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85–710 PDF 2004

S. HRG. 108–221

IMPLEMENTATION OF SMALLPOX

VACCINATION PLAN

HEARING

BEFORE A

SUBCOMMITTEE OF THE

COMMITTEE ON APPROPRIATIONS

UNITED STATES SENATE

ONE HUNDRED EIGHTH CONGRESS

FIRST SESSION

SPECIAL HEARING

JANUARY 29, 2003—WASHINGTON, DC

Printed for the use of the Committee on Appropriations

(

Available via the World Wide Web: http://www.access.gpo.gov/congress/senate
(II)

COMMITTEE ON APPROPRIATIONS

TED STEVENS, Alaska, Chairman

THAD COCHRAN, Mississippi

ARLEN SPECTER, Pennsylvania

PETE V. DOMENICI, New Mexico

CHRISTOPHER S. BOND, Missouri

MITCH MCCONNELL, Kentucky

CONRAD BURNS, Montana

RICHARD C. SHELBY, Alabama

JUDD GREGG, New Hampshire

ROBERT F. BENNETT, Utah

BEN NIGHTHORSE CAMPBELL, Colorado

LARRY CRAIG, Idaho

KAY BAILEY HUTCHISON, Texas

MIKE DEWINE, Ohio

SAM BROWNBACK, Kansas

ROBERT C. BYRD, West Virginia

DANIEL K. INOUYE, Hawaii

ERNEST F. HOLLINGS, South Carolina

PATRICK J. LEAHY, Vermont

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

HARRY REID, Nevada

HERB KOHL, Wisconsin

PATTY MURRAY, Washington

BYRON L. DORGAN, North Dakota

DIANNE FEINSTEIN, California

RICHARD J. DURBIN, Illinois

TIM JOHNSON, South Dakota

MARY L. LANDRIEU, Louisiana

JAMES W. MORHARD, Staff Director

LISA SUTHERLAND, Deputy Staff Director

TERRENCE E. SAUVAIN, Minority Staff Director

SUBCOMMITTEE ON DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND

EDUCATION, AND RELATED AGENCIES

ARLEN SPECTER, Pennsylvania, Chairman

THAD COCHRAN, Mississippi

JUDD GREGG, New Hampshire

LARRY CRAIG, Idaho

KAY BAILEY HUTCHISON, Texas

TED STEVENS, Alaska

MIKE DEWINE, Ohio

RICHARD C. SHELBY, Alabama

TOM HARKIN, Iowa

ERNEST F. HOLLINGS, South Carolina

DANIEL K. INOUYE, Hawaii

HARRY REID, Nevada

HERB KOHL, Wisconsin

PATTY MURRAY, Washington

MARY L. LANDRIEU, Louisiana

Professional Staff

BETTILOU TAYLOR

JIM SOURWINE

MARK LAISCH

SUDIP SHRIKANT PARIKH

CANDICE ROGERS

ELLEN MURRAY (Minority)

ERIK FATEMI (Minority)

ADRIENNE HALLETT (Minority)

Administrative Support

CAROLE GEAGLEY
(III)

CONTENTS

Page

Opening statement of Senator Arlen Specter ........................................................ 1

Prepared statement .......................................................................................... 2

Statement of Julie Gerberding, M.D., M.P.H., Director, Centers for Disease

Control and Prevention, Department of Health and Human Services ............ 2

Prepared statement .......................................................................................... 4

Statement of Anthony Fauci, M.D., Director, National Institute on Allergy

and Infectious Diseases, National Institutes of Health, Department of

Health and Human Services ............................................................................... 11

Prepared statement .......................................................................................... 13

Opening statement of Senator Tom Harkin .......................................................... 17

Opening statement of Senator Patty Murray ........................................................ 17

Prepared statement .......................................................................................... 17

Opening statement of Senator Mary L. Landrieu ................................................. 25

Prepared statement .......................................................................................... 26

Statement of Brian Strom, M.D., M.P.H. Chair, Institute of Medicine Committee on Smallpox Vaccination, director, Center for Clinical Epidemiology

and Biostatistics, University of Pennsylvania ................................................... 27

Prepared statement .......................................................................................... 30

Statement of Louis M. Bell, M.D., Chair, Division of Infectious Disease,

Children’s Hospital of Philadelphia .................................................................... 33

Prepared statement .......................................................................................... 35

Statement of Patrick Libbey, executive director, National Association of County and City Health Officials ................................................................................ 37

Prepared statement .......................................................................................... 39

Statement of Patrick Libbey, executive director, National Association of

County and City Health Officials, presented to the Institute of Medicine Committee on Smallpox Vaccination Program Implementation, December 19, 2002 ............................................................................................ 42

Statement of James August, director, Health and Safety, American Federation of State, County, and Municipal Employees .............................................. 44

Prepared statement .......................................................................................... 46

Statement of Jane Colacecchi, director, Iowa Department of Public Health ...... 49

Prepared statement .......................................................................................... 51

(1)

IMPLEMENTATION OF SMALLPOX

VACCINATION PLAN

WEDNESDAY, JANUARY 29, 2003

U.S. SENATE,

SUBCOMMITTEE ON LABOR, HEALTH AND HUMAN

SERVICES, AND EDUCATION, AND RELATED AGENCIES,

COMMITTEE ON APPROPRIATIONS,

Washington, DC.

The subcommittee met at 9:30 a.m., in room SD–192, Dirksen

Senate Office Building, Hon. Arlen Specter (chairman) presiding.

Present: Senators Specter, Harkin, Murray, and Landrieu.

OPENING STATEMENT OF SENATOR ARLEN SPECTER

Senator SPECTER. Good morning, everyone. The hour of 9:30 having arrived, we will begin this hearing of the Appropriations Subcommittee on Labor, Health and Human Services, and Education.

Today we are going to be examining the issue of smallpox, the risk

which America and the world faces from a smallpox bioterrorist attack, and what the risks are on inoculation, how well-prepared the

United States is to deal with this issue, and it is the fourth in a

series of hearings conducted by this subcommittee.

Our first hearing on the subject occurred in 1999, before 9/11, actually on March 16, 1999, to determine the status of the Health,

Human Services biopreparedness. Then on October 3, just 3 weeks

after 9/11, a hearing was held on the subject of supplemental appropriations, and we were driven out of the Hart Building and out

of the Dirksen Building, where we are holding this hearing, by an

anthrax attack, and we had to convene the hearing in the bowels

of The Capitol, and at that time, we made the request of the Center for Disease Control to provide this subcommittee with a comprehensive list as to all of the potential problems of bioterrorism.

Two additional hearings have been held since October 3, 2001.

Actually, this is the fourth, and we are joined by our companion

committee, the authorizing committee on Health, Education, Labor,

and Pensions, which will be holding a series of roundtable discussions on this subject, which is obviously of great importance.

Last night, in the President’s State of the Union speech, he enumerated a number of bioterrorist potentials from Iraq and from

Saddam Hussein, and detailed them with some substantial specificity, so we know a real problem does exist. We will be considering

two issues of risk, the issue of risk from attack, and the issue of

risk from an adverse reaction.
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PREPARED STATEMENT

With unanimous consent, a formal opening statement will be included in the record.

[The statement follows:]

PREPARED STATEMENT OF SENATOR ARLEN SPECTER

This morning, the Subcommittee on Labor, Health and Human services, and Education will discuss the issue of bioterrorism-preparedness and the implementation

of the smallpox vaccination plan. This is the first in a series of hearings in the Congress on this subject. As appropriators, we will focus on the issues of cost, compensation, and safety related to our efforts on smallpox and other biological weapons. Tomorrow, the Health, Education, Labor & Pensions Committee will hold a

complementary roundtable discussion of these issues.

This is this subcommittee’s fourth hearing related to bioterrorism preparedness.

On October 3, 2001, less than a week before the diagnosis of anthrax in a Florida

man and the discovery of an anthrax-tainted letter in the Senate, we examined

these issues. Two weeks later, Senator Harkin and I were forced to conduct a followup hearing in the Capitol as the Senate office buildings were closed due to anthrax

contamination.

In fiscal year 2002, over $2.83 billion were appropriated by this subcommittee in

the effort to prepare our Nation for potential biological attacks. Among other things,

these funds were to be used to: (1) strengthen infrasture at the centers for disease

control & prevention and State and local health agencies, (2) fund research into preventions and treatments for likely agents of bioterrorism, and (3) to buy enough

smallpox vaccine for every American. Today we will see the status of these efforts.

We have before us this morning, the distinguished directors of two key agencies

in the defense of our Nation against biological attacks. The Centers for Disease Control & Prevention is leading the effort to implement the smallpox vaccination plan.

The National Institute of Allergy & Infectious Diseases is the lead NIH institute on

bioterrorism-related research. Members of our second panel represent groups that

will administer the vaccine or be asked to volunteer to be vaccinated.

STATEMENT OF JULIE GERBERDING, M.D., M.P.H., DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT

OF HEALTH AND HUMAN SERVICES

Senator SPECTER. At this time, we will turn to our first panel,

and our lead witness is Dr. Julie L. Gerberding, Director of the

Centers for Disease Control and Prevention. She also serves as associate clinical professor of medicine at Emory University, a bachelor and M.D. degree at Case Western in Cleveland, and a master

in public health from the University of California in Berkeley.

Dr. Gerberding, thank you for joining us, and we look forward to

your testimony.

Dr. GERBERDING. Thank you. I really do appreciate the opportunity to be here to participate.

Senator SPECTER. Dr. Gerberding, when you start, let me remind

you what you have already been told. We try to stick to a 5-minute

time limit on opening statements. That may seem short. I recently

was a speaker at Ambassador Annenberg’s memorial service and

got 3 minutes, which is the amount of time that former President

Ford got and Secretary of State Colin Powell got, so I want you to

know that a 5-minute allocation would be considered in some quarters generous.

Dr. GERBERDING. Generous. Thank you.

Senator SPECTER. Let us restart the clock at 5 minutes.

Dr. GERBERDING. Thank you for that. I really appreciate the opportunity to be here and to address you and the committee about

the status of the smallpox preparedness program, and we also really thank you and Senator Harkin for the support you have given
3

us for the terrorism preparedness. We did disseminate $1.1 billion

this year to State and local health departments and hospitals to assist us in this effort, so without your support we would not be

where we are today.

If I can just have the first graphic here, I want to remind everyone what we are dealing with and why we are here. Smallpox is

a deadly and disfiguring disease. It is contagious, and even though

we had eradicated natural disease from the face of the earth, we

know that it does pose a threat, that there is a possibility of a

smallpox attack, and we must take steps to prepare our Nation and

to protect our public.

Now, preparedness really consists of four major components. We

have got to have policies, we have got to have plans, we have got

to have products such as vaccines and antidotes to the side effects,

and we have got to have people who are prepared and trained to

implement the program. I am going to just make a few comments

about each of those four elements.

First of all, as you know, the President stated the smallpox vaccination policy last December, and he advised immunization for the

military troops who would be at risk, for civilians who would be

part of the initial smallpox response teams that would manage and

take care of the initial cases, and for responders and health care

workers, who would be at occupational risk for exposure should an

attack occur.

The President did not recommend immunization of the civilian

population at this time, but he did tell us we needed to be prepared

to find a mechanism to give vaccine to the general public for those

members of the population who insisted upon having it.

Our planning has progressed rapidly. If I can have the next

graphic, it just illustrates in very broad terms the state of our

smallpox preparedness before December of 2002, and the way our

preparedness looks now. Our States have done a heroic job of rising

to the occasion and getting funds both for pre-event immunization

of these response teams as well as plans to ensure that we can immunize the entire population in a hurry if we had to, should an actual attack occur. So as of today, we have approved plans for all

50 States for mass vaccination and plans for all 50 States for immunization of the response teams.

Now, what is the timing of this implementation? If I can have

the next graphic, I just, in very general terms, want to show you

how we are going about implementing the program. Over on the

left-hand side of this, two points. First of all, the initial allocation

of the appropriation was made in February of 2002. The remaining

80 percent of the funds, of the $1.1 billion, was distributed by June.

In December, the President announced his policy. On January

24, the State of Connecticut was the first State to initiate in a

small number of vaccinators the civilian immunization program for

responders, and what you can see, then, to the left of this curve

is how we propose to expand this program as safely and as efficiently as we possibly can over the next several weeks to months.

Our priority is to immunize the smallpox response teams, but as

individual States get up to speed and can do this safely, they will

expand to include the broader group of health care workers and

first responders who could be at occupational risk, and there is no
4

time line for completion but, as I said, we are doing this as expeditiously as we safely can.

As of today, in terms of the products necessary for this, the vaccine, we have delivered 98,600 doses of vaccine to 19 States and

Los Angeles County. 35 States and Los Angeles County have requested that 187,000 doses of vaccine be delivered in the next several days to weeks, so we are working with States that have heroically risen to this occasion and really are now prepared and approved to receive vaccine and initiate their programs.

PREPARED STATEMENT

Finally, let me just conclude with a statement about the people

involved in this. Their safety is our highest concern, and we are engaging in a number of educational programs to educate the vaccine

volunteers, the vaccinators in the clinics, the clinicians around the

country, and the general public, and we have made many steps to

do this, and most notably, I think, in the next few days we will be

delivering 31⁄2 million information packets to clinicians around the

country to ensure that they can safely take care of the people and

advise them about their choice to participate in the program.

So thank you very much again for the opportunity to be here,

and I look forward to your questions.

[The statement follows:]

PREPARED STATEMENT OF DR. JULIE L. GERBERDING

Good morning, Mr. Chairman and members of the Committee. I am Dr. Julie

Gerberding, Director of the Centers for Disease Control and Prevention (CDC) and

Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR).

Thank you for the opportunity to testify today about the efforts underway to assure the nation is prepared in the event of an attack using smallpox virus as a

weapon.

THE DISEASE

Smallpox is a serious, contagious, and sometimes fatal infectious disease. There

is no specific treatment for smallpox disease. Prevention strategies involve vaccination of exposed or potentially exposed individuals. Smallpox outbreaks have occurred

from time to time for thousands of years, but the disease was eradicated after a successful worldwide vaccination program. The last case of smallpox in the United

States was in 1949. The last naturally occurring case in the world was in Somalia

in 1977.

Regardless of the mode, magnitude or duration of any terrorist attack, smallpox

would be expected to spread from person to person following its introduction. Much

is known about the natural transmission of smallpox. Generally, direct and fairly

prolonged face-to-face contact is required to spread smallpox from one person to another. Smallpox also can be spread through direct contact with infected bodily fluids

or contaminated objects, such as bedding or clothing. Rarely, smallpox has been

spread by virus carried in the air in enclosed settings, such as buildings, buses, and

trains. Humans are the only natural hosts of variola, the virus that causes smallpox. Smallpox is not known to be transmitted by insects or animals.

THE VACCINE

The smallpox vaccine is the only way to prevent smallpox. The vaccine is made

from a virus called vaccinia, which is another ‘‘pox’’-type virus related to smallpox

virus. The vaccine helps the body develop immunity to smallpox. It was successfully

used to eradicate smallpox from the human population. We have had a lot of experience with the smallpox vaccine and know it is very effective: it was used to eradicate smallpox from the world. It is safe in most people, but in some people it is associated with life-threatening adverse events. This risk of serious adverse events has

made it more difficult to find the right balance between preparedness and not placing people at risk unnecessarily.
5

Routine vaccination of the American public against smallpox stopped in 1972 after

the disease was eliminated in the United States. Vaccination was stopped because

the risk of the vaccine was felt to outweigh the risk from the disease.

Until recently, the U.S. Government provided the smallpox vaccine only to a few

hundred scientists and medical professionals annually who work with smallpox and

similar viruses in a research setting.

The stockpiling of smallpox vaccine was an important priority before September

11, 2001, and smallpox vaccine was already in production at that time. The events

of the fall of 2001 heightened concern that terrorists may have access to the virus

and attempt to use it against the American public. In response to these events, the

Department of Health and Human Services (HHS) increased its order for vaccine,

accelerated production, and began working to develop a detailed plan for the public

health response to an outbreak of smallpox. The United States currently has sufficient quantities of the vaccine for every single person in the country in an emergency situation.

SMALLPOX RESPONSE PLANNING

A single report of a smallpox case in the United States will require an aggressive

outbreak control effort to contain spread of the disease. In partnership with State

and Local Health authorities, DHHS/CDC is in the process of establishing a smallpox preparedness and response program that:

—Enhances community awareness and clinician expertise about smallpox disease

and smallpox vaccination through education and training;

—Performs disease surveillance and laboratory analysis to rapidly detect a single

case of smallpox and any subsequent cases;

—Implements public health interventions, based on careful consideration of epidemiology and mode of transmission of smallpox, in the safest possible manner;

—Provides vaccination and follow-up service, on a voluntary basis, immediately

to those individuals who respond to a smallpox emergency (including, but not

limited to, those who will treat the victims, provide security, vaccinate the population, and perform disease case investigations), then, based on knowledge

gained, expand the program to include those responders who would be occupationally at risk during a smallpox outbreak;

—Provides for the capability to rapidly vaccinate a greater number of responders

or the entire population should a case occur or threat levels of a possible smallpox terrorist attack increase.

Response to an attack

States need to be prepared to rapidly implement aggressive smallpox containment

activities, including the ability to vaccinate their entire populations. On October 28,

2002, CDC issued post-event smallpox planning guidance to the 50 states; the District of Columbia; the commonwealths of Puerto Rico and the Northern Marianas

Islands; American Samoa; Guam; the U.S. Virgin Islands; the republics of Palau and

the Marshall Islands; the Federated States of Micronesia; and the nation’s three

largest municipalities (New York, Chicago and Los Angeles County). To date, all 62

jurisdictions have developed plans that are undergoing review by CDC.

In addition, we are also working collaboratively with other nations (Canada,

France, Germany, Italy, Japan, Mexico, and the U.K.) in the Global Health Security

Action Group (GHSAG) to provide a coordinated and collaborative response to a bioterror event. In particular, we are working closely with Canada and Mexico, as a

smallpox outbreak in either could necessitate a rapid response in the United States.

INCREASING PREPAREDNESS PRIOR TO AN ATTACK

President’s plan

On December 13, 2002, President Bush announced a plan to better protect the

American people against the threat of smallpox attacks by hostile groups or governments. This announcement is a vital step in ensuring that we are prepared to respond to a single reported case of smallpox. The President’s decision will provide

the public health and emergency response system with a cadre of vaccinated individuals who would respond in the event of outbreak of smallpox. The President’s announcement identified the need for the public health system to provide smallpox

vaccine to the following:

Smallpox response teams

HHS has been working with state and local governments to form volunteer state

and local Smallpox Response Teams that can provide critical services to their fellow

Americans in the event of a smallpox attack. To ensure that Smallpox Response
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Teams can mobilize immediately in an emergency, health care workers and other

critical personnel are being asked to volunteer to receive the smallpox vaccine. Preattack vaccination of Smallpox Response Teams will allow them, in the event of a

smallpox attack, to immediately administer the vaccine to others and care for victims. In the initial phase of vaccination, vaccine will be offered to core members of

public health and health care response teams. Then vaccination will expand to include health care workers and others who may be first responders.

Department of Defense and State Department personnel

The President also announced that the Department of Defense (DOD) will vaccinate certain military and civilian personnel who are or may be deployed in high

threat areas. Some United States personnel assigned to certain overseas embassies

will also be offered vaccination.

Members of the general public

The Federal Government is not recommending that members of the general public

be vaccinated at this time. The government has no information that a smallpox attack is imminent, and there are significant side effects and risks associated with the

vaccine. HHS is in the process of establishing an orderly process to make unlicensed

vaccine available to those adult members of the general public without medical contraindications who want to be vaccinated either in 2003, with an unlicensed vaccine,

or in 2004, with a licensed vaccine. A member of the general public may also be

eligible to volunteer for an on-going clinical trial for next generation vaccines.

IMPLEMENTATION OF SMALLPOX PREPAREDNESS PLANS

On November 22, 2002, CDC asked states how they intend to vaccinate individuals most likely to respond to a smallpox attack. CDC requested pre-attack plans

that contain information on the number of people comprising each Smallpox Response Team, information on where vaccines would be administered, the number of

health care facilities identified to participate, and the number of clinics needed to

support this effort. States were also asked to address vaccine logistics and security,

vaccine safety monitoring, training and education, data management, and communications in their plans.

Status of State pre-attack vaccination plans

States have worked diligently to develop plans to vaccinate and have begun implementing them. My oral testimony will address the current status of their implementation.

The plans indicate that approximately 450,000 public health and healthcare personnel may be offered the smallpox vaccine. Vaccination is voluntary and eligible

individuals will make their own decisions as to whether or not to receive the vaccine. There are no negative ramifications employment ramifications for anyone who

chooses not to be vaccinated. About 1,500 clinics around the nation will be set up

to deliver the vaccine to those who choose to receive it. In addition, state health officials have identified over 3,300 health care facilities that will participate in the program.

DISTRIBUTING VACCINE TO THE STATES

The National Pharmaceutical Stockpile (NPS) Program ensures the availability

and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of nerve agents, biological

pathogens, and chemical agents. The NPS Program stands ready for immediate deployment to any U.S. location in the event of a terrorist attack using a biological

toxin, chemical or radiological agent directed against a civilian population at the request of the locality.

The week of January 20, 2003, CDC delivered kits with enough vaccine and needles for 21,600 public health and healthcare workers to Connecticut, Nebraska,

Vermont and Los Angeles County. As of January 22, 2003, 20 states (including 1

county) requested nearly 100,000 doses of vaccine. These were the first shipment

of vaccine to state and local governments under the President’s plan to protect the

American people from an intentional release of the smallpox virus. Under the program, smallpox vaccine is being offered to those most likely to respond to a potential

outbreak of the disease. Each state notifies CDC when it is ready to receive its shipment of smallpox vaccine to begin pre-event vaccination of public health and

healthcare workers. Once CDC receives a request for smallpox vaccine from a state,

the order is forwarded to the National Pharmaceutical Stockpile for processing and

shipment. CDC is providing smallpox handling instructions, cold chain management

guidance, and all appropriate documentation. CDC will deliver DryvaxTM smallpox
7

vaccine, packaged and shipped in increments as small as one vial (100 doses). CDC

will validate all delivery information prior to shipment and will release vaccine after

validation of temperature monitoring information.

TRAINING AND EDUCATION

Because smallpox vaccine has not been used routinely in the United States since

the early 1970s, many of today’s healthcare providers are not familiar with the disease, the vaccine, or the vaccine’s potential side effects. This makes training of those

administering and those receiving the vaccine necessary to ensure that this program

is implemented as safely as possible. Anyone considering vaccination must receive

information on conditions that are contraindications to vaccination (e.g., certain skin

conditions, compromised immune systems, pregnancy, allergies to components of the

vaccine, or household contacts with a condition listed above). CDC has held 19 training and education sessions on smallpox that reached an estimated 800,000 clinicians, members of the public health workforce, and members of the general population. Training has been conducted in classrooms, via satellite, over the Internet,

through videotaped sessions and CD–ROM, and over the telephone. Thirty different

training products, in a wide variety of media formats, currently are available.

Training for response team members

Training and education for Smallpox Response Team members will be critical. In

order to prepare for their participation in a smallpox response effort, all Smallpox

Response Team vaccination candidates will be asked to watch a video distributed

by CDC and will receive a packet of information describing the purpose of the national smallpox preparedness program. The response team members will receive

general information about smallpox disease and the vaccine, including pre- and

post-vaccination worksheets to provide instructions for anticipating and monitoring

any potential side effects, as well as fact sheets on various methods of treatment

for side effects resulting from vaccination. Prior to vaccination, each vaccine recipient will be required to fill out a patient medical history and consent form to confirm

the absence of contraindications and to confirm the patient’s consent in receiving

the vaccine.

Training for clinicians

Clinicians must be able to detect the first symptoms of a potential case of smallpox. During vaccination of response team members, clinicians will be an important

resource for volunteers who are making a decision about whether or not they want

to accept the smallpox vaccine. CDC has an ongoing initiative to educate clinicians

about smallpox, done in conjunction with experts from a variety of medical professional organizations, including the Infectious Disease Society of America, the American Academy of Dermatology, the American College of Emergency Medicine (within

a consortium of other emergency clinician organizations), and several primary care

organizations. We are planning to help these organizations repackage information

from CDC, and distribute it to their constituents in the format most appropriate for

their members. In addition, CDC has established ongoing communication with 66

professional organizations that represent front-line clinicians to determine the

smallpox training and education needs of their members. Within the next month,

CDC is planning a national mail-out of critical clinician information to the nation’s

hospital and clinical community through each state’s licensing board. In addition,

we anticipate hundreds of thousands of clinicians will participate in CDC’s upcoming Public Health Training Network program on ‘‘Clinical Management of Adverse

Events Following Smallpox Vaccination: A National Training Initiative’’ scheduled

for February 4, 2003. To supplement this extensive campaign to educate clinicians,

CDC is also utilizing its normal means of getting information to clinicians, including

the Health Alert Network, the secure Epi-X program, and the Morbidity and Mortality Weekly Report (MMWR). CDC has also contracted to establish a 24-hour-a-day,

7-day-a-week hotline for clinicians to call with questions about smallpox vaccinations.

Training for laboratorians

CDC is providing smallpox training for laboratorians, including detailed instructions on the differentiation of smallpox from other rashes. On January 29, 2003,

CDC will broadcast nationally a training program entitled, ‘‘Smallpox and Vaccinia

Laboratory Testing: A National Training Initiative.’’ The program presents detailed

information, specific to those who perform testing and those who use laboratory

services, such as physicians, nurses, epidemiologists, and state medical officers.

They will also be given specific information on the laboratory role in diagnosing adverse events associated with smallpox vaccination. In addition, CDC has developed
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‘‘Agents of Bioterrorism: A Guide for Clinical Laboratories,’’ which includes information for clinical laboratorians about handling specimens suspected of containing

smallpox. This guide will be distributed to the state public health laboratories within the next two weeks. The state public health laboratories can customize the guide

with state-specific information and deliver it to the clinical laboratories in their

area.

Education for the public and the media

CDC has, and will continue to use, weekly (and as warranted) media briefings,

media advisories, access to smallpox vaccine experts, and public information materials to create awareness of the smallpox vaccination recommendations, the purpose

of the recommendations, and the risks associated with smallpox vaccine. In addition, CDC is using its website to provide easy access to a wide range of smallpox

education materials, including materials designed specifically to meet the needs of

different audiences—such as members of the public, health care providers, people

for whom smallpox vaccination is recommended, and state and local health departments. We have been, and will continue to work with, state and local health departments and other partners to help ensure our messages and materials are visible and

readily available. CDC also operates a 24-hour-a-day, 7-day-a-week public information hotline that is accessible in English and Spanish.

PREVENTING, DIAGNOSING, TREATING, AND MONITORING ADVERSE EVENTS

Ensuring that we can implement this program as safely as possible has been central to our planning. The first part of this effort is to carefully educate and screen

those considering vaccination. We have had a great deal of experience with this vaccine and have information on who is at risk of serious adverse events (e.g., those

who have certain skin conditions, have compromised immune systems, are pregnant,

have allergies to components of the vaccine, or have a member of their household

with a condition listed above). Second, we will, with state and local health departments and the healthcare community, ensure that we diagnose, manage, and treat

adverse events promptly and correctly. Third, we will very carefully monitor adverse

events to ensure that we know of any unexpected patterns or types of adverse

events on a real-time basis and can quickly modify the program to decrease the risk

of adverse events if necessary. Included in this effort is education about what to expect after vaccination, when to be concerned about an adverse event, and where to

go for help.

The Smallpox Vaccine Adverse Events Monitoring and Response System will monitor the occurrence of clinically significant, especially serious, adverse events (AEs).

It will also serve to identify any unexpected adverse events. This process will help

to build state capacity for assessment of adverse events.

Diagnosing and treating adverse events

CDC will provide technical assistance to state health departments, including

screening to identify and exclude persons with contraindications and help in implementing proper clinical procedures. There will be a designated telephone hotline for

state health departments. CDC will monitor state tracking of clinically significant

AEs. CDC will also inform states of any adverse event reports transmitted directly

to CDC.

Efforts are underway to work with healthcare providers to assure they are educated about the smallpox vaccination program and smallpox vaccine AEs. This includes recognizing possible AEs and managing and treating any AEs among their

patients. Standard algorithms are under development to assist physicians in proper

identification and treatment of these patients.

Vaccinia Immune Globulin (VIG) is a product used to treat certain serious adverse

reactions caused by smallpox vaccine. Sufficient quantities of VIG are available now

to treat all anticipated adverse events resulting from the current vaccination program. New VIG is being produced and delivered to the National Pharmaceutical

Stockpile for distribution, if needed, as the vaccination program expands. An effort

is underway to produce new lots that will meet the standards for intravenous immune globulin. Cidofovir is a drug used to treat viral infections in persons with

HIV/AIDS. It may be helpful in treating vaccinia reactions in cases where VIG does

not work.

The state will inform CDC of VIG and/or Cidofovir requests. A CDC clinical team

will then assess the request with the state and treating physician. CDC Drug Services and the National Pharmaceutical Stockpile will coordinate release of VIG and

Cidofovir. The treating physician will then designated as a co-investigator on the

Investigational New Drug (IND) protocol.
9

Reporting

CDC is working with the states to develop an active surveillance system to detect

serious adverse events following smallpox vaccine. CDC intends to implement recommendations that all health care workers have their vaccination sites monitored

in the hospital daily, which will contribute information on serious illnesses that

occur in all vaccinees. In addition, CDC will use the Vaccine Adverse Event Reporting System (VAERS), a national surveillance system administered by CDC and the

Food and Drug Administration (FDA), to monitor smallpox AEs. The data collected

through VAERS will be analyzed to identify any new or rare vaccine side effects,

increases in rates of known side effects, associations with specific vaccine lots, or

patient risk factors.

Post-vaccination surveillance

Post-vaccination surveillance will be conducted for people receiving the smallpox

vaccine. This surveillance will assist in determining the rates of common AEs, assessing impact on time lost from work, and evaluating vaccinee satisfaction with the

immunization program. This will be done by telephone survey 10 and 21 days postvaccination.

Data and safety monitoring board

CDC has established a Data and Safety Monitoring Board to provide advice to the

CDC and program managers on selected aspects of pre-event smallpox vaccination

program implementation.

The committee will review reported adverse events to determine whether rates of

serious events are within expected limits; whether recommendations for screening

out persons with contraindications are being properly observed; whether adverse

events following vaccination are causally or only coincidentally linked to vaccination; and whether the adverse events experienced necessitate a substantial change

in the way the program is run.

IOM COMMITTEE

Through the Institute of Medicine’s (IOM) Committee on Smallpox Vaccination

Program Implementation, the IOM is providing advice to the CDC and program

managers on selected aspects of pre-event smallpox vaccination program implementation. The IOM Committee released its first report on January 17, 2003.

The committee is making recommendations to CDC and state and local vaccine

program managers to improve: CDC guidance designed to identify potential vaccine

recipients at high risk of vaccine adverse events and complications; CDC measures

to ensure the early recognition, evaluation, and appropriate treatment of adverse

events and complications of smallpox vaccination; CDC plans for collecting and analyzing data on vaccine immunogenicity, adverse events, complications, and vaccine

coverage; the informed consent process for vaccine recipients; professional education

and training materials; communication plans for public health and medical professionals and the public; state smallpox vaccination implementation plans; and the

achievement of overall goals of the smallpox vaccination program (e.g., vaccine coverage rate, equity of access, adverse reaction rates, etc.).

CONCLUSION

Assuring the nation is prepared in the event of an attack by a hostile group or

government is one of the highest priorities for the administration. HHS and CDC

are dedicated to assisting the states in increasing smallpox preparedness. We greatly appreciate all the work the states and local jurisdictions have done to develop

plans and begin to implement them. We look forward to continuing to support

states’ efforts to protect the American people.

Thank you for the opportunity to testify before you today on this important public

health issue. I would be happy to answer any of your questions.

Senator SPECTER. Thank you very much, Dr. Gerberding. Just a

few questions before turning to Dr. Fauci. You commented about,

in excess of $1 billion being distributed. This subcommittee had

urged a very substantial funding after 9/11, and that was an outgrowth of the October hearing which we had, so that we had close

to $3 billion in the supplemental appropriations bill.

The Center for Disease Control has been in urgent need of repairs for many, many years, and it was only when this subcommittee made a site inspection 21⁄2 years ago that we found out
10

how deplorable the situation was, and in advance of 9/11 this subcommittee took the lead in putting up $170 million to renovate the

CDC.

We saw, I personally saw a deplorable situation, with distinguished scientists in quarters and with potentially toxic substance

without adequate security, and to have a facility like the Center for

Disease Control in that situation was just really astounding. And

then the following year, we put up some $255 million. We are on

a path to reach in excess of $1 billion to renovate the Center for

Disease Control.

This subcommittee has been very, very attentive to medical research and the kinds of issues which you face. Senator Harkin and

I have taken the lead on this subcommittee to double the NIH

funding, so that it started out at about $12 billion in fiscal year

1996, and with this year’s appropriation, we will exceed $27 billion,

so it is very important that this subcommittee be informed as to

the specifics as to what you need. Now, you say that you have distributed $1.1 billion at the

present time?

Dr. GERBERDING. That is correct.

Senator SPECTER. And what is the basis for that distribution?

How do you decide who gets what?

Dr. GERBERDING. This year, the appropriation was divided into the $918 million that went to health care, or to the State and local

health departments, and the remainder went for hospital preparedness and the health care facilities.

Senator SPECTER. $918 million went to State and local——

Dr. GERBERDING. State and local health agencies.

Senator SPECTER [continuing]. Health agencies.

Dr. GERBERDING. 50 States, four metropolitan areas, and then

several islands that are sovereign and need their independent appropriations. Altogether, there are 62 jurisdictions.

Senator SPECTER. 62 jurisdictions? How far does $918 million go?

Dr. GERBERDING. Well, it has certainly taken us further than we

were the year before we got it. What we have asked the health departments to do is to address 16 critical capacities that deal with

preparedness for terrorism as well as other public health threats

and emergencies.

That includes the kind of planning and program implementation

that I discussed. It includes rehabilitation of laboratory facilities,

which were in dreadful shape in many jurisdictions. It includes the

national pharmaceutical stockpile logistics, so that people can deliver and utilize the measures we have in the stockpile, and it includes provision for communication, alerting, training and overall

preparedness of the clinician community.

Senator SPECTER. On Monday, the day before yesterday, Senator

Santorum and I visited UPMC, the University of Pittsburgh Medical Center, and we observed a facility which they have set up for

decontamination, and the University of Pittsburgh Medical Center

has undertaken this on their own, on their own financing. They are

seeking what we call an earmark from this subcommittee, but obviously the principal line of funding is going to have to come from

the new Department of Homeland Defense, where there is some

$38 billion allocated.
11

Now, admittedly, that has to cover a lot of lines, but I would like

to have your evaluation as a follow-up to this hearing, Dr.

Gerberding, as to what it is going to take to adequately fund State

and local facilities. Wherever I go in my State, and it is just one

State, I hear concerns about the adequacy of funding, and people

are going to be going to the hospitals, and our public health infrastructure admittedly has been in a sad state.

Let the record show the witness is nodding. Now the witness is

smiling.

Dr. GERBERDING. The witness is in complete agreement.

Senator SPECTER. It is a very tough issue, but we have to know

the hard facts. You have got to tell us what it is going to take. This

subcommittee has demonstrated in the past our capacity to provide

what it takes, and I know the President is committed to this, but

you professionals are going to have to tell us, and very candidly,

for a long time we did not hear from the Centers for Disease Control about what you needed, and it was only when we went to Atlanta that we found out, and you have got to tell us what you need.

STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE ON ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN

SERVICES

Senator SPECTER. Dr. Fauci, we welcome you back to this subcommittee. You are a regular.

Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases, with the National Institutes of

Health, came to the NIH in 1860—1968—

Dr. FAUCI. It seems that way.

Senator SPECTER. You have been there almost as long as I have

been in elective office, Dr. Fauci—after completing his residency at

the New York Hospital/Cornell Medical Center, a native of Brooklyn, M.D. degree from Cornell University Medical College.

Dr. Fauci and I had a lively discussion a few months ago about

inoculations and who ought to bear the risk, and I took the position

that parents, maybe even grandparents ought to make decisions. I

did not want the Government to make a decision for my four

grandchildren, and after a while, I think you agreed with me, Dr.

Fauci.

Dr. FAUCI. Yes.

Senator SPECTER. We thank you for the very distinguished work

you have done. We welcome you here and look forward to your testimony.

Dr. FAUCI. Thank you, Mr. Chairman. It is a pleasure to be here

testifying to you and this committee once again on this important

subject.

Dr. Gerberding has mentioned the horror of smallpox as a disease, so I will not spend more time on that, except to say in the

context of my main theme, namely vaccination, that this devastating disease has shaped civilizations, killing more than 500

million people over the years, a fatal disease in 30 percent of cases,

no treatment available. However, a vaccine that has been used now

for decades and decades has been responsible for the eradication of

smallpox in this country and worldwide.
12

The vaccine that was used in this country and was put into storage is what we call Dryvax. As you know, I testified before this

committee, where we had 15 million in storage. That vaccine is

greater than 95 percent effective, and in studies I reported to this

committee sometime ago, we showed that, despite decades of storage, it not only maintained its full potency and take rate, but it

also could be diluted 1-to-5. We will be using the undiluted Dryvax

vaccine on the program that Dr. Gerberding described.

With regard to the adverse effects, these are the numbers that

have been gathered from the 1968 cohort. For every million people

vaccinated, there will be 14 to 52 serious life-threatening events.

There will be 49 to 935 serious but not life-threatening, and one

to two deaths per million. These are for primary vaccinees. People

who have already been vaccinated have a considerably lower incidence of adverse events associated with this vaccine.

What do we do with adverse events when they are serious

enough? We have a standard methodology for approaching. One of

them is what we call Vaccinia Immune Globulin, which is derived

from the plasma of people who have been vaccinated. It is an antibody that can block the Vaccinia vaccine. We currently have

enough now to cover all the possible projected adverse events that

we would see in the program that Dr. Gerberding described, and

by the summer, we will have enough to cover over 300 million

vaccinees.

We also have an experimental product, Sodopavir, which was

originally used against sodomegaler virus, which is now in an IND,

shown to be effective in animal models against smallpox.

Senator SPECTER. Dr. Fauci, when you now say you have enough

to cover all of the adverse effects, quantitatively what do you

mean?

Dr. FAUCI. We mean that if you use the projections we showed

here of what you might expect per million people vaccinated, the

program that Dr. Gerberding described would give you a projected

amount that you might see within a bracket of the lower limit and

the upper limit. We now have enough Vaccinia Immune Globulin

within our stores that we could handle the response and the therapeutic approach to essentially those numbers of adverse events.

So remember, we were discussing months ago, do we have

enough VIG, as we call it? The answer right now is yes, we have

enough now, and we are making more, so that by the summer we

will have enough so that if we have to vaccinate 300 million people

we will have enough.

Senator SPECTER. Thank you.

Dr. FAUCI. You are welcome. We are striving for something very

important, and that is an attenuated vaccine that would obviate

this concern about toxicity. One of the ones we are working on is

Modified Vaccinia Ankara, which is a modification of the vaccinia.

It is attenuated. Experience in the field shows that they have very,

very few toxic side effects and adverse events. We are rapidly pushing this to the point of being able to have enough to use, and that

will likely happen within the next couple of years. There is also another attenuated strain that the Japanese use.

I am going to spend the last minute just very quickly reviewing

the other types of countermeasures that we have, not only for
13

smallpox, but for other agents. I presented our strategic plan and

our category A research agenda to this committee last year. We

now have completed and have published the research agenda for

category B and C pathogens.

All of this is anchored on the concept that we will use the basic

research agenda that is tried and true and tested at the NIH, but

the shift of the paradigm will be a much greater emphasis on the

translation of that basic research into new, definable product countermeasures such as diagnostics, therapeutics, and vaccines. Obviously, this will require close collaboration with academia, and particularly with our industrial partners.

Then finally, on this last slide, I talk about what we would say,

the preparedness from a research standpoint. To compliment the

preparedness that Dr. Gerberding spoke about from a public health

standpoint is the vision of the future, to be able to have universal

antibiotics and antivirals that could be used against multiple

agents, safe and effective new generation vaccines, as well as advances in our capability of modulating the immune system and, finally, molecularly based diagnostics.

PREPARED STATEMENT

At the end of the day, this will have two purposes. One, I believe

it will effectively defend us against agents of bioterror, but also

what it would do, it would serve as well to be able to defend the

population of this country and the world against naturally occurring emerging and reemerging microbes.

Thank you. We would be happy to answer any questions you

have.

[The statement follows:]

PREPARED STATEMENT OF DR. ANTHONY S. FAUCI

Mr. Chairman and Members of the Committee, thank you for inviting me here

today to discuss the implementation of the President’s smallpox vaccination plan,

which is intended to protect the American people against the threat of a smallpox

attack. Because of the long-standing expertise of the National Institute of Allergy

and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) in biomedical research on emerging and reemerging infectious diseases, including smallpox and other potential bioterror agents, the Institute has been designated by President Bush to play a leading role in the nation’s fight against bioterrorism. As Director of the NIAID, I am committed to bringing all of our research expertise to bear

on the full implementation of this important effort.

SMALLPOX VACCINE IMPLEMENTION PLAN

On December 13, 2002, the President announced a plan to prepare and protect

the American people against the threat of a possible smallpox attack by hostile

groups or governments. Under the plan, the Department of Health and Human

Services (DHHS), through the Centers for Disease Control and Prevention (CDC),

will work with state and local governments to form volunteer ‘‘Smallpox Response

Teams’’ who can provide critical services to their fellow Americans in the event of

a smallpox attack. To ensure that these teams can mobilize and perform effectively

in an emergency, it is recommended that health care workers and other critical personnel volunteer to receive the smallpox vaccine. The President also announced that

the Department of Defense will vaccinate certain military and civilian personnel

who are or may be deployed in high threat areas. Some U.S. personnel assigned to

certain overseas embassies also will be offered vaccination. It should be noted that

the Federal government is not recommending vaccination for the general public at

this time.
14

SMALLPOX—THE DISEASE

Smallpox is a serious, contagious, and sometimes fatal disease. The symptoms of

smallpox infection appear approximately 12 to 14 days (range: 7 to 17 days) following exposure. Initial symptoms include high fever, fatigue, and head and back

aches. A characteristic rash, most prominent on the face, arms, and legs, follows in

2–3 days. The rash starts with flat red lesions (a ‘‘maculopapular’’ rash) all beginning at the same time. These lesions become pus-filled and begin to crust, forming

scabs that separate and fall off after about 3–4 weeks. Individuals are generally infectious to others from the time period immediately prior to the eruption of the

maculopapular rash until the time of the shedding of scabs, but are most infectious

during the first 7 to 10 days of rash. The mortality of smallpox infection is approximately 30 percent, although mortality is likely to be much higher in those with compromised immunity, such as individuals with HIV infection and those receiving cancer therapies or drugs to prevent the rejection of transplanted organs. Smallpox patients who recover frequently have disfiguring scars over large areas of their body,

especially their face; some are left blind. There is no licensed treatment for smallpox

disease, and the only known prevention is vaccination.

A massive vaccination program led by the World Health Organization (WHO)

eradicated all known smallpox disease from the world in the late 1970’s, a resounding success story for vaccination and public health. The last case of smallpox in the

United States of America was in 1949, and use of the vaccine in this country was

discontinued in 1972. In 1980, WHO recommended that all countries stop vaccinating for smallpox. At the present time, small quantities of smallpox virus are

stored in two secure facilities in the United States and Russia explicitly for research

purposes, but it is believed that unrecognized stores of smallpox virus exist elsewhere in the world.

Prior to its eradication, smallpox was considered one of the most devastating infectious diseases known to mankind. Today, with the real possibility that smallpox

may be used as an agent of bioterrorism, it may be once again poised to threaten

public health worldwide.

SMALLPOX—THE VACCINE

The ‘‘Smallpox Response Teams’’ and ‘‘first responders’’ identified in the President’s Smallpox Vaccination Plan will receive FDA-licensed Dryvax smallpox vaccine in the undiluted form. This vaccine was made by Wyeth Laboratories and approximately 15 million doses have been in storage since 1982, when the company

stopped making the vaccine. Historically, Dryvax smallpox vaccine has proven to be

95 percent effective in preventing smallpox infection. In unvaccinated people exposed to smallpox, the vaccine can lessen the severity of, or even prevent, illness

if given within 3 days after exposure.

The vaccine is freeze-dried, live vaccinia virus, a poxvirus related to smallpox

virus—it is not a dead virus like many other vaccines. The vaccine is delivered in

an unusual way, using a technique called scarification whereby the material is

pricked into the skin using a two-pronged needle. Successful vaccination is measured by the development of a clear-cut pustule 6–8 days after vaccination. This is

known as a ‘‘take.’’ The blister dries up and a scab begins to form, and by the third

week the scab falls off, leaving a scar. The immunization site remains contagious

for vaccinia until the scab dries up completely and falls off. For that reason, the

vaccination site must be cared for carefully to prevent the virus from spreading. Approximately one week after vaccination, many people experience fever, malaise, myalgia, soreness at the vaccination site, and swelling of the lymph nodes in the area

of the vaccine, particularly under the arms.

In order to determine whether the existing supply of Dryvax vaccine (15 million

doses) retained its potency and could even be diluted to expand the stock, a series

of clinical trials were performed. In this regard, NIAID conducted a study on adults

who had not been previously vaccinated to determine whether Dryvax could be diluted effectively to make more doses of this smallpox vaccine available. This clinical

trial showed that the existing U.S. supply of smallpox vaccine was still very potent

in its undiluted form and could be diluted five-fold and retain its potency, effectively

expanding the number of doses of smallpox vaccine in the United States to 75 million. A report describing these findings appeared in the April 25, 2002, issue of The

New England Journal of Medicine. The Dryvax vaccine also is being studied by

NIAID in previously vaccinated populations to determine whether any residual immunity exists from earlier vaccinations.

In addition to Dryvax, NIAID is sponsoring clinical trials of another vaccine

against smallpox developed by Aventis Pasteur. Eighty million doses of Aventis Pasteur’s smallpox vaccine, a different formulation of the vaccinia smallpox vaccine,
15

have been in storage for 40 years. NIAID-supported studies performed through its

Vaccine Treatment and Evaluation Units will determine the safety and preliminary

efficacy of various concentrations of Aventis Pasteur’s smallpox vaccine in adults.

To further ensure adequate supplies of smallpox vaccine, DHHS has contracted with

Acambis, Inc. to produce a cell culture based smallpox vaccine for licensure.

SMALLPOX VACCINE RESEARCH—CHALLENGES AND OPPORTUNITIES

While the Dryvax smallpox vaccine is currently the most effective weapon against

a possible smallpox attack, it still poses risks, even in healthy populations. Fortunately, most individuals experience only mild symptoms. However, serious reactions

to smallpox vaccination are well documented in studies dating back to the 1960s

when smallpox vaccination was routine in the United States. Those data indicate

that, for every 1 million people vaccinated, there are 14 to 52 life-threatening adverse events such as post-vaccinial encephalitis with 1 to 2 deaths. In addition,

there are 49 to 935 serious, but not life-threatening events. Moreover, because

smallpox vaccination ceased in the United States more than 25 years ago, there is

limited experience with this vaccine in the era of HIV infection, organ transplantation, and immunosuppressive therapy.

The protection of all populations, including immunocompromised individuals,

pregnant women, and children is the next critical important step in addressing the

smallpox threat. NIAID is carefully examining alternatives to Dryvax including

modified vaccinia Ankara (MVA), which may be a viable ‘‘second generation’’ smallpox vaccine for individuals at high risk of complications from the current Dryvax

smallpox vaccine.

Several of the complications of smallpox vaccination can be treated with Vaccinia

Immune Globulin (VIG), which is derived from the plasma of volunteers who previously have received a smallpox vaccination. DHHS currently has more than

enough VIG to cover the adverse events that are projected to be associated with vaccinating the smallpox response teams and first responders under the President’s

smallpox vaccination plan. Furthermore, the CDC has contracted for additional supplies of VIG to ensure an adequate stockpile of this product by this summer to cover

the severe adverse events that might be expected for over 300 million vaccinees.

Assessments of MVA vaccine candidates in multiple animal models, including

immunosuppressed animals, are providing important data on the safety and efficacy

of the vaccine. In addition, historical data from people who received an MVA vaccine

in Germany in the 1970’s adds to the body of scientific data. Importantly, the clinical trials conducted in Germany at the time included children, who are known to

be at risk for adverse events associated with the conventional vaccinia-based vaccine. MVA vaccine also has been tested recently as an experimental vaccine vector

for the delivery of other vaccine candidates, including HIV and cancer vaccines.

These studies suggest that the vaccine may be safe in immunocompromised individuals.

In late 2002, the NIAID issued a Request for Proposals (RFPs) intended to provide resources for the initial development of MVA vaccine candidates. NIAID intends to issue a second RFP during the summer of 2003, entitled ‘‘Production and

Acquisition of MVA Vaccine.’’ The objective of the second RFP will be to manufacture, formulate, fill and finish, and test, in accordance with current Good Manufacturing Processes (cGMP) regulations, up to 30 million doses of MVA vaccine to constitute the U.S. Government’s stockpile for emergency use under Investigational

New Drug (IND) status and to provide a licensure plan to include the conduct of

expanded human safety studies required for licensure and the conduct of pivotal

animal protection studies. A third contract solicitation for the acquisition of a licensed product is being planned for 2005, under the auspices of the CDC.

In addition, the NIAID Vaccine Research Center on the NIH campus in Bethesda,

MD, is conducting a clinical trial to determine the safety of MVA and to compare

the immunogenicity of MVA and Dryvax. This study is being conducted in healthy

volunteers who have not been previously immunized with vaccinia; a future trial

with vaccinia-experienced subjects is being planned. NIAID also is looking ahead to

develop ‘‘third’’ generation smallpox vaccines, including recombinant protein vaccines.

NIAID is also evaluating drugs for use against smallpox virus. NIAID-supported

scientists have developed a form of the antiviral drug cidofovir that can be administered orally. Injectable cidofovir already has been approved by the Food and Drug

Administration (FDA) for treating CMV retinitis in individuals with HIV/AIDS and

has shown activity against smallpox and related viruses in laboratory and animal

studies. Preliminary data from these experiments suggest that cidofovir may be

helpful in controlling the progression of serious vaccinia-related complications. To il-
16

luminate this issue, NIAID worked last year with colleagues at the CDC, the FDA

and the Department of Defense (DOD) to develop an Investigational New Drug application to evaluate cidofovir in the treatment of smallpox. NIAID continues to explore the development of additional therapeutic interventions against smallpox and

other potential bioterror agents.

BIODEFENSE RESEARCH

Smallpox is only one of a number of potential bioterror threats to our nation. In

2002, NIAID convened two Blue Ribbon Panels to provide objective scientific advice

on NIAID’s biodefense research activities involving smallpox as well as other potential agents of bioterror. As a result of these deliberations, the Institute has developed two research agendas: one focuses on the CDC’s Category A agents, which include smallpox, while the second focuses on NIAID’s Category B and C Priority

Pathogens. Guided by the recommendations outlined in these agendas, NIAID developed a total of 52 biodefense initiatives to stimulate research in fiscal years 2002

and 2003; 36 are new initiatives and 16 are significant expansions. During this

same time period, NIAID has seen a 30 percent increase in the number of grant

applications; the vast majority of these are in response to our biodefense initiatives.

In fiscal year 2002, several NIAID initiatives encouraged industry partnerships

and focused on the development of new diagnostics, vaccines and therapeutics for

CDC Category A agents. These types of research initiatives have been well received.

As a result, NIAID has expanded and reissued many of these collaborative efforts

in fiscal year 2003, and plans to do the same in fiscal year 2004. In addition, the

new initiatives will be broadened to address NIAID’s Category B and C Priority

Pathogens.

A number of significant advances in understanding, treating and preventing potential agents of bioterror have already been realized. For example, NIAID-supported scientists determined how anthrax toxin gains entry into a cell and demonstrated how the toxin can be effectively blocked from entering the cell, suggesting

that the development of specific anthrax toxin-blocking compounds could be a viable

approach to treating anthrax disease. Furthermore, intramural researchers at

NIAID’s Vaccine Research Center are working on the development and pre-clinical

testing of an Ebola vaccine, while others have discovered a single gene mutation in

the plague bacterium, Yersinia pestis, which may have been responsible for the

emergence of the ‘‘Black Death’’ in the 14th century.

NIAID also has expanded genomic sequencing of potential agents of bioterrorism,

including anthrax and plague, and has recently awarded contracts to two companies

designed to spur development of a new anthrax vaccine. Similarly, the Institute has

new initiatives planned to encourage development of vaccines against plague and

therapeutic strategies against Botulinum toxin.

In fiscal year 2003, NIAID will establish a nationwide network of Regional Centers of Excellence for Biodefense and Emerging Infectious Disease Research and

pursue an initiative to design, build, and renovate a system of Regional and National Biocontainment Laboratories to serve as national resources for biodefense research and product development. These facilities will include a small number of Biosafety Level-4 (BSL–4) laboratories, the level of containment necessary to study

highly pathogenic organisms.

CONCLUSION

The threat of resurgent smallpox is real and its potential is devastating; however,

the President’s Plan moves us in the right direction to address this threat head-on.

We will continue to work closely with the Administration, including our colleagues

within HHS, to fully implement the President’s smallpox vaccine action plan. In addition, NIAID will continue to bolster our biodefense research efforts, which span

basic, clinical and product development research, and infrastructure development.

With a strong research base and talented investigators throughout the country, we

fully expect that NIAID’s research programs will provide the elements essential to

enhance significantly our nation’s defenses against the threat of bioterrorism.

Thank you for the opportunity to testify. I will be happy to answer any questions.

Senator SPECTER. Thank you, Dr. Fauci.

Before we turn to questions, I would like to turn to our very distinguished Ranking Member, Senator Harkin. We exchange the

gavel from time to time and, I like to say, seamlessly. Tom Harkin

and Arlen Specter learned a long time ago if you want to get some-
17

thing done in Washington, you have to be willing to cross party

lines. And when you deal with health, that is a public matter.

Tom.

OPENING STATEMENT OF SENATOR TOM HARKIN

Senator HARKIN. Thank you very much, Mr. Chairman. I apologize for being late. There was an accident in the tunnel out here

and I got stuck in the tunnel.

First of all, let me thank you for calling this hearing, Mr. Chairman. This is something that is of vital importance.

I will wait for my turn for questioning.

Senator SPECTER. Okay.

Senator Murray, would you care to make an opening statement?

OPENING STATEMENT OF SENATOR PATTY MURRAY

Senator MURRAY. Mr. Chairman, I appreciate you having this

hearing. I will just submit my statement for the record, but I will

just say, this is a huge concern in many communities across my

State, as I hear from hospitals and cities who are now feeling the

burden of having to implement the vaccines, and a lot of questions

about why, how, who is going to pay for it, what the risks are, and

so I really appreciate your having this hearing today. I think we

need to have these questions answered for our communities.

[The statement follows:]

PREPARED STATEMENT OF SENATOR PATTY MURRAY

Mr. Chairman, we all recognize that smallpox poses a threat. The questions we

must answer are: How big is that threat? And is the administration’s plan appropriate and adequately funded?

From the Anthrax incident here in the Senate, we learned that we need to be prepared.

But today as we consider smallpox, many health care providers and hospital administrators do not have the information they need.

It’s hard for them to evaluate the risks and benefits of inoculating their emergency response personnel.

There are simply too many unanswered questions and very few guidelines for

helping health care professionals make this important decision.

This uncertainty has led S.E.I.U.—one of the major unions representing nurses—

to advise its members to not receive the smallpox vaccine.

Similarly, many hospitals—including several in Washington state—have decided

to not participate in Stage One of the Smallpox Response Plan.

We are already asking so much of our emergency room doctors and nurses. We

shouldn’t ask them to accept these new risks without giving them a better understanding of the actual threat.

Clearly, the administration needs to do a better job of communicating the threat

and the potential risks.

I also share the concern of many in my state that unfunded mandates on smallpox

will limit their ability to respond to outbreaks of T.B. and other infectious diseases.

In addition to urging the administration to provide more information about the

risks and benefits, and to provide adequate funding, I would also urge the Administration to allow access to compensation for those workers who are injured or who

suffer adverse health effects from the vaccine.

Relying on Workers Compensation is not the answer because the threshold is set

too high, and the outcome is too uncertain.

Recently, I joined with several Senators in sending this message to the White

House. I would urge today’s witnesses from the administration to carry this message

back.

Injured workers and patients should be justly compensated for injury and harm.

As we address the smallpox threat, let’s make sure we provide the information,

the funding, and the compensation to enable our state and local governments and

our health care professionals to respond appropriately.
18

Senator SPECTER. Thank you, Senator Murray. We will have 5-

minute rounds, which is the custom of the subcommittee.

At the outset, my question goes to our preparedness on a long

list of potential bioterrorist attack items. We asked the Center for

Disease Control about this, and we got this listing last year: anthrax, botulism, plague, smallpox, tularemia, viral hemorrhagic fevers, brucellosis, Epsilon toxin, salmonella, escherichia coli, Glanders, melioidosis, psittacosis, Q fever, ricin toxin, staphylococcal

enterotoxin B, typhus fever, viral encephalitis, water threats, and

the list goes on and on. I will make these a part of the record so

that the recorder will know how to spell them. Maybe somebody

even knows how to pronounce them.

[The information follows:]

BIOLOGICAL DISEASES/AGENTS

CATEGORY A

Anthrax (Bacillus anthracis)

Botulism (Clostridium botulinum toxin)

Plague (Yersinia pestis)

Smallpox (variola major)

Tularemia (Francisella tularensis)

Viral hemorrhagic fevers (filoviruses [e.g., Ebola, Marburg] and arenaviruses [e.g.,

Lassa, Machupo])

CATEGORY B

Brucellosis (Brucella species)

Epsilon toxin of Clostridium perfringens

Food safety threats (e.g., Salmonella species, Escherichia coli O157:H7, Shigella)

Glanders (Burkholderia mallei)

Melioidosis (Burkholderia pseudomallei)

Psittacosis (Chlamydia psittaci)

Q fever (Coxiella burnetii)

Ricin toxin from Ricinus communis (castor beans) NEW!

Staphylococcal enterotoxin B

Typhus fever (Rickettsia prowazekii)

Viral encephalitis (alphaviruses [e.g., Venezuelan equine encephalitis, eastern

equine encephalitis, western equine encephalitis])

Water safety threats (e.g., Vibrio cholerae,Cryptosporidium parvum)

CATEGORY C

Emerging infectious disease threats such as Nipah virus and hantavirus

CATEGORY DESCRIPTIONS

Category A Diseases/Agents

The U.S. public health system and primary healthcare providers must be prepared to address various biological agents, including pathogens that are rarely seen

in the United States. High-priority agents include organisms that pose a risk to national security because they

—can be easily disseminated or transmitted from person to person;

—result in high mortality rates and have the potential for major public health impact;

—might cause public panic and social disruption; and

—require special action for public health preparedness.

Category B Diseases/Agents

Second highest priority agents include those that

—are moderately easy to disseminate;

—result in moderate morbidity rates and low mortality rates; and

—require specific enhancements of CDC’s diagnostic capacity and enhanced disease surveillance.
19

Category C Diseases/Agents

Third highest priority agents include emerging pathogens that could be engineered for mass dissemination in the future because of

—availability;

—ease of production and dissemination; and

—potential for high morbidity and mortality ratesand major health impact.

Senator SPECTER. Dr. Fauci, let me start with you. We are just

talking about one of them today. How well-equipped are we to deal

with this long litany of potential risks that somebody may hurl at

us?

Dr. FAUCI. It is getting better prepared and better prepared, Mr.

Chairman. That is the reason why I showed that slide of the research agenda. At least from the research standpoint, and Dr.

Gerberding could comment on the other aspects of it, from the research standpoint, we are specifically targeting essentially the microbes that you mentioned on that list, and I will give you a few

very brief examples.

In anthrax, we are working on now what we call the second generation anthrax vaccine. The first one is a more crude vaccine in

which you take the supernatant from the cultures of anthrax, and

use that to inject it as a vaccine. Using molecular techniques, we

now have what is called the recombinant, using recombinant DNA

technology, a protective antigen. It is referred to as RPA, and that

antigen is highly immunogenic in inducing an immune response,

and our hope is not only to have a better, safer vaccine, but also

one that does not have to have six vaccination immunizations in

the program. Two or three is what we are aiming for.

The other one that we feel is very important that you mentioned

is botulism toxin. We have horse antiserum against it. We need to

increase that supply, and we have accelerated our research effort

to develop a monoclonal antibody against botulism toxin so that it

can be used safely and in unlimited quantities.

The final, last example, just as a prototype of what you are referring to, ebola, one of the hemorrhagic fevers that you mentioned,

the third, I believe, or fourth or fifth on your list, we have already

shown in an animal model that the vaccine that was developed at

the NIH against ebola protects a monkey from intraperitoneal challenge from live ebola, and we will be starting phase 1 safety trials

in humans in calendar year 2003, so we are making steady, and

in some cases rather rapid and impressive progress on the whole

array of microbes that you listed in your menu there.

Senator SPECTER. Well, Dr. Fauci, are you saying that we are

prepared for this entire laundry list?

Dr. FAUCI. No, we are not prepared. We are not, Mr. Chairman.

We are not prepared right at this moment, but we have them—

those microbes—in our crosshairs. We have targeted them and

some of the ones you have mentioned we actually already have

very good antibiotics against them.

Senator SPECTER. Well, what I would like to have you submit to

the subcommittee, going over this list, is which items we are prepared for, which items we are not prepared for, what we need to

get prepared for all of the items. That is really what we have to

make a determination on, and what will the cost be in preparing

on all of these items.
20

Dr. FAUCI. We have actually done that, Mr. Chairman, and we

can get an updated version of that to you relatively quickly.

Senator SPECTER. And the other question is, how confident are

we that this list is everything? Is it possible that somebody out

there may have some other bioterrorist items that are not on this

list?

Dr. FAUCI. That is always a possibility, not only an item that

might not be on the list—it is unlikely there would be a microbe

we have never heard of. That would be extremely unlikely, but

what could happen, and there is a feasibility we are concerned

about in trying to prepare for, is the genetic mutation of some of

those microbes to get them to perhaps elude the antibiotics, where

they exist, that we have for them, and/or the body’s immune response that you would expect from the vaccine, so that is a concern, and an important part of our priorities is how do we counter

the genetic manipulation of microbes?

Senator SPECTER. Before turning to Senator Harkin for his line

of questioning, let me say—I have been advised that C-SPAN is

starting to carry our hearing live—that we are conducting a hearing, the fourth in a series by this subcommittee, on the potential

of bioterrorism, and our focus today is on the issue of smallpox, and

we have two experts with us at the moment, Dr. Gerberding from

the Center for Disease Control, and Dr. Fauci from the National

Institutes of Health, and we are going over the areas of risk of

smallpox, the items of risk of other potential bioterrorism items for

attack, what progress has been made, and what needs to be done

for the future.

At this time, let me yield to my distinguished colleague, Senator

Harkin.

Senator HARKIN. Mr. Chairman, thank you again for your leadership on this committee, and for your leadership especially in the

whole area of meeting our needs in public health.

As you indicated, we have worked closely together on this. This

is truly one of those issues that transcends any kind of party lines,

and, again, I would just thank you for continuing this effort to ensure that our public health sector in this country is reinvigorated

and rebuilt.

I think we discovered after September 11 that our public health

facilities in America had been neglected for far too long, and we as

a Congress and the President have committed ourselves to rebuilding and reinvigorating that public health structure throughout the

United States. We have provided the funds to do so, and I believe

there is a commitment here to continue to provide whatever funds

are necessary to upgrade and ensure that our public health facilities around America are first-class, and are ready to meet present

needs, but any emerging needs that we might have in the public

health sector.

I want to thank you, Dr. Gerberding, for your leadership in this

area as the head of the Center for Disease Control and Prevention,

and you, Dr. Fauci, for your many years of service to this country

at NIH.

There is a lot of concern, I think, amongst us here, and in my

State, that the funds that we have provided for upgrading our public health facilities are now going to be needed or siphoned off to
21

meet this proposal to vaccinate against smallpox on this broad

basis that we are talking about. I think the decision has been made

to move in that way, but where is the money coming from that will

provide the support for the vaccinations?

I find a lot of concern that our State Public Health Directors are

saying:

‘‘Wait, you have just given us the money to start upgrading our facilities. We are

doing that now. Now we have to slow that down, or stop that, and siphon money

off of that for smallpox vaccination.’’

I guess I would ask you, Dr. Gerberding, to comment on that.

How much money are we talking about total that we are going to

need for the phase 1 for all the first responders, and if we do decide

to go into phase 2—I do not think that has been decided yet, has

it? Phase 1 and 2 have been decided. How much are we talking

about, in terms of total amounts of money, is that going to cost?

Do we have any idea? Can you tell us?

Dr. GERBERDING. This is a very difficult question. I appreciate your asking it. We did put out the $1.1 billion this year for general

public health preparedness for terrorism and other threats, and

when we put that money out, we were not prepared to implement

the vaccination program with those dollars, and so we have to look

at what investments have we made that can contribute to this program, and are there gaps in what we have put out, and what is

really needed to bring this program forward?

We are providing the vaccine free. We have invested in infrastructure and things like how to deliver the pharmaceutical stockpile, how to train clinicians to be prepared, and so forth, and we

have looked at some of the estimates that our colleagues in the

States have provided us. At CDC, we did an economic assessment

which looks at the indirect and direct costs of the program to get

some handle on this, but it is very, very difficult to know, mainly

because we have never done this before.

If we look just at what it costs to actually deliver the vaccine to

people, to get it into people’s arms when they come to a clinic, we

think that the cost-per-injection is somewhere between $10 to $15,

and for planning purposes, we are using the figure of $13, but that

estimate is made on the assumption that the money we just put

out, plus the $918 million we expect we will probably be able to put

out in August with the next installment of the appropriation from

this committee, that we will be able to use that infrastructure to

support this program, and we will have to monitor this and look

at it as we go forward to identify any gaps.

Senator HARKIN. That figure you just gave me is a little bit better than what I have heard in the past, I must admit. I mentioned

in a statement on the floor of the Senate here within the last couple of weeks in talking about this, I was looking at the cost, and

it hit me that some of the figures I had been seeing of several hundred dollars a person just seemed to me to be way out of line with

what it might cost to vaccinate someone for smallpox.

I hope we get a better handle on this, on just what we are talking about in terms of cost, and what we might have to help reimburse the States, or get money out to the States to help them afford this, but whatever it is, I do not want the—I think this is

something we are going to have to deal with separately and apart
22

from the funding that we have already put out for the upgrading

of facilities and to meet the bioterror, other threats we have out

there that Senator Specter just talked about, and that you have

talked about, Dr. Fauci. It has to be a separate type of thing targeted just for smallpox.

Dr. Fauci, this is a question I have about an article that appeared in The Washington Post about protecting against smallpox,

and it says here, ‘‘who should not be vaccinated,’’ and obviously,

people with weakened immune systems, breast-feeding mothers,

younger than 18 years of age.

Dr. FAUCI. Right.

Senator HARKIN. Is that right? I mean, children should not be

vaccinated?

Dr. FAUCI. Right now, if you look at the program as it is constituted, health care workers, military, others, children are not included in that. In the case of an emergency, were we to get hit by

a smallpox massive attack and we instituted a combination of the

ring vaccination with the contacts as well as an extensive, Nationwide vaccination, we certainly would vaccinate children less than

18 years old.

We are talking about the situation right now with the vaccine as

it is being used.

Senator HARKIN. Oh, I see. It is not that they are at any special

risk, because obviously, when I got vaccinated against smallpox I

was in grade school.

Dr. FAUCI. We all were vaccinated as children, but currently the

vaccine we are using right now, for the purposes we are using it

right now, is not going to be involving children.

Senator HARKIN. It is not a medical situation, then, in other

words?

Dr. FAUCI. Well, certainly if you get to infants less than 1 year

old, the problem with infants zero to 1 is higher than that in individuals who are older, but the difference between a 17- or 18-yearold and a 21-year-old is essentially nonmeasurable.

Senator HARKIN. I understand. Okay. I did not understand. I

think I understand. Thank you very much, Doctor.

Senator SPECTER. Thank you, Senator Harkin.

Senator Murray.

Senator MURRAY. Well, thank you, Mr. Chairman. I think everyone here, particularly in this Capitol Building, is certainly aware

of bioterrorist attacks after the anthrax situation that occurred a

year ago, and we understand that prevention is important, and we

understand the impacts of any kind of bioterrorist attack.

As I go out into my communities across Washington State, many

people are expressing real deep concern to me about the risks of

vaccinating a population in whole today, and I know that we are

just looking at our first responders at this point and health care

people who may be exposed early on, but there is a huge question

in the minds of many of what kinds of risks we are taking, and

what the real risk of a smallpox infection could be.

We all understand it is a horrible disease. We do not want to see

any kind of attack occur that would harm our populations, but the

question I get all the time is two-fold: What is the risk of this happening? And second: How are we going to pay for its implementa-
23

tion? There is serious concern in all of my communities—small,

rural, suburban, urban—how they are ever going to be able to pay

for this without funding from us, so let me start with the risk.

I think we all really want to know what are the real risks of a

smallpox attack? Is this something that could potentially end up in

the hands of terrorists? Can it be weaponized? Are there more

sources than we know? I know there are two known sources, one

in Atlanta, and one in Moscow. Are there more than that?

Can either one of you give me a solid answer of what is the real

risk of a smallpox attack in this country?

Dr. GERBERDING. I can try to address part of your question. We

cannot give you an absolute quantitation of the risk, but I do not

think anyone can tell you what is the quantitative probability of a

smallpox attack, and I cannot discuss all of the details because

some of the information is, of course, classified, but I think our

reading of the intelligence that we share with the intelligence community is that there is a real possibility of a smallpox attack from

either nations that are likely to be harboring the virus, or from individual entities such as terrorist cells that could have access to

the virus.

So we know it is not zero, and I think that is really what we can

say with absolute certainty, that there is not a zero risk of a smallpox attack and, as Dr. Fauci pointed out, the disease is so terrible,

and anyone in our country under the age of 30 basically has absolutely no immunity to this at all, that should an attack occur, it

would be absolutely devastating situation for us, and we have to

get our response capacity organized so that should that unthinkable thing happen, we would be able to take the steps we need to

very quickly protect our entire country.

We are not recommending immunizing the entire country right

now, because there are hazards from the vaccine, and the balance

right now in the President’s perspective, and he did a very thorough job of assessing all of the risks and benefits and complications

of this policy, the conclusion was at this point in time the risk is

not sufficient to justify exposing the entire population to the side

effects, but we did need to step up to the plate and get our emergency response capacity ready to go should we need it.

Dr. FAUCI. Senator Murray, one other issue, just to answer another part of your question, I agree, we cannot quantify in any accurate way whatever what the risk is, we just cannot, but you

asked a question about, can it be weaponized. At the time that the

smallpox epidemic, pandemic was declared eradicated, and the

WHO asked all of the nations who have supplies of smallpox to either turn it in or destroy it, and there were two, as you mentioned

accurately, one in the Soviet Union and one in Atlanta.

The fact is, in the 1970s and 1980s, we know, absolutely documented, that the Soviet Union was mounting a massive biowarfare

campaign and making dozens of tons of weaponized smallpox, so

the answer to your question of, Can it be weaponized, the answer

is, Yes, it can. Yes, it can. Yes, it has been in the past.

Supposedly, those stores have been destroyed, but one of the concerns, again with no definitive evidence, is that if you have dozens

and dozens of tons of documented, made smallpox biowarfare at the

time of the dissolution of the Soviet Union, when many of those sci-
24

entists and technicians were in some economic difficulties, the

question always arises, could there have been a possibility that

some of that material got out of the hands of the guards within the

Soviet Union and happened to get into the hands of people who

would use it in nefarious way?

I do not have any definitive intelligence that says that happened,

but that is not an unreasonable possibility, since it is so easy to

grow, and relatively easy to put in a form where you could make

large quantities.

Senator MURRAY. Okay. So you can definitively say there are

risks in not moving forward in some kind of vaccination?

Dr. FAUCI. Yes.

Senator MURRAY. But you can also definitively say that there are

risks in vaccinating our population at the present time, and even

on your own web site, you say who should not be vaccinated. I

think Senator Harkin said those under 18, pregnant women, nursing women. The risks associated with vaccination are clear as well.

Some of the concerns I am hearing are it is not just the person

who is vaccinated, but if they go home, they could infect someone

they live with. Is that a real possibility?

Dr. FAUCI. Yes. That is called contact vaccinia, where someone

gets vaccinated. That is almost exclusively, though not exclusively,

but almost always happens in a situation where someone would go

home in household contact of a child who is vaccinated, who passes

it on to a sibling in the house, or someone who is vaccinated, and

might pass it on to someone with whom they have close contact,

like——

Senator MURRAY. A spouse to a pregnant woman.

Dr. FAUCI. Yes. That is an unusual situation, but it is not impossible. We have to realize that there is a risk, though it usually is

when you vaccinate children, not exclusively. That is something

that we do recognize when we engage in these programs.

Senator MURRAY. Knowing what that risk, then is, what are we

doing to educate those who are now responsible in thousands of

communities across the country who are being told now to vaccinate? How do we educate them, educate the people who are receiving vaccinations to make sure that we eliminate or as closely

as possible reduce the risks associated with vaccination?

Dr. GERBERDING. We are taking many steps to educate a variety

of target populations, but let us just start with the vaccine volunteers, the people who are considering whether they are able or willing to participate in this program. We have several different methods. We are using satellite broadcasts, we are using written materials, we are using webcasts, we are also training the clinicians. We

are encouraging them to engage in conversations about their own

personal risk and their hazard. We are preparing to distribute 31⁄2

million copies of the important elements of this program to clinicians around the United States so that all of the nurses and doctors who might be asked questions or provide consultation will

have that information.

We are also working with the public health system and all of the

people putting together these clinics so that they can train others.

We have put this kind of information in the hands of over 800,000
25

people so far, and we are working on expanding that even further

as we speak.

Today, for example, we are initiating a program to help clinicians

working in the vaccine clinics be able to run the clinic and recognize the adverse events of the smallpox vaccine.

Senator MURRAY. Mr. Chairman, I know my time is up. I would

just say it is a long ways from Washington, DC to counties out in

my State and rural communities, and a lot of steps along the way,

and it is incredibly important that we spend the time to make sure

people get the information so they can make good decisions about

themselves. That has to be a part of that. I was not able to ask

about cost, but that is an associated cost as well that we need to

understand.

Thank you, Mr. Chairman.

Senator SPECTER. Thank you, Senator Murray.

Senator Landrieu.

OPENING STATEMENT OF SENATOR MARY L. LANDRIEU

Senator LANDRIEU. Thank you, Mr. Chairman. I do have a statement to submit for the record. I will just make three very brief

points, and I am, of course, interested in hearing from the panel.

First of all, although it is not the actual subject of our subcommittee, I do think that this whole issue should focus the Congress more directly on the nonproliferation issues. We have focused

for many years on nonproliferation of nuclear weapons, but there

have been calls in this committee. The subject of this committee

should remind us and reenergize us into the issue of nonproliferation of biological and chemical weapons. It is one thing to deal with

the consequences of an attack. It is another thing to spend some

money on the front end in energy preventing the attack by identifying these materials and really investing on the front end, which

is not the subject of this subcommittee, but is the subject of the Appropriations Committee generally, and how our resources as a Nation are being used.

Second, I would hope, Mr. Chairman, that our committee would

be committed to picking up as close to 100 percent of this cost as

possible for the States who are strapped budgetwise. This is part

of our sort of defense as a Nation. I hope that we do not go into

this looking at a 30–70 match, or a 50–50 match. Just like we pick

up about 100 percent of the cost of our military, I think the Federal

Government has a real obligation to try to minimize the cost and

then pick it up as much as possible.

Third, what comes to mind on this subject is the fairness of our

distribution system. It reminds me of the Titanic. When the boat

or the ship hit the iceberg, you know, I remember the movie so

clearly about all the wealthy people got the lifeboats and the poor

people were locked in the lower part of the boat, and ever since I

saw that movie, even as a young child, it was quite disturbing, and

that view still stays in my mind.

So this distribution system, should an attack occur and we cannot rely on the fairness and equity of the health care system—

there are some communities that have lots of nurses, lots of doctors, lots of hospitals, and lots of clinics, and then there are plenty

of places, many of them in Louisiana, who have not seen a doctor
26

in a long time and have to actually recruit nurses to their communities. So this is a huge, huge undertaking for us to try to make

sure that everyone is treated not according to the size of their pocketbook in the event of an attack, or their social status in their community, and it is a tremendous obligation we have, so I hope we

will really think very carefully about that particular issue as we

lay out and appropriate the funds.

PREPARED STATEMENT

The final point I want to make is with the turnover of our personnel, because the pay is usually low, people come in and out of

our health care system all the time. I hope we are setting up a national certification, so whether you were trained as a nurse, but

then went into another business, if an attack hits, there is a database available of people who have been trained and they can be

called from other professions to the front lines, because that is

what it is going to take, and that is going to take a whole rethinking of how we do training and certification, and it becomes sort of

lifelong certification in the event, because we are in this for the

long run.

Mr. Chairman, those are some of my thoughts.

[The statement follows:]

PREPARED STATEMENT OF SENATOR MARY L. LANDRIEU

Mr. Chairman, given that just four days have passed since the thirty-seventh

Superbowl, an event that has become as much a part of America as apple pie, I

thought it would be appropriate to begin my remarks this morning with a tried and

true adage from the world of sports, ‘‘the best defense is a good offense.’’ This certainly proved true for this weekend for the Tampa Bay Bucks and I think that it

applies equally well to the subject at hand. Yesterday, in his State of the Union

Speech, President Bush warned, ‘‘we must assume that our enemies would use these

diseases as weapons and we must act before the dangers are upon us.’’ The evidence

suggests that he is right. I, for one, intend to do all that I can to ensure that America stands ready and that our people are protected.

As this committee knows, through the efforts of the Department of Health and

Human Services and our state and local officials, America has stockpiled enough

vaccine to inoculate our entire population in the event of a smallpox attack. Let that

be a message to those who wish to harm us that we are ready to respond quickly

and effectively to this emergency. The next step, of course, is to ensure that our plan

for delivery of this vaccine is both safe and effective. As a member of the Armed

Services Committee, I was briefed extensively about the dangers of mass hysteria

in an event of this nature. Through careful planning and federal, state and local

cooperation, we can safeguard the health and safety of all Americans.

I would like to personally thank and commend all of those volunteers who have

come forward to form the Smallpox Response Teams. Once again, it is the men and

women of our law enforcement, our doctors, nurses and other first responders who

will help form the first line of defense in this war against terror. Because of you

and the men and women of our Armed Forces, Americans can sleep easier tonight

knowing that there are people who stand ready to protect them and the freedoms

they love.

That being said, I have two concerns that I think need to be discussed further

this morning. First, I think it is imperative that the CDC evaluate more fully investigate the rate of serious reactions, the effectiveness of current warnings on the

risks of being vaccinated, and consider creating a smallpox vaccination compensation fund, which exists for other vaccines but not for smallpox. Without a reasonable

way to reimburse people for their expenses and protect them from undue harm as

a result of the vaccination, people may decline to be vaccinated, thus undermining

the effectiveness of the program.

Second, I am concerned about whether enough thought has been given to the additional cost these vaccination efforts will place on our already struggling state, local

and hospital budgets. Under the President’s plan, 10.5 million people are scheduled
27

to be vaccinated in the next few months. This is yet another example of the President’s apparent budget policy, ‘‘I say, they pay.’’ Protecting the nation from a small

pox attack and effectively managing a small pox crisis should, God forbid, one occur,

is the responsibility of the federal government. Therefore, I think that we should

be prepared to pick up 100 percent of this cost and not shift this burden to the

States.

Finally, I think a lot more thinking has to go into how this plan will be implemented in the event of an attack. Knowing what I do about the vaccination process,

it appears to me that it is an enormous task we are undertaking. I think that we

must think about the many different communities that could be affected. Most importantly, I hope that we ensure that all Americans, regardless of the socio-economic

status, age, or education, will have access to being vaccinated. This calls to mind

the example of the Titanic, when they reached a crisis point, it was the wealthy who

got the life-boats, the poor were left to die. I hope we will not repeat that mistake

in the event of a bio-terrorist attack.

Again, thank you Mr. Chairman for calling this important hearing. I look forward

to hearing from the panels.

Senator SPECTER. Thank you very much, Senator Landrieu.

We are going to move ahead to the second panel, but we would

like for both Dr. Gerberding——

Senator HARKIN. Can I ask one follow-up question, please?

Senator SPECTER [continuing]. And Dr. Fauci to stay.

Senator Harkin, I am suggesting coming back to the witnesses.

We have another panel with five witnesses, and my preference

would be to call the next panel and then to ask Dr. Gerberding and

Dr. Fauci to stay.

Dr. Gerberding, for example, has a vaccine kit which she wants

to demonstrate, and we will come back to you, but I would like, as

a matter of sequence, to proceed with the other witnesses.

Dr. GERBERDING. Thank you.

Senator SPECTER. We will call the second panel now: Dr. Brian

Strom, Dr. Louis Bell, Mr. Patrick Libbey, Mr. James August, Ms.

Jane Colacecchi.

STATEMENT OF BRIAN STROM, M.D., M.P.H. CHAIR, INSTITUTE OF

MEDICINE COMMITTEE ON SMALLPOX VACCINATION, DIRECTOR, CENTER FOR CLINICAL EPIDEMIOLOGY AND BIOSTATISTICS, UNIVERSITY OF PENNSYLVANIA

Senator SPECTER. Our first witness here, Dr. Brian Strom, is

Chair of the Institute of Medicine Committee on Smallpox Vaccination, which earlier this month released a report advising CDC on

its implementation of the vaccination program. Dr. Strom is also

professor and Chair of the Department of Biostatistics and Epidemiology at the University of Pennsylvania, received his M.D. from

Johns Hopkins and his master’s of public health from the University of California at Berkeley.

Dr. Strom, welcome, and we look forward to your testimony.

Dr. STROM. Thank you, Mr. Chairman. Good morning, Mr. Chairman and members of the subcommittee. Thank you for the opportunity to come to speak with you this morning. As mentioned, my

name is Brian Strom. I am professor and chair of the Department

of Biostatistics and Epidemiology and professor of medicine at the

University of Pennsylvania School of Medicine. I am also chair of

the Institute of Medicine Committee on Smallpox Vaccine Program

Implementation.

The Institute of Medicine and the National Academies is an independent, nongovernmental, nonprofit organization operating under

the 1863 congressional charter to the National Academy of
28

Sciences. The Institute of Medicine has provided advice to the Nation on matters of health and medicine for over 30 years. The Centers for Disease Control and Prevention formally engaged the services of the Institute of Medicine in September 2002, and the Committee on Smallpox Vaccination Program Implementation met for

the first time in December 2002.

The committee’s areas of expertise include internal medicine, infectious diseases, including smallpox disease and smallpox vaccination, dermatology, pediatrics, nursing, epidemiology, public health

law and ethics, public health practice, emergency medicine, and

pharmacology. CDC charged the IOM committee with providing advice to CDC and its public health partners on how to best implement the President’s policy on pre-event smallpox vaccination, addressing eight areas.

The IOM agreed to provide advice on these areas through a series of timely reports. During its first meeting in late December

2002, the committee heard from CDC, the Department of Defense,

Israel’s Ministry of Health, and representatives of health professional organizations. The information provided during these presentations and subsequent research were the basis for the committee’s deliberations. Based on these deliberations, the committee released its first letter report on January 17, 2003, entitled: ‘‘Review

of the Centers for Disease Control and Prevention’s Smallpox Vaccination Program Implementation.’’

The committee would first like to convey its appreciation for the

hard work of CDC and its State and local partners in planning the

pre-event smallpox vaccination program and helping it to become

operational so quickly. CDC has done a tremendous job under very

tight time lines. The committee also recognizes that this is a program that is planned nationally but implemented locally. CDC is

offering guidance, training, and assistance to its State and local

public health partners, but the local programs will be making their

own decisions about how and when to operationalize the pre-event

smallpox vaccination programs in their communities.

Our report contains 23 recommendations which are summarized

in appendix A of the report, and it has been submitted for the

record. For the sake of time, I will not discuss all 23 recommendations during my testimony, but would direct you to the full report

for a complete description. I will now focus on the committee’s four

key messages, and draw attention to a few of its recommendations.

The first key message was to highlight the unique nature of the

smallpox vaccination program as a public health component of a

national bioterrorism preparedness policy focusing on the delivery

of clear, consistent, science-based information. The committee believes that it is critically important to stress to potential vaccinees

and to the public that the pre-event smallpox vaccination program

is not a typical public health program.

Public health vaccination programs are typically undertaken

knowing the risks of a disease and knowing they outweigh the risk

associated with the vaccination. With the pre-event smallpox vaccination program, the risk of the disease is based on a risk estimate derived by the President and his advisors based on national

security issues. In this context, the individuals being asked to take
29

this vaccine are being asked to volunteer to join smallpox response

teams for the benefit of the Nation’s bioterrorism preparedness.

The committee believes that the unique aspects of the pre-event

smallpox vaccination program need to be communicated clearly and

consistently to the American public. Because the smallpox vaccination program is unusual, it is important for the American public to

understand that practices in these circumstances might differ from

those of traditional vaccination programs. A clear understanding of

the risks and unique aspects of the pre-event smallpox vaccination

program will be necessary to ensure that all potential vaccinees

can make an informed decision about whether or not to participate.

Our second key message was to proceed cautiously, allowing continuous opportunity for adequate and thoughtful deliberation, analysis, and evaluation; embark on phase 2 only after adequate evaluation of phase 1 has occurred. The current program is designed

with the best possible efforts in the limited time frame available,

but on the basis of data that are decades old. Our scientific approaches have improved since then, and our society has also

changed since then. This means that, as modern experience is

gained, rapid and real-time mid-course corrections may be necessary.

I would like to stress that, by recommending that CDC proceed

cautiously, the committee never implied that CDC was proceeding

too quickly, or without due caution, as has been somewhat misstated in some of the press reports on the committee recommendations. The committee did not recommend that the vaccination program be delayed or slowed down. The committee only encouraged

CDC to facilitate local implementation at the pace that safety

would allow. CDC has acknowledged that these are its intentions,

and the committee believes that CDC will proceed accordingly.

I would also like to stress that we have not recommended any

specific time interval that is appropriate between the two phases.

This is a matter of data analysis, not strictly a matter of time. Recognizing that the CDC has indicated that data analysis will be ongoing throughout phase 1, the time needed to analyze phase 1 data

and evaluate the adequacy of different components of the program

before embarking on phase 2 may range from hours, to weeks, to

months. The committee believes that CDC will be able to determine

when enough data analysis has occurred to commence phase 2 safely.

Our third key message was to use a wide range of methods for

proactive communication, training, and education, and to customize

it to reach diverse audiences, including potential vaccinees, all

health——

Senator SPECTER. Dr. Strom, could you sum up at this point? You

are over time at this juncture.

Dr. STROM. Sure. I will skip through, sure—all health care providers and the general public. Our last message was to designate

one credible, trusted scientist as a key national spokesperson for

the campaign and to sharpen and expand communication plans.

The spokesperson could be Dr. Gerberding herself, certainly an articulate and credible scientist, or someone else.

Last, I just wanted to make a statement about compensation.

Since current discussions about the pre-event campaign are focus-
30

ing on the issue of compensation for medical expenses or lost income for any health care workers who experience adverse reactions, I wanted to highlight the committee’s recommendations

there.

First, we felt that the informed consent forms need very explicit

notification of the availability, or lack thereof, of compensation for

adverse reactions.

Second, we thought that some adverse reactions would be covered by State Worker’s Compensation, but others might not. There

needs to be clarification about that.

Last, we were concerned that the lack of compensation for adverse reactions might imperil the ability of the pre-event campaign

to achieve its goal of preparedness. There are currently no data to

determine that, but we recommended that if it is determined that

a lack of compensation is jeopardizing overall progress, then the

CDC, HHS, and Congress should support all efforts to bring the

issue of compensation for adverse reactions to speedy resolution.

PREPARED STATEMENT

Thank you for the opportunity to speak to you today. The committee hopes that its advice is useful to CDC and the broader community. I would be happy to answer any questions you may have.

[The statement follows:]

PREPARED STATEMENT OF DR. BRIAN L. STROM

Good morning, Mr. Chairman and members of the Subcommittee. Thank you for

the opportunity to come speak to you this morning. My name is Brian Strom. I am

Professor and Chair of the Department of Biostatistics and Epidemiology and Professor of Medicine at the University of Pennsylvania School of Medicine and Chair

of the Institute of Medicine (IOM) Committee on Smallpox Vaccination Program Implementation. The Institute of Medicine of the National Academies is an independent, non-governmental, non-profit organization operating under the 1863 congressional charter to the National Academy of Sciences. The Institute of Medicine

has provided advice to the nation on matters of health and medicine for over 30

years.

The Centers for Disease Control and Prevention (CDC) formally engaged the services of the Institute of Medicine in September 2002, and the Committee on Smallpox

Vaccination Program Implementation met for the first time in December 2002. The

committee’s areas of expertise include internal medicine, infectious diseases (including smallpox disease and smallpox vaccination), dermatology, pediatrics, nursing,

epidemiology, public health law and ethics, public health practice, emergency medicine, and pharmacology.

CDC charged the IOM committee with providing advice to CDC and its public

health partners on how to best implement the President’s policy on pre-event smallpox vaccination, addressing the following eight areas:

1. the informed consent process;

2. contraindications screening;

3. the system in place to assess the safety profile of the smallpox vaccine;

4. guidance for the treatment of vaccine complications;

5. professional training programs CDC is developing;

6. the communications efforts;

7. guidance CDC offers to states in developing their implementation plans; and

8. overall progress at achieving the goals of the program.

The Institute of Medicine agreed to provide advice on these areas through a series

of timely reports.

During its first meeting December 18–20, 2002, the committee heard from CDC,

the Department of Defense, Israel’s Ministry of Health, and representatives of

health professional organizations. The information provided during these presentations and subsequent research were the basis for the committee’s deliberations.

Based on these deliberations, the committee released its first letter report on Janu-
31

ary 17, 2003, titled ‘‘Review of the Centers for Disease Control and Prevention’s

Smallpox Vaccination Program Implementation.’’

The committee would first like to convey its appreciation for the hard work of

CDC and its state and local partners in planning the pre-event smallpox vaccination

program and helping it to become operational so quickly. CDC has done a tremendous job under very tight timelines.

Before getting into some of the committee’s recommendations and key messages,

I would like to point out that the committee realizes that while it had been working

on the report, CDC had been moving ahead with plans for the vaccination program.

Thus, the committee recognizes that CDC may have already accomplished some of

the recommendations laid out in our report.

The committee also recognizes that this is a program that is planned nationally,

but implemented locally. CDC is offering guidance, training, and assistance to its

state and local public health partners, but the local programs will be making their

own decisions about how and when to operationalize the pre-event smallpox vaccination program in their communities.

The report contains 23 recommendations, which are summarized in Appendix A

of the report. For the sake of time, I will not discuss all 23 recommendations during

my testimony, but would direct you to the full report for a complete description of

the recommendations, which I am submitting for the record. I will now focus on the

committee’s four key messages and draw attention to a few of the recommendations.

Our first key message was: Highlight the unique nature of the smallpox vaccination program as a public health component of a national bioterrorism preparedness

policy, focusing on the delivery of clear, consistent, science-based information.

The committee believes that it is critically important to stress to potential

vaccinees and the public that the pre-event smallpox vaccination program is not a

typical public health program. Public health vaccination programs are typically undertaken knowing the risks of the disease, and knowing they outweigh the risks associated with the vaccination. With the pre-event smallpox vaccination program, the

risk of the disease is based on a risk estimate derived by the President and his advisors, based on national security issues. In this context, the individuals being asked

to take this vaccine are being asked to volunteer to join smallpox response teams,

for the benefit of the nation’s bioterrorism preparedness. The committee believes

that the unique aspects of the pre-event smallpox vaccination program need to be

communicated clearly and consistently to the American public. Because the smallpox vaccination program is unusual, it is important for the American public to understand that practices in these circumstances might differ from those in traditional

vaccination programs. A clear understanding of the risks and unique aspects of the

pre-event smallpox vaccination program will be necessary to ensure that all potential vaccinees can make an informed decision about whether to participate.

Our second key message was: Proceed cautiously, allowing continuous opportunity

for adequate and thoughtful deliberation, analysis, and evaluation. Embark on phase

II only after adequate evaluation of phase I has occurred.

The current program is designed with the best possible efforts in the limited time

frame available, but on the basis of data that are decades old. Our scientific approaches have improved since then, and our society has also changed during this

time. This means that, as modern experience is gained, rapid and real-time midcourse corrections might be necessary.

I would like to stress that by recommending that CDC ‘‘proceed cautiously,’’ the

committee never implied that CDC was proceeding too quickly or without due caution, as has been somewhat misstated in some of the press reports on the committee’s recommendations. The committee did not recommend that the vaccination program be delayed or slowed down. The committee only encouraged CDC to facilitate

local implementation at the pace that safety would allow. CDC has acknowledged

that these are its intentions, and the committee believes that CDC will proceed accordingly.

I would also like to stress that we have not recommended any specific time interval that is appropriate between the two phases. This is a matter of data analysis,

not strictly a matter of time. Recognizing that the CDC has indicated that data

analysis will be ongoing throughout phase I, the time needed to analyze phase I

data and evaluate the adequacy of different components of the program before embarking on phase II (such as screening guidelines and surveillance for adverse reactions), may range from hours to weeks to months. The committee believes that CDC

will be able to determine when enough data analysis has occurred to commence

phase II safely.

One way to evaluate the adequacy of different components of the program would

be to take advantage of differences in the way that public health departments and

hospitals administer their local smallpox vaccination programs. Because local vac-
32

cination programs will be making their own decisions about the types of bandages

to use, specific site care instructions, adverse reaction investigation, degree of patient contact allowed, and whether to grant administrative leave to vaccinated

health care workers, the committee urged CDC to utilize and analyze these data before embarking on phase II.

Our third key message was: Use a wide range of methods for proactive communication, training, and education, and customize it to reach diverse audiences, including potential vaccinees, all health care providers, and the general public.

The committee heard evidence that there is much confusion about smallpox disease, the vaccine, and the details of the vaccination program. The committee strongly believes that clear, consistent communications to many different types of audiences is intrinsic to the success of the pre-event smallpox vaccination program.

Given the potential for misinformation and confusion, and the complexity of vaccine

information, it is necessary to begin a campaign of informing and educating the general public as soon as possible. Waiting until reports of serious adverse reactions

surface is too little too late. Communicating in a time of crisis can only be effective

if adequate communication and education have occurred during preparedness planning.

Our last key message was: Designate one credible, trusted scientist as key national

spokesperson for the campaign and sharpen and expand communication plans and

strategies to ensure rapid, transparent, and sustained contact with the media

throughout implementation.

For the public to maintain confidence in the pre-event smallpox vaccination program and CDC, the committee believes that it is important for CDC to speak from

its strength—the science of public health. Discussion of national security matters is

best left to national security experts. The public’s confidence in the vaccination program will be strengthened by the availability of a key scientific spokesperson who

can provide credible and consistent information in a manner that is easily understandable to many different audiences. The spokesperson could be Dr. Gerberding

herself, certainly an articulate and credible scientist, or someone else.

Since current discussions of the pre-event smallpox vaccination program are focusing on the issue of compensation for medical expenses or lost income for any health

workers who experience adverse reactions from the smallpox vaccine, I will highlight the committee’s recommendations that relate to this issue.

Although not specifically identified as an item for our deliberation, the committee

did believe strongly that we needed to address the issue of compensation since it

could have implications to the issues of informed consent and progress at achieving

the overall goal of the program (that being increasing the nation’s bioterrorism preparedness), both of which are clearly within our mandate.

The committee recommended that informed consent forms include explicit notification of the availability—or lack thereof—of compensation for adverse reactions.

The committee was concerned that many potential vaccinees may falsely assume

that the provisions of the Homeland Security Act of 2002 or the federal Vaccine Injury Compensation Program would provide compensation for medical expenses or income loss experienced as a result of receiving or being exposed to the smallpox vaccine (when there are no instances of negligence). This information may be an important factor that could weigh on a potential vaccinee’s decision about whether to receive the vaccine.

The committee also recognized that some adverse reactions experienced by

vaccinees may be covered by state worker’s compensation programs. However, there

is much uncertainty and confusion surrounding the types of vaccine adverse reactions and circumstances leading to those adverse reactions that would be coverable

under each state’s worker’s compensation law. Because of this, the committee recommended that CDC and its state and local public health partners work to clarify

the scope of worker’s compensation for adverse reactions to the smallpox vaccine.

The committee was also concerned that the lack of compensation for adverse reactions might—I stress, ‘‘might’’—imperil the ability of the pre-event vaccination program to achieve its goal of preparedness to respond to a smallpox attack. There currently are no data to determine whether or not the lack of compensation for adverse

reactions is indeed a deterrent to receiving the vaccine. However, the committee recommends that IF it is determined that lack of compensation is jeopardizing overall

progress at achieving the goals of the program (which is an item in our charge),

then CDC and the Department of Health and Human Services should support all

efforts to bring the issue of compensation for adverse reactions—including those reactions that occur despite non-negligent manufacture and administration of the vaccine—to speedy resolution.
33

The committee offered many additional recommendations related to the implementation of the pre-event smallpox vaccination program. I would be happy to answer questions about any additional recommendations of interest to you.

Thank you for the opportunity to speak to you today. The IOM Committee on

Smallpox Vaccination Program Implementation hopes that its advice is useful to

CDC and the broader community concerned about the success of the pre-event

smallpox vaccination program. I would be happy to answer any questions you may

have.

STATEMENT OF LOUIS M. BELL, M.D., CHAIR, DIVISION OF INFECTIOUS DISEASE, CHILDREN’S HOSPITAL OF PHILADELPHIA

Senator SPECTER. Thank you, Dr. Strom. We now turn to Dr.

Louis M. Bell, chief of the Division of General Pediatrics at Children’s Hospital of Philadelphia, also serves as Medical Director for

the Hospital Infection Control Department at Children’s Hospital,

received his M.D. from the University of Maryland, and did his

residency at Hahnemann in Philadelphia. Thank you for joining us,

Dr. Bell, and the floor is yours.

Dr. BELL. Thank you. It is a pleasure to have this opportunity

to speak to the committee on this complex topic of smallpox vaccination and its particular impact on the pediatric hospital population. I am here today representing the physicians, nurses, and

other health care providers and administrators at the Children’s

Hospital of Philadelphia, and I will attempt to summarize a number of issues that we, as a hospital, have been considering in response to President Bush’s December 13 call to develop a voluntary

pre-event smallpox vaccination program.

The Children’s Hospital of Philadelphia is regarded as a world

leader in pediatrics. We operate the largest pediatric health care

system in the United States, handling more than 770,000 outpatient visits each year. On our main campus in Philadelphia, we

admit more than 20,000 children annually and have approximately

65,000 emergency department visits each year.

Now, I recite these statistics not to impress the committee, but

rather, to help you understand two points, first that we are fortunate to have some of the brightest people in pediatric medicine deliberating on this issue and, second, we must carefully consider the

risks and benefits of introducing smallpox vaccination into a pediatric health care environment. This is critically important, since a

high percentage of the patients we treat at the Children’s Hospital

of Philadelphia are very ill or have weakened immune systems.

Let me share with you four questions we have posed, and some

of our thinking to date. The first question: What is the risk of exposure to smallpox through bioterrorism? Fortunately, there have

been no cases of smallpox seen in the world for approximately 25

years. Based on our current information, it is difficult to ascertain

this risk at this time.

The second question is: What are the risks of smallpox vaccination in this hospital environment? To consider this side of the equation, what do we know about the vaccine? Well, we know that the

vaccinia virus, which is the virus used in the vaccine, is effective

in preventing smallpox. We know that this vaccine protects against

smallpox if a person is inoculated within days after exposure. We

know that a person who is vaccinated may spread the virus to

other people or other parts of their own body, and the vaccine certainly has its side effects, which have been outlined previously.
34

Persons with immune systems that are weakened have a greater

risk for these adverse events.

Now, the next question that we think is important, again, viewing this from the vulnerable population in a hospital, is: What is

the risk that vaccinia virus might spread from the arm of a health

care worker to a hospitalized child? An article by Kent Sepkowitz,

which will appear shortly in the New England Journal of Medicine,

reviews the spread of smallpox vaccine virus in hospitals from 1907

until 1975. The spread of this vaccine virus has been reported 12

times in that interval. Eight of the 12 reports of spread within a

hospital were in children, and in pediatric wards in children’s hospitals. Most of the time, it is spread by a health care provider who

transmits the virus on their hands to the patient.

According to this review, the chance of being infected in the hospital could be as high as 10 percent. Nine of the 85 people who

were thus infected by contact died as a result of this infection from

the vaccine virus, thus, our past experience with the vaccine shows

that there are, indeed, potential risks to this in this vulnerable

population within a hospital.

The next and final question is: Are the risks for using the smallpox vaccine in 2003 greater than they were in the 1940s and 1950s

and 1960s? Which is what we are drawing this information from,

and we think the answer to this question is yes. Due to advances

in medical treatment, both the risk and the risk pool have increased dramatically over the last 20 years. For example, children

and infants are on steroids, they are undergoing cancer chemotherapy, they are receiving kidney, heart, liver, bone marrow transplantation. All of these children are immunosuppressed.

Second, in general, we are asked to vaccinate into a pool of young

health care workers who are 30 years old or less, and who have not

been vaccinated previously.

Third, in addition to the thousands of sick children that we care

for, we may have a health care worker who is immunocompromised

actually in that environment, so therefore, weighing these risks

and benefits, the Children’s Hospital of Philadelphia does not currently recommend voluntary smallpox vaccinations for its frontline

health care workers in our institution.

Senator SPECTER. Dr. Bell, that is a very important conclusion.

Would you elaborate why?

Dr. BELL. Well, again, I think the issue is the vulnerable population that we serve, the concerns that, although perhaps not high,

there is a risk. There is a risk that this virus vaccine could infect

a severely ill or an immunocompromised child within this environment and potentially die.

Senator SPECTER. We will come back for more questions in the

Q and A, but just one follow-up at this point. You say because of

the clientele you serve. If you were not serving children, but were

serving adults, would you have a different conclusion?

Dr. BELL. Well, I think that—I am not sure that the risks are

tremendously different between the very sick adults and sick infants. However, with some of the data we have from prior, from the

1940s and 1950s and 1960s, it does seem that hospitalized children

may be at increased risk, given the reports and the review of the

data.
35

Senator SPECTER. I pursue the question with you because it is

rather startling an institution of your prestige would decline to inoculate.

Dr. BELL. Well, I think this is a point in time. We are, at this

moment, declining to do this. This is a very complicated issue. I

think new data, new changes in what we know about the risk from

the other side in terms of the risk of being exposed to smallpox will

be a day-to-day affair in how we process this.

PREPARED STATEMENT

I just want to make a point, though, that this decision in no way

diminishes our willingness to enlist our hospital staff and resources

should this unthinkable thing happen. We will be there and care

for children if this does happen, but at this point in time, weighing

these risks and benefits, and the risks to our patient population,

we have made this decision.

[The statement follows:]

PREPARED STATEMENT OF DR. LOUIS M. BELL

Good morning. It’s a pleasure to have the opportunity to speak to this committee

on the complex topic of smallpox vaccination and its particular impact on the pediatric hospital population. I am Dr. Louis M. Bell, and I have been a practicing pediatrician for almost 20 years. I am Division Chief of General Pediatrics at The Children’s Hospital of Philadelphia and Chair of the Infection Control and Prevention

Committee at the Hospital. I also hold an endowed chair in pediatric medicine at

Children’s Hospital and am co-author of a book entitled ‘‘Vaccines: What Every Parent Should Know.’’

I am board certified in both pediatric infectious diseases and pediatric emergency

medicine. For more than a decade, I have been involved in research that has focused

on vaccine education and improving vaccine delivery to urban children.

I am here today representing the physicians, nurses, health care providers and

administrators at The Children’s Hospital of Philadelphia. I will attempt to summarize a number of issues that we, as a Hospital, have been considering in response

to President Bush’s December 13, 2002 call to develop a voluntary pre-event smallpox vaccination program.

The Children’s Hospital of Philadelphia is regarded as a world leader in pediatrics. We operate the largest pediatric healthcare system in the United States, handling more than 770,000 outpatient visits each year. On our main campus in Philadelphia, Children’s Hospital handles more than 20,000 inpatient admissions annually, with approximately 65,000 emergency department visits each year. We provide

primary, specialty and home care services to children and their families in more

than 40 locations throughout Pennsylvania, New Jersey and Delaware.

In addition, The Children’s Hospital of Philadelphia is recognized as one of the

world’s leading pediatric research facilities. We rank second among children’s hospitals in National Institutes of Health funding, making us one of the largest and

most prestigious pediatric research programs in the nation.

We are also a national resource, accepting referrals from hospitals across the

United States, providing specialized cardiac care, fetal therapy, cancer treatment,

organ transplantation and other specialty services to children of all ages, from before birth through young adulthood.

I recite these statistics not to impress the Committee, but rather, to help you understand two points. First, that we have some of the best minds in pediatric medicine deliberating on this issue. Second, we must carefully consider the risks and

benefits of introducing smallpox vaccination into a pediatric healthcare environment. This is critically important since a high percentage of the patients we treat

at The Children’s Hospital of Philadelphia are very ill or have weakened immune

systems

Let me share with you some of the questions we’ve posed and some of our thinking to date.
36

MEDICAL CONSIDERATIONS

1. What is the risk of exposure to smallpox through bioterrorism?

No case of smallpox has been seen in the world for approximately 25 years. The

only known way to introduce smallpox is through bioterrorism. Based on current information, it is difficult to ascertain the risks at this time.

2. What are the risks of the smallpox vaccine?

To consider this from a risk/benefit equation, we can look back to previous experiences. What do we know about the vaccine? We know that the vaccinia virus, which

is the virus used in the vaccine, is effective in preventing smallpox. This vaccine

protects against smallpox if a person is inoculated within days after exposure. We

also know that this is a live vaccine that is inoculated on the skin. After inoculation,

the vaccine virus grows and forms a scab that falls off in 2 to 3 weeks. As long as

the scab is present, the person who is vaccinated may spread the virus to other people or to other parts of their body. The vaccine has its side effects, which are most

severe in those who have never been vaccinated previously. In addition, persons

whose immune systems are weakened or have eczema are at even a greater risk

of adverse outcomes.

Perhaps the most important question remains...

3. What is the risk that the vaccinia virus might spread from the arm of the health

care worker to a hospitalized child?

An article by Dr. Kent Sepkowitz, which will appear shortly in the New England

Journal of Medicine, reviews the spread of the smallpox vaccine in hospitals 12

times between 1907 and 1975. Eight of the 12 reports involved hospitalized children.

A total of 85 children and adults were infected by health care providers who transmitted the virus on their hands. According to this data, the chance of being infected

in the hospital could be as high as 10 percent. In fact, nine of the 85 people (11

percent) died as a result of the smallpox vaccine. Thus, our past experience with

the vaccine shows that there are potential risks to its use.

4. Are the risks for using the smallpox vaccine in 2003 greater than in the 1940s,

1950s and 1960s?

We think the answer to this question is yes. Due to advances in medical treatment, both the risks and the risk pool have increased dramatically over the last 20

years. For example, children and infants on steroids, undergoing cancer chemotherapy, or receiving kidney, heart, liver or bone marrow transplantations are immune suppressed. Second, in general, we are vaccinating health care workers who

are less than 30 years old and have never been vaccinated previously. Third, in addition to the thousand of sick children treated by our Hospital, we have healthcare

workers who are also immunocompromised.

Therefore, after carefully weighing these risks against the benefits, The Children’s

Hospital of Philadelphia does not currently recommend voluntary smallpox vaccinations for its frontline healthcare workers. This decision is based on thorough analysis of all available data, taking into account concerns about the safety and side effect profile of the vaccine for our staff as well as the potential impact on our patient

population.

As a tertiary care pediatric medical center, a high percentage of our young patient

population is immunocompromised. We are concerned that the introduction of newly

vaccinated healthcare workers could expose our patients and employees to unnecessary risks.

We recognize that this is a complicated issue. Our policy will continue to be evaluated and assessed against new data, scientific advances such as the development of

a new generation of smallpox vaccine and changes in world events.

Lastly, we wish to emphasize that this decision in no way diminishes our willingness to enlist our hospital staff and resources should the unthinkable happen and

there is a smallpox outbreak in the Philadelphia area.

OPERATIONAL CONSIDERATIONS

In addition to the medical issues raised above, healthcare institutions must also

consider a number of operational impacts.

1. Who will bear the medical cost of treating adverse reactions to the smallpox

vaccine in health care providers who volunteer to be vaccinated?

2. Taking into account that introducing the vaccine virus into a population of hospitalized children carries increased risk, should different consideration be given to

pediatric institutions?
37

3. Should administrative leave be granted for health care workers in children’s

hospitals who volunteer to be vaccinated?

4. In addition to these considerations, we recommend that a centralized database

collect information about adverse reactions which occur nationwide as a result of

smallpox vaccination. This data should be made public.

CONCLUSION

Mr. Chairman, we share the administration’s concern that the possibility of smallpox as a weapon of bioterrorism is real. We expect to participate fully in keeping

this country safe. In our daily work as physicians and scientists, we carefully weigh

the risks and benefits of keeping our patients safe.

The issue of smallpox vaccination presents a complicated picture of risks that

needs further clarification. We hope that our testimony will provide government policymakers and other healthcare institutions additional insight into the specific medical risks and operational impacts of smallpox vaccinations at pediatric hospitals.

Mr. Chairman, I am ready to respond to any questions the Committee might

have.

Senator SPECTER. Thank you, Dr. Bell. Stand by. There will be

some more questions for you.

STATEMENT OF PATRICK LIBBEY, EXECUTIVE DIRECTOR, NATIONAL

ASSOCIATION OF COUNTY AND CITY HEALTH OFFICIALS

Senator SPECTER. We turn now to Mr. Patrick Libbey, executive

director of the National Association of County and City Health Officials. He had been director of the Thurston County Public Health

and Social Service Department in Olympia, Washington. B.A. from

Evergreen College in Washington State.

Thank you for joining us, Mr. Libbey, and we look forward to

your testimony.

Mr. LIBBEY. Thank you. Good morning, Mr. Chairman, members

of the committee. As noted, I, up until 5 months ago, had served

as the director of a local health department in Washington State

for the past 17 years. I thank you for the opportunity to address

the committee from the perspective of the actual point of implementation of the smallpox vaccination program.

Ultimately, all vaccinations will be given at a community level,

most often by your local public health system. We are committed

to successfully preparing the Nation for a smallpox outbreak, but

success needs to be defined particularly in the first stage—this first

phase—as being ready to appropriately respond to an initial smallpox case and being ready to rapidly begin vaccinating in greater

numbers other first responders or the whole population if the assessment of threat is significantly increased, or should a case occur.

We believe it is prudent to assure that there is a ready capacity

of voluntarily pre-immunized people to perform disease investigation and containment, and able to treat an initial case, and ready

to begin vaccination of a larger circle of people, up to and including

the entire population.

Success also means that clinician expertise and community

awareness about smallpox disease and vaccination is improved, and

that disease surveillance is in place that can rapidly detect and respond in the event of an outbreak.

We also believe it is unfortunate that numerical goals, the use

of 500,000, the use of 10 million as figures, which were simply earlier planning projections, appear to have replaced these true measures of what successful implementation of this first stage ought to

be. It really should be a simple question: Are we ready, in the
38

event a case is discovered, or if there is significant increase in the

announcement relative to the threat?

I also am here to say, smallpox vaccination is fundamentally different from any of our other current vaccination efforts. It is not

like lining people up in a mall for a flu shot. There are three significant components to smallpox vaccination, to actually having the

ability to deliver and carry this out on a voluntary pre-event basis.

First is the necessary planning and community preparation. This

includes the identification and recruitment of vaccinees, the community and clinician education, further targeted education to specific groups, including emergency medical technicians, other first

responders, the issues of logistics, of receiving, storing, and securing the vaccine, the physical logistics, and the list goes on in terms

of what is necessary to have that community preparation.

Then there is the actual, clinical delivery of the vaccination itself.

This is the part that most people see. In this vaccination effort for

smallpox, it is much more complex in the required steps than other

vaccinations. Following the CDC clinical guidelines for a postevent, there are a number of additional steps. Intake is more complex, the informed consent process is significantly more involved, a

significant amount of screening, the administration of the vaccine

is fundamentally different, and within that clinical setting, having

to make sure that post-vaccination instructions are given and understood.

Last, there is follow-up. Unlike other vaccinations, smallpox will

require an extensive follow-up capacity. The vaccination site is recommended to be looked at daily, the take must be read, there must

be an information and triage capacity in place to respond to concerns about reactions, and that includes both what are within probably normal reactions to smallpox, but outside the normal experience of people with immunizations, as well as those that would be

considered adverse, and there must be a clear linkage and established referral pattern to treatment services in the event of an adverse. We know, by comparison, that these differences from other

vaccinations are of significance, and we have begun costing those.

Let me just—by comparison, your flu clinic, for example, requires

virtually no significant amount of community preparation, other

than generally making it known and available, promoting its availability, and there is no significant follow-up system. A well-run,

planned flu clinic, you will have a patient enter and exit in a matter of very few minutes. Well-run can be as few as 5. The same for

an emergency mass immunoglobulin clinic in the event of an outbreak of hepatitis A in a community.

The smallpox clinic, on the other hand, requires the extensive

community preparation, the follow-up capacity, and the much more

complex vaccination phase. Three weeks ago, the Arlington County

Health Department, at the request of the Secretary’s office, conducted a mock clinic, vaccinating 1,000 persons, using the CDC

clinical guidelines, and this was reviewed by an HHS-selected timemotion consultant.

It took about an hour for a potential vaccinee from the point of

entry to the point of exit to go through those necessary steps. Compare that, again, to the notion of being in and out of a flu in a matter of 5 minutes or fewer. That also includes the 30 percent of peo-
39

ple, by virtue of the system, that were screened out that were not

appropriate to be vaccinated.

With all respect to Dr. Gerberding, I must respectfully but

strongly disagree with her assessment of the cost of doing this

business. At CDC’s request, we have been costing these stages.

This is our business. This is what your local health departments

do. We have the expertise in organizing and conducting vaccination

efforts. We have now cost projections from four large metropolitan

areas throughout the country. Taking these particular stages apart,

and comparable activities, cost range currently for all three stages

runs from a low of $142 to a high of $222.

In Arlington County, the mock clinic that I had mentioned, for

the vaccination stage only, not even setting it up, not the pre-community or post-follow-up, the costs that they came out of that with,

reviewed by their HHS consultant, was about $100 per person

through that.

What you see when you get a vaccination, and what it takes to

do a vaccination, are not the same, and it is very easy for us to

think from our own vaccination experience.

I must also tell you that local health departments are diverting

staff and funding from other bioterrorism preparedness efforts to

work almost exclusively on smallpox vaccination. We know from a

recent survey that local public health departments have made significant progress over the last year in improving their overall readiness, and most of this, frankly, can be attributed to the Federal

resources that you collectively have made available to improve that

readiness in the 16 critical areas Dr. Gerberding mentioned.

Senator SPECTER. Mr. Libbey, you are 2 minutes over. Could you

summarize, please?

PREPARED STATEMENT

Mr. LIBBEY. I can. Two things I would say in conclusion. We are,

in fact, diverting our bioterrorism resources, leaving us less prepared, and probably regressing in the progress we have made, and

we are also starting to clearly see a number of communities that

other public health plans, including chronic disease screenings,

cancer screenings and the like, we are starting to draw resources

from that to be able to speak specifically to smallpox. We need to

progress. We need to do it, stay small, go slow, and assure that we

have the resources to do it appropriately.

Thank you.

[The statement follows:]

PREPARED STATEMENT OF PATRICK M. LIBBEY

Good morning, Mr. Chairman and members of the subcommittee. I am Patrick M.

Libbey. I am Executive Director of the National Association of County and City

Health Officials (NACCHO). NACCHO is the organization representing the almost

3,000 local public health departments in the country. Before beginning work here

in Washington, DC last year, I served as NACCHO’s President and was Director

of the Thurston County, Washington, Department of Health and Social Services for

17 years. I have been deeply engaged in bioterrorism preparedness at both the local

and federal levels. I am here today to explain the challenges faced by local public

health agencies in implementing the President’s smallpox vaccination program and

what resources we believe are needed to meet those challenges.

NACCHO and its members are committed to doing everything within our power

to achieve success in preparing the nation for an outbreak of smallpox, should that
40

terrible event ever occur. Our definition of success is that the nation will have the

ability to identify a smallpox outbreak as soon as possible, to ramp up and vaccinate

as many persons as necessary to contain an outbreak, and to vaccinate voluntarily

every medically eligible United States resident in a safe and timely manner should

that become essential to save lives. The Department of Health and Human Services

(HHS) has recognized that the plans and systems needed to achieve this success will

vary greatly among states and localities. We fully concur with this approach. Therefore, we believe that success will not be measured in terms of numbers of persons

vaccinated in the coming months. Rather, success will be measured by the ability

of states and localities to demonstrate that there is a workable, tested plan in place

to contain any smallpox outbreak, and sufficient numbers of public health and medical care personnel vaccinated to provide care for the initial cases, to do the epidemiologic footwork that will be necessary to identify persons who have been in contact with infected individuals, and to be the first vaccinators in a mass vaccination

campaign.

SMALLPOX VACCINATION IS DIFFERENT

We in public health have long experience in successfully mounting immunization

campaigns to prevent such diseases as polio, measles, influenza, or Hepatitis A, in

both routine and emergency circumstances. Smallpox vaccination, particularly in the

absence of any known cases or known threat, is different. The live virus vaccine carries risks of side effects that are greater and more serious than the risks of any

other vaccine we use. The only purchaser of the vaccine is the federal government.

Planning, implementing, and evaluating a national smallpox vaccination program in

a way that maximizes effectiveness and minimizes risk to individuals therefore involves many more components than routine immunization programs. There is much

more to it than lining people up in a mall to get their flu shots.

A smallpox vaccination program has three basic components. The first is community preparation, which involves planning, training, and community education.

Many local public health agencies are assisting their states in identifying who

should be vaccinated. This has involved intensive work both with public health staff

and with hospitals and other health care providers, as well as the general public.

The needs for education and information have been great. Planning a vaccination

clinic includes components that would be expected for any such enterprise—identifying and arranging for a site, for security, for managing the flow of people, for staffing, for transportation and storage of vaccine and supplies, and for record-keeping.

However, the novel and riskier nature of smallpox vaccination requires additional

steps that take time and resources. There must be a communication plan to inform

the community and the media about what is taking place. Existing information technology systems may require modification to handle special requirements for followup of persons vaccinated and reporting, tracking and management of adverse

events.

The second component is actual administration of the vaccine. The Centers for

Disease Control and Prevention (CDC) has promulgated guidelines for post-event

smallpox vaccination clinics and this model is being adapted for pre-event smallpox

vaccination now. According to these guidelines, the personnel required at a clinic

site include: a registration staff; a patient education staff to provide the information

and obtain the documentation necessary to assure informed consent; medical screeners to review each prospective vaccinee’s medical history forms and interview each

person; medical assistants to prepare the vaccine and keep supplies at hand; persons trained to administer the vaccine and observe for any immediate reactions; administrative staff to assure proper record-keeping; staff to direct people and control

clinic flow; security staff; and emergency medical personnel to address any serious

medical events that might take place. All of these people must be trained in advance

to conduct their jobs safely and effectively. The Arlington County (Virginia) Public

Health Department recently conducted a mock clinic according to these guidelines

and HHS is working on an evaluation so that the guidelines can be improved. That

clinic required 80 staff on-site to serve 90–100 prospective vaccinees per hour for

eight hours.

The third stage is post-vaccination follow-up and evaluation. The job is not over

when a person has been pricked by a bifurcated needle 15 times. The Advisory Committee on Immunization Practices recommends daily checks of the vaccination sites

of health care workers to assure the site is properly dressed, to check for a proper

take, and to spot any swelling, rash, or other adverse reaction. We also fully expect

that a certain number of ‘‘worried well’’ who are vaccinated will request follow-up

assessments. It is therefore necessary to plan for and designate staff to assess vaccination takes and assess or refer suspected adverse events. In addition, there must
41

be a plan for obtaining and distributing vaccinia immune globulin (VIG), which is

used to treat adverse reactions, and a cadre of medical professionals trained to diagnose and treat adverse reactions.

IMPACT OF SMALLPOX VACCINATION PROGRAM ON LOCAL PUBLIC HEALTH AGENCIES

Implementing a smallpox vaccination program with all these components and

complexities is a tall order indeed. We believe it can be done, given sufficient time

and resources. State and local public health agencies, working with hospitals and

physicians, are doing it now and we will continue. However, the crush of the current

smallpox vaccination activity is taking a large toll on public health agencies. We do

not believe it can be sustained without serious harm to a public health system that

has already redoubled its efforts in order to improve the national’s overall public

health preparedness.

NACCHO is monitoring the local experience with smallpox vaccination and conducted a brief Web-based survey last week to determine how the program has affected local public health agencies thus far. We received responses from 718 agencies, representing a broad range in terms of the size of population served, from

under 20,000 to large metropolitan areas. A positive finding was that 37 percent of

the respondents indicated that smallpox or other bioterrorism preparedness work is

enhancing their other public health activities. We believe that this is because public

health preparedness requires building new relationships and devising new ways of

working within the community. Such new relationships—with hospitals, physicians,

emergency responders—improve the effectiveness of other public health activities,

too.

However, more than half (58 percent) reported that smallpox work is hurting

their other bioterrorism preparedness efforts. Some agencies never received bioterrorism preparedness funding and therefore are spending other funds for smallpox

vaccination. Others are rapidly spending down their bioterrorism funding on smallpox vaccination, rather than using it to fulfill many other requirements for bioterrorism preparedness described in CDC’s cooperative agreements with the states.

Our survey respondents were especially concerned about preparing to fulfill the public health role in responding to acts of terrorism using other agents, such as anthrax, ricin, or nuclear materials. This information confirms our concern that the

emphasis on smallpox vaccination is indeed beginning to compromise our ability to

prepare for other acts of terrorism. We are losing the most important potential of

bioterrorism preparedness funding, which was to help states and localities build the

capacities needed to address multiple public health threats.

It is equally alarming to us that more than one-third (35 percent) of the survey

respondents reported that smallpox already is negatively affecting other public

health programs. Public health clinics that provide such services as childhood and

influenza immunizations have been deferred, delayed, or canceled in 182 jurisdictions due to the demands of smallpox vaccination. Staff members who worked in

communicable disease control are now focusing exclusively on smallpox, causing

work such as control of tuberculosis and sexually transmitted diseases to lag. It is

important to note that these negative impacts occurred even before a single person

was vaccinated. We are gravely concerned that, if diversion of general public health

resources to smallpox vaccination continues and grows, our communities will become more vulnerable to ongoing public health threats. We will compromise our

ability to prevent and respond to influenza, childhood diseases, West Nile virus, contaminated drinking water, food-borne illness, and chronic diseases.

COSTS OF SMALLPOX VACCINATION

Early estimates of the cost of smallpox vaccination to state and local governments

were about $85 per person. We are now beginning to assess actual cost data, obtained from a small sample of jurisdictions using a template that ensures that the

costs are comparable. We have available current estimates from four large urban

public health agencies. The costs per vaccine are $142, $155, $177 and $220. They

include all planning, training, communication, data management, clinic implementation and follow-up costs. We believe that this cost range is more realistic than smaller numbers that address clinic costs only. The Arlington County Health Department’s cost per person for implementing a mock smallpox vaccination clinic using

CDC’s guidelines was about $100, a figure that does not include any of the planning

and community preparation component or post-vaccination follow-up.

If it became necessary to vaccinate a much larger group of persons than the initial

public health and medical care response teams, certain fixed costs, such as planning

and epidemiologic surveillance, would not change much and would be spread over

a larger number of individuals. Other costs, such as staff time at clinics, might in-
42

crease because more intensive education and screening would likely be required for

vaccinees who are not already trained public health or medical personnel.

We expect to obtain more extensive cost data as the smallpox vaccination program

moves forward and will be pleased to share our information with the Committee.

There clearly will be differences in cost among states and localities. However, we

believe we have sufficient information now to demonstrate that smallpox vaccination

costs are high, certainly far higher than $10 or $20 per person, and that state and

local governments do not have the resources to bear these costs for much longer.

Many local public health agencies are reporting that the amount of federal bioterrorism funds made available to them, if any, no longer covers the costs of what is

expected now to vaccinate public health and medical teams, let alone any expanded

number of vaccinees. Redirecting all our bioterrorism funds to smallpox halts our

progress in bioterrorism preparedness and leaves us increasingly vulnerable to other

agents. It is also detracting from ongoing local public health work to protect and

provide service to local communities. We strongly urge the Committee to heed these

reports from actual local public health practice and provide state and local health

departments and other parties who must also bear these costs with the funds to fulfill the President’s mandate.

There are many other current obstacles to successful implementation of smallpox

vaccination. I have attached a statement presented on NACCHO’s behalf to the Institute of Medicine Committee on Smallpox Vaccination Implementation on December 19, 2002 that addresses other issues of great importance.

Chairman Specter and Senator Harkin, you have been leaders in providing funding for public health preparedness and in recognizing that local public health departments serve on the front lines in battling public health crises of all types. We

are grateful for your continuing support. I will be happy to answer any questions

you have and to provide whatever other available information you may wish for the

record. Thank you.

Attachment.

STATEMENT OF PATRICK LIBBEY, EXECUTIVE DIRECTOR, NATIONAL ASSOCIATION OF

COUNTY AND CITY HEALTH OFFICIALS, PRESENTED TO THE INSTITUTE OF MEDICINE

COMMITTEE ON SMALLPOX VACCINATION PROGRAM IMPLEMENTATION, DECEMBER 19, 2002

On behalf of the National Association of County and City Health Officials

(NACCHO), I thank you for the opportunity to provide initial comments on the national smallpox vaccination program from the perspective of local public health

agencies. This program has multiple practical complexities. We expect that new

questions and concerns will continue to arise as states and localities gain experience. We look forward to working with the Committee on a continuous basis to identify new issues and lessons learned as implementation proceeds.

NACCHO represents the nation’s nearly 3000 local public health agencies. Many

will be involved in planning and implementing smallpox vaccination in their communities, particularly as the program extends into its second phase of vaccinating

up to ten million first responders, as the President has announced. This program

has serious and far-reaching implications for local public health practice. Our message, based on the classic admonition, ‘‘First, do no harm,’’ is straightforward. It is,

‘‘Slow down and stay small.’’

We all must respect the sense of urgency conveyed by the President. However, we

also believe that, in light of the President’s statement that there is no imminent risk

of a smallpox outbreak, we owe it to our communities to proceed carefully and take

the time to evaluate our vaccination activities as we go. We must also understand

and document clearly the consequences of the necessary diversion of resources from

other critical public health work to smallpox vaccination.

LOCALITIES NEED MORE ASSISTANCE AND FLEXIBILITY IN IMPLEMENTING SMALLPOX

VACCINATION

Planning is well underway for the initial phase of vaccinating 500,000 volunteer

medical and public health response teams. Local public health agencies that will

play a role in this phase are encountering many questions. Among these are the

presence or absence of liability protection for entities engaged in vaccination and the

availability of compensation for vaccinated persons who lose work time or incur

medical care costs as a consequence. The Homeland Security Act and state workers’

compensation laws do not adequately address these concerns, which remain substantial barriers.

Local public health agencies also need consistent guidance in several areas. They

need accurate, uniform guidelines for clinical practice. They need guidance for com-
43

municating with potential vaccinees. They need guidance for communicating with

their communities, particularly in explaining the program as the President has established it and in explaining the particular course of action that their state has

adopted. It is appropriate and expected that state plans for initial vaccinations will

vary, but it is essential that local public health officials be able to explain why the

types and numbers of people who will be asked to volunteer for vaccination vary

markedly among the states.

It is also essential that the federal government take the time to evaluate the initial experience of vaccination. This should include: monitoring side effects; identifying unexpected logistical barriers to vaccination; consulting more thoroughly with

the next larger cohort to be vaccinated; and instituting measures for quality assurance. CDC has undertaken a training program that relies on distance-based training

and a ‘‘train the trainer’’ model for administering vaccinations. It is essential to

evaluate the effectiveness of that training, so that there is greater assurance that

vaccines are administered and ‘‘takes’’ are evaluated properly. We do not believe it

will be appropriate for any community to move forward with vaccinating a larger

population until we have identified what training methods are effective and implemented them to prepare the larger number of vaccinators that will be required.

IMPLEMENTATION OF VACCINATION OF UP TO 10 MILLION FIRST RESPONDERS WILL TAKE

MORE TIME AND RESOURCES THAN ARE NOW PLANNED

The logistics for vaccinating the first 500,000 volunteers nationally remain incomplete, but we are confident that states and localities can master them. However,

those same plans and logistics will not work when the objective expands by a factor

of 20 to encompass up to 10 million first responders. The broader program cannot

be successful unless we take the time not only to apply the lessons learned in the

first phase of the program, but also to tackle significantly greater logistical problems. We have only begun to identify the potential issues. These include: Who will

provide vaccinations and how will they be indemnified? How do we get vaccine to

a larger group of vaccinators and assure its proper storage, handling and administration? How do we train vaccinators? How do we ensure that emergency and routine first responders can be vaccinated without disrupting essential community services? Local public health agencies have long experience in mounting immunization

programs, but the unique characteristics of the smallpox vaccine raise a host of new

questions. We must take the time to answer them before we can expect to launch

an effective vaccination program.

We also need to assess the costs of such a program. We know that they will be

great. States and localities already are diverting significant resources to smallpox

vaccination and there is no endpoint in sight. We are greatly concerned about two

effects of such a diversion. First, staff hired through the state and local grants for

bioterrorism preparedness cannot also pursue the other important preparedness activities that are now underway. We already see these activities slowing or halting

in many locations. A disproportionate amount of resources may be spent on smallpox vaccination for an indefinite time, at the expense of other bioterrorism and

emergency preparedness programs.

Second, the magnitude of a program to vaccinate ten million persons, and possibly

also other members of the general public, will drain general public health resources

at an alarming rate for an unknown period of time. In some jurisdictions, new staff

have been hired with federal bioterrorism preparedness funds because they have the

skills to improve public health capacities in the five focus areas of the cooperative

agreements, including epidemiology, communication, and the application of information technology. These staff cannot readily be transferred into smallpox vaccination,

which requires a different set of competencies. In many other jurisdictions, existing

staff has taken on the additional job of preparing for bioterrorism. In either case,

it is inevitable that existing staff in maternal and child health, immunization, or

other clinical programs will be diverted even more into smallpox vaccination. This

will further disrupt essential community services. We recommend a more measured,

thoughtful implementation, whereby the capacity for smallpox vaccination is incorporated more gradually into routine public health practice. We cannot afford to

exact a sudden, dramatic toll on routine disease prevention and health promotion

activities.

THE SCOPE OF SMALLPOX VACCINATION SHOULD BE LIMITED

We have grave reservations about offering smallpox vaccination on demand to

members of the general public, in the absence of a heightened threat assessment.

Smallpox vaccine is inherently less safe than immunizations we advocate and offer

routinely. We are greatly concerned about both inflicting harm unnecessarily and
44

compromising our effectiveness in routine immunizations. Adverse reactions to

smallpox vaccine will be well publicized and we would expect such publicity to have

a chilling effect on both childhood and adult immunization efforts. Our best chance

to minimize this effect is to limit explicitly the use of smallpox vaccine, thereby distinguishing it from routine immunizations, and to ratchet up our ongoing public

education about the relative risks and benefits of routine childhood and adult immunization.

For all these reasons, we urge a slower, measured approach to smallpox vaccination. We urge that the program be kept at minimal levels and grow only as rapidly

as threat assessment demands, so as not to disrupt other basic community health

protections or cause unnecessary harm.

Senator SPECTER. Thank you very much, Mr. Libbey.

STATEMENT OF JAMES AUGUST, DIRECTOR, HEALTH AND SAFETY,

AMERICAN FEDERATION OF STATE, COUNTY, AND MUNICIPAL

EMPLOYEES

Senator SPECTER. We now turn to Mr. James August, director of

Health and Safety for the American Federation of State, County,

and Municipal Employees. In that position, he oversees the development of training on the identification and control of chemical, biological, ergonomic safety and security hazards in the workplace.

Master of public health from the University of California at Los

Angeles.

Thank you for joining us, Mr. August, and we look forward to

your testimony.

Mr. AUGUST. Mr. Chairman and members of the committee, I am

James August, and I direct the occupational health and safety program for the American Federation of State, County, and Municipal

Employees, a labor union of 1.3 million members, including over

350,000 health care workers and first responders. We appreciate

the opportunity to address a matter of great importance to our

members, their families, coworkers, and patients.

Earlier this month, AFSCME president Gerald McEntee and

other union leaders called on President Bush to delay implementation of the smallpox vaccination plan until a number of very serious safety concerns and workplace issues are resolved. I will quickly summarize our concerns, and I have submitted more extensive

written testimony for the record.

It is our position that the vaccination program should be delayed

until a comprehensive plan is implemented with the following safeguards, many of which mirror what is being done in the military

smallpox plan. Prior to receiving the vaccine, workers must be educated about the risks of vaccination to themselves and the potential

for transmitting the vaccinia virus to patients, family members and

other contacts. Workers must not be pressured in any way into volunteering by their employers, and there must be no reprisals

against workers who decline to be vaccinated for any reason.

Given the potential serious side effects of smallpox vaccine which

others have described, workers must be carefully screened. Prevention is extremely important here. Those who might have a contraindication for the vaccine must be offered free and confidential

medical testing. There must be vigilant medical surveillance following vaccinations to rapidly respond to adverse reactions. Workers must have access to necessary medical treatment, including the

availability of VIG.
45

The Food and Drug Administration needs to quickly approve the

use of bifurcated needles with a built-in safety feature to administer the vaccine, consistent with the Needle Stick Safety and Protection Act which Congress passed in 2002. It is absolutely crucial

that public health systems be provided resources to safely implement a vaccination program, and should not be forced to divert

funds from core public health programs, as the previous witness

described.

As you know, the States are facing their worst fiscal crisis since

World War II. The challenges and risks of the smallpox program

are far too great to impose on State and local health departments

and hospitals without additional funding.

Last, I will address the compensation issue, which I was specifically asked to comment on. In short, State and Federal Worker’s

Compensation programs do not provide an adequate safety net.

Some Worker’s Compensation programs may not cover claims of

workers who have an adverse reaction because they have volunteered to be vaccinated.

Some State Worker’s Compensation programs do not require coverage for all workers. Other States exclude, or permit exclusion of

self-employed workers, which is a particular concern in hospitals

that rely on self-employed agency and contract workers, and since

Worker’s Compensation only applies to injuries that are work-related, a household member or a patient who becomes sick or disabled from the vaccinia due to contact with a vaccinated worker

will not be eligible for any benefits at all.

Now, even where Worker’s Compensation is applicable, workers

will not be fully compensated. Most programs replace only twothirds of workers’ earnings. There are also limits on the maximum

weekly benefits, which means the more highly compensated health

care workers cannot receive anything approaching adequate replacement of their lost income. Also, due to waiting periods, Worker’s Compensation will not apply to the estimated one-third of

workers who will have a reaction that will make them too ill to

work from one to a few days. In addition, there are caps on medical

care, posing a particular problem for workers who suffer a severe

side effect.

In short, Worker’s Compensation programs will not provide the

compensation and medical care that injured workers or individuals

made ill by contact with vaccinated workers would need and deserve.

The Federal Government has initiated the vaccination program

to protect the country against an intentional release of smallpox.

It is unacceptable to ask health care and emergency workers to volunteer to be on the front lines in the defense of the Nation and at

the same time tell them that if they or their family members are

harmed by the vaccine, they are on their own regarding medical

care and compensation. Therefore, it is necessary and appropriate

for the Federal Government to establish uniform protections.

The National Vaccine Injury Compensation Program for children

is an adaptable model for a Federal no-fault smallpox compensation program. It must be easy to access, provide prompt payment,

and fully reimburse affected individuals with respect to income and

medical costs.
46

In conclusion, the current smallpox vaccination program raises a

number of serious safety and workplace problems. The prudent

course of action at this time is to pause, look at the problems more

closely, and then let us correct the problems that exist. We are

eager to assist in designing a program that protects the Nation and

addresses the concerns of frontline health care and public safety

workers.

PREPARED STATEMENT

Thank you for allowing me to present our views on this important matter and, at the appropriate time, I would be pleased to answer any questions you may have.

[The statement follows:]

PREPARED STATEMENT OF JAMES AUGUST

I am James August and I direct the Occupational Health and Safety program for

the American Federation of State, County and Municipal Employees (AFSCME), a

labor union of 1.3 million members. AFSCME represents over 350,000 health care

workers and first responders, many of whom will be asked to receive the smallpox

vaccine in the coming months under the vaccination program launched last week.

I appreciate the opportunity to address a matter of great importance and urgency

to our members, their families, coworkers and patients.

AFSCME has closely monitored the development of the Centers for Disease Control and Prevention’s (CDC) Smallpox Response Plan, particularly the evolution of

the smallpox vaccination component. In the fall of 2001, the plan called for

inoculating 150 CDC staff, who would investigate and respond to a confirmed or

suspected case(s), and initiate a vaccination program anywhere in the country within twelve hours. There was widespread opinion that such a small number of vaccinated medical personnel employing the ring vaccination strategy used during the

worldwide smallpox eradication effort would not be sufficient in this modern and

mobile society, particularly if smallpox was intentionally released simultaneously in

multiple locations. At the June 2002 Institute of Medicine (IOM) meeting to examine the risks and appropriate responses to a smallpox attack, CDC and other government agencies involved in bioterrorism response planning were discussing the

need to vaccinate between 10,000 and 20,000 health care workers. In October 2002,

the Advisory Committee on Immunization Practices (ACIP) recommended that approximately 500,000 health care workers be vaccinated. Near the end of last year,

President Bush called for 10 million additional health care and emergency workers

to be vaccinated in a second wave.

THE NEED TO DELAY THE SMALLPOX VACCINATION PROGRAM

AFSCME agrees with the Institute of Medicine Committee’s statement that:

‘‘Given this profile of high vaccination risk and likely very low to zero benefit, the

administration’s policy to offer vaccination to public health, medical, and emergency

workers must be implemented in a most prudent and cautious manner.’’ Earlier this

month, AFSCME President Gerald W. McEntee and other union leaders called on

President Bush to delay implementation of the smallpox vaccination plan until a

number of serious safety concerns and workplace issues were satisfactorily resolved.

Local unions and nurse associations in a number of states, including AFSCME’s

Local 1199 in Philadelphia, are recommending that their members not volunteer to

participate until these issues are addressed. AFSCME recognizes the need to prepare the nation for a range of possible biological attacks. However, we have grave

concerns that the smallpox vaccination program is being implemented without a

comprehensive and federally funded plan that will ensure that the vaccinations are

administered safely and that those who suffer adverse effects from the vaccination

and exposure to the vaccinia virus will receive compensation and medical care. The

absence of a federally funded, comprehensive approach to the civilian vaccination

program is in stark contrast to the Department of Defense’s more thorough program

for the military.
47

PROTECTING SMALLPOX RESPONDERS AND THE PUBLIC DURING IMPLEMENTATION OF

THE PROGRAM

The vaccination program should be delayed until a comprehensive plan is designed and implemented with the following safeguards.

—Vaccinations should be administered only with full and informed consent.

—Prior to receiving the vaccine, workers must be trained about the risks and benefits of vaccination to themselves, as well as the potential for and consequences

of transmitting the vaccinia virus to patients, family members and other contacts. Educational information must also be made available to family members

of potential vaccination volunteers.

—Workers must be informed about the availability of compensation, or lack thereof, in the event of side effects that require time from work. Workers must also

be informed about the availability of medical care in the event of an adverse

reaction.

—Potential responders should be fully informed of their job responsibilities in the

event there are smallpox cases.

—Workers should not be pressured into volunteering by their employers, and

there should be no discrimination or reprisals against workers who decline to

be vaccinated for any reason. In addition, there must be no discrimination

against workers who experience an adverse reaction to the vaccinia.

—Given the well-known and serious side effects of the smallpox vaccine, workers

must be carefully screened, including an interview with an appropriate health

care professional. Those persons who might have a contraindication for the vaccine must be offered free and confidential medical testing.

—There must be vigilant active medical surveillance following vaccinations to rapidly identify and respond to adverse reactions. Workers must have access to

necessary medical treatment, including the availability of Vaccinia Immune

Globulin (VIG). There must also be surveillance and medical treatment available to those who suffer accidental transmission of the vaccinia virus from a

vaccinated worker.

—The Food and Drug Administration (FDA) must expeditiously approve the use

of bifurcated needles with a built-in safety feature consistent with the requirements of the Needlestick Safety and Protection Act of 2000. The needles included in the smallpox kits being shipped to the states do not include an integrated safety feature to prevent needlestick injuries that can transmit

bloodborne diseases from patients to health care workers. Safety-designed devices for vaccinations have been approved for marketing by the FDA. However,

the safer devices cannot be used by health departments and hospitals until the

FDA approves the substitution of safer devices for the unsafe needles included

in the smallpox kit.

THE NEED FOR NEW FEDERAL RESOURCES FOR IMPLEMENTATION IN THE STATES

Public health systems, including state and local health departments, hospitals,

laboratories, and other entities included in the smallpox response plan, must be provided with new and adequate federal resources to safely and effectively implement

the smallpox vaccination program. Adequate funding and requirements for educating, screening, monitoring and treating workers must be provided to avoid serious vaccine induced adverse effects. Public health departments and hospitals should

not be forced to divert resources from core public health programs or other bioterrorism preparedness activities in order to carry out the smallpox vaccination program. When authorizers designed requirements for states to receive bioterrorism

preparedness grants early last year, they did not include requirements for implementing a vaccination program. Furthermore, the CDC’s Notice of Cooperative

Agreement Award announcing the requirements for biopreparedness grants, issued

in February 2002, did not include the implementation of a smallpox vaccination program as one of the seven activities to be funded under awarded grants. Collectively,

states are facing a $67 billion budget shortfall for fiscal year 2003 and another $60

to $85 billion for fiscal year 2004, the worst fiscal crisis the states have experienced

since World War II. The costs, challenges, and risks of the smallpox program are

too great to impose on state and local governments without new federal funding.

INADEQUACY OF COMPENSATION AND CARE UNDER WORKERS’ COMPENSATION

Congress must address the need for compensation and medical care for persons

who are injured as the result of receiving the vaccine, or individuals who are

harmed as a result of contact with a person who has been vaccinated. State and

federal workers’ compensation programs do not provide an adequate safety net. In
48

a survey of the states, the Association of State and Territorial Health Officials revealed that there is great uncertainty about whether workers’ compensation will be

applicable. Indeed, American Insurance Association’s chief counsel on workers’ compensation has declared, ‘‘I do not see where comp would pay for either the [smallpox] vaccine or for the adverse effects of an inoculation.’’——(Business Insurance,

January 13, 2003.)

The gaps in coverage and applicability are significant. Some workers’ compensation programs may not cover the claims of workers who have adverse reactions because they have voluntarily agreed to be vaccinated. In a classic Catch-22 situation,

one AFSCME local has reported that due to the voluntary nature of the vaccination,

medical expenses resulting from a serious injury will not be covered by the workers’

compensation program. These same workers have also been informed that their

health insurance coverage will not apply because the injury would be considered

work-related. Other states exclude or permit exclusion of self-employed workers, a

particular concern in hospitals that rely upon self-employed, agency and contract

workers including nurses and emergency room physicians. In Texas, workers’ compensation is not compulsory for private employers. Finally, since workers’ compensation only applies to injuries that are work-related, a family member or patient who

becomes sick or disabled from the vaccinia due to contact with a vaccinated health

care worker, will not be eligible to file claims under state workers’ compensation

programs.

Even where workers’ compensation plans recognize adverse effects from smallpox

vaccine as work-related and compensable, workers will not be fully compensated.

Most state workers’ compensation programs replace only two-thirds of workers’

earnings. The same is true for the program covering federal workers who are vaccinated. There are also limits on the maximum weekly benefits, which means that

more highly compensated health care workers cannot receive adequate replacement

of their lost income. For example, the 2002 maximum weekly payment for Total

Temporary Disability in California is $490, and only $400 in New York. (See

www.aflcio.org/yourjobeconomy/safety/wc/upload/unemploy.pdf for more information

on benefits levels available under state workers’ compensation programs.) All states

have a waiting period before any compensation is provided, usually in the range of

three to seven days. Wages lost during this time will not be compensated unless the

worker is off work for an extended period, which is typically 14 to 28 days. Therefore, workers’ compensation will not apply to the estimated one-in-three workers

who will have a reaction that will make them too ill to work from one to a few days.

In addition, there are caps on medical care, posing a particular problem for workers

who suffer severe illness or injury as a result of the vaccinia. Death benefits also

vary widely. In Florida, the death benefit is only $103,000, regardless of the size

of a worker’s family or income at the time of death.

The federal government has initiated the vaccination program to protect the country against an intentional release of smallpox. Since the smallpox vaccination program is a national effort, there should be uniform protections that adequately compensate injured workers. It is unacceptable to ask health care and emergency workers to volunteer to be on the front lines in the defense of the nation and at the same

time tell them that if they or their family members are harmed by the vaccine, they

are on their own regarding medical care and compensation. The National Vaccine

Injury Compensation Program, for children injured by vaccines, provides a model,

with adaptation for workers, for a federal no-fault compensation system. A smallpox

compensation system must be easy to access, provide prompt payments, and fully

reimburse affected individuals with respect to income and medical costs.

CONCLUSION

The President’s smallpox vaccination program raises a number of serious and unresolved safety and workplace issues. The prudent course of action at this time is

to pause, carefully examine the problems, and correct the deficiencies. We are prepared to assist in designing and implementing a program that protects this nation

from an intentional release of biological agents and that adequately addresses the

health, safety and livelihood of front line health care workers and first responders,

their families and their patients.

Senator SPECTER. Thank you very much, Mr. August.
49

STATEMENT OF JANE COLACECCHI, DIRECTOR, IOWA DEPARTMENT

OF PUBLIC HEALTH

ACCOMPANIED BY MARY JONES, DIVISION DIRECTOR, EPIDEMIOLOGY, EMS AND DISASTER OPERATIONS, IOWA DEPARTMENT

OF PUBLIC HEALTH

Senator SPECTER. Our final witness on this panel is Ms. Jane

Colacecchi, interim director of the Iowa Department of Public

Health, previously served in the Governor’s Office as policy advisor

to Governor Vilsack, a graduate of the University of Southern California, and she is accompanied by Ms. Mary Jones, who is the program director of the Office of Medical and Public Health Disaster

Preparedness in the Iowa Department of Public Health.

Welcome, and the floor is yours.

Ms. COLACECCHI. Thank you. We are here today representing

Iowa on the need to implement the State’s vaccination program.

Mary Jones is with me, and serves in a leadership capacity for the

organizational oversight and responsibility for disaster terrorism

activities within the context of the State’s overall public health system. She is here today to assist with any specific questions you

may have on operations.

We are honored to appear before the subcommittee today, and

particularly Senator Harkin of Iowa, an important long-time advocate for public health. We would like to thank Chairman Specter

and Senator Harkin for their dedication and commitment to securing funding for this important initiative. The Iowa Department of

Public Health greatly appreciates your leadership.

We are also honored to provide testimony on one of the most critical issues facing our Nation, bioterrorism preparedness, specifically the smallpox vaccination program. The comments that we

provide are from the perspective of a State health department as

it interacts with Federal agencies and with our local public health,

hospital, and first responder partners. In April 2002, Iowa was awarded $11.5 million from the CDC to

upgrade State and local public health jurisdictions in preparedness

for and response to bioterrorism and other outbreaks of infectious

disease and other public health threats and emergencies. Additionally, Iowa was awarded $1.3 million from HRSA to upgrade hospital, EMS, and other health care entities in preparedness for and

response to bioterrorism.

From the CDC and HRSA funds we have allocated at the local,

regional, and State levels. Through the use of these funds, we have

established six planning regions for public health and health care,

with membership from local public health, hospitals, EMS, and

emergency management. Each region meets monthly and is actively engaged in development of regional bioterrorism preparedness and response plans.

We have conducted a series of educational sessions on bioterrorism and have held multiple conference calls with local public

health and hospitals regarding smallpox planning. We have implemented a Statewide plan to request and receive pharmaceuticals

and medical supplies from the Federal Government to distribute on

a regional basis to local communities for public use. We have implemented a 24–7 emergency notification system for each county

health department through a Statewide paging system, and we
50

have disseminated public information materials on bioterrorism

and smallpox through a supplement in every newspaper in the

State.

Since December 13, 2003, when President Bush announced his

policy on vaccination for smallpox and receipt of subsequent guidance from the CDC, Iowa has been diligently developing a voluntary smallpox vaccination plan and operation procedures for public health and health care smallpox teams. No funding has been allocated for the smallpox vaccination program. Rather, it has been

recommended that States redirect funds from the CDC bioterrorism

cooperative agreement to the smallpox vaccination program. As a

result, our priority has been changed from building a system of

multithreat bioterrorism preparedness to preparedness for a single

biological agent.

Redirecting of funds from the CDC bioterrorism cooperative

agreement to develop and implement State smallpox plans will affect our ability to build a system of bioterrorism preparedness and

response by not funding certain critical capacities benchmarks and

recipient activities. Smallpox vaccination planning and implementation is damaging other aspects of bioterrorism preparedness, not

to mention other public health programs, such as prevention and

treatment of sexually transmitted disease, childhood immunizations, or flu immunizations. Without additional resources, some of

these programs may have to be delayed or canceled to meet the

needs of the smallpox vaccination program.

Cost estimates were assembled in an attempt to reflect the

State’s cost to develop and implement the phase 1 pre-event smallpox program. It is estimated that the cost per vaccine for Iowa is

approximately $400. This cost includes all associated costs, and is

not limited to just the administration of the vaccine.

This includes program development, coordination, management,

including education, training, adverse event surveillance, data

management reporting, statistical service, public information and

education, pre-vaccination screening, volunteer interviewing to exclude from vaccination those with contraindications, education, collecting demographic data and medical data and screening interviews, vaccine and vaccination clinics, which includes vaccine receipt distribution, stockpile management, storage, vaccination administration, providing bandages, supplies to volunteers, clinic setup and operations, staffing, record-keeping, and security, with

vaccinators, with initial vaccinator training and education materials, salary, travel, lodging to staff clinics, volunteer vaccines, or

reimbursement volunteer salaries for vaccination time and vaccine

take check time, and then adverse events, both direct and indirect

costs of complications of smallpox vaccine for adults.

Iowa is developing 15 health care smallpox teams, six regional

and public health smallpox response teams, with an estimated total

vaccine plan of approximately 1,000 public health and health care

workers for the phase 1 program, for a total cost of $400,000.

Vaccination is expected to arrive in Iowa by the end of this week.

Vaccinator training is scheduled for February 3 through 4 of 2003,

with clinics to commence at the end of February. It should be noted

that cost estimates for the program will be reduced in subsequent
51

phases, as some activities will become maintenance or not be necessary.

We must not lose sight of our mission to build a comprehensive

system of public health and health care preparedness for and response to bioterrorism, outbreaks of infectious disease and other

public health threats and emergencies. It is critical that we sustain

the mission of building public health and health care infrastructure, personnel systems, response capacity, and training for bioterrorism. By sustaining the development and implementation of

Iowa’s multidisciplinary and multiuse system of bioterror preparedness and response, we will be prepared and able to respond in any

biological crisis effectively and efficiently. Therefore, additional

funding for the smallpox vaccination is needed.

PREPARED STATEMENT

Thank you again for the opportunity to provide testimony on this

matter of critical national importance. We would be happy to answer any questions.

[The statement follows:]

PREPARED STATEMENT OF JANE COLACECCHI

Mr. Chairman, Members of the Subcommittee, I am Jane Colacecchi, Interim Director of the Iowa Department of Public Health and with me is Mary Jones, Director

for the Division of Epidemiology, EMS, and Disaster Operations at the Iowa Department of Public Health. She has served in a leadership capacity for organizational

oversight and operational responsibility for disaster/terrorism activities within the

context of the state’s overall public health system. We are here today representing

Iowa on the immediate need for funding to develop and implement the state’s smallpox vaccination program.

We are honored to appear before the subcommittee today, and particularly Senator Harkin, as one of Iowa’s Senators and an important, longtime advocate for public health. We would like to thank Chairman Specter and Senator Byrd for their

dedication and commitment to securing funding for this important initiative. The

Iowa Department of Public Health greatly appreciates your leadership.

We are also honored to provide testimony on one of the most critical issues facing

our nation: bioterrorism preparedness, specifically the Smallpox Vaccination Program. The comments that we will provide are from the perspective of a state health

department as it interacts with federal agencies and with our local public health,

hospital, and first responder partners.

In April of 2002 Iowa was awarded $11.5 million from CDC to upgrade state and

local public health jurisdictions in preparedness for and response to bioterrorism,

other outbreaks of infectious diseases, and other public health threats and emergencies. Additionally, Iowa was awarded $1.3 million from HRSA to upgrade hospital, EMS, and other health care entities in preparedness for and response to bioterrorism. This funding has been critical as we begin building the nation’s public

health and healthcare bioterrorism preparedness program. This funding must be

maintained to support ongoing bioterrorism system development as well as preparedness for other public health emergencies. We would like to acknowledge and

thank you for the work you have done in securing this funding for public health

and healthcare.

Funds from CDC and HRSA have been allocated at the local, regional and state

levels. Through the use of these funds we have:

—Established six planning regions for public health and health care with membership from local public health, hospitals, EMS and emergency management.

Each region meets monthly and they are actively engaged in development of regional bioterrorism preparedness and response plans.

—Conducted a series of educational sessions on bioterrorism and have held multiple conference calls with local public health and hospitals regarding smallpox

planning.

—Implemented a statewide plan to request and receive pharmaceuticals and medical supplies from the federal government to distribute on a regional basis to

local communities for public use.
52

—Implemented a 24/7 emergency notification system for each county health department through a statewide paging system.

—Disseminated public information materials on bioterrorism and smallpox

through a supplement in every newspaper in the state.

Each of the cooperative agreements outline mandated critical capacities, benchmarks, and recipient activities that must be funded and completed during the cooperative agreement period. These activities all significantly contribute to building a

statewide system of public health and healthcare infrastructure in preparedness for

and response to bioterrorism. Thousands of hours have been invested by state and

local public health, healthcare, and emergency management agencies and personnel

in development of these activities in order to build an efficient, and effective statewide system of public health and healthcare bioterrorism services that is fully integrated into Iowa’s Homeland Security and Emergency Response Plan.

BACKGROUND AND PROBLEM

Since December 13, 2003 when President Bush announced his policy on vaccination for smallpox and receipt of subsequent guidance from CDC, Iowa has been diligently developing a voluntary state smallpox vaccination plan and operational procedures for public health and healthcare smallpox teams. No funding has been allocated for the smallpox vaccination program; rather it has been recommended that

states redirect funds from the CDC Bioterrorism Cooperative Agreement to the

Smallpox Vaccination Program. As a result, our priority has been changed from

building a system of multi-threat bioterrorism preparedness to preparedness for a

single biological agent. Redirecting of funds from the CDC Bioterrorism Cooperative

Agreement to develop and implement state smallpox plans will affect our ability to

build a system of bioterrorism preparedness and response by not funding certain

critical capacities, benchmarks and recipient activities.

Smallpox vaccination planning and implementation is damaging other aspects of

bioterrorism preparedness, not to mention other public health programs such as:

prevention and treatment of sexually transmitted diseases, childhood immunizations, or flu immunizations. Some of these programs may have to be delayed or canceled to meet the needs of the smallpox vaccination program.

The risk of a widespread domestic smallpox attack may be low, and the benefits

of a vaccination program may be limited if our citizens are never exposed to the

smallpox virus. However in the event of exposure to the virus, the benefits of a vaccination program for our citizens may be very high. Therefore Iowa is fully committed to participation in the public health component of the national bioterrorism

preparedness strategy.

Funding is one of the greatest obstacles facing state success in program development and implementation. The pre-event smallpox vaccination program is a statewide effort to coordinate and manage public health and healthcare smallpox teams,

create medical specialty referral mechanisms, plan and assure the availability of the

vaccine and vaccination clinics, and monitor and manage adverse events. Appropriations for the smallpox program should build capacity to move states into the Phase

2 vaccination program and at the same time build local infrastructure for mass vaccination or treatment if the need should ever arise. Planning for and responding to

terrorism or to any other public health threat or emergency requires full resources

of all local, state, and federal entities.

SMALLPOX VACCINATION PROGRAM IMPLEMENTATION COST ESTIMATIONS

Cost estimations for Iowa’s Pre-Event Phase 1 Smallpox Vaccination Program are

based on information obtained from ‘‘Cost Estimations of Vaccinating Adults with

Smallpox (Vaccinia) in the U.S.: Stage 1 Vaccination Program’’: prepared by Ismael

Ortega-Sanchez and Benjamin Schwartz, CDC, National Immunization Program,

Epidemiology Surveillance Division. Draft Version dated November 6, 2002 and

from estimations made by the Iowa Department of Public Health.

Cost estimations were assembled in an attempt to reflect state costs to develop

and implement the Phase 1 Pre-Event Smallpox Program. It is estimated that the

cost per vaccinee is $400.00. This includes costs associated with:

—Program.—development, coordination, and management (education, training,

adverse event surveillance, data management, reporting, statistical services,

public information and education),

—Pre-Vaccination Screening.—volunteer interviewing (exclude from vaccination

those with contraindications, education, collecting demographic data, medical

data and screening interviews),

—Vaccine and Vaccination Clinics.—includes vaccine receipt, distribution, stockpile management, storage, vaccination administration, providing bandage sup-
53

plies to the volunteers, clinic set-up and operations, staffing, record keeping and

security, —Vaccinators.—initial vaccinator training and education materials, salary, travel

and lodging to staff clinics, —Volunteer Vaccinees.—reimburse volunteer salaries for vaccination time and

vaccine take-check time, —Adverse Events.—both direct and indirect costs of complications of smallpox vaccination for adults.

Iowa is developing 15 healthcare smallpox teams, 6 regional public health smallpox response teams with an estimated total vaccination plan of approximately 1,000

public health and health care workers for the Phase 1 program for a total cost of

$400,000. Vaccination is expected to arrive in Iowa by the end of this week. Vaccinator training is scheduled for February 3—4, 2003 with clinics to commence at the

end of February. It should be noted that cost estimates for the program will be reduced in subsequent phases since some activities will become maintenance only, or

not be necessary. Caution must be used when considering costs for adverse events,

medical care, and liability given the ongoing debate of what will and will not be covered by health insurance, workers compensation, and protections provided by the

enactment of the Homeland Security Act.

SUMMARY

Public health is a new and vital partner in homeland security and national defense for bioterrorism and as such, must build a system of preparedness and response that may be integrated into existing state and federal emergency response

and homeland security plans.

We must not lose sight of our mission to build a comprehensive system of public

health and healthcare preparedness for and response to bioterrorism, outbreaks of

infectious diseases and other public health threats and emergencies. It is critical

that we sustain the mission of building public health and health care infrastructure:

personnel, systems, response capacity and training for bioterrorism. By sustaining

the development and implementation of Iowa’s multidisciplinary and multi-use system of bioterrorism preparedness and response, we will be prepared and able to respond in any biological crisis effectively and efficiently. Therefore, additional funding for the smallpox vaccination program is needed.

Thank you again for the opportunity to provide testimony on this matter of critical national importance. We would be happy to answer questions.

Senator SPECTER. Thank you very much for your testimony, Ms.

Colacecchi.

We will now begin another round of questions, and I would like

for our earlier two witnesses, Dr. Gerberding and Dr. Fauci, to join

us. I begin on a focus on the issue of risk, and that is obviously

very difficult to assess. What is the likelihood that someone will attack the United States with smallpox?

Dr. Fauci testified that you cannot quantify—he said that it

could be weaponized. We know from the experience in the Soviet

Union. Dr. Bell says that it is difficult to ascertain, and this subcommittee will pursue this question beyond the confines of the

medical experts. We will inquire of the intelligence agencies as well

to see if we can find out more as to what the risk factor is.

It is instructive that there are a number of hospitals around the

country who are declining to vaccinate. USA Today published on

January 20 a survey for which they purport to have contacted by

telephone the public health officials in all 50 States, and they came

to the conclusion that the dissenters are a tiny fraction of the 3,000

hospitals recruited by State health officials to vaccinate doctors,

but there are some more than 80 hospitals from every region in the

United States, including leading teaching hospitals and large

urban public hospitals, which are forgoing the vaccinations.

There is an interesting commentary by doctors at the Medical

College of Virginia Hospitals, where they say that instead of having

a vaccination program, they would like to have 4,000 vaccines
54

locked up in a refrigerator so that they could then vaccinate the

staff where a problem arose, because the vaccine can be taken up

to 4 days after exposure and still be effective.

Dr. Fauci, let me start with you. Do you agree that the vaccine

can be taken up to 4 days after exposure and still be effective?

Dr. FAUCI. There are data from a number of studies, including

one from Bangladesh many years ago, that if you vaccinate someone following exposure, there is a window of about 3 to 4 days in

which, if you can get them vaccinated, there is a high probability

that you could prevent them from getting infected. You could extend that out a little bit more if you think in terms of muting the

extent of the infection, or the complications subsequent to the infection, and so there are data from a number of studies suggesting

that, in fact, you do have a window of approximately 3 or so days.

Senator SPECTER. Dr. Gerberding, when there are going to be

vaccinations, you have a fairly substantial group which will be vaccinated, and then you can have some better idea as to what the

risk factors are when you talk about one to two people out of a million dying and 14 to 52 with life-threatening reactions, and 1,000

per million with serious reactions such as rash, will the people who

are accepting voluntary inoculations provide a significant base to

make an evaluation as to whether those risk estimates are accurate?

Dr. GERBERDING. I think we have a long history of using this

exact same vaccine product and the same protocol, and we have the

old data. Our concern is, the old data does not necessarily apply

to the conditions of our current population, so we do need to monitor as we go forward, and we will have more accurate information

as the program evolves.

Senator SPECTER. How many people are going to be vaccinated

under the current plans?

Dr. GERBERDING. The States have requested vaccination for

about 450,000 people during this first phase. The number in the

second phase, where we expand to include the people at occupational risk in the police, fire department and other health care

workers, could be up to 10 million, although we do not think that

immunizing all 10 million is likely.

Senator SPECTER. Well, certainly it is not a desirable situation to

be one of those who is vaccinated with these risks, and to use them

as a basis for making a further determination, but if you vaccinate

people into the millions, you will have a better evidentiary base to

assess risk, will you not?

Dr. GERBERDING. We will have more data as we go forward, and

that is why it is so important that we collect this information as

we go, and we are also learning from the military, because there

is a military immunization program.

Senator SPECTER. And how many are likely to be vaccinated in

the military?

Dr. GERBERDING. I do not have the figures. Part of the information is not publicly disclosed at this time because it has to do with

force readiness, but they are anticipating immunizing many thousands of people.

Senator SPECTER. Well, the uncomplimentary phrase comes to

my mind of being guinea pigs here, really, which we do not want
55

to subject anybody to, but if it is accepted on a voluntary basis—

of course, the military is not voluntary, but we may have a better

evidentiary base to shed some light on what Dr. Bell is concerned

about.

This is obviously going to be an ongoing matter, but we lack any

real, quantifiable assessment of risk of attack here, and there are

comments about North Korea and Iraq likely having the smallpox

virus, and then we have to quantify it and evaluate it in terms of

all this other long list, so it is going to require a lot of analysis,

thought and further study.

Senator Harkin.

Senator HARKIN. Thank you, Mr. Chairman. I think, Mr. Chairman, you have raised the basic issue that I think we really have

to get at here. You said the issue of risk, and I think we need to

have some clearheaded thinking on this, and we need the best information we can have from the experts, Dr. Fauci, Dr. Gerberding,

about the experience.

It is not as though we have never experienced smallpox before,

but we have a wealth of experience about smallpox, how it is transmitted, what the effects are. We also know from past experiences

how it can be contained, so I think we have to begin to think about

this in terms of what the real threat is.

Ms. Colacecchi, I think, in her testimony, and I underline this,

because I think, again, she is talking about this in terms of: ‘‘Are

we going in the direction that is going to siphon off a lot of money

for one threat, as opposed to building a system that will protect our

people against multithreats in this country.’’ As a result, to quote

Ms. Colacecchi: ‘‘our priority has been changed from building a system, a multithreat bioterrorism preparedness, to preparedness for

a single biological agent.’’

So again, what is this threat? For example, I read in one of the

magazines, Newsweek, Time, I do not know what it was, about how

Saddam Hussein, if he has this smallpox, what he would do is, he

would find a willing martyr, inoculate that person with the smallpox virus, put that person on an airline, the airline flies to the

United States, it has got 200 or 300 people on board, they all disembark in New York, and they go to this place and that place and

this place, all carrying the smallpox virus. A very scary scenario.

How real is that, Dr. Fauci? How is the smallpox virus transmitted? If you have it, can you transmit it from you to me right

here?

Dr. FAUCI. I would not be able to transmit it from me to you

where we are staying. It usually occurs, with some exceptions—in

all of biology, there is a bell-shaped curve, there is what usually

happens and then there are exceptions. There are exceptions if you

have very close contact and you do not get infected, and there are

exceptions if you do not have extremely close contact and you do,

but for the most part, it is accepted through close personal contact,

usually within family members, or people who spend a lot of time

in close quarters together.

That could be in a hospital setting from a health worker who is

taking care of a patient who comes in either with recognized smallpox or unrecognized smallpox, or if someone is infected and they
56

go home and there is the close household setting. That is the usual

way that smallpox is transmitted.

Senator HARKIN. I think we need to get to this, because not too

long ago, not too many years ago, 15 years ago, where we got in

all kinds of scary scenarios on how HIV was transmitted, until finally the medical experts said ‘‘No, there are certain ways, and

then, beyond that, you cannot transmit it and contact HIV virus.’’

Dr. FAUCI. Just to make one other point, that is the way that

naturally occurring smallpox is transmitted. What that does not

take into account is an unknown—and getting back to the statement that I made before, I cannot or we cannot quantitate that

risk, but in a situation in which, for example, a material might be

spread in an aerosolized way, that breaks the paradigms of someone just getting it and going into the home and having the very

close personal contact within a family.

Again, I do not know the likelihood of that, but the information

that we have on how we disseminate smallpox is based on the natural evolution of a naturally occurring epidemic, and you just need

to take that into consideration. I do not know what weight you

want to give to it, but you at least need to consider it.

Senator HARKIN. I agree we need to consider it, but we need to

consider it, again, in the framework of what data and what facts

we know about viruses or about smallpox virus in particular here.

I have heard about the aerosolization of smallpox virus, but how

long would the smallpox virus live in the atmosphere?

Dr. FAUCI. Quantitatively, significantly less than, for example,

anthrax spores, but certainly not just seconds. When the Soviets

were making their weaponized form of smallpox, it was for the purpose of putting it in bomblets to be used through missiles. Again,

this is something that we know happened. Whether it is applicable

today, given our current situation, we cannot quantitate that, but

even if you have the virus that does not last long in the sunlight,

which would certainly weaken if not kill it within a reasonable period of time, the aerosolized component is something that we do not

have experience with.

You very appropriately, Senator, made the point that we know

a lot about smallpox. We know a lot about naturally occurring

smallpox. We do not know anything about weaponized, deliberate

bioterrorist smallpox.

Senator HARKIN. Do we know anything at all, from your data,

about the virus itself and whether it—can it be, has it been modified? Has it been changed? We do not know that, do we?

Dr. FAUCI. That is a possibility, but we do not have any definitive evidence that there has been genetically mutated smallpox. We

have no data on that.

Senator HARKIN. And no information that I am aware of that we

have on that. So again, I come back to making sure that we have

adequate data, or at least information available on smallpox, on

the virus, how it is transmitted, and the threat assessment.

Now, correct me if I am wrong, but it just seems to me that if

there is any kind of an outbreak of smallpox, that CDC has developed over time procedures to be followed for building these rings

of protection around any kind of an outbreak, so again, if we are

prepared, and we have that in place, that would answer not just
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smallpox, but other possible viral outbreaks, or anthrax, or whatever it might be, that might be used as a weapon, but if we are

just zeroing in only on smallpox, are we taking a threat that might

be very small, spending a lot of money getting everybody very

upset and excited about this, and perhaps causing some unknown,

unanticipated illnesses and deaths, rather than building the system that will truly protect the American people not just against

smallpox, but against all other kinds of threats that might come

along?

Dr. GERBERDING. Senator, we appreciate so much your perspective on this. This is basically the whole premise of the CDC’s terrorism preparedness program, that we need to build a foundation

of capacity to deal with all threats, but having said that, the investments we are making in this capacity to immunize responders

for smallpox, and then getting them into a shape where we could

immunize the entire population, is a capacity that will serve us

well for whatever countermeasure we have to deliver, so if we can

do this for smallpox, we can deliver antibiotics efficiently for anthrax, we could deliver botulism toxin efficiently if we have a botulism exposure, so it is not totally unrelated to the principle that

you are articulating.

If I could just make a quick statement here to give you some idea

about how this works, when we get a call that says there is a highly suspect case of smallpox, or something that could be smallpox,

two things happen immediately. One is, we get the clinicians in

that place to get the sample to the nearest laboratory that our appropriation from this committee helped support, and get that example to CDC so we can very quickly know for sure if it is or it is

not, and we can do that in about 12 hours.

Simultaneously with that, we send our smallpox advance teams

on a plane that we can charter if necessary, even if the air space

is closed, carrying one of these kits, which carries enough vaccine

to immunize 1,500 people, and our response teams would take this

right to that ring of the contacts, and do everything possible to prevent the spread from that circle of the initial case and the contacts

therein, so that helps us.

Once we have an exposure, we know what to do to contain

spread, but we also believe that once we have a single case of

smallpox, the expectation in all communities will be, now the

threat is no longer questionable, it has happened, and so everyone

will need immunization, and we need to be able to be prepared to

respond to that as well.

Senator HARKIN. Thank you very much, Dr. Gerberding.

Mr. LIBBEY. Senator, if I might, from the point of the actual implementation I would agree with Dr. Gerberding to the extent that

preparing for smallpox in some areas, particularly the phase that

we described as community preparation, ties us into the issue managing the stockpile for other issues and the like, but the level of

resources specific to the vaccination itself, and to the necessary follow-up care, have limited application to other forms of preparedness.

Senator SPECTER. Thank you very much, Senator Harkin.

Senator Murray.
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Senator MURRAY. Thank you very much, Mr. Chairman, and

thank you, really, to all of our witnesses today. I think that all of

us are hearing a lot of concerns from our communities about what

their responsibility is going to be and how they are going to pay

for this, weighed against the risks that clearly have been outlined,

but how real they are, and Mr. Libbey, I am glad you responded,

because I did want to ask you, Dr. Gerberding is speaking from a

national perspective and putting a model together, and certainly in

the case of where smallpox actually occurred, I think we all know

that is different from what we are looking at right now, which is

prevention, and you responded shortly to that, but I would like to

ask you specifically, do you see that model being in place?

You talked in your testimony about diverting from other resources and other public health care crises. Does this model help

you, or does it take it away from other things that public health

officials are trying to do?

Mr. LIBBEY. It has helped in some regards in terms of the public

health community making better and stronger connections with the

medical care community, other parts of the emergency management systems of their community. In that regard, it has been helpful, but that would be the case of overall bioterrorism preparedness.

What we have heard in a survey of about 715 respondents, twothirds said it has detracted from their ability to provide other public health services, as well as from other bioterrorism more broadly,

that general preparedness.

Senator MURRAY. Because of a singular focus on one issue?

Mr. LIBBEY. Because of the singular focus to the issue. There will

likely be, I would not disagree, some residual level of value to preparedness, but to suggest that it is an equivalent transfer suitable

for other agents or other issues, we would question.

Senator MURRAY. You in your testimony said that in metropolitan areas it would cost between $142 and $222 a person to inoculate. I was actually out in Mason County, which is not far from

where used to be—a very small rural community who were very

concerned about the costs. Rural communities, would the price be

higher, because you do not have as many people?

Mr. LIBBEY. I think the difference expressed by Iowa is a very

good example of that, the time travel, the distance, and the fewer

numbers.

Ms. COLACECCHI. We have larger per capita numbers because we

have taken a rather conservative approach in the number of people

that we are inoculating, but we do have increased costs due to the

rural nature of our State in terms of travel, and the ability to train

people on a Statewide basis.

Senator MURRAY. I think that is what we are hearing from a lot

of our communities, is how, with all the other burdens they are in

right now, they are going to pay for this risk, and whether the risk

is worth it. Certainly, these are difficult questions for all of us.

Dr. Gerberding, I wanted to go back to you again, because I listened carefully to Dr. Bell and his testimony in thinking through

the process at his hospital and deciding not to inoculate their

health care officials. I know I am hearing from several hospitals in

my State that have gone through the same process and come to the
59

same conclusion, not children’s hospitals, other hospitals, because

patients in hospitals today are much sicker than they were 30 or

40 years ago, and could possibly be at much higher risk, and

weighing those risks is a very difficult decision for any hospital administrator.

How do you respond to Dr. Bell or to the hospitals in my State

and argue to them a case that is a different conclusion than they

have come to?

Dr. GERBERDING. I am very respectful of the perspective of the

panel, in fact of all the panelists. I think we are all struggling to

find the right balance here between risk and preparedness and expediency and, as I said in my testimony, the safety of the individuals and the patients involved, and this really has to be the highest

imperative for us.

When we put together this implementation plan, we were very

cognizant of what our goal was. Our goal was to ensure that we

had sufficient preparedness capacity so that, should we have a

smallpox attack, we would have the initial infrastructure and personnel to be able to mount a much broader population campaign.

That does not require every hospital to participate. It requires that,

in a jurisdiction, there are sufficient resources in the health care

delivery system to take care of the initial cases of smallpox.

So we knew that not every hospital would choose to participate.

We anticipated that in our calculations, and I am very respectful

of the decision of individual hospitals, but having said that, I must

also say that we are concerned about spread to patients when we

are immunizing health care personnel, and we have gotten expert

input from two advisory committees, our Advisory Committee on

Immunization Practices, as well as our Specialist in Hospital Infection Control, to help us identify what are the hazards to patients

and what we need to do to protect them.

So we have a number of steps that would be required in a facility

to ensure that patients are safe, and that includes the hygiene, the

covering of the wound, and a daily check of each immunized health

care worker to make sure that their inoculation site is not spreading and that it is properly covered, and that the hazard to patients

is minimized.

Senator MURRAY. And are you concerned that in many communities, they do not have the resources, so given this concern now,

they are diverting resources from other public health issues they

may have?

Dr. GERBERDING. I really look forward to working with NACCHO

and other organizations that are assessing that. We received

progress reports from the jurisdictions in November to assess

where they were in terms of their implementation of the expectations from the appropriation that went out in June. Our feedback

from that progress report was that people had taken excellent steps

toward achieving the expected capacities, but if there has been a

change in that, we will need to get it again as we go out for the

next round of evaluation, and so we will take that concern very seriously.

Senator MURRAY. I know my time is running out, but Dr. Fauci,

I wanted to ask you one other question. We know there are risks

to children and pregnant women. What research is taking place at
60

the institutes that will help us better evaluate the long-term impacts on early childhood development, or pregnant women, or fetal

development? Is there any research going on, and what do we know

today?

Dr. FAUCI. To my knowledge, no. I would have to get back to you

on that. That would be through the National Institute of Child

Health and Development, so that would not be in our institute, but

I can get that back to you, Senator Murray.

Senator MURRAY. Okay. I would really like to know that. Thank

you.

Thank you, Mr. Chairman.

Senator SPECTER. Thank you very much, Senator Murray.

On the issue of containment, as opposed to prevention, Senator

Santorum and I were at Carnegie Mellon recently, and the University of Pittsburgh Medical Center, where they are collaborating on

software to identify people who have signs which might be some

bioterrorist attack, and they collate material from hospitals and

from doctors and other medical centers in a context of putting all

the pieces together to try to determine if we are in the incipient

beginning stage of a bioterrorist attack.

Now, if we have 4 days—Dr. Fauci, you were not definitive on

that. You told me about the Bangladesh data, but you did not tell

me what Dr. Fauci thought about it, but if we really have 4 days—

do we have 4 days, Dr. Fauci, in your judgment?

Dr. FAUCI. I would only have to look at the data, because we do

not have experience. The last case of smallpox that occurred in the

United States, I was 9 years old, so I do not have experience in

that regard, but with regard to the information in the literature,

I would say that that is a strong suggestion that, indeed, you do

have a 3- to 4-day window.

Senator SPECTER. Well, how far along are we on detection? The

New York Times had a front page story a few days ago about eight

centers being designated in the United States to collate the material to try to predict at a very early stage whether we are being

subjected to an anthrax attack, or to a smallpox attack.

How good are we at that, and how good could we become, and

if we could really catch it at the outset, and had 4 days, and had

the suggestion made by the Richmond medical facility to have vaccines in the refrigerator, then we do not have to vaccinate all these

people and take all these risks if we could really contain it with

that time interval.

What do you think Dr. Gerberding?

Dr. GERBERDING. We want to be able to detect this virus at its

release, if it is an aerosol release. We are not there yet. Even with

the detection systems that have been deployed, we cannot guarantee that we would be able to detect it.

Senator SPECTER. We are not there yet. When you say yet, are

there prospects for getting there?

Dr. GERBERDING. I think the technology is rapidly evolving. Some

of the research NIH and others are doing will get us there.

Senator SPECTER. Is the NIH doing the research?

Dr. GERBERDING. The NIH is doing some research.

Senator SPECTER. Well, they have lots of money. Dr. Fauci has

lots of money.
61

We have loaded them up with money, $12 billion to $27 billion.

On what date will we have the answer? On what date next month

will we have the answer to that, Dr. Fauci?

Dr. FAUCI. You know, Mr. Chairman——

Senator SPECTER. Do you want a good appropriation this year

again?

Dr. FAUCI. I am going to give you the right answer for that appropriation, Mr. Chairman. We have fundamentally not environmental sensor-type research, but we have research to detect in the

very, very early stage if someone is exposed.

For example, you can do molecular diagnostics where, prior to

the virus being in a form where it could be culturable, when someone comes in with a suspected case, you would send a specimen

down to the CDC for identification.

What we are striving for in the research that is going on at the

NIH is to develop molecular techniques that can actually detect either the genetic material of the smallpox prior to the point where

it is obvious that it has turned into a disease, in other words, postexposure, but prior to the symptomatology stage.

Senator SPECTER. How practical is it to follow the recommendation of the Richmond medical unit to have 4,000 vaccines in a refrigerator to be able to spring into action? Can that be disseminated and dispersed around the country, so that we are in a position to respond within 4 days?

Dr. GERBERDING. The most important part of detection for this

problem is the astute clinician who recognizes the first patient. If

they miss the first patient, we will miss the 4-day window.

Senator SPECTER. Well, how good is our dissemination of information? We really ought to be able to educate the clinicians on

this, should we not?

Dr. GERBERDING. We are doing everything we can. That is part

of the 31⁄2 million kits that we are sending out to all clinics this

month.

Senator SPECTER. These are clinicians who went to medical

school. Did the medical school teach them?

Dr. GERBERDING. That is right, but, you know, they did not see

a case. I do not think there was much emphasis on any of these

agents when we were in school, because they are such rare diseases.

Senator SPECTER. Are the medical schools responding now?

Dr. GERBERDING. Yes, they are.

Senator SPECTER. They are now teaching it?

Dr. GERBERDING. Yes, they are.

Senator SPECTER. And the medical publications are carrying information to educate those who might not know it?

Dr. GERBERDING. The major medical journals have all carried articles. For example, the Journal of the American Medical Association, which is probably the most widely read journal, has had information for clinicians on every one of the select agents.

Senator SPECTER. Well, in the event that any clinician is now

watching C-SPAN, Dr. Gerberding, tell them what to look for. This

is a great educational tool.

Dr. GERBERDING. You are absolutely right. Any patient who presents with fever and a rash, particularly a rash that has evolved
62

over several days in the context of someone who is quite ill and has

the characteristic appearance of the——

Senator SPECTER. Symptoms?

Dr. GERBERDING. Symptoms of smallpox include high fevers,

muscle aches, head aches, and, in general, one of the reasons why

we can contain it after a case has developed is because the people

who have it are so sick that they are not out in the community

spreading it, they are home in bed, sometimes infecting their contacts.

Senator SPECTER. What should the clinician do after observing

such symptoms?

Dr. GERBERDING. If there is a suspicion, the immediate step is

to isolate the patient from others in the health environment so

there is no spread in the emergency room or the clinic. The second

thing is to call the——

Senator SPECTER. And what kind of facility should hospitals have

for isolating? I said that 2 days ago Senator Santorum and I were

at UPMC, University of Pittsburgh Medical Center, and they had

a decontamination room, if the next step is isolation, give a little

description to the hospitals as to what they ought to be doing to

prepare for that.

Dr. GERBERDING. Well, as Dr. Fauci said, this virus is primarily

spread by close contact. We call that droplet transmission, occasionally through the air, but most of the transmission is through

close contact, so simply taking the person and putting them in a

separate room, and preferably a room that has the same kind of

air circulation that we use for tuberculosis patients, and which

most facilities have now, because they had to do it as TB came

back in, so that you isolate them from spreading the virus through

their skin to other patients, and also through the air.

Senator SPECTER. Is there any real risk from moving the patient

from the time the clinician spots the symptoms to some room on

the sixth floor, or some distant part of the hospital?

Dr. GERBERDING. Well, we would like to be able to get patients

to that kind of area with the minimum amount of direct contact

with other health care workers and other patients.

Senator SPECTER. So you would recommend that this room be

close to the emergency entry?

Dr. GERBERDING. That would be ideal.

Senator SPECTER. What other tips do you have for the hospital?

Dr. GERBERDING. I think the hospitals really need to think about

how they will get all of the people in the front line of the delivery

system alert to this, because the infectious disease doctors and the

skin doctors are aware of it, but not all of the primary care doctors,

not all of the residents and interns, so there has to be a comprehensive commitment and education of all the clinicians who are

doing triage.

Senator SPECTER. So the hospitals ought to disseminate this information.

Dr. GERBERDING. The hospitals need to do it, and CDC and HHS

are working very hard to make sure they do have the tools.

Senator SPECTER. Does CDC have a nice booklet that could be

distributed to the hospitals to give to all the clinicians?
63

Dr. GERBERDING. We do. So far, we have distributed 70,000 copies of something called the fever rash poster, which outlines how

to diagnose and identify this disease and, as I said, this 31⁄2 million

mailing is going out as soon as we get all of the addresses of the

nurses and the clinicians at the local level.

Senator SPECTER. 31⁄2 million?

Dr. GERBERDING. Correct.

Senator SPECTER. Is that adequate?

Dr. GERBERDING. Well, it is the biggest step we have ever taken

to provide direct information in the hands of clinicians, but it

comes on top of the Internet, the satellite broadcast, CD–ROM’s,

the medical publications, our speaking at medical conventions and

so on.

Senator SPECTER. Is this information on symptoms available on

the Internet?

Dr. GERBERDING. Absolutely. This is a picture of the poster that

we have distributed to so many clinicians. This is a miniature

version of it. This is easily available on our web site.

Senator SPECTER. So tell anybody who is listening or watching

C–SPAN what to look for on the Internet.

Dr. GERBERDING. Go to www.cdc.gov, and one of the first headings there will link you directly to our smallpox page, and we have

a special service there that is just for clinicians, so they can go into

a segment of our web that gives them the specialized information

that a nurse or a physician or other medical provider would need.

Senator SPECTER. Dr. Gerberding, we are sort of winging it here

as to how you inform clinicians, but would you give some thought

and get back to the committee in a week as to what ought to be

done in a systematic way?

Dr. GERBERDING. Absolutely.

Senator SPECTER. And what you might require by way of funding

to get it done promptly, and maybe some allocation of current resources, with a commitment by the Congress to reimburse you so

you can go ahead and get this information available?

Dr. GERBERDING. Thank you, sir.

Senator SPECTER. Mr. Libbey, when smallpox vaccinations were

administered routinely in the 1950s and 1960s, did the public

health system carry out the follow-up actions, the extensive followup that you say is now necessary, and what has changed since then

that would require the extensive and costly follow-up that you have

testified about?

Mr. LIBBEY. Several conditions, to my knowledge, and I may

have been even younger then 9 at that point. There was not that

same level of extensive follow-up, a couple of reasons different. The

issue of risk and threat was different, because the disease was

present. I suspect if the disease were present now, we would have

less involved processes both in the vaccination and potentially in

the follow-up. We do know and anticipate that there will be adverse reactions.

We also know, absent 30 years of providing this vaccination, people are going to see the reaction and not understand that it is within, may well be within what is normally to be expected, there will

be inquiry that will demand time and attention, and that there will

be adverse reactions that need to be screened.
64

I would also suggest that one of the changes in the last 30 years

in some ways is a change, as was mentioned earlier, the potential

vulnerability of the population, but I would also suggest the nature, the litigious nature of our society has changed somewhat, that

makes having these pieces in place.

I would also point to, these are requirements of the program

guidelines provided to us for clinical operation of the program from

our Federal partners.

Senator SPECTER. Dr. Gerberding, you wanted to show your vaccination.

Dr. GERBERDING. Yes. I just wanted to make sure that the committee was aware of what the needles look like and what the vaccine would come like. I mentioned the Vaccipack that would be

taken out. If we had to vaccinate the population, we have already

kitted and ready to go the smallpox vaccine for 150,000 doses per

kit that our national pharmaceutical stockpile would deliver, and

what a kit looks like is basically this.

There is a small vial of vaccine that we would add a diluent to

using this needle, and then the vaccine needles that we are using

right now, we are distributing to you and the other members of the

committee, which is a little needle that looks like a miniature salad

fork or cocktail fork that would be poked into the arm 3 to 15 times

to administer the inoculation, and I think one of the achievements

of the appropriation that we have received this year is that our national pharmaceutical stockpile can do this efficiently and effectively, and we can simultaneously deliver this vaccine to every

major jurisdiction in the country within 24 hours, just like Federal

Express.

We can get this out from the stockpile repositories to the front

end very, very quickly. That is an enormous step forward in our capacity, and we absolutely would not have been able to do that without the support from this committee, both because we now have

enough vaccine to immunize everybody, so we have the supply, but

we also have this logistical system to get it to people if we need

it, so our preparedness has improved, and we really thank you so

much for that investment.

Senator SPECTER. Well, we are pleased to hear that the funding

the subcommittee has initiated has been so fruitful.

Well, we thank all of you for coming today. I think this has been

a very, very productive hearing in terms of identifying very, very

key factors, and perhaps in educating people as to what we need

to do, but a great deal more needs to be done, and this subcommittee intends to pursue the question of risk.

Dr. Fauci, just one more question to you. Do you have any indication as to which countries have smallpox potential for bioterrorism

attacks?

Dr. FAUCI. No, I do not, Mr. Chairman. The only thing I have

is what I believe you have also, is what we have read in the newspapers about various intelligence reports, but I do not have information of intelligence that you do not have yourself.

Senator SPECTER. Well, what we need to do is to try to make the

intelligence available to the public, if there is any, and we may not

be dealing with much to work on. We can pursue the line that the
65

Soviet Union had weaponized smallpox. That is an important factor.

This sort of comes under the same category as our effort to buy

down their nuclear weapons, the so-called Nunn-Lugar buy-down,

where have put in hundreds of millions of dollars, but we need to

get a better assessment on risk, and we need to have a better assessment as to the 4-day interval and move ahead with the identification of these symptoms, and to try to educate clinicians as to

what ought to be done, and then to try to get the hospitals to have

the isolation rooms like the one I saw on Monday to move ahead.

And I think time is of the essence. We cannot take anything for

granted. We have had a year-and-a-half, but who knows what is

going to come next.

Well, we will all pursue the matter together.

CONCLUSION OF HEARING

Thank you all very much for being here, that concludes our hearing.

[Whereupon, at 11:40 a.m., Wednesday, January 29, the hearing

was concluded, and the subcommittee was recessed, to reconvene

subject to the call of the Chair.]

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