Management and Homeland Security ................................................................ 48 

Stephen G. Jones, M.D., Director, Outpatient Medicine and Center for 

Healthy Aging, Chief Patient Safety Officer, Yale New Haven Health System ......................................................................................................................... 51

Julie A. Polansky, Parent, Vernon Public Schools ................................................ 63 

Page

IV 

Roseann Wright, Director, Waterbury Department of Public Health ................. 66 

Daniel Aloi, Manager, Business Continuity Services, Aetna, Inc. ....................... 69 

Michael Kurland, Director, Student Health Services, University of Connecticut .................................................................................................................. 72 

ALPHABETICAL LIST OF WITNESSES

Aloi, Daniel: 

Testimony .......................................................................................................... 69 

Prepared statement .......................................................................................... 244 

Boynton, Hon. Peter J.: 

Testimony .......................................................................................................... 48 

Prepared statement .......................................................................................... 228 

Cartter, Matthew L., M.D.: 

Testimony .......................................................................................................... 44 

Prepared statement with attachment ............................................................. 204 

Jones, Stephen G., M.D.: 

Testimony .......................................................................................................... 51 

Prepared statement .......................................................................................... 233 

Kurland, Michael: 

Testimony .......................................................................................................... 72 

Prepared statement .......................................................................................... 246 

Milner, Rear Admiral Michael R.: 

Testimony .......................................................................................................... 40 

Prepared statement .......................................................................................... 197 

Polansky, Julie A.: 

Testimony .......................................................................................................... 63 

Prepared statement .......................................................................................... 236 

Wright, Roseann: 

Testimony .......................................................................................................... 66 

Prepared statement .......................................................................................... 238 

Wednesday, October 21, 2009 

Hon. Janet A. Napolitano, Secretary, U.S. Department of Homeland Security . 84 

Hon. Kathleen Sebelius, Secretary, U.S. Department of Health and Human 

Services ................................................................................................................. 86 

Hon. Arne Duncan, Secretary, U.S. Department of Education ............................ 90 

ALPHABETICAL LIST OF WITNESSES

Duncan, Hon. Arne: 

Testimony .......................................................................................................... 90 

Prepared statement .......................................................................................... 279 

Napolitano, Hon. Janet A.: 

Testimony .......................................................................................................... 84 

Prepared statement .......................................................................................... 255 

Sebelius, Hon. Kathleen: 

Testimony .......................................................................................................... 86 

Prepared statement .......................................................................................... 266 

APPENDIX 

Chart submitted for the Record by Senator Lieberman ....................................... 251 

Responses to post-hearing questions for the Record from: 

Secretary Napolitano with attachments ......................................................... 284 

Secretary Sebelius ............................................................................................ 309 

Secretary Duncan ............................................................................................. 333 

Tuesday, November 17, 2009 

Anne Schuchat, M.D., Director, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services ................................................................. 124 

Nicole Lurie, M.D., Assistant Secretary for Preparedness and Response, U.S. 

Department of Health and Human Services ...................................................... 127 

Hon. Alexander G. Garza, Assistant Secretary for Health Affairs and Chief 

Medical Officer, U.S. Department of Homeland Security ................................. 130 

Page

V 

ALPHABETICAL LIST OF WITNESSES

Garza, Alexander G., Hon.: 

Testimony .......................................................................................................... 130 

Prepared statement .......................................................................................... 387 

Lurie, Nicole, M.D.: 

Testimony .......................................................................................................... 127 

Prepared statement with attachments ........................................................... 362 

Schuchat, Anne, M.D.: 

Testimony .......................................................................................................... 124 

Prepared statement with attachment ............................................................. 348 

APPENDIX 

Chart submitted for the Record by Senator Lieberman ....................................... 340 

Combined responses to post-hearing questions for the Record from: 

Dr. Schuchat and Dr. Lurie ............................................................................. 391 

Jeffrey Levi, Ph.D., Executive Director, Trust for America’s Health, statement 

for the Record ....................................................................................................... 403 

Letter to Hon. Kathleen Sebelius from Senator Collins, dated October 26, 

2009 ....................................................................................................................... 409

Letter to Hon. Kathleen Sebelius from Senators Lieberman and Collins, dated 

October 27, 2009 ................................................................................................... 411 

Letter to Senator Collins from Hon. Kathleen Sebelius, dated October 30, 

2009 ....................................................................................................................... 414

Letter to Senator Lieberman from Hon. Kathleen Sebelius, dated November 

10, 2009 ................................................................................................................. 418 

(1) 

SWINE FLU: COORDINATING THE FEDERAL 

RESPONSE 

WEDNESDAY, APRIL 29, 2009 

U.S. SENATE,

COMMITTEE ON HOMELAND SECURITY

AND GOVERNMENTAL AFFAIRS, 

Washington, DC. 

The Committee met, pursuant to notice, at 10:05 a.m., in room 

SD–342, Dirksen Senate Office Building, Hon. Joseph I. Lieberman, Chairman of the Committee, presiding. 

Present: Senators Lieberman, Pryor, Tester, Burris, Collins, 

McCain, Voinovich, and Graham. 

OPENING STATEMENT OF CHAIRMAN LIEBERMAN 

Chairman LIEBERMAN. Good morning and thanks to all who are 

here. I particularly want to thank Secretary Janet Napolitano and 

Dr. Anne Schuchat for joining us today to discuss our government’s 

response to the current outbreak of swine flu. 

We are in the midst of a growing public health emergency whose 

ultimate course is not clear. But one thing is certain, and that is 

that swine flu is moving very quickly and harmfully from the first 

outbreak barely a month ago in a small village in Mexico to the 

first two cases in America confirmed in California barely a week 

ago, to the first American death, a 23-month-old child in Texas, announced and confirmed this morning. This flu has moved very 

quickly. 

By yesterday afternoon in Mexico, more than 2,000 people have 

been hospitalized and 149 people have died from swine flu. This 

morning’s numbers here in America are 66 confirmed cases in six 

States—New York, California, Texas, Kansas, Ohio, and Indiana. 

Globally, excluding Mexico and the United States, there are 39 confirmed cases in six other countries, including New Zealand, Spain, 

Great Britain, Germany, Canada, and Israel. 

On Sunday, our government declared this to be a public health 

emergency. A day later, the World Health Organization (WHO) 

raised its pandemic alert to Phase 4. So this is no media-created 

or media-exaggerated story, as some have suggested. This is a genuine public health crisis. 

The reassuring news, I believe, is that this is a case in which our 

government was prepared for the crisis, as best one can be prepared for a swine flu outbreak whose course is not clear, and our 

top government officials responsible for responding have done so, I 

think, with great strength and effect. 

2 

The fact is, as I said, that we do not know the course that this 

disease will follow. It is possible, as some have suggested, that the 

incidence of swine flu may diminish in the weeks ahead and then 

return with a vengeance in the flu season later this year. 

So the American people are understandably anxious and want to 

know what they can do to protect themselves and what their government is doing and will do to protect them from swine flu. 

This morning, we have two people with us who are really best 

prepared and most responsible for answering those questions. Secretary of Homeland Security Janet Napolitano is the person in our 

government given the authority and responsibility by statute and 

presidential directives to be the overall emergency manager of the 

Federal Government’s response to this kind of threat. That reminds 

us that this newest of Federal departments created in the aftermath of the terrorist attacks of September 11, 2001, was from the 

start intended to be at the center of prevention and response not 

just to terrorist attacks but to natural disasters and to pandemic 

outbreaks, which in many ways mirror the effects of a potential attack by a weapon of mass destruction. 

In the current attempt to limit the spread of swine flu, the presence within the Department of Homeland Security (DHS)—and not 

just the Federal Emergency Management Agency (FEMA), but also 

of agencies that concern and control immigration and access in and 

out and across our border, such as Immigration and Customs Enforcement (ICE), Customs and Border Protection (CBP), and the 

Transportation Security Administration (TSA) has been very important to consolidate the response, as has been the ongoing relations that the Secretary of Homeland Security has with State and 

local officials. 

Dr. Schuchat is here this morning representing the Centers for 

Disease Control and Prevention (CDC), which works under the Department of Health and Human Services (HHS) in this case and its 

new Secretary, Kathleen Sebelius. That Department in turn leads 

the public health and medical response parts of the Federal Government plan now being coordinated by Secretary Napolitano. 

I thank you both and all who have worked with you in the last 

several days for your rapid, strong, and reassuring response to this 

public health crisis. You have tracked the spread of the disease, 

identified and addressed new cases in this country, communicated 

your findings frequently to the American people, and implemented, 

or begun to implement, an array of preventive and response programs. 

I think it is important to note for the record and hope that this 

gives some reassurance to the American people that, unlike other 

crises we have faced, pandemic flu is a threat that our Federal 

Government anticipated and planned. Nearly two decades ago, in 

1992, the Institute of Medicine warned that emerging microbial 

diseases were a serious threat and that a number of modern demographic and environmental factors would facilitate rapid spread. 

We have seen since then global outbreaks of avian bird flu, West 

Nile virus, severe acute respiratory syndrome (SARS), and a host 

of other infectious diseases. 

In response, in the early 1990s or mid-1990s, the CDC developed 

a National Emerging Infectious Diseases Strategy, and President 

3 

Clinton issued a presidential directive for Federal agencies to begin 

coordination for a national response to the growing threat of infectious diseases. But in 2003, we experienced a particularly bad seasonal flu outbreak and a particularly inadequate governmental response. After that, President Bush issued presidential directives, 

and in 2006, the Homeland Security Council agreed on and issued 

a National Strategy for a Pandemic Influenza Implementation 

Plan, which sets out a detailed road map for what to do in a crisis 

such as the swine flu outbreak we are in now. 

States, supported by grants from the Department of Homeland 

Security and the Department of Health and Human Services, have 

pursuant to that plan developed their own plans for addressing 

pandemic flu. In fact, State and local governments have gone 

through demonstrations of preparedness exercises for exactly what 

we are going through now. But that does not mean that we do not 

have a lot of work yet to do and that we do not have to remain 

very prepared, ready, and agile, because we are facing a disease 

here whose course really is unpredictable. 

This morning, we on this Committee are going to ask and hope 

that our witnesses will be able to answer some of the tough questions that remain on the minds of our constituents and on ours as 

well, and we look forward to your answers to those questions. 

Again, I thank you for what thus far has been a very strong and 

a very reassuring response to a very real public health emergency. 

Senator Collins. 

OPENING STATEMENT OF SENATOR COLLINS 

Senator COLLINS. Thank you, Mr. Chairman. All of us are extremely concerned about the human swine flu outbreak that continues to grow in our country and around the world. While the disease has thus far been confined to six States, it is likely to spread 

further in the days to come. 

As the Chairman mentioned, more than 150 people in Mexico are 

believed to have died from the virus, and just this morning the first 

death in our country was confirmed by the CDC. 

There is also the dangerous potential that the flu strain will mutate into an even more deadly strain or one that is even more infectious. The American people have the right to expect that the Federal Government is doing everything possible to combat this potential pandemic, and to date, I would agree with the Chairman that 

it appears that our Federal officials have taken this threat very seriously and responded very effectively. 

Today’s hearing will give us the opportunity to learn more about 

what the Federal Government has done and what it plans to do to 

meet this growing public health threat. 

As the Chairman mentioned, on Sunday the Department of 

Health and Human Services declared this incident a public health 

emergency. That alarmed many in the public. But as Secretary 

Napolitano has carefully explained, that was necessary to allow for 

the release of Federal resources to support our preparedness and 

response efforts. It also gives agencies greater flexibility to put 

rapid measures in place should the flu virus become an even more 

prevalent threat. 

4 

The declaration also places the Secretary of Homeland Security 

in charge of the overall Federal Government’s response. Consequently, DHS must work closely with HHS and its component 

agency, the Centers for Disease Control and Prevention, in shaping 

our response, and I look forward to hearing the testimony of our 

witnesses today. 

Congress has provided authorities and funding to strengthen our 

Nation’s ability to respond to a pandemic incident, including the establishment of the Biomedical Advanced Research and Development Authority (BARDA), at HHS. I strongly supported the creation of BARDA and the increases to its funding. To date, almost $7 billion has been appropriated for Federal pandemic preparedness activities. This funding has been used for 

stockpiling antiviral drugs for the treatment of more than 50 million Americans. It has been used to license a pre-pandemic influenza vaccine, to develop rapid diagnostics, and to complete the sequencing of the entire genetic blueprints of more than 2,000 human 

and avian influenza viruses. 

I mentioned that figure—it is actually 2,250—because it shows 

how many strains of flu we are already dealing with, and yesterday 

the President asked for an additional $1.5 billion to combat this 

disease as part of the supplemental appropriations bill that Congress will soon be considering. 

Despite these authorities and this funding, this Committee has 

uncovered weaknesses in pandemic flu planning and coordination 

in the past. Just last year, our Committee held a hearing on mass 

medical care that would be needed in the response to a pandemic 

flu or the detonation of a terrorist nuclear device. This hearing revealed some serious gaps in the Nation’s capacity to provide mass 

care if thousands were to become ill. 

The Committee has also held a hearing on HHS’ development 

and procurement of the necessary vaccines, drugs, and countermeasures for public health emergencies just like this one. In addition, we previously looked at the poor communications and coordination between DHS and the CDC in an incident involving a Mexican citizen with a multiple-drug-resistant form of tuberculosis who 

was able to enter our country 21 times after being identified by the 

CDC. 

These incidences lead us to several important questions that we 

will explore today. What has the Federal Government done thus far 

to protect the American people from this potential pandemic? Since 

the Department of Homeland Security has put relatively passive 

inspection techniques in place at the border, should more be done 

to protect against cross-border spread of the disease? How are the 

plans working? And have we encountered any unanticipated problems? What role should the State and local health departments 

play? What is the role for hospitals? I met with 21 hospital administrators from Maine yesterday who talked about the number of inquiries that they are fielding about this disease. 

I particularly look forward to hearing about the status of the 

Federal Government’s pandemic planning efforts. A critical part of 

this planning is the antivirals and other medical countermeasures 

from the Strategic National Stockpile that must be distributed rapidly to the public when needed. I would like to have more informaVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000012 Fmt 06633 Sfmt 06633 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
5 

1The prepared statement of Secretary Napolitano appears in the Appendix on page 157. 

tion on how that distribution is working. Is it getting out to every 

State? How are the priorities set? 

As the previous hearings in this Committee’s investigation into 

the Mexican national with tuberculosis highlighted, coordination 

between DHS and HHS is essential, as is communication with 

Mexican officials. These are issues we will be exploring today as 

well. 

Finally, let me indicate that I have been concerned about how 

the lack of appointees at top positions at HHS and DHS may be 

hindering the response. I am sure that HHS has been handicapped 

by the absence of a Secretary, and I am pleased that the Senate 

finally voted last night to confirm Governor Sebelius’ nomination. 

But we still do not have a permanent head of the CDC, though we 

have many very capable individuals from the CDC, and DHS still 

lacks a Chief Medical Officer. I mention this because effective leadership is so important to the effectiveness of our response, and in 

this regard, I am very pleased with the leadership that has been 

shown so far. 

Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thank you very much, Senator Collins, 

and now we will go right to the witnesses, again with thanks for 

your accommodating and moving your schedule to be here with us 

today. Secretary Napolitano, thank you. 

TESTIMONY OF HON. JANET A. NAPOLITANO,1 SECRETARY, 

U.S. DEPARTMENT OF HOMELAND SECURITY 

Secretary NAPOLITANO. Thank you, Mr. Chairman, Senator Collins, Members of the Committee. Thank you for the opportunity to 

testify on the national response to the H1N1 flu outbreak. 

This is, as you have noted, a serious situation that we are treating aggressively. As President Obama said yesterday, it is a cause 

for concern but not for alarm. There is a lot we do not yet know 

about this outbreak, but we have been preparing as if we are facing 

a true pandemic, even though we do not know the ultimate scope 

of what will occur. 

We also have been preparing with the understanding that this 

will be a marathon and not a sprint. We are going to be at this 

for a while. 

Mr. Chairman, as you noted, the Secretary of Homeland Security 

is the principal Federal officer for domestic incident management, 

including outbreaks like this one. Under that role, we have been 

leading a true collaborative effort. HHS and the CDC also have 

lead roles on the health and science aspects of this outbreak. But 

every department of the Federal Government or virtually every one 

has a role to play. 

For example, the Department of Education already has had a 

conference call with 1,400 participants on how to identify, and prevent H1N1 in school facilities. 

The U.S. Department of Agriculture has been working to reassure people of the safety of our pork and pork products and to work 

with other countries with respect to the import of our pork prodVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000013 Fmt 06633 Sfmt 06633 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
6 

ucts. The U.S. Trade Representative I was with yesterday is doing 

the same. 

As you noted, our State, local, and tribal partners are absolutely 

indispensable because on many questions they actually have the 

lead role. They are the first responders. We are now at the Department of Homeland Security conducting daily conference calls with 

these partners. Some days we have had as many as 48 States participating. We have 40-plus States participating on a regular basis. 

Indeed, the public has a role to play here and a responsibility— 

a responsibility to cover our mouths when we cough, a responsibility to wash our hands regularly; if you are sick, not to go to 

work, not to get on a plane or a bus; and if your child is sick, not 

to send them to school to avoid infecting others. 

I am pleased to be here with Dr. Anne Schuchat from the CDC. 

I want to commend the CDC for their work on this. They have been 

absolutely phenomenal to work with here and educating all of us 

about this particular strain and about flu outbreaks in general. The 

career public health officials there are doing a terrific job, as are 

the career officials at the Department of Homeland Security, and 

I want to praise them as well. 

As you noted, part of the preparation is analyzing what we have 

with respect to antivirals. The National Stockpile has 50 million 

courses, and we are releasing 25 percent of the State portion already. 

Senator Collins, you asked about who has been delivered already. 

Indiana, Nevada, Kansas, Kentucky, and Ohio have received 

antivirals from the stockpile. Today, antivirals are on their way to 

Arizona, California, Texas, and Utah. And I would be happy to supply the other schedule for the delivery. But that is the status as 

of this morning. 

We have placed priority on States with confirmed cases of H1N1 

and, of course, along the southwest border. But all States will ultimately get resources, and we intend to have complete delivery by 

May 3, 2009. 

The State Department is also—— 

Chairman LIEBERMAN. Excuse me. That would be complete delivery of the 25 percent. 

Secretary NAPOLITANO. Correct. 

Chairman LIEBERMAN. Not of the full 50 million, right? 

Secretary NAPOLITANO. Correct, Mr. Chairman. 

Chairman LIEBERMAN. Thanks. 

Secretary NAPOLITANO. The State Department also has been involved with the CDC. We have issued travel health alerts and travel warnings for non-essential travel to Mexico, and I anticipate 

those warnings and alerts will be up until the public health officials tell us they no longer need to be. Our actions are being guided 

by science and by what the public health community is telling us. 

In addition, with respect to the Department of Homeland Security, we are moving forward in accord with planning and frameworks that have been worked on for several years. At the land 

ports and at the airports, Customs and Border Protection (CBP) is 

monitoring incoming travelers for possible H1N1 flu symptoms. 

Those who appear sick are put in separate rooms to be evaluated 

by health officials. 

7 

TSA also has protocols, similar protocols for air travelers who appear ill, and the Coast Guard is working with shipping companies 

with respect to possibly ill crew members. 

The Travelers Health Advisory Notices made by the CDC tell 

travelers about the H1N1 flu, what to do if they have symptoms, 

and CBP is distributing tear sheets, cards, at the land ports and 

to those coming in on planes from Canada and Mexico. We are also 

distributing materials to passengers on cruises that stopped in 

Mexico, and, of course, TSA is posting all of this information at airport checkpoints. 

The actions at the border are consistent with and match the recommendations of the CDC and the World Health Organization, and 

here I want to pause a moment. There has been some question 

raised about closing the borders. First, the actual statutory authority is not with respect to closing an entire border. It is with respect 

to closing a particular port or series of ports. But I think as Dr. 

Schuchat will explain in greater detail, making such a closure right 

now has not been merited by the facts. It would have very little 

marginal benefit in terms of containing the actual outbreak of virus 

within our own country. 

As I mentioned, our coordination with State and local partners 

is very robust. We are also coordinating with our international 

partners and with the private sector. I have been in phone contact 

with the governors of many of the States, and I will be making another series of calls this afternoon. I have spoken with my direct 

counterparts in Mexico and Canada. We have adopted in many respects a tri-national approach to this because the virus itself does 

not know when to stop at a border or not. And the Private Sector 

Office and the Infrastructure Protection Office of the Department 

are working with the private sector informing them that it is time 

to dust off their pandemic flu plans, if they have not exercised 

them, to get them ready and to focus on business continuity planning as we move forward. 

Within the Department, we are working to prepare the health of 

our own employees. We are pre-positioning antivirals as well as 

personal protective equipment in case those are needed. And we 

continue our operations in full force. 

Let me conclude with this: Every American has a responsibility 

here with this outbreak. Every community has a responsibility to 

work on and get the word out about preparedness. Obviously, our 

thoughts, prayers, and sympathies go out to the families already 

affected by this H1N1 virus, but our goal is to make sure that the 

country is prepared, that we respond with alacrity and with efficiency to the current outbreak. 

Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thanks, Madam Secretary, for an excellent opening statement. 

Dr. Schuchat, thanks to you and your colleagues at CDC for your 

service all the time, but really for your very impressive ability to 

communicate facts to the American public at this time, which is 

most important. Please proceed. 

8 

1The prepared statement of Dr. Schuchat appears in the Appendix on page 167. 

TESTIMONY OF ANNE SCHUCHAT, M.D.,1 INTERIM DEPUTY DIRECTOR FOR SCIENCE AND PUBLIC HEALTH PROGRAM, 

CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Dr. SCHUCHAT. Thank you. Good morning, Chairman Lieberman, 

Ranking Member Collins, and other distinguished Members of the 

Committee. I am Dr. Anne Schuchat, the Acting Deputy Director 

for CDC’s Science and Public Health Program. I appreciate the opportunity to join the Secretary and to tell you about the current 

steps of what is going on and what we are doing about it. Our 

hearts go out to the people of the communities in the United 

States, in Mexico, and around the world who are coping with this 

challenge, and I think all of us this morning are thinking of the 

family in Texas who did lose a loved one. 

People are concerned, and we are concerned as well. We are responding aggressively at the Federal, State, and local levels to understand the complexities of this outbreak and to implement control measures. Our aggressive actions are possible in many respects 

because of the investments and the support of the Congress and 

the hard work of State and local health officials at the front line 

across the country. 

Flu viruses are extremely unpredictable, making it hard to anticipate the course that this outbreak will have with any certainty. 

We do expect increases in the number of cases, the number of 

States that are affected, and the severity of illness. And during this 

uncertainty we hope that we can remain clear in communicating 

what we do know, what we are doing to protect the health of Americans, and help Americans understand the steps that each one of 

us can take to protect ourselves, our families, and our communities. 

Influenza arises from a variety of sources, and in this case, we 

have determined that there is a novel 2009 H1N1 virus that is circulating both in the United States and Mexico that contains genetic 

pieces from four different virus sources. Additional testing is underway on this virus, including the complete genetic sequencing. 

CDC has determined that this virus is contagious. It is spreading 

from human to human, similar to seasonal influenza, likely 

through coughing and sneezing. Sometimes people may become infected by touching something with the flu virus on it and then 

touching their mouth or nose. But there is no evidence to suggest 

that this virus has been found in swine in the United States, and 

there have been no illnesses attributed to handling or consuming 

pork. There is no evidence that you can get this new influenza from 

eating pork or pork products. 

I want to reiterate that as we look more intensively for cases, we 

are finding more cases. We fully expect to see not only more cases, 

but also potentially greater severity of illness. The specific numbers 

are really less important in understanding the outbreak than the 

more general patterns that we use to help guide our interventions. 

Aggressive actions are being taken. They are being taken here 

and around the world. We are working very closely with State and 

local public health officials in the United States on the investigation to implement control measures. We are providing both techVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000016 Fmt 06633 Sfmt 06633 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
9 

nical support on the epidemiology as well as the laboratory support 

for confirming cases. We are also working with the World Health 

Organization, the Pan American Health Organization, and the governments of Mexico and Canada on really understanding and responding to this outbreak. 

There is a tri-national team that is working in Mexico, including 

members from CDC, to better understand the outbreak and enhance survival and lab capacity so that we can answer critical 

questions, such as why the cases in Mexico appear to be more severe than the initial ones that were seen in the United States. We 

are working closely with Secretary Napolitano and other Federal 

partners to ensure that our efforts are coordinated and effective. 

CDC has issued numerous health advisories for individuals, 

health care practitioners, schools, and communities, and these continue to evolve as our understanding of the situation changes. On 

Monday, CDC issued a travel health warning for Mexico, recommending that travelers defer non-essential travel to Mexico. We are 

also evaluating information from other countries and will update 

travel notices as necessary. 

But, as always, people with flu or flu-like symptoms should stay 

home and not attempt to travel. In fact, a key message from us is 

that there is a role for everyone to play in this outbreak. At the 

individual level, it is important to understand how each one of us 

can help prevent respiratory infections. Frequent hand washing is 

effective to reduce transmission of disease. If you are sick, stay 

home. If your kids are sick, have a fever and flu-like illness, they 

should not go to school. And if you are ill, you should not get on 

an airplane or public transport to travel. So taking personal responsibility for these things will help reduce the spread of this new 

virus, just as it helps reduce the spread of other respiratory illnesses. 

It is important for people to think ahead about what each one of 

us would do if this outbreak deepens in our own communities. 

Communities, businesses, schools, and local governments should 

plan now for what to do if cases appear where you live or work. 

For example, parents should prepare for what they would do if 

faced with a temporary school closure. Do you have all your plans 

in place? 

We also have issued additional community guidance to clinicians, 

laboratory workers, and other public health officials so that they 

know what they should do if they see cases in their community. All 

of these specific recommendations, as well as other regular updates, are on our website—www.cdc.gov. 

CDC maintains the Nation’s Strategic National Stockpile of 

medications for the eventuality that they may be needed in a situation such as we face. As part of the pandemic preparedness efforts 

that the Senator was speaking about, the U.S. Government purchased extensive supplies of antiviral drugs, and our preliminary 

testing is reassuring that the virus that is circulating can be treated with the drugs in our stockpile. That is a really good thing. 

We have released one quarter of the States’ share of the antiviral 

drugs and personal protective equipment to help States prepare to 

respond to the outbreak. We also, working with the Food and Drug 

Administration (FDA), have achieved an emergency use authority 

10 

to facilitate the effective use of some of these materials. Distribution has begun, starting with the States where we already have 

confirmed cases, and the Department of Defense and individual 

States have also stockpiled these antiviral drugs. 

Whenever we see a novel strain of influenza, CDC begins work 

toward the development of a vaccine in case one needs to be produced. CDC worked to develop what we call a ‘‘vaccine seed strain’’ 

that is specific to this novel virus, which is the first step in vaccine 

manufacturing. We have initiated steps so that, should we need to 

make a vaccine as a government, we can work towards that goal 

very quickly. Rapid progress will be possible through the combined 

efforts of CDC, the National Institutes of Health (NIH), FDA, 

BARDA, and, of course, the manufacturing community. 

Finally, it is important to recognize and acknowledge that with 

the strong support of the Congress, there have been enormous efforts in the United States to prepare for this kind of outbreak and 

to prepare really for pandemics in general. Our detection of this 

strain in the United States came as a result of that investment. 

Our enhanced surveillance and laboratory capacity are critical now 

in understanding and mitigating this threat. While we must remain vigilant throughout this and subsequent outbreaks, it is important to note that at no time in our Nation’s history have we 

been as well prepared as we are today. 

As we face the challenges in the weeks ahead, we look forward 

to working closely with Congress to best address the evolving situation, and I look forward to answering your questions. 

Chairman LIEBERMAN. Thanks very much, Dr. Schuchat. That 

was very helpful. I appreciate what you have said and I agree with 

you, though, that we are fighting a serious public health challenge, 

and we do not know now exactly what path it will follow. I want 

to paraphrase what you said. At no time in our Nation’s history 

have we been better prepared to deal with exactly this kind of crisis, and I appreciate what all of you at CDC do to put us in that 

position. 

We are going to have 7-minute rounds of questions for each Senator, and I will begin now. 

Let me ask you a few of the medical questions. You are right, we 

are fortunate to have 50 million—‘‘doses,’’ is that the right term? 

Dr. SCHUCHAT. It is actually ‘‘courses.’’ 

Chairman LIEBERMAN. ‘‘Courses,’’ right, of treatment. 

Dr. SCHUCHAT. Yes. 

Chairman LIEBERMAN. Of two drugs, I gather: Tamiflu® and 

Relenza®, both of which have been found to be effective, and this 

is treating swine flu if it occurs. 

Do you think now that the 50 million courses are adequate to the 

need? And if not, what should we be doing, both on your end and 

on ours, to finance an increase of that inventory? 

Dr. SCHUCHAT. The estimates of how much was needed for the 

Strategic National Stockpile involved a mixture of Federal and 

State responsibilities, and our planning assumptions were to make 

sure that we had enough antiviral medications to treat 25 percent 

of the population. Among our 50 million courses, there are 6 million that are designated for strategic priorities, things like containment, should that have been possible. And I think we are re-evaluVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000018 Fmt 06633 Sfmt 06633 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
11 

ating the issue of whether additional antivirals may be needed in 

the future. We are so fortunate that we made those investments 

and that, with the coordination and planning, we have been able 

to deploy the 25-percent portion of the assets. We do not really 

know if we are going to need to use large numbers of them, but 

I think we are ready if we do. 

Chairman LIEBERMAN. There is a feeling, in response to some of 

the things that experts like yourself have said, that it is possible 

that the current outbreak will diminish as what we have come to 

call ‘‘flu season’’ ends, but then may pick up again in a much greater way next flu season later this year. Is that accurate? Do we 

know that with a reasonable certainty? Or is it possible that the 

swine flu will just keep on expanding and going further? 

Dr. SCHUCHAT. Unfortunately it is very unpredictable. Seasonal 

flu has a fairly clear season and really goes away in our summer 

months. And in pandemics that have been studied in the past, 

sometimes there have been second waves—one spring, and then a 

second wave the next fall or winter. So we do not know what pattern we will see, whether cases will continue to increase or whether 

there will be a decline. 

What we would like to communicate is that if we do see a decline, that does not necessarily mean we are out of the woods. We 

need to be planning and preparing for an eventual recurrence, and 

that is part of the thinking involved with the vaccine discussions 

that we are having right now. 

Chairman LIEBERMAN. Right. And, again, I am sure the public 

understands this. We are talking about two things: We are talking 

about the antivirals, which are a treatment for people who come 

down with swine flu; and then we are talking about trying in a 

really aggressive schedule to develop a vaccine which hopefully 

would prevent the flu from spreading. 

Dr. SCHUCHAT. Yes, that is right, Senator. The antiviral drugs or 

medicines, like Tamiflu® and Relenza®, can treat an influenza illness. We have influenza vaccines that we use every year to treat 

the seasonal flu, and we are discussing, across government and the 

scientific community, the issue of developing a vaccine specific to 

this new influenza virus that has been detected. 

Chairman LIEBERMAN. I know that President Obama has requested an additional $1.5 billion to be prepared to deal with this. 

I presume that a good amount of that money is meant to be available for either acquiring more antiviral courses and investing in 

the development of the vaccine for the next flu season. Is that 

right, Secretary? 

Secretary NAPOLITANO. Yes, Mr. Chairman. And I think it is a 

rough estimate, and we just wanted to have a pool of money, as it 

were, that could be drawn down quickly. 

Chairman LIEBERMAN. Let me ask you now one of the questions 

that my constituents at least asked me, which you touched on in 

your opening statement, which is this: Since this swine flu outbreak began in Mexico, and a lot of the stories we are hearing in 

the media about people who seem to have it, including now some 

suspected cases in Connecticut, more often than not—certainly in 

a disproportionate number of cases—involve people who visited 

Mexico or had some contact with somebody who did. Why not, 

12 

within the terms that you described statutorily, close the border, 

and both ways, both people coming from Mexico to here or Americans—in other words, why not just say no, you cannot go to Mexico 

from the United States for some period of time, not just have a 

travel advisory? 

Secretary NAPOLITANO. Well, I am going to ask Dr. Schuchat to 

respond because we have been taking our guidance there from the 

public health community as to when the facts merit actually closing a port. What is the best thing to do for the safety of the American populace? 

Chairman LIEBERMAN. Dr. Schuchat, go ahead. 

Dr. SCHUCHAT. Thank you. This is a reasonable question that 

people are asking, and we want to make sure we get clear information out. 

There has been a formal policy analysis of this issue, including 

analysis with infectious disease modeling, and the estimates are 

that in 2007 this effort was carried out. 

Chairman LIEBERMAN. OK. Was this done now or previously? 

Dr. SCHUCHAT. And there have, of course, been updates as new 

information comes along, with just that idea of whether it would 

be effective to try to close or partially close the border. And the estimates were that if there were cases in Canada or Mexico, within 

days the ability to stop that introduction into the United States 

would be gone. 

So what we have been doing is really looking at the epidemiologic patterns, the spread of disease, where it is occurring, and the 

scientific assessment is the most effective strategy right now to 

focus on where we have illness, those families and the communities 

around them, and that it is really not an effective approach to try 

to block things at the border. 

Of course, we have our efforts to suggest to the travelers from 

the United States to defer non-essential trips to Mexico, and we 

have a strong partnership with the Customs and Border Protection 

staff to recognize ill passengers or travelers and deal with them. 

There is a personal responsibility element in all of this in terms 

of when each of us is ill not getting on an airplane or crossing a 

border. In fact, the Director General of the World Health Organization has said, at this point the most effective assets really need to 

be focused elsewhere, and the border is a real diversion. 

Chairman LIEBERMAN. Let me just follow up, because the response from my constituents to the answer that I think I heard you 

give, which is the swine flu is already here so we have to contain 

it here, and closing the border or stopping people from going to 

Mexico or coming from Mexico to here does not help at all. 

Their response to that is, well, the more people who go back and 

forth between Mexico and here, isn’t it more likely that there will 

be more contagion occurring? What do you say to that from a medical point of view? 

Dr. SCHUCHAT. From a medical point of view, I think that is not 

the case. I think it is reasonable for people to be asking that question, but that is where that infectious disease modeling goes on. We 

have infectious cases or confirmed cases in many communities in 

the United States, so the probability of exposure from someone who 

has no contact with Mexico is also an important issue right now. 

13 

So I think it is reasonable that they are asking, but we do not 

think that is a good strategy. 

Chairman LIEBERMAN. OK. I am sure that others on the Committee will want to continue this discussion. Thank you. 

Senator COLLINS. I will continue it. 

Chairman LIEBERMAN. Senator Collins, it is all yours. 

Senator COLLINS. Madam Secretary, you have explained, as has 

the doctor, why you do not think the border with Mexico should be 

closed, but there are other steps that could be taken to enhance the 

screening at the border. 

Now, last year, Customs and Border Protection inspected almost 

400 million travelers coming across our borders, so we are talking 

about a very high volume. And as I understand it, DHS has instructed the border officials to use passive surveillance at our ports 

of entry to try to identify individuals who could have symptoms of 

the flu. But other countries are being far more aggressive in their 

screening. Singapore, Thailand, Japan, Indonesia, South Korea, 

and the Philippines are all using thermal scanners. Those were 

also used during the SARS crisis in 2003 at airports, and as I understand it, these scanners are able to detect if a passenger has a 

fever, and the person can be set aside. 

Now, I heard you on television say that you did not think the 

technology was good enough, but, in fact, we have half a dozen 

countries who are employing that. It seems to me that there are 

steps that could be taken to strengthen the screening at the border 

if closing the border is neither practical nor called for, according to 

the public health assessment. Why aren’t we doing more to try to 

screen? 

Secretary NAPOLITANO. Senator, thank you. Actually, the term 

‘‘passive surveillance’’ is really not an accurate depiction of what is 

going on. What our CBP officers are doing is actively monitoring 

travelers that are attempting to cross the border, asking for those 

who appear ill, asking questions about whether they are ill, their 

travel history and the like. And there is a protocol that is in place 

for how that is done. We take our guidance, as I said before, from 

the public health officials as to what steps really would work and 

would be effective. 

With respect to the thermal scanners, they are not always accurate. They are not always as precise as one would wish. But, in addition, you have travelers who actually have the flu who do not 

have a temperature. So they do not really help you sift out travelers who are ill from those who are not. And so the recommendation to us has been that would not be a particularly useful technology. I do not know if Dr. Schuchat has anything to add there. 

Dr. SCHUCHAT. Yes, that is exactly right. Some countries are 

doing this now, and, of course, during the SARS experience, this 

was done quite a bit. The science right now really does not hold 

that up. I was personally scanned many times during the SARS 

issue when I was in China, but I think that we are really trying 

to follow the science here. 

Senator COLLINS. I guess my concern is that even if that technology is not perfect, even if individuals who have the flu do not 

necessarily have a fever at the early stages, it seems to me using 

technology to try to identify some of the individuals would make 

14 

sense. And if you have six other countries doing it, then clearly 

there must be some value in identifying individuals who have fevers, since that is a common symptom, who could be set aside for 

additional screening. It just strikes me that—and maybe ‘‘passive’’ 

is the wrong term, as the Secretary suggests, but, in fact, the reports that we are getting is that the volume is such that it is very 

difficult for officials at the border who are not medically trained, 

after all, to do this kind of selection process or surveillance. 

Dr. SCHUCHAT. I just want to make sure that I am clear. We are 

looking at the pattern of illness that we have here in the United 

States and the many places within our own borders where there 

are now laboratory-confirmed cases and what that tells us about 

our risk within the United States. And I think much of our attention comes from previous outbreaks and modeling and suggests 

that the focus is really in looking aggressively for cases here in the 

United States, responding in our own communities. 

And so I think it is understandable for there to be questions 

about this, and the issues in countries that have not yet seen cases 

may be quite different. But here in the United States we are really 

focusing on what we can do within our own communities where we 

have several States with active cases. 

Senator COLLINS. Doctor, let me ask you a more fundamental 

question. I believe that most Americans would be surprised to 

learn that 36,000 people every year die from the regular seasonal 

flu and that regular seasonal flu produces some 200,000 hospitalizations. Those statistics were surprising to me, and I suspect 

that they would be to most Americans. 

What makes this particular strain of flu particularly dangerous 

and alarming? 

Dr. SCHUCHAT. This situation that we are experiencing now reminds us that seasonal flu is a bad thing also—as you say, the 

36,000 estimated deaths—and we make intense efforts to try to 

protect people from seasonal flu. The difference right now is that 

we are dealing with a novel virus. We do not know yet all of the 

characteristics of how it will behave in human populations, but we 

know that it is a virus that has not been around before, that we 

have not seen immunologically. So what we think is that the general population does not have immunity to this virus. 

With seasonal flu, a good proportion of the population has some 

immunity because of the viruses that circulate every year, and one 

of the risks for future pandemic potential is a new virus that there 

really is not widespread population immunity to. 

We are trying to understand now whether some people who are 

older seniors might actually have some protection, some natural 

immunity against this particular virus because perhaps it is close 

enough to things that were circulating a long time ago. But we 

really worry about that novel strain that is not like the circulating 

seasonal flu strains. 

Senator COLLINS. Thank you. Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thanks very much. Senator McCain. 

OPENING STATEMENT OF SENATOR MCCAIN 

Senator MCCAIN. Thank you, Mr. Chairman, and again, I want 

to thank Secretary Napolitano and Dr. Schuchat also for doing a 

15 

fine job in keeping the American people informed, coming here and 

testifying, appearing on national television. This is something that 

really has Americans deeply concerned, and understandably so. 

Thank you for your continued communication with the American 

people. 

Madam Secretary, if we close the border with Mexico—obviously 

you have the responsibility to make that recommendation. I would 

imagine it would be a presidential decision. And you said that conditions right now do not warrant the closure of the border. What 

conditions would warrant that you recommend that the border between the U.S. and Mexico be closed? 

Secretary NAPOLITANO. Well, if the CDC told us that closing the 

border would have a significant impact on the prevention of disease 

within our country, I think that would be a highly relevant factor. 

But the analysis has been that closing ports, closing the border, 

would not have that kind of preventive impact at this stage. 

Dr. SCHUCHAT. And I would actually like to add to that. Some 

of the planning that we have been doing over the years past had 

the primary assumption that a new strain of influenza was going 

to come from very far away. We were worried about the H5N1 bird 

flu strain of influenza, and we wondered, if we see illness in a very 

distant place, what should be our posture. 

Senator MCCAIN. But I say with some respect, Dr. Schuchat— 

and I do not have much time—if we are not going to close the border because the conditions do not warrant it, what conditions do 

warrant the closure of the border? 

Dr. SCHUCHAT. What I am trying—— 

Senator MCCAIN. Are there any conditions that would exist that 

would? For example, the European Union is just recommending 

that there be no flights from Europe to Mexico. And I would imagine that there will be reciprocal action. 

I think the American people need to know, if we do not have to 

close the border now—and with all due respect, we all know, 

Madam Secretary, that millions of people move back and forth 

across the border on a daily basis. And just observing them, I 

think, is certainly not totally effective, to say the least. What conditions would prevail that would say we need to close the border between the U.S. and Mexico, if any? 

Dr. SCHUCHAT. I do not think there are any. 

Senator MCCAIN. You do not think there are any. I thank you. 

And, by the way, I think it is appropriate, again—as Senator Collins pointed out—36,000 people do tragically die every year from 

the flu that we experience in this country. What do you think the 

percentages are, Dr. Schuchat, the likelihood that it tails off, as 

you said in your prepared statement, during the summer but then 

we find a reoccurrence takes place when flu season begins again? 

Dr. SCHUCHAT. Unfortunately, we really cannot predict exactly 

what is going to happen. There are many things that we will be 

doing to try to understand the probability that there will be another wave. There are issues like looking in the Southern Hemisphere at the pattern of disease that they have. We can also do 

some things to try to understand our population’s immunity. Did 

we already see this new strain go through a lot of the population 

and develop some protection? 

16 

So there has been planning in terms of the research and the epidemiologic studies that could help us better predict. But even with 

all of those, we will not be able to perfectly predict. So our posture 

is to prepare and to be ready if things do get worse. 

Senator MCCAIN. Is it possible, given your experience, to tell me 

your personal prediction? 

Dr. SCHUCHAT. My personal prediction is that I will get in trouble if I make a guess. [Laughter.] 

Senator MCCAIN. Well, that is a good point. 

Madam Secretary, Dr. Schuchat’s point about no conditions warranting closing the border is a very important one. Then if that is 

the case, I really hope that we would pursue vigorously better technological and scientific and, frankly, closer observation of people 

going across the border than is presently the case. And I know that 

we have a huge border with Mexico, and it would be hard to implement immediately. But if the possibility is that we may be in for 

the long term here, as Dr. Schuchat, I think very appropriately, refuses to predict but is a possibility, then we ought to look at ways 

of checking people more carefully as they go across the border between the U.S. and Mexico. 

I know you know that the report of the first death from swine 

flu in the United States just took place in the State of Texas, so 

I think we need to—and I believe you are—maintain a careful balance between not causing panic out there amongst the American 

people, but at the same time making them aware of the implications of this threat, much of which is really not totally known to 

us. But we have experienced SARS and other viruses in the past 

and have been able to gain some control. 

Does the present vaccine, Dr. Schuchat, that a lot of Americans 

routinely get have any beneficial effect on H1N1? 

Dr. SCHUCHAT. Based on the studies that have been done so far 

of this new virus, we do not expect there to be protection. There 

are some additional things that we are looking at to understand 

whether our pessimistic prediction might be wrong and, in particular, looking at serum from certain populations to understand 

whether there might be any cross-protection. But based on the laboratory testing that has been done so far, we do not expect there 

to be any cross-protection. 

Senator MCCAIN. In a best-case scenario, how long would it take 

us to discover and develop a vaccine that would combat H1N1? 

Dr. SCHUCHAT. There are active efforts right now. At CDC our 

role is to develop the vaccine strain that is handed off to industry. 

The steps after that would be pilot lot developments by manufacturing and studies really undertaken by NIH and FDA to make 

sure that we know how to administer the vaccine, the dosing, and 

whether or not you need what is called an adjuvant to increase the 

immune response. 

If everything goes well, production could lead to availability as 

early as September, but, of course, with influenza vaccine production, or even seasonal flu, everything does not always go great 

smoothly. 

So there are lots of entities meeting and taking steps to aggressively move forward and being ready to produce a vaccine should 

17 

we need to. But even with the best case and decisions made quite 

promptly, we would not have product until the fall. 

Senator MCCAIN. Madam Secretary, I hope you will keep revisiting this issue of whether we need to close the border or not. 

I thank you, Mr. Chairman. I thank you all for your fine work. 

Chairman LIEBERMAN. Thanks, Senator McCain. I must say I did 

not come here this morning feeling—and I still do not—that we 

have to close the border with Mexico. But I am surprised at your 

answer, Dr. Schuchat. In the second round, I will ask you more 

questions about it, that you cannot foresee a circumstance in which 

we would possibly want to do that. My own feeling—I am not a 

doctor, to say the obvious—is if we can contain the spread of the 

flu here, one thing we might want to do, just as the Mexican Government is thinking about, is stopping public gatherings, even in 

the worst case, closing down parts of the business sector in Mexico 

City because they do not want it to be communicated. There is a 

kind of common sense that says, well, if it reaches that point, don’t 

we want to avoid increasing the probability of contagion, even for 

a temporary period of time? I understand there would be horrendous economic and personal effects of this on both sides of the U.S.- 

Mexican border. And, of course, this death that occurred today in 

Texas, this child apparently went from Mexico to Texas. So presumably there was some connection there. 

Secretary NAPOLITANO. Mr. Chairman, first of all, you are right, 

and this situation keeps changing. For example, the CDC is going 

to announce that four other States now have confirmed contagion: 

Arizona, Nevada, Massachusetts, and Michigan. They are going to 

announce now 91 confirmed cases. We cannot anticipate that those 

sorts of reports now are going to continue. But the decisions about 

closure of events, closing a school, not having a meeting, that sort 

of thing, those primarily are generated at the local level based on 

the circumstance and environment at the local level. 

That is why it is so important that we work with cities and 

States in terms of their own implementation of their criteria for 

when they would close or not close. And, again, it needs to be informed by the size, the extent of contagion, and what you can prevent by making a closure. 

Returning to Senator McCain’s question, obviously we will watch 

those ports of entry very closely, and I will be happy to share with 

you the protocols that have been given to our CBP officers of what 

exactly they are supposed to be doing at the ports. 

Chairman LIEBERMAN. Thanks, Secretary. I just hope that—and 

I understand, Dr. Schuchat, you are not a political person. You are 

giving your best medical advice, and we ought to give it respect. 

But I hope we will keep open, as we watch the course of this disease, the possibility that we might want for some period of time to 

close some of the ports of entry between Mexico and the United 

States, and if not that, then to greatly ramp up the kind of review 

of people going back and forth that we are doing at this point. But 

I am delaying my colleagues, and I thank you for the responses. 

Senator Tester, you are next. 

18 

OPENING STATEMENT OF SENATOR TESTER 

Senator TESTER. Thank you, Mr. Chairman, and I want to thank 

both participants here today for their information. It is good stuff. 

And I think that we do have a serious problem that we face, and 

I think it is partially because of your good work and your leadership that this will be minimized as much as possible. I think so far 

the response in the country has been good from your end and from 

the local level and everywhere in between, and I think it is good 

news when all parts of government step up to the plate and really 

do their job, potentially to rethink their flu response plans and 

things like that. That is good news. 

I think that the best news is, as I think we all recognize, that 

there are still some gaps. There are still some things we need to 

iron out. I come from a frontier community in a very rural State 

with a border of 545 miles with Canada in this particular case, 

with many ports of entry between Canada and Montana, and I 

think we all realize how important those ports are. We all understand how important trade is. And we also understand how serious 

this potentially could be as it starts to unfold. But we need to make 

sure we take the right precautionary trail as we go forth here. 

Some have said we need to close the border. We have heard 

today that potentially is an option until this blows over. I tend to 

agree with the good doctor. I think that we need to let science lead 

the way here and make reasonable decisions, rational decisions 

based on sound science, mainly because we already have some confirmed cases here in the United States and we see how it is starting to expand throughout the United States, with four more today. 

Secretary Napolitano, you talked in your opening remarks about 

what is going on on the border right now from a perspective of the 

cars and trucks coming across the line, that you—let me see. How 

did you put it? You were monitoring, and the folks who look sick, 

you are pulling them in. What exactly do you do after that? Are 

they looked at by a medical doctor? What transpires then? 

Secretary NAPOLITANO. Yes, Senator, they are put in an isolation 

room, basically, and some of our ports have a public health official 

right there. Other times, they have to call and have one brought 

over to examine the individual. 

Senator TESTER. So how quickly could they know if these folks 

have some other kind of flu or this kind of flu? 

Secretary NAPOLITANO. Well, fairly quickly. I mean, I think the 

longest wait we have had to date has been 2 hours. 

Senator TESTER. What is the incubation period for this, do you 

know? That is maybe directed at the doctor. 

Dr. SCHUCHAT. This is a novel virus, so we are beginning to characterize the incubation period. And from the information we have 

so far, it looks to be between 2 and 5 days. 

Senator TESTER. OK. 

Dr. SCHUCHAT. But that is changing as we get more information. 

Senator TESTER. In many of the rural States around this country, 

we have critical access hospitals that have fewer than 25 beds. Oftentimes, there is a nursing home attached to them. Although I 

have heard that this attacks healthy adults, we see the first confirmed death is an infant, a 2-year-old. What are you recommending critical access hospitals that have nursing homes attached 

19 

to them do to help stop the spread of a potential contaminant coming in, a person, to the elderly population that might be living in 

those nursing homes? 

Dr. SCHUCHAT. CDC has been issuing many new guidance documents and pushing them out to the clinical community—the doctors and nurses, the laboratories, and hospital workers—so that 

they know about infection control practices—the kinds of ‘‘droplet 

precautions’’ is sort of one of the terms we use; the things about 

how to diagnose cases, making sure that patients are isolated, that 

they will not be in a room with someone else and able to spread. 

But what we are also doing is making sure that we do not get 

dogmatic, that we learn from what we are seeing, and that we update recommendations when guidance needs to be changed because 

of the events that we observe. 

Senator TESTER. Can you tell me, how many confirmed cases are 

there in Canada? I do not know that I have read that. 

Dr. SCHUCHAT. Unfortunately, I do not have Canada’s counts myself today. 

Secretary NAPOLITANO. The last I heard was several, some were 

in Nova Scotia and some were in British Columbia. So they were 

spread out. 

Senator TESTER. All around the country. Do you have the ability 

to—CDC or do others have the ability to—my guess is if you get 

a group of folks that get sick, it could become bigger pretty quick. 

So it could affect communities, a certain community much greater 

than 150 or 200 miles away in a State. Are there agreements to 

be able to transfer medical personnel between hospitals or States 

to make sure we have the medical personnel that can meet the 

need? 

Dr. SCHUCHAT. There are some of those agreements. In fact, during the SARS epidemic in Canada, there were American doctors 

that went and helped them. State to State, we also have those 

kinds of approaches. 

Senator TESTER. Who is ‘‘we’’? Is that done at the local level, or 

is that done at your level? 

Dr. SCHUCHAT. Well, no, I think it is more at the State level. But 

the issue that is important to realize, though, in our pandemic 

planning we really had to recognize that the way pandemics of influenza unfold, many communities may be affected, and so few 

places are likely to want to spare their professional staff because 

they may be just around the corner. So this is where our guidance 

helps clinicians know what to do, even with a reduced workforce. 

In particular, we may see a point in the future where we have 

to have simpler ways to care for people—only the most sick coming 

to the hospital and such. 

Senator TESTER. Do you see any challenges dealing with critical 

access hospitals that are going to over and above what you would 

see in urban areas? And what are they? And how will you deal 

with them? 

Dr. SCHUCHAT. What I would like to say is that we do not know 

whether things will be better or worse in those kinds of communities. It may be that the more remote communities will not have 

the kind of problems that we are seeing in New York City, for instance. But another part—well, there is planning on trying to sort 

20 

out how the Federal Government can enhance what is available at 

the State or local level in terms of the medical surge issues. 

Senator TESTER. Thank you, Mr. Chairman. Thank you both. 

Chairman LIEBERMAN. Thank you, Senator Tester. Good questions. Senator Voinovich. 

OPENING STATEMENT OF SENATOR VOINOVICH 

Senator VOINOVICH. First of all, I would like to thank both of you 

for the quick action that you have taken and trying to walk that 

fine line in terms of making sure people have good information and 

at the same time not be panicked by this. I think that is very important. 

But, also, I think that we should be comforted, because Congress 

and the former Administration understood how important this 

issue of pandemic was, that we do have antiviral drugs available 

to us to respond to the folks that are getting sick. 

Some simple questions that people are asking—this is not swine 

flu. It is H1N1. Is that what we say? And we have a lot of pork 

producers in Ohio that have called me and have said, please clarify 

for the public that they should not stop buying pork, or that countries that are having our pork exported to them should not stop 

having it being exported. They said, ‘‘We are hurting now, so please 

clarify that.’’ So it is H1N1 that we are talking about. 

The other thing is thank you very much for your quick response 

to the situation that we had in Ohio. Because you need the help 

of the local officials so much, are you confident that they have the 

proper protocol in terms of how to identify this and deal with it, 

and then getting into the question of when or not you would, for 

example, close a school? When I was president of the student body 

at Ohio University many years ago, I had to cancel Homecoming 

and Mother’s Weekend, and it was not a lot of fun for me. But we 

decided that we wanted to keep folks from coming into the campus. 

And you are going to have instances, throughout the United States, 

where people are going to take local action, and I think they need 

to know that the folks that are acting locally have been properly 

briefed in terms of just how they ought to handle this situation. 

Could you comment on that? 

Dr. SCHUCHAT. Yes, I can comment on that. We have issued community recommendations about things such as school closures and 

the gatherings that are associated with schools, as well as other 

large gatherings in a community. And what I think is important 

to say is that we have issued guidance that we think is prudent, 

that is relatively aggressive, but that recognizes the role of local 

authorities to modify based on the circumstances on the ground. 

We want to make sure every community has good information, but 

some of the local and State officials have even better information. 

So we are pushing this out to make sure everyone has guidance, 

but that it recognizes the local people may want to do more or even 

less than what we said. 

Senator VOINOVICH. Does the communication, Ms. Napolitano, go 

to the governors and then down through to the counties? Because 

usually in our State, the county health officials and the city health 

officials are the folks that are on the ground? 

21 

Secretary NAPOLITANO. Senator, it is both. It is moving communication out to local public health officials and communication with 

governors and the like. So we are trying to get as much out to the 

relevant decisionmakers as possible. 

Senator VOINOVICH. We have talked about the antiviral. The purpose of that is that somebody has the virus, and the antiviral deals 

with it so they do not get sick and die. The other part of this is 

the issue of vaccines, and millions of Americans have taken flu 

shots, including George and Janet Voinovich, my wife and I. And 

I think that you need to clarify that because you have flu shots 

does not necessarily mean that you are going to be exempt from 

this. Is that correct? 

Dr. SCHUCHAT. That is right. It is great that you have gotten 

your flu shot, and I got mine as well. But that protects against the 

regular flu, the seasonal flu, not against this new virus, this new 

H1N1 strain. 

Senator VOINOVICH. When are you going to be able to tell whether or not folks should be vaccinated for this? And, also, as somebody else, I guess, asked the question, how long do you think it 

would take to develop the vaccine? Is the CDC working with other 

world organizations so you can gather the best experts together to 

come up with this thing on an international basis? 

Dr. SCHUCHAT. Yes, CDC has a role at the beginning in growing 

the virus strain and then handing it off to partners to make the 

product. We are working collaboratively, both here across the U.S. 

Government, the FDA, the NIH, and BARDA is really quite important. And through the World Health Organization, we are involved 

in a global basis. CDC’s influenza experts are part of WHO’s committee that picks the seasonal flu virus strains each year and that 

would also, going forward, advise about a pandemic vaccine if we 

needed to make it. So that is happening. 

In terms of the decision to vaccinate, I am glad that you separated the question of the decision to make a vaccine from the decision to vaccinate. Some people look back to 1976 when we had an 

outbreak of swine flu in New Jersey and, reviewing the government 

response to that, wonder whether there was enough deliberation in 

separating the two ideas. So what I can say is we are working aggressively to make sure that if we need to produce a vaccine, we 

will be able to, and it could be available as soon as September 1, 

2009, if all went well; but that we also are separating that particular decision from a later decision about use of a vaccine in the 

fall or when the vaccine was available. And I think that the best 

scientific minds will be contributing to that decision. 

Senator VOINOVICH. Right, because sometimes the vaccine in 

itself gets people sick, doesn’t it? 

Secretary NAPOLITANO. Senator, yes, and that decision, once 

there is a vaccine, about who to vaccinate and how to do it is not 

an easy one, and it will be informed by the best scientific advice 

we can get. I spent last night reading a book about what happened 

in 1976 with the decisionmaking on the last iteration of swine flu. 

So we can learn from past history in terms of what kind of decisionmaking process we need to go through. 

Senator VOINOVICH. Have you decided yet in terms of who is 

most vulnerable, or is it across all ages? Is it that young people are 

22 

more vulnerable or the older people? Or is it just they are all about 

the same? 

Dr. SCHUCHAT. The information so far suggests that we have not 

been seeing confirmed cases in older populations, but it is early. 

We have teams trying to get better information verified from Mexico, and here in the United States we are looking at the cases we 

have. Our cases have an average age that is quite young, in the 

20s, or teens, not seniors. But we are also prepared to see changes, 

and so we are not able to say yet the highest risk group, but we 

are looking into that. 

Senator VOINOVICH. Thank you. 

Last but not least, I am Ranking Member on the Appropriations 

Committee’s Homeland Security Subcommittee, and I understand 

you have enough money to take care of the situation now, but that 

you are going to be looking for money in the supplemental. Is that 

correct? 

Secretary NAPOLITANO. Senator, the President announced yester- day he was going to seek $1.5 billion, and I think that is a rough 

estimate, and it is gauged on perhaps having to purchase more 

antivirals. 

Senator VOINOVICH. But you have enough money right now to 

hold it over because we do not know when that supplemental will 

be finally—— 

Secretary NAPOLITANO. Yes, sir. 

Senator VOINOVICH. Thanks very much. 

Chairman LIEBERMAN. Thank you, Senator Voinovich. Senator 

Pryor, good morning. 

OPENING STATEMENT OF SENATOR PRYOR 

Senator PRYOR. Thank you, Mr. Chairman. Thank you for doing 

this. 

Let me start with you, Dr. Schuchat, and ask about this particular strain of flu. And it may be too early to know the answer 

to some of these questions, but there is a perception that it is 

worse in Mexico, more lethal in Mexico than it is in the United 

States. Is that a fair perception? Or do we know yet? 

Dr. SCHUCHAT. The initial impression was that confirmed cases 

from Mexico were severe, hospitalized young adults with pneumonia. As the investigation in Mexico expands, apparently they are 

confirming illness in milder circumstances, and so I think we may 

yet find that truly they have a worse problem in terms of severity 

than we do, or that it may have just been the quality of the information early on in terms of where we were looking. 

Senator PRYOR. I do not know how the process works in terms 

of you determining the mortality rate of a particular strain of flu 

virus. How long does that take you? And what factors do you consider? 

Dr. SCHUCHAT. There has been a lot of planning around the severity index for a pandemic. Sort of like categories for hurricanes, 

we have been thinking of categories for pandemics, where a seasonal flu would be a Category 1, and a Category 5 pandemic would 

be a higher mortality situation. 

We are in early days. We are looking at the illness that we see 

and calculating the proportion that is fatal. But until there is a 

23 

larger number of definite cases experienced, we cannot precisely 

say things. 

I can say that we are acting aggressively, implementing these 

community guidance efforts to tamp down transmission, assuming 

that this is a serious situation that we can improve through reduced transmission at the community level. 

Senator PRYOR. And I understand that the flu virus mutates. Is 

it, again, too early to know whether you are seeing the mutations 

in this virus? 

Dr. SCHUCHAT. It is very important that we continue to learn, 

that we not make all of our response efforts based on the first few 

isolates of virus that we tested, because it is possible that the 

strain will change over time. It may become more severe or less severe. It may acquire resistance, which it does not have right now. 

So we are following it, and the laboratory scientists at CDC—24 

hours a day we have shifts working on the specimens that we have, 

really doing a phenomenal job. 

Senator PRYOR. Is the news media helping you in your efforts 

right now? I know there is almost wall-to-wall coverage on this, 

and there is a little bit of a media feeding frenzy. Is that helpful? 

Dr. SCHUCHAT. One of the most important things during an outbreak such as this is clear, accurate, timely communication, and 

the media has a very important role to play. We are committed at 

CDC—and I know the Department of Homeland Security feels the 

same way—to be accessible, to get information out as we know it, 

and the media is our partner in that. So I appreciate the help that 

they have given us in making sure people know what is going on. 

I think they are getting tired of a few of our faces at this point, 

but we really do want to get our information out, and we need 

them. 

Senator PRYOR. Good. Thank you. 

Secretary Napolitano, it is good to see you again. Thank you for 

your public service. I know you are doing great things at DHS already, and now you have this pandemic, or at least this flu episode 

that you are dealing with. So thank you for your service. 

Secretary NAPOLITANO. Thank you, Senator. 

Senator PRYOR. Let me ask you about vaccines and antivirals. I 

am assuming that there has been a lot of preparation on how to 

distribute those around the country. One of the questions I have 

is for the States. When the States receive vaccines and other materials, should they use them on their population, or should they use 

them in a neighboring State that may have a worse situation? 

Secretary NAPOLITANO. Well, there is a robust plan for how 

things like vaccine and antivirals are distributed through the public health community, and on this one, what we are doing is the 

first States that are getting the antivirals are the ones where we 

already have either confirmed cases of disease or along the southwest border. But we are moving things out very quickly, so by next 

week every State will have its proportionate share. And because 

this is a rapidly changing picture and every time we get a new report, there are more States that have either reported suspect cases 

or confirmed cases, every State then will get it distributed within 

its own boundaries, according to its own plan. 

24 

Senator PRYOR. And I know it is way too early to be putting together a lessons learned memo on this, but as early as we are in 

this process, are you already seeing areas where you know we can 

do better next time? 

Secretary NAPOLITANO. Senator, it is awfully early. It has been 

less than a week that we have been at this, although we have been 

at it, it seems, 24 hours a day. But obviously we are keeping track 

of what we are doing, and there will always be lessons learned 

from an episode like this. There are going to be things at the end 

that we say we would do differently, but right now we are kind of 

in it. 

Senator PRYOR. Well, you are both doing great work, and we appreciate you, and I think both of you, as well as Federal agencies 

generally, have done a very good job of keeping the public informed 

and giving realistic assessment of what is going on out there. We 

appreciate it. Thank you very much. 

Secretary NAPOLITANO. Thank you. 

Chairman LIEBERMAN. Thank you very much, Senator Pryor. 

Senator Burris. 

OPENING STATEMENT OF SENATOR BURRIS 

Senator BURRIS. Thank you, Mr. Chairman. I want to add my 

thanks to these two distinguished public servants for their prior 

service and current service and, of course, being right in the middle 

of the firestorm. So you have our congratulations, and we want you 

all to keep up the good work. 

Just prior to coming to the Committee, I was on the phone with 

my public health director from the State of Illinois, and we do have 

eight cases that now are suspect. They are now going through the 

testing process, and it is primarily in northern Illinois. So we can 

hope and pray that they are not, but I do not think it looks that 

promising. 

Madam Secretary, I was just concerned about the challenges surrounding this flu and the treatment and the information and how 

you communicate. In the community of Chicago, we have about 30- 

plus languages that have to be spoken, and getting the word out 

in all those different languages will put a strain on the resources 

of the city and the State. And I just wondered if any of those dollars that the President has asked for would be some type of grant 

funds that could go to assist in the overall costs that the States 

and local governments would be experiencing during this situation. 

Secretary NAPOLITANO. Senator, I think that the initial request 

from the President is rather general, and we are working now on 

how to sculpt it to be best used as we go through this epidemic. 

So that will be one of the ideas that we will take back. 

Senator BURRIS. Please do because budgets are already in bad 

shape in the cities and State government. I know mine are operating at major deficits, and these types of crises bring additional 

responsibilities and expenses that have not been budgeted for, 

which means you have to rob Peter again and you will not be able 

to get it from Paul because Paul does not have anything either. So 

keep that in mind that we are going to need some assistance as we 

try to go through the financial part of this. 

25 

Secretary NAPOLITANO. Senator, as a former governor myself, I 

am very sensitive to the fiscal situation of the States and cities in 

the country. And what we want to make sure of is that resources 

are put in the best place to have the greatest impact. And, again, 

all our decisions are going to be based on science and an evaluation 

of what is the most efficacious way to protect the safety of the 

American people. 

Senator BURRIS. I also agree with Senator Voinovich. I have been 

in contact with my pork producers in the great State of Illinois, 

and they are requesting that we come up with some other name 

for this influenza, this virus, because they call it ‘‘swine flu,’’ but 

you always hear the reports saying it has nothing to do with swine. 

And so if that is the case, how do we come up with some other 

name for this? By the way, is it strain A? I thought it was strain 

A. 

Dr. SCHUCHAT. Right, this is influenza A, H1N1, and for the time 

being we are calling it 2009 H1N1 influenza. 

Senator BURRIS. That is not sexy. 

Dr. SCHUCHAT. It really is not catchy, no. But I think I said before you were here that there is no evidence that eating pork or 

pork products is associated with this condition, and we think that 

is an important message to get out, that this is not something that 

you get by eating pork. 

Senator BURRIS. But has it gotten so in the system that you cannot back it off and come up with some immediate terminology? Because our pork producers are really concerned that people are going 

to stop buying it. And you hear when Japan and some other countries have stopped—I think it was China that said they are not 

taking any American exports of pork. Madam Secretary, is there 

any type of name we can—I know you are not the medical one. Put 

on your legal hat. You were also an Attorney General, right? 

Secretary NAPOLITANO. Yes, I have had many jobs. And in my 

written testimony for this hearing, I just call it ‘‘H1N1,’’ and actually, once you say ‘‘H1N1’’ a few times, it does roll off the tongue. 

But I know I was with the Secretary of the Agriculture and the 

U.S. Trade Representative yesterday, and we were talking about 

our coordinated and joint efforts to get the word out that this is 

not a pork-borne illness and that you cannot get it by eating pork. 

But I think we need to continually send out that message, and I 

know the Secretary of Agriculture is dealing with some countries 

that are using this as a purported reason to restrict imports. 

Senator BURRIS. I want to thank you all. I think that is the end 

of my questions. Thank you all very much. 

Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thank you, Senator Burris. Senator 

Graham, good morning. 

OPENING STATEMENT OF SENATOR GRAHAM 

Senator GRAHAM. Good morning, sir. Can you get this from eating pork? [Laughter.] 

Secretary NAPOLITANO. No. 

Senator GRAHAM. OK. Making sure we are on message here. 

The opportunity to deal with this problem in terms of creating 

a vaccine—maybe by September. Is that right, Dr. Schuchat? Do 

26 

we have the legal protections in place that would encourage the 

pharmaceutical companies to develop a vaccine that fast without 

being sued for trying? 

Secretary NAPOLITANO. Well, Senator, there are several protections in place. There is the Public Readiness and Emergency Preparedness Act at 42 U.S.C. 247d, and you might examine that. But 

that is a statute that is guided by the Secretary of HHS, but designed to provide that sort of protection. That is one of the things 

in place now. 

Senator GRAHAM. Well, from my point of view—and I would assume that most of the Committee would share this—if we are going 

to embark on such a bold project, which it seems like it would be 

smart to do, we need to make sure we have the laws in place that 

think through what happens to those who try to help solve this 

problem. So as you go back and inventory the legal environment, 

if you find gaps or you think you need it to be beefed up in terms 

of providing liability protection for those to help us with this problem, please let this Committee or the appropriate committees 

know. 

Now, let us talk about the worst-case scenario for a moment, 

hoping it never happens, but let us just put it on the table. I guess 

the worst-case scenario would be that in the fall this thing spreads, 

that you have to consider closing the border with Mexico. Would 

that be one of the worst-case scenarios? 

Dr. SCHUCHAT. I would like to clarify my previous remarks when 

we were speaking about closing the border. Going forward, there is 

no circumstance in which I think border closure might have value. 

It was a question of if we had no cases here and the first case was 

someplace far away, a border intervention makes sense. 

Senator GRAHAM. Well, let us talk about that. Let us say that we 

have more cases here, but we have a vaccine that works, but they 

do not have one in Mexico that is not working, and they keep having more cases. We are controlling the ones we have. Why wouldn’t 

you want to consider closing the border there? 

Dr. SCHUCHAT. Just a few comments. I think that populations 

that have extensive disease are likely to be protected going forward. Mexico may be in the best place going forward because this 

thing may have already run through their communities. 

Senator GRAHAM. Do you think that has happened in Mexico, 

that it has run through—— 

Dr. SCHUCHAT. No, I am just saying that if we are talking about 

6 months from now when a vaccine might be available. But this is 

really a global issue and a global problem with global solutions, 

and the World Health Organization has been focusing on the international vaccine questions and development and deployment. For 

us, we expect if we went ahead and made vaccine, it would be 

available by the fall. 

Senator GRAHAM. Well, Madam Secretary, if I may be so bold, I 

could foresee a scenario where Mexico or Canada—one of our 

neighbors that this problem could get worse while it is getting better here, that you would have to take some pretty drastic action. 

Do you have a plan in such a situation? Is there any contemplation 

by the Administration of a plan that would indeed seal the border 

if it was required? 

27 

Secretary NAPOLITANO. We have plans for a number of different 

contingencies and scenarios, but I will tell you, Senator, this situation really changes daily. 

Senator GRAHAM. Right. 

Secretary NAPOLITANO. So we will make decisions informed by 

science and what we think makes sense under—— 

Senator GRAHAM. Yes. I am not suggesting that you need to do 

that and hope we never will. I am just suggesting a lot of criticism 

about Iraq is you always assume the best and never plan for the 

worst. Let us not repeat that. 

We have guest worker programs—I think Senator Chambliss 

mentioned it to you yesterday—where we get a lot of labor in the 

agriculture community coming from Mexico and the H–2A and H– 

2B visa program, and the farmers need the labor. Where do we 

stand in terms of making sure that legal immigrant population 

that is coming in to work here during the summer and the fall— 

what are we doing about that problem when we are going to bring 

a lot of people from Mexico here to work in agriculture? 

Secretary NAPOLITANO. Senator, we really are handling the H– 

2A population the way we are handling travelers in general; that 

is to say, they are monitored to see if they have any signs of disease, asked if they have any signs of disease, and handled in that 

fashion. But, otherwise, they are legal travelers because they have 

visas. So they would come in. 

Senator GRAHAM. Are you doing anything new for that population beyond just what you do at the border for somebody driving 

a car through? 

Secretary NAPOLITANO. Not currently. 

Senator GRAHAM. Do you think it would be wise to look at doing 

something new? 

Secretary NAPOLITANO. Yes. 

Senator GRAHAM. That is fair. Now, if we have to administer immunization to the population as a whole—is that a remote possibility, Dr. Schuchat, in a worst-case scenario event? 

Dr. SCHUCHAT. These are early days to know whether that is the 

type of step we would take. One of the things we try to do in this 

stage is learn as much as we can about who is getting sick and who 

is not, and that can inform who might—— 

Senator GRAHAM. Can you see any reasonable possibility down 

the road based on science where that might be required? 

Dr. SCHUCHAT. Yes, absolutely. There is a reasonable possibility. 

Senator GRAHAM. And you are planning for that, I take it. 

Dr. SCHUCHAT. Absolutely. That is why the past several years we 

have been investing in better manufacturing capacity and new 

technologies and so forth. So certainly the planning cases have 

been whole population, two doses. 

Senator GRAHAM. All right. Now, while we have some legal protections for companies that would help develop the vaccine—you 

have talked about that, Madam Secretary. Look and see if you need 

more. What about the people who would administer the vaccine? 

What about the health care professionals that would be tasked 

under the worst-case scenario to go out and administer this drug 

to the population as a whole? Do we have any liability protection 

for them on the books? 

28 

Dr. SCHUCHAT. I am going to need to get back with you about 

that. I am not aware that is a concern. I think the primary one had 

been about the manufacturers. Remember that if vaccine is delivered in this context, it would be under the Federal Government’s 

authority. 

Senator GRAHAM. The only reason I mention that, being a military lawyer, is we have a requirement you get vaccinated for certain problems in the military, and we had a problem with anthrax, 

and we had mandatory vaccinations, and we had a few cases of 

people that react. Well, they do not have the choice in the military 

because you are part of the military, that is your job. But if we do 

go to a mandatory immunization to the population as a whole like 

we have done in the past, I think we need to really think about 

what exposure the health care professionals have and do something 

about it now while we have the time. 

Thank you both. I think you have done a good job. And the only 

reason I am talking about this is if it gets better that is great. If 

it gets worse, that is not so great. And I can understand how hard 

this is, but we have guest workers coming in through a legal system. We have legal liability that is there, I think, in a limited way, 

and we need to look robustly at the guest worker program, a worstcase scenario to seal the border if you had to, and certainly to look 

at legal protections for those who are going to produce the vaccine 

and administer it, so that if that worst-case situation ever happens, 

we will not be behind the eight ball. 

Secretary NAPOLITANO. Senator, thank you, and I think you are 

right that we have to be planning for the worst and hoping for the 

best. The statute that I referred to does include distributors, program planners, persons who prescribe, administer, or dispense. 

Senator GRAHAM. Great. If you could send me a little memo 

about how detailed that is, what kind of liability protections, I 

would like to talk with you about making sure that is enough and 

improving it if we have to. Thank you. 

Chairman LIEBERMAN. Thanks very much, Senator Graham. 

Secretary I appreciate your answer to Senator Graham’s conditional question about whether you would be open to considering increasing the checks on people coming in from Mexico—guest workers, for instance—with regard to their health, because I think if 

you do not, there will be growing pressure to really close the ports 

of entry. And I understand it is complicated with the number—the 

volume is what, 800,000 to a million a day coming across? Does 

that sound right? 

Secretary NAPOLITANO. I will double check. It is an awful lot. 

Chairman LIEBERMAN. It is an awful lot of people. So the 

thought—because, really, in our minds what we would like to think 

is that everybody would be stopped, and you would take their temperature. You would look at them to see if they are coughing or 

sweating or whatever. And the Mexicans would have the right to 

do that to people going in, if they wanted. So how we go from 

where we are now, which frankly does not sound like much—and 

I know how hard it is—to something that will create a slightly 

more demanding screen for people coming in is, I think, very important to think about, or I believe the pressure will grow to do 

29 

something much more definitive, like closing some of the ports of 

entry. 

Secretary NAPOLITANO. Mr. Chairman, I agree, if we go to an enhanced closing the ports or enhanced every individual gets 

screened protocol, we are going to have to be able to explain because that will cause delays and lines in processing. What is the 

advantage we are getting from that other than symbolism in terms 

of actually preventing disease in our country? And right now what 

the scientists are telling me is, beyond symbolism, we really do not 

get an advantage in terms of spread of disease. But if we go that 

far, we are continually thinking and rethinking this. That is really 

the explanation we are going to have to be prepared to give. 

Chairman LIEBERMAN. Yes, this is a classic of the very hard decisions when you are balancing factors. Obviously, you have to listen 

to the science. And, again, common sense would say if we are trying to stop people from congregating places, which they are doing 

in Mexico already—and, of course, it is starting in places here; a 

couple of schools are closed in Connecticut today because of suspected cases—then there is a natural next step to say, well, maybe 

we should then try to stop mixing of people coming over the border 

for the same reason. 

So you have got to weigh what is the public health benefit from 

that. How much does it cost you to implement such a system? And 

then what are the economic consequences and personal consequences on our country and our neighbors in Mexico? These are 

not easy decisions. But if it spreads, I think we are going to be 

faced with those questions, and I think what you are hearing today 

from Members of the Committee is what we are not only thinking 

but hearing from our constituents. And I think those calls will 

grow louder, and you understand that. 

I want to go to another subject. Talk about tough decisions to 

make. I wanted to ask about both the antivirals and the vaccines. 

Here is a basic sort of uninformed patient’s question about the 

medical consequences. Am I correct in assuming that in the case 

of the infant that died in Texas today, the confirmed death from 

swine flu, and the almost 150 people, maybe more now, in Mexico 

that have died, that was because they were not administered a 

course of the antiviral? In other words, why do some people, apart 

from their own vulnerability—and maybe that is it. Why do some 

people die from this and others seem to get it and go on? 

Dr. SCHUCHAT. Influenza is a virus that can cause severe disease, even the seasonal flu. So each year in the United States, 

about 20,000 young children are hospitalized from flu and between 

50 and 150 do die with just regular seasonal flu. 

I do not have the specific circumstances of the child in terms of 

treatment. We know that antiviral drugs can improve the response, 

but people may die with or without them. But we do think antiviral 

drugs are effective at reducing the risk of bad complications. 

Chairman LIEBERMAN. That helps me to understand it. So if we 

hear that people are dying from the swine flu, it is a result both 

of their own vulnerability and perhaps—although this would be the 

rare or unusual circumstance—the antiviral, if they got it, just did 

not work. Or it was administered too late, for instance. 

Dr. SCHUCHAT. Yes, all of those circumstances are possible. 

30 

Chairman LIEBERMAN. But the probability is if you get the 

antiviral treatment, once you have been confirmed, you are going 

to get better. 

Dr. SCHUCHAT. The prompt treatment increases that probability, 

but for vulnerable hosts, sometimes the medicines are not enough, 

and babies are among those at greatest risk for seasonal flu. 

Chairman LIEBERMAN. So one of the judgments that you are 

making, I assume, is how many more of the antiviral courses do 

we need? We have 50 million. We are giving out a quarter of them 

now. Am I right, you are trying to make some projection and then 

go ahead and purchase them with part of this $1.5 billion the 

President has asked for? 

Dr. SCHUCHAT. Yes, that is right. We are looking into what we 

have on hand and what we may need going out. When we made 

the original estimates of how much to procure in the Strategic National Stockpile, it was really forward thinking in a supply-limited 

environment. If we have time now to produce more for the years 

ahead, there may be some benefit in that, but it is being looked at. 

Chairman LIEBERMAN. So now let me go to the vaccine. Am I correct that a decision has been made that if we can develop a vaccine 

for swine flu, we will definitely make it? 

Dr. SCHUCHAT. I do not believe that decision has been made yet. 

What has been made is that we are taking all the steps necessary, 

if we decide to make a vaccine, to make one. So we have the seed 

strain being looked at both with the traditional egg-based cultures 

and then also with this reverse genetics approach. We have the industry lined up to be partnering with the government. We have 

NIH ready to do the clinical trials that would be needed. But there 

is this phase before you actually go to large-scale production, which 

will define whether or not you are going to, and which kind of vaccine you should make. 

Chairman LIEBERMAN. If you all with your extraordinary capabilities develop a vaccine that works against swine flu, why would 

we not make it? 

Dr. SCHUCHAT. First off, CDC does not actually make the vaccine. We are just one part of the family—— 

Chairman LIEBERMAN. Understood. But you know what I am 

saying. I am asking a public policy question. I assume if we could 

develop it, we would make it. 

Dr. SCHUCHAT. Well, I think we will be learning quite a bit about 

what it is going to take to make one in terms of—we were disappointed originally with the H5N1 vaccine products. You needed 

a huge amount of antigen in order to get a response. If you added 

an adjuvant component, you did not need so much. There is a lot 

of science that will be going on in the next few weeks or months 

that will help us understand what we could expect, how much 

could we make, how much response might it give. 

Some of the influenza virus strains do not grow that well, and 

it is hard to make a vaccine from them. So we do not know. 

Chairman LIEBERMAN. Secretary, do you want to weigh in on 

this? Because I would assume that if we can make it, we will. 

Secretary NAPOLITANO. Well, these are obviously—exactly. And, 

again, I want to just say these decisions need to be informed by 

science. 

31 

Chairman LIEBERMAN. Right. 

Secretary NAPOLITANO. But vaccines are not in and of themselves 

benign, and so they can themselves cause a certain amount of illness and mortality in the population at large. And so one of the 

things that you need to look at is what is the overall benefit of a 

large-scale vaccine program in terms of the severity of this H1N1 

virus versus what you might get from a vaccine. So that just illustrates for you, I think, Mr. Chairman, that there are a lot of factors 

that need to be taken into account. 

Chairman LIEBERMAN. I assume that if we decided to produce a 

vaccine because we found one that worked on swine flu, the aim 

here would be to produce 300 million doses so that we could at 

least have the capacity to administer one to every American? 

Dr. SCHUCHAT. The planning that was done was with that in 

mind, and including who would be among the first to get such a 

vaccine, critical infrastructure, and some other groups. 

Chairman LIEBERMAN. Talk about hard judgments to make. 

Dr. SCHUCHAT. Yes, and we actually did both expert group input 

and also public engagement about what did people value the most, 

those who were most likely to die from an illness, those who would 

keep society going. We got very good input from a series of public 

engagement efforts about that in our planning a couple years ago. 

Chairman LIEBERMAN. Do we have the domestic capacity to 

produce sufficient quantities of vaccine up to the 300 million? 

Dr. SCHUCHAT. The investments in pandemic preparedness that 

Congress made possible have resulted in phenomenal expansion in 

manufacturing capacity so that we are very optimistic going forward about what we can expect. But this virus can surprise us, and 

even with all those investments, it may just technically be difficult. 

Chairman LIEBERMAN. Thank you very much. Senator Collins. 

Senator COLLINS. Thank you, Mr. Chairman. 

Doctor, I want to talk further with you about the vaccine issue 

because the 1976 experience is a real cautionary tale, and I know 

that Secretary Napolitano was saying that she was reading a book 

about it, and I have refreshed my memory about it as well. 

In this case, it turns out that health experts were mistaken 

about the kind of flu—it turned out to be an avian flu, not a swine 

flu—and the CDC Director had urged the President and Congress 

to undertake a mass inoculation program of the population. And 

within a few months, almost 25 percent of the population had received the vaccine, but it was not a very happy result. It turned 

out that the vaccine had serious consequences for some individuals, 

producing a rare neurological disease. Five hundred people contracted the disease as a side effect of the vaccine; 25 of them died. 

What have we learned from that terrible experience? It really 

was a debacle. It caused the head of the CDC at the time his job. 

What have we learned from that experience in 1976 that we can 

apply to the situation today? 

The reason I ask this is for those who were not around in 1976 

or who are too young to remember what happened, there is a tendency to see the vaccine as the magic answer, as the solution. 

Could you talk to us about what lessons CDC has learned that 

would prevent a reoccurrence of what happened in 1976? 

32 

Dr. SCHUCHAT. Thanks for that question. I think that it is humbling going forward to look at the complexity of decisionmaking 

that will be necessary, and I think an important lesson to be 

learned is how important careful deliberation, best case and worst 

case scenarios, looking really at all sides of an issue, will be needed—the health benefits, the health risks, the social benefits and social risks, the economic issues. 

I think that we hope to have—CDC is just part of the story, of 

course, but I think we really hope to be able to step back and make 

decisions carefully amongst the affected groups and to seek wise 

counsel from dissenting views, to really get people to look at things 

from a different perspective. 

I can mention that CDC pretty much routinely, for our emergency responses and also for this one, has a Team B, a group that 

is really not involved in the response but stepping back and looking 

at it and trying to think about issues where we really might not 

be going on the right track or where other perspectives might be 

very useful. 

I think Secretary Napolitano might have some other ideas since 

you refreshed your memory last night. 

Senator COLLINS. Secretary Napolitano. 

Secretary NAPOLITANO. Well, I was a college freshman in 1976, 

so my memory was a little stretched. [Laughter.] 

Senator COLLINS. It really bugs me when our witnesses are 

younger than I am, Mr. Chairman. 

Secretary NAPOLITANO. But, yes, I think the doctor has it right. 

And what we want to do is make sure moving forward that we are 

getting lots of different inputs as we approach what can be some 

very difficult decisions where you are constantly weighing what is 

the benefit to be gained versus the cost. And it is not just the CDC, 

but other members of the academic and scientific community. It is 

members of the private sector who have to give us input about 

what would be the economic impacts of some of our decisions. And 

it really has to be taking into account a myriad of different factors 

in terms of whether you do a universal vaccine program. 

Senator COLLINS. That is the point that I wanted to make. It is 

not an easy decision to decide to do a mass inoculation, and while 

I am sure that the science behind vaccines has improved in the last 

30 years, the experience of 1976 should cause us to proceed with 

caution. And I am confident that you will do that. 

Madam Secretary, I want to turn back to the border issue that 

we discussed earlier. You took some issue with my description of 

the process that CBP is using when I described it as ‘‘passive surveillance,’’ and I think it is important for the record to note that 

is the term that the Department of Homeland Security is using, 

and, indeed, as recently as 2 days ago in a press update, the Department has said that the Customs and Border Protection has 

also implemented passive surveillance protocols. 

Furthermore, in that same document, where there is a frequently 

asked questions part, when the question was asked, ‘‘What steps 

are you taking to prevent those with flu-like symptoms from crossing the border?’’ The response is not very reassuring to me and, indeed, to many other Members, because the response is, ‘‘As part of 

CBP’s routine procedures, if someone is crossing the border appears 

33 

ill, the person is referred to a quarantine station or a local public 

health official.’’ 

We should be going beyond routine procedures given the threat. 

Secretary NAPOLITANO. Senator, first of all, I think your point is 

well taken. We have used the phrase ‘‘passive surveillance.’’ But we 

have also used the phrase ‘‘swine flu.’’ As we go through this over 

these days, we are determining better ways and more precise ways 

to communicate. So ‘‘passive’’ seems to suggest that nobody is doing 

anything, and the answer is they are following a direct protocol to 

examine, to look, to ask questions. 

And when they say ‘‘routine,’’ what they mean to say—what that 

is is that, for example, we are constantly at the border trying to 

check to see whether individuals who may have tuberculosis are 

crossing the border as a problem within Mexico, so that if you see 

somebody present who has signs of illness, coughing and the like, 

they have a travel history in Mexico, particularly certain States 

within Mexico, they can be isolated in a room and examined further, that is the routine. But that is virtually identical to how we 

are dealing with identifying those who may have flu. 

Senator COLLINS. Well, let me tell you why I am so concerned. 

In 2007, our Committee did an investigation of the case of the 

Mexican citizen who crossed 21 times back and forth across the 

border, despite the fact that CDC had identified him as having a 

highly contagious, drug-resistant strain of tuberculosis. So here is 

an individual who has been identified by CDC, and yet Customs 

and Border Protection was still unable to stop him from crossing 

almost two dozen times. 

Now, I have a great deal of respect for how hard the Customs 

and Border Protection officials are working. I also know that they 

are very well meaning and that they are well trained. But if they 

cannot catch an individual who has been specifically identified as 

being a public health threat, whose name they actually have, then 

why should I have any confidence that they are going to be able, 

using just what are described as ‘‘passive surveillance’’ protocols, 

not using electronic scanners or other technology, why should I 

have confidence that they are going to be able to screen for this serious flu, particularly since, as the Chairman mentions, the volume 

of people crossing every day is just enormous? 

Secretary NAPOLITANO. Senator, I think the question you raise is 

the same question in a way that Senator Graham was raising: Are 

there some things that we can do with respect to visa issuance and 

the like that will diminish the possibility of somebody carrying flu 

coming over? And we are open to those ideas and suggestions. But, 

again, the decision to actually close the entire border, which is 

what has been raised—and since we have flu in Canada, I would 

anticipate that the same argument would be made there. So closing 

both borders, with all of the huge impacts that would have, in light 

of the fact that the scientists and the epidemiologists say would 

have virtually no impact on the amount of disease in our country, 

when you balance those things, particularly in light, as you say, of 

the difficulty of knowing whether any individual has disease, and 

when you make that whole package of decisions, you understand 

why closing the border is not an adequate answer to this epidemic. 

34 

Senator COLLINS. I realize my time has long since expired, but 

let me just make very clear: I am not advocating closing the border. 

That is not my position. The only time that would make sense to 

me based on the expert testimony we have had today is if you temporarily close the border in order to allow the distribution of medicine to key areas or perhaps the vaccination of Customs and Border 

Protection officials at the border. Then it might make sense to close 

it for a brief time to allow that to occur. So that is not what I am 

advocating. 

I am advocating for a stepped-up medical presence at the borders. I am advocating for the use of technology, perhaps these scanners that six other countries are using. Even if they are not perfect, 

they are going to catch some of the cases. And I am advocating for 

enhanced, active questioning surveillance techniques. 

So I just want to clarify that I think there are steps that can be 

taken between what we are doing now, which I do not consider to 

be adequate, versus closing the border. There are more effective enhanced methods that could be put in place, and I just urge you to 

consider them, which you have already indicated you are willing to 

do. 

Secretary NAPOLITANO. Absolutely. 

Senator COLLINS. And, again, I do want to applaud you for the 

response. I have talked to bioterrorism experts who say that we are 

doing so much better a job. And as the doctor has made clear, our 

preparedness has grown by leaps and bounds due to the investments that Congress has made, and effective leadership. So I thank 

you for that. 

Secretary NAPOLITANO. Thank you, Senator. 

Chairman LIEBERMAN. Thanks, Senator Collins. 

I echo Senator Collins. I was thinking here at the end, naturally, 

we—Members of the Committee, myself included—pushed you on 

some of the tough questions that are in some sense ahead. That is 

the nature of what we are thinking about and what people are asking us. But I do not want that to diminish our feelings—again, I 

speak for myself here—that this was one of those cases where the 

Federal Government is prepared, that we have a plan, that we 

have a Department that is relatively new but that coordinates 

quite a wide array of the agencies that are directly involved here, 

and in cases where it does not have all that direct expertise, it 

works very closely obviously under your incident management position, Secretary Napolitano, with groups like CDC and now Secretary Sebelius at HHS. 

So I think there is a lot of reason for the American people to feel 

encouraged that the Federal Government is really there on this occasion protecting them. I think you have heard—obviously the 

President has indicated this by his request for $1.5 billion—from 

Senator Voinovich, Ranking Member on the Appropriations Homeland Security Subcommittee, that there is going to be no resistance 

here to providing you and the other departments of our government 

with all the money you need to protect the American people from 

the spread of this disease, which we are rightly taking seriously. 

So I appreciate everything you have done. We are going to, as a 

Committee, stay involved in this. I cannot help but express a certain amount of not only gratitude to you, Secretary Napolitano, but 

35 

pride since this is the Committee from which the Department originated, and I think you have shown us thus far in this crisis why 

it was a good idea to form it, not just in response to September 11, 

2001, but to help our government better manage a host of other 

emergencies, including this kind of public health emergency. 

So we are going to keep the record of the hearing open. I suppose 

I should ask each of you—it is a bit unusual—whether you have 

anything you would like to say in closing. 

Dr. SCHUCHAT. Just that we really appreciate the support that 

Congress has had for preparedness in the past and to help us with 

the situation now. 

Chairman LIEBERMAN. Thank you. 

Secretary NAPOLITANO. I echo that, but also to say that communication here is going to be so important. This is an evolving situation. I was just handed a note that they now have 13 confirmed 

cases in Canada, which I was not able to answer earlier. So every 

half-hour or hour we get a different picture, and my goal is to communicate with the Committee, with the Congress, what we are 

doing, why we are making decisions as we make them, and to communicate the same with the American people. 

Chairman LIEBERMAN. It is very important. We appreciate it a 

lot. Thank you. 

The record will stay open for 15 days for additional questions 

and statements as desired. For now, that is it for this morning. 

Thanks for your time. 

The hearing is adjourned. 

[Whereupon, at 12:12 p.m., the Committee was adjourned.] 

(37) 

H1N1 FLU: PROTECTING OUR COMMUNITY 

MONDAY, SEPTEMBER 21, 2009 

U.S. SENATE, COMMITTEE ON HOMELAND SECURITY AND

GOVERNMENTAL AFFAIRS, Hartford, CT. 

The Committee met, pursuant to notice, at 10 a.m., at the Legislative Office Building, Hearing Room 2E, 300 Capitol Avenue, 

Hartford, Connecticut, Hon. Joseph I. Lieberman, Chairman of the 

Committee, presiding. 

Present: Senator Lieberman. 

OPENING STATEMENT OF SENATOR LIEBERMAN 

Chairman LIEBERMAN. I thank everybody for being here, and I 

particularly thank the witnesses. I particularly want to thank my 

wife, Hadassah, because I rarely have the opportunity to say that. 

She is in attendance today. This speaks to the fact that, like everybody else, she is concerned about the topic of this hearing, which 

is the extent to which we are prepared to deal with an outbreak 

of H1N1, what we used to call swine flu, and a lot of people still 

do. 

This is a field hearing of the Senate Homeland Security and Governmental Affairs Committee. We want to particularly look at Connecticut’s preparedness for a resurgence this year of H1N1 influenza. Some might ask why the Committee on Homeland Security 

and Governmental Affairs is interested in this. 

The Committee on Homeland Security and Governmental Affairs 

was created after September 11, 2001, to organize various agencies 

of our government to do everything we could to make sure that 

there were no gaps, there was no lack of communication, so that 

the vulnerabilities that the terrorists exploited on September 11, 

2001, would not be there—to the best of our ability—in the future, 

but it was also put together to make sure that in a coordinated way 

we could deal with natural disasters. The Federal Emergency Management Agency (FEMA), for instance, is in the Department of 

Homeland Security now. 

The Department of Homeland Security (DHS) is designated 

under Executive Order as the Department that manages incidents 

of national significance. And the President has declared this to be 

an incident of national significance, so Secretary Janet Napolitano 

at the Department of Homeland Security is the lead Federal coordinator of our response, even though you see Secretary Kathleen 

Sebelius of the Department of Health and Human Services (HHS) 

a lot, which is quite understandable because of the nature of this. 

38 

I would also say that one of the things that I have worried about 

in this post-September 11, 2001, age is when we were told by the 

9/11 Commission that one of the reasons September 11, 2001, happened was because of a failure of imagination. And what did they 

mean by a failure of imagination? The failure to imagine that people would actually do what was done to us on September 11, 2001. 

So we spend time—it is not the most pleasant way to spend 

time—trying to imagine what others might do to do damage to us. 

We just had a report come out from the Commission that said that 

in terms of fear of terrorists using a weapon of mass destruction, 

that the most likely weapon would not be everybody’s nightmare 

scenario of a nuclear weapon, but it would probably be a biological 

attack because of the relative ease of taking pathogens and making 

them into biological weapons. 

So, obviously, there is a lot that our intelligence community and 

others, Customs and Border Patrol (CBP), the Transportation Security Administration (TSA), a whole range of others, will do to try 

to prevent such an awful thing from happening to our country. But 

then part of what will be on the line, which will determine the extent to which, God forbid, such an attack ever happened, we can 

both limit its impact and treat those who have been affected by it 

involves much the same kind of work we are doing with our public 

health system and with communications to the public to limit the 

spread of H1N1. 

So in those ways, this hearing falls both directly into the Homeland Security Committee and relates to the antiterrorist work that 

the Homeland Security Department and our Committee does. 

Again, I want to thank the witnesses who are here today. They 

represent a broad range of experts in the field, people with responsibility. And they will help us determine what the nature of this 

flu is now, what the potential is during this flu season, and what 

we all can do together to inhibit the spread. 

We are obviously holding this hearing now because we are at the 

beginning of the flu season, but September also happens to be National Preparedness Month, and it therefore gives me an occasion 

because National Preparedness Month is about what each of us can 

do to secure our country. 

Each of us can contribute in our own communities to inhibiting 

the spread of flu by the way we conduct ourselves, things as simple 

as washing our hands and covering our mouths, not with our hands 

but with our elbows when we sneeze, for instance. The point is that 

preventing the spread of the flu is actually something that every 

individual can and I hope will help with, and this hearing I am 

hopeful will help to spread that message. 

H1N1, as we learned last spring, is a fast spreading disease. It 

was just detected last spring. It reached pandemic proportions, 

worldwide, over the summer, and appears to be making a comeback 

as the traditional flu season begins. 

The Centers for Disease Control and Prevention (CDC) estimated 

a few months ago that a million people in the United States had 

become ill with this flu, and they could imagine that millions more 

likely had been exposed to it since then. We know that 9,000 have 

been hospitalized in our country from the flu; that 593 have died 

from flu-related symptoms. Here in Connecticut, about 2,000 cases 

39 

have been confirmed, and by the records, I have seen that nine people have died from flu-related symptoms. 

I would say that unlike other crises of this kind that we face, fortunately pandemic flu is one, through various means, that we have 

planned for and I think are better prepared for, but not as well as 

we should be. 

In response to global outbreaks in recent years of avian flu, West 

Nile virus, and severe acute respiratory syndrome (SARS), the CDC 

developed a strategy for a coordinated national response to infectious diseases. The Homeland Security Council adopted a national 

strategy for how to respond to pandemic influenza. And with support from the Department of Health and Human Services and the 

DHS in Washington, our States, including Connecticut, have both 

been encouraged, pushed, and enabled to develop plans for addressing pandemic flu. 

Following the spring outbreak, the medical and pharmaceutical 

communities have had time to study the H1N1 virus and, I think 

with remarkable speed, to begin to produce a vaccine; in other 

words, a vaccine to a flu that we just learned about last spring. 

That is the kind of world in which we live. 

I never got to meet my paternal grandmother because she died 

in the flu epidemic of 1918 in New York. Obviously, there was not 

this extraordinary ability we have today to isolate a flu, to figure 

out how to develop a vaccine to it, and here it is now. Agencies at 

all levels of government have gotten advance warning that they 

need to be prepared for the possibility of a more severe strain of 

the virus this fall, even though today, thankfully, that has not happened. 

So today, I am going to ask our witnesses representing State and 

Federal agencies what their H1N1 response plans are and whether 

they are working together or is there anything else we, at the Federal level, can do to address this challenge. I am going to ask our 

witnesses on the second panel from public educational institutions 

and businesses if the government planning has been constructive 

to them and what, if anything else, they are doing and they think 

we might do. 

The good news to report today, perhaps it has already been 

known, is that the Federal Government apparently can begin delivery of the H1N1 vaccine to States as early as the week after next. 

Connecticut is expected to receive approximately a half a million 

doses by mid-October, which will be distributed first to those that 

public health officials believe are most at risk. That would include 

pregnant women, young children, daycare workers, health care and 

emergency medical personnel, and those with certain health conditions that make them more vulnerable to the flu, such as diabetes 

or immune deficiencies. The Federal Government is also providing 

money to States to help prepare for the fall flu season and to administer the vaccine. The Connecticut share of that will be about 

$4 million. 

At this point, the State appears to me—but I want to hear from 

you today—on track to stay out in front of a broad H1N1 outbreak. 

The truth is that we are very fortunate that, thus far, most cases 

of the virus have continued to show the same mild to moderate 

symptoms as we observed last spring, but outbreaks of infectious 

40 

1The prepared statement of Admiral Milner appears in the Appendix on page 197. 

diseases are very hard to predict. That is, the course infectious diseases follow is very hard to predict. So circumstances could still 

change significantly to become more serious over the coming 

months. And look, let’s just be specific; nine people have already 

died in Connecticut from H1N1-related disease. So this was not, of 

course, a mild or moderate disease for them or their families or 

friends. 

Therefore, our responsibility is to stay on heightened alert, to 

continue to take preventive action to work together, to communicate effectively with the public. And, as always, while hoping for 

the best and at this moment being confident of the best, we also 

have to prepare our public health system for the worst, for real demands on it. 

So I thank the witnesses. I hope in sum that we can get a clear 

sense of preparedness for this influenza pandemic here in Connecticut and to see what our Committee and the Congress can do 

to help in the months ahead. 

That is my opening statement. I am now delighted to go to the 

first panel. I think we are going to keep you to 7 minutes. We probably will not eject you forcibly if you have to go over a moment or 

two to convey the message. 

This is a very distinguished panel. The first is Admiral Michael 

Milner, who is the Regional Health Administrator, Region I of the 

U.S. Public Health Service of HHS. 

Admiral Milner, thanks for coming to Hartford to be with us this 

morning. 

TESTIMONY OF REAR ADMIRAL MICHAEL R. MILNER,1 U.S. 

PUBLIC HEALTH SERVICE, REGIONAL HEALTH ADMINISTRATOR, REGION I, U.S. DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Admiral MILNER. Good morning, Chairman Lieberman, and your 

staff. I am Mike Milner, as you said. I am with the U.S. Department of Health and Human Services and the Regional Health Administrator in Boston for HHS. 

I wanted to deviate just a second and tell you how much I know 

personally your involvement. The last time I spoke with you, sir, 

was coming off the USS Iwo Jima in New Orleans, and we were 

having a congressional delegation related to our response to Hurricane Katrina. 

Chairman LIEBERMAN. Yes. We came right down after Hurricane 

Katrina. 

Admiral MILNER. Yes, sir. 

Chairman LIEBERMAN. And thank you for what you did. You are 

the heroes. 

Admiral MILNER. I certainly appreciate your passion for this activity and appreciate the opportunity to be here today to share with 

you what our Federal Government has been doing, what our office 

has been doing, and what our Northeast States have been doing together, and specifically partnering with our Connecticut colleagues 

to prepare for the pandemic 2009 H1N1 influenza. 

41 

By way of background, I thought you should know briefly about 

my role and responsibilities with Health and Human Services as 

the Regional Health Administrator and how I came to be before 

you today. I have served as the senior Federal public health official 

for the six New England States since August 2003 and report to 

the Assistant Secretary for Health, Dr. Howard Koh. 

Additionally, I serve as the senior Federal health official for both 

Regions I and II, HHS, as the health official for the regional coordination team as part of the Department of Homeland Security. You 

know that used to be called the Principal Federal Official Regional 

Program. 

You have already stated broadly the outbreak related to the 2009 

H1N1. It has triggered a worldwide pandemic and it is currently 

the dominant flu strain in the southern hemisphere as it is making 

its way north. The evidence to date shows that the virus has not 

changed to become more deadly. Unlike our typical flu season, we 

continue to see flu activity in the United States, and over the summer, of course, we had a lot of outbreaks in our summer camps 

here in New England. More recently, we have seen an increase in 

the activity in States in the Southeast and beginning to get reports 

of increasing numbers of cases here in New England. 

As the fall comes, we anticipate that our communities will see 

more viral transmission, and we are preparing for that. This particular virus will be difficult to distinguish between seasonal flu 

and H1N1, which adds some complexity for us, and we are working 

together to both message and do the outreach and clinical care that 

will be needed. 

Chairman LIEBERMAN. Let me interrupt and we will not run the 

clock on you. But just as a matter—I know people ask me this. 

How does somebody know if they have H1N1 as opposed to regular flu or seasonal flu or even just sort of a bad cold? 

Admiral MILNER. Well, there are a series of symptoms that we 

associate with influenza that tend to be different from the allergy 

reactions, runny nose, and sneezing that would be associated with 

allergies. The clinical presentation—you have to think about what 

is happening in the community. And so when we know that there 

is an increase of a certain type of infectious disease in a community, our suspicion goes up. 

We have chosen, I think, to limit the amount of testing that we 

do simply because of the fact that the H1N1 seems to have crowded 

out the seasonal flu in the southern hemisphere. And we recognize 

that were we to do clinical testing of every one that comes into an 

emergency room (ER) or into primary care office, it would just completely overwhelm our laboratory capacity. 

Chairman LIEBERMAN. In other words, based on what has happened south of us, where the H1N1 has dominated—I mean, it is 

much more frequent than the regular seasonal flu—we are reaching a judgment that if you show certain symptoms—— 

Admiral MILNER. We will make an assumption clinically that you 

have this particular strain. 

Chairman LIEBERMAN. And begin to treat with antivirals. 

Admiral MILNER. Correct. That prompts your clinical decisionmaking surrounding the care of that particular patient. 

42 

Chairman LIEBERMAN. I have heard different answers to this. 

Maybe there is not a single answer, but are there any symptoms 

that are particularly characteristic of the H1N1 virus or the flu? 

Admiral MILNER. Dr. Carter is our resident epidemiologist, for 

infectious diseases. 

Dr. CARTTER. Good morning, Senator. 

Chairman LIEBERMAN. Good morning, Doctor. 

Dr. CARTTER. A lot of folks keep asking, well, is it just the flu? 

And my response to that is it is and it is not. I mean, for the vast 

majority of us, H1N1 is going to feel just like seasonal flu; sudden 

onset of fever, headache, cough, muscle aches. And you are going 

to be sick for about a week and feel like you have been run over 

by a truck. So it is clearly much different than the common cold. 

But there is no defining feature. What is interesting in this particular pandemic is that many of the younger people, children, also 

have gastrointestinal symptoms, and they have nausea, diarrhea. 

And this is a bit different thing than what we sometimes see with 

seasonal flu. 

Chairman LIEBERMAN. Yes. Anybody else want to add anything? 

If not, go ahead, Admiral. 

Admiral MILNER. Thank you. I am going to try to streamline 

things a bit. 

Chairman LIEBERMAN. No. Do not be rushed. 

Admiral MILNER. I think that the important thing from my perspective is that the Northeast States, the health officials, the emergency managers, communication directors, public health and preparedness directors, and a real array of Federal folks—we have 

CDC project officers, FEMA and Department of Defense planners, 

our Assistant Secretary for Preparedness and Response; we have 

emergency coordinators. All of us are working together, Homeland 

Security and HHS. 

We have been engaged in very aggressive, detailed pandemic 

planning now for a number of years, and we have done it through 

face-to-face meetings. We have done it through active listening 

with our stakeholders, the communities we represent, the hospitals, the physician groups, the business sector, and our critical infrastructure sector. We have listened to their needs and tried to 

identify things that we can do to meet their needs during this kind 

of response. 

We have gone as far as hosting multi-day meetings here in New 

England where all of our folks come together. We had an executive 

communications exercise a few years ago which really expanded 

our awareness of our communication challenges. We had the first 

regional exercise in the Northeast that exercised our FEMA concept of operations in terms of how the Department of Homeland Security, HHS, and FEMA will operate together to support our 

States. 

So from the Federal perspective, we feel like we have been ahead 

of the curve nationally. And I think all of those efforts have really 

centered around our communication strategies from a regional perspective, the interstate and interregional cooperation, and work to 

try to improve our understanding of the scientific guidance as it is 

being identified. And we are then applying it to certain things that 

we do and we implement in terms of mitigation. 

43 

We have tried to see what the ground truth is, and we had a 

good opportunity in the spring to really field test this. Beginning 

April 24, we started—every morning, I was on a conference call 

with our New England State health officers. We talked about the 

ground truth and what they were experiencing and how this virus 

seemed different from what we had been planning for. 

In my perspective of this, in my discussions with colleagues 

around the country, I believe New England and the Northeast was 

the tip of the spear in terms of our response. We were able to at 

7:30 in the morning talk about why school closure guidance was 

not making sense because of the challenges that it presented. And 

later in the morning, we had calls from CDC and we shared the 

ground truth, and later in the day, after that, the guidance begin 

to shift. 

So I really applaud the work of Connecticut and our New England health officers because they really were sharing things that 

helped the Federal Government identify areas that we could improve and modify our guidance. 

So I think the truth is that I have been blessed to be in New 

England, to work here and to live here. And my own personal feeling is if I were to live anywhere with this particular virus looking 

at us, I am glad I am in New England and glad I am in the Northeast. 

The rest of my remarks include information about CDC and the 

money that has been provided for the State of Connecticut. The Assistant Secretary for Preparedness and Response asked for that bit 

of money. But I believe the specific relationships that we have in 

the Northeast, our States, the working relationship we have here 

is very strong, and I am very respectful and very happy that I have 

the opportunity to work with such a great group of public health 

and emergency management leaders here in New England. 

I see this light blinking. It is creating nervousness, so I will 

thank you for what you have done on behalf of the—— 

Chairman LIEBERMAN. Thanks, Admiral Milner. 

Admiral MILNER [continuing]. The Northeast, for all of the resources that you have provided here. I believe this group is excellent stewards of those resources, and I believe that we are on the 

leading edge of this response from a Federal perspective. Thank 

you. 

Chairman LIEBERMAN. Thanks, Admiral Milner. That is very reassuring. I appreciate your testimony. I would just say for the 

record that your full statement, and that of all the other witnesses, 

will be printed in the official transcript of the hearing, and I will 

have some questions for you, based on the testimony you have 

given. 

Second is Dr. Matthew L. Cartter, State Epidemiologist working 

out of the State Department of Public Health. 

Thanks for being here. It is good to see you again. 

44 

1The prepared statement of Dr. Cartter with an attachment appears in the Appendix on page 

204. 

TESTIMONY OF MATTHEW L. CARTTER,1 M.D., STATE EPIDEMIOLOGIST, CONNECTICUT DEPARTMENT OF PUBLIC 

HEALTH 

Dr. CARTTER. Good morning, Senator. Thank you. 

As you pointed out in your remarks earlier, H1N1 has been a 

particular interest of yours since the beginning, and I would like 

to thank you and the other members of our congressional delegation for visiting us here at the State Health Department in the 

spring. For those of us who are working on this issue, it has meant 

a lot to have you there, and we greatly appreciated that. 

Chairman LIEBERMAN. Well, we learned a lot and we thank you. 

Dr. CARTTER. I am here to give you an update on the current status of the influenza pandemic in Connecticut and the plans to distribute the newly licensed H1N1 vaccine to the residents of the 

State. As a preliminary matter, I will defer to my colleague, Commissioner Peter Boynton, on issues relating to planning and preparedness, information sharing and outreach, and collaboration, although both of us will try to answer your questions on those issues. 

I am sure you will have some. 

As you mentioned in your introductory remarks, almost 2,000 

Connecticut residents have tested positive for H1N1 infection, I 

want to point out that is really just the tip of an iceberg, and that 

for every person who has tested, there are many more people who 

became ill, stayed home and got better; they had seen a physician 

and not been tested. So when we see those numbers, people should 

not think that there are only 2,000 people that became ill; there 

were many more than that that became ill during that period. 

Most of those folks who tested positive actually tested positive 

back in May, early on, because their focus was to determine where 

is this virus and is it here. And clearly, we saw the spread of this 

virus largely from the New York City area into Fairfield County, 

parts of New Haven County, and Litchfield County as well. 

What I have found to be one of the most important indicators of 

widespread community transmission is looking at hospitalizations 

related to H1N1, and I think this has become an important marker 

for widespread community transmission of interest. Even though 

we were looking for this throughout May, we did not have our first 

hospitalization in Connecticut until the last week of May when we 

had four admissions for H1N1. So even though there was a lot of 

publicity about this in May, we did not see the impact on hospitalizations until then. In June, there were 104 hospitalizations 

related to H1N1, and there were 29 hospitalizations in July. 

Pandemics occur in waves, and we should view that period as the 

first wave of a pandemic of 2009; very distinct, last week of May 

to the first 3 weeks of July. Actually, the peak week was the last 

week of June when there were 40 hospitalizations, a very distinct 

period. 

What is remarkable is that we have only had two hospitalizations for H1N1 since the third week of July. 

Which really suggested we had this first peak, and then we had 

a bit of a break and we are waiting for the second wave to start. 

45 

Chairman LIEBERMAN. Is that because it was not flu season. 

Dr. CARTTER. Well, in many ways, we had a second flu season. 

Chairman LIEBERMAN. Yes. 

Dr. CARTTER. Pandemics do not happen in the normal seasonality of influenza, and this was our first wave. I think largely 

a number of schools in Connecticut run late compared to the rest 

of the country, and in the Northeastern part of the State, the 

schools were still in session until the end of June. And I think it 

is quite remarkable that within 3 weeks we saw a dramatic decline 

in the number of cases. 

In general, though, the pandemic waves, whether it is in 1918 or 

1957 or 1968, tend to last 6 to 8 weeks, which is also true for seasonal flu. Once seasonal flu hits, we usually see intense community 

activity for 6 to 8 weeks in a particular place, and then it moves 

on. 

Chairman LIEBERMAN. Is there any guidance, based on history, 

as to how many waves a pandemic flu will go through? In other 

words, how many times will we be dealing with this? 

Dr. CARTTER. Well, in 1918, there were three waves. Some people 

actually talked about a herald wave in the spring of 1918, but certainly in the fall, and then it returned in 1919. But I think what 

is important is that this virus eventually will become one of our 

seasonal flu viruses. When a new virus gets introduced that first 

year, first 2 years, it keeps returning. But eventually, it becomes 

one of the seasonal viruses. 

So this one is here with us from here on out. It will change a 

little bit every year, just like all the influenza viruses, but in terms 

of what we are experiencing right now, this is characteristic of a 

new one. 

Chairman LIEBERMAN. Interesting. Does that mean that the vaccine that has been developed for H1N1 may become part of the regular flu shot, as we all call it, that we take every year? 

Dr. CARTTER. Well, that certainly would be the goal. The idea 

is—the way seasonal flu vaccine decisions are made in the United 

States is that there is a group that meets in February, chaired by 

the CDC and others, that looks at the experience of the influenza 

season, and then decides what should go in the seasonal flu vaccine. That information is transmitted to the vaccine companies. 

They start manufacturing in the spring and they start shipping in 

the summer. So this February, they will have to make a decision 

about what goes into the next year’s seasonal flu vaccine. 

The virus did not disappear over the summer. There were cases 

in summer camps. But importantly, we have not yet seen in Connecticut any evidence of widespread community transmission. 

One of the systems that we use to track influenza-like illness is 

called the Hospital Emergency Department Syndromic Surveillance 

System, and that is a very long name. Essentially, more than 20 

of our hospitals report electronically to us about syndromes that 

are seen in the emergency department, like the total number of visits. And what we are looking at specifically is the percentage of visits for fever or flu or that is written down in the chart. This has 

been an important indicator for us as to what is going on out there 

in the community, looking at emergency department visits. 

46 

While we have not seen anywhere near the level of activity in 

emergency departments that we saw in May and June, the percentage of visits for fever, flu are starting to go up, which may indicate 

that we are starting to see the beginning of the second wave. 

Chairman LIEBERMAN. But so far, a very small number. How 

many did you say; two or three, actual hospitalizations? 

Dr. CARTTER. We have only had two hospitalizations since the 

end of July. 

Chairman LIEBERMAN. Yes. That is great. We will see, though. 

Dr. CARTTER. I expect first to see the emergency department visits for fever, flu go up, followed by hospitalizations for H1N1. That 

would be our best marker of widespread community transmission 

of H1N1. 

Again, influenza pandemics differ in their severity. This pandemic is at least as severe as seasonal influenza. Over the summer, 

CDC and State and local health departments looked at our experience from the spring and revised many of those guidelines and recommendations that were put out. 

Our State public health laboratory has geared up for testing, but 

again, as has been mentioned, the focus of our testing is for public 

health purposes, and we are ready to use that to track this pandemic when it returns. We are going to focus on hospitalizations for 

H1N1. Our communication and public education plans are in place. 

Now, as has been mentioned before, the best way to prevent influenza is with a vaccine. There have been a lot of work over the 

summer preparing it. I just want to give you some details about 

how we are going to be handling the vaccine here in Connecticut. 

Chairman LIEBERMAN. This will be of interest. 

Dr. CARTTER. We began a preregistration process for public sector and private sector providers who are interested in administering H1N1. The model of the country is moving toward a private sector-public sector blend, where we have some vaccines given 

out by doctors in their offices as well as Public Health Departments 

at clinics. 

Essentially, preregistering in Connecticut, the provider has to fill 

out a provider agreement, and the provider then has a list of terms 

and conditions defined largely by the Federal authorities that providers must sign off on in order to receive the H1N1 vaccine from 

the State. In this scenario, all of the vaccine is owned by the Federal Government and it is being distributed through State Health 

Departments out to providers. 

There is no cost to preregister, and folks who register with our 

immunization programs are actually using a system that we have 

in place for the Vaccine for Children Program. Essentially, there is 

an existing program for getting healthy vaccines out there. So this 

endeavor is built on top of that system, and we are expanding it 

to other providers who want to give influenza vaccines. 

As of this past Friday, we have had 1,439 providers who have 

signed on, indicating that they are interested and willing to give 

H1N1 vaccine. Examples of providers who signed up, we have OB/ 

GYN offices, pediatricians, family physicians, internists, hospitals, 

community health centers, local health departments, and schoolbased clinics. In addition, there are 41 mass dispensing areas that 

are led by local health departments. We have broken the State into 

47 

regions and we are working with these mass vaccination areas to 

coordinate the public sector vaccine. 

I wanted to talk about the amount of vaccine that we expect to 

see. As you pointed out, Connecticut is expecting to get about 

500,000 doses of the vaccine sometime in October. This past Friday, the CDC had a media briefing and announced that there 

would be 3.4 million doses of the live, attenuated vaccine. This is 

the nasal spray vaccine, which will be available the first week of 

October. This is the vaccine that is coming first. 

The nasal spray version, it is a nasal spray, not a shot, and it 

is approved for use only in healthy persons, age 2 to 49, who are 

not pregnant. So many of the people in those groups that you had 

talked about earlier, the target groups, actually cannot get this 

vaccine. So children who have underlying medical conditions, for 

example, or pregnant women cannot get the FluMist vaccine. 

So this will be a challenge as we move forward. Many of those 

shots we are planning on prioritizing for healthcare workers. But 

based on our population, we should be getting about 38,000 doses 

of the nasal spray vaccine at the beginning of October. So at the 

health department, we will be meeting to talk about how best to 

distribute those doses. 

Chairman LIEBERMAN. Am I right that you will be imposing or 

requesting that the private providers follow your judgment about 

vulnerable populations; in other words, who comes first? 

Dr. CARTTER. Yes. Well, what is in the provider agreement is actually based on the provider agreement that was drafted and 

agreed upon by CDC and HHS, which includes those risk groups. 

So that is part of the provider agreement that they will sign. 

Chairman LIEBERMAN. So is there any time frame now for the 

non-nasal spray vaccine that presumably will be effective or can be 

used by pregnant women and others? 

Dr. CARTTER. From what I have heard in CDC briefings, the first 

supply of the shots should be 1 or 2 weeks after the nasal spray 

vaccine comes out. 

Chairman LIEBERMAN. OK. 

Dr. CARTTER. One of the things to remember about October is 

that much of our efforts to vaccinate people will be driven by the 

formulation of the vaccine that we received. There will be a lot of 

the nasal spray vaccine available because the yield of that vaccine 

was much better than the yield for those who are making the vaccine that is injectable. So we really will have to be very flexible 

over the course of October. We will have to see what we are getting 

and then get it to the people for whom it is indicated as quickly 

as we can. 

Chairman LIEBERMAN. Thanks. Is that your testimony at this 

point? 

Dr. CARTTER. That is my testimony. I would like to thank you 

for the opportunity to talk about this today and I would be happy 

to answer any questions you have. 

Chairman LIEBERMAN. Thanks, Dr. Cartter. That was very informational, very helpful, and we will try to spread that word. 

Commissioner Boynton, it is a pleasure to greet you for the first 

time as Commissioner. I have seen you in other capacities before. 

48 

1The prepared statement of Mr. Boynton appears in the Appendix on page 228. 

Welcome as the Commissioner of the Department of Emergency 

Management and Homeland Security. 

TESTIMONY OF HON. PETER J. BOYNTON,1 COMMISSIONER, 

CONNECTICUT DEPARTMENT OF EMERGENCY MANAGEMENT AND HOMELAND SECURITY 

Mr. BOYNTON. Thank you very much, Senator. It is good to see 

you again. Thanks for your invitation to be here. As the others 

have noted, thanks for your interest and attention and the interest 

of your Committee and your staff. We really do appreciate that 

here. 

In my role as Commissioner of the Department of Emergency 

Management and Homeland Security for the State of Connecticut, 

I would like to focus and emphasize on three themes today. The 

first is planning and preparedness; the second theme is information 

sharing and outreach; and the third is collaboration. 

With respect to collaboration, you heard Dr. Cartter in his statement say that he defers to me for incident management. I have the 

exact same statement here saying I defer to him for medical issues. 

But as I was sitting here, I had to reflect that, really, we have a 

typo in our statement because we really are not deferring; we are 

collaborating. 

We spend an awful lot of our time these days at the Connecticut 

Department of Public Health, and that terrific staff, likewise, 

spends a lot of their time with us at the Department of Emergency 

Management and Homeland Security. We have a tradition of working closely between those two departments, and all the more so 

now in preparing for the H1N1 outbreak. 

That leads to my first theme, the importance of planning and 

preparedness. And as I have said, both agencies are working towards that, and let me offer some examples. 

The State of Connecticut has a pandemic influenza response plan 

and an H1N1 vaccine distribution response plan. Both of these are 

authored by the Department of Public Health, which is the State 

agency designated by Governor Rell to lead the H1N1 response in 

Connecticut. 

In addition to the statewide planning that has been done, we 

have also taken many steps to ensure continuity of operations in 

critical State government functions. Going all the way back to December 2005, Governor Rell directed State agencies to engage in 

pandemic continuity of operations (COOP) planning. Led by the Department of Administrative Services here in Connecticut, State 

agencies have participated in COOP training, and that culminated 

in the development of continuity of operation plans for 55 State 

agencies. 

Each State agency in these plans has identified its essential 

functions, created a pandemic incident management team; and 

with that foundation in place, going all the way back to 2005, this 

past August, Governor Rell directed State agencies to review their 

continuity plans, convene their incident management teams in 

preparation for an H1N1-related incident. 

49 

In its emergency management role, the task for my agency, 

Emergency Management and Homeland Security—we, like many 

people in government, refer to ourselves with our acronym, which 

is DEMHS. Our role is not only to maintain our own essential functions but also to assist others at the State and local levels to maintain their operations. 

The role of DEMHS is to coordinate, as we do in every emergency, but in a pandemic incident, the coordination or incident 

management role is a bit different. Rather than dealing with a 

quickly occurring, acute type incident, such as a hurricane or tornado, we must be ready to deal with the long-term or chronic incident in this case. 

DEMHS has established three activation levels. The first is monitoring, the second is partial activation, and the third is full activation. We are currently in the monitoring mode prior to any activation of our State Emergency Operation Center (EOC). 

A key component of the monitoring mode is the subject of my second theme, information review and sharing and outreach to all our 

partners, as well as to the community at large. DEMHS, the Department of Public Health and the State Department of Administrative Services are working with the governor’s office to provide 

accurate, current, and consistent information on the H1N1 situation. 

Some examples. The governor has held three H1N1 summits 

here in the State: The first for school administrators K through 12; 

the second for higher education and residential schools; and the 

third just a couple of weeks ago for municipal officials. 

These summits provided up-to-date information on H1N1 and 

State planning efforts from subject matter experts. They were all 

very well attended with hundreds of people present. They received 

media coverage, and as an additional way to reach out to the general public, these summits were broadcast on the Connecticut Television Network, which as you know is broadcast throughout the 

State. 

The governor has also prepared public service announcements 

(PSAs), which have already begun to air on television and radio, 

and the first PSA emphasized the importance of personal preparedness. The governor’s message also directs Connecticut residents to 

go to the Connecticut Flu Watch Web site, www.ct.gov/ctfluwatch, 

for more information. And this Web site is a central Web portal not 

only for the public, but also for schools, universities, healthcare 

providers and businesses. 

Beginning with the first outbreak of H1N1 in the spring of this 

year, information sharing with our partners, such as public and 

private health directors and providers; emergency management directors and municipal chief executive officers; school officials and 

State agencies, was accomplished through a series of regular telephone conferences that included both DEMHS and the Department 

of Public Health. We are going to use those teleconferences again 

this fall to reach out to the 169 communities and that key triad of 

officials, the chief elected official, the health director and the emergency management director. 

In addition to that, DEMHS is also sharing information on the 

H1N1 incident through a computer system known as Web EOC. 

50 

Web EOC is a real-time, Web-based, situational awareness tool 

that allows us to communicate with Federal, State, and local partners. DEMHS uses Web EOC as a tool to communicate in particular with the emergency management directors and other officials at the local level. 

Over 650 individuals across the State have been trained in Web 

EOC from 150 towns as well as State agency representatives. This 

tool not only allows us the pass information but rely on this to 

maintain the common operational picture across all partners. 

My third theme, collaboration, leverages the success of all other 

efforts. I have already described many of the collaborative efforts 

that have taken place, and continue to take place, such as teleconferences, Web EOC, flu summits, and public education. 

At the local level, collaboration is encouraged in a variety of 

ways. For example, each municipality, each 169, is required by 

State statute to have an all-hazards local emergency operations 

plan, which must be reviewed annually, not only by the local emergency management director but also the local chief executive and 

myself as well. And this all-hazards plan is important because it 

defines key roles and responsibilities for any emergency. 

The State of Connecticut also passed legislation in 2007 creating 

an Intrastate Mutual Aid System that allows municipalities to assist each other. In addition, the State of Connecticut collaborates 

with other States—and we have some great examples of that—and 

our Federal partners. 

For example, just this past July, Governor Rell joined five other 

governors and representatives from DEMHS and public health, 

participating in a national flu summit to discuss the spring time 

H1N1 outbreak and planning for the fall. 

Finally, on August 20, the Northeast States Emergency Consortium held its quarterly meeting of State emergency management 

directors, chaired by the Connecticut Director of Emergency Management, Bill Hackett, in Brattleboro, Vermont. The August meeting was dedicated to H1N1 issues and included not only emergency 

management directors from each of the New England States and 

the State of New York, but also State public health directors; the 

FEMA Region 1 acting administrator, Paul Ford; Admiral George 

Naccara, who is the DHS regional coordination team leader; Admiral Michael Milner, with us here today; as well as Admiral Scott 

Deitchman from CDC. 

So in closing, these opportunities at the local, State, regional and 

national levels for all to meet and exchange ideas, best practices, 

concerns in anticipation of a potential incident enhances our collaborative effort, and enhances it across geographic areas, across 

disciplines, and across levels of government, which will be essential. 

Thank you very much, and I look forward to addressing any 

questions. 

Chairman LIEBERMAN. Thanks, Commissioner. That was very interesting, very encouraging. I want to ask you one question at this 

point. 

I presume that the kind of network that you have set up of communication and the idea that this is an all-hazards network really 

responds to the goals that I was talking about in my opening stateVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000058 Fmt 06601 Sfmt 06601 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
51 

1The prepared statement of Dr. Jones appears in the Appendix on page 233. 

ment. In other words, in the event of a hurricane, or a biological 

terrorist attack, as well as in the event of a flu outbreak, is the 

basic structure there to spring into action and is it multidisciplinary and multi-agency? 

Mr. BOYNTON. I could not agree more, Senator. And as a great 

example, since 2007, there have been nine exercises that are related to H1N1, and yet many of them are not specific to H1N1. 

Some of them relate to continuity of operations planning and practicing that. Some of them refer to different aspects of the response. 

But if you look at this history of exercises, some at the State 

level, some at the regional level within Connecticut, some with 

local partners, some with Federal partners, even though the topic 

may not have been an H1N1 exercise, you can see how they relate 

to this incident. It is very much along the theme of an all-hazards 

approach, which is an efficient approach to being prepared. 

Chairman LIEBERMAN. Well, thank you for that. And people in 

the State should feel better about the fact that is coming together 

here. 

Our final witness on this panel is Dr. Stephen Jones, Director of 

Outpatient Medicine and Center for Healthy Aging. As I get older, 

I am more interested in that subject myself; Chief Patient Safety 

Officer as well, at Yale New Haven Hospital. 

Thanks, Dr. Jones, for being here. 

TESTIMONY OF STEPHEN G. JONES, M.D.,1 DIRECTOR, OUTPATIENT MEDICINE AND CENTER FOR HEALTHY AGING, 

CHIEF PATIENT SAFETY OFFICER, YALE NEW HAVEN 

HEALTH SYSTEM 

Dr. JONES. Thank you, Senator Lieberman, and thank you for everyone here. And my apologies to you behind me who are getting 

my back. I am told that is my best side, so enjoy it. 

It has been said that the most predictable thing about pandemic 

flu is its unpredictability, and that certainly holds true. The emergence of this H1N1 flu earlier this spring was an unwelcomed 

event, but I think in many ways it was also an opportunity for us 

to really look at our preparedness models and our readiness models, which we have been working on for a number of years. And I 

think this is a good opportunity for us to test those models. 

It is important to understand that pandemic flu is a rare event. 

In the past 300 years, there has been only 10 pandemics that have 

occurred. The last one was 40 years ago in 1968, and the worst one 

occurred, as we all know, in 1918, where over 50 million people 

died worldwide, 675,000 Americans. And we would remind you, at 

that period of time, the population of both the United States and 

the world was significantly smaller than it is today. So this was an 

event of massive magnitude. 

One of the problems with pandemic flu is that people do not appreciate the potential for how bad it can be because not many of 

us are still around from that period of time. Having said that, we 

should not expect the worse, but it is always out there. 

Chairman LIEBERMAN. That is a very important point. Well, obviously, there have been deaths, as I said—the numbers that are 

52 

growing are mild, but that is not a definite predictor of what is 

going to happen. 

Dr. JONES. The two things we look at, Senator, are infectivity 

and virulence. This is a highly infective flu, as all pandemics would 

be, and virulence is the key thing. This is not a virulent flu at this 

point; 1918 was, and that really was the difference in the magnitude. 

I would also remind everyone here that in 1918, the flu also 

began in the spring like this one did and was a mild form, and mutated probably in Europe during World War I with the troops and 

returned here as a mutated killer strain. So although we are hoping that is not going to happen, that is always a potential. 

The present H1N1 flu is a direct descendent of the Spanish flu, 

and it is a milder version of it, obviously. So the one thing I would 

point out is that any deficiencies that we see in the strategies we 

have in place now would be magnified with a more virulent strain. 

The challenges facing the healthcare system in a pandemic outbreak are truly daunting. Under normal circumstances, absent a 

pandemic, the following facts hold true for hospitals. On any given 

day, hospitals are operating at near capacity. Intensive care units 

that will receive our sickest of sick are almost always full. There 

are approximately 110,000 respirators, ventilators in the United 

States. Again, on an average date, 75,000 are in use. During normal seasonal flu, that goes up to 100,000. We have very little reserve in that capacity. 

Emergency rooms these days are being used more and more by 

people coming in for their care because of lack of insurance or for 

whatever the reasons, and they are already literally clogged with 

people waiting for care. People sometimes wait for hours to days 

to get a bed in the hospital. Staffing is strained, particularly in 

nursing, and the recent economic downturn has only magnified 

that problem as well because hospitals have had to reduce staffing 

just to survive. 

Hospitals operate in a just-in-time environment. In other words, 

we keep enough supplies to keep us operational for a day to 2 or 

3 days. Blood products, perishables cannot be kept for long term. 

Even food and water has limited supplies. So in short, hospitals 

have limited capacity to flex up for any situation that may increase 

above their normal baseline. 

As far as this pandemic situation is concerned, the biggest challenge facing hospitals with this current strain is their capacity to 

absorb this overwhelming potential for patients seeking care. It is 

estimated that at its peak, this pandemic could afflict 30 to 50 percent of the general population. Bear in mind, that healthcare personnel are also part of the general population. So you would have 

this perfect storm of patients requiring more and more care and 

healthcare workers not being there to provide it. Again, this in the 

setting where hospitals are normally operating at capacity to begin 

with and little margin to absorb any extra numbers. 

Let me share with you just a few of the things we experienced 

early this spring in the Yale healthcare system with the emergence 

of the H1N1 pandemic flu. Private physicians were also impacted 

in their offices, and where do you think they sent their patients 

when they had too many? To the hospital. They sent their patients 

53 

to the hospital for medical care and they sent them there for testing, increasing our load of business as well. 

Our emergency rooms saw significant increases in the worried 

well, people coming in just for sniffles, not really having the flu, 

who were concerned that they had pandemic flu. And to your point, 

Senator, not distinguishing between the symptoms of a cold versus 

the flu. 

There were logistical challenges in terms of isolating people who 

are suspected with swine flu versus those who are not infected, and 

where we could put them at these particular numbers. Respiratory 

therapists, lab workers who tested these patients, were working 

overtime just meeting the demand of this particular population, 

and these were not significant numbers. In addition, CDC and the 

State were not always in sync on their recommendations to hospitals in terms of testing guidelines and recommendations. 

Our infectious disease teams were worked to the hilt between patient care, patient hospital planning, media and just dealing with 

the particular pandemic situation. And amazingly, we saw flu continue into the summer. This is almost unheard of. Even though the 

cases were reduced, we do not see flu in the summer. Seasonality 

is one of those things that has to be addressed with pandemic flu. 

Again, bear in mind this was all happening when the flu was not 

widespread, when our hospitals were fully staffed and operating at 

full capacity. The scenario would clearly be different, and likely 

will be different, when and if this flu reaches its peak in our communities. 

Just other considerations quickly—schools were closed, sometimes appropriately, to address this, and maybe that is the proper 

approach in some cases. But when schools close, parents are required to take those children, and they drop out of the workforce 

as well. They are also healthcare workers like nurses. Supply 

chains may also be compromised with the pandemic; truckers, shippers, people stocking shelves, are less likely to come into work. 

It is also not a local event. This is not like a hurricane or an 

earthquake. With a local event, there are services that can rush in 

from external areas to help. A pandemic, people are basically on 

their own, and hospitals and communities will not be able to tap 

into each other, to any great extent, to care for each other. And 

again, we are operating in a just-in-time environment, so those 

supplies are very limited. Availability and distribution of vaccines 

is also a challenge. We face the same things that were mentioned 

earlier, when will they come in, who gets them first, and how are 

they distributed. 

Finally, Federal funding has been wonderful. Since several years 

ago when we first identified the importance of addressing this, Federal funding has appropriately stepped up. However, hospitals only 

receive a small percentage of this funding. In Connecticut, hospitals receive about 20 percent of this funding; in other States, hospitals receive even less. 

So in summary, much has been done to prepare for this and it 

is commendable on all levels, Federal, State and community. The 

Yale Center for Emergency Preparedness works tirelessly to provide services to our hospitals and our communities to make sure 

we are ready. 

54 

With that in mind, we offer the following recommendations for 

considerations. 

To help hospitals build into this system to capacity to respond 

and absorb patients under these surge conditions. Here in this particular outbreak, since it is mild, we are going to be seeing that impact mostly on the outpatient areas. If it gets worse, it will certainly be on inpatient as well. 

To increase allocation of funding to hospitals to meet the cost of 

managing a pandemic, including staffing, overtime, training, pharmaceutical supplies and testing. 

To improve the coordination between the State and the CDC in 

having their recommendations be timely and in sync. 

To encourage—and I am going to step out of my Yale role for a 

second to speak as a personal physician—healthcare workers to 

step up and do the right thing and get their vaccines to protect 

their patients and also maintain themselves in the workforce. 

One of the things I hear people say to me is, ‘‘Dr. Jones, I do not 

get the flu shot because I’ve never gotten the flu and I do not need 

it.’’ Well, that is simplistic logic. It is the same logic that suggests 

that if I have never gotten into an automobile accident, I do not 

need to wear my seat belt. It does not make sense. 

Finally, we need to support and educate our general population 

on prevention, handwashing gels, and vaccinations. There was a 

study that came out recently that showed that putting hand gel 

dispensers into our elementary schools reduced spread by 20 percent and reduced teacher absenteeism by 10 percent. My own kids’ 

school had that done recently, and I think it has made a difference. 

Recognition of the symptoms, educating the population and what 

we talked about earlier. And finally, preparedness; home planning, 

supplies, medications, advanced planning for child care, what have 

you. 

As stated earlier, the most predictable thing about this is its unpredictability. We would strongly advise that at the conclusion, on 

the other side of this event, that we implement a statewide review 

and debriefing on what happened to look back as to how we can 

look at our victories and look at how we can improve things for the 

future. And having done that, we think we will come out of this, 

again, with the opportunity to improve our already improved situation and preparedness. 

Chairman LIEBERMAN. Thanks very much, Doctor. That was an 

excellent panel, and thank you for concluding it. 

Well, why don’t you just take a moment to develop that last 

thought that you had, that there ought to be a statewide review. 

You mean, after the flu season, for instance? 

Dr. JONES. At the conclusion of this, more on the other side of 

this event, in the pass through, that we again get together with the 

appropriate agencies to look at where we had successes and where 

we had deficiencies. 

I just want to underscore one other important thing about the 

seasonality. It is a misrepresentation, even in physicians, if they 

think that this is a winter event. Pandemic flu is non-seasonal. We 

have a southern hemisphere and a northern hemisphere. This is 

circulating the planet continuously, and we need to maintain our 

55 

readiness throughout the calendar year, not just in the winter and 

the early spring. 

Chairman LIEBERMAN. That is a very important point. And, obviously, even as compared to 1918, and certainly as compared to 

1919, a lot more people are traveling around. It is true that it coincided with World War I, so people were moving from here to there 

and back, but in the normal course of a day, there are many more 

people traveling the southern hemisphere and everywhere else, and 

coming back to the United States. So it spreads. 

Dr. JONES. In 1918, the flu came across on the ships back from 

Europe and traveled the train routes across the United States. It 

took weeks. Now someone can be on a plane in Hong Kong and be 

in New York City in a few hours, so it is a completely different scenario. 

Chairman LIEBERMAN. Let me focus in a line of questions that 

comes off of what you said because it really is important now, but 

it is important in terms of the larger, longer-term capability of the 

public health system to respond to other kinds of disasters which 

require surge capacity. 

It is one thing to have a large national inventory of antivirals, 

that fortunately we had and we have spread them around now, to 

treat people with the symptoms, even to produce a vaccine, but 

quite another to try to increase the physical structure and all the 

services that go with it of a hospital or public health. 

I mean, the fact that we do not have enough is why we have 

reached a national conclusion, and I cannot argue with it, that we 

have to assume when people are showing flu symptoms that it is 

H1N1. We are not going to go through a test because the people 

coming into the emergency rooms would overwhelm the emergency 

rooms. And as you say, in the hospital, generally, in terms of beds 

and in the emergency rooms, most of them, in our State and 

around the country, are already at or near capacity. 

So short term, how do we plan for—and I agree with you; what 

you said is right. The only thing predictable about a flu pandemic 

is that it is not predictable. 

Let’s say it takes a negative turn and we need more bed space. 

What do we do? 

Dr. JONES. Well, in that capacity, we have come a long way. Most 

of the hospitals, including the Yale system have put together plans 

for such a scenario, where we can ramp up a number of beds, either through moving to off-site areas, cutting areas that are normally done for elected procedures, elective surgery. 

We have some capacity to ramp up space for beds. What we lack 

is staffing and equipment. A classic example are respirators. With 

a pandemic flu, if it was a severe pandemic flu, a number of people 

would need to be put on ventilators. We do not have those ventilators. What do we do when those people show up and you have to 

decide the ethical question of a young person versus an elderly person; who gets to decide to put that person on the ventilator? 

So it is more equipment, Senator. It is more staffing than it is 

space. The space, the hospitals can find ways to deal with that in 

a short term. It is really not having anybody to stand next to that 

person’s bed and provide those services to them. 

56 

Chairman LIEBERMAN. That is very interesting. One, I appreciate 

that the hospitals have those kinds of plans. 

Would you say, Dr. Cartter, that most of the hospitals in this 

State have those kinds of fallback plans, for space anyway, if there 

is a surge need for additional bed space? 

Dr. CARTTER. This has been a major focus of pandemic planning. 

One of the things that you need to remember is that we were all 

planning for a pandemic bird flu, and many of these plans have 

been developed over the last 3 or 4 years. But the structural issues 

that Dr. Jones mentioned are significant. It is not easy to increase 

the surge capacity of our acute care medical system. 

Chairman LIEBERMAN. So longer term, as a Nation, what should 

we be doing, particularly in terms of personnel and equipment? Obviously, in a resource constrained time, this is more money that 

may need to be spent. Really, say what is the ideal as a Nation we 

should be investing in now. 

Dr. JONES. To give us more capacity to see patients. 

What has been happening across the country is hospitals are 

struggling financially, that they are going out of business. We have 

had hospitals around us close, and those patients wind up coming 

into our healthcare system, and that overburdens our emergency 

room and taxes our staffing as well. 

As we have this domino effect of healthcare systems collapsing, 

it puts a greater strain on the established healthcare systems. And 

again, it just is a problem going in opposite directions. And so 

when we reach a situation, whether it is a pandemic or even a local 

event, we have limited capacity to step in and really provide help 

to these people. 

So funding would help tremendously. Really, Senator, staffing is 

a major issue. We need people at the bedsides. 

Chairman LIEBERMAN. And that is tough because, obviously, you 

cannot just bring—well, I suppose is something hit a particular 

area—now, this is national, but if there was a particular problem 

here, we could have a system for bringing personnel in for a shortterm to deal with it from elsewhere. 

Dr. JONES. We do table-top exercises in the State of Connecticut 

and through the emergency preparedness, just to do that, where 

the healthcare systems will step in and help each other, but 

pandemics are different. 

Chairman LIEBERMAN. Let me come back to the flu in this way, 

just for a final question to you on this, and, Dr. Cartter, if you 

want to get into it, or Admiral Milner. 

I presume that one of the ways we can take the pressure off of 

hospitals in the public health system, if this does get worse, is to 

have the doctors and the public be advised about how they can take 

care of themselves, unless it gets serious enough that they have to 

become inpatients at a hospital. 

Am I correct? In other words, what people can do self-diagnose 

and what a doctor can do to take care of the patient in the office 

as opposed to sending them to the emergency room. 

Dr. JONES. We have already started telling our patients who are 

coming into the hospital for routine care what to do in the event 

that they get symptoms, that they should probably stay at home 

if they have kind of run-of-the-mill flu symptoms that Dr. Cartter 

57 

mentioned earlier. The symptoms from the head up where it really 

represents a cold is not something you come into the emergency 

room for. 

The other thing is that absenteeism, although a huge problem in 

a situation like this, is also exacerbated by presenteeism, people 

showing up for work who are sick and decide they want to be heroic and do the right thing. That is not in the interest of our communities. We encourage people who are sick with the flu, with 

fever, to stay home, and that is a message we are constantly striving to get out. 

Chairman LIEBERMAN. Well said. 

Admiral Milner, let me go to you in terms of the scope of what 

may happen. We were all unsettled last month when the President’s Council of Advisors on Science and Technology released a report. And it may be that some of the numbers, which were suggestions, were taken too seriously. But they did say that there was a 

plausible scenario in which they could see up to half of the American population infected by this H1N1 flu, with almost 2 million 

hospitalizations and as many as 90,000 deaths. 

Acknowledging what we will now call Jones’ law, which is that 

the only thing predictable about a flu pandemic is that it is unpredictable, based on our current understanding of how this outbreak 

is proceeding, does HHS expect the United States to experience as 

large an outbreak that the Council of Advisors is suggesting? 

Admiral MILNER. I think that we are planning for the worse and 

hoping for the best, like all of us. I think a lot of the messaging 

that has come out of the Department recently has been centering 

around the issue that Dr. Jones raised, that I know our State partners have been working on, and that is how to care for yourself at 

home, how to care for your children, and so on, to try to decompress some of the issues related to hospitalizations. I know, for example, Connecticut is working hard, as our other States are, on alternative care facilities and how we would staff those up and so on. 

I think that, again, the jury is still out on how this is going to 

morph and how the pathogenicity of the virus will change. Again, 

I think all of us are trying to give the right tone to our messages 

that we have shared responsibility personally and we have to work 

together to get through this. 

Chairman LIEBERMAN. So what I hear you saying is that you are 

not prepared to say that the 90,000 death projection is accurate, 

but you are not prepared to predict a number either because it is 

unpredictable. 

Admiral MILNER. Correct. 

Chairman LIEBERMAN. OK. We touched on this a bit. Last 

week—I will give you an intro to this—we held a hearing, the Committee in Washington, for the nomination of the new deputy administrator for FEMA, Chief Richard Serino of Boston. Probably 

you know him. 

Admiral MILNER. Yes, sir. 

Chairman LIEBERMAN. Well, he was quite impressive, he heads 

Boston’s emergency medical services, and he relayed what I find to 

be a striking statistic about Boston experiencing the flu last spring, 

which was that 23,000 residents were stricken with H1N1, and 

58 

that 11 percent of the student population had it—so this is obviously an important factor for the schools, the judgments to make. 

I know that the government is trying to encourage schools, at 

this point, to stay open, even as they experience cases of H1N1 

among their student population. 

I wanted to ask you, what are we saying to the schools about 

what the threshold is for when a school should in fact close? 

Dr. Cartter. 

Dr. CARTTER. Let me also answer and comment on the earlier 

question that you raised about severity and about that report because it leads into the discussion of education. 

Pandemics differ in severity. And also, as part of that, they also 

differ in the number of people that are affected. The 1918 pandemic 

affected about 30 percent of the population, the 1957 pandemic, 

about 20 or 25 percent, and the 1968 pandemic was 40 percent of 

the population was affected. So that report was really describing 

the range of possibilities because we do not know yet exactly what 

percentage. But so far, this appears to be most similar to the 1957 

pandemic, and we are looking more at a range of 25 to 30 percent 

rate of illness in our population. 

Seasonal influenza is about 10 to 15 percent of the population 

every year, although that can vary, but that gets to your perspective. And looking at our control methods, obviously schools are important places of transmission for influenza, but we also have to 

look at the severity of the disease. And this particular illness, at 

least at this point in time, does not seem to be more severe than 

seasonal flu. 

If this were a 1918 situation, the recommendation of the Federal 

Government, as well as the State, is that schools would have been 

closed at the very beginning of the pandemic, and they would stay 

closed for 6 to 8 weeks. Given the severity of this and that this is 

actually very acute, similar to seasonal flu, we are not recommending that schools close to control this illness, as we do not 

make the same recommendation for seasonal flu. We would be closing schools every year in that case. 

The point here is that the best place for well children to be is 

in school; the best place for sick children to be is at home. 

Chairman LIEBERMAN. That is the key. The students who have 

it should go home. 

Dr. CARTTER. Exactly. And working with parents, working with 

teachers and others to make sure that there is a continuity of education is critical. And one of the things that we have been doing 

with our education partners is working on that piece. As for a 

threshold, it really varies. It is important to point out that the 

State of Connecticut Department of Public Health, did not recommend any school closures in May or June. We work closely with 

our communities to keep schools open. 

The second point along that line is that we need to be aware that 

there may be circumstances where schools need to close because 

there are not enough students and teachers present to have a reasonable or meaningful class. And we know of schools that reached 

40 to 50 percent absentee rates last May and June, those who are 

getting into the area where they have to make an administrative 

decision does it make sense to hold class. And we let that decision 

59 

be made at the local level between the school superintendent and 

the local health director. 

Chairman LIEBERMAN. I assume, incidentally, that if a student 

is sent home or a worker is sent home from a job because they got 

the symptoms of H1N1, they really should stay home. I mean, in 

the sense of not going out to the mall or going to a movie. 

Dr. CARTTER. The term used by CDC is social distant things; you 

go home and then go to the mall, and that defeats the purpose of 

going home. 

One of the problems that we have in our society in terms of this 

is that many children may be going home to a home where nobody 

is present because they are at work. So this is a difficult issue at 

the community level because not every child can go home to a 

mother or father or other significant person to take care of them. 

We have to do just like we did in 1918, to call on families and 

friends to take care of those who are sick and make sure that they 

are not at school. 

Chairman LIEBERMAN. Of course, I never knew my grandmother 

because my dad was three when she got the flu in 1918 and died. 

But the picture they painted, not to frighten anybody from doing 

something altruistic, was that she was healthy and she started to 

help other families who were affected by it, and then she got it, 

and she died pretty rapidly. 

I wanted to ask you a medical question just for the record. 

So far, what has been the effectiveness of the antivirals? In other 

words, we see symptoms that look like it, and the person has not 

received the vaccine. We give them Tamiflu or the other one, I forget what it is. 

Are they working, Dr. Jones? 

Dr. JONES. The antivirals are one of those things that people 

have been clamoring for because they think they are a panacea, 

and they probably do not represent that. 

First of all, if the antiviral is to be effective, it has to be given 

very early on in infectivity, within the first 48 hours. And the CDC 

presently is not recommending these medications be used prophylactically or just for kind of simple, run-of-the-mill symptoms. It 

really should be reserved for those who truly needed and are demonstrating either underlying immunocompromised states or situations where they are advancing and becoming more critically ill. 

The Tamiflu at this point probably is responsive to treating the 

infectivity, but, again, it is not something that would be recommended at this point as a first line treatment. 

Chairman LIEBERMAN. I take it that in a lot of cases of people 

with H1N1, they will get over it because their bodies ultimately reject it or it finishes its course and the body gets better again. Is 

that correct? 

Dr. JONES. It is like a flu shot you get to keep from getting the 

virus. It is essentially the same thing. You develop immunity 

through a flu shot or through infectivity. Most people will get over 

this just fine and have some level of immunity as a consequence. 

We have to have this balance between people who overreact to 

these situations and are too complacent, and the answer lies somewhere in between. 

60 

Chairman LIEBERMAN. And at this point, some of the populations 

that you have designated as vulnerable on the list for vaccines, 

they are showing a little less natural resistance to it, some of them. 

Am I right, young children particularly? 

Dr. JONES. Young children have less immunity because they 

have not been exposed to this. People born before 1957 probably 

have some background immunity just from having been exposed to 

this in the past. 

Chairman LIEBERMAN. This gets to the healthy aging idea again. 

Dr. JONES. It gets to the healthy aging as well. 

Chairman LIEBERMAN. Just a few more question, and then we 

will go to our second panel. 

Commissioner Boynton, you mentioned that your office is responsible for reviewing all local emergency operation plans. Since you 

have learned of H1N1 at the end of April—I know you are new on 

the job, but from what you have found, how would you rate the seriousness with which different communities in Connecticut have 

prepared for H1N1 over the last 6 months? 

Mr. BOYNTON. One example I think of the seriousness, Senator, 

is that the requirement for an annual review is a new one that 

started just this year by State statute. And under the statute, the 

reviews are not due until January. By the end of the summer, already over a third of them were in, which is way ahead of schedule. 

I do not think that is because those communities do not have anything else to do. 

So I think they are taking it seriously. And I would also comment that at the flu summits that the governor hosted, particularly 

the third in a series of three, which was focused on municipal officials, there was a huge turnout, tremendous interest, and we had 

panels from a couple of municipalities. In fact, I think some of 

them are in the second panel with you today. And they spoke of 

the type of actions they took back in April, which I think showed 

seriousness and preparedness even back then, which I think, again, 

reflects on what Dr. Cartter said, that we are not just now starting 

because of H1N1. Really, this preparation goes back to 2005 or earlier with substantial preparations for the potential avian pandemic. 

And it does not mean our work is done, but I think there is a substantial record of preparation because of that. 

Chairman LIEBERMAN. Admiral Milner, I must say that listening 

this morning, I am encouraged by the extent of the cooperation 

that I have heard testified to between the State and local government, and between the Federal, State and local. I want to ask you 

from your larger regional perspective—I do not want to put you in 

the awkward position of grading Connecticut in the presence of the 

people you are grading. 

Are we looking good compared to the other States in the region 

that you oversee? 

Admiral MILNER. Absolutely. No question that Connecticut is one 

of the leaders, and they have been one of the leaders through all 

of this planning that we have discussed here. We did an exercise 

in December 2007, where it was open to all of the States. Connecticut was a very active player. Dr. Cartter was one of our key 

participants. 

61 

So from my perspective, looking at all the States, as I mentioned 

earlier, I am glad that I live here and my family lives here in New 

England because all of the States have helped each other stand up 

even more. And we had a call first thing this morning at 7:30 with 

updates about what their thoughts are regarding some of the third 

level of funding that is coming out of CDC, and what some of the 

incidence is in their States and colleges and so on. 

So they are helping each other, and by doing that it is raising 

the boat for all of us. And I would say that Connecticut is in the 

top of the top. 

Chairman LIEBERMAN. Thank you. Yes, Commissioner Boynton. 

Mr. BOYNTON. Senator, if I could just add to that. There is a Federal publication that talks about how States can approach volunteers to help, not just through the H1N1, but with all hazards. And 

it gets to your earlier point about the efficiency, the economy, and 

the effectiveness of an all-hazards approach. 

In this publication—I forget what page it is, about a third of the 

way through—it states that Connecticut has the best practice for 

addressing liability issues for volunteers, and the State worked 

with the legislature, and a lot of that work is now behind us. 

But it is another great example where that work in addressing 

liability issues for volunteers was not directed specifically for 

H1N1, but in the all-hazards environment, it helps prepare us for 

H1N1. And I do not want to say all is done because it is not. There 

is more work to be done, but it is another example where Connecticut is cited as a best practice. 

Chairman LIEBERMAN. It is good to hear. 

Let me ask the last question. I am going to leave you out of this, 

Admiral Milner, because I am going to ask the other three, briefly, 

if there is anything particular that the Federal Government is not 

doing right now to be of help to you in dealing with this H1N1 pandemic? I ask that since I am from the Federal Government and I 

am here to help. 

Dr. CARTTER. Well, I am here from State government and I am 

here to help. The way I would approach that question is to say that 

Mother Nature has not read our pandemic plan. And at this point 

in time, we are close to starting the second wave of a pandemic of 

2009. 

We need to be flexible, not only at the State level but also at the 

level of the Federal Government because as much as we plan, obviously things can be different. We have the virus that is unpredictable, and we also have a supply chain that is going to be challenged, as well as the influenza vaccine arriving in different forms 

and various times. So this is really the moment of truth at this 

point in time moving forward. 

Chairman LIEBERMAN. Good point. Commissioner Boynton, anything more? 

Mr. BOYNTON. Sir, I would just say it depends. As we go forward, 

it depends on the severity of the incident. I think we are pretty 

well schooled across the country with how we get resources to respond to more traditional incidents: Hurricanes, tornados, ice 

storms, etc. 

I think it is important to remember that if incidents are severe, 

we do have a system of incident management that relies on supVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000069 Fmt 06601 Sfmt 06601 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
62 

port. As Dr. Jones pointed out, the Mutual Aid Support is more 

likely to not be available for a pandemic, because if we use the 

equivalent of an ice storm, we could all get this ice storm no matter 

where you live. 

Chairman LIEBERMAN. Right. 

Mr. BOYNTON. So we might not be able to borrow from our neighbors. If it is severe enough, our method of incident management relies on support, for example, like the Stafford Act. We are pretty 

clear on how the Stafford Act works in ice storms, hurricanes, and 

tornados. We need to be clear on how that would work if the severity of this incident is significant. 

Chairman LIEBERMAN. Good point. Dr. Jones. 

Dr. JONES. The final thing I would say is this. We all know that 

vaccines seem to be one of the central approaches to addressing 

this issue, and we have come a long way towards vaccine development, and the government has done wonderful things in terms of 

funding and reducing liability to pharmaceutical companies in the 

development of these vaccines. However, vaccines right now take a 

significant amount of time to make because it is mostly egg-based 

technology. We have the capacity now to improve that. That is in 

process right now. Those efforts need to be supported. 

The final thing, I mentioned early on, this is an opportunity as 

well as a challenge, and the opportunity is to learn. And again, we 

really need to step back at the end of this and look at what those 

lessons are. 

The final point I will make is this. People have a misconception 

that since pandemics are rare events and they occur every 30 or 

40 years, and that we may be off the hook come next year. It does 

not work that way. The probability of a pandemic next year, and 

the year after, and the year after is no less than it was prior to 

this particular event as well. And that is why we need to be on our 

toes preparing and ready to go. 

Down the road, we will have the technology and the science to 

address this with, hopefully, a universal vaccine where we can stop 

having to create vaccines that address one particular influenza. 

That is a significant way down the road, but we have the opportunity to make that happen and we need to get on the ball to do 

that. 

Chairman LIEBERMAN. Thanks. Those are very constructive suggestions. And to take your words, Dr. Carter, I think, at the Federal level—I speak for Congress, but I talk to Secretary Napolitano 

at the Department of Homeland Security enough to know that I 

can speak for her on this—we are staying flexible. It is a good 

point. So far, we are feeling fortunate that the intensity of the flu 

has not been as great as we thought it might be, and yet we know 

it is unpredictable. 

There is a history that no matter what the times economically, 

that Federal Government responds to disasters. If this becomes 

more severe, I am sure we will do everything we can, both with financial assistance and perhaps with some provision of more personnel from Federal Government, including the military. 

We have now divided FEMA after Hurricane Katrina, in addition 

to their national headquarters, they have 10 regional offices, which 

drill for a series of disasters that could potentially happen in those 

63 

1The prepared statement of Ms. Polansky appears in the Appendix on page 236. 

regions. And each one of those regions has representation from various Federal departments, including the military. There is one in 

each one of those. 

You have been really helpful. I thank you for what you are doing 

everyday. I thank you for the testimony that you provided here. I 

think it is a great idea when this is behind us to do a lessons 

learned, and then we will do our best to learn from what you learn 

to protect us into the future. 

Have a good day. Thank you very much. 

We will now call the second panel 

Julie Polansky is a parent from the Vernon Public Schools; 

Roseann Wright is Director of Public Health for the City of Waterbury; Daniel Aloi, Manager of Business Continuity Services at 

Aetna, Inc.; and Michael Kurland, Director of Student Health Services at the University of Connecticut (UConn). 

I want to thank the other folks who have come out, a lot of whom 

who have responsibilities in the public and private sector related 

to dealing with outbreak of H1N1. 

Well, good morning. Thanks for your patience. I hope you have 

found the first panel as interesting as I did, although you have 

probably been hearing a lot of that give and take all along the way. 

We thought that it would be good to have—I was about to say 

just a normal person here; not to say the first panel was abnormal, 

but a parent to reflect on their experience with this. Julie Polansky 

has come to do exactly that. So we welcome your testimony now. 

TESTIMONY OF JULIE A. POLANSKY,1 PARENT, VERNON 

PUBLIC SCHOOLS 

Ms. POLANSKY. Thank you. As you mentioned, I am a working 

parent within the Vernon Public Schools. I have two children in the 

school system right now. I have a middle schooler and an elementary school student. And we did have an experience in the spring 

of this past year, where our schools closed due to suspected cases 

of H1N1. 

It was shortly after spring vacation and Vernon Public Schools 

closed for 2 days due to a suspected case. Most parents, including 

myself, learned of the closure via local television news outlets. The 

school system initially did not notify parents via e-mail or phone 

calls. However, a notice was posted on the school’s Web site. 

Since it was an unexpected closure, or not a snow day, I did hear 

of a few parents who had not watched the local news and were unaware of the situation. Having and utilizing an emergency notification system within the school system would have greatly helped facilitate communications to parents. 

Additionally, communication regarding the reasoning for the closure was vague. Parents were aware the closure was due to H1N1, 

but initially did not receive information about the number of suspected cases, the location, or the school of the potentially infected 

individual or individuals. This lack of communication caused unnecessary speculation and rumor on the part of parents and the 

community. 

64 

Additionally, guidelines for the community of Vernon were lacking. Due to the closure of schools, all Little League practices and 

games were canceled for the 2-day period. In fact, on the day that 

administration closed the schools for the following 2 days, which 

was announced on the news outlets at approximately 4:30 p.m., 

parents and players were turned away when they arrived for practices at the various Little League fields. 

In the case of Vernon, the suspected case that caused the closure 

turned out to be influenza but not H1N1. I understand administration’s cautious decision in the interest of the children, however, it 

was merely one suspected case, and it may have been adequate to 

either wait for the results of testing or close the one impacted 

school, not the whole district. 

I would also like to point out that I do believe the closure of 

schools could be truly warranted if a significant number of children 

and/or staff become infected in one location. 

The impact of the 2-day closure on myself and a number of other 

parents was relatively significant. For myself, I work locally, I have 

a flexible schedule, but I was forced to rearrange my work day and 

make arrangements with friends for daycare. Many other parents 

simply utilized daycare facilities for their elementary age children. 

So my question at that point becomes, does the closure of schools 

actually help to stop the spread of the school virus? What is the 

difference between the children being together at school or at a 

daycare facility, assuming they are healthy? 

I would like to also point out, I have no problem taking time off 

from work and keeping my children home if they are sick, however, 

if schools are closed and my children are healthy, I will continue 

to allow them to play with their friends. 

Subsequent to the closure, the system distributed the State 

guidelines for ill children, and in my view, these guidelines are 

clear and reasonable. Guidance from school administration regarding the make up of the days that the district had to take off was 

also vague. 

In Vernon, initially parents were informed that the days would 

need to be made up at the end of the school year. This would have 

made the last day of the 2008–2009 school year, June 30. The situation caused issues for a number of parents and staff, since it was 

the Fourth of July week. 

Subsequently, the Board of Education reversed the decision, and 

through negotiation and coordination with the teachers’ union, the 

students did not make up the H1N1 closure days. This situation 

caused confusion for a number of parents and staff because they 

went back and forth on whether the days would need to be made 

up. Some guidelines or guidance from the State on whether districts need to make up these days would have been helpful. 

My hope for the current school year is for clear communication 

and careful preparation. I am happy to report that just last week, 

the Vernon public school nurses distributed a flyer to parents outlining the district’s recommendations on how to stop the spread of 

flu and other illnesses. The flyer included details of flu symptoms, 

recommendations on how long children should remain home, information on the vaccine, and prevention kits. It was also noted that 

the nurses are working closely with a local physician and the DeVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000072 Fmt 06601 Sfmt 06601 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
65 

partment of Public Health to monitor the flu condition and make 

decisions about the best steps to take concerning schools. I hope 

the district will continue to provide periodic updates via additional 

flyers, guest speakers at Parent Teacher Organization meetings 

and the school Web site. 

In terms of preparation, I believe it would be prudent for schools 

to have funding set aside for continuous supplies of hand sanitizer 

and periodic extra cleaning of the building. These preventive measures will help to avoid closures in the future. Since most school 

budgets are extremely lean, I wonder if it is possible to have State 

or Federal funding for these preventive measures. Also, a quick 

note. Just Friday, parents started receiving notices asking if they 

could donate hand sanitizer, tissues, all of these items to also help 

the situation. 

Guidance from the government is also crucial. Keeping parents 

informed is part of all these guidelines. So guidelines regarding 

who should get a flu shot, whether sick children should visit their 

primary care physician, how long a child should remain home after 

being ill, when and if a school should close, and how community 

sports, groups, or leagues should handle any outbreaks should be 

readily available to the public. 

Thank you for the opportunity to participate in this hearing. 

Chairman LIEBERMAN. Thank you. That was very helpful. I hope 

and I would guess that some of the response of the Vernon public 

school system was to the complaints that you registered last 

spring. Do you think so? 

Ms. POLANSKY. Oh, I absolutely do. I think that what happened 

was they were being extra cautious in the interest of the children. 

And it also was a result of all of the media, and just not knowing 

what to do at that point. But I also believe that they have set a 

number of guidelines this year to help the situation. 

Chairman LIEBERMAN. Right. Your conclusion is that they are 

handling it a lot more sensibly this year than they did last spring. 

Ms. POLANSKY. Right. 

Chairman LIEBERMAN. That is good. And the advice now nationally and from the State is not to close schools, but to send kids 

home who seem to be sick. You are suggesting a problem or you 

are describing a problem, one part of it here, which is very hard 

to deal with. But you are absolutely right. If the child comes home 

from school, and for various reasons, because of the pressures and 

demands on the family, the child ends up at a childcare center, 

that is no better. 

Ms. POLANSKY. Right. 

Chairman LIEBERMAN. And that is something that is hard for the 

government to handle. It is something we have to ask parents to 

try to do their best to avoid spreading it. 

I like your idea about the hand sanitizers. The experts tell us 

that just washing with soap and water is not bad, but it is obviously easier—I was out at Stop and Shop the other day. It is too 

bad my wife is not still here because she would say he hardly ever 

goes shopping, but he is going to talk about that today. [Laughter.] 

But anyway, as I walked in, there was a container with hand 

sanitizers there. Around the Capitol, they are all over, and in 

Washington, that is important. 

66 

1The prepared statement of Ms. Wright appears in the Appendix on page 238. 

Thank you very much for being a good parent and a good citizen 

and coming forward and telling us what you did. 

Second, Roseann Wright, Director of Public Health, Waterbury, 

Connecticut. Welcome. 

Ms. WRIGHT. Good morning, Mr. Chairman. 

Chairman LIEBERMAN. Good morning. 

TESTIMONY OF ROSEANN WRIGHT,1 DIRECTOR, WATERBURY 

DEPARTMENT OF PUBLIC HEALTH 

Ms. WRIGHT. Thank you for this opportunity to testify. I am 

Roseann Wright, Director of Public Health for the City of Waterbury. I am here today to share our experiences in Waterbury about 

how the Public Health Department, the school district, and the 

school nurses dealt with the influenza outbreak. 

The Public Health Department employs three nursing supervisors, 39 nurses, 20 health aides, and cares for over 22,000 students and 39 public, private and parochial schools. And with the 

22,000 students, that is a fifth of Waterbury’s population. 

As the Director of Public Health, I cannot place enough stress on 

the importance of the school nurse in the academic environment in 

terms of identifying, assessing, and tracking communicable disease. 

Identification of a communicable disease outbreak by the school 

nurse is also a potential indicator of a communicable disease outbreak within our community. The school nurse is often the first 

staff member to identify common signs and symptoms of a communicable disease and alert public health administrators. 

During the pandemic of H1N1, the Waterbury school nurses became integral in conducting surveillance in school populations. 

Early in 2009, a number of confirmed H1N1 cases were reported 

with increasing frequency, prompting the Public Health Department to proactively educate the public and minimize the spread of 

H1N1. 

The Public Health Department planned for the possibility of this 

becoming our next pandemic, and we needed to protect our school 

personnel, such as our school nurses and our health aides, and to 

do this, we set up several public health initiatives. 

With the school nurses, we reviewed the number of incidents of 

absenteeism to determine if outbreaks were occurring in our 

schools. The school nurses and the supervisors became our sentinels for the community’s health. We also increased communications 

between the Public Health Department, the school nurses, the superintendent’s office, and all of our private and parochial school 

principals to see if any H1N1 cases were confirmed in their academic environment. 

The Public Health Department sent all of our environmental 

sanitarians to inspect all the school bathrooms to ensure hand 

soap, paper towels, and hot water were available. We also had bilingual communication sent to parents of the school-aged children, 

addressing signs and symptoms of H1N1, prevention tips, respiratory etiquette, and information regarding swine flu. 

In January 2009, the Public Health Department conducted a 

table-top exercise with the school nurses regarding the roles and 

67 

responsibilities if a pandemic were to occur. This was an opportunity for the nurses to immerse themselves in a scenario that 

would test the responses if and when the pandemic did emerge. 

In addition, the school nurses also participated in a collaborative 

effort with the Waterbury Fire Department to distribute H1N1 flyers to 12,000 households. This was accomplished by staff literally 

walking door to door and speaking to residents face to face. 

As the Nation experienced school closures, so did Waterbury, as 

the superintendent of Waterbury closed an elementary school for 2 

days. In order to avoid additional school closures, the nurses 

worked collaboratively with the Board of Education, and the following non-pharmaceutical mitigation interventions began. 

We instituted several infection control techniques, installation of 

hand sanitizer dispensers for all the health rooms and the cafeterias. We distributed disinfectant wipes to the school nurses and 

teachers. We encouraged frequent bathroom breaks so students 

could wash their hands, especially in the elementary schools. In addition, we encouraged all students and staff to stay home when 

they are ill, and we encouraged them only to attend school when 

they are well. The custodians are also cleaning all surfaces that are 

likely to have frequent hand contact. 

In anticipation of the 2009 school year, the superintendent sent 

out a letter to all parents and guardians to highlight proper protocols when a child exhibits influenza-like illnesses and how the 

schools will maintain a healthy environment within the school district. The letter also mandated that students must stay home until 

signs and symptoms are gone and not to return for 48 hours rather 

than the current guidance of 24 hours. 

This message was also shared with private and parochial principals, so our message was consistent throughout Waterbury. 

In anticipation of the 2009 school year, the Public Health Department began to prepare for H1N1, which consisted of several staff 

meetings. Data collection tools were developed, which were used to 

monitor students with influenza-like illness. These new data collection tools will allow the school nurse to monitor siblings and will 

determine if a child has been returned to school per the superintendent’s 48-hour guidance. In addition, school nurses will conduct a brief risk assessment of the entire student household to determine if other family members are ill. 

The school nurse is also responsible to identify students and staff 

with special medical needs, which will potentially put them at 

higher risk for complications as a result of seasonal influenza. The 

school nurses are our medical professionals in our academic environments and can offer education to students and staff, as well as 

mitigating interventions that will help minimize the infectious 

agent of H1N1. Last year, our 39 school nurses encountered 

175,000 students through our health rooms. The school nurses 

have the ability to provide continuous, repeated education to this 

population. 

The Waterbury Public Health Department is also utilizing State 

and Federal guidance documents as a tool to develop specific strategies that are customized to the needs of Waterbury’s academic environment. These guidance documents are assisting the health department and school nurses to minimize the spread of H1N1 

68 

amongst our students and school staff, while limiting the disruption of day-to-day activities, thus facilitating educational continuity. 

We continue to prepare our school nurses by informing them of 

new guidance from the CDC and the Public Health Department in 

Connecticut. Waterbury recognizes we are not alone in the prevention of H1N1, and we share the same challenges and burdens as 

other municipalities across the State of Connecticut and the Nation. 

The Public Health Department administrators are constantly 

meeting with other directors of health and nursing supervisors 

from various forums, such as Connecticut’s Department of Emergency Management and Homeland Security, Region 5. And here, 

we share our important information, such as mitigation strategies, 

lessons learned and other valuable information, all of which is 

shared by our school nurses. 

In conclusion, as the pandemic continues to increase in intensity, 

the school nurse will continue to provide care to our students, educate our students in keeping themselves healthy and act as our 

sentinels for the community’s health. 

Chairman LIEBERMAN. Thanks very much, Ms. Wright, for a very 

thorough report. I will have some questions for you after we hear 

the final two witnesses. 

Daniel Aloi, as I mentioned, is the manager of Business Continuity Services at Aetna. 

So we have heard from a parent, a public health official at the 

local level, and now we want to hear some thoughts about how 

businesses are dealing with this problem. Thanks for being here. 

You have a great title, the Manager of Business Continuity Services. Tell us what that means. 

Mr. ALOI. Yes. The terminology used in the first panel is continuity of operations. My job basically is to make sure we keep the 

lights on, the phones answered, the claims paid, the patients communicated with, and all our critical customer facing operations, as 

well as, of course, the core function of keeping the corporation running as well. 

Chairman LIEBERMAN. Presumably, in an emergency situation. 

Mr. ALOI. Yes. 

Chairman LIEBERMAN. You are, in a way, sort of the secretary 

of emergency management for Aetna. 

Mr. ALOI. You could say that. And we do subscribe to an all-hazards plan, as mentioned in the first panel, where we have a central 

team, crisis response team, that is well versed and practice over 

and over again in dealing with minor outages while preparing for 

the major outages due to hurricanes or widespread disaster. It is 

an interesting job; never a dull moment. 

Chairman LIEBERMAN. Yes, I bet. What is your background? 

Mr. ALOI. Emergency planning since 1983. I was a manager of 

emergency planning for Millstone Nuclear Power Station, where we 

prepared plans, procedures, training exercises, and worked with 

State and Federal local agencies in exercising those plans, basically 

from one frying pan to another. 

Chairman LIEBERMAN. Yes. It sounds like you are ready. 

69 

1The prepared statement of Mr. Aloi appears in the Appendix on page 244. 

So you are going to tell us what Aetna is doing in regard to this. 

Do you give advice to your business clients about what they should 

do? 

Mr. ALOI. Yes, we do, actually. 

Chairman LIEBERMAN. Well, go ahead. I am interrupting you. 

Mr. ALOI. Since 2006, again, we took the first guidance that 

came out—actually, late 2005—very seriously. We established 

teams to deal with internal operations, but as well as communicating and creating plans for communicating with our plan sponsors to help them help their own members and creating their own 

operations deal effectively and weather a pandemic along with us. 

Chairman LIEBERMAN. Very good. 

TESTIMONY OF DANIEL ALOI,1 MANAGER, BUSINESS 

CONTINUITY SERVICES, AETNA, INC. 

Mr. ALOI. Aetna is pleased to be in attendance today to share our 

plans and experience with the panel. We are members of the 

Homeland Security Critical Infrastructure Subcommittee on Health 

Care and are actively involved with the public and private sector 

in advancing all preparedness, as I said earlier, since 2005. We are 

continually learning, as everyone is, and constantly testing our 

plan. We see no limits on the sharing of information when it comes 

to the public good and the Nation’s resilience. 

Aetna occupies over 100 facilities at various sites throughout the 

country which house a variety of Aetna departments and functions. 

We are fairly dispersed throughout the country in our operations 

center, which is a strength for us. 

To prepare for pandemics, Aetna has developed many recovery 

and coping strategies to ensure continuity of operations and to keep 

employees healthy. Although not implemented solely for pandemic 

planning, among the most notable element is our very robust 

telework program, with large numbers of our employees already 

able to fully function from home effectively. Roughly one-third of 

our workforce today work from home. 

The second most significant capability includes a comprehensive 

work reallocation process, where customer service calls and claim 

adjudications can be redirected to other Aetna offices with almost 

seamless transition. We are very fluid in the way we can transition 

work back and forth amongst our geographically dispersed work 

sites. 

Another important element is that Aetna has a considerable 

bench of contingent workers who are trained and can augment critical staff if there are high absentee rates, as we would expect. Contingent workers are routinely used to help during peak periods. 

Typically, they can consist of trainers, quality service folks, management that may have had some training in that area. It is basically needed every season. 

Actually, the first part of the year is our most intense period 

where all the plans renew. Our customer service people see an 

overload at that point. So we have the ability to bring in additional 

people that are trained and qualified and we test them every year. 

70 

Chairman LIEBERMAN. That is fascinating. These are people who 

are not working when you are not calling on them? 

Mr. ALOI. These are people who are doing other functions within 

the corporation—— 

Chairman LIEBERMAN. I got you. 

Mr. ALOI [continuing]. Functions that we can put aside and 

change our work model to prioritize on the most core functions. 

Chairman LIEBERMAN. Do you use retirees at all in that way? 

Mr. ALOI. We have a program to look at retirees and to call them 

back. We are working on that. That is one of the things we want 

to develop. 

Another important line of events in our capability is to keep employees healthy in the face of a pandemic. Aetna has created many 

strategies to accomplish that. It starts with a short and pointed, 

online course that employees are expected to take. The course provides instructions on hand hygiene as well as sneeze and cough etiquette, because we believe, as others do, that this can be one of the 

best measures in minimizing the spread of virus in the workplace. 

This course is available on line for our employees. It also is available for our members and our plan sponsors as a public service. 

Aetna has placed hand hygiene and stay at home when sick posters at all our Aetna sites as a constant reminder, along with permanent Internet and home page messaging on our Intranet Web 

net page. Aetna’s human resources policies strongly encourage sick 

persons to stay home when symptoms appear with non-punitive, 

pandemic pay policies. Beyond these strategies, Aetna has provided 

a personal supply of antiseptic hand sanitizer to all office based 

persons within our facility, along with the common bulk space dispensers you mentioned earlier. 

Aetna has purchased a stockpile of surgical masks and has deployed these to site crisis managers, along with instructions to 

issue them to any person that is symptomatic or who otherwise feel 

they may be coming down with the flu. Sick persons will be sent 

home or to a healthcare provider if symptoms are severe. There is 

also provision to quarantine that person in the office until they are 

sent home and taken care of. 

Another important planning element is our rapid telework deployment capability for office based workers. This is accomplished 

with an infrastructure, procedures and plans where we can transition additional large numbers of workers to a temporary work-athome setting within days, leveraging the Internet. 

We implement a scaled-down version of this each winter when 

severe weather occurs. During a traditional nor’easter, we typically 

have only 10 to 20 percent of our employees coming into the Connecticut office, and our customers see little or no impact. Under 

rapid deployment to telework, employees will be prioritized by mission critical function, as well as by their technological readiness to 

transition, i.e., broadband capability. 

Efforts will be made to adhere to CDC guidance, where employees in high risk groups are offered an opportunity to work at home 

consistent with employment laws. At many sites, there will still be 

a need for office based workers to come on site no matter the threat 

to keep serving our customers. For these employees, social 

distancing strategies will be employed. To that end, we have plans 

71 

ready to cancel or curtail physical meetings and substitute virtual 

meetings through our robust teleconferencing network capability. 

Additionally, we will enhance facility cleaning, control visitation, 

eliminate unnecessary travel, and spread out employees geographically if needed. 

Efforts will be made to coordinate actions with local and State 

health officials to adhere to any triggers that may be provided by 

health officials for taking additional actions. All site crisis leaders 

have been instructed to establish two-way communications with 

their local and State contacts so they are apprised of the local situation as it changes and they are advised of local actions that 

should be taken. 

The objective of all this is to flatten out the absentee curve at 

all affected sites and maximize our production to serve our customers and members during the peak of each wave. It is our hope 

that if strategies are employed effectively, we believe we can lessen 

that peak absentee curve by about 5 to 10 percent, and this would 

make a big difference if we could do that. There is no scientific evidence in that; that is just our belief internally. 

Last, a separate but very significant part of our response capability is the ability to deal with member needs due to widespread 

disasters, such as hurricanes, wild fires, or terror attacks. We have 

established a dedicated team to review health benefit policies that 

may need to change due to a provider network overload, or due to 

provider network failure, or due to a mass evacuation as in Hurricane Katrina. 

Changes once identified through our evaluation or due to regulator order will be communicated to members and plan sponsors so 

that they can avail themselves of alternate ways to obtain the care 

they need. This process has been successfully demonstrated on September 11, 2001, and in natural disaster after disaster, in recent 

years, and would be implemented if necessary during a pandemic 

as well. 

We thank you for the time today. 

Chairman LIEBERMAN. Thanks, very much, Mr. Aloi. That was 

really interesting. I am going to come back and have a few questions for you. 

The final witness, and we thank you for being here. Michael 

Kurland is the Director of Student Health Services at the University of Connecticut. We know that college campuses have been an 

area in some cases where there has been an outbreak of H1N1. The 

Coast Guard Academy had one here earlier in the year, and then 

some other campuses around the country have been really quite severely impacted. 

So I will be interested in hearing what you are doing and also 

to what extent you are reacting to what you have learned from 

your colleagues at the other campuses that have been more impacted. But thank you for coming. 

72 

1The prepared statement of Mr. Kurland appears in the Appendix on page 246. 

TESTIMONY OF MICHAEL KURLAND,1 DIRECTOR, STUDENT 

HEALTH SERVICES, UNIVERSITY OF CONNECTICUT 

Mr. KURLAND. Thank you so much for letting me speak. The 

message I am really going to convey is that the key strategy in 

dealing with any type of H1N1 preparation is collaboration and 

partnership among many university departments, the Connecticut 

State Department of Public Health, local health districts, Centers 

for Disease Control and Prevention, Department of Education, and 

the American College Health Association. So it is a team effort, and 

we are partnering with parents and with students. 

The University of Connecticut has a Pandemic Flu Continuity of 

Operations Committee, which follows an operational plan based 

upon the National Incident Management System (NIMS) model. 

The committee is comprised of representatives from a number of 

departments throughout the university, including Student Affairs, 

Student Health Services, Facilities, Academic Affairs, Public Safety, Environmental Health and Safety, Human Resources, the Office 

of the Attorney General, the Office of Communications, Finance, 

our regional campuses, and experts in emergency preparedness 

from our continuing studies area. 

The committee has been meeting for the past several months in 

order to plan for all aspects of the health, safety, and continuity 

of operations in the event of an H1N1 flu outbreak. The committee 

is chaired by Major Ron Blicher, who is sitting directly behind me. 

He serves as the incident commander, and in my capacity as director of Student Health Services, I serve as the operations section 

chief. 

Additionally, the Division of Student Affairs maintains an H1N1 

task force, which has been meeting weekly in order to operationalize plans for the health and safety of students and staff. This 

task force is comprised of representatives from Student Affairs, 

Student Health Services, Residential Life, Dining Services, the Office of Student Services and Advocacy, and Wellness and Prevention Services. Meetings have included staff from Environmental 

Health and Safety also. 

The issues that we have been addressing include but are not limited to the following: Prevention strategies in community education. The university is embarking upon a multifaceted health 

communications campaign in order to help prevent the transmission of the H1N1 virus. The focus is on respiratory etiquette, 

social distancing, proper handwashing, staying healthy, proper 

cleaning of personal and work space, and encouraging students and 

staff to self-isolate if they are infected with the flu. 

The methods of dissemination of information include bulletin 

boards, pamphlets, table tents, curriculum infusion, mass e-mails, 

letters, use of a dedicated H1N1 Web site, training of staff, cable 

TV, and radio PSAs. 

The Web site includes many helpful links as well as frequently 

asked quetions pages for both employees and students. Additionally, students have been encouraged to be prepared and to purchase supplies of hand sanitizer, fever reducing medications, fever 

thermometers, and surgical face masks. Hand sanitizer has been 

73 

made readily available in many public areas of the university and 

has been disseminated to students by many departments throughout the university. 

Isolation and support services: The key to preventing transmission is to encourage isolation of sick people. I might add, UConn 

has over 20,000 students and we have 12,400 students living on 

campus. Students who are ill are encouraged to call an advice 

nurse to seek medical assistance for the flu. They are provided with 

an assessment via the phone and are requested to visit the Student 

Health Services, only if medically indicated, in order to avoid burdening the healthcare system and to reduce potential virus transmission. 

They are encouraged to remain isolated if they do not share a 

bedroom with another student. If they share a bedroom with another student, they are asked to return home if their family lives 

within driving distance. Fortunately, 85 to 90 percent of UConn 

students live within driving distance of our campus. 

If it is unfeasible for a student to return home, the university 

has designated a number of beds to provide isolation for these individuals. Students who are self-isolating or have been moved to an 

isolation area are provided with meals delivered from dining services, and are provided with a limited supply of flu kits and supplies 

such as Tylenol, Advil, fever thermometers, and surgical face 

masks. If medically indicated, they will be admitted into the infirmary unit (or inpatient unit) of the Student Health Services facility. 

In terms of academic consideration, in order to reduce the transmission of H1N1, students are advised to be absent from classes if 

they have the flu. Professors have been advised to not require medical excuse notes and to expect higher than normal rates of absenteeism. Additionally, professors have been encouraged to utilize 

Web-based course tools which can assist students in keeping up 

with the curriculum in the event of illness. 

Vaccination is also very important. Students are encouraged to 

receive both the seasonal flu vaccine as well as the H1N1 vaccine. 

Seasonal flu vaccine clinics have already been scheduled. They are 

going to be earlier than usual. We are going to have them next 

week. H1N1 vaccination clinics will be scheduled as soon as the 

vaccine is available. Doses of H1N1 have already been requested 

through the Department of Public Health and will be provided free 

of charge to all students who fall within the target groups, defined 

by the Centers for Disease Control and Prevention. 

As I mentioned previously, we have had coordination with many 

outside resources. The university has been in close contact with the 

Connecticut Department of Public Health and has coordinated with 

the Eastern Highlands health district, which is one of those 41 

health districts that was referred to earlier. And they are the local 

health department for our local 10 town area. 

Now, the current status at UConn, as of this week, we have been 

very fortunate. We only have one confirmed case of H1N1, two 

probable cases of H1N1, less than 20 cases of influenza-like illness. 

We are, of course, monitoring the situation closely as we know it 

can change at any time. 

74 

Some of the challenges that we face are maintaining an ample 

number of isolation beds as the university residents halls are at 

100 percent capacity, so there is no swing bed space. 

Another challenge is maintaining continuity of operations in the 

event of large numbers of employee absences. UConn is its own little city. We have a sewage department. We have dining services. 

We have a police department, a fire department, and a payroll office. You name it, they are all essential, and we need to maintain 

continuity of operations. 

Another challenge is maintaining an adequate amount of supplies to care for those who are sick with the flu. They are not really 

readily available. There are back orders on a number of the supplies. Also, deciding when to cancel public events or classes due to 

a large number of cases of the flu; there is no magic number. It 

is a challenge. 

Another challenge is staffing H1N1 vaccination clinics for an unprecedented number of inoculations. If all 20,000 of our students on 

the Storrs campus decide to get an inoculation, that is a lot of people to vaccinate with limited staff. And then, the last challenge is 

the cost of supplies and personnel to accommodate the outbreak. It 

is not cheap. 

Thank you very much for allowing me to speak. 

Chairman LIEBERMAN. Thank you. Let me ask you a few questions. I am interested in the idea of telling students who live within driving distance to go home. 

Does the university define driving distance? 

Mr. KURLAND. That is a great question. My definition of driving 

distance and other people’s definition of driving distance may not 

be the same. But two to three hours would be a reasonable driving 

distance. We have had students from New Jersey already go home, 

students from Massachusetts and Maine. 

The key thing is they cannot drive themselves and they cannot 

go on public transportation. 

Chairman LIEBERMAN. Right. 

Mr. KURLAND. So it really needs to be a family or friend. 

Chairman LIEBERMAN. That seems like a reasonable rule, taking 

any student from Connecticut and then from the surrounding 

States as well. 

Do you think that the students are taking the H1N1 pandemic 

seriously, in the sense that if vaccines become available, there really will be a large demand among the UConn students? 

Mr. KURLAND. I would hope so. I know the students are very 

knowledgeable. Massive information campaigns are out there, at 

the State level, at the Federal level, and at the university level. I 

know they are aware of the precautions. Whether they are taking 

those precautions, time will only tell. But they have found at a 

number of universities that cases have begun to spike after the sorority and fraternity rush and other large events that do not promote social distancing. 

I would hope that most students would avail themselves of the 

vaccine when the vaccine is readily available because they are in 

the target risk group of those up to age 24. 

Chairman LIEBERMAN. Well, that is an important point. 

75 

Mr. KURLAND. In Connecticut, the median age of people who 

have contracted H1N1 is age 14, so it is a much younger population. 

Chairman LIEBERMAN. So the small number of cases is good to 

hear but do you have it at UConn now? 

Mr. KURLAND. Right. 

Chairman LIEBERMAN. But I presume there were more in the 

spring? 

Mr. KURLAND. No. We had no confirmed cases in the spring. 

Chairman LIEBERMAN. Oh, that is great; a healthy population up 

there. 

Mr. KURLAND. No, lucky. 

Chairman LIEBERMAN. They do not call them Huskies for nothing. [Laughter.] 

Mr. KURLAND. If you were to look at a map of—and Dr. Cartter 

probably would have explained it. But the flu moves up from New 

York City. It started in Fairfield County. By the time it got to 

Windham and Tolland County—— 

Chairman LIEBERMAN. That is interesting. 

Mr. KURLAND [continuing]. It was later in June. So we were just 

lucky because we graduated them and sent them home before they 

could get sick. 

Chairman LIEBERMAN. Yes, great. 

Ms. Wright, tell me about what you understand to be the role of 

the schools in a vaccination program once the vaccines become 

available? 

Ms. WRIGHT. Since the Public Health Department does oversee 

the 39 school nurses, once the vaccine does become available to the 

student population, we have every intention of going into the school 

district and taking care of Waterbury students. 

I am not sure what other directors of health are doing. Their 

pandemic flu plans, I believe, are due the first week in October, so 

everyone is starting to talk about that now. But we have been talking with the mayor’s office and the superintendent of schools. 

Our biggest obstacle that we need to overcome is we need to develop maybe a team of nurses. We cannot utilize the school nurse 

that is in the building. Our middle school nurse might see 110 students a day, so you cannot pull her. And our hope is to go from 

classroom to classroom to keep it more organized and really try to 

keep the educational continuity the same. 

Chairman LIEBERMAN. Interesting. So what you will do then is 

to bring some nurses on—— 

Ms. WRIGHT. Bring a team of nurses to each school. And our middle and our high schools are our largest populations, of over 1,200 

students, so we will probably take a much longer period of time in 

those buildings in terms of dates. 

Chairman LIEBERMAN. Right. 

Ms. WRIGHT. And then we are hoping that the elementary 

schools, the private, and the parochials, some of which are about 

200, will be a little bit easier for us. 

Chairman LIEBERMAN. I presume that the Public Health Department of a city like Waterbury would be a natural place for the distribution of vaccines generally to vulnerable populations. In a week 

76 

and a half or two, we expect the first wave of vaccines that you 

heard today, when the nasal spray comes available. 

What are your plans about how to handle this? 

Ms. WRIGHT. Well, our guidance will come from the State Health 

Department in terms of where the vaccine will actually land once 

it hits Waterbury. But we are talking to our medical providers, and 

the medical providers are now signing up to be vaccinators. 

We will help them if we need to. We put ourselves out there as 

the Public Health Department to hold public health clinics. And 

again, our flu plans are all due, so once we start putting things 

down in writing—and once we really have to figure out how many 

vaccines are coming to Waterbury because that is going to depend 

on where our push is. 

Chairman LIEBERMAN. So you will be the point of distribution for 

Waterbury to private providers; is that right? 

Ms. WRIGHT. We probably will be, but, again, that guidance has 

to come from—— 

Chairman LIEBERMAN. It is not clear. But you will certainly be 

one of the points of distribution for people who come in and show 

that they are in one of the vulnerable or priority populations, and 

you will give them the vaccine right there. 

Ms. WRIGHT. Yes. We are hoping that they do stay with their private provider. Their private provider actually knows their medical 

history and will be able to interview them much better than we 

will. They will have their medical record. But in the event that 

they cannot, then, yes, we hope to—the health department always 

views itself as the last safety net, and we hope to definitely do that. 

Chairman LIEBERMAN. Good. Mr. Aloi, just a couple of questions 

for you. I was fascinated, if I heard you correctly, that one-third of 

the Aetna workers in the State telecommute or work by telephone 

all the time or part of the time? 

Mr. ALOI. Nationally, yes. 

Chairman LIEBERMAN. Nationally. So it may be a little off for 

that in Connecticut, but that is the national number. 

Mr. ALOI. Right. We invested very wisely a few years ago in a 

very robust backbone of infrastructure that can take connectivity 

from home teleworkers through the Internet. So we can accommodate almost our entire staff that way if we had to. So one-third has 

already transitioned to telework. 

Chairman LIEBERMAN. That is impressive. 

Mr. ALOI. Yes, we are one of the leading companies in this area, 

and we are finding very good results from happiness in employees, 

productivity, saving of money for travel, all kinds of benefits from 

it. And it just happens to help us a great deal for this threat. 

Chairman LIEBERMAN. So in this case, if you have somebody who 

is showing the symptoms of H1N1 flu, you can ask them to telecommute for a while. 

Mr. ALOI. Well, if they are showing symptoms, we are going to 

send them home because we do not want them in the workplace. 

Chairman LIEBERMAN. That is what I mean. You are going to 

send them home. 

Mr. ALOI. Once they get better, then a decision will be made 24, 

48 hours, whatever, to bring them back. 

77 

Chairman LIEBERMAN. I presume it takes some kind of capital 

investment, or does it, to enable a worker to work from home? 

Mr. ALOI. Yes. 

Chairman LIEBERMAN. So if a worker was going to be out 3 or 

4 days, it would not be worth it? 

Mr. ALOI. Right. 

Chairman LIEBERMAN. I got you. 

Mr. ALOI. The group I was talking about that we would send 

home would be—and this is some of the things we are looking for, 

for the triggers, is that once it is so significant and so severe in any 

given area, we are going to go to the next level, which is, as I said, 

the social distancing. And part of that social distancing is to send 

as many of those critical workers home because we know that, 

sooner or later, their children are going to be at home and they are 

not going to be able to come to work due to that. And also it will 

help minimize the spread in the workplace because you have a lot 

less folks there able to communicate it to each other. So we can go 

to the next level if we have to. 

Chairman LIEBERMAN. A question about a different kind of Aetna 

relationship to this. 

Ms. Polansky talked about the obvious problem with a working 

parent—let’s say two working parents—when a child is sent home 

from school. 

Has Aetna adjusted its policies in any way to deal with that, particularly if the H1N1 becomes more prevalent than it is now? 

Mr. ALOI. It behooves us to accommodate workers that are encumbered by sick loved ones at home because they are more apt 

to be able to at least spend part of the day at home working for 

us versus losing their whole day of productivity. So they also would 

be prioritized up front for the first wave of folks to be sent home 

and set up pretty rapidly. We can do that in about 24 hours on average. 

Chairman LIEBERMAN. Is there a company policy that shows 

some leniency toward parents that have to go home and take care 

of a sick child? 

Mr. ALOI. There will be a filtering process. Those that are predisposed to a high risk group, of course, that have not received the 

vaccine, we would want to make sure they get home, and that is 

going to minimize their risk. Then next is a mission-critical worker. 

Chairman LIEBERMAN. Let me ask you the broader question because obviously Aetna is a big business and in some sense, therefore, has the capacity to invest in systems like this, and also happens to know the area because it is a health insurance company. 

I asked you earlier and you mentioned that you are doing some 

work with business customers, advising them about this. I am 

thinking particularly of smaller businesses 

What is your impression of how they are handling the potential 

for a spread of this pandemic? 

Mr. ALOI. We get a lot of questions from customers, big and 

small, on recommendations on how they should prepare because 

they see us as one of the experts in the field. We have to that end 

created messaging on our sales Web, which are our account managers who communicate with our customers. And also we have provided policies and recommendations on employer preparations, and 

78 

then also linked it over to CDC and other federally available guidance that we use ourselves, which is the CDC recommendation on 

business preparation. So we push them in that direction. 

Chairman LIEBERMAN. So that is very good. Are you affirmatively sending out guidance to the business customers? 

Mr. ALOI. Yes, we are. And we also, as I said earlier, make our 

course available, the handwashing and the good practices. It is an 

online course. It only takes about 10 minutes. We have made that 

available, free of charge, to all our customers. 

Chairman LIEBERMAN. Are people using it as far as you know? 

Mr. ALOI. Yes. We are getting pretty good hits, especially when 

April occurred; everybody went back and re-took it that had taken 

it in 2006. 

Chairman LIEBERMAN. That is great. 

I have no further questions. You all have been extremely helpful. 

I must say I am impressed by how our society gears up, governmentally, but also in a lot of different private ways, including by 

an active parent, to deal with the problem. And I think it is part 

of the reason, though we never know, why we are prepared to inhibit the spread of this as we go through this second wave. 

As the earlier panel said, and we all know, we have to remain 

flexible and ready because this could take a lot of twists and turns 

before it is over, and a lot of people’s health and, worse, lives will 

be on the line. 

I really thank you for coming in. It has been very helpful. I leave 

here reassured by our state of preparedness, not with any superior 

knowledge about what path the influenza will take, but that in 

many ways we are prepared. And also, in the broader sense that 

I said this, every time we get ready to deal with something like 

H1N1, we also prepare ourselves to deal better with other kinds of 

public health or natural or unnatural disasters, like terrorist activities, so that is encouraging in all those ways. 

We will leave the record of this hearing open for 7 days. If there 

are any further questions or statements—you may want to add to 

your statements. Others on the panel may want to ask you a question; even I may want to ask you some questions in writing. But, 

again, I thank you. It is good to end a hearing feeling encouraged 

about our state of preparedness. 

The hearing is adjourned. 

[Whereupon, at 12:15 p.m., the Committee was adjourned.] 

(79) 

H1N1 FLU: MONITORING THE NATION’S 

RESPONSE 

WEDNESDAY, OCTOBER 21, 2009 

U.S. SENATE, COMMITTEE ON HOMELAND SECURITY AND

GOVERNMENTAL AFFAIRS, Washington, DC. 

The Committee met, pursuant to notice, at 9:36 a.m., in room 

SD–342, Dirksen Senate Office Building, Hon. Joseph I. Lieberman, Chairman of the Committee, presiding. 

Present: Senators Lieberman, Carper, McCaskill, Tester, Burris, 

Kirk, Collins, McCain, and Bennett. 

OPENING STATEMENT OF CHAIRMAN LIEBERMAN 

Chairman LIEBERMAN. Good morning. The hearing will now come 

to order. We have called today’s hearing to discuss measures that 

are being taken to manage the spread of the H1N1 influenza virus, 

which reached pandemic proportions this summer and continues to 

claim new victims every day, especially among young people. 

I want to thank Homeland Security Secretary Janet Napolitano, 

Health and Human Services Secretary Kathleen Sebelius, and Education Secretary Arne Duncan for being with us today. These are 

the three Federal officials who have really been coordinating the 

Federal Government’s and our Nation’s response to this public 

health challenge—I would call it now a ‘‘crisis’’—and we very much 

appreciate that you made the time to be with us here today for this 

oversight hearing. 

Each of your agencies has critical responsibilities for dealing 

with the H1N1 public health emergency that has already taken the 

lives of thousands and thousands of people across the globe. Here 

in the United States, the Centers for Disease Control and Prevention (CDC), I gather, are no longer counting cases because of the 

difficulty of staying on top of the increasing numbers and confirming those numbers. But we do know that at least 2,300 people 

have died in the United States from the H1N1 flu in the last few 

months. 

Under existing Federal Government emergency protocols, the Department of Homeland Security (DHS) is the overall incident manager, coordinating resources across the Federal Government and 

assisting State and local governments in their response to the 

H1N1 virus. The Department of Health and Human Services 

(HHS), including the CDC, has been responsible for leading the 

public health and medical response. And because this H1N1 outbreak poses greater risks for children than the traditional flu, the 

80 

1The chart submitted for the Record by Senator Lieberman appears in the Appendix on page 

251. 

Department of Education has helped guide local districts on how to 

protect their students, under what circumstances to close schools, 

and what to do if a school must be closed. 

This particular strain of influenza—H1N1—has moved with 

alarming speed and taken an exceptionally high toll at a time of 

year when we do not normally encounter significant cases of flu. 

The CDC reports that the H1N1 flu has spread to all parts of the 

country, with almost all States reporting widespread or regional 

outbreaks. 

I want to draw your attention to this chart that my staff has prepared.1 It is actually from the CDC, and we have blown it up. It 

gives you a sense—the three lines chart—of the course of the flu 

outbreak over the preceding three seasons. This is what you might 

call normal flu, seasonal flu, and you can see that the spikes occur 

in January, the highest being 2007–08. It went way up here. We 

are in October now, of course, and these lines all go down to a low 

point, except for the red line, which is the H1N1 outbreak, which 

is now, at a time of year that is normally low in terms of flu impact, higher than the regular flu was at its peak in January. Of 

course, this raises real concerns for us about where this line will 

go in the months ahead. 

Alarmingly, what we do know is that young children are at very 

serious risk, with 43 pediatric deaths tallied so far—11 of which occurred just the week before last, the most recent period for which 

we have data. These pediatric mortality statistics for H1N1 flu are 

already equal to what we usually see over the entire course of a 

normal flu season for children. Presumably, and regrettably, these 

numbers will climb higher as the outbreak shows no signs of waning. 

Pregnant women are also being hit hard by the flu. Of the 100 

pregnant women who required intensive care through late August, 

there were 28 deaths. The CDC, obviously, is concerned about that. 

Thus far, the Federal Government, I will say to the three of you 

Secretaries and your agencies, have responded aggressively and I 

think as effectively as possible to the threat of the H1N1 virus. You 

have quite skillfully tracked the spread of the disease and who it 

is afflicting. You have worked with private sector partners to pull 

off what to us non-science majors looks like a miracle, which is to 

develop a vaccine quickly. You have provided important information to guide State and local officials through perils they may face 

as the virus escalates. And you have remained very publicly accessible and visible, communicating critical developments in this public health emergency to the American public. 

I presume that previous presidential directives and national 

strategies for infectious diseases and influenza pandemics that 

were issued over the last several years informed and in some sense 

facilitated your decisions, which proves again the immense value of 

planning. So there is a lot that should be reassuring and encouraging to the American people. 

I want to say frankly to you this morning that I am concerned, 

as we meet this morning, that the flu is spreading so rapidly and 

81 

in some cases with such intensity that it may well be getting ahead 

of the Federal Government’s ability and the public health system’s 

ability to prevent and respond to it. And I want to give you three 

reasons why I have these concerns and, of course, ask you to respond during your testimony. 

First, the schedule for the production and availability of vaccine—whose existence was really quite remarkable—has slipped. 

The 28 million to 30 million doses that will apparently be available 

by the end of the month is 25 percent below initial governmental 

projections of the 40 million vaccines that you thought would be 

available by the end of October. And there are now very unsettling 

reports of growing vaccine shortages that are leading a lot of people 

to ask us, and we are asking ourselves, if enough vaccine will be 

produced in time for all who will need it as we continue to experience the spread of H1N1 flu. 

This week, one television reporter used the term ‘‘quiet desperation’’ to describe the feeling of public health officials around the 

country facing shortages of the H1N1 vaccine in their areas, and 

I am sure that is as unsettling and unacceptable to you as it is to 

the rest of us. 

Second, I want to express my concern that hospitals and Public 

Health Departments do not have the capacity to care for the surge 

of people who may need hospitalization as a result of the spread 

of the virus. And here I am going to refer to a recent report—and 

this is not a stunning new problem. We have worried in terms of 

this pandemic—and, of course, the concern that this Committee as 

the Homeland Security Committee has generally—about the capacity of our public health system, for instance, to deal with the consequences of a bioterrorist attack on the United States. 

I want to quote from a report this month from the Trust for 

America’s Health that found that 27 States, including my own 

State of Connecticut, could exceed or come close to exceeding available hospital bed capacity during the peak of the outbreak if 35 

percent of the American people become infected with the flu, which 

the Trust says is a plausible number. Just to make it more explicit, 

based on the 35-percent modeling scenario, more than a million 

people in Connecticut could develop the H1N1 virus, which would 

result in more than 17,300 hospitalizations at the peak of such an 

outbreak, which is about 150 percent of the total hospital bed capacity in Connecticut. I am sure that situation repeats itself in 

other States and throughout the country. So that is my second concern. 

The third is about the availability of intravenous antiviral medications to treat people who are critically ill with the H1N1 virus. 

Secretary Sebelius, you have an encouraging but general sentence 

in your prepared testimony about this. And here I want to go from 

a report by the President’s Council of Advisors on Science and 

Technology (PCAST), which posed a plausible scenario in their case 

in which 30 percent of the population would be infected with the 

H1N1 virus, resulting in almost two million hospitalizations. But 

what particularly struck me is their estimate that between 150,000 

and 300,000 of those hospitalizations could be so serious that they 

would require intensive care treatment, Intensive Care Unit (ICU) 

treatment. A lot of those people, from what I have heard from docVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000089 Fmt 06601 Sfmt 06601 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
82 

tors, are probably not going to be able to be treated with the existing antivirals, such as Tamiflu and Relenza. The encouraging part 

of this story—and I want to ask, to the extent you can this morning, Secretary Sebelius, to tell us about it. I know that HHS under 

the Biomedical Advanced Research and Development Authority 

(BARDA) program, which Congress adopted and the President 

signed a couple of years ago, has actually been very farsighted 

about this and invested some money in some breakthrough work 

that is being done to develop intravenous antivirals for those who 

are critically ill with this flu. But this is one of those moments that 

poses a public health, also a kind of ethical, moral dilemma because I gather that they have not fully completed all the trials, but 

at least one of them appears to be moving along, and it is under 

the capacity that the Food and Drug Administration (FDA) has to 

grant compassionate usage authorization. These intravenous (IV) 

antivirals have been used in some critical cases, and I gather generally, though not in every case, have saved the lives of some people who their doctors at least thought would have died otherwise. 

So I want to hear from you and probably will ask you about the 

state of development and of decisionmaking about the availability 

of those intravenous antivirals. 

Bottom line, the three of you, your departments, and all who are 

working with you have worked very aggressively and to the best 

of your ability. It is just my concern as we meet this morning that 

this flu, the H1N1 virus, is moving very rapidly. And while it 

seems to still be affecting most people mildly, it is clearly affecting 

a small percentage, but nonetheless a significant number of people, 

quite seriously. And so, I repeat, I am worried that the virus is getting ahead of the public health system’s capacity at this moment 

to prevent it and respond to it, particularly with adequate treatment. So it is in that spirit that I thank you for being here, and 

I very much look forward to your testimony. 

Senator Collins. 

OPENING STATEMENT OF SENATOR COLLINS 

Senator COLLINS. Thank you, Mr. Chairman. 

By now, everyone in this room is familiar with the threat that 

we currently face from the H1N1 virus. This oversight hearing is 

important, however, because we must continually assess the effectiveness of Federal, State, and local efforts to respond to this pandemic, which appears to strike pregnant women, young children, 

and young people with particular ferocity. 

Just this past week in Maine, Bates College made the news when 

the number of H1N1 flu cases jumped from 6 to 160 in less than 

a week. As of yesterday, 245 Bates students are infected with 

H1N1. 

Public health experts are learning as they go along, sometimes 

with surprising results that run counter to their earlier assumptions about H1N1. For example, the CDC just released a report 

that found that 46 percent of 1,400 adults hospitalized with H1N1 

were healthy and did not have underlying chronic illness before 

they got sick with the flu. While this was a preliminary analysis, 

the new report paints a different picture than previous studies, 

which had concluded that the vast majority of H1N1 patients who 

83 

became severely ill had chronic or other underlying health conditions. New data like this report must constantly be taken into account as we handle our Nation’s pandemic flu. 

It is clear that much work and preparation has gone into preparing for this outbreak. Our country has mobilized as government 

officials at all levels, doctors and other health care professionals, 

nonprofit organizations and private businesses have devoted significant time and resources to tackling the many challenges posed 

by this virus. Principals in the State of Maine have told me that 

virtually every school in Maine has a plan for dealing with the pandemic flu. 

The Post-Katrina Emergency Management Reform Act of 2006, 

which was written by this Committee, mandated comprehensive 

and coordinated disaster planning to improve our preparedness and 

response for both man-made and naturally occurring catastrophes 

like this pandemic. In addition, Congress has allocated nearly $9 

billion to HHS alone over the past 5 years for pandemic preparedness. These efforts have laid a strong foundation for the response 

that we have seen to date. 

Nonetheless, while the government and private sector have accomplished a great deal, significant concerns remain. For example, 

despite the repeated assurances of Federal officials, millions of 

Americans nevertheless remain worried about the safety of the vaccine. They want to know if it is safe to give to their children, what 

kind of testing was done, and whether it contains any dangerous 

additives. The State CDC in Maine reports many calls from citizens 

asking these questions. 

State officials also remain concerned about whether there will be 

a sufficient number of doses of the vaccine. In the next 8 weeks, 

the State of Maine is scheduled to receive only 340,000 doses of the 

vaccine. This falls short of the amount needed to vaccinate everyone in the priority groups that the CDC has identified. 

Like the Chairman, I am very concerned about recent reports on 

inadequate supplies of the vaccine. The CDC has been telling us 

since last September—or since earlier this year that the Federal 

Government had purchased 250 million doses of the vaccine, of 

which 40 million would be available by the end of this month. It 

now appears, as the Chairman indicated, that production delays 

will result in 25 percent fewer doses than had been projected for 

October. This disturbs us because we are seeing such an early peak 

in the flu. 

Another issue is whether or not we have a sufficient supply of 

pediatric formulations of the antiviral medication Tamiflu. That is 

particularly important since the virus disproportionately affects 

children. There are also reports of phony Tamiflu being sold over 

the Internet. 

Another significant concern that the Chairman has raised and 

that I share is whether or not our Nation’s emergency rooms have 

sufficient capacity to cope with a massive influx of sick patients if 

the pandemic worsens. 

The fact that three Cabinet Secretaries are here today demonstrates the seriousness with which the Federal Government is 

preparing for and responding to the H1N1 pandemic. I look forVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000091 Fmt 06601 Sfmt 06601 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
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1The prepared statement of Secretary Napolitano appears in the Appendix on page 255. 

ward to hearing from our witnesses, particularly on the issue of 

shortages of the vaccine. Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thanks very much, Senator Collins. 

We will go to Secretary Napolitano first. Just to say for the 

record, this Committee has a particular interest in this oversight 

hearing because we are the Homeland Security Committee. Secretary Napolitano regularly is in contact and works with us, of 

course, and she is the incident manager for this response with 

overall responsibility. 

And I would just repeat very briefly that this Committee was 

given homeland security jurisdiction in response to September 11, 

2001, and the concern of raising our defenses to terrorist attack, 

but also, of course, to prepare for natural disasters and threats 

such as this one. So I thank you for all your good work in that regard and welcome your testimony now. 

TESTIMONY OF HON. JANET A. NAPOLITANO,1 SECRETARY, 

U.S. DEPARTMENT OF HOMELAND SECURITY 

Secretary NAPOLITANO. Well, thank you, Mr. Chairman, Senator 

Collins, and Members of the Committee, for the opportunity to update you on the steps we have taken Americans for the H1N1 flu. 

In April, I testified before this Committee that DHS and our Federal partners were addressing this situation aggressively and collectively. That was true then; it is true today. 

As you note, Mr. Chairman, under Homeland Security Presidential Directive 5, the Department of Homeland Security is the 

lead coordinator, but we work with our Federal partners in a very 

close way. We have actually been joined at the hip over the past 

months. The Department of Health and Human Services, of course, 

with the CDC is the lead on issues related to the public health and 

vaccine. The Department of Education, as you note, under the leadership of Secretary Duncan, is the lead with respect to our schools 

and our young people. But there are many other departments of 

the Federal Government that you could have at this table that 

have been working with us in planning for the flu, and let me just 

note that our planning has assumed that there would be some gap 

period between when vaccine would be commonly available and 

when the flu would actually be present. In other words, we have 

assumed a lag time between the flu spiking and vaccine availability. So if you were to look at the planning, you would see that 

was built in. 

In addition, we are working with State, local, and tribal partners 

on their planning and prevention issues, and, importantly, we are 

working with the American people. They are really our most important partners here. Communicating the message about how they 

can just by very simple actions, like washing hands and coughing 

properly, help slow the transmission of this virus. 

Let me, if I might briefly, update you on the activities since 

April. 

First, there has been, as noted, extensive Federal interagency 

work and planning that has gone on. We have been working on 

preparation and response actions. We have been making sure that 

85 

mission-critical, mission-essential functions could continue to be 

performed. We have clarified workforce protection steps, and we 

have been in constant communication with key stakeholders—State 

and local governments, the public, our employees, and the like. 

We are also coordinating planning across the Federal Government for continuity in case, in light of this pandemic, we really see 

a surge in absenteeism as well as a surge of entrants into our 

health system. The Federal Emergency Management Agency 

(FEMA) has been coordinating that planning. They have now reviewed continuity plans for all Federal agencies and conducted 30 

training sessions over the summer in terms of continuation of operations and continuation of government during a pandemic. We call 

that COOP and COG, but that is really what it is about: How do 

we work our way through this and make sure the business of the 

country continues? 

We have—and this goes to your point, Senator Collins, about the 

need to continually update data—deployed a common operating picture. It is updated. It is a Web-based tool. It collects all data 

around the country of all different types and provides that data 

both to the government and to the private sector. I myself get an 

update at least once a day from the common operating picture 

about what we are seeing on H1N1 across the country. 

We have clarified issues about workforce protection. This was 

one of the areas that was unclear in the spring outbreak of the disease, and we have provided guidance to employees based on the 

best science available as to what needs to be done and on human 

resources flexibility, personal protective equipment, and the like. 

And all of this guidance, by the way, is available on our Web site. 

I mentioned State, local, and tribal governments. We have 

through FEMA provided training to 56 Incident Management Assistance Teams (IMAT). These teams are designed to be available 

should a State or locality say, ‘‘We need help.’’ The surge in H1N1 

we are seeing is beyond what our own planning has accommodated 

or accounted for and our own personnel can handle. Those IMAT 

teams are on the ready, and we also have a national team. The Office of Intergovernmental Programs at the Department has biweekly calls with all State homeland security advisers. 

One of the lessons learned from this spring, Mr. Chairman, was 

that we had a pretty robust homeland security communications 

system here, and HHS had a very robust system of communicating 

with public health directors, but they were not communicating with 

each other oftentimes at the local and State level. Lashing those 

things together has been one of our efforts over the summer, and 

it is going to be not only one of the lessons learned, but one of the 

improvements made in light of the H1N1 epidemic. 

Over the course of the summer, the Department, with HHS, the 

Department of Education, and others, has released updated guidance for schools, for small businesses, for others affected or impacted by the flu, by this new strain, so they can do their own 

planning. 

We have also been engaged in private sector outreach. We have 

released, with the Department of Commerce, updated private sector guidance. We also have been meeting with critical infrastructure and key resource leaders, again, under the theory that we 

86 

1The prepared statement of Secretary Sebelius appears in the Appendix on page 266. 

could have a surge before everyone is vaccinated, and we need to 

keep the business of the country moving with particular attention 

paid to critical infrastructure. So it is basic things: How to ensure 

continued operations, ways employees can protect themselves, 

human resources steps companies can take during a severe pandemic. And there have been daily update calls over the course of 

the past weeks, particularly with our key private resource partners. 

Last but not least—it was not mentioned in either of your statements, but we did talk about it in April—is the international aspect of this, particularly with response to Mexico and Canada. Suffice it to say that we have been working with both of those countries. The Deputy Secretary was in Mexico City just 2 weeks ago 

to meet with our Mexican and Canadian counterparts to review 

emergency information sharing, communications, and issues with 

respect to our borders. 

Through this all, we have been, as I said earlier, making assumptions that we will work our way through this flu epidemic 

over several months, and during part of that time, the vaccine 

would not be commonly available. 

With respect to the surge issue in the health care arena, while 

the Secretary of Health and Human Services, Secretary Sebelius, 

will address a lot of the vaccine and public health issues that are 

of concern at today’s hearing, let me just share with you that there 

has been at least $3 billion shared with hospitals throughout the 

country to do surge planning. And not only that, we know from our 

own review of what is going on in States and localities that many 

health providers across the country have plans, for example, if necessary, to handle patients outside of the hospital, outside of the 

emergency rooms (ERs), so that the actual acute care is reserved 

for those who are most in need of it. And it can be anything from 

in some cities actually doing some triage in tents, should they need 

to. Houston and Kansas City are two examples of that. In Albuquerque, New Mexico, they are using an old cancer center as a 

place to handle flu patients during the course of the height of this 

pandemic. So a lot of that sort of surge planning has gone on. 

Let me close in just a moment and thank the work of this Committee and my predecessors at DHS. They had done a lot of the 

groundwork on pandemic. We have taken that many steps forward 

in light of the different nature of this flu. It is not the same as 

avian flu. It has different issues with respect to homeland security 

planning, but, nonetheless, we worked from a basis that was quite 

well done. 

Chairman LIEBERMAN. Thanks very much for that testimony, 

Madam Secretary. 

Secretary Sebelius, welcome and we look forward to your testimony now. 

TESTIMONY OF HON. KATHLEEN SEBELIUS,1 SECRETARY, U.S. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Secretary SEBELIUS. Thank you, Mr. Chairman. Chairman 

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mittee, I am pleased to have a chance to appear with my colleagues 

and give you an update at this critical time. And I would start by 

echoing what Secretary Napolitano has said, that the collaboration 

and cooperation of not only the three of us representing three critical front-line agencies but across this government has been remarkable, and we have had wonderful results also with State and 

local partners, tribal partners, the private sector, and others. There 

is no question that we would not be where we are today without 

that collaboration. 

I wanted to point out to the Committee Members that you have, 

I think, packets at your desks which have a couple of important 

pieces of information. We believe strongly, as the President indicated from the outset, that we should be guided in our response by 

the science, and CDC is our lead agency for the science-based advice. Dr. Anne Schuchat, who is with me today, has been widely 

available, but what I have given to Committee Members is a situational update as of October 21. These updates are now being done 

twice a week by CDC to give you an overview. We have some information that gives you some ideas of the kinds of things we have 

been putting forward for business and employers and the private 

sector, and then some examples of what is on flu.gov. And, Mr. 

Chairman, I would tell you that our flu.gov Web site, which early 

on was constructed as a sort of one-stop shop, is now getting 5 million hits a week. So people are using that tool, and I think that 

is very good news because it gives some regular detailed, scientific 

information on a consistent basis. 

We have some good news about this flu epidemic. The virus has 

not changed significantly since April, and that means that the vaccine target is appropriate. It is getting a robust response. And that, 

again, is good news. Except for a couple of cases that seem to be 

outliers, the virus continues to be susceptible to Tamiflu and 

Relenza. That, again, is very positive that we are in a situation 

where the antivirals that we have are working. 

No question, as the Chairman has already said, that we are seeing some very unusual activity. Flu season officially began on October 4, but as the Chairman indicated in the chart he has passed 

out, this does not look like a typical flu season. Visits to doctors 

are higher than expected. Forty-one States represent what we call 

now ‘‘widespread level of activity,’’ which is just the count that they 

are giving, and the remaining States are at elevated levels of flu. 

So this is a national issue. 

One of the most troubling aspects is the higher rate of illness 

among children and young people. There are actually 86 H1N1 labconfirmed pediatric deaths since we began reporting this in April. 

And the number is equivalent to the entire flu season of past years’ 

lab-confirmed deaths of children, so we are already at that level. 

And, tragically, pregnant women are also among those seriously affected. 

Half the hospitalizations for flu-like illness are for people under 

the age of 25, very different picture than seasonal flu, and nearly 

90 percent of the deaths from H1N1 are among people under 65— 

again, a very different picture than seasonal flu, where 90 percent 

of the deaths year in and year out are for Americans over the age 

of 65. 

88 

Those are pretty grim facts, but thanks to the work of this Committee and your colleagues across Congress, I think we are better 

prepared to deal with the current challenge than ever before in history. 

I want to just touch on a couple of efforts that you have helped 

put in place. 

First of all, we have a greatly enhanced surveillance system, so 

the numbers that we are giving you probably 2 or 3 years ago 

would have been anecdotal, at best. The system is very critical to 

monitoring what we are doing and making sure we have adequate 

supplies of materials and vaccine and we can have that relying on 

the fact that we are getting accurate numbers. 

We have an expanded testing capability, again, thanks to the 

planning work that has been done intensely monitoring changes in 

the virus around the United States, but also across the world, we 

need to know what is happening with this virus so, again, we stay 

out ahead of it and using a variety of systems to do that. 

The efforts improve our understanding of the magnitude and the 

trajectory of what we are seeing and help us stay ahead of it. 

We have provided significant recommendations, working hand in 

hand with the Departments of Education and Homeland Security, 

but also Labor and Commerce, clear, actionable guidelines for businesses, for K–12 schools and universities and colleges, which the 

Secretary will address in a few minutes, with community and faithbased organizations, based on the best scientific information— 

again, it is on flu.gov, easy to print, run in multiple languages, updated on a regular basis—but trying to make sure that the information that we know in the scientific community is shared. 

The vaccination program is underway, and as the Chairman and 

the Ranking Member have indicated, the production is slower than 

we would have hoped at this point. But I want to put this in a little 

bit of context. The virus, first identified in April, now has a robust 

vaccine available. That in and of itself is fairly remarkable. 

We are dealing with five producers. That is a very different situation than even we were in as recently as 3 or 4 years ago, so the 

capacity for vaccine has been built. 

As of Monday, we have 11 million doses of that vaccine ordered 

by the States, and those orders are being done on a daily basis. As 

the vaccine becomes available, States and local regions are ordering, and we are pushing them out. We are now up to 150,000 sites 

around the country identified by our State and local partners 

where the vaccine is automatically delivered, so it is not being held 

at points along the way. 

And, Mr. Chairman and Madam Ranking Member, I would remind the Committee that when the more robust estimates were 

being made—and, again, these are production estimates that come 

directly from the manufacturers. We have not made estimates. We 

are relying on their numbers. We were in a situation where we anticipated a two-dose regimen, and those two doses required a 3- 

week gap, and then 2 weeks at the end to have a robust response. 

So approximately 36 days from first dose to immunity was what we 

were looking at earlier. 

We now have some good news. Everyone over the age of 10 will 

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89 

ting at a much shorter time. So rather than 2 weeks, it is in an 

8 to 10-day period. So we are getting their lowers numbers available but a faster response time than we had anticipated, and with 

a one-dose regimen, we actually are in better shape than we had 

hoped with people being immunized at an earlier basis. 

The vaccine early delays are really due to two issues that we 

have identified. One is that the antigen production was yielding 

lower results than had initially been anticipated. We have been assured by the producers that has been fixed, so their yields are now 

more robust, and those numbers are beginning to change. The second is that we have some production lines that have been put in 

place by the manufacturers. That is the good news. The bad news 

is there were glitches in some of those production lines. The fill and 

finish did not work as they had anticipated. We are seeing some 

hurdles. Again, in discussions with all the manufacturers, those 

two issues were corrected so we anticipate that number growing exponentially as we move through the season. 

By early November, we are confident that vaccine is going to be 

far more widely available. There is enough vaccine and will be to 

vaccinate every American who wants to be vaccinated. And we are 

pushing it out as quickly as we can. 

So I just want to mention finally a couple of lessons that we have 

learned in this experience. Again, thanks to the Committee, a lot 

of planning has been done, but we are still too dependent in the 

United States on vaccination production in other countries, and we 

are using old technology. We are still using egg-based technology. 

Thanks to investments through this Committee and others, we are 

committed to developing cell-based and newer technology, faster 

growth time, and that is underway, Mr. Chairman. And we need 

to make all aspects of the manufacturing process appropriate for 

the 21st Century. That does not just help our country. It really 

helps the entire world. So continuing to focus on those issues, I 

know many in this Committee have been very focused on that. 

Vaccination safety is essential, and CDC and FDA monitor the 

safety of all vaccines. And I know in the Ranking Member’s comments, there still are lingering questions. We are in a Catch–22. 

Where is the vaccine on the one hand, and have you taken enough 

time for the clinical trials on the other. We can assure this Committee, this vaccine is being made exactly the way seasonal flu vaccine is made, so we have specific clinical trials on H1N1, but more 

than that, 100 million people each year receive a seasonal flu vaccine, and we expect the same very positive safety results from this 

vaccine as we have had in the past. 

In terms of the antiviral, which is, again, a question that was 

asked, PCAST did recommend the acceleration of an intravenous 

antiviral as part of the recommendation to the President. We took 

that very seriously. That is underway. The good news is we have 

encouraging results from several different candidates, and we anticipate final decisions being made by the scientists very shortly. 

BARDA was wise to move ahead of this pandemic and begin that 

process, so we are very encouraged by the results. But the scientists will lead our recommendations in terms of getting that 

antiviral on the market. 

90 

1The prepared statement of Secretary Duncan appears in the Appendix on page 279. 

And, finally, Mr. Chairman, we are continuing to focus on mitigation. In the meantime, there still are some fairly simple steps that 

people need to take: Social isolation, staying home when you are 

sick, washing hands, coughing and sneezing into arms. I have been 

very impressed that children are listening to Elmo, and they are 

correcting their parents in terms of sneeze technique. And we are 

doing everything we can think of with our partners in terms of the 

communication effort, not only using traditional media, but we 

have great partners in ‘‘Sesame Street,’’ in Sid, the Science Kid, 

where the Secretary and I will launch a new program today, and 

on Facebook and Twitter. ESPN that runs the score scrolls into colleges dorms is a partner in encouraging that age group to get the 

vaccination. We have had YouTube videos. So we are trying to get 

the word out to folks that vaccination is the best offense against 

this flu, and the good news is, I think, it is beginning to become 

available around the country. 

And with that, Mr. Chairman, I will wait and answer additional 

questions. 

Chairman LIEBERMAN. Thanks, Madam Secretary. Very helpful 

testimony. I am sure we will have questions. Also, let me express 

my admiration for your quite appropriate cough into your elbow. 

Secretary SEBELIUS. Thank you. [Laughter.] 

Secretary DUNCAN. Great technique. 

Chairman LIEBERMAN. Great technique. It is not our reflex because for all of our lives, we have been trained otherwise. Also, I 

want to express gratitude to the staff here for the hand cleanser 

that has been left here. 

You are not Arne, the Science Kid, are you? 

Secretary DUNCAN. I am not. I wish I was. He is a lot smarter 

than I am. 

Chairman LIEBERMAN. Secretary Duncan, it is an honor to have 

you here, and we welcome your testimony now. 

TESTIMONY OF HON. ARNE DUNCAN,1 SECRETARY, U.S. 

DEPARTMENT OF EDUCATION 

Secretary DUNCAN. Thank you so much, Chairman Lieberman, 

Ranking Member Collins, and Members of the Committee, for inviting all of us to testify before you today. I really appreciate your collective leadership on this issue. 

I really want to thank my partners here, Secretary Sebelius and 

Secretary Napolitano. The interagency coordination and cooperation in the Federal H1N1 effort from top to bottom, I think, has 

been absolutely extraordinary. I also want to thank our partners at 

CDC. Dr. Anne Schuchat, who is here, and Dr. Tom Frieden, the 

Director, have been great partners. 

Our team at the Department of Education has been working very 

closely with the Departments of Health and Human Services and 

Homeland Security and the CDC since the initial outbreak of the 

H1N1 influenza in April to prepare thoughtful guidance for early 

learning programs, elementary, middle, and secondary schools, and 

institutions of higher education. We have brought copies of our 

guidance here, copies of guidelines for early childhood, guidelines 

91 

for K-12, and then, finally, information for schools of higher education. It has been an extraordinary team effort, one that I hope 

can serve as a model for dealing with other problems and issues 

that cross agency boundaries. 

I want to spend most of my time this morning discussing our efforts to keep children, students, faculty, and staff safe during the 

fall wave of the H1N1 pandemic. And I think I want what I know 

every parent wants: To first and foremost keep our children safe; 

and, second, to keep them learning. 

While I want to concentrate on our current efforts—and by ‘‘our’’ 

I mean all of our agencies together—I think it is also important to 

take a moment and look back to see where we were in the spring. 

I think you will agree that we have made significant progress in 

a short period of time. 

In the spring, from April to June, we found that schools closely 

followed school dismissal guidance developed by the CDC. For example, on April 26, 2009, the CDC advised schools to consider closing when they had a confirmed or suspected case of H1N1, and we 

found that schools adhered to that advice. 

On May 4, 2009, the CDC revised the guidance to state that 

schools should not close ‘‘unless there is a magnitude of faculty or 

staff absenteeism that interferes with the school’s ability to function,’’ and fewer schools closed and many that were closed reopened. From April 27 through June 12, more than 1,350 schools 

in 35 States closed for at least one day. These closures affected 

over 824,000 students and about 53,000 teachers. The greatest 

number of school dismissals occurred on May 5, when 980 schools 

and 607,000 students were affected. As school districts started to 

implement the new guidance on closures, those numbers rapidly 

declined. 

The lesson we learned in the spring was not only that schools follow the CDC’s advice on flu-related issues, but also that quickly 

closing a school is a complex undertaking that has consequences 

beyond the loss of valuable and desperately needed school time. For 

example, unplanned school closures led to the loss of millions of 

school meals for children who rely on these Federal programs to 

eat; loss of wages for parents who had to stay home from work to 

take care of their children; and older students were left home without proper supervision. 

Further, we learned that we had to develop a new way to better 

track school closures and dismissals; the way we were doing it did 

not work well, especially when there were a large number of 

schools that were closed. 

Examination of our efforts during the spring outbreak helped us 

to understand where we could do better. In particular, we needed 

to improve on several things. 

First, we needed to offer schools balanced, measured, clear, and 

concise guidance that reflects the best science available. 

Second, we needed to design a tracking system that provides accurate and on-time data on school dismissals. 

Third, we needed not only to continue to reach out to those we 

reached out to in the spring, but we needed to get to a much expanded audience. Getting the message out and making sure it is 

the right message, and getting it out quickly to as many schools, 

92 

school officials, and parents as possible is the key to our ongoing 

communication strategy. 

Fourth, and finally, we needed to develop more materials for 

schools and educators and to develop those materials in a format 

that made them understandable, useful, and easy to use for schools 

and for educators. 

Let me briefly expand on each of those points. 

With regard to the first point on guidance, we knew that while 

in a limited number of cases school dismissals were warranted, if 

conditions in the fall mirrored those in the spring, schools could remain open as long as they took various prudent measures, such as 

encouraging educators and students to practice good hygiene such 

as washing hands and coughing into their sleeves, having students 

stay home if they are sick, and practicing social distancing such as 

rearranging desks so students could sit a little further apart. 

With regard to the second point, we developed a new K-12 school 

dismissal tracking system this summer. The new school dismissal 

monitoring system is a collaborative effort between the CDC and 

the Department of Education, and it is supported by State and 

local health and education agencies, as well as national nongovernmental organizations. The system is built on a nationwide Federal 

and State partnership. The new voluntary system includes daily, 

direct reporting from State and local agencies as well as daily, systematic searches and confirmations of media reports. 

As I mentioned, this past spring almost 900,000 students and 

more than 1,350 schools were impacted by school closures. This 

fall, however, so far schools are heeding the new guidance. School 

dismissals are significantly lower. In fact, between August 3 

through October 15, only 628 schools closed for at least one day, 

affecting approximately 219,000 students. As of yesterday, just 88 

schools were dismissed in 13 States affecting 28,000 students and 

1,800 teachers. 

In a front-page story in the New York Times on October 8, they 

pointed out that ‘‘[a]ttendance in the New York City’s public school 

system, with just over a million students, was 91 percent. . . . Last 

spring, when the virus was rampant, nearly 60 schools were closed 

and about 18 percent of students were absent.’’ 

The reductions in the number of schools that closed as a result 

of H1N1 are a direct result of a number of things, including much 

improved outreach and communication. 

In our effort to prepare the education community for H1N1, and 

to prevent the virus from spreading to a point that it fundamentally disrupts education, we have worked with our Federal partners 

to develop and distribute guidance for early childhood, K–12, and 

higher education institutions. In this effort, there is a role for nearly every major stakeholder group to play. 

Over the summer, we convened a group of representatives from 

many of education’s major associations—those representing teachers, principals, school administrators, school boards, colleges and 

universities, counselors, and, very importantly, school nurses, and 

parents. We talked about ways that every partner could contribute 

to this massive preparation and prevention effort, and I want to 

thank all of them for stepping up and answering the call. 

93 

For instance, the National Association of School Nurses, the National Parent-Teacher Association (PTA), and the National Association of School Psychologists collaborated on a guide for parents to 

help them talk to their children about H1N1 and support prevention methods. Available initially in English and Spanish, that 

guide—and so many other useful H1N1 resources—has been translated into many other languages as well. And the school nurses association recently heard that a Japanese newspaper had translated 

it into Japanese. 

Also, in September, HHS, CDC, and the Education Department 

held a call for the child-care community to discuss the steps to be 

taken by providers and parents of young children to keep everyone 

safe. We had about 800 participants on that call from around the 

country. We had another 800 participants on a similar call with the 

higher education community. 

We have also been working with the business community, especially educational publishers and national companies in media and 

technology, to make resources available so that students can continue learning if they are home sick or their school is dismissed. 

Thanks to these companies’ commitments, America’s students will 

have a variety of both hi-tech and low-tech ways to stay connected 

to their classrooms. 

As part of this effort, we have developed continuity of learning 

guidance, recognizing that different schools will have different 

ways of carrying this out depending on their situation and where 

they are located. In our appendix to that guidance, we cite a number of efforts by States and school districts around the country, including, for example, the Arkansas Distance Learning Development 

Program. While our prevention efforts must and will continue, we 

are now putting the full-court press on the importance of vaccinating children. 

Let me say here that my wife and I certainly intend to try and 

lead by example by getting our two young children vaccinated at 

the appropriate time. 

We realize that vaccinating students is the best way to ensure 

that the flu does not spread. We have made available for all 

14,000-plus school districts an easy-to-read document that explains 

how schools can work with public health officials to establish or 

host a vaccination clinic. Also, CDC has provided a sample letter 

for schools to use to get parental consent for the vaccine now so 

shots can be given absolutely as soon as they become available. 

And I am delighted to say that we have seen some terrific examples of States doing this well. 

For example, the Rhode Island Department of Health has made 

plans to operate clinics in every single school in the State, using 

licensed medical professionals enrolled through its Statewide 

Emergency Registry of Volunteers. The Public Health Department 

plans to vaccinate middle- and high-school students during the 

school day and offer after-school and weekend clinics for younger 

elementary school students. 

In Kansas, the Sedgewick County Health Department has 

partnered with several local public and non-public K–12 schools in 

the Wichita area, as well as higher education institutions, to provide vaccines through school-based clinics. 

94 

1The chart submitted for the Record by Senator Lieberman appears in the Appendix on page 

251. 

And in Utah, the Salt Lake Valley Health Department has solicited bids from nursing agencies to provide vaccinations in schools. 

These providers already have demonstrated capacity for managing 

these large-scale efforts. Timing may vary by school but officials 

envision setting up clinics in large spaces, such as an auditorium, 

and vaccinating one class at a time those students whose parents 

have provided consent. 

To conclude, all of these efforts will continue so that we can do 

our best to help schools be as prepared as they can be to handle 

the flu. Again, thank you so much for allowing me to testify today, 

and we look forward to your questions. 

Chairman LIEBERMAN. Thank you very much, Secretary Duncan. 

Very helpful information. Obviously, a lot of parents are very concerned about this, and the schools are the significant point of daily 

contact. 

We will do 7-minute rounds of questioning. 

Secretary Sebelius, I have been following this, of course, as a 

parent, a citizen, and a grandparent, but also because of the Committee, and I must say this chart from the CDC really clarified how 

serious this has become because of this extraordinary surge now,1

which is way above what typical flu activity is at this time of year, 

and also the reported cases and deaths. 

I understand this is an unusual—it is hard to predict here, but 

to the best of your ability, what do we expect—in other words, this 

line representing the patient doctor visits has really shot up. Is it 

going to continue to go up? Is it going to merge with the normal 

increase in seasonal flu that would come around January? So, to 

the best of our ability, understanding that, if I may use military 

terms, we are facing an enemy whose movement is unpredictable, 

what do the experts tell you to expect so we can be prepared to, 

if you will, defeat the enemy? 

Secretary SEBELIUS. Well, Mr. Chairman, I think you used the 

appropriate term in ‘‘unpredictable,’’ and what the experts tell me 

is a couple of things. We are not seeing a massive surge at this 

point in communities that had significant outbreaks in the spring. 

And if you remember what the spring looked like, it was very sporadic around the country. New York City, as the Secretaries just 

said, had a very significant outbreak, and two States away there 

was very little flu. We are still seeing the same kind of activity of 

hot spots in various parts of the country and others without a lot 

of activity. 

We anticipate, though, that line will continue to rise until we can 

make a fairly significant dent through the vaccination programs, 

and that is what is very good news, that the vaccine is appropriate, 

it is targeted, and so continuing the mitigation efforts, which are 

having some impact, even the short-term periodic school closings 

are far less, but they seemed to quell the outbreak for a bit and 

go on. But getting people vaccinated is the key. 

Chairman LIEBERMAN. Yes. So this is really a question of the 

vaccinations catching up with and moving ahead of the spread of 

95 

the disease because so far there has been indication that the vaccines are working, of course. 

Secretary SEBELIUS. Absolutely. The clinical trials say that vaccines are right on target, and the robust response hits in about 8 

days, shorter than expected, and people need one dose fewer than 

expected. 

Chairman LIEBERMAN. OK. 

Secretary SEBELIUS. So the goal is to get the vaccine out as fast 

as possible and get as many people, particularly, start with the 

high-priority groups, but get it to everyone who wants a dose. 

Chairman LIEBERMAN. Right. You clarified—and I appreciate it— 

the fact that at the end of October we are going to have 25 percent 

less of the vaccine than you had predicted. Your predictions were 

obviously based on what the manufacturers had told you. 

Secretary SEBELIUS. That is correct. 

Chairman LIEBERMAN. And they simply, although as I said earlier—and I give everybody credit—they worked with remarkable efficiency to develop the vaccine quickly, but they just have not been 

able to produce it as quickly as they had thought. 

Secretary SEBELIUS. Well, as I said, the early yields were significantly lower than they had predicted when we started this modeling in May. That has been corrected. They now have yields which 

are back up to where they thought they would be, so we anticipate, 

again, a much more robust production line. And some of the early 

lines, the new lines of production, particularly the fill and finish, 

had some early glitches, a hard rollout, if you will, that they were 

trying to ramp up. But those both have been corrected, and we are 

in daily contact with the manufacturers. 

Chairman LIEBERMAN. OK. So your goal is—and you predicted, 

in a way guaranteed—that there will be enough vaccine to vaccinate every American who wants to be vaccinated. But am I right 

that there is not now enough vaccine to vaccinate every American 

who now wants to be vaccinated? 

Secretary SEBELIUS. That is correct, Senator. Right now we are 

at a point where the demand is ahead of the yield, and we are 

working—that is why I think it has been very good news that we 

have a distribution contract that really gets the vaccine on a daily 

basis to these multiple sites, 150,000 sites. So as soon as it is out, 

it is being allocated on a per capita basis to States. States can 

order daily and they are taking advantage of that. So we have 

about 13 million doses available. They are being pushed to States, 

overnight. Every day that they come in, we are pushing them out 

the door. 

Chairman LIEBERMAN. OK. Not for now, but I am just going to 

say quickly, and go on to another question, there is an important 

question for all of us to ponder about the fact that if I am right, 

of the five producers of the vaccines for use in the United States, 

only one is in the United States. And we have got to ask ourselves 

questions about what is happening that we have lost that edge, 

that domestic supply. 

But let me go on to the more urgent question I want to ask, and 

that is about the availability of the intravenous antiviral medications. And as a result of the broadcast news report a couple of 

nights ago, there has been a lot of anxiety expressed about this, beVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000103 Fmt 06601 Sfmt 06601 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
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cause these are the most serious cases. These are the people— 

again, the percentage of the population quite small, but if this is 

your relative in an ICU with a serious case of H1N1, facing death 

possibly, you want whatever science can give you to deal with this. 

And I gather that, again, the existing antivirals—Tamiflu and 

Relenza—do not work with these most serious cases. 

I also understand that the FDA has issued some compassionateuse rules in a limited number of cases, as I mentioned. Some of 

these intravenous antiviral medications have worked and have 

been largely successful in saving lives. So with these extraordinary 

predictions of 150,000 to 300,000 cases that will require ICU placement of people, I want to push you a little bit on the status here 

because, truthfully, your response in your testimony was a little 

less reassuring than your statement in your prepared testimony. I 

will read it again. In your prepared testimony, you said, ‘‘Physicians treating critically ill patients with H1N1 influenza will soon 

have access to new antiviral drugs supported by HHS/BARDA and 

administered intravenously under a CDC-sponsored Emergency 

Use Authorization.’’ 

I know that at a National Biodefense Science Board meeting last 

week, the FDA said that they will be making a decision fairly soon 

about the use of a tested but still experimental IV antiviral drug, 

and this is that power that FDA has to issue an Emergency Use 

Authorization before the drug goes through all the clinical trials 

because of the urgency. 

So give us a better understanding, if you can—and I understand 

this is FDA’s decision—about how soon people who are in these severe situations can expect, if they choose, to have an IV antiviral 

available. 

Secretary SEBELIUS. Well, Senator, I would tell you that it is, I 

think, among the highest priorities with FDA and CDC working 

very close together. It has been identified early on by BARDA as 

a need. PCAST recommended that, as we saw the outbreak, we 

move forward. 

I would say that we are very close to having several candidates 

that are being tested in the final stages, and I think that it is imminent. I cannot give you a precise timetable. 

Chairman LIEBERMAN. I understand, but we are really talking a 

matter of days. 

Secretary SEBELIUS. We hope that is the case. 

Chairman LIEBERMAN. Yes. And just to clarify, the FDA and you 

take these threats seriously enough so that what is being considered is an Emergency Use Authorization—in other words, that it 

will be available even though the full clinical trials have not been 

gone through because, for a lot of people and their families, this 

will be a life-and-death decision. 

Secretary SEBELIUS. Yes, Senator, all of that is correct, and it is 

imminent. 

Chairman LIEBERMAN. OK. 

Secretary SEBELIUS. The other antiviral issue, which the Ranking Member mentioned, is the pediatric antivirals and the so-called 

pediatric suspension that is available. We have done two things 

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tion where it is in the pipeline in terms of being licensed for use. 

It has been licensed, but there is a shortage. 

HHS took steps to push 75 percent of the stockpiles out to 

States, so 300,000 doses are now in the hands of State and local 

health officials as of earlier this week. We also simultaneously published guidelines which deal with compounding. On the ground, 

pharmacists can separate the pills, mix them with syrup, and have 

this available for children who are too young to actually take pills. 

And so both of those steps have been taken earlier this week. 

There is plenty of compounding production available throughout 

the country, so we have gotten the stockpiles out and the guidance 

about compounding and asked the manufacturer to ramp up the 

production of this. 

As you all know, sometimes the private market is reluctant to 

anticipate what may be a market, which is why investments in 

BARDA and elsewhere have been so effective. So we are catching 

up. But in terms of the pediatric antivirals, I think there is an onthe-ground solution that is being taken advantage of. 

Chairman LIEBERMAN. Good. Thank you. Senator Collins. 

Senator COLLINS. Thank you, Mr. Chairman. 

Secretary Sebelius, you have given us the good news today that 

the vaccine is effective, that it is as safe as the seasonal vaccine, 

but there still is an issue of whether the vaccine is going to get to 

people too late. You stated in your written testimony that there 

will be enough vaccine for anyone who wishes to receive it. 

But a study that was published last week by Purdue University 

stated that the vaccine will arrive too late to help most Americans 

who will be infected. The authors of this study estimated that the 

greatest number of infections will actually occur this very week 

while most people are still waiting for the vaccine. 

Are you concerned that even though we have been very successful in developing an effective vaccine that it is going to arrive too 

late to do the good that we would hope? 

Secretary SEBELIUS. Well, Senator, we would love to have lots 

more available today, no question about it. I would suggest, 

though, that we are at the very beginning of seasonal flu, and what 

we anticipate is not necessarily a dropping off but a continued rise, 

and particularly as people get seasonal flu and it mixes with H1N1, 

that continues to be a concern. So we have all along urged people 

to take advantage of the seasonal flu shot, and, again, there is a 

good news/bad news about seasonal flu. The demand is significantly higher and earlier than ever before given all of the discussion about the flu, so it has caused, again, a shortage in some areas 

of the country. That is being made up quickly. 

But we anticipate, Senator, that there are still hundreds of millions of Americans who are potential victims of the flu, who have 

not gotten the flu, who will be protected by the vaccine, and what 

the scientists are urging is even if people experienced flu earlier 

this spring or this fall, to go ahead and get the vaccine because, 

as different strains develop over the course of the flu season, it will 

immunize them for what is likely to come. 

Senator COLLINS. The Chairman raised the issue of the fact that 

our country has largely lost the capability to produce vaccines, and 

we have to rely on companies that are located in other countries. 

98 

And it is my understanding that a major reason that we have lost 

that capability is because of liability concerns. 

Is the Administration developing any kind of plan or recommendations to try to ensure that we have the capability to 

produce vaccines right here in the United States? 

Secretary SEBELIUS. Well, Madam Ranking Member, the Congress invested in an entity within the Department of Health and 

Human Services, the Biomedical Advanced Research and Development Authority (BARDA). 

Senator COLLINS. BARDA. 

Secretary SEBELIUS. Which is actually, I think, a very significant 

entity because a lot of these vaccines are developed anticipating 

something will happen. So there is not a lot of private market appetite to spend money and time with development. 

I would say that this vaccine development was a collaborative effort from the outset, where the scientists from FDA sat down with 

the manufacturers and discussed the timetable. They figured out a 

way to reduce the growth time. No safety steps were cut, but the 

production occurred as quickly as could conceivably be done from 

the time that the virus was identified. 

And, finally, in terms of the liability issues, in the various steps 

to deal with pandemic efforts, you have created a liability immunity, not only for the production but every step along the way for 

distribution. So that has been in place for a number of years and 

actually was designed to address just the issue that you raise. But 

the legal protections have been in place I think for the last 5 or 

6 years. 

Senator COLLINS. Thank you. 

Speaking of liability, Secretary Duncan, in Maine many school 

systems have stepped up to the plate and are conducting schoolbased vaccination clinics. But the issue of liability has arisen in the 

State of Maine of whether schools that administer these vaccines 

could potentially be held liable in the rare case that there is an adverse reaction to the vaccine. The Governor of Maine has attempted through an executive order to deal with this issue, but is 

this an issue that you are hearing about from school systems? 

Secretary DUNCAN. It is obviously a really important question, 

and we are thrilled that your schools are stepping up. We want 

schools to be part of the solution, and with young children being 

such an at-risk and vulnerable population, it makes logical sense 

that schools be vaccination clinics. 

In all likelihood, schools will not be liable, which is the good 

news. Schools that are being used as vaccine distribution sites are 

generally protected by the Public Readiness and Emergency Preparedness (PREP) Act, and this law protects school districts and 

their employees from liability for claims that may result from administration of H1N1 vaccine in schools. So unless someone is intentionally doing something to harm a child, they are going to be 

protected. 

Senator COLLINS. Thank you. 

Secretary Napolitano, my staff has passed me a note to say that 

there has been a new development with the outbreak of H1N1 at 

Bates College that I mentioned in my opening statement, where we 

have gone from 6 cases to 245 in just a little over a week’s time. 

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And the Maine CDC has now requested that a component of the 

Northern New England Metropolitan Medical Response System 

(MMRS) deploy to the campus. And that system, as you may know, 

is part of DHS’s efforts and it is funded through a DHS grant program to enhance the medical response in a mass casualty situation. 

Are you aware across the United States of the deployment of 

other MMRS units? 

Secretary NAPOLITANO. Madam Ranking Member, I am not 

aware specifically of the deployment of others, but it does not surprise me. And, with Bates College, that is a large percentage of 

their students. 

Senator COLLINS. It is. 

Secretary NAPOLITANO. But the IMAT teams, the other teams 

that I referenced in my formal testimony were all designed to provide back-up to localities, to States at their request when they had 

a particular outbreak. 

Senator COLLINS. Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thanks very much, Senator Collins. 

As is the Committee’s rule, we call the Senators in order of arrival. Just for information, that would be Senators McCain, Bennett, Kirk, Carper, Burris, Tester, and McCaskill. 

Senator McCain. 

OPENING STATEMENT OF SENATOR MCCAIN 

Senator MCCAIN. Thank you, Mr. Chairman, and I thank the 

witnesses. 

Secretary Sebelius, this chart is one that would cause concern. Is 

that an accurate description of what this chart indicates? 

Secretary SEBELIUS. It is, Senator, and I was reminded by Dr. 

Schuchat that, in response to the question of is it too late for vaccine? Again, what we saw in 1957 was a significant outbreak in the 

fall, and then a die-down, and then another significant outbreak in 

the spring. 

Senator MCCAIN. So you think that in the winter months this 

will come down? 

Secretary SEBELIUS. Well, we are hoping that as vaccine becomes 

available and people get vaccinated that will at least help to stem 

the spread because what we are now seeing is a spread that is not 

mitigated by any immunity. 

Senator MCCAIN. But you also just said there are millions of people who will not be vaccinated. 

Secretary SEBELIUS. There may be people who choose not to be 

vaccinated, Senator. 

Senator MCCAIN. Are you worried about hospital overutilization, 

lack of capacity in the hospitals in America? 

Secretary SEBELIUS. Well, as Secretary Napolitano said, about $3 

billion has been pushed out over the last number of years for surge 

capacity. What we are trying to do is minimize the demand of the 

worried well on hospitals, which is why a lot of the self-evaluation 

tools, a lot of the information on the flu.gov Web site is trying to 

get people to the point where they understand they do not need to 

show up at the hospital unless certain situations are present. 

Senator MCCAIN. So you have significant confidence that will not 

be a problem? 

100 

Secretary SEBELIUS. Well, Senator, I am worried about all of this, 

and I think we are doing everything we can to work with hospitals 

across the country, including an additional $100 million that you 

helped to make available. 

Senator MCCAIN. In your testimony concerning the availability of 

the vaccine, according to a news report yesterday, ‘‘Arizona will be 

getting only a fraction of its first orders of swine flu vaccine which 

could throw a wrench into health officials’ plans to vaccinate hundreds of thousands of residents in coming week. So far, the State 

has only been allowed by Federal health officials to order about 

156,000 doses of H1N1 vaccine, less than half of which has arrived, 

with the rest expected sometime next week. Original planning 

called for 800,000 to 1 million doses to arrive around next Thursday.’’ 

That is a rather significant difference from what they expected 

to receive in Arizona, Madam Secretary. 

Secretary SEBELIUS. Yes, sir. 

Senator MCCAIN. And your statement, as I quote from, ‘‘a series 

of manufacturing delays has caused significant reductions in the 

manufacturers’ projected vaccine output.’’ Maybe for the record you 

could tell us about these manufacturing delays and whether are 

they in the one facility we have in the United States or are they 

from our foreign sources of vaccine? 

Secretary SEBELIUS. Well, Senator, as I had said earlier, the production yields are lower than what the manufacturers estimated 

when they first started. So with the egg-based technology there are 

lower yields of the antigen, and they were wrong with what they 

anticipated. Those yields are now up. They have changed strains. 

They are working now. The virus is equally robust, but they are 

now getting much higher production yields than first anticipated. 

Senator MCCAIN. And what is your estimate as to when they will 

catch up? 

Secretary SEBELIUS. Well, we are hoping by early November that 

they will be back on the track of the number of vaccination doses 

per week that we had originally anticipated. 

Senator MCCAIN. How long would you expect a State like mine 

to not have the quota fulfilled that they had expected? 

Secretary SEBELIUS. Senator, what is happening in Arizona and 

every other State is that daily orders are being made on a per capita basis, they are being pushed out the door, so as soon as it—— 

Senator MCCAIN. When would you expect them to be caught up? 

Secretary SEBELIUS. Senator, I have no idea. I could get you that 

information based on—I cannot tell you when Arizona will be at 

the—— 

Senator MCCAIN. I mean all States. When will all States be 

caught up? Maybe you could supply that for the record. I am sure 

that people are concerned about that. 

Secretary SEBELIUS. I will try to get that. 

Senator MCCAIN. When would we have a sufficient number of 

vaccines necessary? I would be interested in when you anticipate 

for those original estimates will be met. 

Secretary SEBELIUS. We can get you that number, Senator, and 

as you know we are not sure how many people will take it up. The 

seasonal flu take-up rate is below 50 percent. 

101 

Senator MCCAIN. But you did make original estimates as to what 

is needed, and so I would be interested in knowing when you are 

able to—with the manufacturing capability now restored, when we 

will restore to what the original requirements are. 

Secretary SEBELIUS. We will get you that information. 

Senator MCCAIN. Thank you. 

INFORMATION SUBMITTED FOR THE RECORD FROM SECRETARY 

SEBELIUS 

What is the projected date when you believe all States will receive their 

requested number of H1N1 vaccines? 

HHS has now received all its vaccine orders and any American who wants to be 

vaccinated should be able to do so. As of March 12, 2010, States have been allocated 

149,977,200 2009 H1N1 vaccine doses. Thus far, States have consistently ordered 

approximately 80–90 percent of the vaccine doses available to them. So there is sufficient H1N1 vaccine for all States to receive their requested amount. 

When will we have sufficient number of vaccine to make sure we do what 

is necessary? 

As of December 1, 2009, sufficient amounts of H1N1 vaccine (229 million doses) 

had been produced to serve the U.S. population and to meet international commitments for donated vaccine. As a result, production of additional H1N1 vaccine was 

halted. 

When will we be restored to the original requirements? 

The original estimate in the summer was that we would need as many as 600 

million doses to cover the entire U.S. population. When clinical results showed that 

only those ages 9 and under would need two doses and everyone else one dose, the 

number needed was dropped to about 340 million doses. As information on uptake 

and public desire for the vaccine became available, the number was revised downward. By the beginning of December it was determined that 229 million doses would 

be sufficient. 

Senator MCCAIN. Secretary Napolitano, have we still a big concern about visitors to the United States being screened for H1N1? 

Secretary NAPOLITANO. Senator, we take our guidance from the 

CDC, and we are doing our standard screening, but we are not 

doing any different type of screening than we would normally, in 

part because this is not like an avian flu situation. This virus is 

already widespread through the continent. 

Senator MCCAIN. So it is already here. 

Secretary NAPOLITANO. If we thought screening would help the 

public health situation in the United States, we would do something differently. But everything we have been advised is that 

what we are doing is the most that can be expected, and anything 

else would have no practical impact on the public health of the 

American people. 

Senator MCCAIN. Thank you. 

Secretary Duncan, it may not be a large item in the scheme of 

things, but when you close schools, parents have to stay home with 

the children; some of those are health care providers. What is the 

answer? 

Secretary DUNCAN. Well, the answer is we have worked extraordinarily hard to dramatically reduce the number of schools that are 

closed, and those numbers are down—as I mentioned in my testimony—very significantly from the peaks in the spring. So closing 

schools is an absolute last resort. We have seen great response so 

far this school year, and, again, those numbers are down almost 90 

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thing we can to keep schools open. It puts a strain on families. I 

worry about children who do not eat—who rely on those school 

lunches—when schools are closed. That is very difficult to do. The 

social disruption of closing schools is huge, not to mention the loss 

of learning opportunity. So our guidance has been very clear that, 

whenever possible, keep schools open, keep sick children home, and 

let the majority of students attend school. That is critically important to us for a multitude of reasons. 

Senator MCCAIN. Well, thank you. My time has expired. I have 

been observing you, Secretary Duncan, and your efforts at improving education in America, and I applaud many of your efforts, and 

also occasional displays of courage. 

Secretary DUNCAN. Thank you, sir. 

Senator MCCAIN. Frequent displays of courage. Thank you. 

Chairman LIEBERMAN. Thanks very much, Senator McCain. 

Do you have that on tape, Secretary Duncan? [Laughter.] 

Secretary DUNCAN. I hope someone captured it. 

Chairman LIEBERMAN. Well, you deserve that. I thank Senator 

McCain for saying that. 

Senator Kirk, you are next. 

OPENING STATEMENT OF SENATOR KIRK 

Senator KIRK. Thank you, Mr. Chairman, and thank you to the 

Secretaries for your service, and through your prepared testimony 

and your oral testimony, the obvious collaboration that is going on 

is making a difference in terms of making an effective effort on this 

important issue. 

This morning’s Boston Globe had a lead story that basically 

points up the issues that have been discussed, and that is the 

shortage of the H1N1 vaccine and the overrun for the traditional 

seasonal flu vaccine. As a result of the lack of supply or delay in 

supply of the H1N1 vaccine, your partners at the State and local 

levels who have planned for their clinics have been advised to shut 

down the clinics until the supply takes place. So there has been 

some disruption in the supply chain and obviously some frustration 

at the local level. 

I just wanted to understand. On the overrun of the vaccine for 

the seasonal flu, I assume that parents and others are saying, ‘‘If 

I cannot get the H1N1 flu vaccine, I should try to immunize my 

children by getting the seasonal flu vaccine.’’ Is that a fair medical 

assumption? In other words, will the seasonal flu help to immunize 

at all from the H1N1 flu? 

Secretary SEBELIUS. Unfortunately not, but we would strongly 

recommend and have recommended that particularly for vulnerable 

populations they get both. If this virus had been identified earlier 

than April when it was found, it would be mixed with the seasonal 

flu vaccine this year. It is just a different novel strain. But since 

it is a different novel strain and it is not mixed, there really is the 

requirement of two separate vaccinations. 

Right now, Senator, just to give you the numbers, we typically 

have about 114 million Americans who get seasonal flu shots. Already here in mid-October, 82 million of those vaccination doses 

have been out to States and in some cases are running out, I think 

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ing up a lot earlier at flu clinics, and that is, frankly, good news, 

but they need to go back and get the H1N1. 

Senator KIRK. And just as a follow-up on that, given the overrun, 

if you will, on the seasonal flu at this time, is there any danger 

that we will be in short supply of that as we move down the trail 

here? 

Secretary SEBELIUS. No. Actually, we have been assured that 

production is, again, ramping up. We had an early run, if you will, 

much earlier than typical, on seasonal flu. So the production manufacturers are backfilling that, and, again, that will be widely available. 

We may have a much higher take-up rate, though, than is usual. 

I was very alarmed when I saw the data that typically for seasonal 

flu, which kills 36,000 people a year and hospitalizes a couple hundred thousand people a year, our take-up rate is less than 50 percent for most categories, including health care workers. Fewer than 

50 percent of health care workers ever get a seasonal flu shot. The 

only category of Americans who take great advantage of the seasonal flu vaccine are the older Americans, over 65. 

But I think what we are going to see this year is a more robust 

response from every category, and, frankly, that is good news. 

Senator KIRK. Thank you. The other question I had related to the 

colleges in Massachusetts, and, happily, we have a number of colleges and universities. And as I understand it, the allocation of the 

vaccine is determined by population per State. Is that correct? 

Secretary SEBELIUS. Yes. As it becomes available, it is being 

pushed out on a per capita basis. 

Senator KIRK. Right. Has there been any consideration given to 

the inclusion of out-of-State student population, of which we probably have as many as perhaps any other State? Is that configured 

or considered at all as you measure population and distribution of 

the vaccine? 

Secretary SEBELIUS. Senator, I think it would determine how students are counted in Massachusetts and what your per capita 

count looks like. What is happening, though, is that those decisions 

about how much to order and where those orders are going are all 

being made at the State and local level. So I can assure you that 

whether it is Governor Patrick or your State health officials or others, they are very mindful of getting the vaccine to the spots needed and drawing down those orders and making sure that they show 

up on campuses and at schools. 

Senator KIRK. Thank you, and perhaps Secretary Duncan can 

help on this. 

Again, in terms of the delayed delivery of the H1N1 and the oncoming Thanksgiving holidays and so forth, if students, for instance, go home for the holiday and come back, and let us assume, 

sadly, one or more is afflicted with the H1N1 flu, are the colleges 

encouraged to use their facilities as clinics and health facilities? 

Secretary DUNCAN. Absolutely, and many colleges are prepared 

to do that and are stepping up. They have health care clinics. This 

is a natural part of their outreach, so, yes, and I could check some 

of your colleges and universities specifically, but we absolutely are 

encouraging that, yes. 

104 

Senator KIRK. Thank you. The final area is one that has been 

brought up as well by the Chairman and the Ranking Member, and 

it is the question of why we are not helping ourselves and our 

neighbors across the globe in terms of production, manufacturing, 

licensing of these products? And I understand that we cannot really 

get the perfect vaccine until the flu is in the air somewhere and 

that takes some time and has some challenges. But I am troubled 

by the fact that we do have these glitches, that only one of five, 

as I understand it, producers is a United States producer. And 

maybe not for this morning, but I wonder if there are some things 

that Health and Human Services, Homeland Security, and the public health officials of the country could recommend, perhaps 

through this Committee or another, what we collectively should be 

thinking about to bring that talent and research and development 

skill and production skill back here—first, as a global partner; but, 

second, in terms of our homeland security should flu be inflicted for 

some deliberate reason, we want to be able to protect our citizens 

as well. And for the long term, I would think this would be an important investment and would encourage our departments to be 

thinking together about that and maybe suggesting to the Congress 

how we might be helpful as well. 

Secretary SEBELIUS. Well, Senator, I think that is a very wise 

suggestion. Clearly, we are going to have a lot of lessons learned 

from dealing with this pandemic situation that will, I think, be 

enormously helpful. 

What is the good news, I think, is that Congress, starting in 

2005, began a multi-year investment in a variety of planning efforts, including our own research and development wing at HHS— 

BARDA—which exists as a laboratory to begin to look at potential 

issues. We do have five manufacturers at this point. That is up 

from two in 2004. HHS has been investing in helping build capacity around the world. It not only is important here in the United 

States, but we are now in a situation where also much of the world 

relies on our manufacturing capacity to, again, supply vaccines. So 

helping our nations around the world build capacity to take care 

of their own populations is part of that multi-year investment. 

But I think you are absolutely right. We need to refocus on more 

internal manufacturing capacity and, again, new technology because we are still using vaccination technology of a number of decades ago, so we need to accelerate the cell-based technology that 

could more rapidly get from an identified virus to a vaccine. 

Senator KIRK. Thank you all. Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thanks, Senator Kirk. 

If I could just add an exclamation point to the last question Senator Kirk raised, there have been news reports that in at least one 

case—I believe it was the Canadian producer of a vaccine that was 

under very understandable pressure from the Canadian Government to fill Canadian needs for the vaccine before they filled ours. 

It is exactly what we would do with an American producer. And it 

just puts up an exclamation point on the importance of developing 

domestic capacity for production of vaccine in these cases. 

I am not blaming Canada, but I suppose in some sense you could 

say that—it is not the whole answer—the shortage of the vaccine 

today, beneath what we would want it to be, is attributable to forVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000112 Fmt 06601 Sfmt 06601 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
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eign countries telling their local manufacturers, ‘‘Hey, you got to 

fill our needs before you fill anybody else’s.’’ Thank you. 

Next is going to be Senator Burris. 

OPENING STATEMENT OF SENATOR BURRIS 

Senator BURRIS. Thank you, Mr. Chairman. The distinguished 

Secretaries have answered most of the questions, so I just have a 

couple of brief ones before I run off to the floor to make a speech, 

and I just hope that we could deal with this area. A couple of questions. 

Now, we know that certain minority populations are considered 

high risk due to the prevalence of pre-existing conditions such as 

diabetes and asthma. We also know that minorities and low-income 

populations are less likely to get vaccination against the flu. How 

are your departments working to reach out and educate these 

groups about preventing measures and encouraging them to get 

vaccinated? And that goes for the schools, too, for Secretary Duncan, but first, Secretary Sebelius? 

Secretary SEBELIUS. Well, Senator, I think you have raised a 

very important point, and we identified early on some of the challenges of getting to high-risk populations in a variety of ways. So, 

in addition to the normal sites, we asked very early on for our 

State and local partners to think carefully about sites that would 

be available to encourage hard-to-reach populations to get vaccinated, and that is going on. We are working closely with the 

faith-based outreach office for not only HHS’s office but the White 

House’s office to talk about how we reach into communities where 

people may not be presenting themselves traditionally for seasonal 

flu but to get the word out. 

We have had an enormous effort outreaching to not only the African American press—radio, TV, print—but also the same thing in 

the Latino community and working with tribal leaders to try and 

make sure that information is available. So that combination we 

hope will not only get the word out but hope to encourage people 

that it is safe, it is secure—— 

Senator BURRIS. To go get vaccinated. 

Secretary SEBELIUS. You bet. 

Senator BURRIS. Yes, Secretary Duncan, on the educational side, 

you have those urban schools. How are we dealing with this? 

Secretary DUNCAN. I think, again, what you have is folks who 

traditionally maybe did not trust—and this is why I think schools 

are so important. There is a level of trust. Every low-income minority child hopefully is in school. They have a relationship with the 

teacher. They have a relationship with the principal. So having 

schools as sites to be vaccination clinics I think is hugely important. They know the families, they know the community, and they 

can say, ‘‘Hey, this is important to do.’’ And, again, there always 

has to be parental consent. We are not going to mandate anything 

like this. But having schools step up in, whether it is an urban or 

rural area, in Illinois or around the country, I think is hugely important. So far I have been just extraordinarily impressed by school 

officials’ willingness to be part of the solution here. 

Senator BURRIS. So you do not see any lag in any of the areas 

where you are making the emphasis? 

106 

Secretary DUNCAN. Well, we will see, and again, the question 

that Secretary Sebelius keeps raising is how many folks are actually going to step up to the plate. But having schools as sites, 

reaching out to the religious community, reaching out to faithbased leaders, we need to continue to work hard at this, but we do 

not know yet. And we have to do everything we can to make sure 

that not only is it available but people are taking advantage of 

what is available, and there is a difference between those two. 

Senator BURRIS. Thank you. 

Secretary Napolitano, you had mentioned the hospitals and all of 

these areas that you are setting up with the tents and making sure 

that you are having facilities available. I am just wondering how 

you are going to be dealing with medical staffing to cover these— 

should the overload of people show up in emergency rooms that 

they cannot handle, are there medical personnel capable of then 

being able to handle all this? 

Secretary NAPOLITANO. Thank you, Senator. I was just giving 

some examples of what localities have built into their plans. It is 

not as if we are going to see tents all over the United States. But 

it is part and parcel of each locality, making decisions about how 

you triage patients, how you deal with those with milder cases of 

the flu who may present or even the worried well, without using 

the actual emergency room and really reserving that for those who 

need the most serious care. 

With respect to health care providers, we have worked with— 

and, again, we start with local and State. They are the primary 

planners, as it were, of how to handle any type of epidemic within 

their own State boundaries. And then we have augmented that 

with identifying teams that can at a State or locality’s request— 

Senator Collins mentioned an example—come in to provide assistance. 

Senator BURRIS. Yes, but, Madam Secretary, it would raise a 

question to me whether they come into the emergency room or 

whether they come into a situation of overcrowding. Maybe the 

CDC can answer that question. I am concerned about the medical 

personnel being able to then handle the situation, whether you put 

a tent up or whether you have them lined up in the emergency 

room. If the doctors just came off their 48-hour shift in the emergency room and they had two or three cardiac situations, and now 

the people are coming in with the H1N1, is the staffing of the hospital going to be adequate to handle that onslaught? Is that being 

planned by the States or any other health care providers? 

Secretary NAPOLITANO. That is part of the planning process that 

has been underway, and we are going to see that not just this fall 

but this spring as well. And there is no uniform answer across the 

country because the situation will vary where you are in the country, where hospitals are located in the country; urban, rural, that 

is a big issue across the country. But, again, that is why the focus 

has been on doing this kind of planning. 

Senator BURRIS. Thank you. 

Secretary SEBELIUS. Senator, I think also that part of the planning effort underway has been this multi-year strategy so hospitals 

deal not only with their bed capacity but with the provider capacity, where they can draw down additional personnel. We have, 

107 

among other things, a sort of medical reserve corps that came together after September 11, 2001, about 200,000 people identified— 

some of whom are medical personnel who are retired, others are 

volunteers—to help with the triage situation. We have about 6,500 

commissioned corps members who are able in situations to be deployed if needed, so people who can move around to areas. 

But, for instance, here in Washington, I visited one of the surge 

hospitals. There is a facility set up here in D.C.—and there are five 

of these around the country—designed specifically so that as local 

hospitals would reach capacity, you would actually have a unit that 

would come into high readiness who could figure out where to send 

patients, where to send personnel, who is ready and able to do just 

that. So the infrastructure, I think, for planning is there. 

What you see right now in some of the tent situations—and there 

are hospitals with tents—they have wisely decided, rather than 

having a potentially very sick person sit in an emergency room and 

cough and sneeze on everyone around him or her, sharing the 

virus, to actually triage those folks in a more isolated situation outside. So some of what you are seeing is really the planning that the 

Secretary has talked about being implemented, how we separate 

people who really may need to be eventually in the hospital, but 

how to make sure that they do not make other people sick while 

they are waiting to be seen. 

Senator BURRIS. You have satisfied my questions, and I am glad 

to hear that those plans are underway, and good luck to you. Let 

us do it. Thank you all very much. God bless you. 

Secretary NAPOLITANO. Thank you, Senator. 

Senator BURRIS. Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thanks very much, Senator Burris. Senator Tester. 

OPENING STATEMENT OF SENATOR TESTER 

Senator TESTER. Thank you, Mr. Chairman, and I want to thank 

all three of you for your testimony and for being here today. 

In a previous question, Secretary Napolitano—and this is a question for you, Secretary Sebelius—had said that additional screening 

is not being done at the border, and I tend to agree with that. So 

just for my information, is the outbreak of H1N1 greater or about 

the same in Canada, Mexico, China, India, and Europe? 

Secretary SEBELIUS. Well, again, we are monitoring that regularly. We are seeing about the same presentation as this travels 

around the world. The good news was at least in the Southern 

Hemisphere, which went through their flu season without vaccine, 

is we did not see a mutation. 

Senator TESTER. OK. So we are—— 

Secretary SEBELIUS. But it is spreading, the same target populations, the same—— 

Senator TESTER. The same target population, about the same occurrence for population. 

Secretary SEBELIUS. Right. 

Senator TESTER. For example, is Canada or Mexico doing the 

same thing we are? 

Secretary SEBELIUS. Yes, there is a very coordinated effort not 

only in the Americas, if you will, who we are out in front of this, 

108 

but throughout the world in terms of vaccination, mitigation, and 

sharing information, sharing strains, surveillance teams. The reason it is a pandemic is it is global. 

Senator TESTER. And to get to the point that Senator Kirk had 

raised and that the Chairman had followed up on, should the 

United States be more entitled to that vaccine than some other 

country in the world? 

Secretary SEBELIUS. Well, I think the balance is difficult. The 

President clearly has made it clear that his priority is safety and 

security of the American people, and immediately he also adds that 

we are a global partner. So we have joined now with 11 nations in 

terms of 10 percent of the vaccine will be made available to developing countries. We stepped up and organized. 

Senator TESTER. I mean, I agree with that. But since there are 

four suppliers outside this country and one inside this country, why 

wouldn’t they supply, for instance, to the highest bidder or to their 

own people first? 

Secretary SEBELIUS. Well, it is the orders, and one of the things 

that we urged Congress to do—and, wisely, you did it—is that in 

the supplemental appropriation bill, you granted resources so we 

could place orders on behalf of the United States, and it really is— 

the orders will be filled in priority terms. 

So we are really sort of at the front of the line with some of these 

in terms of getting vaccine as it is produced. 

Senator TESTER. I appreciate that. I guess the whole concern of 

outsourcing everything and now we are here outsourcing this, and 

I know you have the same concerns. 

You talked about cell-based versus egg-based research that is 

being done. I was wondering. Is that research being done in this 

country? 

Secretary SEBELIUS. Yes, not only is BARDA engaged in that, but 

a lot of work being done at the National Institutes of Health (NIH) 

right now. But I would say it is going on all over the world, too. 

Really at this point, everybody is trying to get a much faster growing technique. 

Senator TESTER. You talked about the robust response to the vaccination. At this point in time, can you tell me if you get the vaccination, is it 100 percent you will not get the flu? 

Secretary SEBELIUS. I do not think anything is 100 percent, but 

we are seeing an 85-, 90-percent response, which is very good. 

Senator TESTER. And how about if you have had the flu, the 

H1N1, can you get it again? 

Secretary SEBELIUS. We do not know, but the scientists are saying get the vaccine. 

Senator TESTER. Rural versus urban, have you seen any difference in outbreaks there? 

Secretary SEBELIUS. Not that we know of. I am asking my CDC 

sources. I thought that was the answer, but I want to give you correct information. 

Senator TESTER. This is for you, Secretary Duncan, and you 

touched on it a little bit in your opening remarks. That is, there 

are a lot of folks that get school lunch programs, school breakfast 

programs. They get sick, they head home. Are there any concerns 

as to whether they are going to get the proper nutrition at home? 

109 

1Secretary Duncan’s response to Senator Tester’s question appears in the Appendix on page 

334. 

And this is really wild for me. It shows where we are at, I guess. 

It is just crazy. But is there any concern about nutrition at home 

versus what they would get in the school? And what can be done 

about that? 

Secretary DUNCAN. Absolutely. That is a very real concern. I 

think there are multiple reasons, that being one of the main ones, 

why it is so important to keep schools open and do that whenever 

possible. Just to put it in context, at its peak last year one day we 

had 980 schools closed. As of yesterday, we only had 88 around the 

country—so a 90-percent reduction. That is 88 out of 95,000 schools 

in the country. So we are trying to keep schools open so that kids 

can eat. 

Senator TESTER. But for those kids that go home, I mean, that 

is beyond your purview, correct? 

Secretary DUNCAN. No. We are actually working on it. It is beyond my direct purview, but we are working very closely with Secretary of Agriculture Tom Vilsack and his team and really thinking 

about, if these closures are for a protracted period of time, how we 

do some—— 

Senator TESTER. I appreciate that. 

Secretary DUNCAN [continuing]. Feeding at the school, and so the 

Department of Agriculture (USDA) has been really thoughtful on 

this and is part of the partnership. 

Senator TESTER. I appreciate that. School nurses, are they still 

a part of the equation, or did they go by the wayside? 

Secretary DUNCAN. No. They are leading this thing. They have 

been phenomenal. 

Senator TESTER. OK. 

Secretary DUNCAN. We would not be in this position without 

their extraordinary leadership. 

Senator TESTER. Is their availability in rural America the same 

as it is in urban America? 

Secretary DUNCAN. I think there is a scarcity of nurses everywhere. I do not know if it is a rural versus urban issue. We do not 

have enough school nurses. 

Senator TESTER. Any idea on what the staffing of school nurses 

are in our public education system today? Are we understaffed by 

20, 30, 40, or is it near 100 percent? 

Secretary DUNCAN. I think education is underfunded, and one of 

many places where education is underfunded in school nurses. So, 

yes, I would say we are underresourced in nurses—urban, rural, 

and suburban. 

Senator TESTER. Could you find out what that is? I would really 

like to know what that is. I do not expect you to know it, but I 

would love to find that out. And if there is a difference between 

urban and rural, I would like to know that. 

Secretary DUNCAN. I will check that.1 I will tell you they are 

working unbelievably hard, the ones we have, and I could not be 

more proud of them. 

Senator TESTER. Yes, but I think it is one of the keys to maybe 

getting our arms around this. 

110 

Secretary DUNCAN. Yes. 

Senator TESTER. Secretary Napolitano, I did not want to leave 

you out of this. We are bringing in vaccines from other countries, 

produced in other countries. Is there anything that you have done 

to expedite their ability to get across the border? Or can it be done 

as per usual? 

Secretary NAPOLITANO. There has been no reported delays at 

that particular issue, Senator, and there will not be. 

Senator TESTER. Good. I want to thank you all very much for 

your testimony and your concise answers. Thank you very much. 

Chairman LIEBERMAN. Thanks, Senator Tester. 

Senator Carper, with your permission—you got here a little earlier, but Senator McCaskill has been here all morning, so I am 

going to call on her first. 

Senator CARPER. You are kidding. [Laughter.] 

I just want you to show me—no, go ahead. 

Senator MCCASKILL. There you go. 

Chairman LIEBERMAN. Yes, Missouri. Senator McCaskill, then 

we will go to Senator Carper. 

OPENING STATEMENT OF SENATOR MCCASKILL 

Senator MCCASKILL. Thank you. 

I want to make sure I understand. You know, we have a problem 

with reporting both ways, I think. We want to make sure that the 

information we are getting is accurate, but there is also, I think, 

right now because of the heightened awareness, some inflationary 

reporting that may be going on. I want to make sure I understand 

this document. 

This says the percentage of all visits to doctors’ offices that are 

due to flu symptoms, is my understanding. 

Secretary SEBELIUS. Flu-like symptoms. 

Senator MCCASKILL. Flu-like symptoms. So, indeed, this spike is 

not confirmed cases of H1N1. It is, rather, the tendency of the population right now to go to the doctor more quickly when they have 

flu-like symptoms because of all the attention that we justifiably 

have put on this new flu virus. Correct? 

Secretary SEBELIUS. That is correct, Senator. We are actually not 

testing individual cases any longer. We are testing cases of hospitalizations and deaths to make sure that we are tracking really 

whether the virus has mutated. But the treatment for the flu is the 

flu is the flu is the flu, so we are not testing at that point. So these 

are not confirmed H1N1 cases. 

Senator MCCASKILL. So in some ways, this chart is good news because it means people are more likely to go to the doctor right now 

because of flu-like symptoms than they were this time last year. 

Would that be a fair statement? 

Secretary SEBELIUS. I think that is a very fair statement. I have 

been told by Dr. Schuchat, we have virological surveillance, and 

that is also showing an uptick, and we use multiple systems to get 

the tracking. But you are right, this may indicate that people are 

concerned. We have seen definitely an uptick in seasonal flu vaccine uptake, which is good news. 

Senator MCCASKILL. Right, which is good news. 

111 

Secretary SEBELIUS. Getting that public health information out, 

we have a vaccine, go get vaccinated. In the past, people did not 

pay a lot of attention to it except older Americans, and now a lot 

of people are paying attention, and that is good news. 

Senator MCCASKILL. So that we can have some perspective of 

what the numbers are that we can confirm, what are the confirmed 

deaths to H1N1 this year compared to what the typical deaths of 

regular flu would be in a year? 

Secretary SEBELIUS. I want to get you the accurate—I know we 

have 86 confirmed H1N1 pediatric deaths, and that is as high, if 

you average the last several flu seasons, as we have in the entire 

regular flu season. So that is a high number because typically—— 

Senator MCCASKILL. Obviously, because of the kids. 

Secretary SEBELIUS [continuing]. The kids do not die with seasonal flu. 

Senator MCCASKILL. Right. But the overall numbers, what are 

they, regardless of pediatric or otherwise? 

Secretary SEBELIUS. What I have been told by Dr. Schuchat is 

that is really the number that is probably the best number to 

track, that and the hospitalizations. What we know now is 90 percent of the hospitalizations are the under-25-year-old, which is a 

very different number than we see in seasonal flu. So those trends 

are really what we are looking—36,000 people every year die from 

the seasonal flu. About 200,000 are hospitalized. So we are significantly below those numbers, but this is a very different population, 

and it is moving. 

Senator MCCASKILL. Well, and I understand the point you are 

making is that we need to pay attention because we have a different population that appears to be vulnerable to this flu, and obviously it is a population—— 

Secretary SEBELIUS. And flu is serious, year in and year out. 

Senator MCCASKILL. Absolutely. But I still want us to get perspective, that the number of deaths per year from the flu that we 

are all familiar with wildly exceeds any confirmed death number 

for H1N1 at this juncture. 

Secretary SEBELIUS. That is absolutely correct. 

Senator MCCASKILL. Speaking of statistics, it is my understanding now you guys have quit trying to collect individually and 

now you are just doing regionally. Is that correct? 

Secretary SEBELIUS. We are not—— 

Senator MCCASKILL. Hospitalizations? 

Secretary SEBELIUS. Oh, hospitalizations, we are getting reporting, yes, out of State, yes. 

Senator MCCASKILL. Let me talk about fraud for a minute. Because of this heightened awareness, the good news is we have a lot 

more people going to the doctor because of the heightened awareness. We have more people getting the regular flu vaccination because of the heightened awareness. I think everyone is paying attention, which is terrific. But there are also hoaxes out there right 

now. 

Secretary SEBELIUS. You bet. 

Senator MCCASKILL. There are people advertising fake drugs, 

going on the Internet and saying, ‘‘Click here, and we can save you 

from H1N1.’’ Can someone address for me the fraud issue and what 

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you all are doing to protect consumers in this country from 

scumbag con men and women? 

Secretary NAPOLITANO. Well, with respect to our scumbag initiative—— [Laughter.] 

No, we are addressing that and have been through Immigration 

and Customs Enforcement (ICE) and Customs and Border Protection (CBP), going after counterfeit narcotics. We have undercover 

investigations on the way. We are looking both at undercover physical sales, mail sales, Internet sales, and the rest. Field offices have 

all been given guidance in terms of these kinds of investigations. 

We are also coordinating inspections at the border. And it is my 

understanding that the State attorneys general are also going after 

the fraud element. 

There is a fraud element that seems to accompany any kind 

of—— 

Senator MCCASKILL. Any problem we have got, somebody is 

going to take advantage—— 

Secretary NAPOLITANO. Yes, there is going to be a fraud element. 

Senator MCCASKILL. Right. 

Secretary NAPOLITANO. And so part and parcel of what we have 

been implementing and planning for now is dealing with that fraud 

element. 

Secretary SEBELIUS. Senator, also, I would say the Food and 

Drug Administration is being very aggressive in terms of—actually 

the Deputy Director recently ordered a series of products to determine indeed that they were scurrilous and fraudulent, and they are 

clamping down in terms of medical claims being made, making it 

very clear that people need to be very cautious about purchases. 

But, unfortunately, there are folks selling things out there to take 

as medication or flu prevention that are totally bogus, and so we 

are not only going after it in the legal realm, but also in the medical realm. 

Senator MCCASKILL. Well, I think with the heightened awareness out there right now and the media interest in this, the sooner 

you guys can put somebody in handcuffs on TV for doing this kind 

of thing, the better off we are all going to be, because it would get 

a great deal of attention right now, and that would have the kind 

of deterrent effect, as you all know—I know certainly Secretary 

Napolitano knows—there are certain crimes you can deter and 

there are certain ones you cannot. This is one you can deter with 

some high-profile prosecutions, and I would certainly urge you in 

your collaborative fashion—which is great the way you are working—to get with the Attorney General and to get with Justice and 

to get with the National Attorneys General Association and even 

the National Prosecuting Attorneys Association, and see if you guys 

cannot ramp up some significant prosecutions as quickly as possible so we can save some heartache for a lot of people that are 

going to be taken advantage of. 

Finally, let me just ask one definitive question. There are thousands of hard-working Missourians that make their living raising 

hogs in Missouri, and this is a difficult time for them in this economy. Can we state for the record definitively—it cannot be said 

often enough—that no one can contract H1N1 from eating pork? 

Secretary SEBELIUS. No one can contract H1N1 from eating pork. 

113 

Senator MCCASKILL. Did you hear that, Mr. Chairman? 

Secretary SEBELIUS. No one. 

Senator MCCASKILL. No one can contract H1N1 from eating pork. 

Chairman LIEBERMAN. Yes. 

Secretary SEBELIUS. In fact, it may protect you. I am not exactly 

sure, but it may. 

Senator MCCASKILL. Pork is delicious. You can go bacon if you 

are not on a diet. You can go lean, the other white meat, if you 

are on a diet. Pork rules. There is no reason to avoid pork. Thank 

you, Mr. Chairman. [Laughter.] 

Chairman LIEBERMAN. Unless, of course—— 

Secretary NAPOLITANO. Yes, let us be specific about the kind of 

pork we are talking about, right? [Laughter.] 

Senator MCCASKILL. Unless it is an earmark. 

Chairman LIEBERMAN. No. Unless, of course, you respond to a 

higher authority. [Laughter.] 

Senator MCCASKILL. Sorry about that, Mr. Chairman. 

Secretary SEBELIUS. You will not get H1N1. 

Chairman LIEBERMAN. It has nothing to do with H1N1. Thanks, 

Senator McCaskill. 

Senator Carper, thank you for your patience. 

OPENING STATEMENT OF SENATOR CARPER 

Senator CARPER. For those of you responding to a higher authority and for those of you just somewhat leery of eating pork, as a 

guy who comes from a State where there are 300 chickens for every 

person, there are other alternatives. [Laughter.] 

I would just lay that at your feet. 

Before Senator McCaskill leaves, I just want to say how much I 

enjoyed listening to her questioning. We serve on a couple different 

committees together, and I love especially the new words that I 

learn from her. One of my favorites is ‘‘pond scum.’’ That is a word 

we are starting to spread around Delaware as well, not the pond 

scum but certainly the terminology. 

My colleague from Montana has left, but he raised the issue of 

school nurses and whether they have too few school nurses and so 

forth. In one State—and that is my State—every public school has 

a school nurse. In my State, every high school has a wellness center. And we are very proud of that, and we decided to do that about 

a dozen or so years ago. We are not the only State, I am sure, who 

has done that, but we feel that it has positioned us for challenges 

just like the one that you all are helping us to address. 

I want to say, too, to the Chairman, I do not think you could 

have three better witnesses here today. This is the A Team, and 

we are delighted not just for the work that you are doing and your 

Departments are doing, I love the way you are collaborating. And 

I remember we used to battle in my old job, there were a whole 

bunch of challenges in our State, traditionally the departments 

worked in stovepipes and there was not the kind of collaboration. 

We worked on it for 8 years to try to change that, and I think with 

some good effect. I am sure that Governor Napolitano and Governor Sebelius are fully familiar with that in your own States. But 

I love the way that the three of you are collaborating, and it is not 

just the three of you, but the folks who work for you as well. 

114 

I want to say, Mr. Chairman, I think this idea of taking the right 

approaches, being careful ourselves in things that we do, the way 

we cough and wash our hands and so forth. I think it is starting 

to spread. I was walking down the hall for the second time coming 

back to this hearing. As I walked down the hall, I walked by a lady 

standing at the elevator, and I watched her as I walked along. She 

removed from her purse a tissue, and she use that tissue over her 

finger then to hit the down button, and I have never seen that in 

my life. [Laughter.] 

I think the message is getting out there. 

We have had a couple of personal brushes with H1N1 in our own 

family. Our oldest son, who goes to school up in the Boston area, 

is a senior up there, and he is a pretty good athlete, too. And he 

was stricken about 31⁄2 weeks ago, with H1N1. Did not miss any 

classes but was sick every day for about 3 or 4 days. And just to 

show you how quickly you can bounce back from this stuff, he ran 

a marathon on Sunday. So I would not suggest that people get 

H1N1 just so they can prepare for marathons, but they do bounce 

back. 

I mentor on Mondays at a K–5 public charter school in Wilmington, and last week they closed that school on Wednesday and 

closed it for the balance of the week and reopened it on Monday. 

I was there Monday, and we had just about everybody back. So 

kids are resilient. They do bounce back. 

I want to, if I could, mention two things, and a question first of 

all, if I could, for Secretary Napolitano and Secretary Sebelius. In 

addition to the terrific men and women who comprise our first responders and hold the lines every day in protecting the public from 

the spread of serious illness, we also have in our back pocket an 

immense technological arsenal to help our government to fight diseases and influenza from taking over our communities. And whether it is the various surveillance models, modeling programs that 

help us predict where to apply countermeasures next or advanced 

vaccines such as through vapor mechanisms, I feel that we must 

continue to invest in these kinds of technologies, and I would urge 

you to continue to do that. 

If possible, would either or both of you please take a moment to 

describe your respective departments’ approaches to incorporating 

or seeking out new technologies to fight current and future pandemic outbreaks? 

Secretary NAPOLITANO. I will start, Senator. We have an entire 

Directorate that is called ‘‘Science and Technology.’’ I would mention that we are still waiting for the Under Secretary to be confirmed there. Her name has been pending for quite a while. But 

that department is where we focus a lot of our research and outreach efforts, and, one of the goals that we have is to be actually 

more robust in some of the research that we are doing, not just in 

terms of pandemic, but other issues that can affect the public safety of the populace. 

Senator CARPER. All right. Thank you. Secretary Sebelius. 

Secretary SEBELIUS. Senator, we have, I would say, multiple 

agencies within the Department who are, again, collaborating on 

this. We have the science team led by NIH, which has the vaccine 

program; the Food and Drug Administration, who has the reguVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000122 Fmt 06601 Sfmt 06601 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
115 

latory and safety steps authority; and the Centers for Disease Control and Prevention, which has surveillance and outreach capabilities. And they work very closely on things related to vaccination. 

We have an assistant secretary who is specifically focused on 

emergency response. As you know it is not only the pandemic effort, but what happens after a different kind of disaster, a regional 

disaster, how that medical response is done, everything from 

search and rescue to ongoing meeting the medical needs. So we 

have a focused unit on that. 

We have a very robust Global Health Affairs Office that is, again, 

trying to coordinate some of this activity internationally, and we 

work closely with the World Health Organization in terms of responsiveness efforts. 

I have an Assistant Secretary on Health. I would say that within 

our agency we have virtually every department kind of teed up on 

this. Our Office of Children and Families is looking at everything 

from Medicaid waivers to try and get populations out and reimbursed to what we do with kids in foster care. We had a meeting 

last week on homeless shelters, a real challenge in terms of isolating sick people. If you have families in a shelter, where is an ancillary isolate? So working with the Department of Housing and 

Urban Development (HUD) on trying to figure this out. 

So we have had a sort of ‘‘all hands on deck’’ moment within the 

Department, which I would say has been a very good effort not 

only within the Department but certainly with colleagues across 

the Cabinet. 

Senator CARPER. That is great. One of the things I am very 

proud of that is going on in my State—and my guess is it is going 

on in your States and other States as well—is trying to find new 

ways to develop vaccines using things like tobacco plants in order 

to derive them, and trying to move away from an egg-based vaccine 

that sometimes takes a long time to create and a long time to replicate. 

As this outbreak continues to grow, and with the vaccination programs that are being rolled out in all of our communities across the 

country, we have been seeing an immense amount of misinformation surrounding not only the vaccinations but also the Federal 

Government’s policy on who is to receive it as part of their profession. Specifically, I am referring to the false reporting of how the 

Federal Government is employing a mandatory vaccination program, which, as we know, is not true. And this may have been discussed when I was out of the room, but let me just ask you to take 

a moment and just briefly describe the work that you all are doing 

to dispel these false rumors, and maybe give us some advice as to 

how we can help. 

Secretary SEBELIUS. Well, Senator, it is a great point. What we 

are trying to do, among other things, is encourage people to visit 

flu.gov, the one-stop shop. We have a whole series of myths and 

facts: Is the vaccine safe? What are you finding out in clinical 

trials? What has happened to try and dispel some of the rumors 

that are, unfortunately, making people have second thoughts about 

vaccinating their children or getting the vaccination themselves. 

In terms of the mandatory versus voluntary, I think the confusion has been that there are some local health systems who have 

116 

decided that their employees must be vaccinated in order to come 

to work, and I would suggest this did not start with H1N1 vaccine. 

There are some local health units that decided that a number of 

years ago with seasonal flu vaccines. They did not want their workers either to be sick with the seasonal flu or potentially make patients more sick than they already were in the hospital. But that 

has led to, I think, misinformation. 

The Department from the outset has recommended a voluntary 

vaccination program. We continue to recommend that. That does 

not override the local authorities’ opportunity to impose some mandatory guidelines, but that has not come from our Departments, 

been advised by our Department, or been advised by the CDC. So 

we are just continuing to try and get the message out. 

You are a great messenger in Delaware, so I hope you are helping us spread the word about what is real and what is not, but urging folks to visit flu.gov I think is a very good way to get parents, 

employers, and providers some real information. 

Senator CARPER. Great. Thank you. Flu.gov it is. I want to say, 

Secretary Sebelius, we were so grateful to you in Delaware for coming to our State earlier this year. We look forward to welcoming 

Secretary Duncan to the First State next Tuesday morning with 

Race to the Top. Race to the Top with Arne Duncan. Thanks so 

much. 

Chairman LIEBERMAN. Thanks, Senator Carper. 

I want to thank the three of you for your testimony this morning 

and go back to the beginning and thank you for the work that you 

have done since this H1N1 virus appeared and broke out in April 

of this year. Obviously, you are hearing from the Committee some 

of what you are feeling, which is the impatience, the restlessness, 

and frankly just plain anxiety about the H1N1 flu spreading. Senator McCaskill was right. The chart does reflect the percentage of 

all doctor visits that are due to the flu, but I think that parallels 

the increase in not just anxiety but the actual incidence of the flu. 

So this is a real problem. 

And on the three points that I raised at the beginning, I come 

away understanding better why we are going to be about 25 percent short of the vaccine at the end of October that the manufacturer said that we would have. But I know that you understand it, 

and I know you will do everything you can to push them to get this 

to us as quickly as possible. 

I appreciate what you have done to expedite the distribution system, too. That is very important. But the reality is that there is 

not enough now, and we have got to get ahead of the spread of the 

disease. 

On the second point, on the hospital preparedness, on how the 

public health system is prepared for the potential surge that is beyond its capacity, I am encouraged from what you have said to conclude that there is a lot of emergency planning being done in which 

the hospitals will have essentially off-site—if I am hearing you 

right—locations for the less severe cases, if that happens, and then 

use in-hospital facilities for the most severe. 

I am also encouraged about the intravenous antivirals from your 

testimony, Secretary Sebelius, that a decision for emergency usage 

authorization will happen soon. My appeal to you after that hapVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000124 Fmt 06601 Sfmt 06601 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
117 

pens is to the extent that you can, really the hope that you can, 

I want to say ‘‘over-order.’’ I do not think any of us want to be in 

a situation where there are people in critical condition in an ICU, 

their doctor and their family wants an IV antiviral, and we do not 

have enough of it. So based on—again, I hope the PCAST projections of 150,000 to 300,000 people in the country needing ICU care 

because of H1N1 infections, do not ever materialize. But God forbid 

they do, there are going to be a lot of people looking for the IV 

antivirals. 

So, bottom line, thanks for everything you are doing. I know you 

are working really hard at this, and overall I am very grateful for 

what you have done. Senator Collins. 

Senator COLLINS. Thank you, Mr. Chairman. I want to thank you 

for holding this hearing and the three Cabinet Secretaries for appearing before us today. 

I am heartened by the coordinated response. There is one issue 

that I had hoped to bring up that I will bring up for a response 

to the record, and that is, our investigation into the failed response 

to Hurricane Katrina showed a large variation among the States 

in their capabilities and their response when there is a crisis, 

whether it is man-made or naturally occurring. And for the record, 

I would ask that our witnesses today evaluate the evenness of the 

response across the United States and answer the question of 

whether you are targeting specific States that may not do as good 

a job as Maine or Connecticut is doing right now to ensure that 

just because some of our citizens live in states that have less developed capabilities they are not left behind as we fight this pandemic. 

So that is an issue that we did not get to today, but that I would 

appreciate your responding to for the record. Thank you. 

INFORMATION SUBMITTED FOR THE RECORD FROM SECRETARY 

SEBELIUS 

It is important that States and local jurisdictions have the capability to appropriately respond during a crisis. Our Nation’s investment in public health infrastructure, particularly at the State and local levels, remains a critical challenge that 

has real life consequences. Our experience with the 2009 H1N1 pandemic, and the 

lessons we have learned, demonstrate a need to examine new paradigms for 

leveraging the public health infrastructure and our healthcare system to develop the 

needed capabilities to ensure every community is prepared to respond to and recover 

from future disasters. 

As I mentioned earlier during my testimony, HHS is using multiple systems to 

track the impact of the 2009 H1N1 influenza outbreak on our health care system. 

We are in constant communication with State health officials and hospital administrators to monitor stress on the health care system and to prepare for the possibility 

that Federal medical assets will be necessary to supplement State and local surge 

capabilities. To date, State and local officials and health care facilities have been 

able to accommodate the increased patient loads due to 2009 H1N1 influenza, but 

HHS is monitoring this closely and is prepared to respond quickly if the situation 

warrants. 

Since its inception in 2002, HHS has provided nearly $7 billion to States through 

our Public Health Emergency Preparedness Program to help them develop and 

maintain critical public health, communications, and laboratory capabilities at the 

State and local level that are needed to prepare for and respond to emergencies. To 

supplement traditional PHEP funding, in 2009 Congress appropriated funding to 

prepare for and respond to the influenza pandemic. This funding became the Public 

Health Emergency Response (PHER) grant program. Through its four phases, over 

$1.4 billion was provided to States to support activities including vaccination, 

antiviral distribution, community mitigation, laboratory, epidemiology, and surveilVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000125 Fmt 06601 Sfmt 06621 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
118 

lance activities. In addition, since its inception in 2002, our Hospital Preparedness 

Program (HPP) has provided more than $3 billion to fund the development of medical surge capacity and capability at the State and local level. A result of Congress’ 

investment in these programs is that State and local health departments have developed plans for distributing and dispensing critical medications, have better mechanisms in place for disease surveillance efforts, and have initiated or improved coordination of their emergency response assets. Hospitals can now communicate with 

other responders through interoperable communication systems; track bed and resource availability using electronic systems; protect their healthcare workers with 

proper equipment; train their healthcare workers on how to handle medical crises 

and surges; develop fatality management, hospital evacuation, and alternate care 

plans; and coordinate regional training exercises. 

As we learn from the experiences of the 2009 H1N1 pandemic, we look forward 

to working with you to improve strategies to ensure that our Nation has the right 

assets at the right time to minimize the health impacts of an influenza pandemic, 

hurricane, bioterrorism event, or other national emergency 

Chairman LIEBERMAN. Thanks for raising that point. I agree totally. Do any of you want to say something in conclusion? 

Secretary NAPOLITANO. No. I would simply say that an enormous 

planning effort is underway. The frustration now is with delay— 

not shortage but delay, although in context, this is a new flu that 

we did not even know about a few months ago. But the vaccine will 

be pushed out to over 150,000 locations as quickly as humanly possible, and in the meantime, we have a web of other plans underway 

so that business as usual proceeds in the United States and that 

we take care of our critical operations and critical information as 

we work through the problem. 

Chairman LIEBERMAN. Thanks. 

Secretary SEBELIUS. Mr. Chairman, I would just say that from 

the outset, Dr. Tom Frieden, the new head of CDC, reminded us 

that we will either have more than enough vaccine or a shortage 

of vaccine. There may never be the right amount. 

The good news is, I think, people are educated and are eager for 

this immunization, and we will do our best to continue to ramp up 

the production and push it out the door and hopefully to work with 

our partners to mitigate the spread in the meantime. 

Chairman LIEBERMAN. You know, it is a good point. I saw a couple of a stories that indicated it. In California, there were some 

people in the priority categories—I forget which was which, but in 

one State—this was California or New York. In one State, people 

in the priority categories were complaining that they did not have 

enough vaccine. In another State, they had it and some of them refused to take it. So that is the place we are in. 

Secretary Duncan. Thank you for your leadership. 

Chairman LIEBERMAN. Thank you all very much. We are going 

to leave the record open until Friday at the close of business for 

additional statements and questions, and because this is ongoing, 

to the extent that you can answer the questions as quickly as possible, we would appreciate it. 

Secretary SEBELIUS. Sure. 

Chairman LIEBERMAN. Thank you very much. The hearing is adjourned. 

[Whereupon, at 11:52 a.m., the Committee was adjourned.] 

(119) 

H1N1 FLU: GETTING THE VACCINE TO WHERE 

IT IS MOST NEEDED 

TUESDAY, NOVEMBER 17, 2009 

U.S. SENATE, COMMITTEE ON HOMELAND SECURITY AND

GOVERNMENTAL AFFAIRS, Washington, DC. 

The Committee met, pursuant to notice, at 2:57 p.m., in room 

SD–342, Dirksen Senate Office Building, Hon. Joseph I. Lieberman, Chairman of the Committee, presiding. 

Present: Senators Lieberman, Carper, Pryor, McCaskill, Kirk, 

and Collins. 

OPENING STATEMENT OF CHAIRMAN LIEBERMAN 

Chairman LIEBERMAN. Good afternoon. Thanks for your patience. 

As you know, we had two roll call votes on the Senate floor which 

intervened with our getting here on time, but I appreciate your 

being here. 

We hold this hearing on the H1N1 flu outbreak against the backdrop of two crucial numbers going the wrong way: More flu deaths 

than previously realized and fewer vaccine doses than originally 

promised. And this has led to understandable public frustration 

and anger, mixed with confusion over just who should get vaccinated, with States and even individual cities and counties creating different priority lists. 

It also has led, I am afraid, to some of the highest-risk individuals, such as pregnant women and children with asthma, waiting 

in those long lines for vaccine shots that ultimately were not available. And it has created anxiety, sometimes fear among parents 

going on wild goose chases trying to get vaccine for their children 

that their government says they need but that they, the parents, 

cannot find. 

As I said in our previous hearings, I am very grateful for the 

work that Administration officials from the three agencies that are 

represented before us today have done since the H1N1 virus appeared in April. Particularly, the H1N1 vaccine was developed in 

record time and safely. And I know how hard each of you and the 

people you work with have been working since the onset of this 

global pandemic. 

But with so many eligible Americans still unable to get the vaccine, I am afraid that a good situation has turned bad. I worry that 

we are undermining confidence generally in our public health system, and, of course, as I mentioned before, that some of the people 

most at risk from the H1N1 virus not only are having a hard time 

120 

getting vaccinated—some of them—but they may actually stop trying. 

Last week, to get to the numbers, the Centers for Disease Control and Prevention (CDC) released new estimates of the toll the 

H1N1 virus has taken to date, and they are significant: 22 million 

Americans have become ill with this virus; 98,000 people have 

needed hospitalization; and approximately, a little short of 4,000 

people, including about 540 children, have passed away, either directly from H1N1 flu or from a combination of the flu and complications from it. 

That is a quadrupling of the previously reported death toll as it 

was understood in October, and I know a different count, a different system was used, which I think is actually a more accurate 

system, and I appreciate it and I look forward to Dr. Schuchat’s 

testimony on it. 

Another set of estimates, which is the amount of vaccine available, has unfortunately been revised downward again and again 

since planning for the pandemic began in April, and this I believe 

is really at the heart of what has caused so much frustration and 

fear, which I think was unnecessary. And, again, I want to explore 

this with the witnesses. 

Three months ago, CDC estimated the Nation would have 120 to 

160 million doses on hand by the end of October. That, as we heard 

in our previous hearing, was based on estimates that the manufacturers of the vaccine had made. Those doses would be used, first, 

to inoculate five target groups based on vulnerability: Pregnant 

women, caregivers of infants under 6 months, health care providers, anyone between the ages of 6 months and 24 years, and 

high-risk adults under the age of 65. 

These groups total a very large number, actually more than half 

of the U.S. population, about 160 million people. And the consistent 

message to the public coming from the Department of Health and 

Human Services (HHS) and CDC was that these initial target 

groups needed to get vaccinated. So where did those numbers come 

from? 

Well, we learn a lot as we go on. The Advisory Committee on Immunization Practices, a longstanding committee, is the one that 

identified those priority groups, but I was interested to learn that 

they also generated a secondary and smaller list of approximately 

42 million people who were the most at risk—not just at risk but 

the most at risk—in case vaccine availability fell short of what was 

planned for. Those most-at-risk groups included pregnant women, 

again, caregivers of infants under 6 months, health care workers, 

but then a smaller subset: Children aged 6 months to 4 years and 

high-risk children aged 5 to 18. 

Dr. Schuchat described this target alternative at a press briefing 

that CDC gave at the end of July as a ‘‘just-in-case scenario’’ that 

likely would not be needed, but which we should have in our—I 

think you said ‘‘back pocket.’’ And that made sense. Then 2 months 

ago, the just-in-case scenario became the reality we are dealing 

with today as the estimate of available vaccine dropped to 85 million doses, then by the end of October to under 27 million doses. 

Now there are here past the middle of November approximately 42 

million doses available—remarkably and I guess coincidentally the 

121 

1The chart sunmitted for the Record by Senator Lieberman appears in the Appendix on page 

347. 

exact same number as the small most-at-risk target group by the 

Advisory Committee. 

So the States were handed two sets of guidelines and told to use 

their own discretion with respect to how to implement them, either 

the broader group of those who are vulnerable more than most, 

which is 160 million, or the smaller group of those who are most 

at risk, 42 million. Some States opened their vaccination programs 

to everyone in the initial large target groups; other States, including Connecticut, took a more conservative approach and have started with the smaller targeted subset. But the general notification to 

people, including a lot of media focus on this, I think created tremendous interest and, in fact, anxiety about getting the vaccine. 

The chart up there based on CDC data shows how significant the 

gap between what would be needed to provide enough vaccine for 

the 160 million people in the broad priority groups and the 42 million people in the targeted subset and what is actually available.1

And I think—and I want to really invite the witnesses to respond 

to this—that is what has caused the public outrage, basically the 

initial description of the 160 million people who are eligible—not 

just eligible but at risk, and then ending up with now finally 42 

million, which happens to be the number in the smaller subset. 

At our hearing last month, Health and Human Services Secretary Kathleen Sebelius expressed optimism that the problems 

with manufacturing and production of the vaccine that had been 

the obvious cause for the much smaller number than had been predicted had been resolved. Things looked better 2 weeks ago when 

11 million more doses were delivered, with another 8 million projected to be available last week. But by last Friday only about 5 

million were available, and I am concerned, I want to ask the witnesses, whether this was a problem of forecasting or whether something again has happened at the manufacturing facilities. 

Senator Collins and I wrote a letter to Secretary Sebelius after 

our last hearing raising many of these concerns, and I must say, 

respectfully, I did not find the Secretary’s response to our letter 

satisfactory. She did explain in some detail why HHS made some 

of the decisions it made along the way, but the response to me just 

did not say that we have learned from this disappointing experience and we have learned how to make it better next time. 

Look, bottom line what I continue to be concerned about is that 

after it became clear that the manufacturers were not going to deliver the number of vaccine doses that we expected, HHS did not 

say to everybody in the country, ‘‘Wait a second, we do not have 

as many as we thought. Now these are the ones who are most at 

risk, and, therefore, you should come in and everybody else should 

wait.’’ Obviously, people who got there first got the doses, so some 

people who were not in that most-at-risk population got vaccinated, 

and others—pregnant women, children with asthma, etc.—who are 

most at risk did not get the vaccine. 

So, mistakes are made. Things like this do not just happen, and 

I think it is important that we acknowledge them so that we can 

have confidence that we have adjusted our thinking going forward 

122 

as this pandemic continues, and then that we have learned from 

this in a way that will make us better prepared for the next public 

health crisis of this kind. 

Senator Collins. 

OPENING STATEMENT OF SENATOR COLLINS 

Senator COLLINS. Thank you, Mr. Chairman. 

Mr. Chairman, thank you for holding this important hearing to 

focus on the continuing problems regarding the supply and distribution of the H1N1 flu vaccine. 

This hearing is critical to peeling away the layers of misinformation and miscommunication that have hampered the Federal Government’s flu response strategy. 

Many of our constituents, especially those most vulnerable to the 

virus, are frustrated and perplexed by the problems they face in 

getting vaccinated. To illustrate that frustration, let me tell you the 

story of an 11-year-old boy named Brendon Stearns from Greenwood, Maine. 

On October 27, Brendon wrote me a letter. He described his attempts to get the vaccine. He has two autoimmune diseases and 

asthma, placing him in the high-risk group for complications. Yet 

even after his mother called several possible sources—schools, the 

Maine CDC, doctors’ offices both in Maine and in Boston, hospitals, 

health care clinics, and pharmacies—she could not find any vaccine 

available for her son. Finally, her persistence paid off when a 

source was found at a home health agency in Rockland. That was 

a nearly 6-hour round trip from this family’s home in Greenwood. 

I was dismayed to learn about the extraordinary effort this family had to undertake in order to get the vaccine for their high-risk 

child. 

Brendon’s mother also wrote me a letter in addition to his. She 

talked about the worry that her son went through. She said, 

‘‘Brendon has already asked me what hospital he would have to go 

to if he contracts the virus.’’ What a difficult discussion to have 

with your son. To have this thought running through an 11-yearold’s mind is just not right. And that is indeed why we are here 

today. 

Such extreme measures should not be required. And it raises 

troubling questions: How many others, just like Brendon, are still 

waiting for their vaccination? 

Despite consistent reassurances from the Federal Government 

that the vaccine would be available for all who wanted it, the bottom line is that people like Brendon and his mother often have 

been left to fend for themselves. Scores of people in Maine are telling me similar stories. A veteran from Biddeford with a compromised immune system due to a liver transplant came to my Biddeford office asking for help. School nurses have contacted me frustrated with last-minute changes regarding vaccine delivery and 

availability. 

What is the national strategy? Where was the plan? And as Senator Lieberman has said in his opening statement, why wasn’t the 

plan altered when manufacturing problems first became evident? 

And those problems appear to have become evident in late June 

and early July, according to our interviews with the manufacturers. 

123 

Instead of false assurances, why wasn’t the Federal Government 

explaining the challenges with the manufacturing process and distribution and revising and clearly communicating a new vaccine 

distribution strategy? 

If I were to summarize the sentiments of so many Mainers and 

so many others across the country who have hit obstacle after obstacle in trying to obtain the H1N1 flu vaccine, I would choose one 

word: ‘‘Frustrated.’’ 

Parents are frustrated that they cannot get the vaccine for their 

children. 

Doctors and nurses are frustrated because they cannot give their 

patients accurate timelines for vaccine arrival. 

State and local officials are frustrated because they cannot plan 

a cohesive community response because the promised supply of vaccines often does not arrive on time—if at all. 

Americans across the Nation are frustrated because they want to 

take recommended steps to help protect themselves and their family’s health, but they cannot. 

Let me cite another example across the country from Maine. The 

Web site for the Department of Public Health for San Francisco 

has a section called ‘‘Frequently Asked H1N1 Swine Flu Vaccine 

Questions.’’ Let me read some of the questions and the frustrating 

answers. 

Question: My pediatric office has live virus vaccine. When will 

they get the injectable vaccine? Since obviously the live virus vaccine is not suitable for everyone. 

Answer: The Health Department has no way of knowing that, 

and neither does your doctor’s office. All orders are being filled on 

a random basis. 

Question: I go to an internal medicine doctor for my care. When 

will she have the vaccine? 

Answer: This is unknown. At the rate vaccine has been trickling 

in, it could be in 1 to 2 months. 

Question: Why does the doctor’s office across the street from 

where I take my children have the vaccine, but my children’s doctor does not? 

Answer: Orders are being filled on a random basis. There is no 

way to predict who will get what and when. 

The final question that I will read is perhaps the most poignant. 

Question: What am I supposed to do if I am in a high-risk category 

and I cannot find any vaccine? 

Answer: Take comfort in the fact that you are not alone. It remains unclear to all involved when the full supply of vaccine will 

be in place, so please remain patient and calm and know that the 

whole country is experiencing the same wait. 

What an awful answer to have to give to someone like my constituent who had a high-risk child with two autoimmune diseases 

and asthma and is searching the entire State to find a supply of 

the vaccine. 

It is also frustrating, confusing, and aggravating to our constituents when we learn that while a high-risk veteran has been unable 

to get vaccinated at the Veterans Affairs (VA) hospital, terrorist detainees at Guantanamo Bay may be getting the vaccine ahead of 

Americans in priority at-risk groups. We learned that executives at 

124 

1The prepared statement of Dr. Schuchat appears in the Appendix on page 348. 

bailed-out banks, such as Goldman Sachs and Citigroup, may be 

getting the vaccine ahead of children and pregnant women. 

Just this last month, this Committee held a hearing to examine 

the government’s efforts, and as the Chairman said, there is much 

to applaud with the early identification and development of a vaccine. But when we asked about vaccine availability, we received 

rosy reassurances from the Secretary of HHS about the supply. She 

said—and I want to quote because it has not come to pass. Secretary Sebelius said, ‘‘By early November we are confident that 

vaccine is going to be far more widely available. There is enough 

vaccine, and will be, to vaccinate every American who wants to be 

vaccinated, and we are pushing it out as quickly as we can.’’ 

Well, Mr. Chairman, it is now mid-November, and we know that 

supply production is still lagging behind those repeated assurances. 

Only after our October 21 hearing did the truly dire nature of 

the vaccine shortage come into clear focus, and I join the Chairman 

in expressing great disappointment in the responses that we have 

received from Secretary Sebelius in reply to our specific questions. 

What we received in response were generalizations and non-answers. 

The Administration needs to do a better job working with State 

and local public health officials who can then set attainable goals, 

and surely all of us should agree that the vaccine, while it is still 

limited, should be distributed to the most vulnerable groups. 

Americans—like Brendon Stearns—deserve answers. H1N1 may 

well resurge, perhaps in a more powerful form, next year. In any 

event, we know well that this will not be the last pandemic that 

we face. 

Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thank you very much, Senator Collins. I 

appreciate that. I welcome the witnesses. Do you have a preferred 

order to go in? 

Mr. GARZA. No, Senator. 

Chairman LIEBERMAN. Is it appropriate to start with Dr. 

Schuchat? I want to just move across the table. We welcome you 

back. 

Anne Schuchat, doctor and admiral, if I am not mistaken, is Director of the National Center for Immunization and Respiratory 

Diseases, Centers for Disease Control and Prevention. Thank you 

for being here. 

TESTIMONY OF ANNE SCHUCHAT, M.D.,1 DIRECTOR, NATIONAL 

CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES, 

CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Dr. SCHUCHAT. Thank you, Chairman Lieberman, Ranking Member Collins, and Members of the Committee. I am really pleased to 

be able to speak with you today to update you on the Administration’s response to the H1N1 pandemic. I am going to give a brief 

update of the situation and then go into more detail into the response and the vaccination situation, which I believe is the heart 

of the focus. 

125 

1The chart referenced by Dr. Schuchat appears in the Appendix on page 361. 

Chairman LIEBERMAN. Right. 

Dr. SCHUCHAT. As you mentioned, we did last week update the 

estimates of the full toll that we believe the virus has had in the 

first 6 months. We do not think the reporting of lab-confirmed 

cases really tells the whole story, so we are estimating 22 million 

people have been infected and ill since the first 6 months. 

Chairman LIEBERMAN. So the big difference is that the previous 

estimates were just, as you said, based on laboratory-confirmed 

cases. 

Dr. SCHUCHAT. That is right. What we have done is taken a 

number of surveillance systems and efforts to correct for underreporting the accuracy of the lab result and so forth, and we have 

come up with this 98,000 hospitalizations, nearly 4,000 deaths, and 

as you said, tragically, over 500 deaths in children, probably. 

Right now the H1N1 virus is still widespread in 46 States. In 

many States it is beginning to decrease, but it is still way above 

the estimates of what is normal for this time of year, and it is continuing to increase in the northeastern part of the country, where 

you both live. 

So far there has been no change in the illness pattern. The majority of illness is in younger people. Many of the severe cases are 

in people with underlying conditions or in pregnant women. So far 

there is no change in the virus. It has not mutated to become even 

more virulent. The good news is the vaccine is an excellent match 

with the virus that is still circulating, so we expect high efficacy 

of the vaccines that we have. 

But, unfortunately, influenza, including H1N1, is unpredictable, 

and we cannot tell you the trajectory, how much longer we will 

have this widespread disease, how many more waves will follow, 

whether we will have a substantial additional wave after the first 

of the year, which is what happened in 1957. 

It is important, I think, to thank Congress for the incredible investments in preparedness that have made the rapid detection and 

the response that we have had possible. Without those investments, things would be much worse. We know that there are many 

places where there is room for improvement, but I do believe that 

we are much better off than we would have been without the years 

of preparedness investments. 

On the poster and then in the handout that you have, I have 

tried to summarize CDC’s role in the response, and you will hear 

from Dr. Lurie about HHS’s broader role.1 We, as you mentioned, 

identified and rapidly characterized the virus. We developed candidate vaccine strains that could be handed off to industry. We 

used our epidemiology and laboratory efforts both in the United 

States and globally to understand what was going on, how far this 

was spreading, and to develop science-based interventions. 

We have had aggressive comprehensive science-based response 

with rapid deployment of the assets in the Strategic National 

Stockpile, life-saving antivirals, and other measures, including respiratory protection. 

We developed and distributed laboratory kits to all of the public 

health labs in the United States and to 150 countries so that we 

126 

could understand what was going on abroad. That was all based on 

investments that had come through the preparedness resources. 

And we deployed field teams to provide technical assistance at 

home and abroad and continue to do that. 

We issued science-based guidelines for key sectors, including 

mitigation efforts that focused on schools, businesses, and health 

care workers, including treatment with antivirals such as those in 

the Strategic National Stockpile, and also additional products that 

came to be available through emergency use authorization. 

Communication and State and local support were key 

underpinnings to our response, and then, of course, one of the key 

pillars of the response has been vaccination. This has been an unprecedented effort to develop the strain, to prepare to carry out 

clinical trials, to develop recommendations for use, and, of course, 

to launch the voluntary program. 

I share your disappointment in the initial production and the set 

of supply constraints that we have today. We have all been victim 

to the biologic processes of a slow-growing virus, and it really 

underscores the need for those long-term investments in vaccine 

technology and expanding production capacity. But production is 

accelerating and substantial amounts are becoming available, not 

as much as we want, but more every day. 

Today, 48.5 million doses of H1N1 vaccine are available for the 

States to order. About a quarter of that is the nasal mist that you 

mentioned, which, of course, can only be given to healthy people 2 

to 49 years of age. 

We have prioritized for the use of this vaccine groups that were 

at the highest risk for disease or the highest risk to spread. The 

national standards were set by that Advisory Committee for Immunization Practices that you referenced, but we have been supporting State and local decisionmaking on the best ways to put vaccine in the path of the priority populations. 

We know that States are carrying this out in a variety of ways. 

Thirty-four States so far have initiated school-located vaccination 

efforts. Virtually all of the States are providing vaccine to providers. Some are using lotteries to decide who gets the vaccine. 

Some have ethics boards. Some are focusing on the high-risk providers that serve the highest-risk children or adults. 

We have heard of some success stories in the midst of all of this 

challenge. I have to say that the State of Maine has been doing an 

extraordinary job. At the end of this week they expect to have completed vaccinations at all 130 school districts. They have also provided vaccine to providers with those highest-risk patients—unfortunately, not early enough for many of the families who had to go 

through the nightmare that you described, Senator Collins. 

We know that Connecticut, Delaware, and others really focused 

on the high-risk providers, hospitals, Federally qualified health 

centers, and others are now actually beginning to be able to provide some vaccine to retail venues which can reach additional people or to workplace clinics that can reach the high-risk groups 

while they are at work and not requiring them to leave work to get 

vaccinated. 

This is definitely a State and city-run implementation effort. Our 

Advisory Committee reiterated in October, once we knew about the 

127 

1The prepared statement of Dr. Lurie appears in the Appendix on page 362. 

supply shortages, that the State and local people were in better 

shape to sort out the subprioritization efforts and how best to reach 

the important groups. 

It has been critical to use the vaccine doses as quickly as they 

become available and not have them sit on the shelf, and I really 

want to applaud the public health folks at the State and local level 

who have been working day and night to carry this program 

through. 

I also want to mention safety. We are committed to a safe vaccine system, and although we do not expect any problems with this 

product, we are carefully monitoring the situation, working with 

external advisory groups and so forth, to make sure that if anything unusual occurs we are able to intervene promptly. 

We have been working very hard across HHS and with other 

parts of the U.S. Government to make sure that the State and local 

health departments are in the best position possible to support prevention efforts on the ground. I think that this H1N1 pandemic 

really highlights the need for long-term investments in that infrastructure that is the front-line response system. 

And just in closing, I want to say I will be happy in the questions 

and answers to address the specifics of the distribution system and 

really share the frustration that you describe. I wish that we had 

more vaccine and that it was much easier for people at risk to get 

vaccine. 

Chairman LIEBERMAN. Thanks, Doctor. I am sure you do. I am 

sure you are at least as troubled as we are and as people in our 

States are when they cannot get the vaccine. We want to come 

back to it, but I want to know what you would do differently next 

time to try to avoid a similar crisis, particularly once the production was way below what the estimates of the need were. 

Dr. Nicole Lurie, this is actually a good room to get sick in, if 

you want to—we have three doctors as witnesses. I am not suggesting anything serious, but there is a plethora—— 

Dr. LURIE. I thought you were commenting on my virus. 

Chairman LIEBERMAN. Dr. Lurie is the Assistant Secretary for 

Preparedness and Response (ASPR), Department of Health and 

Human Services, who will provide testimony, I hope, detailing the 

development and production of the H1N1 vaccines, including monitoring of manufacturers’ timelines for vaccine distribution. 

Dr. Lurie, thanks for being here. 

TESTIMONY OF NICOLE LURIE, M.D.,1 ASSISTANT SECRETARY 

FOR PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF 

HEALTH AND HUMAN SERVICES 

Dr. LURIE. Great, and thank you so much for the opportunity to 

come and talk with you today about our efforts during this pandemic. I, too, would like to start by taking the opportunity to thank 

you for your continued support. It was really due to your foresight 

that we began rebuilding the vaccine infrastructure several years 

ago when we decided to pursue vaccine for H1N1. It turned out we 

already had pre-existing contracts with manufacturers already licensed in the United States, enabling us to get out of the blocks 

128 

1The chart referenced by Dr. Lurie appears in the Appendix on page 385. 

quickly with vaccine manufacturing, and the right-hand side of 

that graphic 1 really identifies some of the investments that were 

made to make that possible. 

I want to really start by just reviewing for you the role of my office in this, which is really four-fold. 

First, our role is to coordinate across-department response and to 

work across the interagency, including with my colleague Dr. 

Garza. 

Second, ASPR stimulates the development of and contracts for 

vaccines and antivirals. 

Third, is to ensure that we can backstop States and communities 

when they get overwhelmed and request our help. 

And, fourth, really importantly, is to stay prepared for any other 

emergency, not to take our eye off the ball during this critical time. 

And you will remember that we did respond to the tsunami in 

American Samoa in the middle of this. 

I want to say that this H1N1 response has been a public-private 

partnership from the beginning. I think you have already highlighted the incredible speed with which vaccine was made, and I 

want to say that also would not have been possible without our 

partnerships with industry. But while modest amounts of vaccine 

came a little ahead of schedule, a combination of poor production 

yields, late completion of seasonal vaccine, problems with new filling lines, decisions in the home country of a manufacturer, all 

caused delays—and, frankly, repeated delays—in the availability of 

vaccine, but I want to stress not just for the United States but for 

the world. And the left side of the graphic,1 the pieces in orange 

in that graphic go through the vaccine manufacturing process and 

show you really all of the places where things have gotten stuck 

along the way. 

While we have all been, I think, really frustrated by the delays 

and tear our hair out each time we hear about another problem 

and another delay, I think from my perspective we have done our 

best to communicate directly with the American public each time 

we have learned of one of these problems. As said, now the number 

of doses that have been produced and distributed, as you heard, 

continues to grow steadily, and we continue to expect increasing 

amounts of vaccine in the coming weeks. 

We remain incredibly vigilant here. We talk to the manufacturers every day. Right now we have full-time people at two of the 

manufacturing facilities just to monitor and assist, to give us a 

heads-up if any problems are occurring, and to help with on-theground problem solving. In addition, Secretary Sebelius and I have 

spoken directly with the chief executive officers on more than one 

occasion to identify opportunities to work together to speed the delivery of vaccine and, frankly, to be sure that there are not any arcane, bureaucratic obstacles in the way at our end to making that 

happen. 

So while the delays are really frustrating to everybody—and we 

hear that, and it is frustrating to us as well—it is really the virus 

that is the real enemy here. I think as Dr. Schuchat said, and I 

think you know well, it continues to really reinforce the need to 

129 

move forward to new technologies, to more robust manufacturing 

capacity, to more robust filling capacity so that, frankly, a virus of 

the future does not defeat us. 

Although the focus of this hearing is on vaccines, I do want to 

highlight progress that we have made in antivirals. As you know, 

we now have the first ever intravenous antiviral available under 

emergency use authorization. We are procuring over 30,000 doses 

across three different types of IV antiviral drugs to treat critically 

ill in-hospital patients. 

We have also been really focused on ensuring that the health 

care system itself—in communities—can remain able to care for 

people. The President’s emergency declaration has enabled us to 

support hospitals and health systems that need to be decompressed 

with 1,135 waivers, and we stand ready to deploy Federal assets 

where necessary to support health care facilities. Our first Federal 

vaccination team is actually being deployed to Delaware next week 

to help with vaccination there. 

We have partnered very closely with the private sector health 

care system—health insurers, pharmacists, big box stores, the 

American Medical Association (AMA), the public health community—to find ways to pay for vaccine administration so that cost is 

not a barrier. 

Let me move on a little bit to some lessons learned. 

First, as I said, the support of Congress has been really critical 

in helping us to strengthen the vaccine infrastructure, enabling us 

to respond quickly. But yet it is clear to all of us, I think, that 

chronic underinvestment in public health, whether in that infrastructure, at the Federal, the State, or the local level has realworld consequences. And I think we are seeing some of those. We 

cannot afford to let that happen again ever. And while we have 

made vaccine in record time without cutting any corners, in retrospect the original projections which were based on the collective experience with seasonal flu manufacturing and H5N1 pandemic preparedness manufacturing, were optimistic in the face of what 

proved to be daunting challenges provided primarily by Mother Nature and despite the best efforts of the Federal Government and 

our manufacturing partners. 

Congress and the public have rightfully asked for projections 

about the numbers of doses, and we want to be transparent. But 

at the same time, we have to provide all of the caveats about the 

uncertain and changeable nature of these projections. In the face, 

again, of Mother Nature, this continues to be fraught with uncertainty. 

A real challenge here, though, especially has been the fact that 

as messages get captured with shorter and shorter sound bites, you 

lose all the detail about all of these caveats and these contingencies. This has led to frustration for everybody involved. So as 

the supply improves and we incorporate early lessons now from the 

vaccination efforts—and I want to say that there have been a number of those, and each time we learn one of these lessons, we incorporate it, we pass it on to our partners in State and local areas. 

And so, they are able to work to do things, to get those lines shorter and to make it easier for people to have an easier time getting 

vaccinated as time goes on. 

130 

1The prepared statement of Dr. Garza appears in the Appendix on page 387. 

I do want to mention the past week because you talked about 

this week’s projections. The storm that was the remnants from 

Hurricane Ida delayed shipment to one of the major depots and, 

frankly, nearly derailed vaccination campaigns in States from 

Maine to Alabama. I want to credit the staff at CDC and the office 

of the Assistant Secretary for Preparedness and Response that 

worked all weekend to be sure that vaccine could be ordered and 

shipped on Sunday night so that clinics scheduled for this week 

could go on as planned. 

Importantly, we are far from done with the science and advanced 

development related to vaccines and with building manufacturing 

capacity in the United States. In other words, that underinvestment in advanced development is also chronic. And as you said, 

Senator, my fear is that when this is over, we will decide we do 

not need to worry about another pandemic for the next 30 years, 

and nothing could be further from the truth or be more dangerous. 

I also want to point out that much of what we do today is relevant for any new threat we need to confront, whether made by 

Mother Nature or made by human beings. Despite these challenges, I think that much of what we have learned and we are continuing to learn through this pandemic and the investments we 

have made to address it will serve us well in confronting public 

health emergencies and threats for many years to come. 

I, too, look forward to providing a more detailed explanation of 

the graphic, the timelines, and other matters during our questionand-answer period. 

Chairman LIEBERMAN. Thanks, Dr. Lurie. 

Finally, we have Dr. Alexander Garza, welcome back, Chief Medical Officer and Assistant Secretary for Health Affairs at the Department of Homeland Security. Dr. Garza will testify about the 

Department’s actions since our Committee’s hearing on October 21 

and the Department’s assessment of how States are managing the 

outbreak. 

Welcome back. Thank you. 

TESTIMONY OF HON. ALEXANDER G. GARZA,1 ASSISTANT SECRETARY FOR HEALTH AFFAIRS, AND CHIEF MEDICAL OFFICER, U.S. DEPARTMENT OF HOMELAND SECURITY 

Dr. GARZA. Thank you, Mr. Chairman, and good afternoon to you 

and Ranking Member Collins and the rest of the Committee today, 

and thank you for allowing me to testify here this afternoon. 

Before I get started, I wanted to offer a quick thanks as well for 

my confirmation hearing this summer. This is the first time I have 

been able to testify before you, and I thank you for that. 

The current H1N1 pandemic is a unique event. There is no 

ground zero. There is no location where it is most likely to make 

landfall. There is no discrete beginning or end, and although this 

pandemic will not destroy buildings, it can cause a lot of stress to 

our society, as you have mentioned. And although this hearing is 

focusing on vaccine, I wanted to discuss some of the Department 

of Homeland Security’s efforts in dealing with the H1N1 pandemic. 

131 

To this end, we have focused our efforts on protecting the people 

and the country from the effects of the pandemic. As you know, 

Senator, DHS has a dual mission in combating the flu. While we 

are intimately involved in the national planning and response efforts, we also work internally with our policies and procedures to 

protect our workforce so that they can continue to safeguard our 

country. 

The principal tasks of the Office of Health Affairs (OHA) regarding the current pandemic are providing information, analysis, and 

advice to Secretary Napolitano, co-leading the DHS H1N1 planning 

effort, helping ensure that the DHS workforce is protected, and 

serving as the lead representative for the Department of Homeland 

Security in the interagency coordinating body. 

Together with our interagency partners, DHS has led a strong 

Federal response. We have learned from our experiences and have 

implemented changes to help us both currently and in the future. 

The key lessons that I would like to describe are interagency coordination, planning, workforce protection, and communication. 

The spring outbreak illustrated the necessity of strong interagency coordination. We have worked closely with our Federal 

partners, including my colleague Dr. Lurie at ASPR, with the Department of Health and Human Services, with the Centers for Disease Control and Prevention, as well as the Department of Education and the White House. 

In addition to working horizontally across our Federal partners, 

we have also worked vertically with State, local, tribal, and territorial governments, as well as the private sector and faith-based 

communities in providing guidance. The DHS Office of Intergovernmental Programs conducts weekly calls and meetings with our 

homeland security advisers across the country, and National Protection and Programs Directorate (NPPD) coordinates with critical 

infrastructure representatives, and this is just to name a few of our 

efforts. And we will continue to collaborate and push information 

out to all. 

As my experience in the Army has taught me, plans must be 

flexible enough to adapt to the reality on the ground. This Department has learned this as well. As we all know, plans never survive 

first contact with the enemy. 

While we originally planned for a worst-case scenario of pandemic flu that originated outside of our continent, we quickly realized that this was not the case. Having plans flexible enough to 

adapt and maneuver to the changes of the current reality are imperative if we are going to meet future challenges. 

Additionally, we tested our internal coordination and planning by 

conducting tabletop exercises that brought together the leaders 

across the Department of Homeland Security and which were actually attended by the Secretary as well as the Deputy Secretary in 

order to test our programs for the stress that H1N1 would place 

on our components. This provided an opportunity for us to identify 

how to meet our mission-critical functions while protecting employees during an influenza pandemic event. 

As I mentioned earlier, DHS has a dual mission where one complements the other. Eighty percent of the Department of Homeland 

Security personnel are operational, and for comparison, this is 

132 

roughly the size of the Marine Corps. OHA and DHS have moved 

aggressively to ensure that our forces are protected. We have widely disseminated evidence-based guidance to our employees and 

posted it on our Internet sites. In addition, we spearheaded the acquisition, storage, and forward-positioning of our protective measures, including personal protective equipment and antiviral medications. 

By performing these functions, we are helping assure that the 

threat of the current pandemic will not influence the security posture of this Nation. Because our job at DHS is to ensure a coordinated Federal response, information sharing is essential. OHA coled the operational planning team that served as a hub for the collection of data to present leadership a clear picture of what was occurring during the pandemic. In addition, our National Biosurveillance Integration Center led a modeling effort in the spring to get 

a better idea of what was possible with the resurgence in the fall, 

especially the impact on our critical infrastructure and key resources. 

We recently shared this with our leadership as well as our partners at the State, local, and private sector. As a result of these efforts, we have partnered with Health and Human Services on further modeling efforts to understand the effects of the flu. As we 

move forward through the fall flu season, we will continue to build 

on these strong relationships formed with our partners across all 

levels of government and the private sector. 

Again, I would like to thank you for the opportunity to testify before you today, and I look forward to answering any questions. 

Thank you. 

Chairman LIEBERMAN. Thank you very much, Dr. Garza. We will 

do 7-minute rounds of questioning for Members of the Committee. 

Dr. Schuchat, let me just start with the numbers here on the incidence of the virus, and as you said, you changed the method of 

calculating—in other words, going beyond laboratory confirmed 

cases. If my recollection is right, in the new projections or estimates you are making, both the incidence and particularly the 

number of deaths has gone up significantly from what originally 

had been thought to be the case. Am I right? And if so, what does 

that tell you as an expert in this about the incidence of H1N1? 

Dr. SCHUCHAT. Since the beginning of the pandemic, we have 

tried to use approaches to surveillance that were appropriate to the 

resources available and the stage of the pandemic. So, initially, we 

were counting individual cases. It was very important for testing 

to occur in a widespread way so that we would know whether it 

had arrived in additional places. 

At a certain point, individual case counting was no longer an efficient use of resources or an efficient use of the health care system, 

and so individual case counting was stopped, and we worked with 

the State health departments to identify other approaches to tracking the disease. 

All the way through, we have been saying that reported cases, 

whether lab confirmed or based on other definitions, would be an 

underestimate of the true burden of infection. Many people do not 

seek care when they are ill. Many people who are ill do not get a 

test performed. Many people who get a test performed have a negaVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000140 Fmt 06601 Sfmt 06601 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
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tive result because the tests are not 100 percent accurate. And then 

not all positive tests get reported into the various systems. 

So, really, since the beginning we spoke about the measured burden and then the unmeasured burden, and we worked to find a 

science-based approach to accurate estimates. We released some estimates earlier this year about the disease from April through July 

and last week were able to talk about the first 6 months of the 

pandemic, and there came away with these numbers that were 

much greater than reported cases, but we believe much more accurate. 

Chairman LIEBERMAN. Were you surprised when the numbers 

came in? They are pretty high. I was surprised, 22 million illnesses, 98,000 hospitalizations, more than 3,900 deaths, including, 

as we said, about 540 children. 

Dr. SCHUCHAT. I would say that I was not surprised. I was sobered. But I also want to say that we have been taking this seriously from the beginning. Some people thought we were overreacting to this new threat, but I think the idea of a new strain of 

influenza that the population is susceptible to means that you can 

get these kinds of tolls. Even if the virus is not as virulent as the 

H5N1 bird flu strain or the 1918 strain, a new virus in a susceptible population can lead to large-scale illness. And that is really 

why we have had this focus on methods to decompress the health 

care system, have the sickest people cared for, rapid use of 

antivirals for them, but people with less severe illness were able 

to be cared for at home without clogging up the emergency departments. 

So I think we have been taking this very seriously, so the numbers were expected for me. 

Chairman LIEBERMAN. Let me go on to this main question, which 

is the lines, the frustration, and the fear of people not getting the 

vaccines. And I want you to respond. My theory on this—and I am 

just observing—is that the government, HHS, CDC, should have 

done a large national announcement of a reduced list of people who 

had to go out and get the vaccine and everyone else should stay 

home for a while when it was clear we were going to get fewer vaccines. 

If that was not the case—again, you have spent so much time on 

this. You have got to be as frustrated and in some ways embarrassed as anybody else, more so about the problem with distribution of the vaccine. So is my theory right? And if it is not, what 

did cause this problem? Because it did not just happen. Something 

went wrong. 

Dr. SCHUCHAT. Yes. You mentioned the just-in-case scenario with 

the smaller population. 

Chairman LIEBERMAN. Yes. 

Dr. SCHUCHAT. Our Advisory Committee met July 29, 2009, but 

they met again in October. We re-asked the question to them. Are 

the scenarios of supply that we are looking at now such that we 

really ought to go systematically nationwide for that smaller 

group? We also consulted State and local health department leaders, the Association of Immunization Managers. There was an active discussion at our public meeting of the Advisory Committee. 

134 

What we heard pretty consistently was leave the flexibility to the 

State and locals, let them decide whether to subprioritize—and a 

number did—or go broader. 

We also had a bit of an unfortunate occurrence in the beginning 

of the supply that, the first week or two, almost all of the supply 

was the nasal spray. That does not stretch very far with the highest-risk group. It will not get a child with asthma. It cannot be 

used in pregnant women. We wanted to be able to use those doses. 

We also heard clamors from many that they really wanted to do 

school-located clinics. They thought protecting children was important, and also slowing spread by protecting children would be important, and also children under 10 need two doses. So many 

States wanted to be able to move forward with the school-located 

clinics. 

Chairman LIEBERMAN. Let me interrupt. So looking back, don’t 

you think mistakes were made here? Because it did not work as 

you hoped it would. It is possible—I am a lay person. I know there 

are experts on the Advisory Council, but, my own reaction to this 

is that they were wrong. 

Dr. SCHUCHAT. I think that looking back is very important, and 

we are also trying to look forward and learn. I think we are committed to continuous learning in this. 

One thing I think we can look back and say was a mistake is 

some of our communication, that whether we meant to or not, I 

think we led expectations of availability to be higher than they 

have been, and so that I think can lead to frustration. 

But I would say that, I have tremendous faith in the American 

public. I hate that people had to wait in line or that people have 

not been able to find vaccine. But our surveys tell us that those 

who looked for vaccine and were not able to get it, nine out of 10 

plan to look again. And, fortunately, it is getting a little bit easier 

each day, although not yet at the point where demand and supply 

have gotten close enough together. 

Chairman LIEBERMAN. All right. I appreciate that. And, actually, 

I think you used the word ‘‘mistake,’’ and it is important to acknowledge that here because this is going to happen again and we 

do not want to let the mistakes happen again. 

I tell you, one of the things that, it seems to me, happened here 

is that this is a national problem, and there was a focus on national alerts about this, so that the fact that you gave the States 

some latitude did not really sink in nationally. And, of course, if 

you happen to live adjacent to another State where the distribution 

was different or even in another community in the same State 

where one set of parents could get the vaccine at their doctor’s and 

the other could not—I mean, we have all had this in all of our families. I was hearing from my children who are trying to get vaccines 

for my grandchildren. 

I think this is a case really where it would have been better to 

have a national answer and in this case not go for federalism—in 

other words, not let the States and localities make their own decisions on prioritizations—because everybody was focused on the national warnings about the disease and the urging to go out and get 

vaccinated. 

135 

Dr. SCHUCHAT. Yes, just briefly, I think that we did really feel 

that local and State experts and authorities were in a better position than we were in Atlanta or others were in Washington to 

know how to best reach the populations in their midst—some of 

them, as I said, going very heavily with the private sector providers, others making mass clinics available for priority groups, 

others using sort of a hybrid approach. 

I think that the sense of trust and the sense of planning really 

needed to be closer to the community level. Whether we supported 

the States and locals sufficiently, we did give resources for communication so they could do messaging. I am not sure it was, as effective as it could have been. 

Chairman LIEBERMAN. I do not think it was. My time is up, but 

I understand about the particular places of distribution. That is an 

appropriate decision for State and local public health authorities to 

make. But I honestly believe, looking back, that CDC or HHS, 

when it was clear that the production of the vaccine was going to 

be so much lower than expected and predicted, should have just nationally said, OK, you decide, States and locals, who is going to 

give it out, but here is the most at-risk population, 42 million, and 

this is who you have got to concentrate on first. 

My time is up. Senator Collins. 

Senator COLLINS. Thank you, Mr. Chairman. 

Doctor, let me continue on the line of questioning that the Chairman has just begun. It is my understanding that in July your Advisory Committee met and it identified 159 million people that could 

be categorized in the priority group. Now, that is a very large number, and that was based on CDC’s initial estimates that there 

would be approximately 120 million doses by October. Is that correct? 

Dr. SCHUCHAT. Well, one clarification is that in the summer, 

when the Advisory Committee met and set the policy of that group, 

there was actually an expectation that everyone was going to need 

two doses of vaccine. So the number of doses is not directly translatable to the number we are looking at now, because, fortunately, 

it turned out that people 10 and up only need one dose of vaccine. 

Senator COLLINS. Well, that actually makes the situation worse 

because if you were assuming that two doses might be needed for 

much of this population, then there is a far greater mismatch on 

the number of high-priority individuals, almost 160 million people, 

versus 120 million doses. So that is even a bigger mismatch. And 

that was the July 29 meeting. Is that correct? 

Dr. SCHUCHAT. Yes. And let me give you a sense of where the 

Advisory Committee was coming from. Our Advisory Committee 

recommends influenza vaccine for about 263 million people, and 

about 100 million people get vaccinated each year with seasonal flu 

vaccine. 

It was impossible to know what demand for vaccine would be 

like, but we rarely equate a size of a population with a number of 

doses. They felt that they wanted a broad priority group. They did 

not want to micromanage the risk groups because they felt that demand may be fickle. It may be different in New York City from 

Maine. It may be different in October from November. And so they 

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pitalized, who was dying, where was the social disruption, and focused on a group that was quite large, the 159 million group. 

Senator COLLINS. But then what happens is the Advisory Committee, I believe in August, created a smaller priority group. 

Dr. SCHUCHAT. It was actually at that same July 29 meeting. 

The publication was finally issued in August, but on July 29, they 

voted on both the 159 million and the 42 million groups. 

Senator COLLINS. The larger group and the smaller group. My 

point is that the Advisory Committee in the summer had identified 

a smaller priority group of 42 million people at highest risk. That 

included pregnant women and children. These are the people that 

we really want to make sure are going to get the vaccine. And yet 

at the same time, you are starting to realize that there are manufacturing problems that are beyond your control, beyond the Federal Government’s control, that are greatly reducing the production 

of the vaccine. 

So we have already identified the priority group that is smaller, 

and we know the good news that most people are protected with 

just one dose of the vaccine. 

I just do not understand why the Federal Government did not 

then instruct States and local public health officials to concentrate 

on this priority group. And I believe the American people will put 

the highest priority people first gladly. But if they are not getting 

a revised distribution plan from the Federal Government, you create chaos. You create the chaos that we have seen of clinics not 

having enough, of people standing in long lines, and people who 

need it most not getting it. 

And I so agree with the Chairman’s point. I do not understand 

why, when it became evident that there was a mismatch with supply and demand, the priority group was not clearly communicated 

and Plan B put into effect. 

Dr. SCHUCHAT. We did a substantial amount of outreach that 

was targeted to the 42 million population, working with caregiving 

groups, health care providers, and advocacy groups that served the 

very children with disabilities, high-risk condition groups. We also 

were somewhat cornered by the availability of the nasal spray, as 

I say, which cannot be used for pregnant women, children with 

asthma. 

One of the striking features of the pandemic was the effect on 

children. Every time a healthy child has been hospitalized, it has 

been very different for each family and for each community or 

school. I think it is important to recognize that the 42 million 

group does not include healthy school-aged children. And I know so 

many parents who have been really anxious to get their young children and older children vaccinated; they are not in the 42 million 

group. 

I would say that each decision that has been made has been 

taken very seriously. We have sought external advice. We have 

tried to look at things in different ways. And I think reasonable expert people could disagree on the best way to go forward. We are 

trying to improve every day. 

Senator COLLINS. I think one of the lessons here is that when we 

do run into these problems, we need to prioritize the distribution 

of supplies. 

137 

Dr. Lurie, in my remaining minute, I want to raise two issues 

with you. When I have talked to public health officials and other 

experts, they say to me that they believe HHS made mistakes in 

two areas that would have made a real difference in terms of increasing the supply. The first was the requirement that individual 

syringes be filled with the vaccine. The manufacturers tell me that 

took longer than if you had approved batches to be distributed and 

then syringes could be filled at the local level, that it was a lot 

more complicated for individual syringes to be filled. 

The second issue that I have heard repeatedly—and I know it is 

more controversial—is the use of adjuvants, and it is my understanding that the use of an adjuvant in a vaccine can dramatically 

increase the supply of the vaccine since each vaccine dose requires 

less antigen, for reasons that I realize we do not fully understand. 

But it is my understanding that in the European Union the vaccine 

is being made with the adjuvant and, thus, the supply is more 

abundant. 

So I would like you to comment on those two decisions because 

from what I am hearing they would have had an impact on supply. 

Dr. LURIE. Sure. Well, let me take each of them in turn. 

First, with regard to the prefilled syringes, we did contract for 

a mixed supply of prefilled syringes and what are called multi-dose 

vials, the biggest bulk ones. As soon as we became aware—and 

that was pretty early on in the season before most vaccine was 

even being put into vials—one of the things we did was say to the 

manufacturers our priority is to get the most doses out fast. And 

so what that meant was, first, taking all of the available vaccine, 

the antigen you had, and putting it in those multi-dose vials to 

kind of saturate those filling lines; and then if you had stuff left 

over, go ahead and continue to fill the prefilled syringes instead of 

letting them lie fallow because you could get more doses out with 

that combination than with just the prefilled syringes. 

So while you are right, it takes longer to fill a prefilled syringe 

than a multi-dose vial, I think in the long run everybody was asked 

to do those multi-dose vials first so that we could get as many 

doses out as possible. And, frankly, some of the manufacturers 

changed plans early on after we had the discussion about that to 

say how do you get as many doses out as possible. 

And so while I hear that, I guess I do not think that it has contributed substantially to a shortage. At the same time, we need to 

have sort of an array of products out there that are acceptable to 

the kinds of choices that different people want to make. 

Let me address the use of adjuvant because I think it is a really 

important question on a couple of fronts. 

First of all, from the beginning, we sat down and have done this 

whole huge decisionmaking set of matrices or trees, and one of the 

really early things we said was at several points along the way we 

are going to have to decide if we want to use an adjuvant. And we 

said, well, what would be the early warning signs that we would 

need to use an adjuvant and what would make us go there. And 

at very regular intervals we have revisited that. So the early warning signs would be if the disease got worse, if people did not have 

a good immune response to the vaccine, or if there were not enough 

doses. 

138 

Every time we have had a decrement in projections, we have 

gone back, and we have looked at those decision trees and those 

triggers and convened senior scientists at the highest level to say 

should we move ahead with adjuvants. And every time the answer 

has been no, for two reasons. One is if we shifted to adjuvants, it 

would take a lot of the unadjuvanted vaccine out of the system 

while we made that shift. And two, as I think the public’s confidence in vaccines in this country is just not as robust as we want 

it to be. The adjuvants would be a new vaccine. They might have 

to be used under an emergency use authorization. And so we did 

not really want to rock the public’s confidence in a new vaccine. 

A last point I want to make—and I think I said it in my testimony—this is a worldwide problem. Even with adjuvanted vaccine 

being licensed and available, we are still one of the very first countries to mount a large-scale vaccination campaign. Most developed 

countries have not. And we have distributed, even with 

unadjuvanted egg-based vaccine, more doses to be administered 

than any country in the world. So as frustrated as we are with the 

vaccine supply—and we are all really frustrated—I think it is just 

really important to keep that perspective. 

Chairman LIEBERMAN. Thanks, Senator Collins. 

I noticed a column in the Washington Post today by Anne 

Applebaum, and it speaks to the global confusion, if you will, about 

the problem. And I think when this is all over—and hopefully it 

will be before long—it is not just the U.S. Government but the 

World Health Organization that has to go back and take a look at 

how this all developed. Again, part of it is the global nature of 

media today and the way in which it portrayed the outbreak. This 

is serious and this is a real disease. Obviously, it has killed almost 

4,000 people here in the United States in the last 6 months. But 

the media coverage created a kind of panic in some countries 

around the world, which makes our lines seem relatively mild. But 

they weren’t mild for people who were waiting in them. 

The Senators in order of appearance: Senators Kirk, McCaskill, 

and Carper. Senator Kirk, thanks for being here. 

OPENING STATEMENT OF SENATOR KIRK 

Senator KIRK. Thank you, Mr. Chairman, and thank you for the 

timeliness and importance of this follow-up hearing. 

Like my colleagues, we had a promise of some 3.5 million doses 

to Massachusetts by this time. We have 900,000, I think, that have 

been distributed, so it is roughly 25 percent of what is needed at 

this time. And from what I understand from the testimony in the 

earlier hearing, in large part what your Departments tell us about 

what will be available is dependent on what the manufacturers 

have estimated. And I am wondering whether—in addition to site 

visits and monitoring and so forth—do the Departments have the 

ability to develop an expertise where they could make their own 

independent analysis in something like this? And if so, how is that 

applied? And if not, should we develop that expertise so we are not 

just totally dependent on the word of the manufacturer and they 

say this is what they have told us so, America, this is what you 

will get? 

139 

Dr. LURIE. I think it is a really good question. What I would say 

is that in our Department and in the Biomedical Advanced Research and Development Aurhority (BARDA), we have a really professional staff, many of whom came from the vaccine industry and 

I think have a pretty good sense of how all the supply chains work. 

We track every single lot of vaccine and are able to watch it in the 

pipeline. 

That said, that early part, growing the vaccine and getting to 

those early doses, I think was the biggest problem. As we watch 

it come through the pipeline, I think we have pretty good visibility 

on what goes on with it, but I do want to say, per that schematic 

over there, you do continue to run into problems with production 

lines or at the end, even if you ship stuff to CDC and a temperature sensor goes off or a box breaks open in the truck, that makes 

you have to pull that amount of vaccine out and test it to be sure 

that it is still safe and effective before you can release to the public. So while we watch it, we cannot necessarily change it. 

That said, one of the things that we have been really working 

hard on in our partnership with the manufacturers is additional 

ways to communicate about the vaccine supply. We are working 

with them to see if we can put out, public information by manufacturer, or by product numbers. 

I hope that we will get to a point soon where we figure out how 

to do that so that we can provide an additional level of transparency for the public. But as I said, right now we have people in 

the plants, and I actually feel quite good about the communication 

that the manufacturers are having with us, sometimes multiple 

times a day. 

That said, things still go wrong—not that we do not always know 

about them, but there is not an easy fix. But I very much take your 

point about forecasting and projections. I think the best way to do 

that is to have a more reliable way of making vaccine so that we 

are not dependent on the vagaries of growing virus in eggs. 

Senator KIRK. Another question going to dependency, if you will, 

and that is—I mentioned this in the prior hearing to the Secretary—that four out of the five suppliers, as I understand it, are 

offshore. And I am wondering whether there really is serious thinking and planning about dealing with that issue. 

We know in the instance of one of the suppliers, in Canada, quite 

understandably, said Canadians first and are taking care of their 

population. I did not know whether that was in the thinking and 

the estimates that were initially projected, that Canada might do 

that or whether you knew they would. That is sort of one question, 

but a side question. 

The larger question really is whether the Administration and the 

health professionals are thinking about what we should be doing 

to encourage development and manufacture of these vaccines in the 

United States. 

Dr. LURIE. I think it is just a really great point, and I might 

want to make a clarification first; that, early on we learned—it was 

actually the Australian Government that was experiencing a really 

severe first wave that said Australians first. And as soon as we 

knew that, we were able to say to the American public we are 

140 

going to have a lot fewer doses early on than we thought because 

of that. 

That said, I think BARDA is in about year 3 of a 5-year strategic 

plan to modernize vaccine manufacturing. We have done a lot of 

retrofitting of facilities just to be ready for this one. A new cellbased manufacturing facility is going to open. Many of us are going 

to the ribbon cutting next week for a new Novartis facility that I 

think will be able to start making seasonal flu vaccine in 2011. It 

is only going to get us to half of the required doses we think that 

we might need to surge, and I do not know that cell-based vaccines 

are the end game because they still require virus to grow. 

So we actually want to go ahead and make a mid-course revision 

to our 5-year strategic plan to think about even more modern 

science, even more robust manufacturing capacity, more advanced 

development. We are supporting very innovative manufacturing 

techniques, for example, in a company in Connecticut that is making recombinant vaccine in insect cells and others, and a lot of 

things that really show a lot of promise. But we have to get to domestic issues, say, robust, fast manufacturing capacity in the 

United States. We are taking this very seriously, and we very 

much look forward to further partnership with this Committee as 

we try to move that forward. 

Senator KIRK. Thank you. Maybe one more question, Mr. Chairman? 

Chairman LIEBERMAN. Go right ahead, Senator Kirk. 

Senator KIRK. This is perhaps to Dr. Schuchat, and it is a question that has been written about the hybridization and the possibility, the ‘‘what ifs’’ if this particular flu should cross-pollinate, or 

whatever, with the bird flu. 

Can you give us any thoughts about that? Is that a realistic possibility? And, in any event, will we be prepared for something like 

that? 

Dr. SCHUCHAT. Influenza viruses change and they reassort. They 

can combine between viruses. Right now, the world is seeing a very 

transmissible virus in the 2009 H1N1 strain, and we still do have 

a very severe virus in the H5N1 bird flu strain. It has not figured 

out to be efficiently transmitted, but it is very fatal. Two-thirds of 

those infected with the H5N1 suffer death. 

There are parts of the world now where both strains are circulating, the H5N1 primarily in birds and H1N1 in humans. So that 

idea of reassortment is not science fiction. That could actually happen. But if that does not happen, we still have the real probability 

of future pandemics, whether they are H5N1 derived or H1N1 or 

the H9 strain. Influenza is out there, and really the seriousness 

with which the Committee has been taking pandemic preparedness 

in the past just needs to be reinvigorated. 

Some of us wish that now that we are having one it would mean 

we have 30 years off, but, unfortunately, I do not think we do. And 

so everything we can learn about preparedness from this, to be better able to cope if we had a more severe virus or if we have one 

where the circumstances are even more grave than what we are 

seeing now. 

Senator KIRK. Thank you. Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thanks, Senator Kirk. I appreciate it. 

141 

1The letters referenced by Senator McCaskill appear in the Appendix on page 409. 

OPENING STATEMENT OF SENATOR MCCASKILL 

Senator MCCASKILL. Thank you, Mr. Chairman, and I would like 

to formally on the record thank the Ranking Member for my pork 

hat. After I tried to make a very big point of the fact that this virus 

had nothing to do with the delicious meal of pork in our country, 

the Ranking Member was kind enough to send me a pink hat that 

points out my love of pork—the kind you eat, not the kind you appropriate. [Laughter.] 

So I thank the Ranking Member for that. 

Senator COLLINS. My pleasure. 

Senator MCCASKILL. I decided to do a little secret shopping today 

in my office in preparation for this hearing. After reading the 

Chairman and Ranking Member’s letters that were sent,1 I think 

yesterday, I was concerned and so I asked some members of my 

staff today to call around Missouri and see what would happen if 

they asked about the availability of the vaccination. I had women 

in my office do it, and I said if you are asked, say you are pregnant. 

And it really was surprisingly a good exercise. We called seven different communities of various sizes, including the two major metropolitan areas, some very rural areas, and in between. 

Almost all of them did the appropriate checklist about risk factors when we called, and once it was determined that this was a 

woman who was pregnant, three of the seven that we called made 

available today or tomorrow a vaccination. Two said this week they 

would have clinics. One said in 2 weeks there would be another 

clinic. And one said you need to check with your doctor or your 

local pharmacy. 

Now, in all of them, they did say to us, ‘‘You should check with 

your doctor first.’’ So it is clear to me that what the local and State 

health organization in Missouri is doing is they are distributing 

part of this to the doctors’ offices, and they are holding on to part 

of it for their own clinics. And I think in fairness, I think that can 

be confusing to people. Now, should I be going to the clinic to get 

the vaccination or should I be calling my doctor? 

We got pretty clear guidance on the phone when we called today, 

and I was pretty impressed that we got as clear a guidance as we 

did. But I take it this is totally a local decision as to how they are 

distributing this virus between doctors’ offices and hospitals and 

local health-based clinics. 

Dr. SCHUCHAT. The State health departments or in four large 

city or county areas are the ones doing the ordering. Many are 

working with their local health departments, and most are working 

with the provider community. They may have the local health departments enroll the providers, or they may be doing it centrally 

at the State level. 

We do know that we have had, I think, 116,000 distinct shipments of vaccine from the central distributor to date, and they 

have gone to a variety of venues, to the local health departments, 

hospitals, doctors’ offices, and so forth. 

One challenge for the provider offices is the minimum shipment 

of 100 doses, and so some of the providers’ offices are not able to 

use 100, and they are asking for smaller amounts, so there is a litVerDate Nov 24 2008 13:10 Mar 22, 2011 Jkt 51020 PO 00000 Frm 000149 Fmt 06601 Sfmt 06601 P:\DOCS\51020.TXT SAFFAIRS PsN: PAT
142 

tle bit of breaking up amounts to get them their supply or sharing 

between practices. But we do believe right now that a substantial 

amount of the vaccine has gone to providers’ offices. 

In some places, there has been tremendous interest in signing up 

to be a provider for the H1N1 vaccine, but in others it has been 

a mixed uptake. Providers’ offices are really busy, lots of people 

who are ill. For obstetricians, it is not always the usual thing. In 

many States, there has been great turnout by the obstetricians to 

be providers, to be able to give vaccine to their pregnant patients. 

But in other areas, the providers have had to say, ‘‘We are not 

going to be able to handle it. We do not have the right kind of refrigerator storage. We do not want the vaccine to spoil. But here 

is the hospital that we are partnering with. Here is where you as 

my patient can go to get your vaccine.’’ 

Senator MCCASKILL. I am confused, though, who is making that 

decision. I mean, I think the problem here, Dr. Schuchat, is, who 

is deciding whether a doctor’s office is getting it and who is deciding whether the Jackson County Health Department is having 

those doses for a clinic that they advertise and is open to the public 

based on risk groups? 

Dr. SCHUCHAT. Right. Well, at the CDC level we have advised 

here are the priority populations, these are the groups that need 

to be reached. At the State leadership level, they are designating 

the strategies. Should we focus on providers? Should we have a mix 

of health departments and providers? Part of it depends on the fragility of the health care system in that State. Is the provider community able to do this? Part of it depends on the robust public 

health infrastructure—— 

Senator MCCASKILL. OK, so it is the State health department 

that is making this decision? 

Dr. SCHUCHAT. Absolutely. 

Senator MCCASKILL. It is not being made at HHS. It is not being 

made at CDC. It is not being made at the Department of Homeland 

Security. The State health directors are deciding where the dosage 

that is going to their State is actually landing. 

Dr. SCHUCHAT. That is right, and a lot of them have been updating their plans. They have identified plans, and then they have realized, well, we are going to need to make a few more venues available because we are getting calls and people are not able to get it 

from the ones we have set up. But they are in the lead on the implementation. That is right. 

Senator MCCASKILL. Of the 160 million that were identified at 

the very beginning in the risk groups, how many do we anticipate 

will actually get—let us assume that we did not have a problem in 

the private sector with the availability of as much vaccine as we 

had been told we were going to get. I mean, the government was 

clearly told by the private sector they were going to get more vaccine than we got. Let us assume for a minute that there was no 

problem with the supply and that there was plenty of vaccine out 

there. 

Best-case scenario, what percentage of that 160 million based on 

previous influenza problems in this country did you anticipate 

would step up and get the vaccination? 

143 

Dr. SCHUCHAT. I will give you two figures. For seasonal flu, it is 

about a third of people that step up, but we have been doing surveys throughout the summer and fall and find right now that up 

to 50 percent of people in those groups are interested in being vaccinated or having their kids vaccinated. There is a group that is 

distinctly not interested, and their principal reason is they do not 

think this is a serious threat. But of the group that is interested 

there, it is pretty steady that they are remaining interested. We 

know, though, from a lot of behavioral surveys that intent to take 

a behavioral action is different than actually following through 

with it. And, of course, the easier we can make it for people, the 

more likely they will be to follow through. 

Senator MCCASKILL. So if we get 80 million people vaccinated in 

the at-risk groups, you are going to consider this a great success? 

Dr. SCHUCHAT. I regret every person who has waited in line and 

not made it through, and I think the ease with which people can 

be vaccinated is an important metric as well. 

Senator MCCASKILL. That is fair enough. 

Let me talk about the military for a minute, and Wall Street. I 

am assuming the decision to give any vaccinations to major companies in New York was made by the city of New York? 

Dr. SCHUCHAT. The city had a plan of how to distribute their vaccine. 

Senator MCCASKILL. And was there any role at all for the Federal Government in that decision? 

Dr. SCHUCHAT. No. But we are aware that their decisionmaking 

was—they had a first tier, which was hospitals and provider offices 

and the community clinics, and a second tier that included employer-based occupational health clinics, which is a place where a 

lot of adults in the workplace are vaccinated. That was not their 

first tier. It was a lower tier. But it was with a distinct provider 

agreement signed saying this will be for priority populations—pregnant women, parents of newborns, and so forth. 

Senator MCCASKILL. It just was really weird that a company on 

Wall Street would get the same number as a hospital. That looked 

horrible. It made all of us really mad. 

Dr. SCHUCHAT. Absolutely, and based on the information that I 

have seen, most hospitals got a lot more vaccine. 

Senator MCCASKILL. A final question about the military. It is my 

understanding—I think we have two members of the military here 

that can speak to this. It is my understanding that the Department 

of Defense controls all the vaccinations for the military and that 

the armed forces are, under their directive, required to be vaccinated first, and that it is only after 90 percent of the forces are 

vaccinated that we even get to civilian personnel within the military, and only after 100 percent of the forces have been vaccinated 

and all of the civilian personnel would we ever get to any detainees 

everywhere. Is that correct? 

Dr. SCHUCHAT. Yes. I am actually wearing the uniform of the 

Commissioned Corps Public Health Service, but that is correct. 

Senator MCCASKILL. Close enough. [Laughter.] 

In government work, close enough, right? Unfortunately. Is that 

correct? 

Dr. SCHUCHAT. Yes. 

144 

Senator MCCASKILL. So the rumors out there that we are supposedly giving the vaccination to anybody at Guantanamo that is 

being detained is just not true? 

Dr. SCHUCHAT. You are right. 

Senator MCCASKILL. Thank you. Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thank you, Senator McCaskill. 

Senator Carper, with an amazing sense of timing, has come 

through the door at exactly the moment I was otherwise going to 

proceed. Senator Carper. 

Senator CARPER. Thanks, Mr. Chairman. That was pretty good 

timing. 

Our thanks to each of our witnesses for joining us today and for 

trying to explain what is going on here and what you all are trying 

to do to expedite the situation and maybe what we need to do to 

help. 

Let me just ask this, and you may have covered this already in 

earlier questioning. But we have been asking you what you are 

doing and what our country is trying to do to expedite the availability of the vaccine for people throughout our country, particularly on a most urgent basis. What do we need to be doing on the 

legislative side? Anything? I think we have appropriated money. 

Hopefully we have appropriated resources. What else do we need 

to be doing? 

Dr. LURIE. I think that is a great question. Thank you for that. 

I guess I would say that there are a couple of things that you could 

help with, and I very much, again, want to say how grateful we are 

for the support to date, both on the manufacturing side and in response to this pandemic, not only so that the Federal Government 

could buy vaccine for people, but also to support public health on 

the ground, which you know has been really struggling because of 

the kinds of cutbacks in Federal, but also in State and local budgets. So as we talk to public health people on the ground, their 

workforces are down by about a third, and they are trying to really 

struggle with this pandemic. 

So this whole experience has told us that it is really time to 

think seriously about how it is that we revitalize public health at 

all levels and how it is that we revitalize our public health infrastructure. 

So I think a lot of what we would love to talk with you about 

going forward is very much to look forward, how to do that. How 

do we not get in this situation again? We have talked about it with 

the advanced development of vaccines and countermeasures. We 

have talked about it with manufacturing. We need to have that 

same conversation about the rest of the public health infrastructure, whether it is about surveillance, whether it is about public 

health on the ground, or whether it is about the fact that while we 

have a good system to buy and distribute vaccine for children in 

this country, we have no system to do that for adults. So going forward, I think that there is an awful lot that we take away from 

this that helps us be a lot better prepared. 

Senator CARPER. All right. Thanks very much. 

Anybody else with a real quick response? Or I will go right to my 

next question. Anybody? 

145 

Dr. GARZA. Well, I will put in a plug for Homeland Security. I 

think what H1N1 did illustrate is that the health effects to national security are real. And although DHS does focus a lot on terrorism and overt acts of aggression against our country, this is a 

primary example on how health effects can and do affect national 

security, and those issues need to be taken into account when we 

are looking at planning, funding, and issues such as that. 

The Office of Health Affairs is a fairly small office. However, we 

carry a big mission: Taking care of our forces as well as planning 

for disasters and responding to the health effects. And I think the 

pandemic has brought that to the forefront. 

Senator CARPER. OK. Thanks very much. 

I think the Department of Health and Human Services last 

month announced contract awards, I think for up to about 120,000 

treatment courses of intravenous antiviral drugs, known as IV, to 

help treat hospitalized 2009 H1N1 influenza patients. The IV alternative has been proven, I am told, to be very effective in treating 

sick people. 

Could I ask each of our HHS witnesses today to briefly detail the 

deployment plan for IV vaccines? And just to let us know, is there 

a plan to order any more of the initial 120,000? 

Dr. LURIE. Let me make a quick clarification here. We have right 

now procured about 30,000 doses across three different kinds of 

vaccines. As you know, the vaccine is not yet—I mean, the 

antivirals are not yet licensed. They are available under an emergency use authorization because they have not gone through the 

full array of clinical testing to know that they are really safe and 

effective. 

So one of the things that we need to do through this is to learn 

just how effective they are so that if they are effective, they can 

move forward on a pathway to full licensure. 

In the meantime—and, frankly, I think learning from a lot of our 

experience with distribution; this is an example where we took experience and turned it around to immediate learning—we have 

done a couple of things. We have set up a Web site that is open 

24 hours and a telephone line that is open 24 hours so that any 

clinician in the country who feels as though they need to have this 

antiviral for their patients can call. It is managed by a distribution 

site, and there is overnight shipping so that it can be there within 

24 hours. So far, there have been orders for—as of yesterday, I do 

not know as of today—634 treatment courses. So that is really 

right now the distribution system. 

Should there be a really big demand for more intravenous 

antivirals, we will go ahead and procure more. But we are monitoring carefully that burn rate so that we are sure that we do not 

run out. 

Senator CARPER. All right. Did you want to add to that, please? 

Dr. SCHUCHAT. Yes, just to say CDC is managing that Web ordering system, and we have been getting orders through the weekend and at night and are able to commit through the vendor that 

shipment should arrive within 24 hours of order, usually much earlier, depending where it is getting shipped. This is an intravenous 

antiviral, and so it is primarily critically ill people in intensive care 

146 

units that are receiving it. But it has been stood up very quickly 

and tried to be as responsive as possible to the health need. 

Senator CARPER. All right. Thanks. 

There are reports that if the H1N1 pandemic grows more potent 

and ubiquitous throughout our communities, we as a Nation could 

face a serious drop in blood donations. While it is proven that a 

low-level flu strain cannot travel through the bloodstream as the 

West Nile virus does, for example, some scientists feel that a more 

potent H1N1 flu could infect our body’s circulatory system and prevent people from donating blood. This, of course, could create a serious problem for hospitals who rely on these blood donations for 

minor to serious medical procedures, as you know. 

Could either of you perhaps comment on this and if you have a 

battle plan for if the H1N1 strain morphs? 

Dr. LURIE. Well, let me first start by telling you that we monitor 

very carefully the country’s supply of blood, and I get a report on 

that every week. One of the things that we have noticed coincident 

with this pandemic is that the supply of blood, which is usually 

about 8 days in most hospitals, is down to about 6 days. Whether 

it has anything to do with H1N1 or canceled blood drives or any 

other kinds of things, I do not think we know cause and effect, but 

we are keeping a very close eye on it. 

We also have, I believe, very good ways to look at the country’s 

supply and to be able to move blood from one place to another were 

that to happen. But despite the fact that it is down to 6 days, we 

are not aware of any shortages. 

Is there a battle plan? I think any part of preparedness requires 

a battle plan to be sure that blood as a critical resource is always 

available as needed. And, the battle plan really means stepping up 

blood donation and calls for blood donation, in which case, the 

American public is usually very responsive. To prepare for that, the 

CDC has issued guidance for blood donation centers to help them 

figure out how to have blood donation go on safely and without 

transmitting the virus among the people who work there or the 

people who choose to give blood. 

Senator CARPER. All right. Thanks. Thank you both. In fact, 

thank you all very much. 

Thanks, Mr. Chairman. 

Chairman LIEBERMAN. Thanks, Senator Carper, for those questions. We will do one more round for Senator Collins and me. 

I mentioned in my opening statement about the two numbers 

that were going the wrong way, the way we would not like to see 

them go: The number of cases of H1N1 going up, and understand 

that part of that is the recalculation; and then the vaccines available going down. But you have reassured us, and I just want to 

come back to that, Dr. Lurie, the explanation for the drop in the 

availability of vaccines last week was not a problem in the manufacturing but, according to your testimony, was the result of the 

hurricane and the distribution problems. Am I right? 

Dr. LURIE. Let me say that it was two-fold. The way we do these 

projections and allocate is that we have a cutoff for when vaccine 

has to arrive at a warehouse, let us say Wednesday at 2 o’clock. 

If it gets there at 2:01, it gets counted for next week. 

Chairman LIEBERMAN. OK. 

147 

Dr. LURIE. And so one of the things that happened was, because 

of the hurricane, some of the vaccine manufacturers’ insurance 

companies did not want them to ship, and they did not want to 

take that risk of shipping and destroying their cold chain driving 

through this. And some of the vaccine got there late, and that is 

why when we woke up—or when we heard on Friday that there 

was potentially no vaccine to be allocated—we first heard from 

Maine, then from Massachusetts, then from others—we said, well, 

we know that their vaccine is there; it just did not get in under 

the wire, let us stay open this weekend and allocate it. 

A second thing had to do with some doses of vaccine that—remember how I said at that last stage, when you ship, if a temperature sensor goes off or a box opens? 

Chairman LIEBERMAN. Yes. 

Dr. LURIE. So a second thing that happened was that for some 

vaccines some temperature sensors went off, and so they could not 

go ahead and distribute those vaccines right away, but they had to 

be sure, in fact, that those vaccines were still safe to be able to use. 

So that is what happened. 

Chairman LIEBERMAN. So no new problems within the manufacturing chain. 

Dr. LURIE. That is right. 

Chairman LIEBERMAN. Other than what you have said about 

weather delays along the way, we can anticipate—I am not going 

to ask you to predict another problem—a pretty steady production 

now in availability of the vaccines, increasing every week. Obviously, we have a long way to go until we get to the 160 million of 

the initial group at risk. 

I have forgotten the facts on this, but I am not sure—and I ask 

you now—whether we had as many Federal employees—I presume 

HHS or maybe CDC—in the manufacturing facilities as we do now 

monitoring activities there. Is that one of the lessons we have 

learned in this? In other words, am I right that we have more people on site now from the Federal Government? 

Dr. LURIE. That is correct. 

Chairman LIEBERMAN. So would you say that next time we get 

into this, that will be something that we will do? Or maybe we will 

just keep our representatives there from now on. 

Dr. LURIE. I would say it depends. I think certainly throughout 

the rest of this or until things even out and there is really a very 

ample supply of vaccine and we understand that things are stable, 

we very much want to keep Federal employees at the manufacturing facilities. 

As I said, we have talked to them every day. We do frequent site 

visits. It has been helpful to have people on site. 

Another way it has been helpful to have people on site—and it 

is not related to manufacturing—is to have representatives from 

State and local health departments and the Association of State 

and Territorial Health Officials and National Association of County 

Health officials actually embedded in the operations center at CDC 

so that there is another level of what is going on, what do you expect, how do you communicate that back. 

So I think at every step along the way—more people on site, 

more exchange, more transparency is better. 

148 

Chairman LIEBERMAN. All right. Well, that is an important lesson learned, and I appreciate it. 

Let me go back to the intravenous antivirals, which I asked several questions about at the last hearing. The first thing I want to 

do is say thank you that the Food and Drug Administration did 

issue an emergency use authorization. And for people in the room 

or watching on TV, as I have learned as we have gotten into this, 

the IV antivirals are needed for the people with H1N1 who are the 

most sick, usually in intensive care, and, therefore, cannot take the 

normal antivirals by mouth and so have to have IV medication. So 

I appreciate very much that was done. 

I was interested in how you are distributing them. I want to urge 

you, as I did last time, particularly because of the problems we 

have talked about with the vaccine, that you really stay on top of 

it to make sure that we do not come to a point where there is a 

shortage of the IV antivirals because that would be the worst of all 

because these are the most seriously ill patients, obviously, and it 

literally could be life or death if they do not have it. 

Dr. LURIE. You have that commitment. 

Chairman LIEBERMAN. I appreciate it. 

Following the CDC reports, as my staff does, I note, sadly, that 

last week 35 children died of influenza in hospitals, which was up 

from 28 the week before, as we mentioned earlier, a total of approximately 540 children. I wondered if either of you know whether 

any of those were treated with the IV antivirals. 

Dr. SCHUCHAT. I do not have that information. I know that of the 

children that we are seeing who die, about two-thirds have underlying diseases. 

Chairman LIEBERMAN. Right. 

Dr. SCHUCHAT. Some die at home. They do not actually make it 

to the hospital. But we are collecting additional information. So I 

do not know yet whether any of those children got the medicine. 

Chairman LIEBERMAN. OK. To the extent that you can find that 

out—you have other things to do—I would appreciate just having 

an answer to that for the record. 

Dr. SCHUCHAT. Sure. 

[The information follows:] 

INFORMATION SUBMITTED FOR THE RECORD FROM DR. SCHUCHAT 

CDC does not track specific patient outcomes related to administration of 

antiviral drugs, and therefore does not have the information on how many pediatric 

patients died after receiving IV antiviral drugs. Based on data from the Emerging 

Infections Program, among hospitalized laboratory confirmed pediatric patients between September 1 and November 24, 85 percent of patients received the antiviral. 

That compares to 58 percent during the spring wave (April 15, 2009-August 31, 

2009) and 17 percent during the previous season (2008–2009). 

As of December 13, 992 requests to CDC for IV Peramivir doses have been filled, 

including 89 requests for pediatric Peramivir. 

Chairman LIEBERMAN. I am going to stop at that point and let 

you go ahead, Senator Collins, because the vote has just been 

called on the floor. Thank you. 

Senator COLLINS. Thank you, Mr. Chairman. 

I am just going to bring up one final issue in light of the vote 

beginning. Dr. Garza, I know you thought you might get off scot 

free at this hearing. [Laughter.] 

149 

And I just could not allow that to happen at your first appearance. 

Dr. GARZA. Thank you, Senator. 

Senator COLLINS. I knew you would appreciate that. 

You have some responsibility in this area for making sure that 

State and local public health agencies can handle a pandemic or a 

bioterrorism attack. In other words, DHS in general has a responsibility for assisting State and local governments in their preparedness and response capabilities. That is why we have appropriated 

literally billions of dollars in homeland security grants to help improve the preparedness at the State and local levels. 

Dr. Schuchat mentioned that the State of Maine has done an excellent job—and it has, and I am very proud of that—and one reason is they had a plan in Maine to use the schools as a basis for 

the clinics. And I believe every single school in the State of Maine 

participated. That gives you a great distribution method, and I 

think a lot of other States could learn from Maine’s experience. 

But then we have what appears to be the situation in San Francisco, a much larger public health division than the whole State of 

Maine would have, where we have answers being given on their 

Web site saying orders are being filled on a random basis, there is 

no way to predict who will get what and when. That to me is an 

appalling answer to someone who has a child who is at high risk 

and needs the vaccine. 

My point is that as we found with our investigation into the response to Hurricane Katrina, there are huge variations in the capabilities at the State and local level, and I can see Dr. Lurie is nodding her head in agreement. 

So when we are through the peak of this pandemic, what is DHS 

going to do, working with HHS and the CDC, to evaluate the response at the State and local level? 

Dr. GARZA. Well, I would say even before the pandemic is 

through that DHS has been working together with HHS in evaluating State plans, primarily through the Federal Emergency Management Agency (FEMA) which partnered up with HHS at the regional levels to ask questions of emergency managers and to review 

their plans and evaluate whether there are any gaps that need to 

be filled, were there any issues that needed to be resolved. 

Furthermore, FEMA has worked together with HHS to provide 

any logistical support should that be needed for vaccine distribution or any other issues related to the emergency response. 

Fortunately, it has not risen to that level where we have needed 

to interact at that level, but they have done a tremendous amount 

of work in working with our partners throughout the interagency 

to be prepared. 

If I may, ma’am, one success story I believe that you mentioned 

in an earlier hearing with Secretary Napolitano was Bates College, 

particularly the Metropolitan Medical Response System (MMRS) 

team, which was requested to come up and assist with the vaccinations since they had a large vaccine allotment and not enough people to do that. But that is precisely the way the system should 

work, that they requested the MMRS team to assist them. The request went through Emergency Management, it was approved, and 

within 2 days a team was sent up there to vaccinate the students. 

150 

And so if I may, I would say that is one example of a very good 

success story and how DHS is assisting. 

Senator COLLINS. It is, but we need to learn from this experience, 

and when we have a major public health department saying it is 

all random, it should not be all random. It should be prioritized. 

And I still share the Chairman’s view that it would have been fine 

to leave it to State and local governments regardless of their capabilities if there had been plenty of vaccine. But once we realized 

the vaccine supply was falling far short, I believe the Federal Government should have stepped in and set the priorities to ensure 

that those at highest risk were being served first. And I do believe—just as you said, Dr. Garza, that the best of plans always 

collide with reality, I do believe that we need a thorough evaluation 

of the preparedness at the State and local levels. It does vary enormously because some States devote a lot of resources and some 

States do not. Some States are making good decisions, and some 

States are not. And that applies to big-city health departments as 

well. So I hope that will be done. 

Doctor Schuhat, I can see you want to say something—— 

Dr. SCHUCHAT. Yes, I just wanted to respond to two points. 

One is we are not waiting for States or cities to fail. We are 

working very actively monitoring the ordering, understanding what 

is going on, offering assistance, and working on some of the 

missteps that we believe may be happening in some areas. As you 

heard, we have liaisons from the city and county health agency and 

the State health officer agency in Atlanta, and we are working 

daily with the States to help them succeed. 

The second point I just want to make because I forgot to make 

it is that our survey data suggests that we are reaching the priority populations in much higher levels than others. So I know this 

is of keen importance to both of you, and our survey data bears out 

that they have higher receipt of the vaccine than others do, which 

I think is important to all of us. 

Senator COLLINS. Thank you, Mr. Chairman. 

Chairman LIEBERMAN. Thank you, Senator Collins. I appreciate 

that. 

I want to ask you one take-away, Dr. Schuchat, and, Senator Collins, I will understand if you got to vote before it gets too close to 

the end. 

Senator COLLINS. Thank you. 

Chairman LIEBERMAN. She has got a perfect record. I do not 

want to be the cause of creating a flaw there. 

Am I right, from what I have heard previously and what you said 

in your opening statement, that you cannot as a scientist, or any 

of the others on the panel, predict what the course of the H1N1 

virus is going to be from here on out? 

Dr. SCHUCHAT. That is right, and we looked to the past, to other 

pandemics, to see what has happened. We do not know whether we 

will continue to have this high level of activity all the way through 

May, which is the usual end of flu season. 

Chairman LIEBERMAN. And then coincide with the seasonal flu? 

Dr. SCHUCHAT. Right. It could coincide with seasonal, but we 

looked very closely at 1957 where they had this fall increase like 

what we are having. It got a little better in December, and then 

151 

they had another big wave after the first of the year. People actually thought we do not need to bother vaccinating in December, and 

we do not want to make that mistake. So we do think we need to 

be ready for additional waves here in the United States. 

Chairman LIEBERMAN. So the plan is, because of that unpredictability, although somewhat informed by experience, that the manufacturing facilities are going to continue to turn out the vaccine, 

and the country is going to continue to urge people, particularly in 

that 160 million at-risk population, to get the vaccine. Am I right? 

Dr. SCHUCHAT. Yes, that is right, and we would imagine for the 

following year that if this strain is persisting, it might be rolled 

into the seasonal vaccine, a trivalent vaccine. For the winter—— 

Chairman LIEBERMAN. In other words, in the same shot. 

Dr. SCHUCHAT [continuing]. And spring, we do feel like, ongoing 

efforts at prevention are going to be important. 

Chairman LIEBERMAN. Well, I appreciate the testimony. I had a 

question for you, but since Senator Collins put you in the limelight 

and I have got to go vote, Dr. Garza. Obviously, the Secretary of 

Homeland Security is the incident manager here, and I know you 

staff her and support her in that role. I hope that you and she together will go back and look at this and try to draw some lessons 

from it so that some of the great things that have been done here 

do not for some reason end up causing the kind of frustration and 

anxiety that occurred this time around. 

I appreciate that you looked back here in testimony today and 

acknowledged some things that you would do differently, and this 

is very important to the Committee not only because of the concern 

that influenza epidemics and pandemics will continue in the years 

ahead—you are right, we cannot expect to wait another 30 years— 

but also, of course, because of our homeland security responsibility 

to do our best to get the public health system up and ready to respond, God forbid, to, for instance, a biological terrorist attack, a 

bioterrorist attack. So, I thank you for all the hard work you have 

put in, for the testimony you have offered today, which is encouraging, and we look forward to seeing you again. 

The record of the hearing will stay open for another 15 days for 

any additional statements or questions. 

I thank you. The hearing is adjourned. 

[Whereupon, at 4:47 p.m., the Committee was adjourned.] 

(153) 

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