[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
THE NATION'S FLU SHOT SHORTAGE: HOW IT HAPPENED AND WHERE WE GO FROM
HERE?
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
OCTOBER 8, 2004
__________
Serial No. 108-231
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
______
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96-948 WASHINGTON : 2004
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
DAN BURTON, Indiana HENRY A. WAXMAN, California
CHRISTOPHER SHAYS, Connecticut TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
DOUG OSE, California DENNIS J. KUCINICH, Ohio
RON LEWIS, Kentucky DANNY K. DAVIS, Illinois
TODD RUSSELL PLATTS, Pennsylvania JOHN F. TIERNEY, Massachusetts
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
ADAM H. PUTNAM, Florida DIANE E. WATSON, California
EDWARD L. SCHROCK, Virginia STEPHEN F. LYNCH, Massachusetts
JOHN J. DUNCAN, Jr., Tennessee CHRIS VAN HOLLEN, Maryland
NATHAN DEAL, Georgia LINDA T. SANCHEZ, California
CANDICE S. MILLER, Michigan C.A. ``DUTCH'' RUPPERSBERGER,
TIM MURPHY, Pennsylvania Maryland
MICHAEL R. TURNER, Ohio ELEANOR HOLMES NORTON, District of
JOHN R. CARTER, Texas Columbia
MARSHA BLACKBURN, Tennessee JIM COOPER, Tennessee
PATRICK J. TIBERI, Ohio BETTY McCOLLUM, Minnesota
KATHERINE HARRIS, Florida ------
MICHAEL C. BURGESS, Texas BERNARD SANDERS, Vermont
(Independent)
Melissa Wojciak, Staff Director
David Marin, Deputy Staff Director/Communications Director
Rob Borden, Parliamentarian
Teresa Austin, Chief Clerk
Phil Barnett, Minority Chief of Staff/Chief Counsel
C O N T E N T S
----------
Page
Hearing held on October 8, 2004.................................. 1
Statement of:
Gerberding, Dr. Julie L., Director, Centers for Disease
Control and Prevention; Dr. Anthony S. Fauci, Director,
National Institute of Allergy and Infectious Diseases; and
Dr. Lester M. Crawford, Acting Commissioner, Food and Drug
Administration............................................. 16
Grant, Christine, vice president for public policy and
government affairs, Aventis Pasteur, Inc., accompanied by
David Johnson; James Young, president, research and
development, Medimmune, Inc.; and Robert Stroube, State
health commissioner, Virginia Department of Health......... 51
Letters, statements, etc., submitted for the record by:
Davis, Chairman , a Representative in Congress from the State
of Virginia:
Letters dated October 7 and 8, 2004...................... 80
Prepared statement of.................................... 4
Prepared statement of Mr. Pien........................... 46
Fauci, Dr. Anthony S., Director, National Institute of
Allergy and Infectious Diseases, information concerning
various charts............................................. 20
Grant, Christine, vice president for public policy and
government affairs, Aventis Pasteur, Inc., prepared
statement of............................................... 54
Stroube, Robert, State health commissioner, Virginia
Department of Health, prepared statement of................ 76
Waxman, Hon. Henry A., a Representative in Congress from the
State of California, prepared statement of................. 8
Young, James, president, research and development, Medimmune,
Inc., prepared statement of................................ 63
THE NATION'S FLU SHOT SHORTAGE: HOW IT HAPPENED AND WHERE WE GO FROM
HERE?
----------
FRIDAY, OCTOBER 8, 2004
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10:05 a.m., in
room 2154, Rayburn House Office Building, Hon. Tom Davis
(chairman of the committee) presiding.
Present: Representatives Davis, Burton, Mica, Souder,
Blackburn, Tiberi, Burgess, Waxman, Kanjorski, Cummings,
Kucinich, Tierney, Watson, Van Hollen, Ruppersberger, Norton,
Cooper, and McCollum.
Also present: Representative DeFazio.
Staff present: Melissa Wojciak, staff director; David
Marin, deputy staff director; Keith Ausbrook, chief counsel;
Ellen Brown, legislative director and senior policy counsel;
Jennifer Savavian, chief counsel for oversight and
investigations; Anne Marie Turner, counsel; Drew Crockett,
deputy director of communications; John Cuaderes, senior
professional staff member; Susie Schulte, professional staff
member; Teresa Austin, chief clerk; Robin Butler, financial
administrator; Allyson Blandford, office manager; Corinne
Zaccagnini, chief information officer; Todd Greenwood, staff
assistant; Phil Barnett, minority staff director; Kristin
Amerling, minority deputy chief counsel; Karen Lightfoot,
minority communications director/senior policy advisor; Anna
Laitin, minority communications and policy advisor; Sarah
Despres and Rosalind Parker, minority counsels; Josh
Sharfstein, minority professional staff member; Earley Green,
minority chief clerk; and Jean Gosa and Teresa Coufal, minority
assistant clerks.
Chairman Tom Davis. Good morning. A quorum being present,
the Committee on Government Reform will come to order. I want
to welcome everybody to today's oversight hearing regarding
recent developments in the U.S. influenza vaccine supply.
As many of you know, a major flu vaccine manufacturer
announced on Tuesday it would be unable to deliver any of its
flu vaccine to the United States. British regulators suspended
the manufacture's license, and held up the doses destined for
the United States because at least some of the supply was
contaminated.
The loss of the Chiron flu vaccine poses a serious
challenge to the U.S. vaccines supply for the upcoming flu
season. Chiron was to export between 46 to 48 million flu shots
this year to the United States, almost half of our Nation's
supply.
The Department of Health and Human Services had planned for
a vaccine supply of about 100 million doses this season, after
a demand of about 87 million doses last flu season.
Today we will examine the contributing factors that led to
the severe flu vaccine shortage, the public health implications
of the vaccine shortage, and the U.S. Government and vaccine
manufacturers plan to address this problem. Our government
witnesses are here today to reassure and inform the public.
The public health implications of this development are
potentially enormous. Every year approximately 36,000 die and
200,000 people are hospitalized due to complications from
influenza. With a significant shortage of vaccines, the number
of people who die from or are hospitalized for influenza could
increase drastically this year.
The Center for Disease Control and Prevention issued
interim recommendations for influenza vaccinations on October
5, 2004. They give priority for vaccination with Fluzone the
primary vaccine that remains available to the high risk
population.
And nasal spray is another alternative, but there will be,
at most, 2 million doses ready for distribution this year. As a
result of the shortage, millions of healthy people and even
many in the high risk population will have to forego
vaccination. We have been telling people for years now that the
flu is not something to take lightly. It is no wonder that
phones at hospitals, clinics, and doctor's offices have been
ringing off the hook this week.
Vaccination clinics with shuttered doors do not inspire
confidence or trust. People want to know how this happened.
They want to know what it means for them and their families.
They want to know how are we going to make sure that it doesn't
happen again.
In the short term, coordination and cooperation between
Federal, State and local public health providers will be
crucial. It will be more important than ever to identify
individuals who fall within the high risk population, and
ensure that they receive priority.
We will collectively have to grapple with the public's
understandable frustration and feelings of helplessness.
Preparing for the annual flu season highlights the importance
of strong cooperation between different health agencies and
private sector companies at all levels.
However, this year's vaccine shortage starkly underscores
the need to ensure that adequate production capabilities exist.
We are not here today to point fingers, but we go into today's
hearing already concluding that the current system is flawed.
In a committee hearing we held last February, witnesses
discussed the possibility of a similar situation unfolding. The
committee was concerned that Chiron did not have a
manufacturing plant located within the United States. It was
theorized that should a flu pandemic occur, the UK could
nationalize Chiron's vaccine supply, resulting in the loss of
half of the U.S. flu vaccine supply.
With only a few vaccine manufacturers producing flu
vaccines every year, we concluded then, and we reiterate today,
we need to consider what can be done to strengthen the market
and increase production capabilities.
The current vaccine shortage begs the question: Do we need
new mechanisms, new incentives to guarantee that an adequate
number of safe and effective flu vaccines are produced and
delivered annually?
Questions continue to mount, and hopefully today some will
be answered. Why did both Chiron and U.S. officials anticipate
that only 4 to 8 million doses would be lost? Why did they not
know before Tuesday that a license suspension was possible? Are
any of the Chiron doses salvageable?
Our witnesses today will discuss the factors contributing
to the flu vaccine shortage, how the Government and vaccine
manufacturers will respond to and manage this crisis, and the
steps that must be taken to be prepared for next year's flu
season.
I know we all share the same goal at the end of the day, a
public health system prepared to deal with the annual influenza
season. We have a great selection of witnesses today, and I
would like to thank all of them for appearing before the
committee, and I look forward to your testimony. I now yield to
Mr. Waxman for an opening statement.
[The prepared statement of Chairman Tom Davis follows:]
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Mr. Waxman. Thank you.
Chairman Tom Davis. Let me just start--I know Mr. DeFazio
is here from another committee. I would ask unanimous consent
that he would be allowed to participate. Without objection, so
ordered.
Mr. Waxman. Well, thank you, Chairman Davis, for calling
this hearing on a critical flu vaccine shortage facing the
United States. Three days ago, one of the two major companies
providing vaccines in this country announced it would not ship
any flu vaccines this year.
Just weeks before the start of the flu season, it appears
we have lost half of our vaccine supply. As a result, an
estimated 40 million Americans who would otherwise have been
protected against the flu will not. One key question is how
this all could have happened?
In late August, the flu vaccine manufacturer, Chiron, which
has a manufacturing facility in Great Britain announced that
there were potential contamination problems with several
million doses of the vaccine. The company began working with
the Food and Drug Administration and British regulators to
identify the problem, and to ensure the safety of the remaining
lot of vaccines.
While the company was assuring the public that the problem
was under control, and while FDA was reviewing the company's
investigation, British regulators sent a team of inspectors
that shut the plant down.
The British Government immediately announced that it had
already purchased a back-up supply of vaccine, it nearly
completely offset its reliance on Chiron. In the United States,
public health officials appeared to have been taken completely
by surprise. After the public announcement, senior FDA
officials flew to Britain to determine whether any of Chiron's
vaccines could be usable this year.
A second key question is, what can be done to ensure that
the highest risk individuals are vaccinated? The CDC responded
instantly to the crisis by issuing new flu vaccine
recommendations with priorities for vaccination. But following
those recommendations will be an enormous challenge. Some
hospitals, clinics, doctors offices and State public health
departments are scheduled to receive their full order from
Aventis, the only major flu vaccine supplier left this year.
Other hospitals, clinics, doctors offices, and public
health departments are left entirely without the vaccine. It is
important to discuss what role the public sector can play in
overcoming these disparities. While this hearing will, by
necessity, focus on the current situation, I hope we can also
find time to discuss a third key question, how can we shore up
our fragile public health care system?
For 5 years we have seen a series of experts reports
calling attention to major deficits in vaccine supply for both
children and adults. In February, our committee heard testimony
about the urgent need to improve flu vaccine supply and
planning. And just last week, the Government Accountability
Office testified before the Senate that ``there is no mechanism
in place to ensure distribution of flu vaccine to high risk
individuals before others when the vaccines is in short
supply.''
This raises the question of what more can be done to better
prepare for possible vaccine delays and shortages in the
future? It is long past time for Congress to pay attention to
these calls for action. In May, Chairman Davis and I asked the
Appropriations Committee to restore cuts and enhance public
health funding in the President's budget. Even this minimal
request was not granted.
I am very pleased that our Nation's leading public health
officials and other distinguished witnesses have taken the time
to testify this morning. We are all indebted to your efforts
and eager to hear your testimony. Thank you.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Hon. Henry A. Waxman follows:]
[GRAPHIC] [TIFF OMITTED] T6948.003
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[GRAPHIC] [TIFF OMITTED] T6948.005
[GRAPHIC] [TIFF OMITTED] T6948.006
Chairman Tom Davis. Any other opening statements?
Mr. Mica.
Mr. Mica. Thank you, Mr. Chairman. I have taken a personal
interest in this since I came to Congress. It is nice to talk
about some of the effects of, say, vaccine or vaccination that
went bad. My uncle, who has passed away, probably partly from a
broken heart, he had two children who were vaccinated and they
had adverse reaction.
And both of them went into convulsions. And at the time
they didn't know, but both of them were brain damaged. Both of
them are still alive, but they require constant care, and none
of them have lived normal lives. So it is something that our
family has dealt with. My brother, when he came to Congress,
Dan Mica, worked on the Vaccine Compensation Fund, I think,
with Mr. Waxman and Mr. Burton and others who were here.
And I took an interest and have tried several times to
amend the fund so that it would be more effective. And,
unfortunately, some folks walked away from revising that. But,
how did we get here, with the United States basically relying
on vaccines, flu vaccines and other vaccines, to other
country's manufacturing?
The number of vaccine manufacturers in the United States
has dropped from 20 to only 3 in the past 15 years, largely as
a result of lawsuits filed on behalf of supposed victims. Now,
everyone has--can have an adverse reaction. I have some of my
pills here that I take. Some people actually can have an
adverse reaction to aspirin. And some people actually can die
from these, and do die from these.
But, one of the major problems is that we haven't dealt
with the liability question. So we forced the manufacturer
overseas or some place else for the large part. You know, they
blame the insurance industry, but the insurance industry won't
even cover liability in these cases. We blame the drug
manufacturers. And they won't manufacture here. Doesn't
somebody get it?
Go on the Web and look at--try to get a little information
on vaccines. Pull up the Web. And this is offensive. The first
thing that comes up is a law firm, vaccine injury. Sue. Sue.
Sue. So what the hell do you get? Nothing.
So we have senior citizens and others put at risk, young
and others, because this Congress and others won't change the
law. I will tell you, it really--it is really sad that--and if
it was just medicine, we are outsourcing the whole production
of manufacturing. I come from the business sector. Most of the
business people here in Congress don't have a clue as to how
business operates. But it actually operates by making a profit
and being able to exist without lawsuits, overly regulated and
without oppressive taxation.
So we have run them all off, whether it is--you know, we
don't even produce any ladders in the United States. Vaccines
and ladders. Why? Because of the field day we have created for
trial attorneys. So I am pretty bitter about it. This should
have been changed a long time ago. We should have changed the
liability laws, and we should have changed the vaccine
compensation fund so that it works, and it does provide
compensation.
Mr. Chairman, I yield back the balance of my time.
Chairman Tom Davis. Thank you. Any other Members wish to
make opening statements.
Ms. Watson.
Ms. Watson. Thank you, Mr. Chairman, for conveying this
hearing so quickly. This is a very disturbing development. And
it is very essential to have sufficient doses of flu vaccine
available for millions of Americans that are at risk for
complications due to the flu.
The number of anticipated doses falls far short of the
CDC's goal of vaccinating at least 85 million people this year.
The CDC guidelines to ration the vaccine to high risk adults,
children between 6 and 23 months of age, health care workers
and the elderly is an appropriate response.
I have concerns about what this means for our national
bioterror response system. Yes, I know it is somewhat of a
separate issue, but it can get--or we can get so caught off
guard with distributing flu vaccines, and are we at risk for
similar problems with emergency distributions of antibiotics or
vaccines, or anthrax or small pox? I hope the witnesses can
address this point.
In dealing with this crisis, we must make sure mercury,
listed as Thimerasol in vaccines is removed from the dosages of
young children. On September 28, 2004, our Governor in
California, Governor Arnold Schwarzenegger signed a bill
sharply restrict the mercury content in vaccines for women and
babies.
Mercury is a known neurotoxic substance. Mercury inhibits
brain function among other detrimental effects. Children
between the ages of 6 and 23 months should not be subject to a
substance that we would close down and--that we would close
down a high school for 1 week after spilling a few of the
grams.
Manufacturers in the last few years have voluntarily
eliminated Thimerosal or reduced it to trace elements. The only
exception is Aventis Pasteur, who is the sole supplier of flu
innoculations for children under 2 years old. Vaccination is an
important health policy for our society. And we have the
ability to vaccinate without mercury used as a preservative.
In signing the message, Governor Schwarzenegger noted that
the U.S. Food and Drug Administration and the American Academy
of Pediatrics recommended the removal of Thimerosal from
childhood vaccines in 1999. So we have a combination of issues
here, Mr. Chairman, and we must get to the bottom.
I feel that here in our own country, we must support the
research on inoculations and vaccinations and the elements that
make these potent medicines, and we must see, as a policy body,
that we contribute the necessary resources so that we can
develop our own vaccinations without the harmful ingredients
that we feel are present at the current time. Thank you so
much.
Chairman Tom Davis. Ms. Watson, thank you very much.
Dr. Burgess, did you have any comment.
Mr. Burgess. Thank you, Mr. Chairman. I will be very brief,
because I do want to hear what our witnesses have to say this
morning. And I do thank you for conveying this hearing. I thank
the witnesses for coming together so quickly.
Mr. Mica made the plea about reforming liability as it
reflects our vaccine manufacture in this country, and I just
couldn't agree more. I think his point was extremely important.
We forget in this country, the success of vaccine preventable
disease. We don't see diseases any longer that in my father's
and grandfather's generation used to affect hundreds of
thousands of children and adults in this country.
When I graduated from medical school in 1977, the year
before, we all gathered around a hospital room in Houston
because there was a child with diphtheria, and no one had seen
diphtheria for so long, and everyone wanted to make sure that
this class of medical students at least saw one case of
diphtheria before they graduated.
It is a tremendous success story that you all have, and a
story that is not often told. We get distracted by words such
as outsourcing and Thimerosal. I urge this panel, though, to
come to some conclusion about what we can do to alert the
liability structure in this country so that we are not driving
these manufacturing jobs offshore, and so that we are not
tarnishing the good reputation that what vaccines have done for
this country and what life--how much better life is without
vaccine preventible diseases in our midst.
Thank you, Mr. Chairman.
Chairman Tom Davis. Thank you very much. Any other Members
wish to make opening statements? Ms. Norton.
Ms. Norton. First, Mr. Chairman, I know we are near the end
of this term, but I want to thank you and commend you for not
letting us go home without looking into this matter, because I
think all over the country there is a serious concern about--we
see it in our own region, the region you and I live in, about
entire parts of the region whose supply comes from this
particular provider, and therefore who have no supply.
First, I want to say it is--I regard this as kind of a test
or trial run. Ms. Watson spoke about bioterrorism. It ought to
tell us that the failure to have a back-up plan for vaccines or
medicines that can mean the lives of the American people simply
must be allowed to happen again. It seems to me that it is much
more serious when it happens with regard to the flu vaccine,
because it is more likely that flu will take tens of thousands
of lives whereas a bioterrorism attack would probably be
contained maybe even to a small facility, who knows?
So I certainly hope this is a shot across our bow. For
years there have been difficulties of one kind or the other
with respect to the flu vaccine. I simply want to raise two
points. One is the point of science. I look at the science. I
will be interested to know when--how what we have done in the
development of this science, where we identify the virus,
apparently it has to be identified pretty late, here it was
identified in the late winter or early spring.
But then we grow the strains in chicken eggs. The first
thing that occurs to a nonscientist to me is by now shouldn't
we have some alternative environment that allows us to grow the
strains more quickly, especially this country, which has done,
I must say, things that seem to me to be far more miraculous
than what I have just asked.
Second, the notion of such a major provider, such a major
provider of an insensible vaccine being offshore. Now, if there
are liability concerns, we need to bring those out. I think
there may be other concerns as well.
But, there has been a lot of talk about jobs offshore, or
outsourcing, the economic concerns that outsourcing raises.
But, there has been almost no concern, no talk about what
happens when you outsource a major medicine or vaccine that is
indispensable to the American people. And I think that this
crisis forces us to face it.
We raise it at the end of the session. I think it gives us
time to follow it through and see whether we have made any
movement as the new session begins. A third concern is how in
the world this plant, this operation, passed FDA inspection in
2003, and yet the British have to shut down the place. I don't
understand the difference between the regulators in both
places. And my fourth concern is apparently the total absence
of a back-up plan. Everybody knows that tens of thousands of
people will die without the vaccine.
Everybody knows that half the supply was offshore, and here
we are sitting here wondering what are we going to do with no
backup plan? This is inexcusable and I think we have to begin
to bring forward something that, one, gives us an explanation,
and two gives us a road map to a solution in the future.
Chairman Tom Davis. Thank you. Any other Members wish to
make opening statements? We will proceed then to our panel. I
am very pleased to have a distinguished panel. We have Dr.
Julie Gerberding, the Director of the CDC. Dr. Anthony Fauci,
the Director of the National Institute of Allergy and
Infectious Diseases, and Dr. Lester Crawford, Acting
Commissioner of the Food and Drug Administration here to
discuss efforts being taken at the Federal level to respond to
the flu vaccine shortage.
They will also describe coordination efforts with State and
local authorities to manage this crisis. As you know, it is our
committee's policy that we swear you in. So if you just rise
with me and raise your right hands.
[Witnesses sworn.]
Chairman Tom Davis. Thank you very much. I think you know
the rules. There will be a light on in front of you. It will be
green when you start. When it turns orange that means you are
at the 4 minute mark. Red, it is your 5 minute mark.
We want you to make sure you say everything you want to
say, but your entire written testimony is in the record, and we
have read that and the questions will be based on that.
So we are just very pleased and honored that you could make
time to be here with us today. This is an important and serious
crisis. And we know you are working on it.
Dr. Gerberding, we will start with you. And thanks for
being with us.
STATEMENTS OF DR. JULIE L. GERBERDING, DIRECTOR, CENTERS FOR
DISEASE CONTROL AND PREVENTION; DR. ANTHONY S. FAUCI, DIRECTOR,
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; AND DR.
LESTER M. CRAWFORD, ACTING COMMISSIONER, FOOD AND DRUG
ADMINISTRATION
Dr. Gerberding. Thank you, Chairman Davis, Mr. Waxman, and
the committee. We are very happy to be here to give you an
update on the current flu situation.
On Tuesday morning, I was unhappily awakened by the CEO of
Chiron to notify me that we were losing 50 percent of our flu
supply this year, just as I was preparing to testify in front
of a different House committee. So this has been certainly the
top challenge that the CDC is facing this week.
While we were disappointed to learn this news, we were not
entirely unprepared. We have been concerned about vaccine
shortages for years. We knew in August that there may be a
delay in shipping some doses from this manufacturer, and we are
looking at avian influenza throughout Western Asia.
So the Department has been aggressive in developing the
pandemic flu plan. Secretary Thompson and the administration
requested for fiscal years 2004 and 2005 $100 million to expand
our vaccine supply capability and modernize our vaccine supply
capability, Congress provided $50 million this year, and we
hope you will support the full $100 million in fiscal year
2005.
We also have initiated, for the first time ever, a
stockpile for flu vaccines for children. We have 2\1/2\ million
doses in that stockpile. We are procuring at least 2 million
more doses from Aventis. We also have a stockpile of antiviral
treatment, and are hoping to expand that stockpile eminently.
Within hours of the announcement, the Secretary conferred
with all of the vaccine manufacturer CEOs, and the Secretary
announced the new recommendations from the immunization
advisory committee. These advisory recommendations had actually
been developed by the CDC as a back-up plan for vaccine
preparedness when we learned that we may have a shortage this
year. So we had undertaken a contingency planning effort at the
CDC just in case we ended up in this situation.
Within hours, we also had a press conference, we
communicated to our health alert system to more than 90,000
clinicians and 88 partner organizations who resubmitted the
information to their membership, so we were able to reach
hundred of thousands of clinicians in just a matter of minutes,
in part because of the investments bioterrorism preparedness.
Within the first 48 hours, the FDA was dispatched to the
UK, as you have already mentioned. We have had several more
press briefings, conducted media tours, stood up our clinician
hotline and done everything we can to try to communicate the
priorities for immunization under this new constraint supply
situation.
Let me just describe the next steps that we will be taking.
First and foremost, we will continue our traditional efforts to
monitor flu activity in the United States, so that we know
where the hot spots are emerging and we can use that as part of
our prioritization efforts. In addition, we are working with
the State and local health officers through ASHTO and NASHO to
assess the current supply of vaccine in individual counties as
well as the estimated demand for vaccines in those counties.
Third, I am working with my colleagues at the CDC and the
Department with the CEO of Aventis Pasteur to develop a
distribution plan for the doses of vaccine that have not yet
been distributed. I must say that we have had absolutely
extraordinary cooperation from Aventis Pasteur as well as
Chiron, who has let us know who their high priority recipients
are, the people that they had contracted with who were serving
the highest priority populations.
Unfortunately, for the flu vaccine, the government only
procures about 10 percent of the total supply, so we have very
little independent capacity to modify distribution, and this
voluntary effort is something that we are very grateful for.
We are also, as I mentioned, taking steps to expand the
stockpile, and also to expand our capacity to treat and
prophalax people with antiretroviral--with antiviral therapy.
And, finally, we are asking Americans and clinicians across the
country to collaborate with us in this effort. This is really a
tough time. There are going to be many frustrated people. Not
all people who need flu vaccines are going to be able to get
it.
And we are going to have to work together to do the very
best we can to match the supply that we do have with the demand
among the people who are the most vulnerable to the serious
complications of flu.
And I really thank you, but I also hope that this committee
and Congress would regard this as a call to action. The
situation has gone on far too long. We continue to have a
completely fragile vaccine production capability in this
country, and it is getting more and more fragile every year. So
we need to work together in a bipartisan way with the
administration and Congress and really take the appropriate
steps to protect all Americans who are at risk for vaccine
preventable diseases. Thank you.
Chairman Tom Davis. Thank you very much.
Dr. Fauci.
Dr. Fauci. Thank you, Mr. Chairman, for calling this
hearing. And, Mr. Chairman, members of the committee, thank you
for giving me the opportunity to testify before you today. I am
going to spend a few minutes talking about the role of the
research component of the Department of Health and Human
Services, in this case the NIH, in the vaccine development
process, but also in addressing some of the problematic issues
that we face today with the recent events that have occurred
over the past couple of days.
If you look over at these posters, this is just a schematic
diagram of the role of the research endeavor in influenza
vaccine development. All of the way to the left is where the
academic and NIH community generally concentrates their effort
in concept development and early basic research that feeds into
and informs the production and development of vaccines that are
done in very strong partnership with industry.
So of all of the endeavors that we engage upon, industry,
academic, and government collaboration is not only important,
it is essential to the ultimate endeavor. So what I am going to
talk about is some of the research endeavors that have occurred
and how hopefully this will help us getting to where we want to
go.
To give you an idea of the depth of the commitment to
vaccine research, this is the budget of my institute, the
Infectious Diseases Institute, which in 2004 was $4.3 billion.
As can you see, a full 27 percent of all of our resources are
directed at vaccine research to the tune of about $1.2 billion.
What do we do with that? This poster designates schematically
some of the issues that we address directly. We do a bit, a
little bit of surveillance in epidemiology. The bulk of this is
done extraordinarily well by the CDC.
We fundamentally concentrate on basic research, and the
research capacity, to allow us to get to the end game of where
we are going, which in this case is diagnostics, therapeutics
and vaccines. Just a moment on therapeutics, because we are not
specifically talking about that at this hearing, but it is an
important component of the armamentarium, the development of
new and better drugs to be used as antivirals in influenza.
But the question that was asked by at least a couple of
Members of the question, particularly Ms. Norton when she asked
about what we can do about going from the antiquated techniques
that we have, there are two among several, but two very
important components in vaccine development. One of them is
isolating the virus that you are going to be dealing with,
providing a seed virus for a pilot lot to start the production.
That was generally done in a way that was reliable, but in
some respects unpredictable. If you look at the blue virus,
that is a tried and true virus that we use all of the time in
developing vaccines. If this were the virus in question, that
we were looking to make a vaccine against, you put these
together, and you hope that over a period of time, weeks or
possibly months, but hopefully weeks, it would reassort and
recombine to give you the genes expressed of what you want in
this one with the other genes here.
New techniques developed by NIH grantees called reverse
genetics allows us now to take the unpredictability out of
this, by genetic manipulation, taking the genes directly from
one of these viruses, and taking the genes directly here, put
them a carrier component called a plasmid, and directly
inserting them into the cell line that you want to make that
seed virus in.
That is one thing that will take away some of the
unpredictability. Importantly, the production has relied, and I
think with good results over the years, on egg-based culture
systems to grow the virus to make the vaccine. The difficulty
with that is that it takes a lot of startup time. Chickens to
eggs, eggs are there, you inject the virus in, you make it
grow. And it really is cyclic. It is not something that
generally grows year round.
We need to gradually move away from that, improve the
efficiency of a cell-based culture in which you have more
direct control over. If we had that as the major component of
influenza, we would have much more flexibility, speed and
dependability.
In fact, on this next slide, this shows the potential
advantages of where we want to go with cell culture-based
influenza vaccine. It is faster production, it allows a rapid
response to the discovery of new and evolving flu strains. It
requires less manufacturing space, and this is important, it
circumvents possible problems that are presented by highly
virulent flu strains such as those that are lethal to chicken
embryos and it is tolerated by people with egg allergies.
And on this final poster, it shows what we have been doing
in the enormous increase over the past couple of years in our
influenza research funding, particularly gauged not only at the
possibility of the evolution of pandemic flu, but also
understanding, as we have heard Dr. Berberding allude to, the
fragility of the system that we and many components of the
Department would like to address.
And hopefully the research component of this will
contribute to the speed, the flexibility and the dependability
of the process of influenza vaccine development, to allow us to
respond better and to anticipate problems such as we are facing
today. Thank you, Mr. Chairman.
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Chairman Tom Davis. Thank you very much.
Dr. Crawford.
Dr. Crawford. Thank you very much, Mr. Chairman. I want to
assure the members of the committee and the American public
that the FDA is very serious about its vaccine safety
responsibilities.
Influenza vaccine is unique in that the active vaccine
ingredients change almost every year, which as a result,
present new manufacturing challenges. These viruses are
continually evolving or mutating, and the recommendations for
which viruses to include in the vaccine are based on the
surveillance data provided from laboratories worldwide.
Early each year, public health experts evaluate the data to
determine the strains of virus to include in the influenza
virus vaccine administered in the fall. For this reason, it is
impossible to stockpile influenza vaccine for use in future
years, when there may be a shortage due to manufacturing
issues.
The FDA works closely with manufacturers to facilitate the
rapid production of influenza vaccine each year. As soon as the
strains are recommended, manufacturers begin to grow the virus
strains in fertile hen's eggs. These seed strains used by each
manufacturer are tested by FDA's Center for Biologics
Evaluation and Research [CBER], to ensure that they are the
same as the recommended strains and to assure the safety and
effectiveness of the vaccines.
Then, manufacturers submit the results of their testing
along with sample vials from each lot for lot release by CBER.
Lot release consists of a review by CBER of the manufacturer's
test results for each bulk lot of the vaccine.
Finally, manufacturers and CBER perform additional testing
prior to distribution to assure the safety and efficacy of
these products. FDA inspected Chiron's manufacturing facility
in 1999, 2001, and 2003. As is the case with most FDA
inspections, FDA investigators identified compliance issues at
each inspection.
Chiron's corrective measures in response to these
deficiencies were reviewed by FDA and found to be adequate. On
August 25, 2004, the company informed FDA that they had
discovered bacterial contamination in eight lots of the final
vaccine product, and that Chiron was thoroughly investigating
the problem. Chiron was holding all vaccine lots during its
investigation, and did not release any of the product.
Throughout September, FDA, CDC and Chiron had weekly
conference calls to discuss the status of the investigation.
Chiron informed the FDA that they had identified the cause of
the contamination, and it was limited to specific lots.
The company indicated to FDA that there was no evidence
that any other lots were affected. But, nonetheless, they were
retesting all final lots. Chiron later informed FDA that
results of the testing were negative. The company indicated
that they were going to submit their final report on the
investigation this week, and a call was scheduled for Tuesday.
The FDA had no knowledge of the British decision to suspend
the firm's UK license to manufacture flu vaccine prior to being
informed by the relevant agency from the UK this week.
Dr. Jessie Goodwin, director of CBER and a team of senior
scientific and compliance officials, met with FDA's counterpart
yesterday in the UK to gain further understanding of their
action. Today, they are meeting with Chiron officials onsite in
England and will begin an inspection of the company's
manufacturing facility over the weekend. During that inspection
they will be joined by two senior inspection officials from the
UK.
Clearly, the loss of this vaccine poses a serious
challenge. However, it is important to remember that we have
faced influenza shortages in the past. We work with our HHS
colleagues, health officials and manufacturers on how to best
use the limited supply. For example, Aventis Pasteur has
indicated to the FDA that they will provide an additional 1
million doses, increasing their total number of available doses
to 55.4 million.
Nonetheless, this is still well below last year's supply of
87 million doses. We are encouraging people to take advantage
of the MedImmune FluMist vaccine. FluMist is recommended for
healthy individuals, 5 to 49 years of age, and therefore
provides an option for those who would not receive vaccine
under CDC's priority vaccine guidelines.
MedImmune anticipates having 1 to 2 million doses of
FluMist available this year. Now, in the future, we must create
more efficient ways to produce flu vaccine so we can better
deal with shortages or unexpected problems.
Each of the past two budgets, the Department has requested
$100 million to shift vaccine development to new cell-culture
technologies, as well as to provide for year-round availability
of eggs for egg-based vaccines. We received 50 million in the
fiscal year 2004 budget for this activity, and urge Congress to
fully fund $100 million request in the fiscal year 2005 budget.
FDA has also been investing its energy and resources in
important initiatives such as the current good manufacturing
practices for the 21st century, known as the CGMP Initiative,
and the Critical Path Initiative.
These activities will also help increase the availability
of vaccines and other medical products. It is imperative that
we invest in the more efficient, reliable and modern method for
producing influenza vaccines. With adequate supply and
widespread immunization, the morbidity and mortality from
influenza can be markedly reduced. Once again, I thank you for
having me here today. I look forward to the rest of the
hearing.
Chairman Tom Davis. Well, thank you all very much. We may
be expecting votes in the 11 o'clock timeframe, which gives us
about 25 minutes, about 5 rounds here. I am going start, Dr.
Gerberding.
Virginia, Maryland and the District of Columbia were all
heavily dependent on Chiron to supply vaccines for the public
sector. Is the CDC exploring the option of acquiring the
undelivered Aventis Fluzone doses, which I think is about 20
million, and then distributing it to States that contracted
solely with Chiron?
Dr. Gerberding. Thank you. The CDC is working with Aventis
to look at the undistributed doses of vaccine. Of those,
certain doses are considered to be very high priority, for
example, those needed for force protection or for populations
that we know are extremely high risk, and so Aventis will be
certainly honoring their contracts in that regard.
A small number of doses have not been sold. CDC is hoping
to purchase those. We will work with Aventis to ensure that
they are used in the highest priority areas. Then there are
doses in the middle, some of which go to high priority
populations such as nursing homes. We are also working with
Chiron, because we have gotten the information about where the
unmet high priority contacts are.
Right now, it appears that we will be able to honor all
public sector requests for vaccine purchase. I don't want to
commit to that today, but it looks very promising. And we will
be announcing the overall supply plan soon, after we are sure
that we have accounted for the parts of the geographic
distribution that are most vulnerable right now.
This is not going to be perfect. And we are still going to
have to rely on prioritization. When we issued the guidelines
this week, we were very careful to refer to them as interim
guidelines, knowing as we got more information about where the
demand is, where the supply is, and where the flu is, we may
have to even make those recommendations more or less stringent.
Chairman Tom Davis. The priorities right now, would be as
you would rank them. Seniors? HIV?
Dr. Gerberding. People who are 65 years of age and older,
are at the very highest risk for hospitalization and death due
to flu. So they are the highest priority. Children between the
ages of 6 months and 23 months are also a high priority,
because they have a disproportionate hospitalization rate, and
are at some risk of death.
Anybody with an underlying medical condition is at risk, so
they are included in the prioritization risk. And then there
are people who are caretakers of individuals in those other
groups. So because they might spread flu to somebody else, they
are included in the priority list right now.
Most of those people are well, and some of them certainly
could qualify for FluMist. So we would like to emphasize the
comment about using FluMist for those people who are otherwise
healthy and between the ages of 5 and 49.
Chairman Tom Davis. Dr. Fauci, I have heard someone suggest
that, because of the shortage, the possibility of diluting the
vaccine doses in order to double the supply. Is that a
possibility, or would there be a need or clinical trials
beforehand?
Dr. Fauci. Well, that is based on a study that was
performed through NIH funding at six institutions throughout
the country from the 2000-2001 vaccine trivalent vaccine. What
it did was look at 1,000 individuals and give half of them a
half a dose and the other half a full dose. And it was found
that although the full dose gave more of a measurable response
that you would correlate with protection, there was not
substantial different, suggesting that in time of dire need,
you might be able to do that.
These data are available. The NIH, as of a couple of days
ago, submitted it to the FDA, and it is something that at least
needs to be considered. There is certainly no decision or no
promise that we can be able to do that. But, depending upon how
things unfold, it is something that we will at least have on
the table to look at.
And this importantly could only be used in individuals who
are the healthy adults, because the study was done in that
group of individuals.
Chairman Tom Davis. Dr. Crawford, I understand FDA
currently has a team of scientists and researchers in Liverpool
meeting with Chiron. We appreciate your proactivity there. Do
you think any of the Chiron Fluviron doses are salvageable? And
legally what can you do, because I understand there are already
some doses in the United States?
Dr. Crawford. It is not possible to say if any of them are
salvageable at this point. The inspection of the facility
itself and the examinations that would be attendant upon that
sort of conclusion will begin tomorrow.
The meetings with the Chiron officials are going well, as
they did with the MHRA people yesterday. But, I have to present
to you a pessimistic point of view of whether or not we can
clear any of these. As you know they are contaminated with a
bacterium, in the gram negative range, and it is not clear to
me whether or not we can or not. I would like to be able to say
that there is some optimism. There is the possibility that we
will consider this on a risk-based evaluation.
Chairman Tom Davis. My time is up, but just before I ask--I
want to just ask one last question. What steps are we taking
with Chiron to make sure that they are going to be able to
produce vaccines next year? Because right now they are under
suspension.
Dr. Crawford. Yes. We are meeting with the MHRA, and they
have pledged to work with us. That is the regulatory
counterpart in the UK. And so I think together they are on the
ground, and we are also on the ground. And I think we can work
with them to bring them forward.
Frankly, we will have to provide some technical service, as
we often do, to vaccine manufacturers. And I would be
optimistic about that prospect. What I am concerned about, is
that these kinds of events often result in a further
consolidation of the industry, the lack of competition in that
industry is something that we have testified about before. But
that worries me a great deal.
Chairman Tom Davis. Thank you.
Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman. Evidently in August,
we had some idea that there was a contamination possible to the
supply from Chiron that was the vaccine that was being produced
in Great Britain. And the British knew about it. And they went
out and made arrangements immediately to make sure they had a
full supply for their needs.
Obviously their needs are less than ours, and, second, they
have other companies they can go to other than the two that we
have to rely on.
Dr. Gerberding, our system is so fragile, and contingency
planning is so important. What happened in August when you
first heard about the possible shortage? What actions did CDC
take?
Dr. Gerberding. The initial contingency plan was to assume
the worse case scenario, that we wouldn't get vaccine from
Chiron, and then identify what is the most restricted number of
people who must get vaccines. And that is about 50 million
people, based not only on the numbers in the high risk groups
but also on patterns of requests for vaccination that we have
observed in previous years.
So, for example, in 2002, through our national health
interview survey, we recognized that of the people who should
have been receiving vaccines, what proportion actually were
vaccinated. And we could extrapolate that into the current
year, and make a guess at how many people were likely to
request vaccines if these patterns held up.
That was about 50 million people, give or take several
million, depending on the demand and the severity of the flu
season. So that was the first step. It is also very important
to remember that by August, vaccine was already under contract.
We only have access to about 10 percent of the total supply,
and we have procured what we could for the stockpile, with the
$40 million appropriation that we had to do that. So we had no
flexibility to go to a different manufacturer and buy vaccine,
because they had already sold it.
Mr. Waxman. Now, Chiron--I mean, Aventis, which is now the
only company that is supplying this vaccine, has its own
contracts. They have contracts with clinics, but they also have
contracts with the private sector.
Do you know, and more importantly, do the State and local
people that run the vaccine programs know to whom they are
selling the vaccine, to whom they have already delivered it,
and whether there can be some redirection either of the
existing supply that has already been distributed or that part
of the supply that has yet to be distributed so that you can
make a determination that the prioritization schedule is going
to be met?
Dr. Gerberding. The vaccine manufacturers consider that
information proprietary and we have no legal authorization to
demand it. However, we have been able to develop an arrangement
with Aventis Pasteur where we are getting that information to
the county level, which I think is a very reasonable approach,
so that the county health officers or the local health
officers, the State health officers can see how, for our
population, we have a very large imbalance or we are doing OK
or no shortages are reported.
We are hoping that will help us map out the patterns that
we need to address with the reallocation of the remaining
doses. And I think it is commendable that we are even talking
about a manufacturer being willing to deflect some doses of
vaccine from people who are expecting to receive it, to meet
the highest priority demand.
So this is voluntary, it is very difficult, there is no
mapping of vaccine supply authority in this country. But, we
will do the best we can.
Mr. Waxman. Is there any mapping or knowledge within the
county of who has the vaccine and who does not?
Dr. Gerberding. The county health officials, as well as
State health officials, have been surveying their members. The
first survey to come out of the National Association of City
and County Health Officers indicates that all of the
jurisdictions are making an attempt to map availability within
their jurisdiction, and they are certainly able to know what
they have in the public sector.
But some private sector participants are not willing to
disclose the amount of vaccine they have. We sense that there
is probably some hoarding going on, and people are waiting to
make sure that their patients or their customers are served
first.
Mr. Waxman. You could ask Aventis to give you that
information. They don't have to, but you could ask for it,
couldn't you?
Dr. Gerberding. We have asked for it. And the one caveat is
that some of the vaccine is purchased, for example, by a large
drugstore, and then they redistribute it across the United
States. So we don't have a one-to-one mapping of exactly where
the doses of vaccine are.
Mr. Waxman. Dr. Crawford, in August Chiron announced
several million doses of its flu vaccine might have been
contaminated by bacteria. The British regulators immediately
sent out an inspection team to review the manufacturing
standards at the facility. FDA did not.
Was FDA aware that this extensive review by British
regulators was going on? And why did FDA not conduct its own
investigation of the facility, and is there a communication
between the British equivalent of the FDA with you so that you
know what they are up to and you can communicate freely and
respond?
Dr. Crawford. Actually, when those conclusions were reached
we did have inspectors in the plant from the United States.
They were in Liverpool at the time on August 25. And they did
review the records. It looked like at that point, the maximum
number of lots that might be turned down were something less
than 10 percent.
We arranged, in cooperation with the Centers for Disease
Control a weekly conference call to see what progress they were
making. The United Kingdom did the same thing. And so what
happened is, is that we obviously hoped for the best. It was
too late on August 25 to start a new cycle of vaccine
production, because that is a 6-month enterprise as we
mentioned earlier.
But we hoped for the best. We gave them all we could in
terms of help, as did the British. And I think it is fair to
say that our final conference call with them where we would
reached a go-or-no-go decision was on the same day that the
British announced, the time differential made us a few hours
behind. I was in a meeting in Geneva with one of the officials
of the MHRA who told me about this situation very early in the
morning. And also revealed that they would be--they would have
20 percent less vaccine in England than they had anticipated
needing.
Their level of vaccination is not as great as ours, so they
didn't have quite as much of an impact.
Mr. Waxman. Can I just ask you one question, Mr. Chairman
if you permit? Could you contrast the FDA review with the
British review? They seemed to be much more involved than FDA.
You were looking at the records, but they were already
inspecting the plant. Is that a fair statement?
Dr. Crawford. No. Actually we were in the plant on August
25. So I think it was about the same thing.
Mr. Waxman. Thank you. Thank you, Mr. Chairman.
Mr. Souder [presiding]. Dr. Burgess.
Mr. Burgess. Yes, Dr. Crawford. Following the same line of
questioning that Mr. Waxman was taking. Was there some evidence
that the British equivalent of the FDA had that was more
compelling than the evidence that you had, because it does seem
that their decision was different? You have to wonder if the
data that was presented to both was consistent.
Dr. Crawford. The decision day, which was Tuesday of this
week, was the same for the British as it was for the United
States. They did have a meeting on Friday when they considered
options.
But their final decision was not announced until Tuesday
after further meeting on Monday afternoon and into the night.
So I would say the availability of information was the same to
the two governments.
Mr. Burgess. The data presented was the same and the
conclusion reached was identical with the two agencies.
Dr. Crawford. Yes.
Mr. Burgess. Are you at liberty to tell us what bacteria is
involved in the contamination?
Dr. Crawford. It's called serratia marcesens.
Mr. Burgess. Dr. Gerberding, we saw headlines about the
shortage of the flu vaccine and how it affected some of the
youngest patients in this country. There was a contingency in
place for this year if there was a similar bad actor from the
flu standpoint where there was a run on the vaccine as we saw
last year, is that correct?
Dr. Gerberding. Yes, sir. We actually had expected a record
number of doses of flu vaccine to be produced this year, in
part to allow more surge than we had last year and in part
because we had added the recommendation for children between
the ages of 6 and 23 months to be immunized. Last year, 87
million doses of vaccine were administered--83 million doses
were administered. This year, we had anticipated 100 million.
Even with the loss of the 6 to 8 million doses from Chiron,
based on their projections, we still anticipated we would have
more vaccine than last year.
But, nevertheless, I am a pragmatic South Dakotan, and I
always prepare for the worst-case scenario, and when you know
that some doses are contaminated, even though all testimony--
the CEO of Chiron was here a week ago testifying they expected
full delivery in October. He met with the Secretary and
expected full delivery in October. So we were prepared for the
delay, but in the background we had a backup plan in case the
worst case happened, and indeed it did.
Mr. Burgess. Do you think that preparation that you
undertook last year, perhaps it is fair to say that is going to
blunt some of the potential trouble that is going to accrue
from the loss of the British vaccine?
Dr. Gerberding. It is very helpful that Aventis' production
was higher this year than last year for several reasons. They
tried to make more, but also the vaccine yield was very good.
So we were able to get a few more doses from Aventis Pasteur
than they had initially projected several months ago.
The opposite issue is that FluMist, which went unsold last
year, only made 1.5 million doses instead of the 4.5 million
doses. So we lost the opportunity to use the nasal vaccine for
the healthy people who aren't on the priority list this year
under the shortage condition.
So, again, flu is always unpredictable, but the demand for
flu vaccine is equally unpredictable. What we need is a robust
surge capacity so that when demand exceeds supply we have some
place to go to fill in the gaps.
Mr. Burgess. Do you feel you have the pieces in place to
make certain that the healthier members of the community
understand that they need to use the internasal FluMist?
Dr. Gerberding. We are engaged in full communication at
CDC, so we are reaching out directly to consumers in those age
groups. We are reaching out to employers across the business
community. I have been interacting with the National Business
Group on Health, and they have blasted out information to their
memberships. We are working with stakeholder groups from our
employee sector through NIOSH and other parts of CDC, and we
are engaged--several CDC people are doing radio tours, and we
are setting a satellite uplink up so that we can blast out
through those mechanisms. There have been several press
briefings already, and we will continue to try to use that menu
for outreach.
Our next emphasis will be on translating this information
into all relevant information so that people in all communities
will have it. We are setting up an 800 number so that people
who cannot find vaccine will have a place to call or people who
are confused about whether they need vaccine or not have a
place to call to get that information from the CDC. We will be
mapping those calls by district and by county, and then we will
use that information as helpful input to the local health
officials to recognize supply and demand mismatches in their
community.
So these activities are all ongoing, a lot of effort made
to communicate. But with any public health situation of this
magnitude and as challenging as this one is, you can never
communicate enough. So we will continue to look for every
opportunity to try to shape people's decision in a way that
allows us to get the people who need the vaccine the most get
vaccinated.
Mr. Burgess. Dr. Fauci, you mentioned the funding
difference between the 100 million that would help you go to a
cell culture for technology. If you got that funding today from
this Congress, that $60 million shortfall was made up, how
quickly could we expect to see the end result?
Dr. Fauci. I think we would be able to implement it almost
immediately.
There are two components to that additional amount that the
Department had asked for. One is to provide a guaranteed year-
round availability of eggs for egg-based culture and the other
is to push the envelope on the development of the cell-based
culture. Since research is already ongoing on the cell-based
culture, not only through our grantees and contractors but the
companies themselves are starting to phase some of that in, the
money as it becomes available will literally hit the ground
running in making this happen.
Chairman Tom Davis [presiding]. The gentleman's time has
expired. Mr. Kanjorski.
Mr. Kanjorski. Thank you, Mr. Chairman.
Just being a total layman, it seems to me that you are
testifying that we are involved in a crapshoot with vaccines.
If there had been contamination at Aventis, we would be without
a vaccine in the country and have no capacity to produce it.
And I can understand that, but I can't figure out that there is
a definite plan until you get the new technology in place, but
it will take probably 5 to 7 years. This shortage could happen
this year or the following year, and there is no methodology in
place other than that you have a great informative thing after
the occurrence to notify people who can't get the vaccine.
My question is, what do we have to protect that next year
this won't happen and what can we do or what role should the
government play with the private sector to try and insulate? I
am not hearing whether we should have duplicate manufacturing
facilities, separate manufacturing facilities, onsite, constant
inspection and when critical decisions will be made if there's
a contamination problem. And this is just a contamination
problem. It could have been a terrorist problem.
Dr. Gerberding. You are absolutely right, that we are
vulnerable to failures in the manufacturing process. We have
known this for more than a decade. In the years 2000 to 2003 we
saw this problem come up over and over again with childhood
immunizations, and we need more manufacturing capability and we
need more manufacturers of these vaccines.
Mr. Kanjorski. Doctor, aren't we involved in a terrorism
war, or am I missing something in the last 3 years? I seem to
hear you testifying like we are in any age that we could have
been in the 1980's and 1990's and that vaccines and responding
to bacteriological problems should be one of our highest
priorities. Can you tell me what Department of Homeland
Security and this government has done in the last 3 years to
make sure that this eventuality that has now occurred shouldn't
have occurred or we should have had a backup plan?
Dr. Gerberding. I agree with you completely. We have been
trying to make a strong case for the fact that influenza is a
public health threat and it deserves macroinvestments.
Mr. Kanjorski. That is a given. We are talking about
something that probably half a million people may die that
wouldn't have died if they had vaccine. Is that probable?
Dr. Gerberding. In an average year, 36,000 people die from
influenza. We can't predict whether this year will be a severe
flu season or a mild season.
Mr. Kanjorski. And then we can say that because, with half
the dosage, the likelihood we may suffer 18,000 additional
deaths or at least 5,000. We are going to have people really
die and as many or more people than died in the World Trade
Center.
Dr. Gerberding. Every year, even with an adequate vaccine
supply, people die from flu because we don't get everybody.
Mr. Kanjorski. Doctor, are any more people likely to die in
the United States because of this contamination than otherwise
wouldn't have died if we had adequate vaccination capacity?
Dr. Gerberding. I don't know, but I'm worried about it.
Mr. Kanjorski. You have no professional opinion that you
can project, the likelihood? Because maybe we shouldn't spend
anything in vaccination. If we can use half the production and
we don't need the whole, then we obviously don't need that
protection out there. There must be some mathematical scale
that this is a life-death issue.
Dr. Gerberding. I agree with you completely, and we
cannot----
Mr. Kanjorski. I'm not condemning your organization or the
others at the table, other than we are 3 years into the war on
terrorism and it doesn't sound right to me. I'm not condemning
your agencies, your asking for money and preparation. I have
visited these manufacturing facilities, and they have called my
attention to the fact that they don't know what will happen to
this country in a pandemic and how we are going to respond to
it. Have you presented to the Congress and to the President a
plan to meet terrorism and pandemics and have we responded to
it?
Dr. Gerberding. As we said, we requested resources to scale
up the surge capacity for vaccine from Congress last year.
Secretary Thompson and the administration requested $100
million; Congress appropriated $50 million. We have asked for
the opportunity to expand the vaccine stockpile so we could
purchase a reserve. We are making progress toward achieving
that, but we haven't had the full appropriation to accomplish
that yet.
Mr. Kanjorski. So this Congress has failed to respond to
the agencies of the executive department of this government
that would have been a response to homeland security because we
do not have the capacity potentially to meet the biological
protections against biological warfare, is that correct?
Dr. Gerberding. We requested $100 million, and we received
$50. We are hoping Congress will support the full $100 million
in fiscal year 2005.
Chairman Tom Davis. Mr. Souder.
Mr. Souder. Thank you, Mr. Chairman.
First, I would like to add my voice to the many others that
Dr. Gerberding--I hope next time the network does a TV show
they give you full credit. Your agency deserves full credit for
the work that you do.
Based on conversations I have heard here, I want to ask you
a couple of questions. My colleague from Indiana, Senator Bayh,
introduced legislation a year ago that sounds to me like it
attempts to address some of the things you raised. One of the
things that Dr. Crawford raised was a seeming lack of
competition in the marketplace. One of the things there would
be to encourage through investment credit more people to get
into the business. Do you think that would help at all? What do
you think is the biggest stumbling block?
And I would appreciate a further comment on that, because--
and let me add this, and we will start with Dr. Crawford and
move through. A second part of the legislation deals with
trying to make sure that the government buys--or if the market
doesn't meet, the government will back up and purchase a larger
supply so we have a backup supply.
It is not without precedent. I remember working as a
staffer with MRE companies, because we have these pulses in
Ready-to-Eat meals at wartime. So part of the goal had been to
keep two or three of these companies in business so that when
we had a policy we had the capability to do that.
How do you feel about what impact on the market that would
have if we had a backup guarantee if the production rate were
higher? One question is, can we get more people into an
investment credit; and, second, would having some backup
guarantee for the high-risk population that guaranteed that if
they produced it, like FluMist did--and my question along the
same lines, FluMist is going to testify, who manufacture that,
in the next panel that they had to cut back because the market
didn't do it and they're restricted in the areas that the
government backs up and we are losing manufacturers. What, if
it isn't those two things that I mentioned earlier, would you
do to try to get more manufacturers in the business?
Dr. Crawford. What we are trying to do--as you know, we
don't have funding for like startup companies and that sort of
thing. We basically regulate them. We are the bad news for
them, rather than the good news. What we are trying to do is
improve our process so that we create a favorable regulatory
environment for more companies to get involved.
I mentioned the good manufacturing practices, which we have
just announced after a 2-year study; and what this will do
would make it--it would be a newer approach to manufacture. It
would be less onerous, more scientific, more systematic. And
over time, along with the new research initiative that we are
working with the National Institutes of Health on called the
critical path, we believe it will make it a more predictable
climate for vaccine manufacturers but one that produces better
products with more certainty of success.
In the lots that we have now, I mentioned earlier that 8 of
100 were originally considered to be defective. As we go
through our examination tomorrow, this will actually be a test
case. We don't know how many or if any are badly contaminated
until we do the inspection. But certainly a better regulatory
environment where it is more modernized, if we take a newer
approach at it, would help; and that is what we're committed
to.
Mr. Souder. I agree that the regulatory environment in all
kinds of things is a deterrent, and certainly all the
manufacturers say that to some degree. We have only been able
to move that slightly. I hope we continue to move that and keep
people's health safe.
The question is also is there a tipping point here where a
small investment or even a medium investment tax credit would,
say, impact these new technologies or if we, in effect, backed
up some of the purchases for pulse components. Dr. Fauci.
Dr. Fauci. You bring up an important point that has many
ramifications for what has been said thus far today as we keep
referring to the fragility of the vaccine development industry.
I think it boils down to things that we in the Department at
all three of our agencies have been facing, and that is a real
lack of a climate of incentivization to get companies involved.
People say, how come you only had two companies involved for
the vaccine for influenza? Those were the only two companies
licensed in this country to make it and distribute it. It isn't
as if we had 15 companies, and we decided on 2, and I think
that sometimes gets misunderstood.
If you look at the climate of how we look at vaccine
development, it's very risky business for a company to get
involved, risky because of the profit margin, risky because you
are dealing with biologics and they are much more difficult to
predict the success of it. And there's the issue of the use of
vaccine which is used once or twice or three times in a
person's lifetime, as opposed to the other possibility of the
same company developing a blockbuster drug that someone would
use everyday of their lives for the rest of their lives that
they could make millions at.
What we are trying to do is to do everything from
regulatory incentives to research by pushing the envelope more
to take away some of the risks by the approaches that I showed
in my opening statement about perfecting things like the
reversed genetics or perfecting things like the use of cell
culture base. And then, finally, it is the issue of pricing and
how our culture views how much one is willing to pay for a
vaccine.
This morning, in preparation for the hearing, I got on the
phone in my office very early and I called up a pharmacy in
Bethesda and I asked about the relative prices of things,
because we talk about it a lot. And I asked them what would be
the retail price of a year's supply of Lipitor, which is a
blockbuster, cholesterol-lowering drug. $1,608. What would be
the yearly cost of 50 milligrams of Viagra? $3,500 a year per
person. What is the cost of the Aventis Pasteur vaccine? $7 to
$10.
You are talking about the idea of any company wanting to go
toward something that has a major profit margin. We need to
help with incentives. We could do it researchwise or
regulatorywise, but it is a rather broad, generic issue. We
hope, working with the committee, we will be able to find
solutions to that.
Mr. Souder. Could I see if Dr. Gerberding has anything to
add?
Dr. Gerberding. In the short run, before we are able to
scale up and using some of the tools you described, that the
backup plan of the government purchasing additional doses of
vaccine is one that we are already doing on a small scale; and
it is conceivable that, by expanding that, manufacturers would
be incentivized to make as much vaccine as they could. The
downside of that is that taxpayers would have to be prepared
that, most years, we would throw vaccine away and it would be a
waste of tax dollars. So there is a tradeoff with flu vaccine
because we have to get a new vaccine preparation every year.
Chairman Tom Davis. Ms. Watson.
Ms. Watson. Pass.
Chairman Tom Davis. Mr. Tierney.
Mr. Tierney. Dr. Crawford, does the Food and Drug
Administration pretty much agree with the determination made by
the British health authorities?
Dr. Crawford. I can't answer that until we get through our
inspection. We are looking through the lots and hoping for the
best, but there is an air of pessimism, so probably we will.
Mr. Tierney. Is anything being done about the prospect of
price gouging?
Dr. Gerberding. We are concerned about price gouging. The
first step is to identify where it's happening, and the second
step is to alert the State and local health officials that it's
happening in their jurisdiction and also the FTC who has the
regulatory responsibility to evaluate and take the appropriate
steps. I think it is tragic. We know in any market where
there's a shortage of product that there is a tendency to raise
the price, these unfair price increases; and they really add
insult to injury.
Mr. Tierney. Are you satisfied that our officials are
actually working on this issue, giving the proper notice to
people?
Dr. Gerberding. I don't have an answer on that today, just
48 hours into this, but we will be looking for it and also make
our hotline available if there are reports of this so people
can alert us and we can pass the information onto the
appropriate response agencies.
Mr. Tierney. Dr. Fauci, you should have slept over last
night. You were here yesterday on the West Nile virus.
Doctor, with respect to our research, MedImmune says they
are developing vaccines for--and giving it for free to
government inspectors or researchers, but they obviously charge
others who create a profit from it for that. Do we need to
address our patent laws at all to make sure that enough people
have access to the reverse genetics processes or anything or is
it fine the way it is?
Dr. Fauci. I think what you are referring to is what is
going on is a dispute about the pattern of the reverse
genetics. I'm not sure we need to address the patent laws on
that. We need to clarify pretty quickly what the patent issues
are involved there so we can get the ball rolling on this, but
I don't think this is a generic patent law problem.
Mr. Tierney. A moment ago you were talking about the
different prices that you get for different prescription drugs.
The fact of the matter is, it's not the government that is
keeping the price of the flu vaccine low, is it? We don't set
the price and keep it low?
Dr. Fauci. Actually not. But one of the issues we face--
what I was referring to was not that it's the government or
industry.
Mr. Tierney. It's a market situation.
Dr. Fauci. Culture of people feeling and maybe in some
respects, appropriately so.
Mr. Tierney. It is the market. Because if people made more
of a demand for it, the price could be raised higher. It it's
raised higher, they're afraid people won't buy it at the higher
price.
Dr. Fauci. Also, the third party payers wouldn't
necessarily pay it. That's an important issue.
Mr. Tierney. One of the things--I think Dr. Gregory Poland
from the Mayo Clinic gave the options. We either have to
subsidize or give incentives to manufacturers to get them into
the business, or the government has to own or operate either
themselves or to a contractor a plant to produce the vaccine.
Seems to lay out some of the options that you say we went from
regulation to doing it yourself.
But as long as we leave it entirely without a regulation to
the industry, we get the lower prices, we get less demand, and
we get two manufacturers instead of more, and it creates a
problem. Anybody in any of these agencies before us right now
debating this issue as a policy matter, whether the government
ought to have a contractor get in there and somehow subsidize
them to create this or get in the business themselves or
regulate the price, is that discussion going on?
Dr. Gerberding. That discussion is ongoing and has been
going on for some time. Just on Monday, the National Vaccine
Advisory Committee, who has responsibility for advising the
Department and the government on those issues, issued some
statements that recommended that we look at those options that
you just mentioned. There is not a long list of options, and we
need to bite the bullet here and come up with a plan.
Mr. Tierney. This is absolute free market aspect when it
comes to health care. It doesn't always seem to fit the same
model as if you're selling widgets. Health care is a different
item here, and we get that right across the spectrum of health
care issues. I know that everybody is paranoid of the word
regulation or any government involvement, but we expect the
government to step forward for our safety and protection. I
hope that debate accelerates. I think Congress ought to be
involved in this debate, and there ought to be further hearings
on this away from the ideology as to what is a practical matter
of how we take care of health concerns, and that may mean a
little less of absolute free market and more intervention here
to make sure we have this product available.
Chairman Tom Davis. Mr. Mica.
Mr. Mica. I remember previous hearings on the subject of
the cost of some of these vaccines. I remember someone holding
up a vaccine vial, and in that testimony they said that the
cost of the vaccine itself was less than $1 or around $1, but--
I don't remember--if you can get insurance, the cost was like
about $20 some. I don't know if that's still the case. Is that
a typical ratio, Dr. Fauci? I think you were talking about some
of the costs.
Dr. Fauci. I'm not actually sure, and I would hesitate to
make any statement about the relative costs of the liability
insurance that they would have to pay.
Mr. Mica. Are they having trouble getting it,
manufacturers? I heard you cite some incentives. Isn't that one
of the major problems, the most significant problem to
manufacturers in the United States?
Dr. Fauci. I best leave that for the companies to answer.
But I know when you are dealing with childhood vaccines we do
have a childhood vaccine fund for compensation. But not in the
adult.
Mr. Mica. Right now, we are looking at blaming sort of the
bureaucrats, and you all haven't paid enough attention to this,
and there probably will be horrible things like price gouging
because the supply is down. You had a responsibility. And it
was kind of interesting, someone said you had to fly--who flew
over to check it?
Dr. Fauci. The FDA.
Mr. Mica. So we had to fly to Europe to check the supply.
I'm sure it is much more beneficial to manufacture this outside
the United States and keep an eye on it. I understand you have
an annual inspection?
Dr. Crawford. Depending on what the risk is expected to be,
it can be as little as every 2 years.
Mr. Mica. How many did we have here at the site that went
bad? Can you supply a record of your visit for the committee?
Dr. Crawford. Absolutely.
Mr. Mica. This is a research and development budget for the
National Institute here, and it says vaccine research. We
supply $1.18 billion in research. Mr. Sanders and I several
years ago went over and met some of the drug manufacturers
trying to figure out why--what was happening in the
marketplace. At that time, they told us there was no R&D in
Europe, that it was all being done in the United States for
most drug development and vaccines. Is that still the case?
Dr. Crawford. For pharmaceuticals?
Mr. Mica. Yes.
Dr. Crawford. Sixty-three percent of the profit, it is
reported, from pharmaceuticals worldwide is gained through U.S.
sales. So quite naturally----
Mr. Mica. We were told, quite frankly, that there is no R&D
going on or very limited. Almost all of it comes from the
United States. The U.S. taxpayers are financing R&D in vaccines
and other pharmaceuticals, and then we are outsourcing because
you can't manufacture in the United States because you get your
butt sued. And you also certify or do you approve the drugs?
The FDA approves those vaccines, right?
Dr. Crawford. Yes, we do.
Mr. Mica. You know, I think it's time we looked at some
system where we took responsibility and there would be plenty
of drugs available at low costs if we limited the liability, if
we set up some funds for decent compensation for victims,
whether it is a pharmaceutical or a vaccine. Wouldn't that be a
better solution, Dr. Fauci?
Dr. Fauci. I think the idea of compensation is something
that needs to be----
Mr. Mica. We have done some of it with children's
immunization. We produce it.
Our responsibility is to have an agency like the FDA to say
that this is a good drug. Now we force the manufacturing
outside. We are paying for the R&D. It would behoove us to
manufacture in the United States and have better control and we
are certifying it whether it is manufactured in the United
States or outside that it is good. So shouldn't we have some of
that responsibility, FDA?
Dr. Crawford. Yes, we should.
Chairman Tom Davis. The gentleman's time has expired.
Ms. Norton, you will be the last questioner.
Ms. Norton. Look, having been caught without a backup plan
already, I'm really compelled to ask what is the backup plan in
case the volunteer sharing doesn't work out?
Now the most generous people in the world are health care
people, so I'm sure everybody is doing what you'd expect them
to do. What are you empowered to do if, in fact, your, quote,
backup volunteer plan proves as insufficient as having no
backup plan for half of the supplies which now are unavailable,
what are you empowered to do? What would you do if in fact
people begin to make their own assessments, particularly since
the private sector controls most of the supply?
Dr. Gerberding. Thank you. That's an important distinction
between childhood vaccines for routine prevention of vaccine-
preventible diseases and influenza where we have such a small
proportion of the market share in the governmental control. CDC
has no authority to regulate distribution of vaccine or to
regulate the manner in which vaccine is supplied. We rely on
our best technical advice. We rely on altruism, as you have
described.
We have experience with this in 2000, 2001, where we had a
similar vaccine shortage. We found that, overall, there was
adherence to the recommendations. In fact, we ended up in many
areas with excess doses of vaccine because people complied so
carefully with the recommendations.
What we are talking about here is a very fine line between
what we have and who needs it the most. I just don't think it's
a matter of doses, but it's a matter of where are those doses,
and we have no authority to redistribute the vaccine.
Ms. Norton. I don't want to take the entire time. Are you
prepared to come back during the lame duck session and get some
authority to do something now that you know full well that the
private sector could turn you down and could decide on its own
where the supplies go?
Dr. Gerberding. We would be delighted to work on with
Congress on solutions. Our colleagues at the FDA, who is the
regulatory agency, has a role to play in this as well, but we
would be willing to look at all possible solutions.
Ms. Norton. I'm asking you and Mr. Crawford to, in fact, be
prepared now that there is no backup plan, now that we cannot
in our economy force the private sector to do things with
respect to supplies in their hands, to be back here when we
come here to tell us what it is we need to do. We can't just
sit here saying we don't have the authority, there's nothing we
can do about it.
In order to let other Members ask questions, I'm going to
forego the rest of my questions.
Chairman Tom Davis. We have 3 minutes left to vote.
Mr. Cooper.
Mr. Cooper. Following up on my colleague's line of
questioning, could this Congress save lives by passing a law
making sure that only high-priority recipients got the
vaccine--seniors, infants, people with chronic diseases, health
care workers? Would that save lives in this country?
Dr. Crawford. I should defer that to Dr. Gerberding.
Basically, you are saying that you would codify their
recommendations, CDC's recommendations?
Mr. Cooper. With the force of law behind the voluntary
guidelines that Dr. Gerberding has mentioned, would that save
lives in this country? Because, in response to Mr. Kanjorski
earlier, it seemed like the normal casualty rate that we could
face with influenza could go up substantially this year as a
result of this manufacturing shortage. You only have voluntary
guidelines at your disposal and you're not empowered to do
more? Would you be able to save lives if you had that extra
legal authority?
Dr. Crawford. I'm not prepared to answer that. I think she
expected good compliance based on past years, but I better
defer to Dr. Gerberding.
Dr. Gerberding. I don't have an answer for you either. This
is a work in progress. In past years, we have been able to have
a good match between what we expect and how people adhere to
those recommendations. Whether we would have more benefit from
codifying it or more mess from codifying it, I can't really
tell you right now. I think enforcement of that would be a very
difficult challenge to patch together on short notice, but we
will look at that as an option and, as the Congresswoman
suggested, come back with a set of options that we could
discuss with the committee during the next session.
Chairman Tom Davis. Thank you very much.
I'm going to dismiss this panel with our thanks. We will
take a recess to go vote and be back in 15 minutes.
[Recess.]
Chairman Tom Davis. The committee will come to order.
The gentleman from Indiana is recognized.
Mr. Burton. Mr. Chairman, you really are fast with that
gavel, and I love it.
I'm sorry, Mr. Chairman, I wasn't here earlier today when
the hearing started--and this is on a related subject. I got my
flu shot this morning, and I guess a lot of Americans so far
haven't been able to do it because of the shortage. But the
concern that I have, part of the contents of the vaccination
that people are getting. There is a substance called
thermarisol, which is about 50 percent ethyl mercury in the flu
vaccine, and most adult vaccines have mercury in it.
Governor Schwarzenegger of California recently signed a
bill in California which prohibits children up to age 3 from
getting a vaccination that contains thermarisol; and the reason
for that is because the mercury in vaccines--and we have had
hearings on this over the last 4, 5 years--the mercury in
vaccines is seen by many scientists around the world as a major
contributing factor to neurological disorders such as autism in
children and Alzheimer's in adults.
Now we are getting it out of most of the children's
vaccines. It's in about three or four of the children's
vaccines today. In California, they are going to get it out of
all of them, which is a giant step in the right direction, and
I congratulate the legislature out there and the Governor for
doing that.
We need to get mercury out of all vaccinations. Mercury is
toxic to the human body, to the human neurological system. It
is in the flu vaccine and in most of the adult vaccines. It
needs to be removed. You can go to single-shot vials without
having mercury in them; and, Mr. Chairman, it would be great
for the American people and the world if we removed that.
Mercury toxicity is a major ecological problem for the
whole world. It is in our water, in our fish. We are being told
not to eat fish in many cases because there is mercury in them,
and we continue to put it in vaccines that's injected in our
children and adults.
We used to have 1 in 10,000 children that were autistic. It
is now 1 in 166 according to CDC. We used to have Alzheimer's
that was recognized quite frequently, but now it has become an
epidemic. So we need to get these toxic substances out of our
vaccines. I think the pharmaceutical industry has done a great
job for the people of this country and for the world, but there
are certain things that can be cleaned up. One of them is
getting the mercury out of the vaccines.
Mr. Chairman, I thank you very much for yielding to me; and
this is another shot across the bow, the pharmaceutical
industry, to get the mercury out of all vaccines for the good
of humanity.
Chairman Tom Davis. Thank you very much, and you have been
consistent in your position on this.
We move to our next panel, and I thank our witnesses for
appearing. They are the three flu vaccine manufacturers to
discuss vaccine production capacities to respond to shortage
crisis.
We will hear from Christine Grant of Aventis Pasteur,
manufacturer of Fluzone, the vaccine. Dr. David Johnson
accompanies Ms. Grant, and he is available to respond to
questions.
We also have Dr. James Young from MedImmune, which
manufactures the nasal spray vaccine, FluMist.
Unfortunately, a representative from Chiron is unable to
attend this hearing, but the company has submitted written
testimony for the hearing record. I ask unanimous consent that
Chiron's testimony be included in the official hearing
language. And without objection, so ordered.
[The prepared statement of Mr. Pien follows:]
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Chairman Tom Davis. We also have a visitor to this
committee who I have known for many years, Dr. Robert Stroube.
He is the Virginia State Health Commissioner. He is no stranger
to this committee either. He's here to provide an assessment of
State and local public health departments' ability to respond
adequately to the vaccine shortage threat.
We swear all witnesses before you testify. So if you would
rise and raise your right hands.
[Witnesses sworn.]
Chairman Tom Davis. Ms. Grant, we'll start with you; and
we'll move straight on down. I can't thank you enough for being
with us and being patient, but we'll try to get through
questions as quickly as we can.
STATEMENTS OF CHRISTINE GRANT, VICE PRESIDENT FOR PUBLIC POLICY
AND GOVERNMENT AFFAIRS, AVENTIS PASTEUR, INC., ACCOMPANIED BY
DAVID JOHNSON; JAMES YOUNG, PRESIDENT, RESEARCH AND
DEVELOPMENT, MEDIMMUNE, INC.; AND ROBERT STROUBE, STATE HEALTH
COMMISSIONER, VIRGINIA DEPARTMENT OF HEALTH
Ms. Grant. Good morning, Chairman Davis and members of the
committee. Thank you for the opportunity to testify today on
behalf of Aventis Pasteur.
During the past 10 years, Aventis Pasteur has been a
reliable supply of influenza vaccine for the United States,
consistently increasing our annual production. This year, we
expect to produce 55.4 million doses, 33 million of which have
already been distributed.
I'm here to communicate our company's pledge to continue to
do everything we can to manage this influenza season consistent
with the recommendations of Federal and State health
authorities. Vaccines have proven to be the most cost-
effective, preventive intervention in human history; and all of
our employees are passionate about the contributions they make
to lifesaving work.
Aventis Pasteur is the world's largest vaccine company with
nearly 9,000 employees. The company's global experience has
been utilized to manage influenza epidemics over many decades.
Vaccine has been produced at the Swiftwater, PA, location for
over 100 years and influenza vaccine produced there for more
than 30 years. Today, we produce approximately one-half of the
U.S. influenza vaccine supply. Although there have been years
where disruption and shortages have ensued in the influenza
vaccine marketplace, Aventis Pasteur has been able to deliver
vaccine to our customers on a timely basis during influenza
season.
As I previously stated, Aventis Pasteur intends to achieve
its plan to produce approximately 55.4 million doses of Fluzone
for the United States this season. Customers had already placed
orders for more than 52 million of those doses prior to
Chiron's announcement. This included approximately 4.5 million
doses for the CDC, including the late season strategic reserve,
which the CDC proactively and wisely planned. It is important
to note that over 85 percent of all influenza vaccine is
administered by the private health care sector.
So since hearing the announcement 3 days ago, we have
worked with the CDC and the FDA to determine whether we can
manufacture additional doses later this year. Any additional
doses available from going back into production, however, would
not be available until February or March; and such a decision
would have implications for the amount of vaccine which can be
produced for next 2005-2006 season.
Mr. Chairman, as we have heard today, the supply shortage
has caused many policymakers to ask: Why are there so few
vaccine manufacturers in the United States and what needs to be
done to encourage vaccine manufacturers?
Over the last several years, we testified before Congress
about the urgent need for Federal policymakers to do more to
cherish and promote vaccine companies; and we suggest five
recommendations to achieve this goal.
First, demand for vaccine drives supply. We need to work
together to steadily increase annual reliable demand to achieve
Healthy People 2010 goals. This will give companies confidence
to continue to reinvest and thus increase supply.
Second, annualize the funding for CDC's strategic influenza
vaccine reserve, which was only budgeted for two seasons yet is
proving to be a very wise investment.
Third, liability exposure chills interest in this field. We
are pleased to acknowledge the House of Representatives passage
of the JOBS bill just late last night, which included the
Influenza Vaccine Excise Tax; and we strongly encourage the
Senate and White House to take quick action on the bill. This
will ensure that influenza vaccine is now covered under the
Vaccine Injury Compensation Program.
Fourth, we encourage the committee and Congress to begin
now to plan to address special vaccine liability issues that
will occur when there is an influenza pandemic.
Fifth, we encourage the committee to help resolve
inconsistencies between SEC accounting guidelines for routine
pediatric stockpiles and CDC's desire to implement such
stockpiles, for which Congress has already authorized the
appropriated funding.
We are aware that vaccine companies have left the U.S.
market in the last decade. This included two companies that
produced influenza vaccine. It's important to remember that,
even if a new company were to plan a new facility today, it
would require a minimum of 5 to 7 years to build, validate,
license, manufacture and deliver vaccine to the marketplace.
This is due to the inherent complexity of building reliable
production facilities that meet necessary health and safety
standards.
Aventis Pasteur has been a leader in introducing innovative
technology. We have learned through experience it takes years
to develop and incorporate new processes into routine
manufacturing. For example, we are working on the promising
technology known as cell culture, but we caution it is going to
take years to transition this technique from research to full-
scale production. Additionally, the technique will not
substantially reduce the total production time.
Mr. Chairman, we share the committee's concern and
frustration with this year's supply problem. However,
government authorities and the private sector have worked well
together in the past to manage difficult situations to ensure
optimal immunization rates; and we want to commend HHS, the CDC
and the FDA's leadership for their immediate and decisive
action to address what is inherently the unpredictable nature
of vaccine production. In less than 12 hours, as you heard, the
CDC's Advisory Committee on Immunization Practices issued
interim recommendations to prioritize influenza immunization
for high-risk populations.
The National Flu Summit, a public-private partnership of
the CDC, professional associations, public health authorities
and companies such as ours, has already discussed how best to
implement those recommendations; and influenza professionals
are recommending that health care providers who actually see
patients are best equipped to determine who is at high risk.
In summary, Aventis Pasteur pledges to continue to do
everything we can do to manage this season consistent with the
recommendation of Federal and State health authorities; and we
commend Congress for your prompt interest to address this issue
during your busiest week of your session.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Ms. Grant follows:]
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Chairman Tom Davis. Dr. Young, thanks for being with us.
Dr. Young. Good afternoon, Mr. Chairman. Certainly a
pleasure for me to be here this afternoon to address the
committee on this very important topic, and I commend you on
inviting members of the manufacturing community here to provide
their perspective.
My name is Dr. Jim Young. I'm president of research and
development at MedImmune, a biotech company headquartered in
Gaithersburg, MD. As you may know, MedImmune is new to the
influenza vaccine business, having introduced a new type of flu
vaccine this past year called FluMist, approved by the FDA for
use in helping individuals 5 to 49 years old. Unlike the other
flu vaccines which are injected into the muscle, this vaccine
is simply sprayed into the nose to protect against influenza.
MedImmune currently has the manufacturing capacity to
produce 20 million doses of FluMist. This year, however, we
produced only 2 million doses of bulk vaccine and before this
week's events had planned on filling and finishing only 1.1
million of those doses, which we did. That finished material,
I'm pleased to report, was released for distribution by the FDA
yesterday.
I'm sure you are sitting there thinking, with the capacity
to produce 20 million doses of this innovative vaccine, why did
we only fill 1 million doses? Quite simply, because, one, the
product was approved with a very narrow label indication by the
FDA; two, it has been faced with significant confusion and
misinformation propagated in the marketplace; three, has not
had strong support from the recommending authorities; and,
four, was launched into a climate of overwhelming complacency
and with a lack of awareness on the part of the public as to
the severe illness and death that is associated with influenza.
It is these factors that account for an insufficient demand
to justify increased production of FluMist.
Nearly 8 months ago, I sat before this committee testifying
that close to 4 million of the 5 million FluMist doses
manufactured last season would be destroyed at the end of the
2003-2004 influenza season, a season in which there was a
vaccine shortage and 152 children died from flu. Thirty-nine of
those children actually were eligible to receive FluMist and
could have received the vaccine but didn't. The fact of the
matter is that there were 4 million lost vaccination
opportunities with product that we had available that went
unused.
Consequently, as a result of last season's experience and
based upon FluMist's existing licensure for the restricted
population of healthy individuals 5 to 49 years, MedImmune
planned very limited production this season, somewhere between
1 and 2 million doses. This was a substantial about-face from
original intent when we decided to enter the influenza vaccine
business nearly 3 years ago with the desire to increase the
number of influenza manufacturers in the United States and
worked to fulfill the stated goals of public health officials
to expand the number of U.S. citizens receiving influenza
vaccination.
However, in response to the vaccine shortage announced this
week, we are committed to filling the remaining bulk material
we have in inventory actually starting today and expect to
produce up to 1 million additional doses of FluMist for
distribution. Under normal circumstances, getting these
additional lots of FluMist approved and released by the FDA
would likely take well into December. However, we are in
communication with the FDA and hopeful that, with their
assistance, the timing of this release can be expedited.
As they did during the flu crisis last season, the FDA has
also indicated that it may be willing to consider waiving other
logistical and distribution requirements, including the need
for a freezebox to store vaccine in frost-free freezers, in
order to broaden the distribution of these additional doses.
None of these expedited procedures will, of course, pose any
added risk to the consumer or to the quality of the product. By
producing up to 2 million doses for the healthy population
between 5 and 49, we are freeing up 2 million doses of the
injectable vaccine for use in the highest risk population,
which could potentially save hundreds of lives.
After our initial very disappointing and sobering
experience as a flu vaccine manufacturer, we spent several
months earlier this year evaluating whether we should remain in
the influenza vaccine business or whether we should cut our
losses and get out after dealing with the costly and
overwhelmingly difficult regulatory landscape to bring this new
and effective vaccine to the market. Our partner with FluMist
last year, Wyeth, a former manufacturer of the inactivated flu
vaccine, also went through this same internal debate. In April,
Wyeth opted to exit while MedImmune decided to stay in the
business.
MedImmune's decision to stay in the flu business was based
on a continuing belief that influenza is an extremely important
disease and that FluMist is an important new addition in
prevention, warranting our investment to become a meaningful
contributor to the vaccine production in this country. Since
taking over complete control of the future of FluMist, we have
cut the price of the product from $46 a dose last year to a
price as low as $16 a dose this year for the private market and
negotiated even lower prices for government purchases. We are
working with the CDC, VA and DOD, providing them the option to
purchase a significant proportion of the additional product we
are now working to deliver to the marketplace.
While we are here today because of an imminent and serious
vaccine shortage, I want to emphasize the problem is much
larger and transcends well beyond the season. As Speaker of the
House Dennis Hastert stated on Wednesday, ``there are only a
handful of vaccine manufacturers left in the world. We know
that our current production capabilities would not be able to
handle a massive surge for vaccine products caused by a flu
crisis. We need to take steps to address this situation before
it becomes an even bigger problem.''
Bigger? How much bigger does this problem need to become?
How many more hearings, analyses, consultants, discussions and
testimonies must there be before any action is taken? Already,
King Pharmaceuticals, Wyeth, Parke-Davis and Merck have pulled
out of the influenza vaccine business over the past few years.
Why are they exiting? Two reasons.
First to participate in the influenza vaccine business
requires enormous investment in clinical development,
manufacturing facilities and regulatory requirements; and the
return on the investment is abysmal, given the low price
received for the vaccine. On our part, MedImmune has invested
$1 billion to bring FluMist to the market with what is a very
narrow label and expects to invest $200 million more in an
attempt to expand the indication to a broader U.S. population,
an amount that you saw this morning from Dr. Fauci's
presentation, which is greater than the NIH is expected to
spend on FluMist over the next 3 years.
Second, the demand for influenza vaccine is inconsistent,
such that when manufacturers increase capacity in anticipation
of broader demand, interest often wanes and unused product is
wasted. Demand is strongly influenced by policies set by the
Federal authorities. Current influenza vaccine recommendations
primarily target high-risk individuals. However, the burden of
the influenza virus illness is significant in healthy persons
who fall outside of these targeted age groups as well and in
otherwise healthy unvaccinated school-aged children who serve
as vectors for transmission of influenza to their families and
to high-risk individuals with whom they have contact.
The vast majority of stakeholders in influenza prevention
are reaching the same conclusion, that the recommended
population for influenza vaccination must be expanded greatly,
a movement that we all endorse. A universal recommendation that
all Americans receive annual flu vaccine will drive the demand
for routine annual vaccination and the development of
sufficient infrastructure to develop the vaccine, which will in
turn provide the impetus on the part of vaccine manufacturers
to increase their production. This will ensure the capacity
needed to produce even larger quantities of vaccine in the
event of the emergence of a new pandemic strain.
Ironically, it is a situation like the one we are now faced
with, where we are telling healthy individuals not to get
vaccinated, which runs counter to the message public health
authorities need to send to expand demand. History tells us
that it will take several years before many healthy individuals
again seek vaccination for flu.
What is it that MedImmune specifically recommend that the
Federal Government do?
First, we believe that regulatory authorities should look
at the available scientific and clinical data pertaining to
FluMist and reconsider a broader role FluMist could play
potentially within the context of public health given the
benefits that we have demonstrated in clinical studies of this
vaccine. This is particularly relevant to the 50 to 64-year-old
high-risk group that will otherwise go unprotected this year.
Second, the government needs to find ways to incentivize
companies to build manufacturing facilities in the United
States. There is an increasing trend for U.S.-based companies
to build manufacturing plants offshore in order to gain access
to a well-trained pool of potential workers as well as
significant tax advantages. With this trend comes the increased
risk of the type of event we are currently experiencing.
Companies will face regulatory decisions that may prevent
product from entering the United States or, worse yet, in the
event of a catastrophic event or the emergence of a new
pandemic strain, the host country may embargo vaccine for use
in its own borders.
Third, logistical and accounting issues need to be sorted
out so that the Federal Government can stockpile additional
product or even bulk vaccine, a relatively inexpensive step in
the manufacturing process. Bulk material could be stored for up
to 2 years or until a new influenza strain is introduced and
could be filled at a defined schedule as needed.
Finally, the Federal Government should provide incentives
for manufacturers to develop innovative production methods that
could expand the capacity. They should make potential new
vaccine strains available to the manufacturer sooner and
eliminate the need for the FDA release for flu vaccine lots.
All of these would result in earlier and greater product
availability.
In conclusion, I would like to reiterate that MedImmune has
manufacturing capacity to produce 20 million doses of influenza
vaccine; and with the addition of our new $75 million state-of-
the-art manufacturing facility currently being validated and
modest changes in the works at our current facility, we will
soon be able to produce 40 to 50 million doses of vaccine. In
order to make production at these levels a viable option, we
need the Federal Government to create sufficient support and
demand to reduce regulatory hurdles and to place a far higher
value upon influenza vaccination for all Americans.
Thank you for this opportunity to speak to you today.
Chairman Tom Davis. Thank you very much.
[The prepared statement of Dr. Young follows:]
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Chairman Tom Davis. Dr. Stroube.
Dr. Stroube. Mr. Chairman, distinguished members of the
committee, my name is Robert Stroube; and I'm the State health
commissioner for the Commonwealth of Virginia and honored to be
testifying before you today. I would like to thank the Chair
and the committee for holding this hearing regarding the recent
developments concerning the U.S. influenza vaccine supply.
The recent flu vaccine shortage is creating a serious
challenge for public health. The present system of vaccine
production and distribution is incapable of effectively
responding to the current demand for the vaccine, let alone a
large-scale flu outbreak or pandemic. It is imperative the
Federal Government take steps now to improve our current flu
vaccine production and distribution system.
In Virginia, the health department ordered about 110,000
doses of flu vaccine from Chiron, which we will not receive.
This is almost all the flu vaccine that we typically provide to
adults through 119 local health departments. Not having this
vaccine will mean that many people, especially those at high
risk for flu complications, will not be able to count on their
local health department for a flu shot this year.
At this time, we expect only to receive about 11,000 doses
of adult flu vaccine, but this is a drop in the bucket compared
with the amount of flu vaccine that is needed for those people
in our communities who are most vulnerable to serious
complications from the flu. Any flu vaccine available from our
local health departments will be provided to those people in
the high-risk priority groups recommended by the Advisory
Committee on Immunization Practices this past Tuesday.
The flu vaccine shortage hopefully will not impact the more
than the 115,000 doses of flu vaccine we have ordered from
Aventis for children in the Vaccines for Children program. This
program is for underinsured children, Native American children
and those on Medicaid. But the health department provides only
a very small proportion of the flu vaccine that is provided to
the public. Most vaccines are provided by the private sector.
The biggest difficulty is determining how much flu vaccine
is available in the private sector within our State and how to
advise the at-risk population on where to find any available
vaccine. We do not have a way of tracking flu vaccine
availability in the private sector. We do not have any legal
authority to redirect flu vaccine in the private sector.
We are making every effort to encourage the medical
community to follow the ACIP recommendations and prioritize the
available supply for people in the priority groups identified.
We have distributed information from the CDC to the health care
community through our Health Alert Network. Over 54,000 health
care providers were notified by e-mail or faxed Tuesday night
and Wednesday.
In addition to our outreach to the medical community, we
distributed a Statewide press release urging the prioritization
of available flu vaccine, we have conducted numerous media
interviews, and we have taken hundreds of phone calls from
citizens. We are providing people the best information we have
available regarding this developing situation.
This serious situation is compounded by the fact that we
have gone to great lengths over the past few years to educate
the people about the importance of getting their flu shot each
year. We have not only encouraged people in the high-risk
groups to get their flu shot, but more and more it has been
encouraged for all people.
We had just launched our Statewide education efforts for
this year--prior to receiving the unexpected news from Chiron.
Our education efforts have now been undermined again due to
this situation. For example, we had to cancel our annual
``vaccinate and vote'' campaign, which targets the vaccination
of high-risk individuals on Election Day.
Six upcoming smallpox vaccination dispensing exercises for
a bioterrorism preparedness program are now on hold because we
were going to use flu vaccine to get volunteers to participate
in these exercises.
This current situation follows similar problems we had last
year when we ran out of flu vaccine at the height of the
season. Last year, VDH, the Virginia Health Department,
administered more than 160,000 of flu vaccine to the public,
which is more than double the number of flu shots that we
typically provide.
When we ran out of the flu vaccine last year, many high-
risk patients went without vaccine, parents could not get young
children vaccinated, and health care providers could not
vaccinate their staff. Attempting to prioritize vaccine to
high-risk patients was a local health department nightmare. In
some cases, security was needed to maintain control of
demanding patients.
Now Virginia and other States are faced with the
difficulties of prioritizing a limited supply of flu vaccine
again, even more limited than last year. We anticipate that
many people will go unvaccinated this year.
As you know, only three companies are licensed in the
United States to produce the vaccine. Chiron was expected to
provide about half of the vaccine supply. Aventis is the other
company that produced the flu vaccine for injection. The third
company produces the live attenuated nasal flu vaccine, which
is not targeted for the high-risk patients.
As I stated earlier this year when I testified before this
committee, Congress needs to support the development a of a
more reliable vaccine production and distribution process. The
current year-long process is incapable of meeting increasing
vaccine demands or timely adjustments to vaccine formulation.
The Nation's influenza program must include a comprehensive and
critical look at all aspects of the system, including
production and distribution of vaccine.
The current situation over the past few years caused
concern regarding our ability to address an influenza pandemic
in the United States. Virginia has a pandemic flu response
plan, but that plan cannot be effectively carried out without
having an adequate supply of vaccines and antiviral
medications. We must rely on the Federal Government to assure
this.
In Virginia alone, we estimate that during an influenza
pandemic there could be more 1.3 million outpatient visits,
over 28,000 hospitalizations and over 6,200 deaths in a 12-
week period. The thought of these statistics alone are enough
to make improving the flu vaccine production and distribution
system a high priority.
Given the estimated 36,000 people that die each year in the
United States due to flu, I believe addressing the flu vaccine
production and distribution problem should be a high priority
for Congress. Government must support improvements of the
vaccine production process and consider ways to ensuring that
enough flu vaccine is available.
Thank you for the opportunity to speak to you, and I will
be glad to answer questions.
[The prepared statement of Dr. Stroube follows:]
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Chairman Tom Davis. Well, thank you all.
I would ask unanimous consent to put in the record a letter
from a Mr. Victor Schwartz talking about his concerns about
product liability issues for a national vaccine strategy.
And Mr. Waxman wanted to put in the record a letter to
Secretary Thompson signed by Evan Bayh and Rahm Emanuel.
Without objection, those will go into the record.
[The information referred to follows:]
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Chairman Tom Davis. Let me start the questioning.
Dr. Young, on MedImmune, it just was called to my attention
in terms of what NIH was telling some of their employees about
the FluMist for some of their health care workers. For healthy
people who don't fall into those vulnerable areas, FluMist is
about all we are going to be able to get this year. What level
of protection does that give, and if you are a health care
worker or a vulnerable population, why isn't this used for
them? Can you explain that?
Dr. Young. Currently, because of the body of data we have
from our clinical trials, supports the use in healthy 5 to 49
year olds. That is where the FDA approved it. We have done
numerous studies in younger populations, older populations----
Chairman Tom Davis. Your 5 to 49-year-olds. Vulnerable
population is 65 and over?
Dr. Young. Absolutely.
Chairman Tom Davis. That leaves me out. What do you do if
you are 55?
Dr. Young. Although we have done studies----
Chairman Tom Davis. If you are a 55-year-old healthy guy
where does that put you?
Dr. Young. You know, I ask the same question. I am 51 years
old, and I ask why should I not be able to receive FluMist when
my 49-year-old peer can. I certainly don't believe that I am at
any worse risk to receiving----
Chairman Tom Davis. This was just in clinical trials.
Dr. Young. That is right.
Chairman Tom Davis. There is no evidence that it doesn't
work. It is just that is where it has been----
Dr. Young. Well, in fact, we have--our original clinical
trial was in adults up to age 64. It is an interesting
situation where, when we went to the Vaccine Advisory Panel of
the FDA the first time, 4 years ago, they actually recommended
approval for all adults up to age 64. In the meantime, 2 years
later, 50 to 64-year-olds had become a recommended population
for the vaccine. When the committee was asked again, should
this be approved now for 50 to 64-year-olds, we were in a
double jeopardy situation, and they said, well, we think it is
safe, but we can't be sure that the efficacy has been
demonstrated sufficiently to recommend approval.
We had actually gotten the reverse message from the FDA on
that. They thought that we needed more efficacy data when, in
fact, there is no--all of the evidence from the clinical trails
suggests it is just as efficacious in that segment as in the
lower population, adult population segment.
So I think we need to relook at that, particularly in a
situation where last year we were recommending that 50 to 64-
year-olds are a high risk population and yet now we are saying
that they shouldn't get it, when in fact we may have a vaccine
that could be useful in that population.
Chairman Tom Davis. Now, based on last year's sale, you
produced a smaller supply of flu vaccines this year, is that
right?
Dr. Young. That is correct.
Chairman Tom Davis. Does the vaccine shortage this season--
will that affect your decision next year? And is there any way
you can cook up a larger batch this year or it is too late?
Dr. Young. As I mentioned in my testimony, we actually had
some additional unfilled product in inventory in freezers,
which we are now thawing out and re--and filling to provide
potentially another million doses of vaccine. But we can't ramp
up de novo new additional supplies beyond that.
Whether it will influence us to produce more vaccine
remains to be seen. We still have a lot of questions in the
marketplace, a lot of confusion.
Just this morning you heard Dr. Gerberding report about the
revised recommendations that came out 2 days ago suggesting
that healthy health care workers and those who care for young,
young children should be encouraged to use FluMist. While she
was testifying to that, the NIH put out a memo to their
employees saying they should not, in their hospitals, should
not receive FluMist. So again adding to the confusion that the
agencies are putting out different mixed messages out there to
the constituencies.
Chairman Tom Davis. OK. Thank you.
Ms. Grant, you mentioned in your testimony that demand
drives supply. What can the government do to help ensure that
the demand for the annual flu vaccine is predictable? We do
that for farmers. I mean, vaccine is pretty important.
Ms. Grant. Well, I am going to start with a nonfinancial
incentive first. That is to make sure that we are all pulling
in the same direction in looking at the groups that aren't
getting immunized. Only 67 percent of the seniors are getting
immunized today, and yet we all know that is a recommendation.
So that we can work with our agencies that care for Medicare
patients, only 37 percent of our health care professionals in a
year are getting immunized. They, obviously, are role models as
well as needing to protect themselves. So we need to pull
together to make clear year after year that we aren't anywhere
near meeting the Healthy People 2010.
I think the other issue, a financial incentive that needs
to continue to be discussed and reviewed, is you heard about
the strategic stockpile this year. Certainly that has turned
out to be a wise investment that CDC thought of planning for,
having a few million extra doses; and that is something which I
would encourage your committee to continue to look on
favorably.
Now a little of a good thing goes a long way, and then we
have to balance to make sure what the appropriate sizing of
such an annual strategic stockpile would be so we don't risk
throwing away excessive doses. But those two approaches would
help drive demand, which will drive supply.
Chairman Tom Davis. Thank you.
Mr. Kanjorski.
Mr. Kanjorski. Thank you, Mr. Chairman.
Mr. Chairman, I have the great honor and privilege of being
the Member of Congress representing Aventis in the Poconos in
Pennsylvania. I have had the occasion to be at the plant on
numerous occasions where 1,700 of some of the most highly
qualified people are working day and night to provide
protection not only for the influenza but other necessary
vaccines.
My impression, having been there and met with the officials
of that organizations is that their first mission is to meet
the needs of the American population and the world population
to fight infectious diseases such as influenza. It seems to me
they have the capacity to do so.
They are frustrated, if I may say, that government has not
participated in the best way to get that done. We talk about
it. We have hearings on it. I think, as the Secretary referred
and the other gentleman on the panel, that nothing seems to be
accomplished.
It seems that the Congress has hearings when we find out a
disaster such as this occurs, but after that we all go home. I
dare say we won't have another hearing on vaccinations or
vaccines until the next terrorist attack or other such pandemic
occurs in the world, and we will all come in here, rub our
hands, and say why didn't we all prepare for this, when all of
the three witnesses today that are appearing at this panel, and
the three earlier witnesses, are telling us out that there are
things we can do to make sure that we smooth out the line for
demand, that we anticipate future needs, that we anticipate
pandemics and that we prepare to meet those challenges at
relatively small cost.
I think I heard the figure of $100 million for a plant, and
I think I have heard in the past maybe $1 billion of investment
and other incentives to this industry would really bring us up
to high speed to prepare for whatever we need at the highest
technical response that science can give us and industry can
give us.
I did a little calculation, and that was part of my
antagonism toward the first panel. I am sure they are capable
and doing the best they can. But what you are talking about, if
it were $1 billion, it would cost us only 2 days of the cost of
the Iraq war; and we are talking about the risk of 300 million
Americans and 6 billion people in the world.
When you will look at the numbers in any regard and the
lead time necessary to meet these challenges, the expenditures
of 2 days of the Iraq war or a week of the Iraq war is
miniscule. That money I think could be made available by the
Congress, and probably there is a full intent to do so, except
we have pretty terrible communication between the executive
branch with a plan, the Congress with a response of priority,
and then the people that are going to do the work, the private
sector in this country and all around the world, that seem to
be left out except when they run into a problem or we have a
problem. Then we have this tremendous partnership that joins
for these few days to soothe the American population so that
everybody can go home and think that we are prepared. We are
neither prepared for a world influenza epidemic, and we are
certainly not prepared for a biological attack.
So, with all of this criticism, Mr. Chairman, it is not
without a suggestion. I have enjoyed all of my visits to
Aventis. I think they would entertain either this full
committee or a representative portion of this committee to come
up to the great Poconos Mountain areas for a day or two, show
you what they do, show you what the industry does, show you the
lack of coordination and cooperation between government and the
industry and our various regulatory authorities and that we can
walk away in 24 or 48 hours with an actual knowledge of what
has to be done by this Congress and the executive branch of
this government to really put a coordinated response to the
challenge of viral and bacterial infections in the United
States. I highly recommend it.
Now I know I have a few minutes left.
Chairman Tom Davis. I will ask the staff to look at the
that, too.
Mr. Kanjorski. It is my invitation. Come on up there. You
will enjoy it.
Chairman Tom Davis. It will certainly be better for me than
the last time that I was in your district.
Mr. Kanjorski. I agree with you, Mr. Chairman.
Mr. Chairman, Ms. Grant represents Aventis here. I just
want to throw the question: What do you think the government
has to do to help your company and other companies meet these
challenges, not only of influenza but biological attack? What
do we have to do? And lay it out and be candid with us.
Ms. Grant. Well, thank you, Mr. Congressman; and we are
equally honored to have you and your capable staff representing
our employees and our district. So I thank you.
I would say we certainly welcome the committee's visit to
the great State of Pennsylvania and the wonderful Poconos. You
might want to consider doing it before the snow sets in, but--
or after--but we would love to have you up there.
Congressman, I had mentioned five recommendations; and I
will just reiterate two at this point.
First of all, it is the kind--a little kind of thing that I
mentioned. And that is, for some reason, there are SEC
accounting guidelines that just popped up in the last year or
so which suddenly have created inconsistencies with the
language that CDC has been using quite successfully with our
and other companies for many decades to build strategic
stockpiles. So it is like the old adage of, but for the nail in
the horse's shoe, the battle was lost. So this little thing,
which seems certainly within the purview of this committee, to
perhaps talk about getting those two agencies together to see
if we can't work that out.
The second issue, the very important issue you mentioned,
planning for pandemic. CDC, through the National Vaccine
Program Office, has just put out a draft plan for pandemic. We
would strongly encourage this committee to think about the need
to prepare now for the inevitable vaccine liability concerns
and exposure that are going to emerge when any company in the
world is asked to prepare a pandemic vaccine that by its very
nature will not have had years of clinical trails and
experiences.
What we are saying is we need to bring that issue to your
attention. We need to work with you to make sure that we
balance compensation and liability concerns so you are not
disappointed when the companies point out that they just can't
get in the business of working on the pandemic vaccine when we
are in the middle of the pandemic.
So those are two of the five that I bring to your
attention.
Chairman Tom Davis. Thank you very much, and thank you for
what your company is doing.
Mr. Cooper, thanks for your patience.
Mr. Cooper. If we focus on the short-term concerns for a
second. The earlier panel discussed the possibility of being
able to halve the dose so that twice as many people could
receive the vaccine or the FluMist. What are the practical
obstacles to making that happen, assuming that you got FDA
approval for that?
Ms. Grant. I am sorry, sir. As Dr. Fauci said, that is
certainly something that--I am not sure it is a short-term
solution. Because here we are in the midst of a season where we
are already being advised by the public health authorities not
to go the route of immunizing healthy individuals; and, as you
heard, the trials done to date have been on healthy
individuals. So while I believe my medical colleagues would
suggest that there may be some promise in looking at that, it
is probably too late this year to really think that is going to
solve our problem.
I would be happy to ask my colleague, Dr. Johnson, to
comment if he wishes.
Dr. Young. If I can make a comment to that. I think the
biggest concern is that there is concern now that the
injectable vaccine doesn't work as well in the elderly as their
immune system starts to decline with age. So the thought of
halving a dose in a population which is currently thought to be
suboptimally responding to the vaccine----
Mr. Cooper. So your product is for the healthy, 5 to 49,
and could you halve the dose there?
Dr. Young. Actually, half the dose would still fall in the
specification for the vaccine.
Mr. Cooper. So you could do it?
Dr. Young. The problem is that then you would have to
adjust the shelf life to make it a much shorter half life so it
doesn't fall below that spec over time. So unless the vaccine
is used very quickly, that would be a problem.
Mr. Cooper. But FluMist could probably do it, if you got
FDA approval?
Dr. Young. Unfortunately, there is not a lot of data that
supports being able to do that.
Mr. Cooper. I said if you got FDA approval.
Dr. Young. Certainly.
Mr. Cooper. Second question. A number of jurisdictions
across the country unfortunately ordered only from Chiron. What
do we tell those jurisdictions that basically have no flu
vaccine at all right now?
Ms. Grant. As Dr. Gerberding said, literally Tuesday
morning, as Blackberries were being worked at another hearing
and the impact of this announcement became known, our company
began to work with her staff to being to understand which
States, particularly the public health sector, although it only
buys about 10 percent of the vaccine, is and is not--does and
does not have access.
As you heard, and I would like to reiterate, what we are
working on together is to figure out where there is lack of
coverage and then do the best we can. As she said, it won't be
perfect, but the pledge is to try to make sure that we are able
to provide some vaccines to all public health sectors.
Mr. Cooper. Let me put in a word for Nashville, TN, because
it is my understanding that none of our hospitals in our city
were able to get any vaccines. So it would be helpful there.
Third, for Aventis. When you sell the vaccine to a
distributor, are there any safeguards against price gouging in
the contract?
Ms. Grant. OK. Well, in the case of a distributor, by their
very nature, they intend to sell it on. So as far as our
contract goes, we do not, per se, have controls over the price
they charge.
I will say, however, Congressman, that as both an attorney
and as a former health commissioner, I am well aware of the
price--I think we should all be aware of the price-gouging laws
that exist in every State and certainly our company would find
that--any kind of price-gouging behavior absolutely outrageous
and would encourage, if we hear from any customer or patient,
to contact their local authorities to find out what their
remedies are.
Mr. Cooper. How would you define price gouging? As a
doubling of the price? What would it be?
Ms. Grant. That is an interesting question. I really
haven't thought about it to begin to volunteer a standard. But
that might be one of those things that we would know when we
see it.
Mr. Cooper. I think we are going to have a hard time
reporting it unless we give them an idea of what the standard
would be. If they don't know what they are going to report, you
know, what is--what does the average vaccine sell for?
Ms. Grant. Well, I will just say that our company has made
very clear--our prices are known. It would be visible.
Mr. Cooper. What is the price?
Ms. Grant. As was suggested, in general, it varies by the
customer class and the type of vaccine. In general, this year
it is between $8 and $10; and then the pediatric vaccine, the
list price is about $12 a dose.
Mr. Cooper. So if customers were to see, $20, $25, that
would be a doubling of the price; and that might count as
gouging.
Ms. Grant. A customer certainly might want to ask questions
about that.
Mr. Cooper. There are a lot of other long-term concerns.
I appreciate everyone's testimony. I think you have given
this panel and Congress a lot to think about; and hopefully we
will be able to respond not only to this sort of problem but
also a possibly larger problem, should bird flu or things like
that come to the fore. Thank you very much.
Chairman Tom Davis. Thank you.
Mr. Van Hollen, thanks for your patience.
Mr. Van Hollen. Thank you, Mr. Chairman. I also want to
thank all of the witnesses for their testimony; and, Dr. Young,
thank you for your testimony.
MedImmune is in my congressional district, Mr. Chairman,
right here in Gaithersburg. So I think when we are planning
that trip, Mr. Chairman, I just want to--we should make sure we
stop in Gaithersburg, which is, of course, very close by here.
I am sure that the company would be happy to have the committee
visit.
Let me ask you, Dr. Young, or anybody else, but you in your
testimony talked about the fact that there were a number of
children last year who died of the flu who would have been
eligible to receive FluMist. You were here I think for the
testimony of Dr. Gerberding, and she was very reluctant to
answer the question: What will be the direct health effect of
this shortage that we are facing now in terms of the numbers of
deaths and the number of people hospitalized? And her answer
was we can never predict the severity of the flu season and flu
strain.
I understand that in terms of absolute numbers. But in
terms of percentages, you know, given a particular flu season
and the severity of that, do you have any estimate as to what
this crisis is going to mean in terms of additional lives lost
in this country?
Dr. Young. I think it is very hard to come to a precise
number, and it all depends on how well the available supplies
of vaccine are deployed to the highest risk individuals.
Clearly, if we can continue to administer the available
vaccine in that highest-risk elderly population, then clearly
we can avoid a fair number of deaths, much like previous years.
Mr. Van Hollen. Right.
Now, I guess the question--maybe this was asked earlier.
But Aventis has obviously got contracts with certain providers
already; and some of those, I assume, were providers who were
going to be providing the product to people in the healthier
range who would be eligible for FluMist. I guess the question
is whether or not there is any discussions under way where we
would redirect the Aventis product, which has been cleared for
the broad age group, to the people at most severe risk and
allow FluMist to be directed to those in the healthier age
range.
Ms. Grant. Well, I hope I gave the right figure about 33
million of our vaccine doses have already been distributed; and
they certainly were, I am sure, sold to customers caring for
all different populations.
You heard Dr. Gerberding say that, as we speak, our people
are working with her people to figure out, certainly at the
county level, where vaccine is. So I think we are always open--
I mean, that will be, of course, a matter among the health
providers at that level. The sheer scale--it would be unwise to
promise too much because the sheer scale of the difference
between the vaccine that we have produced and what under the
best of circumstances can be available from FluMist won't solve
the problem. But we will work together through CDC.
Mr. Van Hollen. Let me ask you. You mentioned Dr.
Gerberding and the fact that you are in discussions with some
of your--the people you provided the product to and trying to
figure out where it is and how we can get it to the most at
need and risk populations. Has there been any reluctance on the
part of Aventis to provide that information to public health
officials at the county and State levels?
Ms. Grant. I wouldn't characterize--I think the cooperation
has been terrific. As I understand and in personally talking
with her and in personally talking with our CEO who has been
working with her, we are trying to do everything the best we
can.
We are suggesting that there are some ways--just last year
when we faced the late season surge demand and there was sort
of the first instinct to, well, let's know where all of the
vaccine is, having worked in the field for some 30 years our
people knew that a lot of that vaccine had already been
distributed. So that probably the first instinct should be
let's ask people what they still have. Rather than trying to
set up an enormously elaborate information system, sending
things out, wondering why we are not hearing back, just go out
to people generally and say, if you have vaccine, please
contact your local health officers. And that was actually
rather successful.
So I don't think it is a question of reluctance. I think it
is question of talking through practically what are you likely
to get in the way of the best response to solve the problem.
And that is as I understand where we are.
Mr. Van Hollen. Good. Now I understand that with respect to
the FluMist, because of the whole range of issues you discussed
in your testimony, you didn't plan to produce more this year;
and given the production times, it is just not feasible to do
more than an additional million doses. Is that----
Dr. Young. That is absolutely correct.
Mr. Van Hollen. Dr. Fauci testified about some very, very
important and good long-term options, but as we discussed the
short-term options, I think your testimony is pretty clear. It
is not so much in terms of our ability to generate more
vaccine. It is a question of just using what we have and
redistributing it.
Dr. Young. Oh, yeah. If you look at the long-term planning
that goes into supply requirements, it is years of planning. We
have long-term 3-year, 4-year contracts with the egg producers
to make sure that we have adequate supplies of substrate we
need to grow the vaccine. Once we finish our campaign and stop
making vaccine, the egg supply dries up; and, consequently, we
can't go back and manufacture more product in a rapid response
mode. So we have to really understand up front where the demand
is going to be in order to ensure that we have adequate
supplies on hand.
Mr. Van Hollen. All right. Let me just ask one more.
In previous years, as I understand it, individuals in the
50 to 65-year range were also defined to be at high risk, is
that right?
Dr. Young. That is correct.
Mr. Van Hollen. So when we get the list now of who is a
high-risk group, it is really not based on a health decision.
It is saying, here is the doses we have available, these are
the people most at risk, but that those other individuals in
this other age category, in terms of health analysis, they
continue to be at risk as much this year as they were last
year, right?
Dr. Young. Absolutely. It is basically a triage system to
say, with limited supply, who can we prioritize and ensure that
we have the least--the greatest benefit for the amount of
vaccine we have. And that is--it is a very difficult decision
to have to say to someone, last year, you--we told you to get
the vaccine. This year, we are telling you not to get the
vaccine.
Mr. Van Hollen. Thank you very much.
Chairman Tom Davis. OK. Any other questions?
Mr. Van Hollen. No.
Chairman Tom Davis. Thank you all very much.
I know Ms. Blackburn is on her way over, so I am going to
ask a couple of other questions as well.
Dr. Stroube, let me ask you: For those individuals who
don't fall into the high-risk priority group for the flu
vaccine, what precautions can they take to reduce their risks
of contracting the flu?
Dr. Stroube. Well, what we put out in--I was trying to find
my press release so I can tell you exactly what we are telling
people. It is, basically, wash your hands if you have--anytime
you think about it, anytime you have been with somebody or if
you have a runny nose, to keep from spreading, to use good
hygiene, to avoid--if you are sick with the flu, going in
nursing homes, around people who are ill. Those are the type of
recommendations we are making.
Chairman Tom Davis. Now, washing the hands, that is not--
how does washing the hands help? Because your hand comes in
contact with your face and everything else?
Dr. Stroube. You rub your mouth and eyes, and then you have
picked it up on your hands and you are transmitting it back to
yourself.
Chairman Tom Davis. So washing your hands frequently would
be one thing.
Dr. Stroube. That is one thing. That is a traditional
public health message for all kinds of things. But that is one
of the things that we are stressing.
Chairman Tom Davis. What are we trying to do in Virginia
since the British supply is now canceled for us? Are we going
to try to work with the Center for Disease Control and Aventis
and try to get some of that released for our vulnerable
population?
Dr. Stroube. Well, yesterday we had a video conferencing
with all of our health directors all across the State and their
staffs; and we are trying to find out what is going on from
southwest Virginia, northern Virginia, the whole place, and
come up with some consistent policies for the State. So we put
a freeze yesterday on the vaccine we did have until we can sort
out where it is and make sure it is equitably distributed.
Some of our local health departments got vaccine directly.
Others didn't. So we want to try to do that. We want to come up
with some knowledge of where the most needs are.
Yesterday, we were overcome, overwhelmed with nursing homes
calling in and said they were relying on getting the vaccine
from Chiron and don't have it. So we have to sort out who has
vaccine, who needs it, and then figure out how we can match
that up. And some will need persuasion, hopefully moving some
of the vaccine that people have and using their good will to
let us take it to other places on it.
We were actually hoping that we would be able to do more
with the halving of the doses, but that doesn't look like it is
going to be viable.
Chairman Tom Davis. How do private doctors get it? Do they
get from the State or contract individually?
Dr. Stroube. In Virginia, they contract directly with the
distributors on it.
Chairman Tom Davis. Are you coordinating with them, too, to
see what they have available, what doctors might----
Dr. Stroube. Exactly. We sent out--like I was saying,
54,000 e-mails and faxes went out late Tuesday, early Wednesday
to all of the health care providers. We have a law in Virginia
now that requires that to provide their e-mail and fax to us,
and we have that in a data base. We sent it out urging them to
work with us, and we will be following up on that, trying to--
at a local level, that will be passed off to our districts.
Chairman Tom Davis. Thanks. Let us know how we can help.
Obviously, you learn from what has happened this year, and we
just want--we don't want a reoccurrence, but we have to get
through this year as well.
Mrs. Blackburn.
Mrs. Blackburn. Thank you, Mr. Chairman; and I want to
thank our panel for being here, all of the witnesses that have
participated today.
In my State, in Tennessee, this is something that is
important to us; and we are, of course, concerned about our
supply, just as everyone else is. We have two suppliers, Chiron
and--does about a third of the supply, and then Aventis does
about two-thirds of the supply.
My question, Ms. Grant, is to you. You mentioned in your
testimony, in your written statement, that demand drives the
supply and what can the government do to help ensure that the
demand for the annual flu vaccine is more predictable each
year? Because one of the things that concerns me, and this is
the reason that I asked the question of you, is it seems that
so many times, regardless if we are looking at public health
policy or we are looking at operational policy for governmental
entities, whether it is the Federal, State or local entity, we
are more reactive than proactive; and we fail to plan. We think
in short-term segments and not long-term segments.
We know that you all have said--more than one of you have
said in your written statements in your testimony that it takes
from 5 to 7 years for a new company seeking to locate in the
United States to be able to provide that vaccine. So, you know,
I want you to, if you will, talk for just a moment about
process and what we can do to do a better job with the
predictable nature of what we would need each year.
Ms. Grant. Well, as I mentioned in a couple of the
recommendations, that it is very, very important that we all
speak with the same language consistently, that despite the
occasional setback, as we clearly are going to face this year
which is frustrating to all of us, that we have to all agree
that we are going to pull together to continue to recommend to
the various risk groups the importance of being immunized.
And it is interesting, in Tennessee, I know that they are
taking very seriously something that wasn't taken seriously a
couple of years ago, and that is the importance of using
standing orders when people are admitted to hospitals or
nursing homes to make it very easy and routine. That is a
process. It is a simple thing, in a sense. It is not so simple
to execute it, but it is a simple thing to ensure that every
single patient who is a resident of a nursing home or hospital
year in year out is offered influenza vaccine.
There are millions of those patients, and that would have a
profound affect on a certainty that demand--if all hospitals in
all States we knew would do that, we would know how much more
vaccine is likely to be utilized.
We talked about the health care workers, only 37 percent.
If we had a common understanding that health care workers are
ready, willing and able to--and interested in protecting
themselves and their patients by being immunized.
So there are many individual things that we can do.
I mentioned the strategic reserve. Again, while the
strategic reserve is not the total solution, the predictability
of the government working with us collectively to think about
what is the appropriate amount to guarantee that the government
sector is interested in buying--we are not looking for that to
be the total solution. It is a private market. It is working
reasonably well. But those are a couple of very important
things that we can start talking about.
Mrs. Blackburn. Thank you.
Dr. Young, I would like to hear from you and then Ms. Grant
talking about, with a company who wants to locate, wants to
create a flu vaccine and the 5 to 7-year window of time--which
I think really is pretty optimistic if you are looking at it.
But knowing the demand for vaccine is not going to be
decreasing, it is going to increase, talk for a moment, if you
will, about what you think that we should be looking at to
shorten that window of time to create some efficiencies within
what is a very heavily bureaucratic system which makes it very
difficult for anyone who is doing R&D work or creating a
vaccine to walk through that process. I would love to hear your
thoughts on that.
Dr. Young. It is a very complex issue, to say the least.
Clearly, the vaccine business--the entire pharmaceutical
business is highly regulated, as it well should be, to protect
the safety of the public who receives these vaccines and drugs.
So, clearly, very stringent standards have been established for
current good manufacturing practices; and it is quite clear
that it takes significant investments to meet those standards
to design, construct, validate. We have to demonstrate that the
process works reproducibly within certain parameters, time in
and time out, to assure the quality of the product.
It is particularly significant when you start talking about
biological products like this. It is not like chemical
processes that are very easy to control and maintain strict
control over the parameters of production. It is the
manufacturing of biological products that become very labor
intensive and testing intensive to ensure the high quality of
that product.
So, unfortunately, there aren't really any easy shortcuts
building a plant, designing a plant, and then validating and
operating that plant. We have to put in some very strict
standards to ensure the reproducibility, the safety and the
potency of that product time in and time out; and,
unfortunately, there aren't just any shortcuts to doing that.
Mrs. Blackburn. Ms. Grant.
Ms. Grant. I would say certainly, as a company, we are used
to planning 5, 10 years out. So while it is a long timeframe,
the most important thing I would say for the government and
this committee to think about right now are two or three things
not to do. To tell our management and our shareholders in the
world that we should continue to increase our capacity, which
we want to do at Aventis, we have to make sure that the
government is not going to chill our interests. So two things I
would not do.
I would not think about what is sometimes described as the
GOCO, or the government-operated facility. That is not what we
are looking for in the way of competition. We are looking for
healthy private sector competition, and we will welcome that.
I think the second issue is the notion that we are sort of
skirting around today, some of the taking issues. We would like
to say that the first order of business is to really work
collaboratively with the public sector to make sure that we get
through tough situations and seasons without sort of jumping to
more Draconian solutions.
It is always very welcome to have Congress work with State
officials on environmental issues to make sure that, while we
never compromise safety or other standards, that, nevertheless,
that things--we work together and know that we want to get
there in the next few years and work out those issues.
Mrs. Blackburn. Thank you. Thank you, Mr. Chairman.
Chairman Tom Davis. Thank you very much.
Just a couple of last questions and we will let you go.
Ms. Grant, it is already October. Soon you are going to
begin the process of developing and producing a new flu vaccine
for next year. What does this do to avoid the shortages next
year and the contingency plans, and we are not even sure that
Chiron will be producing next year at this point. How do you
factor that in?
Ms. Grant. Well, certainly everyone in our company is very
concerned about that type of issue; and I can only finish by
repeating the pledge that we are taking into account all of the
information in the environment, just as this year. We are
seeing how we can optimize, maximize our production capability.
This will certainly influence, as we hear more from the
government over the next month or so, what we can do. We do
have a certain maximum capacity. We are scraping up against
that. But we are going to do everything possible to make sure
we maximize.
Chairman Tom Davis. Easy for me to say, but then all of a
sudden, if everybody else gets in the business and you are
stuck holding 40 million shots, then it hits you financially.
So isn't that part of the equation?
Ms. Grant. It is a factor. And I just would say that is why
we have to work together to make sure that we continue to
increase the demand so that we always feel comfortable our
ability to sell increased supply is justified by seeing the
demand will be there.
Chairman Tom Davis. Well, we appreciate what you are doing.
I am glad you are here. You are our saviors this year.
And, Dr. Young, that goes for your company as well. Same
answer that I just talked about in terms of capacity for next
year.
Dr. Young. Absolutely. I mean, I think we have to look at
the overall situation. Clearly, if more vaccine were available
and the recommending bodies would be more proactive in trying
to promote the use of the vaccine--just like this year. They
have cut back on vaccine when it is--the recommendations in
terms of who should get it, to prioritize who gets the vaccine
in the event there is excess vaccine, they ought to be going in
the other direction and saying, look, we have extra vaccine. We
ought to be using it more broadly in kids. Only 10 percent of
kids get vaccinated now. We ought to be pushing that in that
event in order to spur more demand.
Chairman Tom Davis. 36,000 deaths, that is a lot of people
that could have probably been--any of those been vaccinated? I
mean, these are the people who don't get vaccinated for the
most part, right?
Ms. Grant. It certainly is an issue. We knew last year that
most of the children, sadly, the pediatric cases that resulted
in death had not been vaccinated. So the public needs to
understand that it is a very serious disease in the elderly and
the young children and make sure they are immunized.
Chairman Tom Davis. Guys like me and Dr. Young, I guess we
just keep washing our hands.
But thank you very much, both of you, for what you are
doing. Dr. Stroube, thank you for your leadership at the State
level. Let's work with you every way we can in the
Commonwealth.
With that, the hearing is adjourned.
[Whereupon, at 1:35 p.m., the committee was adjourned.]
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