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U.S. PUBLIC HEALTH PREPAREDNESS FOR SEASONAL INFLUENZA: HAS THE RESPONSE IMPROVED? 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FOURTEENTH CONGRESS 

FIRST SESSION 

NOVEMBER 19, 2015 

Serial No. 114–102 

( 

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 ...................................................................................... 4 

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

New Jersey, opening statement .......................................................................... 6 

Prepared statement .......................................................................................... 6 

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

prepared statement .............................................................................................. 70 

WITNESSES

Anne Schuchat, M.D., Principal Deputy Director, Centers for Disease Control 

and Prevention, Department of Health and Human Services .......................... 8 

Prepared statement .......................................................................................... 11 

Answers to submitted questions ...................................................................... 139 

Robin A. Robinson, Ph.D., Deputy Assistant Secretary for Preparedness and 

Response and Director, Biomedical Advanced Research and Development 

Authority, Department of Health and Human Services ................................... 19 

Prepared statement .......................................................................................... 21 

Answers to submitted questions ...................................................................... 142 

Carole A. Heilman, Ph.D., Director, Division of Microbiology and Infectious 

Diseases, National Institute of Allergy and Infectious Diseases, National 

Institutes of Health .............................................................................................. 33 

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

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

Services ................................................................................................................. 44 

Prepared statement .......................................................................................... 47 

SUBMITTED MATERIAL

Subcommittee memorandum, submitted by Mr. Murphy .................................... 72 

Correspondence of April 2015 from Department of Health and Human Services personnel to committee and subcommittee leadership, submitted by 

Mr. Murphy .......................................................................................................... 84 

Letter of July 29, 2015, from Mr. Upton, et al., to Sylvia Burwell, Secretary, 

Department of Health and Human Services, submitted by Mr. Murphy ........ 116 

Letter of September 30, 2015, from Jim R. Esquea, Assistant Secretary for 

Legislation, Department of Health and Human Services, to Mr. Upton, 

submitted by Mr. Murphy ................................................................................... 120 

Memorandum of May 6, 2015, from Nicole Lurie and Influenza Risk Management Group, Department of Health and Human Services, submitted by 

Mr. Murphy .......................................................................................................... 131 

(1) 

U.S. PUBLIC HEALTH PREPAREDNESS FOR 

SEASONAL INFLUENZA: HAS THE RESPONSE 

IMPROVED? 

THURSDAY, NOVEMBER 19, 2015 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 9:59 a.m., in room 

2322 Rayburn House Office Building, Hon. Tim Murphy (chairman 

of the subcommittee) presiding. 

Members present: Representatives Murphy, Griffith, Bucshon, 

Flores, Brooks, Mullin, Hudson, Collins, Cramer, DeGette, Castor, 

Kennedy, Green, and Pallone (ex officio). 

Staff present: Rebecca Card, Assistant Press Secretary; Brittany 

Havens, Legislative Associate, Oversight; Charles Ingebretson, 

Chief Counsel, Oversight and Investigations; Graham Pittman, 

Legislative Clerk; Chris Santini, Policy Coordinator, Oversight and 

Investigations; Alan Slobodin, Deputy Chief Counsel, Oversight 

and Investigations; Waverly Gordon, Democratic Professional Staff 

Member; Tiffany Guarascio, Democratic Deputy Staff Director and 

Chief Health Advisor; Christopher Knauer, Democratic Oversight 

Staff Director; Una Lee, Democratic Chief Oversight Counsel; and 

Elizabeth Letter, Democratic Professional Staff Member. 

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

Mr. MURPHY. Good morning. We have the subcommittee hearing 

from Oversight and Investigations. Earlier this year, in February, 

this subcommittee held a hearing on last year’s flu vaccine mismatch. This mismatch to the predominant flu virus resulted in 

more deaths and hospitalizations because of the vaccine’s lower 

than usual effectiveness. 

Today, we are returning to that issue to discuss what our public 

health agencies have learned in the intervening months. I want to 

thank my friend, the Ranking Member Diana DeGette of Colorado, 

for her assistance and continued passion on this important topic. 

We work closely on this issue sending bipartisan letters and receiving briefings, not only on this year’s flu vaccine, but also on our 

broader response to seasonal and pandemic flues. 

Influenza is a leading cause of death in the United States, especially in a severe flu season. Each year, millions of Americans reVerDate Mar 15 2010 09:55 Sep 15, 2016 Jkt 037690 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X102FLUPREPMORESCANS091416\114X102FLUPREPPENDIN
2 

ceive flu shots to help protect against the illness. Getting a flu shot 

is important. Even in a bad flu season, the vaccine can reduce the 

symptoms and duration of the flu, and I encourage everyone who 

has not already received a flu shot this season to get one, even if 

the vaccine is not perfect. 

Last year, the United States experienced a severe flu vaccine 

mismatch and public health officials designed the vaccine based on 

information available in February. But the virus mutated before 

the flu season began resulting in an effectiveness rate of only 19 

percent of the vaccine and even lower for senior citizens. 

We have learned, however, that even in a good year, the effectiveness of the vaccine is lower than it should be. In 4 of the last 

10 years, the flu vaccine effectiveness rate fell below 40 percent 

and it is clear that the seasonal flu can cause severe public health 

impacts on the same scale as a pandemic flu. 

The time for an updated approach to dealing with the flu has 

long passed. The committee’s oversight work has made a difference. 

The Department is now treating the seasonal flu as a high priority. 

Tools and plans typically reserved for pandemic flu situations are 

being considered in the fight against the seasonal flu. 

An HHS Influenza Working Group has compiled 13 issues and 

recommendations to improve the influenza vaccine development 

and manufacturing process. They are working to improve surveillance, utilize technology to speed vaccine production, and make 

more effective vaccines. But there is still much work to be done. 

The issues surrounding the flu vaccine are not new. We are still 

largely manufacturing flu vaccines and detecting flu virus changes 

with technology developed during the 1940s. At the same time, 

more and more influenza viruses are emerging each year. Increases 

in travel and trade make it easier than ever for these viruses to 

spread. Our current system is not as responsive and effective as it 

should be. 

The system is badly in need of modernization and must better 

capture advances in technology over the past decades. We need better testing to quickly learn of mutations and seasonable influenza 

viruses. We must increase our capacity to create cell based and recombinant vaccine doses instead of heavily relying on the more 

problematic egg-based vaccine doses. 

The estimated production time for cell-based and recombinant 

vaccines is significantly quicker than egg-based vaccines, allowing 

for greater flexibility in the vaccine selection and manufacturing 

process. 

NIH, the Biomedical Advanced Research and Development Authority, known as BARDA, and other agencies undertaking research in influenza and the flu vaccine must determine what precisely is limiting vaccine effectiveness, particularly with respect to 

the dangerous H3N2 seasonal flu strains. We must also better understand how to use adjuvants to boost the effectiveness of the vaccine, particularly among high-risk populations such as the elderly 

and the young. 

We need a better contingency plan for vaccine mismatch uses 

whether due to antigenic drift or egg adaptation issues. The public 

health organizations must increase surveillance particularly in the 

3 

Southern Hemisphere so we can know as early as possible when a 

seasonal flu vaccine will not be as effective as we hope. 

The CDC must have a more robust and effective communications 

strategy when dealing with the flu. In particular, healthcare professionals must be better educated about the use of antivirals instead of antibiotics when treating the flu. The CDC must also come 

up with a better plan to increase vaccination rates. 

And finally, HHS must prioritize updating its pandemic plans 

some of which have not been updated for over a decade. These updates which are now not expected until sometime next year are 

long overdue. 

I am encouraged by the work that has been done in the wake of 

last year’s flu season, but we must also ask ourselves where we are 

falling short and what we need to do to modernize our response to 

influenza. Our Nation deserves a 21st century response to this 

problem. 

I thank our witnesses from CDC, FDA, BARDA, and NIH, and 

look forward to hearing their testimony today. 

[The prepared statement of Mr. Murphy follows:] 

PREPARED STATEMENT OF HON. TIM MURPHY

Good morning. Earlier this year, in February, this subcommittee held a hearing 

on last year’s flu vaccine mismatch. This mismatch to the predominant flu virus resulted in more deaths and hospitalizations because of the vaccine’s lower than usual 

effectiveness. Today, we are returning to that issue to discuss what our public 

health agencies have learned in the intervening months. I want to thank the ranking member for her assistance in this important topic. We have worked closely on 

this issue, sending bipartisan letters and receiving briefings, not only on this year’s 

flu vaccine, but also on our broader response to seasonal and pandemic flus. 

Influenza is a leading cause of death in the United States, especially in a severe 

flu season. Each year, millions of Americans receive flu shots to help protect against 

the illness. Getting a flu shot is important—even in a bad flu season, the vaccine 

can reduce the symptoms and duration of the flu. I encourage everyone who has not 

already received a flu shot this season to get one, even if the vaccine is not perfect. 

Last year, the United States experienced a severe flu vaccine mismatch. Public 

health officials designed the vaccine based on information available in February, but 

the virus mutated before the flu season began, resulting in an effectiveness rate of 

only 19 percent for the vaccine, and even lower for senior citizens. We have learned, 

however, that even in a good year, the effectiveness of the vaccine is lower than it 

should be. In four of the last 10 years, the flu vaccine effectiveness rates fell below 

40 percent. It is clear that the seasonal flu can cause severe public health impacts 

on the same scale as a pandemic flu. The time for an updated approach to dealing 

with the flu has long passed. 

The committee’s oversight work has made a difference. The Department is now 

treating the seasonal flu as a higher priority. Tools and plans typically reserved for 

pandemic flu situations are being considered in the fight against the seasonal flu. 

An HHS influenza working group has compiled 13 issues and recommendations to 

improve the influenza vaccine development and manufacturing process. They are 

working to improve surveillance, utilize technology to speed vaccine production, and 

make more effective vaccines. 

But there is still much work to be done. The issues surrounding the flu vaccine 

are not new—we are still largely manufacturing flu vaccines and detecting flu virus 

changes with technology developed during the 1940s. At the same time, more and 

more new influenza viruses are emerging each year. Increases in travel and trade 

make it easier than ever for these viruses to spread. Our current system is not as 

responsive and effective as it should be. 

The system is badly in need of modernization, and must better capture advances 

in technology over the past decades. We need better testing to quickly learn of 

mutations in seasonal influenza viruses. We must increase our capacity to create 

cell-based and recombinant vaccine doses, instead of heavily relying on the more 

problematic egg-based vaccine doses. The estimated production time for cell-based 

4 

and recombinant vaccines is significantly quicker than egg-based vaccines, allowing 

for greater flexibility in the vaccine selection and manufacturing process. 

NIH, the Biomedical Advanced Research and Development Authority (BARDA), 

and other agencies undertaking research into influenza and the flu vaccine must determine what precisely is limiting vaccine effectiveness, particularly with respect to 

the dangerous H3N2 seasonal flu strains. We must also better understand how to 

use adjuvants to boost the effectiveness of the vaccine, particularly among high-risk 

populations such as the elderly and the young. 

We need a better contingency plan for vaccine mismatch issues, whether due to 

antigenic drift or egg adaptation issues. The public health organizations must increase surveillance, particularly in the Southern Hemisphere, so we can know as 

early as possible when a seasonal flu vaccine will not be as effective as we hope. 

The CDC must have a more robust and effective communications strategy when 

dealing with the flu. In particular, health care professionals must be better educated 

about the use of antivirals instead of antibiotics when treating the flu. The CDC 

must also come up with a better plan to increase vaccination rates. 

Finally, HHS must prioritize updating its pandemic plans, some of which have not 

been updated for over a decade. These updates—which are now not expected until 

sometime next year—are long overdue. 

I am encouraged by the work that has been done in the wake of last year’s flu 

season. But we must also ask ourselves where we are falling short and what we 

need to do to modernize our response to influenza. Our nation deserves a 21st century response to this problem. 

Mr. MURPHY. And I now recognize ranking member of the subcommittee Ms. DeGette of Colorado 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 really think 

it is so important the bipartisan work that we are doing on these 

flu issues. Oftentimes, people ask me what keeps me up at night 

and I always say having been in Congress when we had the H1N1 

flu some years ago, the concept of a flu pandemic and what it could 

do for our country and our constituents and the world at large, it 

is what is keeping me up at night. And that is why I think it is 

important that we have a hearing every year. I am really happy 

we are having it this year before the flu season has started. I think 

it is really critical so that we can examine what—first of all, what 

is happening with the seasonal flu as best as we can predict, and 

secondly, what we are doing to prepare ourselves for better response to the seasonal flu and also more devastating potentials. 

I see we have some medical professionals in the room here and 

I am always happy to see. It looks like you are students. My 

daughter is a medical student, and so she is also very interested 

in these issues. 

Last year, I think, was a really harsh reminder that infectious 

disease is always around us and try as we might, we are not always 100 percent successful in treating the annual flu. Last year’s 

flu vaccine was only moderately effective. Fortunately, it was not 

a severe strain, but nonetheless, it resulted in increased hospitalizations, particularly for vulnerable populations like senior 

citizens and young children. 

During the course of the last season, in fact, CDC announced 

that the flu vaccine had only a 23 percent effectiveness rate which 

is significantly lower than we have observed in recent years. That 

was largely because the virus mutated in the 8 months between 

the vaccine strain selection and the onset of the flu season. And 

5 

that resulted in a mismatch between the strain of the virus used 

in the vaccine production and the one that we were actually circulating. 

Still, we need to protect ourselves and last year even 23 percent 

was better than nothing. But Dr. Frieden reminded us last year 

that even a vaccine with a low effectiveness rate still protects millions of people from getting sick and we hope and I hear that some 

of the early indications are that it is a better match this year, but 

it is still kind of a crap shoot every year as to what is going to happen. And so that is why I am always happy to have these witnesses 

here today, some of whom who have been to this committee before, 

some are new, to hear about ways that we can strengthen our response for the future. 

I want to ask the CDC about this flu season, but I also want to 

hear how we are going to respond in the event of a severe flu season and what we are doing to continue to prepare for the inevitability of some kind of a pandemic flu. 

I was pleased to see that the administration put together a 

memorandum for the Secretary of Health and Human Services, 

based in part on lessons from last year’s flu season. It offers several key areas where improvements could be made including better 

technology to quickly identify and isolate flu strains and efforts to 

improve vaccine manufacturing. And the plan also provides rough 

estimates of when certain activities can be achieved and which 

agencies are responsible for each goal. 

But Mr. Chairman, as you pointed out, we are still relying on 

egg-based vaccines even though we have better—we have cellular 

techniques that are better. And frankly, this is the eighth hearing 

that we have had in the last 10 years. And I remember 10 years 

ago asking about the development of a new and more nimble vaccine potential and here we are again talking about this same thing. 

And so I am really looking forward to hearing from the witnesses 

about the goals that they share and the memorandum that was 

issued and also where we are towards moving towards better technologies on vaccine production and what we are doing to improve 

all of the rest of our systems for more serious identification and 

prevention. The importance of a strong public health infrastructure 

that allows us to prepare and respond simply cannot be overstated. 

And we are in a good position, but I think our position could be 

improved. We need coordinated response capabilities, effective communication strategies, and critical investments so we can strengthen our response to all types of flu threats. 

And so let me conclude by thanking the witnesses and agencies 

here today. All of you I know are very committed to this effort and 

we look forward to partnering with you in this on-going fight. And 

I yield back. Thank you, Mr. Chairman. 

Mr. MURPHY. Thank you. I don’t think we have any on our side, 

and, given that we are going to be voting soon, we will submit 

those for the record. 

And Ranking Member Mr. Pallone wants to make a statement. 

You are recognized now for 5 minutes. 

6 

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

Mr. PALLONE. Thank you, I will try to shorten it, Mr. Chairman, 

in light of what you just said. I just want—obviously, it is important for many vulnerable Americans, seasonal flu can be dangerous. Older Americans, pregnant women, and young children are 

all at heightened risk for flu complications, hospitalization, and 

death. And last year, we experienced a severe flu season across the 

country. Hospitalizations were up. Seasonal flu remains a significant public health burden that requires considerable attention from 

our public health officials. 

In addition, the lag time between the selection of the strains for 

the flu vaccine and the completion of the vaccine manufacturing 

process raises inherent difficulties. We can all get vaccinated. 

Under the Affordable Care Act, flu and other immunizations are 

required to be covered by your health insurance without any copayments or coinsurance. I went and got my shot this morning in the 

infirmary. It was free and it is as easy as going to the pharmacy 

around the corner, so there are really no good reasons not to do it. 

An annual flu vaccination continues to be the best method for preventing flu. 

Even in a year where the flu vaccine is less effective, flu shots 

still protect against and decrease the severity of flu-related illnesses. Unfortunately, many Americans still haven’t gotten their 

flu shots. Even though we have made great progress, vaccination 

lags behind in adults, particularly in 18-to-64-year-olds. And the 

mismatch vaccine during the 2014–15 flu season highlights the 

need to improve our vaccine manufacturing process as well as our 

capacity to conduct surveillance and virus characterization in cooperation with our global partners. 

So I just want to thank all of the witnesses for coming today. 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

Mr. Chairman, thank you for holding this hearing today. I think this is an important hearing on a topic of bipartisan concern. 

While it is easy to get complacent about seasonal flu, it is important to remember 

that for many vulnerable Americans, seasonal flu can be dangerous and even deadly. Older Americans, pregnant women, and young children are all at heightened risk 

for flu complications, hospitalization, and death. Between 1976 and 2007, yearly estimates of flu-related deaths in the United States ranged from a low of about 3,000 

to a high of 50,000. 

Last year, we experienced a severe flu season. Across the country, hospitalizations 

were up. For people aged 65 and older, CDC recorded the highest hospitalization 

rates since they began collecting that data in 2005. 

Seasonal flu remains a significant public health burden that requires considerable 

attention from our public health agencies. The tendency of flu viruses to change constantly results in challenges to our public health capabilities. We do not yet have 

the ability to predict in advance how severe a flu season will be, when it will peak, 

and what flu strains will dominate. There are also many things that we still don’t 

know about why the flu vaccine is more effective in certain individuals, and how 

the health status of the individual may affect the body’s immune response. 

In addition, the lag time between the selection of the strains for the flu vaccine 

and the completion of the vaccine manufacturing process raises inherent difficulties. 

We saw this become a problem in the 2014–2015 flu season. The H3N2 virus strain 

that circulated during the flu season had become significantly different from the 

7 

H3N2 virus that had been used to develop the vaccine, resulting in the reduced effectiveness of the vaccine. 

But here’s what we do know, and what we can all do. We can all get vaccinated. 

Under the Affordable Care Act, flu and other immunizations are required to be covered by your health insurance without any copayments or coinsurance. I am going 

to get my flu shot today. It’s free, and it’s as easy as going to the pharmacy around 

the corner, so there are really no good reasons not to do it. 

Annual flu vaccination continues to be the best method for preventing flu and its 

potentially severe complications in both children and adults. Getting the flu vaccine 

reduces flu-associated illness and adverse health outcomes. For instance, in the 

2013–2014 flu season, vaccination prevented an estimated 7.2 million influenza-associated illnesses, 3.1 million medically attended illnesses, and 90,000 hospitalizations. 

Even in a year where the flu vaccine is less effective, flu shots still protect against 

and decrease the severity of flu-related illnesses. Moreover, flu shots don’t only protect the vaccinated. Vaccinating yourself not only increases the odds that you won’t 

get sick this season, but also protects everyone you come in contact with, such as 

your older parents, or your sister’s new baby. 

Unfortunately, many Americans still haven’t gotten their flu shots. Although we 

have made great progress in getting children vaccinated, particularly young children, vaccination rates lag behind in adults, particularly in 18-to-64-year-olds. I look 

forward to hearing from CDC about what strategies have been effective in improving vaccination rates in the past, and how we can continue to improve vaccination 

rates going forward. 

Additionally, the mismatched vaccine during the 2014–2015 flu season highlights 

the need to improve our vaccine manufacturing process, as well as our capacity to 

conduct surveillance and virus characterization in cooperation with our global partners. I look forward to hearing from BARDA, CDC, NIH, and FDA about new technologies and initiatives to better detect emergent viruses, enhance vaccine effectiveness, and speed vaccine production. 

I want to thank all the witnesses for coming today. I look forward to hearing from 

each of you about what your agencies are doing to improve flu surveillance, vaccine 

manufacturing processes, and vaccination rates. 

Mr. PALLONE. If I could submit my full statement to the record, 

Mr. Chairman, I would ask unanimous consent to do that. 

Mr. MURPHY. Without objection, we will do that. And if any other 

Members have an opening statement, I will ask unanimous consent 

the Members have those submitted without objection and will be 

entered into the record. 

I would now like to introduce the witnesses on the panel for today’s hearing. Dr. Anne Schuchat is the Principal Deputy Director 

for the Centers for Disease Control and Prevention. Dr. Robin Robinson is the Director of the Biomedical Advanced Research and Development Authority, otherwise known as BARDA, within the Office of the Assistant Secretary for Preparedness and Response. Dr. 

Carole Heilman is the Director of the Division of Microbiology and 

Infectious Diseases within the National Institute of Allergy and Infectious Disease, the National Institutes of Health. And Dr. Karen 

Midthun is the Director of the Center for Biologics Evaluation and 

Research at the U.S. Food and Drug Administration. We probably 

have about a century of education at that table. Thank you. 

I will now swear in the witnesses. You are aware that the 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? 

[No response.] 

Seeing none, 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 you desire to be advised by counsel during 

your testimony today? 

8 

And everybody says no. So in that case, please rise and raise 

your right hand. I will swear you in. 

Do you swear the testimony you are about to give is the truth, 

the whole truth, and nothing but the truth? 

All the witnesses have answered in the affirmative. You are now 

under oath and subject to the penalties set forth in Title 18 Section 

1001 of the United States Code. We will recognize you each for a 

5-minute summary of your statement. Please try and keep it on 

time because we are tight for votes. 

Doctor, you are first. 

STATEMENTS OF ANNE SCHUCHAT, M.D., PRINCIPAL DEPUTY 

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

ROBIN A. ROBINSON, PH.D., DEPUTY ASSISTANT SECRETARY 

FOR PREPAREDNESS AND RESPONSE AND DIRECTOR, BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, DEPARTMENT OF HEALTH AND HUMAN SERVICES; 

CAROLE A. HEILMAN, PH.D., DIRECTOR, DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTE 

OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH; AND KAREN MIDTHUN, M.D., DIRECTOR, 

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH, 

FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 

HEALTH AND HUMAN SERVICES 

STATEMENT OF ANNE SCHUCHAT 

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

the committee. I am Dr. Anne Schuchat, Deputy Director of the 

Centers for Disease Control and Prevention. 

I shared with the committee last February in the midst of the 

2014–15 season that influenza is a formidable adversary. The propensity of influenza viruses to change presents unique challenges. 

New flu vaccines are made each year and updated as needed based 

on our best determinations of which viruses are likely to be most 

common during the next season. The vaccine development process 

is complex and time consuming with the vast majority of flu vaccines still dependent on egg-based production technology. 

And while we tackle seasonal influenza, we must conduct constant global surveillance and prepare for the emergence of dramatically changed or shifted influenza viruses that could trigger the 

next pandemic. 

The 2014–15 season was especially severe. The H3N2 influenza 

viruses that dominated posed substantial challenges. Even during 

seasons when vaccine and circulating viruses are well matched, we 

tend to see more severe disease when H3N2 viruses are predominant. H3N2 viruses have been becoming more difficult to grow in 

eggs. And last season’s H3N2 viruses were difficult to characterize, 

using the routine lab tests that still work well for other influenza 

viruses. 

The unique properties of H3N2 viruses also present challenges 

for vaccine production. Last year, we saw how devastating seasonal 

influenza can be. The severe season typical of H3N2 years was exacerbated by circulation of strains that had drifted away from the 

9 

H3N2 strain used for vaccine development. We saw disappointing 

vaccine effectiveness against these viruses. We saw the highest 

hospitalization rates in people 65 and older that we have seen since 

this type of tracking began nearly a decade ago. Despite this, the 

vaccine actually worked well against influenza B viruses that also 

circulated last season. 

I will briefly mention where we are now as we head into the 

2015–16 flu season, then describe the steps we have been taking 

to improve our efforts in light of the problems we faced last winter. 

Currently, influenza circulation is low and flu season hasn’t yet 

begun. We can’t predict exactly when flu activity will start accelerating or which viruses will circulate most commonly in the weeks 

and months ahead. Thus far, we have seen more H3N2 viruses 

than H1N1 or B viruses. 

Current global lab data continues to indicate that most circulating flu viruses remain similar to the reference vaccine viruses 

used for development of the 2015–16 U.S. vaccines. While we can’t 

predict how effective this season’s flu vaccines will be, the composition of the 2015–16 U.S. vaccine was updated from the ’14-’15 one 

to better match circulating viruses. And global data available right 

now, suggests that a vaccination with Northern Hemisphere flu 

vaccine should offer protection against the majority of viruses. 

I could speak at length about the significant improvements we 

have made to our influenza program over the last decade. Instead, 

I will describe what CDC learned from the past season and what 

we have done to improve our ability to rapidly detect, respond, and 

prevent flu. 

First, we continue to work toward better detection of influenza 

viruses and overcome challenges in characterizing H3N2 viruses to 

detect important changes to them. We are implementing new testing paradigms where we perform sequencing first on all specimens 

received for characterization. This gives actionable data much 

quicker than before. We are working with domestic and international public health partners to transfer this technology to them, 

reducing processing time by weeks. We are developing better assays to characterize seasonal viruses and enhance our ability to 

identify emerging viruses. This season we are implementing right 

sizing virus surveillance initiative with 64 public health labs. 

We have put out the call to all our international partners to increase frequency and numbers of specimens shipped to Collaborating Centers and we are trying to maintain the gains we have 

made in the last 10 years in our global surveillance. We are working to provide better characterized vaccine viruses to WHO and 

manufacturers for vaccine production We are increasing the number of viruses with the potential drift capability that are fully characterized as cell and egg propagated viruses to expand the pool of 

viruses available for vaccine composition decisions. And we are improving upon the vaccine virus selection process, exploring a staggered approach whereby decisions about difficult vaccine components are made closer to the season and talking to the WHO Flu 

Network and manufacturers about moving the decision time line as 

a whole closer to the season. 

Although I have spoken about things we would like to do better, 

I want to remind you the vast progress we have made in detecting, 

10 

preventing, and responding to influenza threats over the past decade. Flu is a formidable opponent, but CDC is working 24/7 to protect Americans from this and other threats at home and abroad. 

And I am happy to answer questions. 

[The prepared statement of Dr. Schuchat follows:] 

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Mr. MURPHY. Thank you. Dr. Robinson, you are recognized for 5 

minutes. 

STATEMENT OF ROBIN A. ROBINSON 

Dr. ROBINSON. Good morning, Chairman Murphy, Ranking Member DeGette, oh sorry. Good morning. And I would recognize the 

chairman, Ranking Member DeGette, and the distinguished members of the subcommittee. Thank you for the opportunity to speak 

with you again today. 

I am Dr. Robin Robinson, the Director of the Biomedical Advanced Research and Development Authority or BARDA, and the 

Deputy Assistant Secretary to the Assistant Secretary for Preparedness and Response or ASPR, as well as a former developer of 

influenza vaccines in industry. 

ASPR is charged with coordinating Federal public health and 

medical preparedness and response to public health emergencies, 

providing integrating public policy and strategic direction over the 

national response framework, and through BARDA oversees advanced research and development and procurement of novel and innovative medical counter measures such as vaccines, therapeutics, 

diagnostics, and medical devices for the entire Nation to address 

medical consequences of manmade and naturally occurring threats 

like the 2009 H1N1 pandemic, the 2013 H7N9 influenza outbreak, 

and the recent bola epidemic. 

We have funded and successfully managed the advanced development of more than 80 medical countermeasures for pandemic influenza and 18 receiving FDA approval and licensure since 2007 and 

6 in the last 3 years. Additionally, we developed and procured vaccines and antivirals used in the 2009 H1N1 pandemic and stockpiled vaccines that were prepared against H5N1 and H7N9 viruses. 

Through partnerships with NIH, CDC, FDA, industry, and academia, we have met and overcome many, but not all, of the challenges inherent to making vaccines for seasonal and pandemic influenza. These achievements include first modernization of influenza vaccines through the development and licensure of new celland recombinant-based influenza vaccines and antigen-sparing 

adjuvanted vaccines; second, shortening pandemic influenza vaccine manufacturing time lines through advancements such as synthetic biology and new vaccine potency assays; third, establishment 

and maintenance of pre-pandemic influenza vaccine stockpiles for 

H5N1 and H7N9 viruses; fourth, multi-fold expansion of domestic 

pandemic influenza vaccine production to meet U.S. pandemic vaccine needs; and lastly, providing emergency response capabilities to 

develop, manufacture, and test new pandemic influenza vaccines 

through our national medical countermeasure response infrastructure. 

Despite these significant accomplishments, our influenza vaccine 

preparedness work is not over. Incremental 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, novel adjuvants, and 

heterotypic prime/boost vaccine strategies may afford more durable 

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and broader immunity and spark renewed interest and efforts to 

develop more effective influenza vaccines with universal potential. 

With the National Institute of Allergy and Infectious Disease, we 

are supporting the development of several new influenza vaccine 

candidates that may be more effective against a wider range of influenza viruses and that may serve both seasonal and pandemic influenza needs. Additionally, the National Institute of Allergy and 

Infectious Disease and we are supporting new methods to help forecast the select seasonal and pandemic influenza vaccine strains 

based on evolutionary biology technologies. 

With our HHS partners, we are bringing a number of our advancements in pandemic influenza vaccines to address virus antigenic drift and seasonal influenza vaccine mismatch issues. These 

actions include better virus surveillance and characterization, new 

seasonal virus risk assessment tools, faster preparations of better 

candidate vaccine viruses, faster potency assays and reagent lot 

variation and more effective influenza vaccines. 

Beyond the successes that we have achieve domestically, improved global coordination is critical. We have engaged our global 

partners and industry several times this year on our improvement 

efforts for seasonal influenza vaccines. Recently, we evaluated several of these actions in a tabletop exercise with HHS agencies, 

WHO, representatives from other countries, and vaccine manufacturers. The exercise showed that several of these mitigation measures may improve the way that we prepare candidate vaccine 

strains and make seasonal influenza vaccines. 

In addition, the exercise provided improved framework on how 

the U.S. and global partners may manage viral antigenic drift and 

vaccine mismatches better. 

In conclusion, influenza viruses that may cause seasonal 

epidemics and potential pandemics continue to evolve and change, 

infect animals and man and pose significant threats to global and 

domestic public health. Last year’s limited seasonal influenza vaccine effectiveness and this year’s arrival of H5 avian influenza viruses in U.S. poultry underscore our urgent and compelling need 

to complete the mission. 

To be better prepared, our Nation must continue to invest in domestic seasonal and pandemic preparedness and work with key 

global partners. Thank you for your generosity and I look forward 

to your questions. 

[The prepared statement of Dr. Robinson follows:] 

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Mr. MURPHY. Thank you. Dr. Heilman, you are recognized for 5 

minutes. 

STATEMENT OF CAROLE A. HEILMAN 

Dr. HEILMAN. Mr. Chairman, Ranking Member DeGette, and 

members of the subcommittee, thank you for the invitation to discuss the National Institutes of Health’s (NIH) response to the public health threat posed by influenza. The National Institute of Allergy and Infectious Diseases (NIAID) is the lead NIH institute for 

research on immunologic, allergic, and infectious diseases, including influenza. 

The NIAID mission balances research addressing current medical challenges with the capacity to respond rapidly to new threats 

from emerging and re-emerging infectious diseases, including seasonal and pandemic influenza. Given the morbidity and mortality 

of influenza in the United States every year, and the disease’s economic burden, there remains a concerted U.S. interagency and 

international effort to study the global emergence and spread of 

novel influenza viruses to ensure that we are prepared not only for 

the coming flu season, but also for strains with pandemic potential. 

As part of this response, NIAID’s long-standing influenza research program spans basic translational and clinical research and 

includes efforts to develop a universal influenza vaccine that could 

provide durable protection against a variety of seasonal and pandemic influenza viruses. 

Important to NIAID’s effort are on-going collaborations with academia, biotechnology, and pharmaceutical industries and other 

Federal partners, particularly, CDC, FDA, ASPR, and BARDA. 

NIAID’s basic research on influenza focuses on understanding 

how influenza virus strains, including those with potential pandemic potential, evolve and causes illness in animals and humans. 

Many of the ways NIAID contributes fundamental knowledge about 

influenza is through our Centers of Excellence for Influenza Research and Surveillance Program which studies the global emergency and spread of novel influenza viruses and provides critical 

information to the World Health Organization. 

NIAID also is using bioinformatic approaches to learn more 

about how influenza changes over time and how it can be prepared 

to rapidly respond to these changes. For example, NIAID is supporting the development of antigenic cartography, a computational 

method to understand evolutionary changes to influenza. This 

method is now being applied to data from WHO Collaborating Centers to help provide information relevant to the strain composition 

of the annual seasonal influenza vaccine. 

In addition, an NIAID supported computational method, known 

as antibody landscaping, has enabled scientists to visualize how 

the human immune system responds to a lifetime of influenza infections. This technique is also being employed to design antigenically advanced vaccines that may allow us to vaccinate against 

influenza strains that have not get emerged. 

To help diagnose and promptly treat influenza, NIAID supports 

the development of diagnostic tools that examine the molecular 

makeup of influenza viruses to quickly distinguish between seasonal strains and those with pandemic potential. NIAID is also 

34 

supporting development of clinical assays to determine influenza’s 

sensitivity to neuraminidase inhibitors, drugs that can lessen the 

severity and duration of influenza and potentially prevent influenza in close contacts of patient. 

NIAID is also responding to the emergency of antiviral resistance 

influenza strains by exploring new and better treatment options including broad spectrum antiviral drugs, RNA polymerase inhibitors 

and peptide inhibitors. 

As we all know, annual influenza vaccination is the primary 

method to prevent seasonal influenza. Because influenza viruses 

evolve as they spread from person to person, the strains used in 

the influenza vaccine must be reevaluated every year. While recent 

analysis suggests that strains in the current seasonal influenza 

vaccine match the current circulating influenza strains, the mismatch experienced during 2014 and ’15 flu season underscores the 

importance of NIAID’s sustained support for influenza research 

and in particular, work towards a more broadly cross-protective or 

universal influenza vaccine that could generate long-lasting protection against influenza strains over multiple seasons and enhance 

pandemic preparedness. 

NIAID research on universal vaccine is focused on several concepts, but the common principle behind each of these concepts is 

to identify those parts of the influenza viruses that are similar 

across multiple influenza strains and then maximize the immune 

system’s potential to respond to them. 

In addition to the efforts of NIAID scientists, the Institute in collaboration with BARDA is supporting a development of several potential promising universal influenza candidates by industry and 

academic partners. Although we cannot predict when a universal 

influenza vaccine will be publicly available, NIAID’s lead effort has 

generated encouraging progress towards this goal. It is important 

to note that we develop universal influenza vaccines, promising 

candidates will need to be evaluated over several influenza seasons 

to determine the extent and durability of their protection. 

NIAID is also helping to address scientific challenges in influenza virus reduction and NIAID is supporting efforts to create a 

flexible vaccine manufacturing process for seasonal pandemic influenza vaccine development including modern molecular biological 

techniques to help increase production efficiency and shorten manufacturing time.NIAID will continue to focus on advancing new 

tools to prevent and combat seasonal pandemic influenza in collaboration with academic, the biotechnology institutes, and pharmaceutical industries and other Federal partners. 

Thank you for the opportunity to provide this overview of 

NIAID’s influenza research program. I would be pleased to answer 

any subcommittee questions. 

[The prepared statement of Dr. Heilman follows:] 

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Mr. MURPHY. Thank you. Dr. Midthun, you are recognized for 5 

minutes, and please try and keep it to 5 minutes. We are running 

over. Thank you. 

STATEMENT OF KAREN MIDTHUN 

Dr. MIDTHUN. Mr. Chairman, Ranking Member DeGette, and 

members of the subcommittee, I am Dr. Karen Midthun, Director 

of the Center for Biologics Evaluation and Research, the center 

within FDA responsible for regulating vaccines. Thank you for this 

opportunity to be here today to discuss FDA’s role in the highly collaborative effort in preventing influenza through vaccination in the 

United States. 

Each year, influenza causes illness in a large proportion of the 

U.S. population and may result in serious complications including 

hospitalization and death. Influenza viruses continually undergo 

changes in their genetic makeup and resulting proteins that interact with the immune system. Therefore, the composition of influenza vaccines must be periodically updated to be effective against 

circulating viruses anticipated to predominate in the upcoming season. The strains of virus and the vaccine include two distinct 

subtypes of influenza A and one or two influenza B strains depending upon whether the vaccine is trivalent or quadrivalent. 

To identify vaccine strains likely to cause illness during the upcoming season, the WHO convenes experts to study recently circulating influenza viruses from around the world and recent global 

disease patterns. Based on this assessment, the WHO makes recommendations on the composition of 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 a recommendation 

for the composition of influenza vaccines licensed by FDA for use 

in the U.S. during the upcoming season. 

Once the strains are selected, candidate influenza viruses that 

are adapted for high growth are generated and accepted by the 

World Health Organization Collaborating Centers and are provided 

to manufacturers to generate the seed viruses for manufacturing 

vaccines. FDA then confirms the antigenic suitability of the manufacturers’ seed viruses. The manufacturing demands are tremendous and the time lines are tight. No other vaccine is produced. 

FDA approved and distributed every year across the U.S. within a 

6 month time frame. More than 170 million doses will be manufactured. 

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

in the time lines for vaccine manufacturing and availability. 

45 

In parallel with vaccine manufacturing, FDA develops and calibrates reagents that are provided to the manufacturers and our 

regulatory counterparts throughout the world. These reagents are 

used both by FDA and the manufacturers to test the vaccines for 

potency and identity before FDA approves the new U.S. 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. 

Every year, FDA begins working with manufacturers at the earliest stage of the influenza vaccine development process and we 

continue to assist throughout the production phase. We engage 

companies and technical and manufacturing issues and conduct facility inspections as warranted to ensure compliance with good 

manufacturing practice. 

As part of the efforts to improve public health emergency preparedness for seasonal and pandemic influenza, HHS staff with expertise in influenza convene monthly at the Pandemic and Seasonal Influenza Risk Management Meeting. This group deliberates 

policy and programmatic issues regarding influenza medical countermeasures. 

HHS has taken a series of steps to increase the probability that 

a late season change to trivalent or quadrivalent vaccine could be 

made or that a supplemental monovalent vaccine could be produced 

if warranted. Several actions by HHS for immediate implementation were proposed and tested and will be further refined based on 

a tabletop exercise that was conducted on November 10 with HHS 

agencies, vaccine manufacturers, and other global partners. 

In spite of the difficulties inherent in preparing influenza vaccines, we have made progress in our preparedness efforts in collaboration with BARDA, CDC, NIH, and other stakeholders and we 

thank Congress for support of these efforts. New influenza vaccines 

have been licensed including cell-based vaccines, recombinant protein vaccines, and quadrivalent vaccines. To enhance pandemic preparedness, FDA licensed an adjuvant of 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 A. 

Surveillance efforts are more extensive than ever before and offer 

the potential for early detection of emerging influenza viruses. The 

number of candidate vaccine virus strains available to manufacturers has increased greatly 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 methods to measure 

vaccine potency and sterility. 

To further address the challenges presented by the constantly 

changing nature of influenza viruses, scientists affiliate with Government, academia, and vaccine manufacturers are working to develop a new generation of vaccines that might provide longer-lasting and broader protection including against drifted strains. Although these development efforts are still in early stages, some 

may have the potential increase and broaden protection against influenza. We will work with U.S. Government partners, manufacturVerDate Mar 15 2010 09:55 Sep 15, 2016 Jkt 037690 PO 00000 Frm 00049 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X102FLUPREPMORESCANS091416\114X102FLUPREPPENDIN
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ers, and other stakeholders to continue to facilitate the development of new vaccines and identify methods that have the potential 

to speed manufacturing process. 

I thank you and look forward to any questions you have. 

[The prepared statement of Dr. Midthun follows:] 

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Mr. MURPHY. Thank you. Since we are going to vote soon, we will 

get to as many as we can and then take a break and come back. 

Let me start off and recognize myself for 5 minutes. Dr. 

Schuchat, have the influenza strains grown increasingly complex 

and are they being distributed more broadly across the globe now? 

Dr. SCHUCHAT. CDC has expanded our surveillance so that we do 

have testing of viruses from more and more places, but we actually 

need to do even more. The H3N2 virus that was predominant last 

year really showed us that these strains have evolved away from 

the tools that we have been using. We have had to modernize our 

tools and move to a sequence first approach which helps us overcome the old HI test that wasn’t really helping us understand the 

distribution of strains. So there have been important changes in 

the evolution of H3N2 that have made it difficult with the old tools 

to track what is going on. 

Mr. MURPHY. And there has been a large increase in human infections with the influenza A virus over the past 20 years. And is 

it true that there are many new types of highly infectious influenza 

strains the world is racing to keep up with, a wider range of types? 

Dr. SCHUCHAT. We have increased the sophistication of testing so 

we are picking up unusual types, the types that jump from animals 

to people. We have seen more of those. It is difficult to say whether 

this is happening more or we are finding it more. We really have 

increased the global capacity of countries all around the world to 

recognize influenza, test for it, and provide specimens that can be 

further characterized. 

Mr. MURPHY. But as you are talking about those global aspects, 

is part of this also that there is the issue of increased international 

travel and trade that is also spreading faster and influencing some 

of this? 

Dr. SCHUCHAT. There are so many factors that have made infectious threats greater and greater today. The closeness with which 

animals and people interact these days, some of the manufacturing 

or agricultural practices around the world, of course, travel and 

trade means that people are in contact with each other in different 

ways. So not just for influenza, but for many threats, we really see 

infections anywhere. Could be here at home soon. 

Mr. MURPHY. So what you are talking about then is you are picking up more. There is increased threat and unpredictability, but 

has the flu modeling really changed to more accurately reflect the 

best information of flu viruses, specifically is it being changed to 

more accurately prepare for an influenza vaccine? 

Dr. SCHUCHAT. The application of modeling approaches to the genetic data has advanced substantially. We have an enormous 

amount of genetic sequence data now that is being used in more 

sophisticated ways. So we think this is a very important tool for 

the future to actually use modeling really to predict what would be 

better reassortants that could make better vaccines. 

Mr. MURPHY. And in another area, Doctor, are serum banks useful for testing candidate viruses for the flu vaccine? And if so, could 

more use of serum banks help provide better sampling for testing 

candidate viruses? 

Dr. SCHUCHAT. I am probably not the best person to answer that 

question. 

58 

Mr. MURPHY. Who would be? 

Dr. SCHUCHAT. But I could begin. 

Mr. MURPHY. OK. 

Dr. SCHUCHAT. Basically, the ways we are testing candidate vaccine viruses or that we are testing circulating viruses include old 

tools and new tools. We have been using this HI hemagglutinin inhibition test which was developed in the ’40s and is really not 

working anymore for many of these difficult strains. We are switching to neutralization assays and to synthetic receptor models that 

we would like to invest in. 

Serum banks isn’t sort of the cornerstone of how we would be 

going about this, but there may be others who want to try and answer. 

Mr. MURPHY. Does anybody else have any thoughts on that? If 

not, I will go to my next question. OK. 

So are there any studies currently underway examining the 

immunological profile throughout our country to determine if there 

is any regional differences on what influence of viruses are predominant and what traces of immunity are in local populations? 

Dr. SCHUCHAT. You know, that is a very interesting question. 

Mr. MURPHY. That is why I asked it. 

Dr. SCHUCHAT. OK. You know, we have expanded our Vaccine 

Effectiveness Network in the U.S. to have more communities included in larger numbers. One thing that we found last year with 

the difficult strain that we had in the drift was the vaccine effectiveness was poor generally, but in one area which happens to have 

been Pennsylvania, the vaccine worked quite well and we think 

that the strains that were circulating in Pennsylvania were of a 

different clade or subtype. They were the old strain, not the drifted 

one. So in fact, the vaccine worked better than most places in 

Pennsylvania. 

We think it is really important for us to have lots of viruses and 

to test them with the best tools so that we really can understand 

what is circulating and that we need very good vaccine effectiveness platforms, both in the United States and in the Southern 

Hemisphere to really understand how the vaccines are performing 

in actual use, not just predicted to perform through the lab assays 

before we start using them. 

Mr. MURPHY. Thank you. My time has expired. I now recognize 

Ms. DeGette for 5 minutes. 

Ms. DEGETTE. Thank you, Mr. Chairman. I am always encouraged to hear researchers and experts come in and talk about the 

new development methods that we are beginning to achieve for flu 

vaccine, but Dr. Midthun, we are still primarily using egg-based 

technology to produce the flu vaccine right now in this country, correct? 

Dr. MIDTHUN. It is correct that most of the influenza vaccine is 

produced with egg-based technology. 

Ms. DEGETTE. And one of the problems with egg-based technology is that obviously it takes time if the virus should mutate or 

need to be changed. Is that correct? 

Dr. MIDTHUN. It does take time, but it also takes time if you 

make the product using cell-based or recombinant technologies. 

There may be some time savings, but nonetheless you need to be 

59 

able to have the virus that will grow well in the cell base as well 

as well as the—— 

Ms. DEGETTE. But the other problem, as we have seen in past 

hearings, is that if you have some kind of pandemic, then the additional problem to the time it takes to grow the virus in the eggs 

is the egg availability. We saw that with the avian flu and other 

things. Is that correct? 

Ms. DEGETTE. You know, I might ask Dr. Robinson to add here, 

but actually a lot has been invested in both—— 

Ms. DEGETTE. But all I am asking is it takes a lot longer if you 

have to rapidly grow vaccine in eggs to get the eggs, yes or no? 

Dr. MIDTHUN. It depends. In general, it is possible to get a virus 

that will grow more quickly in a cell-based system than an eggbased system. 

Ms. DEGETTE. Look. I have 5 minutes. Yes or no. If you have to 

increase egg production it takes a long time. Is that right? OK, 

never mind. You are not going to answer my question. 

Let me ask you, Dr. Robinson, because you testified that we have 

developed a lot of these new technologies, but they are not being 

used on a routine basis for the seasonal vaccine. Isn’t that correct? 

Dr. ROBINSON. So both recombinant and cell-based vaccines are 

licensed for seasonal purposes. 

Ms. DEGETTE. That is correct, but they are not being used widely. Isn’t that correct? 

Dr. ROBINSON. That is correct. 

Ms. DEGETTE. OK, why is that? 

Dr. ROBINSON. They are competing when the incumbent vaccine 

industry where you have egg based and they are new to the enterprise and they are fighting it out in the markets. 

Ms. DEGETTE. Part of the problem is it is a market-based technology? 

Dr. ROBINSON. Correct. 

Ms. DEGETTE. And so it costs more money, right? 

Dr. ROBINSON. So far, that is correct. 

Ms. DEGETTE. How do you see the markets moving particularly 

with development of pandemic types of vaccines? Would we be able 

to be nimble enough to use those new technologies if we had some 

kind of pandemic flu and how long would it take us to ramp up? 

Dr. ROBINSON. So to answer your question, yes, they are part of 

what we do for pandemics. They have been part of what we have 

developed and they are part of our capacity to make the U.S. independent of other countries providing those vaccines. 

Ms. DEGETTE. How long would it take? Because right now, we 

don’t have a stockpile of pandemic flu vaccine. 

Dr. ROBINSON. We have stockpiles for H5N1 and H7N9. The new 

pandemic—— 

Ms. DEGETTE. Some of those are 10 years old, right? 

Dr. ROBINSON. And we are actually testing those exactly right 

now in fact to see whether or not they are still good. 

Ms. DEGETTE. Can you supplement your testimony to let us 

know if they are still good? 

Dr. ROBINSON. I would be happy to. 

Ms. DEGETTE. Once you finish that. That would be good. But so 

let us say we had a new strain of avian flu or some other kind of 

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pandemic flu. How long would it take us to develop those vaccines 

then? 

Dr. ROBINSON. Having been around for the H1N1, we took about 

23 to 25 weeks for us to start to actually have vaccine available in 

October of 2009. H7N9, 2013, we actually broke that record by several weeks, in fact, and we now have more tools that we can actually do it a little bit faster if we start for a new pandemic virus. 

Ms. DEGETTE. So you think you could go down to like 20 weeks? 

Dr. ROBINSON. Our goal, our aspirational goal is to actually have 

the vaccine in 4 months. 

Ms. DEGETTE. OK, so the problem is, of course, which we all understand is if you see a pandemic flu, 4 months is going to be a 

long time to try and develop a new vaccine. Are there ways that 

you think with our support we could get that even shorter? 

Dr. ROBINSON. Certainly if we can keep all of these manufacturers going for seasonal influenza vaccine markets, then we have a 

greater chance to have those available and make larger predominance of those vaccines available, both seasonal and pandemic. 

Ms. DEGETTE. I am out of time and I know we are trying to get 

a lot of questions in, but I am going to have a lot more answers 

that I would love it if you guys could respond in writing. Thank 

you. 

Mr. MURPHY. Thank you. We will have time for Mr. Collins for 

5 minutes. 

Mr. COLLINS. Thank you, Mr. Chairman. Maybe to follow up a 

little bit on Ms. DeGette’s questions, Dr. Robinson, on the pandemic flu, the H5N1 that has been stockpiled for 10 years, what 

is your—since it has never jumped to humans, H5N1, right? 

Dr. ROBINSON. There has been a number of individuals that have 

been infected with H5N1. It is highly lethal. 

Mr. COLLINS. Right, but didn’t jump. 

Dr. ROBINSON. It is not easily transmitted. 

Mr. COLLINS. Correct. 

Dr. ROBINSON. From man to man. 

Mr. COLLINS. Correct. So on what basis did you characterize or 

decide how to produce the H5N1 vaccine since it has never really 

jumped from animals to humans? 

Dr. ROBINSON. So we have been working over about 10 years putting together the H5N1 vaccine development plans with our colleagues at FDA, NIH, and also at CDC and with industry partners. 

And we actually were able to successfully make the first one that 

was licensed in 2007, more recently with adjuvants were licensed 

2013. And we were able to actually show that we can actually 

produce at very high levels, and we can do it quickly. We actually 

had experience in 2013 for another avian influenza virus, H7N9, in 

which we were able to use egg, cell, and even recombinant technologies to make those vaccines sooner using all the new methods 

that we have. 

Mr. COLLINS. So let us say that something happens and it does 

become a pandemic. Is your organization looking at any post-symptomatic treatments for a person—it is so deadly, especially in this 

case, healthy individuals, for any kind of post-symptomatic treatments? 

61 

Dr. ROBINSON. So we have invested very heavily in new antiviral 

drug candidates and some of those have actually been approved by 

the FDA. Preamivir was in 2014. We are looking at nonneuraminidase inhibitor type of molecules and also 

immunotherapeutics, antibodies that be used to treat—— 

Mr. COLLINS. Monoclonal or polyclonal? 

Dr. ROBINSON. In our case, monoclonals. There a number of good 

candidates out there and we have started supporting those. 

Mr. COLLINS. Why not a polyclonal? 

Dr. ROBINSON. So if there are good candidates, we certainly 

wouldn’t be looking at those presently. The monoclonals look like 

they have several advantages. 

Mr. COLLINS. I am not sure what the advantages are since they 

target a specific—on anything that mutates as rapidly as this 

virus—— 

Dr. ROBINSON. So they actually are targeted to regions of the 

virus that do not mutate. They are highly conserved. 

Mr. COLLINS. So is your opinion the stockpile we have adequate 

if something were to happen? 

Dr. ROBINSON. So for the antiviral drug stockpile that we have, 

the Strategic National Stockpile is responsible for. It is designed 

and is equipped to handle what we would have for severe influence 

of pandemic. 

Mr. COLLINS. So a question on the adjuvant. You have done that 

only to make it a more potent, if you will, vaccine that would—— 

Dr. ROBINSON. So for originally why we actually used adjuvants 

is because it was going to take so much vaccine and so many eggs 

at the time when we started the work that we couldn’t have 

enough. 

Mr. COLLINS. Makes it more potent. 

Dr. ROBINSON. Makes it more potent. But it actually also allows 

now, we understand, for the vaccine to actually protect against different strains of influenza. 

Mr. COLLINS. I know our time is running out, but make a question for Dr. Schuchat, the elderly sometimes are more at risk just 

because of their health. Is that a population where we might decide 

to have two versions of even the seasonal vaccine, one adjuvanted, 

one not, and have those over whatever 65 or in poor health, have 

the adjuvanted vaccine? 

Dr. SCHUCHAT. You know, right now there are more than one formulation for the elderly, so a high dose vax formulation has been 

licensed for the elderly and adjuvanted formulations are under review. So I think we really do focus on the elderly who suffer the 

most from influenza in most seasons with hospitalizations and 

deaths and in a pandemic typically, not the 2009 one, but typically 

would also suffer extensively. And we do think better vaccines are 

important for that population. There has been a lot of progress and 

there is more progress we look forward to in the future. 

Mr. COLLINS. But currently, there is not an adjuvanted version 

of the seasonal? 

Dr. SCHUCHAT. That is right, not yet. But there is one that is 

under review. 

Mr. COLLINS. Yes. 

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Dr. MIDTHUN. Yes, we have a license application for an 

adjuvanted vaccine for individuals for seasonal vaccine, 65 years of 

age and older which was discussed in advisory committee 2 months 

ago and is currently under review. It shows, it compared the immune response to the adjuvanted versus the unadjuvanted and it 

did not actually show that the adjuvanted vaccine indicated a superior immune response, but nonetheless, we are considering this for 

licensure. 

Mr. COLLINS. Thank you very much. My time has expired. I yield 

back. 

Mr. MURPHY. Thank you. We have about 3 1⁄2 minutes left in the 

vote. So we are going to break. We will back in about 40, 45 minutes, my guess. We will get right back to questions. We should get 

in all the questions in from all the Members before the second series of votes after that. So we will be back. Thank you. We are in 

recess. 

[Recess.] 

Mr. MURPHY. All right, we will reopen the hearing here, and now 

I will recognize the gentleman from Texas, Mr. Green, for 5 minutes. 

Mr. GREEN. Thank you, Mr. Chairman. And I thank our witnesses for understanding our vote schedule on the floor and hope 

you had some rest between the questions earlier. 

I represent a very urban district in Houston. It is actually medically underserved and so 20 years ago we started doing vaccinations for children in our elementary schools in August just before 

school started so we would raise our vaccination rate. And we have 

been doing that since then and it has been really successful. We 

partner with our local school districts, our county health department, Texas Children’s Hospital, and so in a sense we have raised 

in our ZIP Codes, the percentage of children who are immunized. 

And I always talk about immunizations are the cheapest medical 

dollar we can ever spend because it is most effective. 

Last weekend, we actually did a flu vaccine effort. Texas Children’s Hospital did children’s vaccines. Walgreens, our pharmacy, 

one of our chain pharmacies in our community, did adults and the 

seniors. We didn’t get a good turnout because this was our first as 

compared to having 20 years of experience, people expect us in August to do the children’s vaccines. But my concern was last year because of the effectiveness of the vaccine and we want more people 

to get the vaccine, but when you hear that it is 20 percent or so, 

give or take, efficiency, what can we do to help make sure that you 

have the tools to make that efficiency much better? 

I know flu mutates. It is really a challenge. But we would hope 

we could do better than 20 percent. And I know that has been 

other questions and I would be glad to see what Congress can do 

to help the agencies be able to do a better job. 

Doctor, if you want to start? 

Dr. SCHUCHAT. Sure, I can start and I can pass it along. The people represented here, our institutions have been working really 

closely together to improve influenza vaccine both a seasonal flu 

vaccine pandemic and then future vaccines that might be even better. But from the CDC perspective, the more viruses from more 

places that we have characterized really well gives us information 

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that can lead to better candidate vaccine viruses that we can then 

turn over to FDA to make sure they are OK and to industry to 

produce. So sustaining that investment in strong surveillance 

around the world including newer approaches here at home with 

more samples coming in of the minority strains that we have and 

then sequence first so we get the information right that is actionable. 

I did just want to say that that issue of will people even want 

to get vaccinated after the year that we had last year? We have 

been investing in communication research to really understand 

what is going on in people’s minds, what are their attitudes so that 

we can sustain better and better immunization coverage going forward. 

Mr. GREEN. OK, anybody else have—— 

Dr. ROBINSON. Yes, sir. We have had the mantra for a number 

of years of more and better vaccines sooner. We built capacity in 

the United States to have more. We are working on getting it made 

sooner. We are making it with new technologies and not just for 

cell- and recombinant but also even for egg-based to make those actually be made faster. That better part, actually more effective and 

efficacious vaccines is the one that NIH, Dr. Heilman and we are 

working on to actually address the problem of it being not 23 percent, but 75, 80 percent every year, year in and year out. That is 

our goal. We may never be able to attain it, but it is what we want 

to do and that is why the universal flu vaccine initiative that we 

work on and to be able to have funding to go forward with that, 

not just for one year, but multiple years, because that may take a 

long time to get there. But it will be the ultimate answer to this. 

Dr. HEILMAN. I just want to thank you for your support of NIH 

and your recognition that research is really a foundation point for 

which to move forward on. And I think as Robin and Anne and 

Karen can attest to, you know, the ability for us all to get together 

to work on a common goal, we each have a contribution to this. So 

even though the things that we do are kind of a little bit more 

downstream, upstream, you know, it really does impact the opportunities for not just next season, but for seasons afterwards. We 

constantly want to evolve and improve whatever we are doing, so 

appreciation for the recognition that research has. 

Mr. GREEN. I am almost out of time. Previously, in our committee both the Oversight and Investigations and our Health Subcommittee over the years, we were actually concerned about 

enough flu vaccines. I know a few years ago, there was a shortage 

early on. But again, it is hard. If we are going to continue vaccinate 

folks and say oh, I don’t want one because it is not effective and 

I will get a sore arm anyway or something like that, we don’t want 

to give people a reason because again for the elderly and for the 

disabled, the flu vaccine is so important because their immune systems are already challenged and we need to make sure it is as effective as we can. 

Mr. Chairman, I thank you. And thank you for calling the hearing today. 

Mr. MURPHY. Thank you. Now I will recognize Mr. Mullin of 

Oklahoma for 5 minutes. 

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Mr. MULLIN. Thank you, Mr. Chairman. Thank you for holding 

this. I have to admit I am one of those people that I am not sure 

if I have ever received a flu vaccine and however, there are a lot 

of people that are very consistent on getting one and I understand 

the importance of it. But I am concerned with the stockpiles that 

we have had. 

Dr. Robinson, you have said in your opening testimony and the 

effort to stockpile the vaccines against a flu outbreak, but at the 

same time we also know that the flu changes constantly. And so 

for stockpiling it, how are we testing it? How are we knowing that 

what we are going to send out is actually going to be effective because we have already had one case, actually several cases that the 

vaccine that we sent out wasn’t actually the one that we needed 

to target. 

Is there something we can help you with? Is there a way that 

you are testing? Can you help me understand that a little bit? 

Dr. ROBINSON. Thank you for the question. It is very appropriate 

because I want to explain that the vaccine that we stockpile is 

what we call pre-pandemic vaccines for viruses that potentially 

could cause a pandemic, like the avian influenza H5N1, the H7N9 

viruses. For example, the H5N1 viruses appeared in 1998. We 

thought we got rid of them and they reappeared in 2003 and we 

still see cases and they spread from Southeast Asia across Asia 

into the Middle East and Europe. 

We are always watching those viruses and we actually do a periodic risk assessment with our colleagues across the board here with 

CDC, FDA, NIH, and others in the Department and with experts 

across the world in which we look at that risk assessment to say 

is this virus still something to worry about? And so the stockpiles 

that we have, we actually made—every day that we have those 

stockpiles, they break a record. Usually we think that the flu vaccines you can only keep them around for about 12 months, maybe 

18 months. Some of these are 8 and 9 years old. The potency of 

those vaccines is still very high. 

Mr. MULLIN. How often do you test? Do you do a random test? 

Dr. ROBINSON. No, we actually test every 3 months. 

Mr. MULLIN. All? 

Dr. ROBINSON. All the lots that we have and—— 

Mr. MULLIN. Every 3 months? 

Dr. ROBINSON. Every 3 months. And now we are actually testing 

those in the clinic to actually answer the question to say a vaccine 

that has been around for 8 years versus one that is newly made, 

when we put those into people do they get the same immune response and just as important, do they well tolerate the vaccine. 

Mr. MULLIN. So while we are looking at stockpiling for potential 

outbreaks, does that hurt us actually being able to manufacture 

enough of the current flu outbreak? Because we seem like we have 

shortages constantly. 

Dr. ROBINSON. The time in which the manufacturers make these 

vaccines is when they are not making seasonal influenza vaccines. 

So it does not impact the ability for them to make their capacity 

for seasonal flu. 

Mr. MULLIN. Dr. Schuchat, did I say that right? OK, and I apologize. We have been hearing from doctors back in Oklahoma that 

65 

they are having a hard time getting the vaccine, especially for children right now. And so we contacted the Oklahoma Health Department and they said there was a shortage, that they were having 

a hard time getting a hold of it. Are you familiar with this? 

Dr. SCHUCHAT. You know, the flu vaccine distribution so far this 

year is quite good with 133 million influenza vaccine doses shipped 

around the country so far. But we do know that a couple of the 

companies have had some limited or delayed production of one or 

two of the pediatric formulations. It is still a lot of vaccine that is 

out there, but there may be some particular practices that don’t 

have all the pediatric vaccine they want. 

We also learned that there are some States that the way that 

they handle the vaccine for children vaccine that CDC buys and it 

is shipped to central distributors and managed by the States, that 

there are probably more efficient ways for them to allocate the vaccines to the pediatricians and their communities. So CDC and the 

Association of Immunization Managers are working with the State 

health departments to really try to make sure we are streamlining 

those distributions so that the docs are getting the product when 

they need them. 

Mr. MULLIN. How often do you look at the product to say do we 

need to change it or not? And the reason why I say this is because 

my Larra, my 7-year-old daughter who was 6 at the time, last year 

she got two different strains of the flu. 

Dr. SCHUCHAT. I am so sorry. 

Mr. MULLIN. She got the shot. The first one she got and she still 

got it. The second one they said there wasn’t a vaccine for it yet. 

Dr. SCHUCHAT. OK, well one thing I can say is that we do vaccine effectiveness studies every year to see how well the vaccine is 

performing. You know the vaccines are often changed each year 

and people get vaccinated every year. And we have a network that 

is studying how well the vaccines actually protect people. We have 

expanded that network and we have increased how intensively they 

are working so we can get information sooner. 

Last year, we were able to present interim results in January, 

the earliest ever, to know how the products were working. 

Mr. MULLIN. Dr. Schuchat, thank you so much. And Dr. Robinson, appreciate your insight on that. I yield back. 

Mr. MURPHY. Can I ask a follow-up question to what Mr. Mullin 

has asked? In terms of stockpiles, Dr. Robinson, what are the size 

of these stockpiles? Are they thousands, tens of thousands, millions? 

Dr. ROBINSON. For H5N1s, we have tens of millions of doses and 

for H7N9, we have millions of doses. 

Mr. MURPHY. It is just the two areas you have? 

Dr. ROBINSON. Those are the two viruses. For H5N1, we have 

four different strains of H5N1 viruses represented in that stockpile 

and for H7N9 we have one strain. 

Mr. MURPHY. And you were saying they are effective for 8 years 

so far? 

Dr. ROBINSON. So far for the H5N1 vaccines, the potency is still 

very high for those stockpiles. 

Mr. MURPHY. And you are holding on to those that if it erupts 

again, you are ready to go? 

66 

Dr. ROBINSON. So far, we don’t have to throw them away. We can 

still use them and we can use with adjuvants to provide greater 

cross protection against even new H5N1 virus. 

Mr. MURPHY. OK. Thank you. Mrs. Brooks, you are recognized 

for 5 minutes. 

Mrs. BROOKS. Thank you, Mr. Chairman. And thank you for 

holding and highlighting this important issue. The hearing though 

is a reminder that public health threats like influenza are also 

threats and can be threats to our national security. The same 

issues we saw with last year’s seasonal flu drifting and mismatched strains can happen with other influenza strains that can 

cause even deadlier pandemics. And obviously, the pandemic we experienced in 2009 with the H1N1 killed, as I have been told, 18,000 

Americans and most people don’t realize that. And if we think 

about that, we weren’t prepared for that threat then and thousands 

of Americans lost their lives. 

I am very proud to be working on some bipartisan legislation 

with my colleague, Congresswoman Eshoo, who has been a leader 

in this space, and other colleagues on this committee to improve 

our biodefense enterprise. 

H.R. 3299, the Strengthening Public Health Emergency Response 

Act, would improve the medical countermeasure development process, would provide new incentives for the development of these livesaving countermeasures and would strengthen our public health response capabilities. 

And so, Dr. Robinson, in part because of this legislation, my 

questions are going to be directed primarily to you because obviously, it is the job of Congress to ensure that BARDA is doing, and 

I thank you, all of you for your work, but BARDA is doing everything it can to develop those medical countermeasures as quickly 

and as effectively as possible for pandemic outbreaks, and in the 

spirit of the focus today for pandemic influenza. 

But I am going to ask you and maybe because I am a lawyer, 

I have some very specific questions I would like your answers to 

and I understand we have a former colleague on the committee, 

Congressman Dingell. A series of simple yes or no questions. I 

would like to ask you because they are relevant to the types of 

issues that we have identified in H.R. 3299. And if you wouldn’t 

mind just giving me a yes or no and we can get into further discussion a bit later. 

Do you believe that additional incentives are needed to get the 

private sector more involved in this risky, time-consuming, and 

costly endeavor of developing medical countermeasures? 

Dr. ROBINSON. Yes. 

Mrs. BROOKS. Thank you. Do you believe that the creation of the 

priority review voucher limited to the 12 material threats identified 

by the Department of Homeland Security already, would be a useful incentive to get the private sector interested in medical countermeasure development? 

Dr. ROBINSON. Yes. 

Mrs. BROOKS. Did Congress give BARDA a unique national security mission, something no other agency in HHS has currently? 

Dr. ROBINSON. Yes. 

67 

Mrs. BROOKS. When Congress gave BARDA this unique mission, 

was BARDA also provided with unique contracting authority? 

Dr. ROBINSON. Originally, yes. 

Mrs. BROOKS. And do you believe it would be helpful to further 

expedite the medical countermeasures contracting process, to expedite that contracting process? 

Dr. ROBINSON. We always look for ways to expedite. 

Mrs. BROOKS. Thank you. And would it be helpful for you to have 

direct control over BARDA’s advanced development and procurement contracts for medical countermeasures? Would that be helpful, yes or no? 

Dr. ROBINSON. It would be helpful, anything that we can do to 

expedite, yes. 

Mrs. BROOKS. OK. Thank you. And I understand that it has 

changed over time from its origin from when BARDA was created, 

but that is the basis and part of what Congresswoman Eshoo and 

my work is designed to do. And I would really like to ask all of you 

and Governor Ridge and Senator Lieberman have just released this 

incredible report, multiple recommendations. Can you talk to us, 

starting with you Dr. Robinson, whatever time I have left, in what 

more we can be doing as a Government to build up a robust, domestic production capability? 

Dr. ROBINSON. Thank you for that question. I will answer briefly, 

but I can talk for hours on this. 

Mrs. BROOKS. And we will at another time then. 

Dr. ROBINSON. At this point, we need to continue the mission 

that we set out to do and that is to go forward with the early development that NIH does and advanced development that BARDA 

does to actually have those products available, not just for manmade threats and pandemic influenza, but emerging infectious diseases which Ebola showed it could be either one. 

Secondly, where we can’t stockpile, we need to do so. But in other 

instances, we need to have emergency response capabilities when 

we can’t stockpile to actually have those available and have those 

capabilities of those technologies and many of those platform technologies going forward. We have made great strides with FDA 

being able to move us forward quickly and be able to have absolutely the regulatory capability to do that. I think we can do more 

though and they need to be funded to provide that capability going 

forward. 

Mrs. BROOKS. Thank you. And thank you all very much for your 

work. I yield back. 

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

gentleman from Virginia, Mr. Griffith, for 5 minutes. 

Mr. GRIFFITH. Thank you very much, Mr. Chairman. In 2014, the 

Centers for Disease Control and Prevention Advisory Committee 

for Immunization Practices, ACIP, updated its adult vaccine schedule to recommend that older adults get a pneumococcal vaccine in 

conjunction with routine influenza immunization with a routine influenza immunization and a follow-up pneumococcal vaccine within 

6 months. 

When the recommendations were published, primary care physicians expressed some concern about the logistics of these recommendations and about Medicare reimbursement. Since that 

68 

time, the Centers for Medicare and Medicaid Services announced 

it would cover the second pneumococcal vaccine. 

Dr. Schuchat, can you update us on these new recommendations 

and what CDC has done to work with primary care physicians on 

addressing their concerns and confusion? 

Dr. SCHUCHAT. Thank you so much. The pneumococcal conjugate 

vaccine that targets 13 types was recommended initially by ACIP 

for everybody 65 and over in addition to the earlier polysaccharide 

vaccine, the 23-valent type, that we also have recommended for everybody 65 and over. 

The summer of 2014—sorry, the summer of 2015, we updated 

those recommendations to simplify them because we had heard 

about the confusion that primary care physicians had and we 

changed them to make them simpler so that you get one pneumococcal conjugate vaccine when you turn 65 or later and the second 

one a year or more later. 

CMS does cover two doses of pneumococcal vaccines and it 

doesn’t matter which one comes first, but we regularly recommend 

getting a conjugate first. It is very important for seniors who are 

often hospitalized and can die and it is particularly important in 

influenza season because pneumococcal pneumonia frequently follows flu. So we recommend everybody 65 and over get an annual 

flu shot, and get an pneumococcal vaccine, the conjugate one, followed a year or more later by the 21-valent polysaccharide. 

Mr. GRIFFITH. Also when ACIP makes its recommendations, does 

it consider how to ensure uptake is as efficient and streamlined as 

possible? 

Dr. SCHUCHAT. It is a very important part of the recommendations. We have practitioners and public health experts who are 

members of the ACIP and we work closely with partners to implement the ACIP recommendations and make it easier for people to 

protect themselves and their families. So we work very closely with 

the American College of Physicians, the American Academy of 

Family Physicians and so forth to really make sure that it is easy 

to get a vaccine and to protect yourself and your family. 

Mr. GRIFFITH. OK. According to the CDC’s estimates, four in ten 

seniors are not vaccinated for pneumonia, meanwhile flu vaccination rates have not significantly increased for seniors in the last 15 

years. How is CDC working with the internal medicine physicians 

and family physicians to improve vaccination rates among seniors 

and ensure seniors get the recommended flu and pneumococcal vaccines when appropriate? 

Dr. SCHUCHAT. You know, one of the challenges with adults is 

that they still think vaccines are for kids and so both providers for 

adults, as well as adults themselves, often don’t recognize that vaccines can be lifesaving for all of us. 

In addition to working with the clinical community, CDC works 

closely with the private sector and you know, everybody has seen 

pharmacies and chain stores really take up providing vaccines. 

There are now better insurance efforts that mean everybody has 

access to recommended vaccines with no copay, no deductible, as 

long as they are vaccinated in an in-network provide and there are 

public insurers that cover the vaccine. 

69 

The good thing for 65-year-olds and over is that Medicare coverage is very good for the pneumococcal and the flu vaccine. 

Mr. GRIFFITH. Well, I appreciate those answers. Appreciate you 

all being here. 

Mr. Chairman, I appreciate you holding this hearing and I would 

say that while I was not in the room and I apologize for that I was 

trying to do a couple of things at the same time. I was listening 

to some of the testimony earlier and I have some of the same concerns that Ms. DeGette has in regard to egg-produced vaccines. So 

just note that she is not the only voice up here that is concerned 

about that issue. 

Mrs. BROOKS. Would the gentleman yield the balance of his time? 

Mr. GRIFFITH. Yes. 

Mrs. BROOKS. Thank you. I have a very brief question, a followup question for Dr. Robinson. Can you share with me what is the 

status of the 2005 HHS pandemic preparedness plan and has it 

been updated since it was issued by Bush administration? 

Dr. ROBINSON. Yes, fortunately, the Department is in a very strident effort right now to update that. We expect that it will be 

available at the end of next summer. The entire Department represented here and others are actively working on that, using that 

pandemic plan and the National Strategic Plan as a base and then 

go forward with that and have combined a number of different efforts that have been going on for a number of years to funnel it 

towards that plan. 

Mrs. BROOKS. Thank you. I yield back. 

Mr. MURPHY. Ms. DeGette, I am going to re-recognize you for followup. 

Ms. DEGETTE. Thank you, Mr. Chairman. I don’t really have 

questions. I just want to say that I recognize that we have come 

a long way and I appreciate the efforts of all of the agencies, but 

I am still concerned about some of the market forces that we had 

discussed during my questioning. I am concerned that those market forces are really keeping us stuck in some old ways of thinking, 

and I think that probably all of us would like to work with the 

agencies to figure out how to update that so that we can be in the 

21st century. And that is my main goal. 

And Mr. Chairman, I really thank you for holding this hearing. 

I think it is something we should do every year about this same 

time. And I encourage all of you to continue your good work, both 

on the seasonal flu vaccinations and readiness and also on the 

longer-term issues around pandemic flu. Thank you, Mr. Chairman. 

Mr. MURPHY. Thank you. I just have a followup to a couple of 

things that Mr. Griffith and Ms. Brooks said here. So when you are 

talking about seniors then is the vaccine less effective for seniors? 

And if so, why? 

Dr. SCHUCHAT. Many vaccines are less effective in seniors than 

in younger people. The influenza vaccine is often less effective in 

seniors. There have been a lot of efforts to try to overcome that. 

We think about it as senescence of the immune system and it is 

particularly worse in the very elderly. So both influenza vaccines 

and pneumococcal vaccines work less well in the elderly than they 

work in younger populations. That said, getting vaccinated is the 

70 

best way to protect yourself. And so we recommend everybody 65 

and over be vaccinated against the pneumonia with the pneumococcal vaccines. And we recommend everybody, 6 months and over 

get an annual flu vaccination. 

Mr. MURPHY. So finally, I would ask each person is the flu vaccine less effective against H3N2 flu strain compared to other 

strains targeted by the vaccine? Does anybody have any comments 

on that? 

Dr. SCHUCHAT. The review of vaccine effectiveness data from the 

past decade provides us some clues that on average the vaccines 

that we are using are less effective against the H3N2 strains, even 

in years where there is a reasonably good match. On the other 

hand, we still see efficacy most years, not all, but most years and 

we strongly recommend people get vaccinated. 

At this time of year, we don’t know what strain is going to dominate and how well the vaccine is going to work, but we do know 

that being vaccinated protects you substantially compared to not 

being vaccinated. 

Mr. MURPHY. Thank you. Anyone else want to comment on that? 

Then let me also echo what some of the Members have said here, 

because these hearings have been going on for a decade. And we 

want to see that your agencies are updating also their scientific approach to this, not only trying to guess what the next nasty bug 

is going to be coming around, and trying to predict that, develop 

a vaccine, and find out that it mutates faster than we can manufacture them. 

But do we need different scientific designs on that? 

I hope that when we approach this again in the coming months, 

first of all, I hope that this is more accurate for this year’s vaccine. 

We hope people get it. We hope people eat right, rest right, and exercise so the person won’t work on a person that is weak and sickly 

anyways or less effective. But we want to be able to come back and 

say lessons learned, lessons applied much more effective and I 

thank you all for your testimony today. We really appreciate you 

being here today, and with that—I might want to add here that I 

ask unanimous that the correspondence between the committee 

and HHS, CDC, BARDA, NIH, as well as HHS’s May 6th memorandum be introduced into the record. 

[The information appears at the conclusion of the hearing.] 

Mr. MURPHY. And without objection, the documents be entered 

into the record. 

We ask also that, as you receive questions, you respond back to 

the committee quickly. Members have 10 business days to submit 

those questions to the record. And with that, I now adjourn this 

hearing. Thank you. 

[Whereupon, at 12:06 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

Continuing our longstanding efforts on flu preparedness, today’s discussion follows up our hearing last February that focused on a very harsh flu season with a 

mismatched vaccine that had an overall effectiveness of only 19 percent. Although 

the official statistics for last flu season are not available yet, in such a severe flu 

season, we would see up to 50,000 deaths, more than 400,000 hospitalizations, and 

an economic burden of about $87 billion. I, like others on this subcommittee, exVerDate Mar 15 2010 09:55 Sep 15, 2016 Jkt 037690 PO 00000 Frm 00074 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X102FLUPREPMORESCANS091416\114X102FLUPREPPENDIN
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pressed my belief at that February hearing that we can—and must—do better in 

addressing this major public health threat to protect folks in Michigan and across 

the country. 

Earlier this year, the World Health Organization (WHO) warned that flu strains 

have grown increasingly complex, and have been distributed broadly across the 

globe. This diversity and geographic distribution is unprecedented since the advent 

of modern tools for flu virus detection and analysis. Last year’s poorly matched seasonal flu vaccine and the bird flu H5 viruses that killed millions of birds in the Midwestern U.S. earlier this year are the most recent examples of this complexity. The 

WHO cautioned that the consequences of so many flu viruses emerging are ‘‘unpredictable’’ and ‘‘potentially ominous.’’ 

Since the February hearing, our committee has been conducting bipartisan oversight into how to improve the U.S. public health response on seasonal flu and the 

adequacy of HHS efforts in monitoring the impacts of the bird flu outbreak. I am 

pleased to learn that Secretary Burwell and HHS leadership have made the response to seasonal flu vaccine mismatch a greater priority, and that HHS has been 

working throughout the year on various actions to improve seasonal flu preparedness. I look forward to discussing the details about these actions, and how they are 

expected to improve the response. 

Flu is a major public health challenge. The actions from HHS and its agencies 

are a good start. We recognize, however, that much work needs to be done. We will 

also be asking questions to make sure our preparedness efforts are addressing all 

potential problems and gaps. Our discussion today is aimed at being constructive, 

and detailing ways we can work with HHS to improve our flu response to save thousands of lives. 

I appreciate the hard work and dedication of the folks at HHS, the CDC, the FDA, 

BARDA, and the NIH on flu preparedness. I look forward to today’s testimony, and 

continuing the work to improve the U.S. flu response. Our collective efforts are 

about keeping Americans healthy during the flu season. From babies who are 6 

months old to the elderly, and everyone in between, folks in Michigan and across 

the country should have the peace of mind and faith that their flu shot will keep 

them healthy. Our bipartisan work continues. 

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