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EXAMINING THE U.S. PUBLIC HEALTH RESPONSE 

TO SEASONAL INFLUENZA 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FOURTEENTH CONGRESS 

FIRST SESSION 

FEBRUARY 3, 2015 

Serial No. 114–6 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

TIM MURPHY, Pennsylvania 

Chairman 

DAVID B. MCKINLEY, West Virginia 

Vice Chairman 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

H. MORGAN GRIFFITH, Virginia 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

KATHY CASTOR, Florida 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

JOSEPH P. KENNEDY, III, Massachusetts 

GENE GREEN, Texas 

PETER WELCH, Vermont 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Tim Murphy, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 3 

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 5 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 6 

Prepared statement .......................................................................................... 7 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 9 

WITNESSES

Anne Schuchat, M.D., Director, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Department 

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

Prepared statement .......................................................................................... 14 

Answers to submitted questions ...................................................................... 112 

Karen Midthun, M.D., Director, Center for Biologics Evaluation and Research, Food and Drug Administration, Department of Health and Human 

Services ................................................................................................................. 26 

Prepared statement .......................................................................................... 28 

Robin A. Robinson, Ph.D., Director, Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness 

and Response, Department of Health and Human Services ............................ 37 

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

Answers to submitted questions ...................................................................... 115 

Anthony S. Fauci, M.D., Director, Nationa Institute of Allergy and Infectious 

Diseases, Nationl Institutes of Health ............................................................... 51 

Prepared statement .......................................................................................... 53 

SUBMITTED MATERIAL

Subcommittee memorandum .................................................................................. 99 

Letter of February 2, 2015, from Mr. Pallone, et al., to Mr. Upton, et al., 

submitted by Ms. DeGette ................................................................................... 109 

(1) 

EXAMINING THE U.S. PUBLIC HEALTH 

RESPONSE TO SEASONAL INFLUENZA 

TUESDAY, FEBRUARY 3, 2015 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:02 a.m., in room 

2123 of the Rayburn House Office Building, Hon. Tim Murphy 

(chairman of the subcommittee) presiding. 

Members present: Representatives Murphy, McKinley, Burgess, 

Blackburn, Griffith, Bucshon, Flores, Brooks, Mullin, Hudson, Collins, Cramer, Upton (ex officio), DeGette, Schakowsky, Castor, 

Tonko, Clarke, Kennedy, Green, Welch, and Pallone (ex officio). 

Also present: Representative Ellmers. 

Staff present: Charlotte Baker, Deputy Communications Director; 

Sean Bonyun, Communications Director; Leighton Brown, Press 

Assistant; Noelle Clemente, Press Secretary; Brad Grantz, Policy 

Coordinator, Oversight and Investigations; Brittany Havens, Legislative Clerk; Charles Ingebretson, Chief Counsel, Oversight and Investigations; Emily Newman, Counsel, Oversight; Alan Slobodin, 

Deputy Chief Counsel, Oversight and Investigations; Peter Bodner, 

Democratic Counsel; Elizabeth Letter, Democratic Professional 

Staff Member; and Nick Richter, Democratic Staff Assistant. 

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA 

Mr. MURPHY. Good morning. Today we convene the first meeting 

of this session of the Subcommittee on Oversight and Investigation 

of the 114th Congress. I welcome back Members who served here 

last session, particularly, my friend and colleague, Diana DeGette, 

the ranking member from Colorado, and the new members from 

the 114th Congress, which we hope, as we come up, you may introduce them today, and I will introduce ours on our side. 

The subcommittee is here to examine a very serious U.S. public 

health response to seasonal influenza. America is experiencing a 

severe flu season with an unstable predominant strain that could 

result in one of the deadliest and costliest flu seasons in recent 

memory. An estimated 50,000 people will die. Over 200,000 will be 

hospitalized, and most of these will be senior citizens. 

Last February, when public health officials needed to decide 

what strains would go into this year’s seasonal flu vaccine, the 

FDA bet on the wrong predominant strain. Just a few weeks after 

2 

the FDA’s decision, doubts were already beginning to creep in the 

scientific community about the FDA’s decision. By September, the 

U.S. vaccine was such a poor match for the dominant strain of flu 

that the World Health Organization, with consultation from the 

CDC, revised the vaccine formula, but not for the United States. 

It was changed for the Southern Hemisphere nations. In other 

words, the American people were stuck with a vaccine that wasn’t 

going to work for nearly 4 out of 5 people, and for nearly 9 out of 

10 seniors. Despite a growing body of knowledge that the vaccine 

for the United States would not be effective, production went forward anyway for a number of reasons that we hope to discuss 

today. 

With a mismatched strain, this year’s vaccine is estimated to be 

only 23 percent effective. It is even lower for the elderly at 12 percent. While this season’s vaccine has a lower-than-usual effectiveness, CDC is still recommending vaccinations for everyone 6 

months or older. In addition to vaccination, CDC has also recommended that all high-risk patients should be treated with 

antiviral drugs as soon as possible when influenza is suspected. 

So what are agencies doing to communicate with the public? 

Many are choosing not to vaccinate against the flu because they 

hear the vaccine doesn’t work, so why bother. We are seeing a similar result with measles vaccinations but for very different reasons, 

and now we are paying the piper for more than 100 cases have 

been stricken with a disease of measles that had once been eradicated from our shores. 

False rumors still exist that vaccines and a preservative for 

multi-dose vaccines, which once used a microscopic amount of mercury as a preservative to prevent bacteria growth, led to autism. 

There is no credible evidence to support that claim. In fact, mercury is not used as a preservative in the MMR vaccine, and in developing nations where vaccination rates have increased, autism 

rates have not changed. So in addition to understanding why this 

year’s flu vaccine missed so badly, and what should be done to protect the public in future years, I hope we can use this platform to 

educate the public and advance vaccine development in the interest 

of public health. 

Now on to the flu vaccine. We must know: Did the Federal Government do everything it could at the right time to respond to the 

challenge of this year’s flu season? As I noted, the CDC knew in 

late September that there was a significant mismatch, as great as 

50 percent, with the U.S. vaccine, however, the CDC did not issue 

a health advisory in response to this mismatch until more than 2 

months later. Did the CDC make the right public health decision 

to delay the health advisory, especially on delaying a recommendation to treat high-risk patients with antivirals? Could vaccine manufacturers have developed a new vaccine for high-risk groups? The 

CDC and the FDA tell us that the significant change in the strain 

could not have been addressed any earlier than September 2014, 

way too late to make changes in the U.S. vaccine. However, one flu 

expert at the University of Utah School of Medicine has stated on 

the record that there was a pretty good indication that the drifted 

strain by April or May 2014, that probably would have led to a deVerDate Mar 15 2010 09:03 Jun 23, 2015 Jkt 037690 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114_6SEASONALFLUSCAN_061915\114-6SEASONALFLUPDFMADE
3 

cision to change at that time if strain selection decisions for manufacturing were made in May instead of February. 

In hindsight, it was a bad decision, and thousands will die. Surely there are lessons to be learned here to do something different 

in the future, and we want to know how we can partner with these 

agencies to come up with some solutions. 

In 2009, when there was a similar outbreak of the swine flu, 

Federal agencies declared a public health emergency and responded by producing a monovalent, or single strain, vaccine to 

protect the public in a very short time. In only 12 weeks, they had 

developed this new vaccine. Here, we must know, was a 

monovalent rescue vaccine targeting the drifted strain a possible 

response? Who made the decision to not go forward with a different 

vaccine? If not, was this partly because the FDA and other agencies 

lacked emergency authority to respond? Did they recognize the 

problem and ask for authority to respond quicker? If an astounding 

50,000 deaths and 200,000-plus hospitalizations does not equal an 

emergency then what is? Shouldn’t we be treating this problem 

with more urgency, and is there even a backup plan in the event 

a vaccine mismatch to a deadly strain exists? 

HHS has set a goal for vaccines to vaccinate 70 percent of their 

population as part of the Healthy People 2020 initiatives, but overall vaccination rates in the U.S. have been around 45 to 46 percent 

in the last few years. CDC has not even met its target of 50 percent. Does the CDC have an effective strategy to increase vaccination rates, or is there a better strategy for reducing flu deaths than 

seeking further increases of vaccination rates in all subgroups? 

So we are here today to challenge some of the policies and decisions, but in the spirit of us all working together to make improvements in the public health response to seasonal flu. I am encouraged by the potential of ongoing research and innovation. We appreciate the cooperation and attendance of these excellent witnesses from the CDC, the FDA, NIH, and BARDA. We need your 

input to help us decide how we change this system for the better. 

I welcome our witnesses today, and thank them for help in this inquiry. 

[The prepared statement of Mr. Murphy follows:] 

PREPARED STATEMENT OF HON. TIM MURPHY

Today we convene the first meeting of the Subcommittee on Oversight and Investigations in the 114th Congress. I welcome back members who served here last session, particularly my friend and colleague, Diana DeGette, the ranking member, and 

our new members for the 114th Congress. 

The subcommittee is here to examine the U.S. public health response to seasonal 

influenza. America is experiencing a severe flu season with an unstable predominant strain that could result in one of the deadliest and costliest flu seasons in recent memory. An estimated 50,000 people will die. Over 200,000 will be hospitalized, most of these will be senior citizens. 

Last February, when public health officials needed to decide what strains would 

go into this year’s seasonal flu vaccine, the FDA bet on the wrong predominant 

strain. Just a few weeks after the FDA’s decision, doubts already were already beginning to creep in the scientific community about the FDA’s decision. By September, the US vaccine was such a poor match for the dominant strain of flu that 

the World Health Organization, with consultation from the CDC, revised the vaccine 

formula—But, not for the United States. It was changed for the Southern Hemisphere nations. 

4 

In other words, the American people were stuck with a vaccine that wasn’t going 

to work for nearly 4 out of 5 people and nearly 9 out of 10 seniors. Despite a growing body of knowledge that the vaccine for the United States would not be effective, 

production went forward anyway for a number of reasons we will discuss today. 

With a mismatched strain, this year’s vaccine is estimated to be only 23 percent 

effective. It’s even lower for the elderly (12 percent). 

While this season’s vaccine has lower-than-usual effectiveness, CDC is still recommending vaccination for everyone 6 months or older. In addition to vaccination, 

CDC has also recommended that all high-risk patients should be treated with 

antiviral drugs as soon as possible when influenza is suspected. What are agencies 

doing to communicate to the public? 

Many are choosing not to vaccinate against the flu because they hear the vaccine 

doesn’t work, so why bother. We’re seeing a similar result with measles vaccinations 

but for very different reasons, and now we’re paying the piper as more than 100 

have been stricken with a disease of measles that had once been eradicated from 

our shores. 

False rumors still exist that vaccines and a preservative for multi-dose vaccines, 

which once used a microscopic amount of mercury as a preservative to prevent bacteria growth, led to autism. There is no credible evidence to support that claim. In 

fact, mercury is not used as a preservative in the MMR vaccine, and in developing 

nations where vaccination rates have increased, autism rates have not changed. 

So in addition to understanding why this year’s flu vaccine missed so badly—and 

what should be done to protect the public in future years—I hope we can use this 

platform to educate the public and advance vaccine development in the interest of 

public health. 

Now on the flu vaccine, we must know: Did the Federal Government do everything it could at the right time to respond to the challenge of this year’s flu season? 

As I noted, the CDC knew in late September that there was a significant mismatch—as great as 50 percent—with the U.S. vaccine. However, the CDC did not 

issue a health advisory in response to this mismatch until more than two months 

later. Did the CDC make the right public-health decision to delay the health advisory, especially on delaying a recommendation to treat high-risk patients with 

antivirals? Could vaccine manufacturers have developed a new vaccine for high risk 

groups? 

The CDC and the FDA tell us that the significant change in the strain could not 

have been addressed any earlier than September 2014, way too late to make 

changes in the U.S. vaccine. However, one flu expert at the University of Utah 

School of Medicine has stated on the record that there was a pretty good indication 

about the drifted strain by April or May 2014, that ‘‘probably’’ would have led to 

a decision to change at that time if strain selection decisions for manufacturing were 

made in May instead of February. In hindsight it was a bad decision—and thousands will die. Surely there are lessons to be learned here to do something different 

in the future. 

In 2009, when there was a similar outbreak of the swine flu, Federal agencies declared a public health emergency and responded by producing a monovalent—or single strain—vaccine to protect the public in a short time. In only 12 weeks they had 

developed this new vaccine. Here we must know—was a monovalent ‘‘rescue’’ vaccine targeting the drifted strain a possible response? Who made the decision not to 

go forward with a different vaccine? 

If not, was this partly because the FDA and other agencies lacked emergency authority to respond? Did they recognize the problem and ask for authority to respond 

quicker? 

If an astounding 50,000 deaths and 200,000-plus hospitalizations does not equal 

an emergency then what is? Shouldn’t we be treating this problem with more urgency? 

Is there even a backup plan in the event of a vaccine mismatch to a deadly strain? 

HHS has set a goal for States to vaccinate 70 percent of their population as part 

of the Healthy People 2020 initiative, but overall vaccination rates in the U.S. have 

been around 45 to 46 percent the last few years. CDC has not even met its target 

of 50 percent vaccination. Does CDC have an effective strategy to increase vaccination rates? Or is there a better strategy for reducing flu deaths than seeking further 

increases of vaccination rates in all subgroups? 

So we’re meeting here today to challenge some aof the policies and decisions, but 

in the spirit of us all working together to make improvements in the public health 

response to seasonal flu. I am encouraged by the potential of ongoing research and 

innovation. We appreciate the cooperation and attendance of witnesses from CDC, 

FDA, NIH and BARDA. We need your input to help us decide how we change this 

system for the better. 

5 

I welcome our witnesses today and thank them for their help in this inquiry. 

Mr. MURPHY. And I recognize the ranking member for 5 minutes. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you so much, Mr. Chairman. I am really 

happy that our first hearing of this new Congress is on an area of 

bipartisan concern and interest. And I want to join you in welcoming our new members on both sides of the aisle to this committee. This is a venerable committee that has a long history of bipartisan investigations, and I think it is going to be a really important year to continue this trend. 

Flu preparedness and response is incredibly important, and this 

committee has a long history of hearings and investigations on this 

issue. What we need to do is come together in support of a strong 

public health infrastructure that prevents outbreaks, and responds 

quickly and appropriately when they occur. 

These past several months have been a harsh reminder that infectious disease is all around us. Last October and November, this 

subcommittee convened hearings on the Ebola outbreak and the 

dire situation in West Africa. We saw and, frankly, continue to see, 

the deadly consequences of a breakdown in the public health infrastructure there. Fortunately, we are now seeing the lowest number 

of new Ebola cases since last June, largely because of international 

efforts both to build and operate effective Ebola treatment centers, 

and also education of local populations on Ebola prevention and 

control. But, you know, it is interesting because as much attention 

as we have given to Ebola in this country, far more people die 

every month from influenza than they do of Ebola, and this is a 

continuing problem. 

This month, we are hearing about the measles outbreak, which 

was linked to Disneyland in California and has now spread to at 

least 14 States. Infectious disease experts at the CDC and the 

State health departments have mounted a fast and aggressive response to prevent this highly contagious disease from spreading. 

And, Mr. Chairman, I know you have received a letter from me 

and Ranking Member Pallone and Ranking Member Green asking 

this committee to hold a targeted hearing on the measles outbreak 

and the urgent public health threat. I would like to make a copy 

of that letter part of the record, Mr. Chairman. 

[The information is available at the conclusion of the hearing.] 

And, while that letter is pending, I want to commend you, Dr. 

Fauci. I saw you on the news last night telling all of the families 

in America to get their measles vaccine, and I really appreciate 

that. I want to add from this podium, as the mother of two daughters, one of whom is immunocompromised: Vaccinate your children 

against measles. There is no reason not to, and there is every reason that they could be a threat to themselves and other children 

if they don’t get that vaccine. So I just want to pile onto that. It 

is very, very important. 

But on to the flu, which is the topic of this hearing, the predominant strain of flu is H3N2, which is resulting in increased hosVerDate Mar 15 2010 09:03 Jun 23, 2015 Jkt 037690 PO 00000 Frm 00009 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114_6SEASONALFLUSCAN_061915\114-6SEASONALFLUPDFMADE
6 

pitalizations, particularly for vulnerable populations like seniors 

and young children. And the CDC announced several weeks ago 

that the flu vaccine has only 23 percent effectiveness. That is significantly lower than in recent years, and as the chairman mentioned, it is largely due to changes in the virus that have resulted 

in a mismatch between the strain of the virus used in vaccine production and the one actually circulating. But even with a 23 percent effectiveness, we still need to protect ourselves as much as we 

can. Dr. Frieden reminded us several weeks ago that even a vaccine with 23 percent effectiveness will still prevent millions of people from getting sick. And so, therefore, as the chairman said, people also need to get this vaccine. And it is not too late; flu season 

is still going on. We have to do everything we can to protect our 

vulnerable populations; young children, seniors, pregnant women, 

and others with compromised immune systems. 

So I am looking forward to hearing from our wonderful witnesses 

today about what we can do to mitigate the effects of this flu season, and how doctors and hospitals are prepared to respond. I also 

want to look to the future. What can we do to inform our prevention and response efforts in future flu seasons? I want to hear 

about the research and technological developments in diagnostics, 

antiviral treatments, and vaccines. 

In our last hearing on this topic in February 2013, we heard 

about FDA approval of quadrivalent vaccines and cell base technology. Today, I am hoping our witnesses can give us encouraging 

news about the development of a universal flu vaccine. 

So regardless of the particular effectiveness rate in a given season, the flu vaccine remains the best tool that we have to protect 

as many people as possible, and we need to have ongoing work on 

that. This flu season reminds us that it is almost impossible to predict what the strain will be, but it underscores the importance of 

a strong public health infrastructure. 

And so, Mr. Chairman, I just want to say I appreciate the witnesses coming today. I hope we can all work together to move the 

country toward better flu preparedness. 

Mr. MURPHY. I thank the gentlelady. And now recognize the 

chairman of the full committee, Mr. Upton, for 5 minutes. 

OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. UPTON. Well, thank you, Mr. Chairman. 

This is an important issue, that is for sure, and it has been an 

especially harsh flu season, and preliminary estimates show that 

this year’s vaccine is only 23 percent effective in preventing folks 

from going to the doctor for treatment, even lower for high-risk 

groups, which is often the case I know. 

Usually, the flu vaccine is about 50 to 60 percent effective, and 

I, like many folks back in Michigan and across the country, would 

like to see us do better in addressing this major public health 

threat. 

Every year, between 5 and 20 percent of Americans get the flu. 

In a severe flu season like this one, there could be more than 

50,000 deaths, over 200,000 hospitalizations, and more than $10 

7 

billion spent on direct medical costs. The flu is and should be a top 

priority for all of U.S. public health. 

This year’s vaccine, we know, is less effective because it is not 

a good match for the flu strain that has become dominant. The flu 

virus strain changed significantly during the 6 months after the 

strain selection decision for the U.S. was made. The World Health 

Organization, in September, recommended changing the flu vaccine 

for the Southern Hemisphere to use in their upcoming flu season 

that starts in April but by the time the change in virus was evident, it was too late to change the U.S. vaccine. 

Now, it is worth pointing out that the CDC continues to recommend vaccinations in the U.S., even with a lower effectiveness, 

and that high-risk patients should be treated as soon as possible 

with all antiviral drugs. 

When we learned that there was a shift in the virus, what options were available to respond to the mismatch in viruses? Was 

there a way to deploy a rescue vaccine targeting just the changed 

virus? Was there a way to improve the effectiveness of this year’s 

vaccine by adding substances to boost the immune response? Those 

are some of the questions that we need to have answered as we 

proceed with this hearing. 

And I appreciate the folks that are testifying today and yield to 

Dr. Burgess and then to Marsha Blackburn. 

[The prepared statement of Mr. Upton follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

Thank you, Mr. Chairman, for convening this hearing on the U.S. public health 

response to seasonal influenza. We remain in the midst of a particularly harsh flu 

season and preliminary estimates show that this year’s vaccine is only 23 percent 

effective in preventing folks from going to the doctor for treatment, even lower for 

high-risk groups. Usually, the flu vaccine is about 50–60 percent effective. I, like 

many folks back in Michigan and across the country, believe we can do better in 

addressing this major public healththreat. 

Every year between 5 percent and 20 percent of Americans get the flu virus. In 

a severe flu season like this one, there could be up to 50,000 deaths, over 200,000 

hospitalizations, and more than $10 billion spent on direct medical costs. The flu 

is, and should be, a top priority for U.S. public health. 

We understand that the reason this year’s vaccine has lower effectiveness is because it is no longer a good match for the flu strain that has become dominant. The 

flu virus strain changed significantly during the six months after the strain selection decision for the U.S. vaccine was made, and we have been told it was too late 

to change the vaccine for the U.S. As a result of the evidence of change in the virus, 

the World Health Organization in September 2014 recommended changing the flu 

vaccine for the Southern hemisphere to use in their upcoming flu season that starts 

in April. The CDC continues to recommend vaccination in the United States, even 

with the lower effectiveness, and that high-risk patients be treated as soon as possible with anti-viral drugs. 

While it is difficult to know when or how seasonal flu viruses are likely to change, 

leading to a need to change the vaccine for that year, we have made significant improvements in the past 10 years and it seems like we should be able to do better. 

There were known weaknesses in the surveillance system. In 2011, the World 

Health Organization conference found that a key test used to check for flu virus 

changes was not very effective in detecting evidence of changes in the deadliest flu 

strain. Our understanding is that this same test is still used. What tests were used 

as an alternative to the inadequate test? 

And when we learned that there was a shift in the virus, what other options were 

available to respond to the mismatch in viruses? Was there a way to deploy a rescue 

vaccine targeting just the changed virus? Was there a way to improve the effectiveness of this season’s vaccine by adding substances that boost the immune response? 

8 

Improving our response to a severe flu season with a mismatched vaccine could 

mean saving thousands of lives. My concerns and questions do not diminish my admiration and support for the dedication of the U.S. public health agencies working 

on flu preparedness. It is because of their talent and hard work that I believe improvement is really possible. We can work together to make that happen. I am also 

eager to learn about the latest research and innovation, and how we can better support and leverage these advances to improve our response to seasonal influenza. 

I welcome all our witnesses, and look forward to their testimony. 

Mr. BURGESS. I thank the chairman for yielding. And, Mr. Chairman, thank you for holding the hearing today. 

In fiscal year 2014, the estimated Federal investment in seasonal flu preparedness exceeded $850 million. The public-private partnership driving research and development has had successes, but we 

must do better. 

First, communication between agencies and with the public must 

improve. If there is a mismatch in the vaccine, which became apparent in May or even as late as September, it is unacceptable that 

advisories were not issued until December. Second, there must be 

transparency and consistency in the regulatory pathways for innovation in vaccines. Experts have recognized the promise of 

adjuvanted flu vaccines for over a decade, yet not one is licensed 

in the United States, and no guidance has been issued. Third, 

greater emphasis must be placed on modernizing the development 

and manufacture of flu vaccines. I would add my acknowledgement 

to the ranking member of the subcommittee, I too at one time was 

promised a universal flu vaccine, I think in this committee at a 

hearing just like this. That was probably in 2004 or 2005. We are 

still waiting. We want to see it. 

So I appreciate the opportunity to be able to speak on this. I look 

forward to hearing from our witnesses. 

And I will yield the balance of the time to Mrs. Blackburn, Vice 

Chair of the full committee. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. And I want to continue our conversation about vaccinations. And, yes, we are talking 

about flu today, but there is another issue out there and Ms. 

DeGette mentioned this. Vaccine politics injected into 2016, measles outbreak infects politics and debate. 

Now, this is far too serious an issue to be treated as a political 

football. People still die from measles. And the CDC Web site tells 

us it was eliminated from the U.S. in 2000, but yet we are seeing 

this outbreak. And I have to tell you, it is of tremendous concern 

to me as a mother and a grandmother. I am hearing so much about 

this from my constituents, and they want to know some answers, 

they want to know how you all are addressing this. And I will tell 

you, when I hear about counties in California that have lower immunization rates than the Sudan and Chad, this is something that 

is of concern to me. 

I am a Rotarian. We have invested decades into eliminating and 

wiping out polio, and then to hear this about the U.S., I am concerned. 

We know the measles outbreak started in California. It has affected over 100 people in 14 States, and that most of those people 

were not vaccinated. So we do want to veer off and ask you some 

questions in this realm today. 

And I yield back. 

9 

Mr. MURPHY. The gentlelady yields back. I now recognize Mr. 

Pallone for 5 minutes. 

Mr. PALLONE. Thank you, Mr. Chairman, and thanks for holding 

this hearing today. 

I have to tell Ms. DeGette that this is actually the first time that 

I have been a member of the O&I Subcommittee, so I am very 

happy. 

Ms. DEGETTE. And we are happy to have you, Mr. Pallone. 

Mr. PALLONE. Thank you. 

Mr. MURPHY. Welcome aboard. It is the best subcommittee in 

Congress. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you. So this year, we are seeing a severe 

flu season. Across the country, hospitalization rates are higher, especially for seniors over age 65, and for young children, and public 

health experts predict these flu activity levels will continue and 

even increase in the next few weeks. 

The Centers for Disease Control and Prevention continues to recommend that we all get the flu vaccine. Initial estimates show that 

this year’s flu vaccine is 23 percent effective, meaning that 23 percent of those vaccinated for the flu will still have to visit a doctor 

because of the flu. But despite being less effective this year than 

the recent past, flu shots will still protect against and decrease the 

severity of flu-related illnesses. Moreover, flu shots don’t only protect the vaccinated, they also protect those who have not been vaccinated from getting sick, and as members of Congress, I think we 

all have to play a role to ensure that message gets out and it is 

not too late to get your flu vaccine. 

This hearing is also a good opportunity to talk about how we can 

improve vaccination rates. We took important steps in the ACA to 

provide coverage for preventative services like immunizations. 

Since the law went into effect, nearly 76 million Americans have 

received no-cost coverage for preventative services, and as millions 

more receive coverage through the ACA, we hope to see the vaccination rate improve so that we can realize the benefits of a better-protected population. However, we still must improve public 

awareness, and continue to improve access to these preventative 

services. This is especially of concern as we hear reports of the 

measles outbreak that began at Disneyland, and is now spreading 

throughout the country. Just yesterday, the President urged all 

parents to get their children vaccinated against measles, and I 

would certainly echo his comments. 

Dr. Tom Frieden, who heads the CDC, is warning that the U.S. 

could see a large outbreak of measles. There are now over 100 

cases in 14 States, and measles is extremely contagious, 90 percent 

of those exposed to the disease will be infected unless they have 

been vaccinated. According to Dr. Frieden, there has been growing 

evidence that more parents are not vaccinating their children 

against measles, and that these lower vaccination rates have led to 

the latest increase in measles cases. The CDC is further assuring 

families, and parents especially, that the measles vaccine is safe 

10 

and effective, and we were able to eliminate measles in the U.S. 

in 2000, largely because of a highly effective vaccination program. 

So it is important to reiterate that measles is a preventable disease 

for which there are safe, effective and available vaccines. 

So I look forward to hearing from our public health officials 

today about how we can improve vaccination rates for the flu, but 

we also need to learn how we can improve vaccination rates for the 

future for other infectious diseases, including measles. 

I know that Ms. DeGette mentioned that both herself and Mr. 

Green and myself sent a letter yesterday asking for a hearing with 

regard to the measles public health emergency, and I hope that we 

can actually see that occur. I think it would be very important. And 

I just want to thank everyone. 

And I would now yield the balance of my time to Representative 

Castor. 

Ms. CASTOR. Well, thank you for yielding the time, and good 

morning. Thank you, Mr. Chairman and Ranking Member DeGette, 

for holding this important hearing to better understand the flu and 

the flu vaccine. 

Vaccines are incredibly valuable tools to protect and improve the 

health of all of our neighbors. And as we have seen with the recent 

and surprising measles outbreak, vaccines protect lives. According 

to reports, there have been 102 cases of measles reported across 14 

States, and those who do not vaccinate their children are putting 

them at risk, and they are putting others at risk. Vaccines are safe 

and effective. 

I want to give particular thanks to Dr. Schuchat from the Centers for Disease Control for traveling to the Tampa Bay area a few 

months back to raise awareness with another important vaccine, 

the anti-cancer vaccine of HPV. Thank you for meeting with our 

public health students, and anti-cancer advocates to explain. See, 

Florida had one of the lowest rates of HPV vaccines, and we can 

save lives and prevent cancer if people will understand the importance of the HPV vaccine. Your visit was a great boost to our efforts to prevent cancer through the HPV vaccine, so thank you 

again for the work you do to educate the public on vaccinations. 

You know, we are so fortunate to live in America where we have 

studied and investigated and tested all of these vaccines to ensure 

that they are safe and effective. So thank you to all the panelists 

for all the work you do, and I look forward to your testimony. 

I yield back. 

Mr. MURPHY. Thank you. 

I would now like to introduce the witnesses on the panel for today’s hearing. First is Dr. Anne Schuchat. Did I pronounce that 

correctly? The director of the National Center for Immunization 

and Respiratory Diseases at the Center for Disease Control and 

Prevention. Dr. Karen Midthun is the director for the Center for 

Biologics Evaluation and Research at the U.S. Food and Drug Administration. Dr. Robin Robinson, the director of Biomedical Advanced Research and Development Authority, otherwise known as 

BARDA, within the Office of the Assistant Secretary for Preparedness and Response. And Dr. Anthony Fauci is the director of the 

National Institute of Allergy and Infectious Diseases at the NaVerDate Mar 15 2010 09:03 Jun 23, 2015 Jkt 037690 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114_6SEASONALFLUSCAN_061915\114-6SEASONALFLUPDFMADE
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tional Institutes of Health. I welcome you all here and we look forward to your testimony. 

I will now swear in the witnesses. 

You are aware that this committee is holding an investigative 

hearing, and when doing so, has the practice of taking testimony 

under oath. Do any of you have any objections to testifying under 

oath? Seeing no objections, the Chair then advises you that under 

the rules of the House and the rules of the committee, you are entitled to be advised by counsel. Do any of you desire to be advised 

by counsel during your testimony today? Everybody has said no. In 

that case, if you would please rise and raise your right hand, I will 

swear you in. 

[Witnesses sworn.] 

Mr. MURPHY. Thank you. You are now under oath, and subject 

to penalties set forth in Title XVIII, section 1001 of the United 

States Code. You may each now give a 5-minute summary of your 

written statement. Make sure you pull the microphone close to you, 

and watch that red light. 

Dr. Schuchat, you can begin. 

STATEMENTS OF ANNE SCHUCHAT, M.D., DIRECTOR, NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY 

DISEASES, CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; 

KAREN MIDTHUN, M.D., DIRECTOR, CENTER FOR BIOLOGICS 

EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; 

ROBIN A. ROBINSON, PH.D., DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS 

AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN 

SERVICES; AND ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH 

STATEMENT OF ANNE SCHUCHAT 

Dr. SCHUCHAT. Good morning, Mr. Chairman, and members of 

committee. I am Dr. Anne Schuchat, Director of the National Center for Immunization and Respiratory Diseases at the Centers for 

Disease Control and Prevention. 

Influenza virus is a formidable adversary. Influenza’s propensity 

to change presents unique challenges. New flu vaccines must be developed each year based on the predictions of which viruses are 

likely to be most common during the next season. Vaccine development is complex and time-consuming, typically requiring vaccine 

candidates that grow well in eggs and provide immunity in humans. And while we tackle seasonal flu, we must conduct constant 

global surveillance and prepare for the emergence of dramatically 

changed or shifted influenza virus that could trigger the next pandemic. 

Over the past decade, we have made significant improvements in 

our ability to detect, prevent, and respond to influenza, yet, despite 

our improvements, the current severe influenza season has been 

difficult. My colleagues and I represent agencies that work together 

12 

to respond to seasonal and pandemic flu. The NIH supports research on vaccines, diagnostic tools, and antiviral drugs for seasonal and pandemic influenza. The Food and Drug Administration 

regulates influenza vaccines, convening public health and influenza 

disease experts to recommend which influenza virus strains should 

be included in FDA-licensed vaccines. 

The Biomedical Advanced Research and Development Authority, 

BARDA, supports advanced research, development, and procurement of innovative medical countermeasures to address manmade 

and emerging infectious diseases, including influenza pandemics. 

And at CDC, we support surveillance and diagnostic capacity to 

rapidly detect, prevent, and respond to annual influenza epidemics, 

and novel and pandemic influenza threats. 

Our CDC systems provide the scientific basis for global vaccine 

virus selection for seasonal flu, vaccine as well as for pandemic vaccine stockpiling. We monitor for genetic changes in the flu virus, 

and identify how these changes affect disease transmission and severity. We build public awareness and provide our knowledge about 

prevention and early treatment, and support public sector delivery 

of routine and emergency immunizations. 

The 2014/15 influenza season has proven a particularly bad season. The virus that is predominant, H3N2, is associated with more 

severe disease. The vaccine we are using is not well matched to circulating H3N2 strains. Antivirals can be important aids in some 

patients, but clinicians are underutilizing them. 

How do we find ourselves with vaccine that isn’t well matched 

to the circulating H3N2 viruses? When the 2014/15 flu vaccine 

strains were selected last February, the drifted virus we are seeing 

now was not yet detected. A small number of these drifted viruses 

were first detected in March 2014, and CDC continued to monitor 

them throughout the summer, looking for genetic patterns and geographic spread. 

In September 2014, when we began promoting seasonal vaccination, about 1⁄2 of the H3N2 viruses circulating were like the vaccine 

component. When the influenza season took off at the end of November, only 1⁄3 of the H3N2 viruses CDC detected were like the 

vaccine component. Our early vaccine effectiveness estimate found 

people vaccinated had about 23 percent lower risk of influenza infection requiring a medical visit. While this is lower than we usually see, the vaccine is providing some protection. 

Influenza viruses follow their own schedules, not ours. New 

strains can emerge at any time. Some appear and die out, and others persist and spread. Our actions are proportional to risks. We 

work year-round to detect and characterize viruses of concern that 

circulate globally, monitor their emergence and geographic spread, 

and develop viable vaccine candidates for drift viruses as they 

occur. When we detected relatively small numbers of the drifted 

H3N2 strain late last spring, CDC began preparing candidate vaccine virus strains. 

As the Nation’s public health agency, we are committed to provide the information people need to protect their patients’ and families’ health, and to be transparent in our assessments and the evidence base that supports our recommendations. 

13 

As a physician and a public health professional, I too wish we 

could guarantee better protection each year, yet, we have made significant advances on several fronts. Our surveillance network is 

characterizing more viruses with improved methods. Significantly 

more Americans get flu vaccine each year, and information on viruses, disease, and vaccination is released more rapidly. 

In closing, this flu season has caused more suffering and serious 

disease than many previous years, and there will be more challenging seasons ahead, but collaboration across the agencies, and 

with our public and private partners, holds promise for the future, 

including progress toward development of universal influenza vaccines, since better, broader, and long-lasting protection could transform our approach to this challenging virus. 

[The prepared statement of Dr. Schuchat follows:] 

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Mr. MURPHY. Thank you. 

Dr. Midthun, you are recognized for 5 minutes. Thank you. Make 

sure the microphone is turned on and it is close to you. Thank you. 

You still have to turn it on. Press the—there you go. 

STATEMENT OF KAREN MIDTHUN 

Dr. MIDTHUN. Thank you. Mr. Chairman and members of the 

subcommittee, I am Dr. Karen Midthun, Director of the Center for 

Biologics Evaluation and Research, the center within FDA that is 

responsible for regulating vaccines. Thank you for the opportunity 

to be here today to discuss our role in a highly collaborative, multipartnered effort in preventing influenza through vaccination in the 

U.S. 

Influenza viruses continually undergo changes in their genetic 

makeup, and the resulting proteins that interact with the immune 

system. Due to these continuous changes, the composition of influenza vaccines must be periodically updated so that they are effective against what are anticipated to be the predominant circulating 

viruses in the upcoming influenza season. 

The strains of virus in the vaccine include 2 distinct subtypes of 

influenza A, H1N1, and H3N2, and 1 or 2 influenza B strains, depending upon whether the vaccine is trivalent or quadrivalent. To 

identify virus strains likely to cause illness during the upcoming 

season, the World Health Organization convenes influenza and 

public health experts to study recently circulating influenza viruses 

from around the world, and recent global disease patterns. After 

careful evaluation of the assessment, WHO makes recommendations on the composition of the influenza vaccines, usually in late 

February for the upcoming season in the Northern Hemisphere, 

and in September for the upcoming season in the Southern Hemisphere. The recommendations must be made months in advance because of the time required for manufacturing, testing, lot release, 

and distribution of a very large number of vaccine doses. 

Each year, following the WHO recommendations, FDA convenes 

its vaccines and related biological products advisory committee, 

typically in late February or early March. The committee considers 

the WHO recommendations and reviews information regarding viruses that caused illness in the previous year, how these viruses 

are changing, and disease trends. Based on the data available at 

the time of the meeting, the committee makes recommendation for 

the composition of the influenza vaccines licensed by FDA for the 

upcoming season in the U.S. Once the strains are selected, candidate influenza viruses that are adapted for high growth are generated and accepted by WHO collaborating centers, and are provided to manufacturers who generate the seed viruses for manufacturing vaccines. The manufacturing demands are tremendous and 

the timelines are tight. No other vaccine is produced, FDA approved and distributed every year across the U.S. within a sixmonth time frame. 

This season, more than 150 million doses were manufactured. 

Given the yearly need for a new vaccine, there is limited flexibility 

in the timelines of vaccine manufacturing and availability. And 

parallel with vaccine manufacturing, FDA develops and calibrates 

reagents which are used by both FDA and the manufacturers to 

27 

test vaccines for potency and identity before FDA approves the new 

formulation for distribution. Manufacturers submit their vaccine 

testing results, along with samples from each lot, to FDA for lot release. As FDA releases lots, the manufacturers can make these lots 

commercially available throughout the U.S. 

In February 2014, when the strain selection recommendation for 

the current influenza season was made, it reflected the circulating 

viruses. The drifted H3N2 viruses were first detected in March 

2014 and were uncommon. Over the ensuing months, the drifted 

strains gradually increased. By late September, when WHO made 

its recommendations for the 2015 Southern Hemisphere influenza 

vaccine, the drifted H3N2 strains were common, prompting a recommended change in the upcoming Southern Hemisphere vaccine 

composition. Because of the manufacturing time required, there 

was not enough time to make a similar change for the current 

Northern Hemisphere influenza season. The drifted strains have 

caused the majority of influenza cases this season, however, vaccination is still important to prevent disease and minimize the public health burden of influenza. Influenza vaccines contain three or 

four influenza viruses, so even when there is a less than ideal 

match or lower effectiveness against one virus, the vaccine may 

protect against the other viruses. 

FDA has made progress in our preparedness efforts and collaboration with BARDA, CDC, NIH, manufacturers, and other stakeholders, and we thank Congress for your support of these efforts. 

New influenza vaccines have been licensed, including cell-based, recombinant protein vaccines and quadrivalent vaccines. To enhance 

pandemic preparedness, FDA licensed an adjuvanted H5N1 avian 

influenza vaccine, and has worked with U.S. Government partners 

and manufacturers to facilitate the development of candidate vaccines directed at H7N9 avian influenza. Surveillance efforts are 

more extensive than ever before, and offer the potential for early 

detection of emerging viruses. The number of candidate vaccine 

virus strains available to manufacturers has greatly increased over 

the last few years, providing them with more options to increase 

vaccine yields. We continue efforts with our Government partners 

to develop high-yield candidate vaccine strains, as well as more 

modern, faster testing methods for vaccine potency and sterility. To 

further address the challenges presented by the constantly changing nature of influenza viruses, scientists and Government laboratories, academic institutions, vaccine manufacturers, are all working to develop new generation vaccines that might provide longerlasting and broader protection against influenza viruses, including 

drifted strains. Although these development efforts are still in early 

stages, some may have the potential to increase and broaden protection against influenza. 

FDA will continue to work with its Government partners, manufacturers, and other stakeholders to facilitate development of new 

vaccines, and identify methods that have the potential to speed the 

manufacturing process for existing vaccines. Our goal is to better 

protect the American public against influenza. 

Thank you. 

[The prepared statement of Dr. Midthun follows:] 

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Mr. MURPHY. Thank you. 

Now, Dr. Robinson, you are recognized for 5 minutes. 

STATEMENT OF ROBIN A. ROBINSON 

Dr. ROBINSON. Good morning, Chairman Murphy, Ranking Member DeGette, and distinguished members of the subcommittee. 

Thank you for the opportunity to speak with you today. I am Dr. 

Robin Robinson, Director of the Biomedical Advanced Research and 

Development Authority, and Deputy Assistant Secretary for Preparedness and Response, as well as a former developer of influenza 

vaccines in industry. 

BARDA is the Federal Government agency mandated to support 

advanced research and development, and procurement of novel and 

innovative medical countermeasures such as vaccines, therapeutics, 

diagnostics, and medical devices for the entire Nation to address 

the medical consequences of manmade and naturally occurring 

threats like the H1N1 pandemic, the 2013 H7N9 influenza outbreak, and the current Ebola epidemic. 

Pandemic influenza is one of our primary concerns. We understand that preparedness for pandemic influenza is directly tied to 

seasonal influenza. Medical countermeasures for seasonal influenza 

underpin the vaccines, antivirals, and diagnostics used for pandemic influenza. BARDA has invested in the advanced development of medical countermeasures that have utility for both seasonal and pandemic influenza preparedness. 

BARDA transitions medical countermeasures from early research 

and development at NIH, into advanced development toward FDA 

approval and potential procurement. BARDA has funded and successfully managed the advanced development of more than 60 medical countermeasures for pandemic influenza. More than 20 of 

these medical countermeasures for influenza have been FDA approved, with 6 receiving approval in the last 3 years, as Dr. 

Midthun indicated. Additionally, BARDA developed and procured 

vaccines and antivirals used in the 2009 H1N1 pandemic, and 

stockpiled vaccines for preparedness against H5N1 and H7N9 viruses. BARDA, through partnerships with NIH, CDC, FDA, industry, and academia, has met and overcome many but not all of the 

challenges inherent to making medical countermeasures associated 

with seasonal and pandemic influenza. Specifically, BARDA, with 

our partners, has made major progress in the following pandemic 

areas. 

First, modernization of influenza vaccine manufacturing through 

the development and licensure of new cell- and recombinant-based 

influenza vaccines, and antigen-sparing pandemic vaccines with adjuvants towards meeting our strategic goal of more and better influenza vaccines sooner. These new vaccines were part of our successful H7N9 response in 2013. 

Second, shortening influenza vaccine manufacturing time by 

weeks, effected through the Influenza Vaccine Manufacturing Improvement initiative, as recommended by PCAST, to optimize the 

generation of high-yielding vaccine seed strains, and alternative potency and sterility assays. Many of these improvements, such as 

biosynthetic technology, were employed during the H7N9 vaccine 

response in 2013, which was the fastest on record. 

38 

Third, establishment and maintenance of pre-pandemic influenza 

vaccine stockpiles for H5 and H7N9 viruses that may be used to 

immunize tens of millions of persons at the onset of an influenza 

pandemic with these viruses. 

Fourth, and last, multi-fold expansion of domestic pandemic influenza vaccine production capacity, afforded by retrofitting of older 

manufacturing plants, building new state-of-the-art manufacturing 

facilities for making 21st century influenza vaccine, and establishing three centers for innovation and advanced development and 

manufacturing, with rapid, nimble, and flexible manufacturing capabilities through public-private partnerships with industry. 

The new national infrastructure responded in 2013 to the H7N9 

outbreaks, and today, in the Ebola epidemic. Despite these significant accomplishments, our pandemic preparedness work is not 

over. Making a more effective influenza vaccine remains a significant scientific challenge. Indeed, progress towards more effective 

influenza vaccines has been noted in recent years, but much more 

is needed. 

Going forward, there is reason for hope that more effective influenza vaccines may be within our grasp. The discovery of new influenza viral targets within the last 4 years has renewed interests 

and efforts to develop new universal influenza vaccine candidates. 

Developing more effective pandemic influenza vaccines is one of 

our top priorities, and BARDA will support new methods based on 

evolutionary biology that may help forecasting and selection of new 

seasonal and pandemic influenza vaccine strains. 

In parallel, we are launching this month an initiative to support 

advanced development of new, more effective influenza vaccine candidates that may elicit greater, broader, longer immunity in all 

populations against divergent influenza virus variants, and that 

may serve as primers for pandemic influenza vaccines. 

In conclusion, influenza viruses with pandemic potential continue 

to evolve and change, infect animals and man, and pose significant 

threats to global and domestic public health. This year’s limited 

seasonal influenza vaccine effectiveness, and the arrival of the first 

human case of H7N9 virus in North America underscore our urgent 

need to complete this mission. To be better prepared, our Nation 

must continue to invest in domestic pandemic preparedness, and 

work with key global partners. 

I thank you for this opportunity to discuss how we can be better 

prepared for seasonal and pandemic influenza, and I look forward 

to your questions. 

[The prepared statement of Dr. Robinson follows:] 

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Mr. MURPHY. Thank you, Dr. Robinson. 

Dr. Fauci, you are recognized for 5 minutes. 

STATEMENT OF ANTHONY S. FAUCI 

Dr. FAUCI. Mr. Chairman, Ranking Member DeGette, members 

of the committee, I appreciate the opportunity to discuss with you 

today very briefly the role of the National Institute of Allergy and 

Infectious Diseases in research addressing both seasonal and pandemic influenza. 

[Slide shown.] 

As shown on this slide, the NIH research agenda is really based 

on the traditional approach that the NIH has taken with all diseases; namely, fundamental basic research, clinical research, and 

field research, the provision of research resources both to the academic community, as well as to the biotech and pharmaceutical 

companies. The endgame is to ultimately produce interventions in 

the form of diagnostics, therapeutics, and vaccines. You have heard 

about the diagnostics and therapeutics. We can talk about them a 

little bit later. I want to focus the remainder of my remarks on a 

subject of obvious importance; namely, the development of influenza vaccines. 

[Slide shown.] 

Traditionally, the classic what we call platforms, or the way you 

develop the vaccine, have been based on growing the virus itself either in eggs, which is somewhat cumbersome, or more recently 

using it in cell lines, which are a bit more predictable. You either 

have a live attenuated vaccine or an inactivated vaccine, and that 

has been the traditional approach towards vaccines. It is cumbersome, it takes a long period of time because you have to grow 

the virus. 

[Slide shown.] 

Our researchers, both at the NIH and our grantees and contractors, over the last several years have been attempting, with some 

success, to make a conversion to what we call a recombinant DNA 

technology, molecular-based approach that would obviate the need 

to actually continue to grow the virus to make a vaccine. Several 

of these are illustrated on this slide. We don’t have time to go into 

each and every one of them, but they are particularly suited to develop a vaccine that we are all hoping for, and that Dr. Burgess 

mentioned in his 5-minute remarks, and that is a universal influenza vaccine. 

[Slide shown.] 

This is the cover of a Nature Medicine article that I wrote with 

my colleague, Dr. Gary Nabel, the former director of the Vaccine 

Research Center, namely, how we can induce what I called unnatural immunity; namely, immunity that a normal vaccine induction 

or the virus itself doesn’t induce, and that is broad protection 

against subsequent exposures to different types of influenzas that 

have a tendency to drift over a period of years, and sometimes to 

even shift, which gives us a pandemic. 

[Slide shown.] 

Now, the reason we can do this, and I just want to point out on 

this slide, on the lower right is a blown-up schematic of the influenza virus. The proteins that coat the outside are referred to as heVerDate Mar 15 2010 09:03 Jun 23, 2015 Jkt 037690 PO 00000 Frm 00055 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114_6SEASONALFLUSCAN_061915\114-6SEASONALFLUPDFMADE
52 

magglutinin, and that is where we get the H for H3, H2, or H1. 

It is a designation of a major protein. The other one is N for 

neuraminidase. But notice how those proteins are clustered on the 

surface of the virus, so that what the immune system sees generally is just the top, what we refer to as the head or the bulb of 

that protein. 

[Slide shown.] 

If you look at this slide, that head is where most of the antibodies that protect you and me against influenza are made. That 

is the good news. The sobering news is that is a variable region, 

which tends to change as influenzas drift from season to season 

and change an awful lot when it goes to a pandemic. 

If you look at the little stem, the thin part of that protein, that 

the immune system doesn’t see very well, interestingly, we found 

out several years ago that that is the part—that is what we called 

highly conserved. It doesn’t change from necessarily a Texas H3N2 

to a different type, a Singapore or a variety of others. They stay 

the same, which means that if you can induce an immune response 

against that unchangeable one, you might be able to get what we 

call a broader reactivity. 

[Slide shown.] 

And over the last several years, we have made considerable 

progress as shown on this slide here, where a number of candidates 

have used molecular techniques to essentially show the body predominantly the part of that protein that doesn’t change. And there 

are a number of ways of doing that. Instead of giving the body the 

entire virus, either killed or attenuated, by molecular techniques, 

you show the body only the part that you want it to respond to, 

unencumbered by the physical structures that don’t allow the body 

to see it. And we now have done this in several candidates—in 

mice, in ferrets, and what we call phase one studies in humans— 

which means we know it is safe, we know it can induce the kind 

of response that is more broad. In collaboration with BARDA, we 

are now starting to produce that to go into larger trials. And as Dr. 

Burgess said, we are not there yet, but we are clearly many steps 

further than what we were the last time I testified before this committee. 

So I will stop there and be happy to answer any questions. 

[The prepared statement of Dr. Fauci follows:] 

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Mr. MURPHY. Thank you. 

I will now recognize myself for opening questions for 5 minutes. 

But let me just start off, and I know that a lot of concerns about 

vaccines and autism. As a psychologist, I have seen many a child 

with autism. It is a deeply concerning problem with the families. 

Past publications have been discredited, and data was deemed 

fraudulent. Multiple studies said there is no link between developmental disorders such as autism and vaccines. 

I want to ask each of you, do you agree, Dr. Schuchat? Dr. 

Midthun, do you agree? Dr. Robinson, do you agree? Dr. Fauci, do 

you agree? And—yes, you can say this verbally. Should parents 

have their children vaccinated? Dr. Schuchat? 

Dr. SCHUCHAT. Vaccines save lives and are the best way for parents to protect their children—— 

Mr. MURPHY. Yes, right. 

Dr. SCHUCHAT [continuing]. From vaccine-preventable diseases. 

Mr. MURPHY. Dr. Midthun, yes or no? Yes? 

Dr. MIDTHUN. Yes. I have three children, and they were all vaccinated on time with all the recommended vaccines. 

Mr. MURPHY. Dr. Robinson? 

Dr. ROBINSON. Absolutely. 

Mr. MURPHY. Dr. Fauci? 

Dr. FAUCI. Definitely. 

Mr. MURPHY. OK. Dr. Schuchat, flu expert Dr. Andrew Pavia at 

the University of Utah School of Medicine said, ‘‘By April or May, 

there was good evidence of the drifted A/Switzerland strain. It 

wasn’t clear it was going to be a dominant strain, but there was 

a pretty good hint, we probably would have chosen the vaccine differently.’’ Dr. Schuchat, do you agree that there was good evidence 

of the drifted strain by, say, April or May of this last year? 

Dr. SCHUCHAT. We were certainly keeping a close eye on this 

drifted strain last May, and that is when the CDC began to develop 

a candidate vaccine virus, but as you know, it can be very challenging to develop candidate vaccine viruses, and to take it from 

a candidate to all the way to production of vaccine, all the way to 

production of hundreds of millions of doses of vaccine. 

Mr. MURPHY. But by May, there was evidence of a 17 percent 

mismatch. Do you think that 17 percent mismatch was a concern 

at that point, and were there any discussions about that at CDC? 

Dr. SCHUCHAT. Yes, there were. In fact, in March, we started to 

reach out to the global community, the international WHO collaborating centers, when we saw the first handful of this drifted strain 

to ask others were they seeing it. 

I think it is important to realize that strains emerge and can disappear, and in the spring, it is very difficult to know which ones 

will still be around in the summer or fall. We actually respond to 

these new drifted strains by working on candidate vaccine viruses, 

but it is very difficult with influenza to predict what strains will 

dominate, whether it is going to be an H3N2 year or a H1N1 year. 

And so we continue to go through the routine seasonal flu work 

while we are also developing the candidate vaccine virus—— 

Mr. MURPHY. Well, let me ask about this pattern. We have here, 

I am looking at the mismatch notes, by March there is about a 10 

percent mismatch drift, by May, 17 percent. We understand by 

64 

September it was already up to 50 percent. Do we know in these 

gaps of April or June or July or August what those drift rates 

were? Was there a problem by those times that was being seen? 

Dr. SCHUCHAT. Yes, we have information for the summer. It is 

important to remember that there is very limited influenza circulating here in the U.S. in the summer, and it takes off in the fall. 

That is one of the reasons we do global worldwide surveillance—— 

Mr. MURPHY. Sure, but right here—— 

Dr. SCHUCHAT [continuing]. And we have greatly increased the 

numbers there. 

Mr. MURPHY. But here in September, a decision was made for 

the World Health Organization to change this for the Southern 

Hemisphere. And so I am wondering, because there are big gaps 

here, were there discussions between all your agencies that we 

ought to be doing something differently other than telling people to 

have some kind of an antiviral medicine? 

Dr. SCHUCHAT. Thanks. I think it is important—Dr. Fauci talked 

about the idea of drift and the idea of shift, and I think the members remember in 2009 where, in the spring of 2009, we did decide 

it was important to go forward with a monovalent vaccine—— 

Mr. MURPHY. Right. 

Dr. SCHUCHAT [continuing]. Against a pandemic. We think of 

pandemics as having catastrophic risk because they generally are 

defined by a new strain that the population has no protection 

against at all. It is so differing from—— 

Mr. MURPHY. But you could do that fairly quickly during that— 

the issue of the Swine—from 2009. Once it reached this level where 

we are now only 23 percent effectiveness, and about 12 percent for 

senior citizens, a high-risk group for death, for mortality and morbidity, why not move forward at this point with at least a 

monovalent strain for high-risk groups and high-risk geographical 

areas? 

Dr. SCHUCHAT. The time between developing a candidate vaccine 

virus, which we started working on in May, and the ability to have 

a lot of doses is about 6 months. So it really wouldn’t be available—— 

Mr. MURPHY. But you did it in 12 weeks in 2009. 

Dr. SCHUCHAT. The large amounts of vaccine were only available 

in November in 2009, after having really started in May. 

Mr. MURPHY. But you did it in a much shorter time, but not the 

6 months. My point is, when you identify something that is going 

to have that level of mortality and morbidity, and it can be done 

in a short period of time, were your agencies talking with each 

other and saying—clearly, a decision was made in September, hey, 

for the Southern Hemisphere, we need to change that, but for the 

Northern Hemisphere it says let us keep going with what we have, 

recognizing that it is only effective for 1 out of 5 people and 1 out 

of 10 seniors. It seems to me that you need a different decisionmaking process. 

Dr. SCHUCHAT. Thanks. I think another point that is important 

to make is the difference between the laboratory mismatch and the 

clinical protection. In 2003/04, we had a laboratory mismatch. It 

turned out that when we measured clinical protection, protection 

was about 50 to 60 percent in different populations. So seeing that 

65 

in the lab in that hemagglutinin inhibition testing that there is 

drift or that there is a difference between the strain and the vaccine, and the strains that are circulating, doesn’t perfectly predict 

how the vaccines will work in practice. So I think it is very important to differentiate that decision to make a monovalent vaccine 

against a pandemic where we know there is not going to be the 

widespread protection because people haven’t seen the strain before, and where it is a race against time in terms of the—although 

it is challenging with current technology, the value of trying to 

make a vaccine is worth it. 

Mr. MURPHY. I am way over time. I need to—— 

Dr. SCHUCHAT. By which—OK. 

Mr. MURPHY [continuing]. Pursue other members. 

I recognize Diana DeGette for 5 minutes. 

Ms. DEGETTE. Thank you very much, Mr. Chairman. 

Well, following up on the chairman’s question, Dr. Schuchat, 

would it be fair to say, and really yes or no would work here, would 

it be fair to say that the way we are going to be able to substantially reduce the time between when we identify a strain and developing the vaccine will be what Dr. Fauci is talking about, which 

is development of new platforms and ways to get the vaccine? 

Dr. SCHUCHAT. Absolutely. 

Ms. DEGETTE. Now, Dr. Fauci, I want to turn to you because, 

over the years, you have come and talked about the development 

of these vaccines. I remember when we had a hearing in this committee when we were trying to move from the egg to the cell vaccine. And now you say you have the cell techniques, but you also 

say that you are getting ready to go into larger clinical trials on 

these new platforms, is that correct? 

Dr. FAUCI. That is correct, Ms. DeGette. The important point is 

that we really think that anything that needs to grow the virus—— 

Ms. DEGETTE. Right. 

Dr. FAUCI [continuing]. And produce it just is a time sink. So 

that is the point that I made on the—— 

Ms. DEGETTE. Right. 

Dr. FAUCI [continuing]. Slide. 

Ms. DEGETTE. No, and we actually, even those of us who only 

took high school biology, understood that point. 

Dr. FAUCI. Yes. 

Ms. DEGETTE. So—— 

Dr. FAUCI. Yes. 

Ms. DEGETTE [continuing]. Good work again. But what I want to 

know is now that you have done your phase 1 trials, and you are 

trying to move beyond that, what is your time frame for that? 

Dr. FAUCI. Well, you know, it is going to really depend on, first 

of all, testing it in a season to show that even though you don’t specifically have it against this particular strain, that it is covering 

that strain. So when you are trying to prove universality, you want 

to test it in a season in which it is a broader response. One of—— 

Ms. DEGETTE. Right. 

Dr. FAUCI. Yes. One of—— 

Ms. DEGETTE. So would that be like next season—— 

Dr. FAUCI. Well, we—— 

Ms. DEGETTE [continuing]. Do you think? 

66 

Dr. FAUCI [continuing]. Actually are going to try now, in collaboration with BARDA, to make enough of that new concept to be able 

to test it—— 

Ms. DEGETTE. Test it in this season. 

Dr. FAUCI [continuing]. In the following season. 

Ms. DEGETTE. Dr. Robinson, you are—— 

Dr. FAUCI. Following season. 

Ms. DEGETTE [continuing]. You are nodding your head, yes. 

Is—— 

Dr. ROBINSON. Yes, the following season. 

Ms. DEGETTE. OK. So what can Congress do to help you with 

that? Do you need additional resources? What do you need to be 

able to start to expedite that research? 

Dr. FAUCI. Well, I mean, obviously, you ask a scientist if they 

need resources, the answer is an automatic knee-jerk—— 

Ms. DEGETTE. Well—— 

Dr. FAUCI [continuing]. Of course we can do better with more resources, but we actually need your continued support to keep the 

focus on the need for this, because when we do these tests, remember, we don’t have control over the companies that make the contracts with the various—— 

Ms. DEGETTE. Right. 

Dr. FAUCI [continuing]. Health organizations that distribute this, 

but I think the focus that this committee has continually put on 

this has been very helpful to us. 

Ms. DEGETTE. Now, in your written testimony, you talk about 

the difference between seasonal flu and pandemic flu. Can you 

briefly explain that to us? 

Dr. FAUCI. So I mentioned in my oral testimony a few moments 

ago that influenza viruses tend to change slightly. We call that a 

drift. 

Ms. DEGETTE. Right. 

Dr. FAUCI. Right. 

Ms. DEGETTE. Every season. 

Dr. FAUCI. That is a little bit. Now, if it changes slightly, even 

if you don’t get the vaccine match right, there is enough background immunity in the community against similar viruses that 

the vast majority of the population are not going to have a catastrophic outbreak where people would be completely unprotected. 

Ms. DEGETTE. Right. 

Dr. FAUCI. When you have an influenza that has what we call 

a shift, not a drift, that means major changes, so when you look 

at the general population, the overwhelming—— 

Ms. DEGETTE. Right. They don’t have that. 

Dr. FAUCI [continuing]. Majority don’t have any background protection. So it is almost as if you are totally naive to this new—— 

Ms. DEGETTE. And that is what happened in—— 

Dr. FAUCI [continuing]. Virus. 

Ms. DEGETTE [continuing]. 2009 and 2010. 

Dr. FAUCI. Indeed. The bad news, it happened in 2009. The 

somewhat comforting news is that it wasn’t a particularly virulent—— 

Ms. DEGETTE. Right. Exactly. And that is what we—— 

Dr. FAUCI [continuing]. Virus. So we—— 

67 

Ms. DEGETTE [continuing]. Were worried about. 

Dr. FAUCI [continuing]. Were lucky. 

Ms. DEGETTE. So, Dr. Robinson, now, you said in your testimony 

that there remains significant technical challenges before a substantially better influenza vaccine is available, and I would assume 

that the biggest concern for both of you gentlemen, well, for all four 

of our witnesses, would be that if we don’t develop that significantly better vaccine system, and we get a virulent pandemic flu, 

is that right, Dr. Robinson? 

Dr. ROBINSON. That is right. I mean, as Dr. Fauci pointed out, 

we actually have new ways to actually make these vaccines by 

looking at a different portion of one protein. We normally make the 

vaccines against the hemagglutinin and our immunities to that, the 

head of that, and now we can actually look at the stalk which we 

are making these candidates. We may be able, that way, to protect 

against many different drifted strains and serve as a primer for a 

pandemic so that you have one dose of this, so you only need one 

dose of pandemic vaccines instead of maybe two. 

Ms. DEGETTE. Yes, and so what we are concerned about, or what 

I am concerned about, what keeps me awake at night, is if we don’t 

do enough, both Congress and also our research institutions, to be 

able to have that vaccine available if we get a virulent pandemic 

flu. Dr. Fauci? 

Dr. FAUCI. So another important point besides the fact that all 

of the issues, the advantages of this universal flu vaccine, namely, 

molecular biology rather than growing—— 

Ms. DEGETTE. Right. 

Dr. FAUCI [continuing]. The critical issue is if you—if we get it 

right, you could actually stockpile it. 

Ms. DEGETTE. Right. 

Dr. FAUCI. So we wouldn’t have to worry about the chart that the 

chairman put up about it changing and trying to keep up with 

it—— 

Ms. DEGETTE. Right. 

Dr. FAUCI [continuing]. Because if you stockpile it, you could 

stockpile it the same way you stockpile polio vaccine, measles vaccine, et cetera. That is really the endgame. 

Ms. DEGETTE. Thank you. Thank you very much, Mr. Chairman. 

Mr. MURPHY. Thank you. 

Now recognize Mrs. Blackburn, vice chair of the full committee, 

for 5 minutes. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. And as I said earlier, I want to focus on measles because we are hearing so much 

about this. And bear in mind, I have a daughter who has two children. They are in kindergarten and pre-K, and I can tell you, and 

I am sure you all and your teams, are fully aware that a lot of the 

mommy blogs are focused on this issue right now. And it is a big 

issue with our constituents. 

And, Dr. Schuchat, let me come to you first. I just want to be 

sure what the known knowns are about the measles virus. If you 

would elaborate for just a second. We are hearing 102 cases, that 

out of these only five had a vaccination against measles. Do you 

know what the rate is how they are affecting elderly as well as 

children? If you will give us just 1 minute on this. 

68 

Dr. SCHUCHAT. Yes, so far, there have been 102 people from 14 

States that have developed measles in 2015. There are another 11 

cases of measles from the end of 2014 that were linked to the 

Disneyland outbreak. Not all of the 102 cases this year are linked 

with Disneyland, but the majority are. 

The majority of people in these outbreaks so far have not been 

vaccinated. Only a small number are known to have been vaccinated. Important to remember that there are about 20 million 

measles cases around the world each year, and so measles is literally a plane ride away. When it gets into communities like the 

United States now, in certain pockets where a lot of people are 

unimmunized, it has a chance to spread. And so that is why California is really working day and night to follow every lead and put 

an end to it there. And that is why the health departments in 

every State are really on alert right now. 

Mrs. BLACKBURN. OK. Let me ask you this. As a physician, and 

a representative of our Nation’s public health agency, if you are 

talking to a parent, should they be more fearful of the disease, 

measles, or the measles vaccine? 

Dr. SCHUCHAT. Every parent wants their child to be healthy and 

safe, and I absolutely respect that. As a physician and as a public 

health expert, I can tell you the measles, mumps, rubella, or MMR, 

vaccine is very effective and very safe. 

Measles can be serious, and I would hate for a parent to think 

that everything will be fine, and have a bad outcome with their 

child. So I strongly recommend people talk with their physicians 

and get the right information, but personally, I would definitely 

have my child vaccinated. 

Mrs. BLACKBURN. Thank you. 

Dr. Fauci, same question to you. 

Dr. FAUCI. Same answer from Dr. Schuchat. There is no doubt, 

if you do a risk/benefit of the vaccine versus the disease, I think 

it is very, very clear that you have one of the most highly effective 

vaccines against any virus, and you have a highly contagious disease, measles, that can have serious complications, so to me it is 

really a slam dunk what the decision would be. 

Mrs. BLACKBURN. So if it were your child or grandchild, you 

would say vaccinate? 

Dr. FAUCI. Without a doubt, and I have done that with my three 

children. 

Mrs. BLACKBURN. Excellent. Thank you, sir. 

Dr. Robinson, I am going to let you off the hook today. I usually 

have quite a group of questions for you. And I do, I have some 

questions on Tamiflu and on the stockpile and the shortage, but as 

one of my researchers from Vanderbilt told me this weekend, we 

don’t always get the flu right and had a way of terming how we 

go about looking at this. I am going to, in the interest of time, submit these and would love a response from you. 

And I yield back. 

Mr. MURPHY. Thank you. The gentlelady yields back. 

Now Mr. Pallone is recognized. Thank you. 

Mr. PALLONE. Thank you, Mr. Chairman. I wanted to start out 

with Dr. Midthun. I am concerned about the low flu vaccine rate 

for children. By November 2014, only 42 percent of children beVerDate Mar 15 2010 09:03 Jun 23, 2015 Jkt 037690 PO 00000 Frm 00072 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114_6SEASONALFLUSCAN_061915\114-6SEASONALFLUPDFMADE
69 

tween the ages of 6 months and 17 years have been vaccinated for 

the flu, and I think we need to change this. And, of course, the 

measles outbreak raises more concerns about childhood vaccination. Yesterday, we mentioned that Ms. DeGette, Mr. Green, and 

myself called for a separate hearing on the outbreak, and the importance of vaccination to prevent the spread of measles. 

I am sorry, actually, my question is of Dr. Schuchat. What can 

we do to increase childhood vaccination rates, both for the flu and 

for other infectious diseases? 

Dr. SCHUCHAT. You know, I think that parents’ decisions to vaccinate their kids are often related to their sense of the threat and 

their sense of the value of the intervention. And we are so fortunate in this country that our disease rates have been quite low, 

that many parents don’t realize these diseases are still out there, 

and that if their children aren’t vaccinated, they will come back. So 

with the measles outbreak, I think most parents who weren’t vaccinating didn’t realize measles was still around and could be dangerous. 

In terms of the value of the intervention, it is important for parents to have all the information they need about the safety, the effectiveness, the risks, and benefits. It is important to me that parents know that the immunization system is deeply committed to 

transparency, to monitoring vaccine safety, to sharing information 

about risks when we determine them, and to updating our recommendations whenever there is new data. Right now, we know 

that the vaccines we are giving are saving lives and saving money. 

For each dollar we put in, we get about $10 back for the childhood 

immunization series. 

So what we do to try to support and promote immunization is a 

strong public-private partnership between healthcare professionals, 

doctors and nurses, and pharmacists, and community groups and 

consumer groups, to get information where it is needed, when it is 

needed, in many different formats. We know that most people trust 

their doctors and nurses more than they trust me or other public 

figures, and so we really try to support the doctors, nurses, pharmacists, that are that frontline. 

Mr. PALLONE. Well, thank you. Let me continue with you. I know 

that the flu activity began in early December, and continued to increase through the end of 2014. Has the flu activity peaked for this 

year, and what data do you evaluate to make that determination? 

Dr. SCHUCHAT. We are well along in the season, but it is difficult 

to say whether there will be a long tail or not. In many areas it 

is flattening off but not deeply declining yet. And sometimes later 

in the season, we see another strain increase. We have had many 

seasons where one of the H1N1 or H3N2 starts off the season, and 

one of the B strains will be quite common later on. So we are not 

out of the woods. It is important for people to be thinking about 

this. And we particularly want people to know that if they develop 

flu-like symptoms, and they are pregnant or they are very elderly, 

or have other immuno-compromising conditions, early treatment 

with antivirals could be very helpful to them. So they should speak 

with their clinician. 

Mr. PALLONE. All right, let me go back now. I did have a question of Dr. Midthun. The flu vaccine comes in different forms. 

70 

There is the high-dose shot recommended for seniors, a quadrivalent nasal spray recommended for young children, and a recombinant trivalent, I don’t know if I am pronouncing it right, recombinant trivalent shot recommended for those with egg allergies. 

How do you communicate to different groups about the variety of 

vaccines, and can the greater number of options for vaccines increase the rates? 

Dr. MIDTHUN. As you point out, there are a number of different 

options now, and what we try to do is really communicate clearly 

the information that we provide on our Web site in our package inserts as to what groups were studied and for which age groups the 

product is indicated. So, for example, the high-dose vaccine you 

were referring to was actually evaluated in individuals 65 years of 

age and older, and was shown to decrease the rate of influenza by 

23 percent, relative to those who got the normal dose vaccine. And 

likewise, quadrivalent vaccines are now available for four different 

manufacturers; three are inactivated and one is the live attenuated. They are indicated for somewhat different groups across that 

spectrum, and again, that information is put forward. 

The recombinant vaccine that you mentioned has only so far 

been evaluated and shown to be safe and effective in 18 years of 

age and above, and so again, our prescribing information will reflect that. But I think I should really turn to Dr. Schuchat because 

that is really the advisory committee on immunization practices, 

which is an advisory committee for the CDC that then recommends 

how these vaccines should be used. 

Dr. SCHUCHAT. And just briefly, we recommend people get vaccinated with the vaccine that is available. And so while providers 

and pharmacists get all that information about the different types, 

it is much more important to get a vaccine than to worry about 

which one is there. 

Mr. PALLONE. All right, thank you. Thank you, Mr. Chairman. 

Mr. MURPHY. Thank you. 

I now recognize the vice chairman of the subcommittee, and welcome aboard as vice chairman, Mr. McKinley of West Virginia. 

Mr. MCKINLEY. Thank you, Mr. Chairman. Just a quick observation on this—what I have heard and read in your testimony and 

done a little research is, this whole process of designating which 

vaccine we are going to come up with in September just seems archaic. In fact, it seems more of a game of chance and probability. 

And by virtue of us continuing this process, erroneously now with 

this mismatch, we have 50,000 Americans who are going to die this 

year. Fifty thousand Americans. That is more than died in combat 

in Vietnam, over a decade of that warfare. And they are going to 

die because of a game of chance and probability. 

I am just astounded by that. I wonder what better techniques 

can we use to predict ahead. And that leads me then to the second 

question perhaps, or maybe associated with that, is that the highdose vaccine has been found to be 24 percent more beneficial to 

senior citizens, and you have a meeting coming up late in February 

and it is not on the agenda as a possibility for September. Could 

one of you explain just briefly why that is not on the agenda if it 

has been proven to be helpful for senior citizens? 

71 

Dr. SCHUCHAT. Yes. Let me answer sort of both parts. The highdose vaccine is one of the licensed vaccines that is recommended, 

and the company that makes it doesn’t make enough of it for all 

people 65 and over—— 

Mr. MCKINLEY. Um-hum. 

Dr. SCHUCHAT [continuing]. But they have been increasing the 

production. So it is included in the September and February recommendations. The recommendations are really just which vaccines to—which virus strains to target, and then there are all these 

different formulations like high-dose. 

The other thing I just wanted to comment on about is sort of the 

mismatch. I want to just point out that in the past 20 years, this 

is the fourth time that we have had an important mismatch between one of the circulating viruses and the vaccine and what 

dominates. So it is very disturbing when we have this and we have 

excess disease burden, but the vast majority of recommended 

strains have actually been on track. Even though, when we have 

a good match, a well-matched vaccine type, we have a lot of morbidity and mortality from influenza, and I think it is one of these 

diseases that we as scientists take very seriously, but the American 

public takes a bit for granted. So we wish that we had more people 

vaccinated each year, and that we wish that people who need to get 

the antivirals would get them early, but we have work to do in 

terms of the medical community and the public—— 

Mr. MCKINLEY. Thank you. 

Dr. SCHUCHAT [continuing]. And in having them take—— 

Mr. MCKINLEY. Thank you, doctor. Is—— 

Dr. SCHUCHAT [continuing]. It seriously. 

Mr. MCKINLEY. I want to build a little bit of background for the 

chairman and his chart. When it was discovered first in May, I 

guess it was, that—or March, there was some anomaly showing up. 

May, 17 percent, September, 50 percent. It was obvious there was 

a problem with it. So if I go back to Robinson’s testimony, he said 

that the PCAST report recommended improving vaccine manufacturing to meet a national goal of making the first dose within 12 

weeks. Now, yes, it would have taken to go to a national supply 

to go 6 months, which again, is a real concern about the production, and some of the techniques that we can use to reduce that— 

but if we could have produced a vaccine, knowing in September it 

was 50 percent, so September, October, November, the 1st of December, we could have had a modified drug, even if it is limited 

supply, that we could have tried—whether it is an antigen or a new 

vaccine entirely, wouldn’t you have recommended let us try this 

and do trials, see what the result is, did we solve it, can we do this 

in 12 weeks and the next time? So my question: Did you do it? Did 

you try to do anything to modify the vaccine that was wrong? 

Dr. SCHUCHAT. Um-hum. I want to stress that we were not—— 

Mr. MCKINLEY. It is a yes or no, isn’t it? 

Dr. SCHUCHAT. There were many activities taken to address the 

emergence of drifted strain, including preparing a candidate vaccine virus—— 

Mr. MCKINLEY. Did you try and modify it? 

Dr. SCHUCHAT. The issue of protection is both what strains are 

dominant, what efficacy the vaccine has, and how many people can 

72 

get the vaccine. So a highly effective vaccine with very few doses 

available may not be as good as a moderate- or a low-efficacy vaccine and a lot of doses available. 

Mr. MCKINLEY. I will take your answer—— 

Dr. SCHUCHAT. I don’t think that—— 

Mr. MCKINLEY [continuing]. As a no, that you didn’t try and—— 

Dr. SCHUCHAT. No, what I am saying is that we did begin to prepare the candidate vaccine virus so that companies would be able 

to produce a vaccine against the drifted strain. This particular 

strain has been quite challenging to produce vaccines against. 

Mr. MCKINLEY. Thank you. Fifty thousand Americans died. 

Mr. MURPHY. Now recognize Ms. Castor for 5 minutes. 

Ms. CASTOR. Thank you very much. 

Dr. Schuchat, on average, maybe take the last 10 or 20 years, 

how many Americans suffer each year from influenza, how many 

are hospitalized, and how many die? 

Dr. SCHUCHAT. Thank you. Yes, for the past 5 years or so, we 

have ranged between 19 and 35 million cases of influenza illness 

each year, between 110,000 and almost 600,000 hospitalizations 

each year, and 5,300 to 39,000 deaths attributable to influenza. 

Those are in the past 5 years. In that same period, the vaccination 

efforts we have had have been reducing the full burden by about 

16 to 17 percent. You know, we would have more disease, deaths, 

and hospitalizations without vaccination, but it is not as high a 

prevented—— 

Ms. CASTOR. Um-hum. 

Dr. SCHUCHAT [continuing]. Fraction as we see for measles, 

where we are preventing 99 percent, you know, of the disease. And 

that is partly because we don’t have high coverage. 

Ms. CASTOR. How many are vaccinated? 

Dr. SCHUCHAT. Well, we have gone from 19 percent of Americans 

getting vaccinated against flu, to 46 percent. So that is a big improvement, but it is not the majority yet. The other factor though 

besides the coverage is the effectiveness, and even in a good year, 

we are seeing vaccines that work about 60 percent efficacy, and so 

that is why we are very committed to the interagency work on developing vaccines that could have higher effectiveness, particularly 

in the most vulnerable populations. 

Ms. CASTOR. And when it comes to the deaths, what age range? 

We know the elderly are more vulnerable, but what are the—— 

Dr. SCHUCHAT. Yes, you know, the vast majority of deaths are in 

seniors, but unfortunately, we do have children die every year. 

More than 60 children have died so far this flu season, and I fear 

that is not going to be the end of it. So we know that statistics say 

if you are elderly, if you have medical immunocompromising conditions, if you are under 2, you have more chance of being hospitalized or dying from flu, but many parents can tell you that their 

child was perfectly healthy and they actually lost a child. So I really want parents and the general public to know to take flu seriously. 

Ms. CASTOR. And this year, it is a particularly severe flu season 

with higher rates of hospitalization and mortality. This is especially worrisome for those vulnerable populations; children, the elderly, pregnant women, and others with weakened immune sysVerDate Mar 15 2010 09:03 Jun 23, 2015 Jkt 037690 PO 00000 Frm 00076 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114_6SEASONALFLUSCAN_061915\114-6SEASONALFLUPDFMADE
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tems. Dr. Midthun, the severity of this year’s flu can be partially 

attributed to the fact that it is an H3N2 predominant year. Tell us 

what that means in simple terms. The fact that this is an H3N2 

predominant year. Dr. Midthun. 

Dr. MIDTHUN. I think oftentimes in H3N2 prevalent years, there 

may be more morbidity and mortality, although I think it is very 

important to remember that all influenza can cause morbidity and 

mortality. H1N1 was responsible for 2 pandemics, 1918 and the 

one in 2009. And also B strains can be very serious, especially for 

children, and cause very serious outcomes. But Dr. Schuchat may 

want to add to that. 

Dr. SCHUCHAT. Yes. Overall, the H3N2 serious years have higher 

total morbidity and mortality, but as Dr. Midthun says, the H1N1 

has a predilection for younger people. 

Ms. CASTOR. Uh-huh. So you were talking about the effectiveness 

of the current vaccine before this year’s flu vaccine shows 23 percent effectiveness. I want to hear more about how we assess the 

flu vaccine effectiveness, and better understand this. How do we 

gather information on infections and mortality and then test for 

vaccine effectiveness? 

Dr. SCHUCHAT. One of the things that the investments in influenza have permitted, the resources that CDC has gotten over the 

past several years, is expansion of the systems by which we track 

influenza, and track influenza vaccine coverage, and track influenza vaccine effectiveness. So we have much better data today than 

we had several years ago. We are able to provide estimates in the 

middle of the year of how many people have gotten vaccinated, as 

well as how well the vaccine is working so far. 

We work with State and local health departments in the surveillance systems, and we work with academic university partners in 

measurement of influenza vaccine effectiveness, essentially, comparing people who have influenza laboratory-confirmed disease 

with others to look back at their vaccination history and basically 

quantify the vaccine effectiveness that way. We release our data 

every week on something called FluView. It is on our Web site. And 

so you can essentially look in October 3 and see the first information about the drifted strain. So every week as that comes out, you 

can follow what is going on. But in mid-January, in fact, we sped 

up the vaccine effectiveness estimates so that the public would 

know them as quickly as possible. 

Ms. CASTOR. Well, I know I marched my whole office down to get 

the flu vaccine, but I think this is very important that people understand what the experts are saying today, that this mismatch, 

parents with children need to be especially careful because of the 

predilection for younger folks. But in America, if we only have 46 

percent, and that is kind of high watermark for flu vaccinations, 

we can do a whole lot better. So thank you very much. 

Mr. MURPHY. Thank you. 

And now I recognize Dr. Burgess for 5 minutes. 

Mr. BURGESS. Thank you, Mr. Chairman. 

And, Dr. Schuchat, let me just pick up for a moment on what you 

were discussing with the vice chair of the subcommittee, Mr. 

McKinley. Now, you had a drifted strain that kind of appeared on 

the scene. The Southern Hemisphere designation is out of phase 

74 

with what the vaccine release in the Northern Hemisphere, correct? So you had identified the drifted strain when the recommendation was made for the inclusion in the vaccine that was 

released in the Southern Hemisphere, is that correct? 

Dr. SCHUCHAT. Yes, that is right. 

Mr. BURGESS. So why not then come forward with a recommendation for a booster shot or some additional protection for 

people in the Northern Hemisphere if we already were developing 

a different vaccine based on a drifted strain for the Southern Hemisphere? Your neighbors to the north might have been interested in 

that, don’t you think? 

Dr. SCHUCHAT. You know, the manufacturing capacity to respond 

in September to vaccine strain recommendations in large number 

of doses would get us a large number of doses probably February 

or so. So I mean Dr. Robinson might be able to comment a little 

bit more, but the ability for us to make a Northern Hemisphere 

recommendation for a vaccine in September, and have doses in 

time for the flu season, would be very low. And we take that type 

of step when we are worried about a pandemic, and I think the 

committee is raising the question of should we take that type of 

step when it is not a pandemic situation but a drift. 

Mr. BURGESS. We would like you to react with a little bit more 

clarity and be flexible when so many lives are on the line, as Mr. 

McKinley outlined. And I mean, look, we are dealing with a, what, 

a 40 percent uptake of the vaccine as it is. If people read the headlines and say only 1 in 5 are protected anyway, I would just as 

soon not get stuck. 

Dr. SCHUCHAT. Yes. 

Mr. BURGESS. So I would think you, as an agency, you would 

want to have that flexibility and want to show utility for people 

that we are on top of this, we are working on this 24 hours a day, 

7 days a week, 12 months out of the year. We are monitoring your 

health and your safety when it comes to the flu virus, and we can’t 

be perfect every time, but when we are not, we are going to be 

there to help you stave off the effects. I mean, again, that is what 

I am hearing as a result of this hearing. And as Dr. Fauci acknowledged, we have had these hearings before. We had a hearing when 

we only had a trivalent vaccine, and we talked about a quadrivalent vaccine. I mean these things, they are important, people do 

pay attention to them. Our vaccine rates for influenza are lower 

than they should be for the country. 

Dr. SCHUCHAT. Um-hum. 

Mr. BURGESS. I have gotten my flu shot every year except 2004 

when it was politically inadvisable for a Member of Congress to receive a flu shot because there was a shortage—— 

Dr. SCHUCHAT. Right. 

Mr. BURGESS [continuing]. Because of the serratia contamination 

that occurred in one of the manufacturing labs. Separate story, but 

every other year I step up and get the vaccine because I meet a 

lot of people every day, I ride on an airplane twice a week, this is 

just a commonsense reaction to what is an inevitability on the 

ground. 

I want to shift gears for just a moment, and I do feel obligated 

to talk about the measles issue because it has achieved so much 

75 

in the way of headlines, and I am going to breach—I am going to 

violate HIPAA, and I just want to tell HHS that I am going to violate HIPAA. I am going to release sensitive clinical information 

about myself. So I never had the measles vaccine. I didn’t have it 

because I was too old. I mean I was—well, when I was a child in 

the ’50’s, it hadn’t—it wasn’t there, it wasn’t available. I don’t remember every scraped knee, every sniffle from my childhood, but 

I remember the measles. 

Dr. SCHUCHAT. Um-hum. 

Mr. BURGESS. It was bad. I mean you can see—and I see in Harrison’s here online, hard, shaking chills. I mean that—it—yes, 

hard, shaking chills doesn’t even begin to describe it. The chills are 

so hard they are painful. You want to cover up, you want to pull 

a blanket around yourself, but you don’t want anything touching 

your skin. That is measles. I mean it is a different disease. And we 

had forgotten about it, quite frankly, because, you know, you just 

never see it, and now we are faced with the prospect that we are 

seeing it. It is important for parents to have their children vaccinated. 

Dr. SCHUCHAT. Um-hum. 

Mr. BURGESS. There are things that can happen to you as a consequence of having had the measles. I remember in medical school 

learning about subacute sclerosing panencephalitis, and I remember asking at the time why do I have to learn about this, no one 

is going to get it anymore. But, in fact, people may get it because 

it is a consequence of having had an infection with measles. So 

these issues are important. 

Now, if I recall correctly, and suddenly somehow this is interjected into presidential politics, which is inappropriate because, if 

I recall correctly, since President Gerald Ford, there has not been 

a Federal mandate for any vaccination. And I will ask that question generally to the panel, Dr. Fauci, am I correct on that? 

VOICE. Microphone. 

Dr. FAUCI. When President Ford essentially mandated through 

the department that there be massive vaccination for the 1976 influenza, that famous catastrophic event with the Guillain-Barre, 

but I don’t think there has been official mandating about—— 

Mr. BURGESS. Correct. So these are State-mandated vaccines 

that people have to take before attending public schools, and there 

is a reason for that. It should be a State mandate. There is no one 

asking for a Federal mandate. It doesn’t mean that the vaccination 

is not important. And for people who are listening and paying attention today, please have your children vaccinated. 

Thanks, Mr. Chairman. I will yield back. 

Mr. MURPHY. Thank you. 

I now recognize Mr. Green for 5 minutes. 

Mr. GREEN. Thank you, Mr. Chairman. Thank our panel for 

being here. 

Data from the National Immunization Survey found that fewer 

than half of children and adults are vaccinated by November of this 

current flu season. My numbers said 40.3 percent, but, doctor, you 

said 46 percent. Forty-six percent of the people and 6 months or 

older received the flu vaccine. These numbers seem similar to what 

we have seen in the last few years. 

76 

I wanted to hear why these vaccination rates continue to be so 

low and what we can do to improve it, although I have to admit, 

the recent news that it is only 20 percent—23 percent effective, and 

those of us who are much older it may only be 12 percent, that 

would probably tell people not to get it. But somehow along the 

way, we need to do it, and encourage much more than 46 percent 

to be able to get that. The data showed that nearly 60 percent of 

the people had not taken advantage of it. Is that accurate? 

Dr. SCHUCHAT. The 46 percent that are vaccinated is based on 

last year’s end of season, so the 40-some percent was the early, you 

know, by November, how many had gotten vaccinated. 

You are right that the majority still haven’t gotten the flu vaccine, and this is something that we think is going to take years of 

work. Part of the issue is whether there is a concern about the disease, and part of the issue is whether there is confidence in the 

intervention. And as you know, the intervention has different efficacy, different years. So it is not a simple message and it is one 

that we work hard to communicate honestly and clearly. 

Mr. GREEN. Well, I guess part of the problem is if we think it 

is bad now with the news coverage about the less effectiveness, 

what can we do to make sure that next year we have, one, an effective flu vaccine—I know it is almost like throwing darts against the 

wall—and that way we will convince more people to get it, because, 

again, the more people vaccinated, the more we will defeat it. 

Dr. SCHUCHAT. The vaccine prediction is most of the time good. 

So out of the last 20 years, this is the fourth time where there has 

been an important mismatch. And in some of the previous times 

where there has been mismatch, there has still been much higher 

efficacy than what we are seeing this year. This year will be a difficult year to follow in terms of our messaging. We do want people 

to know that influenza can be serious, and that the vaccine is still 

the most effective way to reduce your risk, but we also want people 

to know about antivirals, because we think those are also underutilized and could actually reduce the duration of the illness, and even 

reduce the chance of being hospitalized in some patients. And so 

we think it is important to get both messages out. 

Mr. GREEN. Is there anything that Congress could do because, 

when you found out that the effectiveness was so low—I know 

there were some questions earlier from Dr. Burgess saying, OK, we 

need a booster for those of us who got the vaccine—are there resources available where you could do that and make it an issue, 

saying, you know, it is only 23 percent but this booster will get you 

to 50 percent? 

Dr. SCHUCHAT. You know, I think the resources that have been 

provided have been incredibly valuable, and there is both a shortterm and a long-term strategy. You know, the short-term strategy, 

to use available tools better, and to make incremental improvements in the production and distribution of vaccine, and the longterm strategy that Dr. Fauci and Dr. Robinson were talking about 

with the research and investments in universal vaccines. So I think 

we can’t just do one or the other, we really have to do both, but 

it will be years before there is that really much, much, much better 

flu vaccine. And we are fortunate that we have a lot of options now 

and a much better supply horizon than we have had, you know, 5 

77 

or 10 years ago. So I think we really need to just stick with it and 

make those incremental improvements, and make sure that the 

public gets the correct information, the accurate information, that 

we are honest when he have a year like this where it is quite difficult. And unfortunately, the vaccine is only preventing about 23 

percent of what it might be, but that is still significant protection. 

Mr. GREEN. Well—and again, since the percentage is lower for 

the most vulnerable population of the elderly, we need to encourage 

the elderly to—even if it is only, I don’t know what percentage it 

was, 12 percent, because it still gives them that 12 percent. But we 

would sure like to see it up above the efficiency much better. 

Dr. SCHUCHAT. Yes. Ironically, the elderly are the best at getting 

vaccinated. It is about 70 percent or so of them, but the vaccine 

works the worst in that population. And they really do rely on the 

rest of the population being protected to have more confidence that 

they will be safe too. So it is one of those vaccine-preventable diseases where the more people that are immunized, the better. And, 

of course, in the future we hope that we will have even more effective tools. 

Mr. GREEN. I know this has come up before, but—— 

Mr. MURPHY. Thank you. 

Mr. GREEN [continuing]. Ranking Members Pallone and DeGette 

yesterday talked about the measles outbreak in Disneyland, and I 

know that is a concern too that—to do it. And let me just follow 

up, Mr. Chairman, I remember when I was in the fifth grade, the 

whole county, we got a polio vaccine. Was that mandated by the 

Federal Government? 

Dr. SCHUCHAT. You know, in that era, you didn’t need to mandate polio vaccines. People were lining up. I think the whole country was so thrilled that there was a polio vaccine licensed—— 

Mr. GREEN. Um-hum. 

Dr. SCHUCHAT [continuing]. In 1955 because that was such an incredible scourge. The mandates, the school requirements, really 

were shown in the 1980’s to massively reduce the risk of measles 

outbreaks in schools, and it was really only when States required 

kindergarten entry to have measles vaccine documentation that we 

started to get a better handle on—— 

Mr. GREEN. Thank you. 

Dr. SCHUCHAT [continuing]. Measles, and then—— 

Mr. GREEN. Yes. 

Dr. SCHUCHAT [continuing]. Of course, in 2000, we were able to 

eliminate native measles here in the U.S. 

Mr. MURPHY. The gentleman’s time has expired. Thank you. 

I now recognize Mr. Griffith of Virginia for 5 minutes. 

Mr. GRIFFITH. Thank you, Mr. Chairman. 

Let me try to get some blanks filled in here. I don’t have the answers. The meeting took place with WHO in CDC and FDA and 

others in February. In March, we know that there was a drift that 

was picked up of about 10 percent, is that correct? 

Dr. SCHUCHAT. Actually, it was lower than that. 

Mr. GRIFFITH. About 7 percent I think I saw in your testimony. 

Dr. SCHUCHAT. It was like 4 percent. 

78 

Mr. GRIFFITH. OK. Do we know what April was, because we have 

a few numbers on the chart but we have a lot of question marks? 

And if you don’t—— 

Dr. SCHUCHAT. In April—— 

Mr. GRIFFITH [continuing]. You can provide it—— 

Dr. SCHUCHAT [continuing]. Fourteen viruses were shown that 

had reduced susceptibility to the strain, and that was out of 127, 

so that would be 11 percent. 

Mr. GRIFFITH. OK. And then we have a number from May. Then 

June and July, we don’t have another number on this chart until 

September. What were you all seeing in June, July and August? 

Dr. SCHUCHAT. In June, July, and August, there were 88 viruses 

identified from the whole world that had reduced reaction, and so 

that comes to 36 percent. 

Mr. GRIFFITH. OK. 

Dr. SCHUCHAT. With reduced, you know, that were mismatch. 

Mr. GRIFFITH. And then there is another meeting, and there is 

a different Southern Hemisphere recommendation made, and we 

don’t make the—I think that is five. If you can get us the other 

numbers just so we can kind of track it, that would be great. But 

then—— 

Dr. SCHUCHAT. Absolutely. 

Mr. GRIFFITH [continuing]. My question comes up, and I am 

happy for anybody to answer it, why didn’t we have the manufacturing capacity for the virus to do turn somewhere in this process, 

I think you said by June, July, we were in the 36 percent range, 

recognizing that flu season doesn’t generally hit in a big way for 

another fair number of months, why does the United States lack 

that manufacturing capacity, and as a subpart of that, if there was 

the capability of producing, and I am trying to pronounce this correctly, monovalent vaccine, why didn’t we do so? And if you all 

could focus on that. Any member of the panel please. 

Dr. SCHUCHAT. Yes, maybe I can start and let Dr. Robinson continue. 

I think one thing to recognize in the summer is that we were 

looking at increasing proportions of H3N2 that were not well 

matched to the vaccine, but we still had the other 2 or 3 different 

strains that were in the vaccine. So the concept of producing a 

monovalent vaccine—we might have been asking the American 

public to take a monovalent vaccine plus the tri or quadrivalent 

seasonal vaccine. As we have been hearing, the American public 

isn’t all that keen to get one flu vaccine a year. Would they really 

be lining up to get 2? But there are, of course, major limitations 

in the manufacturing capacity to make 2 different products for the 

same season. So I will let Dr. Robinson answer that. 

Mr. GRIFFITH. Dr. Robinson? 

Dr. ROBINSON. Thank you. During the manufacturing season, 

they are producing three or four vaccine strains all the way to 

June, maybe even July if it is a tough year for them. At that 

time—and most of those are egg-based. At that time, they within 

the summer are putting those together, we call them blending and 

putting together, to go forward with the vaccine that was released 

in September to go out on the shelves. 

79 

The ability to have what was called a competent vaccine that 

could be very quickly—that is certainly true, it can be maybe faster 

than some of the egg-based vaccines, but the capacity that we have 

right now with the licensed vaccine, the only one recombinantbased vaccine, is very, very small. It would have only been able to 

produce maybe hundreds of thousands of—— 

Mr. GRIFFITH. OK. Let me—— 

Dr. ROBINSON [continuing]. Doses. 

Mr. GRIFFITH. Let me ask the why on that. Is it because there 

is not a profit—— 

Dr. ROBINSON. No, no. 

Mr. GRIFFITH [continuing]. To be made? 

Dr. ROBINSON. One instance, it is a new vaccine—— 

Mr. GRIFFITH. OK. 

Dr. ROBINSON [continuing]. And, two, since it is a new vaccine, 

they are just scaling up to the market. This is an incumbent market, very competitive, and they were licensed in 2013. We are actually supporting their efforts in building a much larger facility to 

produce maybe tens of millions of doses, and so that they actually 

can going forward be able to produce, say, 50 million doses in 4 

months of a monovalent vaccine for a pandemic or, maybe in this 

case, another influenza vaccine. 

Mr. GRIFFITH. So you anticipate that our capacity will be greater 

in the next couple of years than it is today to react? 

Dr. ROBINSON. Indeed, it will be, because we will actually have 

the cell-based influenza vaccine facility down in North Carolina 

that has a large capacity, and we will be able to have that product 

on the market. But again, they are limited in that they are making 

seasonal flu vaccine at the same time that we may have wanted 

to do that. 

The other thing is that these manufacturers also produce vaccines for the Southern Hemisphere. So when they came off of making the vaccine for the Northern Hemisphere, then they started 

back to actually making the vaccine for the Southern Hemisphere. 

So we would have had to make a decision and tell them in September, stop doing that and go forward with the new vaccine. And 

we know that that is a difficult midcourse shift. 

Mr. GRIFFITH. But if we—— 

Dr. ROBINSON. The future will be—— 

Mr. GRIFFITH. But we could have done that even in, say, July 

when we knew we were at 36 percent that had drifted? 

Dr. ROBINSON. It would have been very, very difficult, sir. 

Mr. GRIFFITH. OK. All right. I appreciate it. I see my time is up 

and yield back. 

Mr. MURPHY. All right, I want to clarify something. So you said 

36 percent, June, July, and we have a 50 percent cutoff. So some 

time in September the 50 percent number was significant enough 

to say, OK, we need to do something different in the Southern 

Hemisphere. What is the magic number where you say we need to 

make a change here? 

Dr. SCHUCHAT. Actually, it wasn’t that there was something different, it is that every September the strains are reviewed worldwide. All—— 

Mr. MURPHY. Why not—— 

80 

Dr. SCHUCHAT [continuing]. Of them. 

Mr. MURPHY. Why not August? What I am concerned about is, 

we want to break through, if there is some bureaucratic hurdles, 

this committee wants to help—— 

Dr. SCHUCHAT. Thank—yes. 

Mr. MURPHY [continuing]. But if you say, well, we don’t look at 

this until—we don’t really meet and discuss this until September, 

that is not a lot of solace for what Mr. McKinley was raising for 

the hundreds of thousands of seniors who are going to be sick. 

What—what is—what do we do? 

Dr. SCHUCHAT. Right. In September every year, the groups convene to review all the data for the Southern Hemisphere production, and that is because it takes that long to get vaccine that will 

be ready by that time. It is not—— 

Mr. MURPHY. I am not—— 

Dr. SCHUCHAT [continuing]. Because we are not looking all the 

way between. 

Mr. MURPHY. Yes, but you have already said you can get a vaccine ready in 12 weeks when you need a monovalent strain when 

there was a pandemic. 

Dr. SCHUCHAT. Not—— 

Mr. MURPHY. Wasn’t that done in 2009, you did something quickly—— 

Dr. SCHUCHAT. No. 

Mr. MURPHY [continuing]. Dr. Robinson? 

Dr. ROBINSON. OK, go ahead. 

Dr. MIDTHUN. No—— 

Mr. MURPHY. I want to be clear. 

Dr. MIDTHUN [continuing]. I think in 2009 the virus emerged in 

April. In May it was recognized that it was causing significant disease, and at that time a decision was made across the HHS that 

a monovalent vaccine would be pursued. And so all stops were 

pulled out to do that, but in point of fact, the first vaccine was not 

available from—for that H1N1 monovalent until the end of October, and the bulk of vaccine was not available until late December, 

into January. So just point taken that the manufacturing process 

itself takes many months, and although we—— 

Mr. MURPHY. To get to the critical number. I know it is Mr. 

Tonko’s turn, but we are talking about just to start to give it to 

some seniors and high-risk group. 

Mr. Tonko, you are recognized for 5 minutes. 

Mr. TONKO. Thank you, Mr. Chair. And welcome to the panel. 

There has been much discussion here today about parents and 

the advice they get about having their children vaccinated or not 

vaccinated. I would like to ask it from yet another perspective. Yesterday, a United States senator asserted that routine vaccinations 

could cause, and I will quote, ‘‘walking-talking normal children to 

wind up with profound mental disorders.’’ 

And so my request of the panel is a simple yes-or-no response. 

Is there any shred of credible evidence that shows that this, in fact, 

is the case? Dr. Schuchat? 

Dr. SCHUCHAT. Not the vaccines we are using today. 

Mr. TONKO. Dr. Midthun? 

81 

Dr. MIDTHUN. No, not for the vaccines we are using today, although I think it is important to note that any vaccine can have 

some safety issues associated with it, but typically, they are very 

rare, and that is why we also have the Vaccine Injury Compensation Program. 

Mr. TONKO. Dr. Robinson? 

Dr. ROBINSON. I am in agreement with Dr. Schuchat and Dr. 

Midthun. 

Mr. TONKO. Dr. Fauci? 

Dr. FAUCI. Agree. 

Mr. TONKO. Pardon me? 

Dr. FAUCI. Agree with my colleagues. 

Mr. TONKO. Thank you for clarifying. 

In addition to promoting vaccination, Dr. Schuchat, how else does 

the CDC work to prevent spread of the flu? For example, does the 

CDC recommend symptomatic individuals to stay home from work? 

Dr. SCHUCHAT. Yes, we have a multipronged approach to prevention. The best protection is to get vaccinated. We also recommend 

sensible measures like washing your hands, covering your cough, 

staying home when you are sick, staying away from other people 

when you are sick. And then, of course, if you are ill, and particularly those with underlying conditions or the elderly, we think 

prompt antivirals can be important, and so talk to your clinician 

about that. 

Mr. TONKO. Are there any data showing how many flu transmissions occur in the workplace when symptomatic individuals do 

come to work? 

Dr. SCHUCHAT. I don’t have that data, but there have been analyses showing the value of vaccination to reduce workplace absenteeism and to improve productivity. 

Mr. TONKO. Um-hum. 

Dr. SCHUCHAT. So we think it is a good thing for health, and it 

is also a good thing for the workplace to be protected against flu. 

To stay home for when you are sick for a variety of conditions is 

good counsel. 

Mr. TONKO. I do know that in speaking with my constituents, 

there are a number of working moms and dads who can’t afford to 

take time off of work because it would mean they are not paid, and 

so they attempt to come to work even though they really shouldn’t. 

In your opinion, would paid leave policies help to prevent the 

transmission of the flu and other illnesses by encouraging more 

workers to stay home when they are indeed sick? 

Dr. SCHUCHAT. We think the easier it is for people to do the right 

thing, the better. 

Mr. TONKO. OK, thank you. 

Dr. Midthun, the FDA has licensed a number of new vaccines 

since the year 2009. How have these new vaccines contributed to 

preparedness efforts in the last several years? 

Dr. MIDTHUN. Thank you for that question. I think what they 

have done, especially with regard to the cell-culture-based vaccine 

and the recombinant protein vaccine, is they offer an alternative 

manufacturing platform relative to the egg-based manufacturing 

that was the basis for the vaccines that had been approved up until 

that time. And it is always important to have a diversified way in 

82 

which you can manufacture vaccines. It also widens the platform 

available in the event of a pandemic because, typically, the pandemic vaccines are made on the same manufacturing platforms 

that the seasonal vaccines are made on, and so it really provides 

greater diversity and more resilience. 

Mr. TONKO. And, doctor, in your testimony you talked about 

work to speed up the manufacturing process for existing vaccines. 

Can you tell us more about that work? 

Dr. MIDTHUN. Yes. It is actually a very strong collaboration between BARDA, CDC, NIH, and ourselves, and it looks at a number 

of different aspects. One aspect is to look at the potency testing 

that is done for vaccines. Right now, that relies on reagents that 

are made by immunizing sheep, you develop antiserum, this usually is a process that can take up to 2 months. And so, obviously, 

having potency assays that are much more rapid would really decrease the time that it takes to do this, to make these reagents. 

And so there are some approaches using more modern platforms, 

and in conjunction with some of our colleagues, there actually are 

some tests that are being planned that will be embarked upon later 

this year to compare some of these newer assays to the standard 

assay that is used right now, the radial immunodiffusion test, to 

see how these compare to each other in actual testing of vaccine 

samples that the manufacturers are providing to us. And some of 

the manufacturers have actually expressed interest in also participating in the testing to see what the feasibility is. So that is one 

aspect that we are working on. 

Another one that has been very important, and that the CDC 

and others have really done a lot of work on, but we have also contributed to, is to try to identify high-growth viruses that will lead 

to good yield when you grow the virus in the eggs or in the cell 

culture. As you recall, Dr. Fauci was referring to the fact that that 

can often be a rate-limiting step. And so trying to develop viruses 

that you know will yield high growth when these new strains 

emerge could really facilitate and take time off that process. 

And then also there was the sterility testing, and the FDA actually changed its regulations in 2012 to allow for more flexibility in 

sterility testing. Up until that time, it was very prescriptive and 

this 14-day test by USP had to be used, but now manufacturers 

can come in with novel testing, and we actually know that some, 

you know, testing that has been described in the literature could 

actually be accomplished in 5, 6 days potentially. 

Mr. TONKO. Thank you. 

Mr. MURPHY. Thank you. 

Mr. TONKO. I yield back, Mr. Chairman. 

Mr. MURPHY. Thank you. 

I now recognize a new member of the subcommittee, Dr. 

Bucshon, who is a cardiothoracic surgeon by training, and is here 

from Indiana. Welcome to the subcommittee, and you are recognized for 5 minutes. 

Mr. BUCSHON. Thank you, Mr. Chairman. First of all, I would 

like to associate myself with the unanimous comments of our expert panel in recommending that parents get their children immunized to prevent childhood diseases. All my children are immunized. 

83 

Based on the testimony we have heard today, it seems like we 

could have had a monovalent vaccine available by maybe December, and if that is true, Dr. Schuchat, do you lack the authority to 

make that happen in that way, because through the testimony, I 

think a lot of members have asked what can we do to help, but for 

us, for Congress, to help, we have to have a specific thing to help 

with. So is there new authority or any other authority that would 

be helpful to make this happen? 

Dr. SCHUCHAT. I don’t believe so. The key issues is a risk assessment and trying to predict the most likely course of events, but I 

believe there are authorities if the decision is made to go ahead 

with the monovalent, whether for pandemic or for drift. 

Mr. BUCSHON. OK. As a healthcare provider, I know that, you 

know, liability is a significant issue in our American healthcare 

system, and not only physician malpractice, but product liability is 

a substantial issue, I know, that has an effect on the healthcare industry. Anyone can comment on this. Do product liability issues affect our ability to act in a more nimble way when it comes to vaccines, because you do have private companies that produce these. 

And so let us start with that and then I will spearhead off from 

there. 

Dr. SCHUCHAT. The Vaccine Injury Compensation Program exists 

so that product liability won’t be a factor, so that we can make sure 

that we have vaccines made but the people who are injured by vaccines are compensated. And so the funding from that comes from 

an excised tax on every vaccine dose that is sold, so that we know 

that vaccines are very safe, but there are sometimes rare, important complications, and the Injury Compensation Program exists 

for those families who have been injured. 

Mr. BUCSHON. OK. Thanks for clarifying that, and I think that 

is important to understand. 

Dr. Midthun, from the FDA’s standpoint, is there—how do I 

want to say this—a risk-averse regulatory process? It seems like at 

the FDA, you know, over a number of years—but for a variety of 

reasons have—I think been, in my view, sometimes overly cautious 

with new products or changing quickly. Do you see that as an 

issue, you know, and that comes into the liability issue again, is 

there resistance or reluctance to quickly move based on the concern 

about these type of things? 

Dr. MIDTHUN. No, I don’t see that. I think in the influenza domain, we, every year, are primed to approve the new vaccine 

strains that are recommended for inclusion in the vaccine those 

years. I think also our record of having approved since 2003—I 

think in 2003 we had three licensed influenza vaccines. Today we 

have 16 licensed influenza vaccines, including our cell-based, recombinant-based, quadrivalent, high-dose, and also I should point 

out that many of those we actually approved using accelerated approval, which actually allows us to approve something based on the 

new response that is likely to predict clinical benefit. And so we 

have used accelerated approval regulations to approve many of 

those and get them to market more quickly. So I think we—and 

also I should point out we approved the novel adjuvanted H5N1 

vaccine in 2013. So I think that we really looked very carefully, 

84 

and balanced the benefits and the risks, and are really very flexible. 

Mr. BUCSHON. Great. That is good to hear. 

There is a recent CDC study that looked at clinician practices on 

patients that come to the emergency room with—and the data is 

striking, only 16 percent of patients with laboratory-confirmed influenza were prescribed antiviral drugs. 

So the first question I have, do they work? Do the antiviral drugs 

work? 

Dr. SCHUCHAT. Yes, last week there was a new meta-analysis of 

all the published and unpublished randomized control trial data on 

Oseltamivir, and it shed new light on the benefits as well as potential risks that—there is—— 

Mr. BUCSHON. So they—— 

Dr. SCHUCHAT [continuing]. Benefit for the work. 

Mr. BUCSHON. Short answer, they do work, because I am running 

out of time. 

Dr. SCHUCHAT. Yes. 

Mr. BUCSHON. Because surprisingly, 30 percent of the patients 

with laboratory-confirmed influenza were—30 percent were prescribed one of three common antibiotics, which are for bacteria, not 

viruses. Is there anything that we can do to better, you know, as 

a physician, better make the, you know, change that practice? 

Maybe Dr. Fauci can answer that. 

Dr. FAUCI. Yes, that is another whole issue of antimicrobial resistance, which we have even discussed before this committee. So 

certainly, over the last year, there has been an extraordinary effort 

on the part of the Congress and the administration in everything 

from executive orders to 5-year plans to counter the kinds of practices that lead to antimicrobial resistance, and one of the most common, as I am sure you are aware, sir, is that someone comes in 

with a viral infection and they get an antibiotic. That is very, very 

common, unfortunately. 

Mr. BUCSHON. I yield back, Mr. Chairman. 

Mr. MURPHY. Thank you. 

I now recognize a new member to the committee, Ms. Yvette 

Clarke, who represents—Ms. Schakowsky is next? I am sorry, I 

thought Clarke was next. 

Ms. SCHAKOWSKY. I was here earlier. 

Mr. MURPHY. All right, thank you. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. 

So if the vaccine that we are using now has been viewed as 23 

percent effective, and usually in the past it has been 50 to 60 percent effectiveness, are we seeing—maybe it is Dr. Schuchat, are we 

seeing a commensurate increase in the incidents of flu? 

Dr. SCHUCHAT. Yes. When we compare this season with 2 years 

ago, the 2012/13 season, the last big H3N2 season, much of the 

pattern is similar, but our hospitalizations in the elderly are much 

higher at the same time this year. So we will get the end-of-season 

statistics, but it has been a very bad year for the elderly. 

Ms. SCHAKOWSKY. I see. So the lab tests predicted 23 percent—— 

Dr. SCHUCHAT. Um-hum. 

Ms. SCHAKOWSKY [continuing]. But you are seeing it actually out 

in the country, that it is also much higher? 

85 

Dr. SCHUCHAT. Right. Yes, we are seeing, you know, both the lab 

mismatch and then our vaccine effectiveness low estimate, and 

then the incidents of the hospitalizations is high. 

Ms. SCHAKOWSKY. OK. With the passage of the Affordable Care 

Act in 2010, we took important steps on preventive medical coverage for free, and since the law went into effect, approximately 76 

million Americans have received no-cost coverage for preventive 

services. So I am wondering if we are seeing that there actually 

was an impediment to getting these preventive services, vaccines, 

because of the cost, and now without the cost, that more people are 

making that available to themselves. 

Dr. SCHUCHAT. For influenza vaccine, I think it is too soon for 

us to see, but we do know that there are important disparities in 

influenza vaccination coverage, and that insured people have been 

more likely to be vaccinated than uninsured. So I think that over 

the years ahead, we may start to see some progress there. 

Ms. SCHAKOWSKY. So we do think, although we don’t have the 

new data—— 

Dr. SCHUCHAT. Um-hum. 

Ms. SCHAKOWSKY [continuing]. That cost has been a barrier in 

the past—— 

Dr. SCHUCHAT. That is right. We—— 

Ms. SCHAKOWSKY [continuing]. Is that what you think? 

Dr. SCHUCHAT. And we know even for the workplace, for instance, when workplaces will offer flu vaccine for free for workers 

or, particularly for healthcare workers, the uptake is better than 

when it is out-of-pocket, off-site, need-to-seek vaccine. 

Ms. SCHAKOWSKY. I think it is great that we are having this 

hearing today because this whole question of vaccines, as many of 

my colleagues have mentioned, has really been in the news, and it 

is disturbing that a number of high-profile political figures have 

weighed in on this in a negative way, I would say, that this is, you 

know, parents should make the decision, and I have seen some 

children that have been deeply affected by vaccines in a negative 

way. What I am wondering is, what is the public health outreach 

effort to make sure that—you heard my colleague Marsha 

Blackburn talking about the mom blogs. I mean there is a lot that 

is going on, not only on television, and I am glad you were on, Dr. 

Fauci, and that is very important that we get the message out in 

every medium, but I am just wondering if we are also just looking 

at how people are communicating with each other in the social 

media and getting the facts out. 

Dr. SCHUCHAT. Yes, we spend quite a bit of time and attention 

monitoring the social media as well as the general media, and we 

work closely at the national level, but also at the State and local 

level, on communication, both direct to consumer as well as 

through clinicians and other trusted partners, because we think 

getting information that speaks to you close to where you are is 

really important in your health behaviors. 

I would just like to say that the vast majority of parents vaccinate their kids against most of the recommended diseases on 

time, and yet there are some minor voices that get a lot of attention. 

86 

Ms. SCHAKOWSKY. Exactly. I think maybe we need to make sure 

we communicate with all political voices as well that are out there 

to make sure that we are communicating the science, the facts, 

that suggest that all parents should vaccinate their children. 

So I yield back. 

Mr. MURPHY. All right, now we recognize Mr. Flores from Texas, 

who is also new to this committee. Third term in Congress, and we 

welcome him to this subcommittee. 

Mr. FLORES. Thank you, Mr. Chairman. I also want to thank the 

panel, particularly for your positive comments regarding the benefits of having children vaccinated for measles. I have an extended 

family member who has not done that for her children yet, and it 

just baffles me why she can’t do that. And so I hope she is hearing 

this today, that she heard your comments, and that she will do so. 

I want to talk about the weakness in the strain selection process, 

and talk about the opportunities to mitigate that weakness. And I 

want to focus my questions to you, Dr. Robinson, because BARDA 

is a tool, I think, that we have to do this. 

And so my first question is this. Is BARDA funding any projects 

or initiatives to develop two things: one, better testing technologies, 

or two, better approaches for making the vaccine candidates? 

Dr. ROBINSON. So the answer is yes on both. In my testimony, 

I identified that we were supporting the development of evolutionary biology methods that would actually help the existing methods 

inform what strains are out there. There are only so many ways 

a virus can mutate. 

Mr. FLORES. Right. 

Dr. ROBINSON. And we know that you can do the experiments to 

show which ones would predominate, and that may actually inform 

which ones we may see the next season. And certainly, the underpinning of that the NIH has funded over the years, and so we are 

moving forward primarily for our pandemic purposes, but certainly 

could be used in seasonal. So that is one way towards the selection, 

and then informing new vaccine designs. 

Mr. FLORES. OK. 

Dr. ROBINSON. Secondly, with the technologies, we have supported with our colleagues here from NIH, CDC, and FDA, new 

technologies to make these vaccines, whether it be cell-based or recombinant. And working with the NIH, we are looking at universal 

flu vaccine candidates with a number which Dr. Fauci enumerated 

of going forward. It is not because those technologies haven’t been 

tried before, but as he explained, there is a limitation in how the 

body actually sees these viral proteins. And so there are some new 

ways now that we can do that, we couldn’t do before. 

Mr. FLORES. And in terms of looking at BARDA’s priorities, 

where would you say that getting these better technologies for the 

strain selection process is in your sort of list of all the things you 

have to do on your wish list? 

Dr. ROBINSON. Yes. Well—— 

Mr. FLORES. Is it in the top third, or the middle, or the bottom, 

or—— 

Dr. ROBINSON. No, it is at the top. 

Mr. FLORES. OK. 

Dr. ROBINSON. Yes. 

87 

Mr. FLORES. Great. Sounds like we should keep it there, from 

what I am hearing today. 

The third question is how can we expedite the development and 

deployment of better technologies, say, use of genetic sequencing, 

to detect virus change, which you have talked about, to ensure that 

the U.S. has a vaccine that can be matched to a drifted H3N2 

strain? 

Dr. ROBINSON. Certainly, one of the ways that we actually have 

employed with biosynthetic technology work with the Craig Venter 

Institute and then one of the manufacturers. We did that in 2013 

with H7N9 to actually come up—what we didn’t need the traditional way of having the virus actually sent from one laboratory to 

another. We actually had the nucleotide sequences available, then 

using that, and actually made the virus seed strains and went forward with H7N9. Regardless of if it is an egg-based or cell-based 

or recombinant, we can do that. 

Mr. FLORES. OK. 

Dr. ROBINSON. And we are moving forward with those efforts 

also. 

I just want to say one other thing that Dr. Midthun had talked 

about, and that is high production yield seed strains. Why is that 

important? It means that the virus doesn’t have to be passaged to 

eggs or cells or medium many times because, very early on, we can 

actually have high production seed strains, and that is why the 

manufacturers keep passaging the virus to get high production. If 

we had that immediately, then the virus that actually is in the vaccine is going to be very similar to the circulating virus. 

Mr. FLORES. Um-hum. 

Dr. ROBINSON. Much more so. 

Mr. FLORES. OK. And then the last question I have: I have always been fascinated with the initiatives to try to develop the universal flu vaccine, and I appreciate what Dr. Fauci talked about 

today, and educating the committee and subcommittee on how to 

do that. 

What role does BARDA play in the development, deployment and 

stockpiling of a universal flu vaccine? 

Dr. ROBINSON. So certainly hand in hand with the NIH, we are 

moving forward with the development, not only for seasonal, as I 

had pointed out, for pandemic purposes. It may serve as a primer 

for future pandemic vaccines. Again, you may only need one dose 

of the pandemic vaccine as opposed to two which you normally 

would need. And so we can stockpile that vaccine or actually have 

it as part of our commercial products that are out there every year. 

Mr. FLORES. OK. Thank you for your responses. As you know, 

this is important to me because you have a facility in my district 

that I think is doing some great work. 

Mr. Chairman, I yield back. 

Mr. MURPHY. Thank you. 

And now I recognize Ms. Clarke of New York, the Brooklyn area, 

as a new member of the subcommittee. Welcome. You are recognized for 5 minutes. 

Ms. CLARKE. Thank you very much, Mr. Chairman. 

Being the low one on the totem pole, oftentimes, it comes with 

the territory. 

88 

Let me welcome our panelists as well, and pick up on some of 

the line of questioning that my colleague Mr. Tonko raised with respect to research. 

So, Dr. Fauci, your testimony discussed the potential for a universal flu vaccine that could provide protection against numerous 

strains of the flu over several seasons. What can you tell us about 

the research on this vaccine? 

Dr. FAUCI. OK. So the research on this vaccine, as I had mentioned, really starts off with the fundamental basic observation 

that a part of the protein that is the target of the vaccines that we 

have developed over decades is one that, unfortunately, has a component of it that tends to change from season to season. We refer 

to that as a drift. Big change is the shift. The part that doesn’t 

change is the part that we have just recently recognized on the 

thin stem part of the protein that we now know that if you show 

it to the immune system in a certain way, and you can only do that 

by molecular biological techniques because, generally, when you 

show the immune system the whole virus, the part that you really 

wanted to make an immune response is crowded out and covered 

by the larger part. So now you are essentially teasing it out and 

showing the immune system just the part that you want to make 

a response again. And we have done that. We have done it with 

a number of different platforms, and we have shown now in a small 

animal, in a ferret, and now even in a human, that, A, it is feasible, B, it is safe, and C, it does induce the kind of response that 

you would predict would have a much broader effect. 

So that is the real first solid step. We have to perfect that, and 

then we have to show in a broad study that it actually does protect 

against multiple strains. 

Ms. CLARKE. That sounds very promising, Dr. Fauci. 

Dr. Robinson, you mentioned in your testimony a new initiative 

to support development of new flu vaccine candidates that offer 

broader, longer-lasting immunity. Can you tell us more about this 

initiative? 

Dr. ROBINSON. Certainly. We are working with Dr. Fauci with 

many of the candidates that he has talked about, and in addition, 

there are other ways in which we can broaden the immunity. Some 

might be with adjuvants, and other designs of the vaccines going 

forward, and not only for seasonal but for pandemic purposes. 

Ms. CLARKE. So it sounds like we are moving into the 21st century. 

Dr. ROBINSON. Yes. 

Ms. CLARKE. Very well. Very well. I would like to shift a bit to 

the idea of strains, the strain selection process, Dr. Midthun. Can 

you outline the role of the FDA’s Vaccines and Related Biological 

Products Advisory Committee in the strain selection process, and 

when does this process actually begin? 

Dr. MIDTHUN. The process is actually year-round. CDC and other 

WHO collaborating centers for influenza are monitoring influenza 

strains year-round to be looking for trends, changes, emerging situations, so that is going on all the time. Then you have—— 

Ms. CLARKE. How does the advisory committee arrive at its recommendations on the selection of a strain? 

89 

Dr. MIDTHUN. OK. So what happens in usually February or early 

March, when the Vaccines Advisory Committee meets, is that we 

have experts come and present the data on the influenza strains 

that have been circulating over really the last year, and those 

strains are evaluated to see which appear to be prevalent, and really based on those data a decision is made about which vaccine 

strains should be included in the vaccine manufacturing. And then 

once that recommendation is made, of course, the manufacturers 

then use that information to start manufacturing their vaccines. 

But I think a very important point to note is that, typically, manufacturers actually start manufacturing the vaccine before the advisory committee is even held. They usually start in January. Why? 

Because they are aware of the data also. As I mentioned, this is 

an ongoing process year-round, and so they will usually anticipate 

what they think will be the strain that is not going to change. They 

do this at risk, but the point is that—— 

Ms. CLARKE. That is what I was going to ask—— 

Dr. MIDTHUN [continuing]. It is a process—— 

Ms. CLARKE [continuing]. Has there ever been an incident where 

perhaps the advisory committee did not necessarily agree and the 

manufacturer is already proceeding? 

Dr. MIDTHUN. Yes, that can happen. I mean you would have to 

ask individual manufacturers—— 

Ms. CLARKE. Yes. 

Dr. MIDTHUN [continuing]. But I suspect that that has definitely 

happened, although, typically, I think they will go with something 

that they think, based on the data, is unlikely to change. But it 

really is a process where we make the recommendation in February, but clearly, there is a lot of work that precedes that and 

there is a lot of work that continues after that to actually have vaccine available. And usually vaccine becomes available in July, August, that time frame, and then it is continued to be released really 

throughout the end of October. So you can see it is a process that, 

even though you do a recommendation in February, and much 

work starts before that even, it really does take many, many 

months to actually have vaccine available for the influenza season—— 

Mr. MURPHY. Thank you. 

Dr. MIDTHUN [continuing]. Which, you know, typically can begin, 

you know, October, November, although sometimes not until later. 

Mr. MURPHY. Thank you. 

Ms. CLARKE. Thank you. 

Mr. MURPHY. Thank you. 

Now I recognize another new member for the committee, Susan 

Brooks of Indiana, who has a second term of Congress. Previously 

she was in the Homeland Security Committee and was a U.S. Attorney. We look forward to you being a part of this committee. You 

are recognized for 5 minutes. 

Mrs. BROOKS. Thank you, Mr. Chairman. I do want to thank all 

of the witnesses for your work with respect to the public health and 

safety of our citizens. On Homeland Security, I chaired the subcommittee on emergency preparedness response and communications, and this is something that we know everyone is passionate 

about. I think, obviously, when we have an epidemic the way we 

90 

have right now, the public pays a lot more attention to it, but I 

think the public also expects us to get it right. And the public is 

expecting us to leave no stone unturned and to continue to ask the 

questions and figure out how can we do it better, how can we do 

it faster, what mistakes have we learned from in the past, and 

what do we do to keep our country safe. 

This year is a much higher death toll, as you have said. In Indiana, there were 72 deaths statewide. The year before, 70. We have 

already had 108 deaths in Indiana, and it is just the end of January, and the flu season, as I understand it, goes often in through 

May, so we have a lot that we are very, very concerned about. I 

spoke with the head of our Marion County, which is Indianapolis’ 

Public Health Department, and she has indicated that the flu has 

gotten so severe in Indianapolis that she is barring anyone under 

the age of 18 from visiting hospitals. So if you are 15 years old and 

your mom is in the hospital, you can’t visit your mom. So we have 

reached, just to let you know, as I am sure you know, and you are 

very focused on this, but these types of precautions are obviously 

being taken for the safety of the patients, but we also know, as we 

have heard, vulnerable, you know, whether they are children or 

seniors, are so vulnerable. But yet one of the things she also shared 

with me, and she was explaining the ag. culture technology that we 

use, and it takes a long time, but yet she shared the new cell mediated technology that you have mentioned in production is faster, 

but yet it is not widely used. And so I would like to explore why. 

You mentioned a cell-based facility in North Carolina. Can we 

please talk a bit more about if these technologies are out there, 

why are they not being more widely used? And I don’t know if, Dr. 

Schuchat, you want to start, and Dr. Robinson. 

Dr. SCHUCHAT. Yes, I will just make an overview comment that 

production of flu vaccine has been increasing over the past decade, 

with more, you know, factories in the U.S., more companies, more 

products, but we also have to work on demand, and the more vaccine we use every year, the more the companies will make. They 

don’t make lots of vaccine at a risk. And so it is a cycle that is 

interdependent. But Dr. Robinson can talk about the cell-based 

plant and some of the other manufacturing efforts. 

Mrs. BROOKS. And is that correct, that a cell-based technology 

would allow vaccines to be produced faster? Is that correct or is 

that not correct? 

Dr. FAUCI. Not significantly faster. The cell-based is more consistent, whereas eggs, you know, it depends on supply of eggs, 

whereas you can keep growing up cells. I think that is a common 

misconception that there is a game-changing difference in the 

amount of time it takes. And the answer to that, and I am sure 

Robin will verify that, isn’t the case. You both have to grow the 

virus, that is the problem, as opposed to in a recombinant DNA or 

molecular technology, be able to make it more quickly. So even 

though we welcomed the transition, and hope we even do more 

from egg to cell, the answer for the time frame itself is not going 

to be solved by cell-based technology. 

Mrs. BROOKS. What is the answer to shorten the time of production? 

91 

Dr. FAUCI. And that is what I just said when I was talking about 

changing from a need to grow the virus, to the ability to do it from 

a molecular way where you actually develop a vaccine by recombinant DNA technology, which doesn’t require your having to grow 

the virus. That is really the major transformation from one platform to another. 

Mrs. BROOKS. Dr. Robinson, how do we—— 

Dr. ROBINSON. No, I agree with them. I mean that is where we 

see the biggest savings in time is with recombinant vaccines, but 

they are new and they are just with very limited capacity, they will 

grow in time. With the cell-based vaccines, we may even be able 

to shave a couple of weeks off than what we have with the standard egg-based vaccines at this time. 

The other issue is that it is a new product, and this is a very 

competitive industry, and they are trying to get their market share 

at this time. And as they improve to be equal to or better, then 

they will actually become more commonplace in the overall vaccine 

supply. 

Mrs. BROOKS. So are you saying that there is just one manufacturer that is manufacturing in that manner? 

Dr. ROBINSON. That is cell-based in the U.S., there is only one 

licensed manufacturer. 

Mrs. BROOKS. Is there any issue in the licensing process? 

Dr. MIDTHUN. No, there is no issue in the licensing process. We 

have approved one cell-based manufacturer and one recombinantbased manufacturer. We basically work with anyone who wants to 

come in and make a product, and we are there to facilitate that 

process, but it really is up to, you know, the sponsor to come in and 

say we would like to do this. Certainly, you know, BARDA has 

done much to support some of these new technologies, and certainly, again, we are grateful for the support you have given in 

that regard. 

Mrs. BROOKS. OK. 

Mr. MURPHY. Thank you. 

Mrs. BROOKS. Thank you. 

Mr. MURPHY. We now recognize another new member of the committee, Markwayne Mullin of Oklahoma. We welcome you, and you 

are recognized for 5 minutes. 

Mr. MULLIN. Thank you, Mr. Chairman. 

Dr. Robinson, my State of Oklahoma has been hit particularly 

hard this year. According to Walgreens, Oklahoma City is the number one place for prescriptions to be issued out for Tamiflu. Tulsa 

is number five. I think we have had somewhere like 50 deaths, and 

in the neighborhood of 1,300 individuals being hospitalized. My 

family was hit real hard this year. Out of my five kids, four got 

it. My fourth daughter, who is 6, received actually two different 

strains of the flu. My wife and all my family missed the swearing 

in because of the flu. And now it is kind of ironic that I am sitting 

up here talking about this. 

Just some follow-up questions. My understanding is, part of the 

challenge of being able to respond to the mismatch vaccine is the 

burden of regulations, but underneath declaration of maybe an 

emergency, those regulatory burdens change. Is that correct? 

92 

Dr. ROBINSON. Certainly, if a public health emergency is declared 

then we can move forward, but there are regulatory issues, I think 

Dr. Midthun may want to testify—— 

Mr. MULLIN. No, I just wanted a yes or no on it. If it is declared 

an emergency, those regulatory burdens change quite a bit, right? 

OK. 

In 2009, the President declared a public emergency during the 

swine flu, or the H1N1, crisis. That is correct, right? 

Dr. ROBINSON. Correct. 

Mr. MULLIN. How many cases of swine flu had been confirmed, 

not deaths but had been confirmed in the U.S., when the President 

declared that public emergency? 

Dr. ROBINSON. I think Dr. Schuchat can answer that. 

Dr. SCHUCHAT. I don’t have the numbers, but there was a—— 

Mr. MULLIN. It was 20. 

Dr. SCHUCHAT [continuing]. An enormous change in the epidemiology—— 

Mr. MULLIN. We do have the number, there were 20 of them that 

was in that—— 

Dr. SCHUCHAT. Well, but instead of flu coming down, it was going 

up after the season—— 

Mr. MULLIN. Right. 

Dr. SCHUCHAT [continuing]. With a completely different strain. 

Mr. MULLIN. But there was—— 

Dr. SCHUCHAT. So—— 

Mr. MULLIN. But there was an emergency declared with only 20 

confirmed cases in the U.S. There has already been 50 deaths in 

just my State of Oklahoma. 

Dr. SCHUCHAT. Um-hum. 

Mr. MULLIN. So I am trying to make a comparison here. 

I believe the flu season goes through May in the Northern Hemisphere, is that correct? Right? 

Dr. SCHUCHAT. It can extend to May. It can end earlier. 

Mr. MULLIN. OK, what exactly is the definition of a public health 

emergency? Dr. Robinson, do you want to take that? What are the 

criteria of us meeting a public emergency? 

Dr. SCHUCHAT. Yes, a public health emergency is not a blackand-white definition. 

Mr. MULLIN. So there is no set of specific criteria that we can 

look at, like the number of deaths or hospitalization to determine 

what is in the public’s best interest as far as a health emergency? 

Dr. SCHUCHAT. Yes, the issue with a pandemic is that the potential impact is exceptionally greater than the normal range. It—— 

Mr. MULLIN. So it doesn’t matter how many deaths we have, it 

is just 100 percent of—— 

Dr. SCHUCHAT. One would be—— 

Mr. MULLIN [continuing]. CDC to make that—— 

Dr. SCHUCHAT. One would be declaring that much in advance of 

seeing the deaths, because of the time needed to take steps to intervene. 

Mr. MULLIN. Would it help if Congress or you guys could come 

up with maybe some criteria that we could look at that could 

maybe trigger it, rather than just waiting for the next crisis to happen, or, honestly, a public outcry? 

93 

Dr. SCHUCHAT. I think we could probably provide the language 

about a public health emergency. What I was trying to say was 

that it is not the same for each condition, for each disease or—— 

Mr. MULLIN. I understand there is some type of flexibility and, 

you know, there has got to be a little bit of more understanding of 

what we are dealing with, but it seems odd that there is no criteria 

at all for us to understand it—— 

Dr. SCHUCHAT. Yes, I—— 

Mr. MULLIN [continuing]. When something like the swine flu, 

that just had 20 cases in the country, was declared an emergency 

by the President, and yet we have a pandemic going on right now 

with the flu, and we could have maybe changed some of this with 

the regulatory burdens going through if we would have declared it 

an emergency faster, where maybe we could have got help to individuals. 

Dr. SCHUCHAT. In 2009, a new strain emerged from animals that 

had genetic re-assortment that was completely unique to humans. 

And so what we are dealing with with the drift is slight changes, 

a very different scenario. But what you indicate is correct that the 

ultimate burden of disease from a drifted H3N2 strain may end up 

being greater than a completely new to humans re-assortment like 

the H1N1—— 

Mr. MULLIN. So—— 

Dr. SCHUCHAT [continuing]. Swine-origin pathogen in 2009. 

Mr. MULLIN. Could you maybe help us maybe draw some type of 

criteria that needs to be laid out so the next time this happens, we 

could have something to compare it to? 

Dr. SCHUCHAT. We would be happy to provide follow-up on the 

public health emergency and how that is defined. Sure. 

Mr. MULLIN. Thank you. I yield back. 

Mr. MURPHY. Thank you. Gentleman yields back. 

I now recognize another new member of our committee and subcommittee, Chris Collins of New York, a second term in Congress. 

Welcome aboard, and you are recognized for 5 minutes. 

Mr. COLLINS. Thank you, Mr. Chairman. 

I will be as quick as I can to get the information really directed 

more at Dr. Fauci and Dr. Schuchat. 

And I appreciate your issue of the jump on swine flu, the same 

thing we were worried about with the bird flu, that didn’t happen. 

That is the good news of RNA viruses, they don’t jump off to—but 

if they do, it can be devastating. So my question is really on the 

universal vaccine discussion. And I don’t think it has been made 

clear here. We have DNA viruses and we have RNA viruses. And 

when we talked about the vaccine for HPV, the vaccine for herpes, 

smallpox, chickenpox, those are all DNA vaccines. And it is relatively straightforward to get a vaccine for a DNA-based virus. 

Then you have your RNA viruses; HIV, Ebola, West Nile, SARS, 

influenza. They mutate a lot, that is what they do, but they don’t 

jump species much. 

So my question is this: Since we are talking about an RNA virus, 

so you can’t compare influenza with HPV, you can’t compare influenza with herpes, and I don’t think that was made clear, but now 

that we are talking about an RNA-based virus, I guess my question 

is this, because they mutate, drift so often, that is the insidious naVerDate Mar 15 2010 09:03 Jun 23, 2015 Jkt 037690 PO 00000 Frm 00097 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114_6SEASONALFLUSCAN_061915\114-6SEASONALFLUPDFMADE
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ture of RNA viruses, which is why the answer to a lot of the questions coming here is more because they do mutate, that is the basis 

of that virus. So how is it that since measles is an RNA virus, polio 

is an RNA virus, rubella is an RNA virus, and so is mumps, so you 

have mumps, measles, rubella, and polio on the one hand, RNA, 

and we have vaccines for them, what is the difference in the reason 

we don’t have vaccines for things like influenza? 

Dr. FAUCI. You have asked a very complicated question, and I 

can tell you that there is not a one-to-one relationship of whether 

you can or cannot get a vaccine, whether it is an RNA or a DNA 

vaccine. And also, RNA viruses do jump species. I mean the—— 

Mr. COLLINS. Rarely. 

Dr. FAUCI. Yes—well, HIV, influenza, I mean, there is the fowl 

virus that jumps, HIV, the chimp virus that jumps, so—— 

Mr. COLLINS. Yes, but much less—— 

Dr. FAUCI. Yes. 

Mr. COLLINS [continuing]. Likely than a DNA virus. 

Dr. FAUCI. But the things that go into whether or not—your 

point is very well taken, that if you have in general, and—— 

Mr. COLLINS. Um-hum. 

Dr. FAUCI [continuing]. You have to be really careful when you 

pick this one or the other one, in general, a virus that has a proofreading mechanism, which RNA viruses have—— 

Mr. COLLINS. Right. 

Dr. FAUCI [continuing]. They don’t correct their mistakes when 

they mutate, allows it to do what influenza does—— 

Mr. COLLINS. Right. Right. 

Dr. FAUCI [continuing]. Drift. It allows it to do what HIV does. 

If you give it one drug, it will mutate to be resistant unless you 

give it—— 

Mr. COLLINS. Sure. 

Dr. FAUCI [continuing]. Three drugs. 

Mr. COLLINS. Sure. 

Dr. FAUCI. You are perfectly correct on that. However, it really 

isn’t specifically that. These are easy to make one against, and 

these are difficult. It just doesn’t work that way because there are 

a lot of other things that go into whether or not you are going to 

have a successful vaccine. But the fundamental principles that you 

mentioned are correct. 

Mr. COLLINS. So how did we end up with one for measles, polio, 

and why has it been so god-awful, if not impossible, to get one for 

HIV or influenza? Is there any—— 

Dr. FAUCI. Well, the body makes a very good immune response 

against measles, even when it is a serious disease. Ultimately, the 

body will completely clear measles in the—— 

Mr. COLLINS. Right. 

Dr. FAUCI [continuing]. Overwhelming majority of people. So we 

already know the body has the capability of inducing an effective 

immune response, therefore, you follow what the body does and you 

induce the same response that natural infection does. With HIV, 

the body does not make an adequate immune response against 

HIV, so there is no proof of—— 

Mr. COLLINS. Yes, but now, HIV, that is where the immune system doesn’t even see the viral particles. 

95 

Dr. FAUCI. Well—— 

Mr. COLLINS. Now, that is different than influenza. 

Dr. FAUCI. Well, I am sorry, sir, it does see it, it just doesn’t 

make a good response. 

Mr. COLLINS. It doesn’t react to it. 

Dr. FAUCI. It doesn’t make a good response—— 

Mr. COLLINS. Right. 

Dr. FAUCI [continuing]. Against it. 

Mr. COLLINS. Right, but that is what is unique about HIV. 

Dr. FAUCI. Exactly. You need the body’s ability to do it naturally 

to mimic it. That is what vaccines are all about; mimicking natural 

infection without—— 

Mr. COLLINS. Sure. 

Dr. FAUCI [continuing]. Hurting the host. 

Mr. COLLINS. So one real quick question for Dr. Schuchat. They 

use adjuvant-based vaccines in Europe. We don’t do it here. The 

question on the monocrobial, if we did that with an adjuvant, we 

could extend that production, we could produce much less, extend 

it, because you were saying production is the big issue. If it was 

adjuvant-based, you wouldn’t need as much. Should we be looking 

at that as a natural part of the monocrobial? 

Dr. SCHUCHAT. You know, I think that adjuvanted influenza vaccines hold a lot of promise, and I know that the FDA has licensed 

one so far in the U.S. In terms of extending the supply and 

also—— 

Mr. COLLINS. Right. 

Dr. SCHUCHAT [continuing]. And also potentially expanding the 

immune response. As you heard from some of the measles discussions, here in the U.S. our population has a lot of questions about 

vaccines and about their safety, and they have, even in 2009 when 

we were doing community engagement around H1N1 vaccination, 

we had lots of questions about whether there would be adjuvants 

in those vaccines or not. In Europe, they use adjuvanted—— 

Mr. COLLINS. Right. 

Dr. SCHUCHAT [continuing]. H1N1 vaccines and we didn’t. Our 

public really needs to come along with us in the scientific endeavor, 

and so I think that is an area where the FDA is really critical in 

reviewing the safety data. 

Mr. COLLINS. Yes. Thank you very much. 

Yield back, Mr. Chairman. 

Mr. MURPHY. Thank you, Mr. Collins. 

And now as a tradition of this committee, if another member of 

the committee wishes to be part of this, we will welcome back a 

former member of the subcommittee for this special visit, Mrs. 

Ellmers of North Carolina. You are recognized for 5 minutes. 

Mrs. ELLMERS. Thank you, Mr. Chairman, and thank you to our 

ranking member also, for allowing me to be part of this important 

subcommittee hearing on this very timely issue. And to our panel, 

thank you for being here today. 

And I just want to point out a couple of things. One, in October, 

looking at this issue and knowing the importance of it moving forward, especially when it comes to vaccine production, I had the 

honor of hosting a roundtable discussion in the Research Triangle. 

Dr. Midthun and Dr. Robinson, thank you again for participating 

96 

in that very important discussion. We learned a lot from that. As 

we all know, Chairman Upton is leading the 21st Century Cures 

Initiative, and the vaccine space fits right in there. And I am working on very important legislation right now to actually bolster vaccine production and bring vaccines to market. As we know, it is 

very, very important. And I have also the honor of having the facility in Holly Springs, North Carolina, which has been referred to already, which will be addressing the issue of seasonal and pandemic 

vaccine production, using the cell culture technology. Very important to my district. And I also want to point out, and I think this 

is something that we need to look at into the future when we are 

trying to solve these problems. This was a public-private partnership between Novartis, HHS, and BARDA. So, again, thank you all 

for your input today. This is a very, very difficult situation, but I 

believe that we can get ahead of it and we can move forward, and 

we can identify ways that we can improve upon this process. 

Dr. Schuchat, I have a question for you. In the legislation that 

I am working on right now, my bill, we create mechanisms to help 

increase the communication and sharing between the CDC and industry, and ways that we can get that information out to impact 

public health. In your opinion, how can the CDC work more closely 

in partnership with industry to reduce the risk and uncertainty of 

investing in the novel vaccines? 

Dr. SCHUCHAT. We appreciate the chance to work closely with industry as they are doing their early development and research. 

Mrs. ELLMERS. Um-hum. 

Dr. SCHUCHAT. We welcome companies to come meet with us to 

share their ideas, and we—— 

Mrs. ELLMERS. Um-hum. 

Dr. SCHUCHAT [continuing]. Share all of the information—— 

Mrs. ELLMERS. Um-hum. 

Dr. SCHUCHAT [continuing]. We have in terms of the public 

health burden—— 

Mrs. ELLMERS. Um-hum. 

Dr. SCHUCHAT [continuing]. Need and likely interest in terms of 

public or providers. 

Mrs. ELLMERS. Um-hum. 

Dr. SCHUCHAT. So we do that regularly, and we welcome the opportunity to do it systematically. 

Mrs. ELLMERS. Dr. Midthun, again, thank you for being here, 

and again, thank you for being a participant in the roundtable discussion that I had back in the District in October. As we are looking at vaccine manufacturers to more readily export vaccines from 

the U.S. and make them available to people around the world, 

again, the legislation that we are working on right now helps to expedite the licensure process. In addition to expediting export licenses, what else can the FDA do to help speed up production and 

approval on delivery of flu vaccine availability? 

Dr. MIDTHUN. No, I think we currently use all the expedited 

pathways that are available. So we can use accelerated approval, 

which we—— 

Mrs. ELLMERS. Um-hum. 

Dr. MIDTHUN [continuing]. Have done for numerous influenza 

vaccines. 

97 

Mrs. ELLMERS. Um-hum. 

Dr. MIDTHUN. We also did recently for the 2 meningococcal B 

vaccines that we approved; one in October and one just last month. 

We also used the breakthrough designation which basically means 

that there is a very concerted interactive approach early on and 

throughout the process with industry to really accelerate the development of products. So we use all of these tools, and they are very 

important. They, of course, do rely on having certain science. 

Mrs. ELLMERS. Um-hum. 

Dr. MIDTHUN. So, for example, to use—— 

Mrs. ELLMERS. Sure. 

Dr. MIDTHUN [continuing]. Accelerated approval, you typically 

rely on what we call a surrogate endpoint. Usually in the case of 

a vaccine it would be some immune response. But you need to have 

information that actually indicates that this immune response 

is—— 

Mrs. ELLMERS. Um-hum. 

Dr. MIDTHUN [continuing]. Is really likely to predict clinical benefits. So there is also a scientific piece that is very, very important 

that others, for example—— 

Mrs. ELLMERS. Um-hum. 

Dr. MIDTHUN [continuing]. In industry, NIH, and other partners, 

need to work on—— 

Mrs. ELLMERS. Um-hum. 

Dr. MIDTHUN [continuing]. To make that kind of—— 

Mrs. ELLMERS. Um-hum. 

Dr. MIDTHUN [continuing]. Process available, but we work very 

closely, obviously, with our sponsors to facilitate whatever their development plans are. 

Mrs. ELLMERS. Thank you. And one last comment that I would 

like to make, Mr. Chairman, if you would indulge me. One of the 

concerns that was raised by Mr. Tonko from New York, having to 

do with the issues that our families are dealing with, with sick 

children and having to take time off of work, I would advocate for 

my good friend, Martha Roby from Alabama, she has a wonderful 

bill, Working Families Flexibility Act, that actually addresses this 

issue and allows our workforce to be able to take part in the availability and ability to use overtime and bank it so that in the event 

that pediatric appointments need to be made, or any of these 

things, families can make those choices. So I would advocate to the 

co-sponsorship of that bill. It is a very good bill, and it addresses 

the very issues that we are talking about today. 

Mr. MURPHY. Thank you. 

Mrs. ELLMERS. So thank you, Mr. Chairman, and I—— 

Mr. MURPHY. Thank you. 

Mrs. ELLMERS [continuing]. Yield back. 

Mr. MURPHY. And I want to thank the panelists. Look, I think 

we are all frustrated, we need to be speeding up this process and 

the science, and if there are other legislative things we need to do, 

please let us know. This is the day after Groundhog Day, and I 

don’t want to be here with another Groundhog Day a couple of 

years from now running into the same problems, with the same 

issues, and having the same crisis with so many Americans getting 

sick and dying for whatever this is. So I ask—— 

98 

Ms. DEGETTE. Would the gentleman yield for one second? 

Mr. MURPHY. Yes. 

Ms. DEGETTE. I completely agree with the Chairman, but I will 

say I want to commend this panel and others at the CDC and NIH 

because, having been on this committee now for 18 years, we really 

have made advances from when we first started with those early 

hearings on egg-based technologies. We just need to accelerate 

that. So anything we can do to help, we are here to help. Thank 

you. 

Mr. MURPHY. Appreciate that. I ask unanimous consent that 

Members’ written opening statements be introduced into the 

record, and without objection, the documents will be entered in the 

record. 

In conclusion, thank you again to the witnesses and Members 

that participated in today’s hearing. I remind Members they have 

10 business days to submit questions for the record, and I ask that 

all witnesses agree to respond promptly to those questions. 

And with that, this committee is adjourned. Thank you. 

[Whereupon, at 12:34 p.m., the subcommittee was adjourned.] 

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