[Senate Hearing 111-876]
[From the U.S. Government Publishing Office]
S. Hrg. 111-876
THE SWINE FLU EPIDEMIC: THE PUBLIC HEALTH AND MEDICAL RESPONSE
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
ON
EXAMINING THE SWINE FLU EPIDEMIC, FOCUSING ON THE PUBLIC HEALTH AND
MEDICAL RESPONSE
__________
APRIL 29, 2009
__________
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
EDWARD M. KENNEDY, Massachusetts, Chairman
CHRISTOPHER J. DODD, Connecticut MICHAEL B. ENZI, Wyoming
TOM HARKIN, Iowa JUDD GREGG, New Hampshire
BARBARA A. MIKULSKI, Maryland LAMAR ALEXANDER, Tennessee
JEFF BINGAMAN, New Mexico RICHARD BURR, North Carolina
PATTY MURRAY, Washington JOHNNY ISAKSON, Georgia
JACK REED, Rhode Island JOHN McCAIN, Arizona
BERNARD SANDERS (I), Vermont ORRIN G. HATCH, Utah
SHERROD BROWN, Ohio LISA MURKOWSKI, Alaska
ROBERT P. CASEY, JR., Pennsylvania TOM COBURN, M.D., Oklahoma
KAY R. HAGAN, North Carolina PAT ROBERTS, Kansas
JEFF MERKLEY, Oregon
J. Michael Myers, Staff Director and Chief Counsel
Frank Macchiarola, Republican Staff Director and Chief Counsel
(ii)
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C O N T E N T S
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STATEMENTS
WEDNESDAY, APRIL 29, 2009
Page
Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio,
opening statement.............................................. 1
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming,
opening statement.............................................. 2
Dodd, Hon. CHristopher J., a U.S. Senator from the State of
Connecticut.................................................... 4
Prepared statement........................................... 5
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina....................................................... 7
Prepared statement........................................... 8
Mikulski, Hon. Barbara A., a U.S. Senator from the State of
Maryland....................................................... 9
Besser, Richard E., M.D., Acting Director, Centers for Disease
Control and Prevention, U.S. Department of Health and Human
Services, Atlanta, GA.......................................... 10
Prepared statement........................................... 13
Fauci, Anthony, M.D., Director, National Institute for Allergy
and Infectious Diseases, National Institutes of Health, U.S.
Department of Health and Human Services, Bethesda, MD.......... 15
McCain, Hon. John, a U.S. Senator from the State of Arizona...... 24
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of
Pennsylvania................................................... 25
Roberts, Hon. Pat, a U.S. Senator from the State of Kansas....... 27
Reed, Hon. Jack, a U.S. Senator from the State of Rhode Island... 29
Merkley, Hon. Jeff, a U.S. Senator from the State of Oregon...... 31
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Response by Richard Besser and Anthony Fauci to questions of:
Senator Kennedy.......................................... 37
Senator Enzi............................................. 37
Senator Murray........................................... 41
Response to questions of Senator Burr by:
Richard E. Besser, M.D................................... 43
Anthony Fauci, M.D....................................... 45
(iii)
THE SWINE FLU EPIDEMIC: THE PUBLIC HEALTH AND MEDICAL RESPONSE
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WEDNESDAY, APRIL 29, 2009
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 3:03 p.m., in
room SD-430, Dirksen Senate Office Building, Hon. Sherrod
Brown, presiding.
Present: Senators Dodd, Mikulski, Reed, Brown, Casey,
Merkley, Enzi, Burr, McCain, and Roberts.
Statement of Senator Brown
Senator Brown. I call the Health, Education, Labor, and
Pensions Committee to order. Thank you all for being here. I
want to thank my colleagues, Senator Dodd, Senator McCain,
Senator Alexander, and Senator Enzi.
Emerging public health threats, SARS, anthrax,
bioterrorism, all of these serve as a wake-up call to bolster
our public health capabilities. Chairman Kennedy and Ranking
Member Enzi exercised over these years swift and decisive
leadership shepherding new legislation to prepare our public
safety and public health care systems to respond to these
threats. We see how important their actions were.
We see now that the possibility of pandemic outbreak is a
very real threat and that if we let our public health
infrastructure falter, it is all of us in this great country
and around the world that will suffer.
I would like to thank Dr. Fauci and Dr. Besser for taking
the time to provide with us an update on the Administration's
ongoing efforts to contain and combat the swine flu outbreak.
Dr. Fauci, who has just done terrific work over the years on
all kinds of public health issues, is with us. Dr. Besser will
testify by video.
Earlier this week, the World Health Organization raised the
influenza pandemic alert level from phase 3 to phase 4 out of
6, I might add, indicating that the likelihood of a pandemic
has increased but not that a pandemic is inevitable.
Domestically we are seeing increases in cases of swine flu.
As of this afternoon, the Centers for Disease Control was
reporting 91 laboratory-confirmed cases of the swine flu in 10
States, including 1 case in my State of Ohio. This morning it
was reported that an infant in Texas died from this flu, the
first confirmed fatality in the United States.
Internationally the situation has become more serious with
additional countries reporting confirmed cases of swine flu.
Yesterday confirmed cases were identified in New Zealand and
Israel, representing the first evidence that this virus has
spread to the Middle East and to the Asia Pacific regions.
Confirmed cases have also been identified in Great Britain,
Canada, Scotland, and Spain.
Today, virtually all cases outside of Mexico have been mild
and sporadic but geographically widespread, suggesting that
more cases will likely emerge. For these reasons, it is
important that Congress examine what efforts are currently
being undertaken to ensure the safety of our citizens now and
what actions are being taken going forward to limit the spread
of this virus and to prevent future outbreaks.
To date CDC and the Department of Homeland Security have
taken aggressive and proactive steps to respond to this
outbreak and protect our Nation's public health. CDC's Division
of the Strategic National Stockpile has already released one-
quarter of its antiviral drugs, Tamiflu and Relenza, personal
protective equipment, and respiratory protection devices to
help States with confirmed cases of swine flu respond to the
outbreak.
CDC continues to issue daily guidance to public health
departments and individuals and families about how to protect
against this disease, what to do if you are feeling sick, and
how best to utilize community mitigation strategies in
responding to the outbreak.
In addition, earlier this week, CDC issued a travel warning
recommending that people avoid non-essential travel to Mexico.
As the scope and extent of the swine flu outbreak become
more clear over the next few days and weeks, it is vitally
important that Congress stay informed about all efforts taking
place to protect our citizens and our families.
It is also important that Congress work to ensure that
Federal agencies responsible for leading our Nation's efforts
against this outbreak have the resources and the funding
necessary to do their jobs and to protect our people.
I am anxious to hear from our witnesses about the magnitude
and extent of this outbreak, what we should expect in the
coming days and weeks, how best our citizens should protect
themselves, what efforts are currently underway to fight this
deadly outbreak, what plans and infrastructure are in place
should the situation worsen, and how we can help you and them
do their jobs.
The Senator from Wyoming, Senator Enzi, for his opening
statement.
Opening Statement of Senator Enzi
Senator Enzi. Thank you, Mr. Chairman. Because of the
urgency of the information, I was not going to give a
statement. I was going to introduce Senator Burr to do one on
our side so that there would only be one on our side, but since
he is not here, I am going to go ahead and do the statement.
We are facing the early stages of what may become a global
pandemic and infection. We are calling it H1N1 so that does not
affect the pork market. It is being referred to everywhere else
as swine flu, and it has claimed 100 lives in Mexico. Other
countries, from Canada to New Zealand, have confirmed cases.
This disease does not know any borders.
While the World Health Organization has yet to declare a
pandemic, the early information on the flu bears eerie
parallels to the 1918 pandemic. That virus took a devastating
toll on the United States and other nations, ultimately killing
50 million people worldwide.
To prevent the flu from becoming the next pandemic and to
ensure the health and safety of Americans and individuals
around the world, we will respond aggressively to this threat.
Our agencies must work closely together and with our global
partners to stop the threat of the flu, to help individuals who
may be infected find the right treatment as early as possible.
Over the last 5 years, Congress and the previous
administration have taken actions to prepare our country for
potential disease outbreaks and other public emergencies. In
particular, I do want to single out and thank Senator Richard
Burr for all he has done to make sure that we are better
prepared today for this potential crisis. He and his staff put
in months of hard work to craft the Pandemic and All-Hazards
Preparedness Act that has put in place the important tools that
are now allowing us to respond to the swine flu outbreak.
Senator Burr's legislation provided the authority to purchase
50 million treatments of Tamiflu, which has so far been
effective in treating swine flu. It also helped promote the
development of new diagnostic tools to quickly evaluate to see
if illnesses are related. Other countries are now relying on
those technologies for quick testing.
In addition to expanding our Nation's supply of flu
therapies and increase in global supply of diagnostics, Senator
Burr has established the Biomedical Advanced Research and
Development Authority, also known as BARDA, which provides
Federal coordination for the development and procurement of
vaccines, drugs, therapies, and diagnostic tools for public
health emergencies.
His legislation also enhanced coordination procedures, and
now the Centers for Disease Control and Prevention, CDC, is
working closely with the State and local public health
departments to train and prepare communities to respond to
public health emergencies.
It has been my experience that we in Washington seldom work
on a solution ahead of time, and it is even rarer that what we
work on turns out to be needed and we got it right. To that
extent, I think we are better prepared to deal with this crisis
today, and Richard Burr deserves much of the credit. This whole
committee worked on it, and I can remember watching the
negotiations as we finished it up so that it could actually be
signed by the President. A tremendous effort by the people on
this committee, and again a bipartisan, very cooperative
effort.
Although the United States is more prepared for pandemic
flu today than ever before, there are still gaps in the system
and we have to fill those to ensure that States are able to
respond quickly and effectively. We have to continue to prepare
for another pandemic flu outbreak like the one in 1918 but, of
course, with better communication, but also more transportation
which enhances the problem--by funding research to find newer,
better, less resistant treatments.
While I am reassured by the fact that our public health
monitoring system was able to catch the outbreak early on, I am
concerned about the ability and capacity of CDC and local
communities to test and treat for swine flu, should this
outbreak continue to spread and come back in the fall even
greater.
I welcome our two doctors today to testify, one by high
technology and I am looking forward to seeing how CDC and NIH
will work together to prepare for the flu and what actions they
are taking in response to the H1N1 flu outbreak. We need to be
sure we are doing everything in our power to bring attention to
the global threat and stop the spread of the flu before it
becomes a pandemic. I look forward to the testimony today.
Senator Brown. Thank you, Senator Enzi.
Senator Dodd.
Statement of Senator Dodd
Senator Dodd. Well, Mr. Chairman. I will ask consent that a
statement be included in the record because I know we have got
our witnesses here and a good participation by members.
I see Richard Burr, my colleague, has arrived. I remember
those long days we spent in Bill Frist's office, you and I and
Senator Kennedy--Mike Enzi was there--and working on it. I
mentioned yesterday on the floor of the Senate the important
work you did in that effort. We appreciate it very, very much,
and we are in better shape today because of those efforts, and
they deserve to be recognized as well.
Mr. Chairman, in fact, I live in a very small town in
Connecticut, and there is a suspected case, not yet confirmed,
but just in a small town on the Connecticut River where they
closed the high school yesterday. They are going to open up
again, soon, after cleaning it thoroughly. This has reached all
across our country. While not every State has been affected
yet, there are certainly legitimate concerns that it could
spread very, very quickly. So it is important we have a good
briefing here by our two very distinguished witnesses to share
some thoughts on this.
One issue I would like to raise--Ted Stevens and I offered
a piece of legislation last year on paid family medical leave
and, as many of my colleagues know, spent a long time years ago
drafting the Family Medical Leave Act. It became law in
February 1993. It is unpaid leave, obviously. Some 60 million
Americans have been able to use family medical leave.
One of the concerns we have here is that, obviously, as
people stay out of work, the lack of contact could be really
very important. I presume Dr. Fauci and others will share with
us steps people can take. For an awful lot of people, one out
of three Americans, they just cannot take unpaid leave. It is
just difficult. They cannot afford to do it. I raise that only
because it is an example like this where we need to be
thinking. Senator Stevens and I worked on a proposal that
involved both employees, employers, and others so as not to be
overly burdensome on employers to talk about paid leave.
Nonetheless, I think it is something I would like to see
the committee re-examine as we look at an issue like this,
where we could be faced with people spending time out of work
and not being able to be there, and to the extent they are able
to keep those jobs and not lose the necessary income to support
their families is something worth exploring. I just raise that
as an issue that we might want to explore at some point.
I thank the chair and I thank Senator Kennedy for his
leadership on the issue and Sherrod Brown for taking over the
chair on this important matter.
Again, we thank our witnesses.
And again to Richard Burr for those days of working
together on that issue in Bill Frist's office. I remember those
long evenings very, very well.
[The prepared statement of Senator Dodd follows:]
Prepared Statement of Senator Dodd
Mr. Chairman, thank you for convening this hearing on the
continued spread of the H1N1 (swine) flu outbreak.
Today's hearing is especially timely given the apparent
rapid spread of human swine flu throughout the United States
and the world. One need not look further than any news channel,
including those that cover the financial markets, to see the
global impact of this outbreak.
I look forward to hearing from Dr. Besser and Dr. Fauci
about their ongoing efforts to address this outbreak and I am
particularly interested in hearing the status of
countermeasures and any plans the CDC or NIH have to fund
vaccine development.
As of this morning, the CDC reported 91 confirmed cases of
the H1N1 flu in the United States with multiple
hospitalizations, and a likelihood that many more cases would
be identified in the coming days and weeks. Tragically, one
child in Texas has died as a result of this outbreak.
The situation in Mexico, as we've all heard, is more dire.
Reports show more than 150 deaths and more than 1,600
illnesses. Additional cases have been identified in Canada, New
Zealand, Spain, the United Kingdom, and Israel. Earlier today,
the World Health Organization indicated that the spread of the
H1N1 virus is moving closer to Phase 5 out of a scale of 6 on
its worldwide pandemic alert which would indicate widespread
human infection.
In my own State of Connecticut yesterday, two unconfirmed
but probable cases of swine flu were identified in adults who
recently traveled to Mexico--one in Stratford and one in
Southbury. According to authorities in Connecticut, a third
potential case has also been identified. All of these cases
have been sent to the CDC for further analysis.
Additionally, the Superintendants in East Haddam, CT--the
town where I live--and Wethersfield, CT have ordered schools
there closed after students and family members became ill upon
returning from Mexico.
I have spoken with our Commissioner of Public Health, Dr.
Bob Galvin, as well as the Selectman and Superintendant in East
Haddam, CT about the situation in Connecticut as it is
unfolding. I can report that there is a great deal of
coordination going on at the State level and between my State
and the Federal Government.
The traditional flu season recently ended but in
Connecticut, our public health lab reports an unusual spike
this week in the number of positive rapid flu test specimen
from all over the State. The State lab is preparing for what it
anticipates being an onslaught of additional positive specimen
in the coming days and weeks.
I am concerned about the capacity of our State and local
public health labs to conduct surveillance and detection during
this swine flu outbreak given their current resources and
workforce shortages. These are the same labs that conduct food-
borne illness surveillance and detection as well as newborn
screening and many other critical public health functions.
In Connecticut, these vital functions are performed by a
staff of 100 which has been cut in recent years. Nationally, I
am told that over 500 public health lab staff out of a total
workforce of 6,500 have been laid off in the past year. That
includes approximately 10,000 State and local public health
positions in the United States that have been lost due to
budget cuts and other factors. &
I am also concerned about the capacity of our Nation's
hospitals to handle a sudden surge in sick patients and whether
the right countermeasures will be available at the right time
to patients of all ages.
I understand that President Obama has submitted a request
for $1.5 billion in additional funding to address the swine flu
outbreak. Although funding is not within this committee's
jurisdiction, I hope the Senate will move quickly to get the
President and Secretary Sebelius the funding they have
requested. I know my colleague Senator Harkin is hard at work
at making that happen.
I suspect we are only at the beginning of our understanding
of this global outbreak. The American public--and I include
myself here--is full of questions about the swine flu outbreak:
How can I protect myself and my family? What should I do if I
or a family member becomes ill? Is the danger of the situation
likely to grow?
One question that I suspect will grow in significance is
what will happen to my job if I have to stay home to care for
myself or a family member?
The CDC has recommended that those sick with the flu ``stay
home from work or school and limit contact with others to keep
from infecting them.'' Workers will need access to leave from
work to recover and protect others from contracting the
illness. In order to limit the spread of this virus, we will
need workers to stay home and limit their contact with others.
The Family and Medical Leave Act provides 12 weeks of job-
protected, unpaid leave in a 12-month period for eligible
workers. The FMLA has helped millions of workers take much-
needed time off of work to attend to a new child, their own
health, or a family member's health.
However, for every employee who can take advantage of leave
without pay, there are three more who cannot afford the loss. I
believe they deserve paid leave, and the need for this will
only become clearer if the swine flu becomes a pandemic. I
introduced legislation last year, and will do so again this
year, that would give eligible employees 8 weeks of paid leave
over a 12-month period.
Our country is in the midst of a public health emergency.
The FMLA allows workers time off from work to take care of
themselves and their family members when they need to, often
unexpectedly. The Federal Government's policies must reflect
employees' need for paid family and medical leave, especially
as a growing number of Americans deal with this outbreak.
I want to commend the Obama administration for its handling
of the swine flu threat thus far. It is clear that the various
agencies of government are working closely and collaboratively.
As a result of the work of the HELP Committee and many of
my colleagues in the Senate to write and fund the Pandemic and
All-Hazards Preparedness Act and predecessor bioterrorism
legislation, the country as a whole has made great improvements
in surveillance, coordination, communications, and treatment
capabilities. The U.S. response to this current global threat
is evidence that those preparedness efforts are paying off.
Now we have a Secretary confirmed at the Department of
Health and Human Services. I am confident in Secretary Sebelius
and her ability to lead the public health response to this
outbreak.
Above all, I think it is important that people stay calm
and not panic, but it is equally important that they take the
necessary precautions and remain vigilant. Federal, State and
local public health officials have issued recommendations to
the public for how to protect itself from the spread of the flu
through some simple steps.
I thank Dr. Besser and Dr. Fauci for being here today on
such short notice. I look forward to their testimony and hope
they can address some of the issues I have raised.
Senator Brown. Thank you, Senator Dodd.
Senator Burr.
Statement of Senator Burr
Senator Burr. Mr. Chairman, I would also ask unanimous
consent that my opening statement be a part of the record.
I just want to thank my colleagues for their very kind
remarks and to also publicly thank Chairman Kennedy for his
help and support.
I also want to thank Tony Fauci. Tony was instrumental in
what we have constructed to address the possibility of pandemic
in the future. We were focused on one thing. Tony, we made
tremendous progress, and boy, now all of a sudden, we get a jog
in the road and we are headed in a different direction. I think
this is a challenging thing and something for all of us to
remember. We may think we know where we are going but we do not
always, and that is why we have got to have in place an
architecture that allows us to address every possible scenario
that can come up.
The good thing is that not only were we focused on a
vaccine for pandemic. Now all of a sudden, we have H1N1 and we
have the tools in the tool kit for Secretaries to make split-
second decisions that I think will, when needed, affect the
lives of the American people and communities in which they
live.
Clearly, part of that whole process were folks at the CDC.
It was Mike Leavitt at HHS at the time who was engaged--and we
have staff there today that was set up under his leadership--
that I am sure minute by minute, hour by hour is watching the
risk that we are faced with.
The only thing I would like to add, Mr. Chairman, which I
think I share with all members is that we are ready, willing,
and able to work with the Administration on any potential
additional needs that we have.
I also want to urge my colleagues--we have never fully
funded BARDA. We have relied on Dr. Fauci to surge moneys out
of the NIH when needed when we saw promising research. That is
not the way BARDA was designed. It was designed for us to be
almost a venture capital partner with companies that had
promising research, and we were going to fund them through that
valley of death. We are not there yet.
I would just encourage my colleagues. Let us take what we
are going through not as a definitive example of what could
happen, but as a warning sign to us, to set up the things we
knew we needed, fund them at the right level so that they can
operate the way they were designed, and the basket of tools
that we will have in the future will be even greater than what
we have today.
I thank the chair.
[The prepared statement of Senator Burr follows:]
Prepared Statement of Senator Burr
Senator Brown, thank you for holding today's hearing on
this very important topic of the 2009 H1N1 flu outbreak, which
has also been referred to as ``swine flu'', and our Nation's
public health and medical response. I would like to thank our
witnesses, Dr. Besser and Dr. Fauci, for taking the time to be
with the committee today to bring us up to speed on the latest
with this outbreak. Thank you for your leadership in protecting
our Nation's health. I look forward to hearing your honest
assessment of the current situation. We are deeply saddened and
sobered by the news this morning of the first death in the
United States, a young child. Americans, especially parents,
are understandably concerned and are watching this situation
very closely.
During the 109th Congress, I chaired the Subcommittee on
Bioterrorism and Public Health Preparedness. Building on the
lessons learned from Hurricane Katrina and September 11th,
Congress took a hard look at how we could better prepare and
respond to public health and medical emergencies. The
subcommittee held multiple public hearings, roundtables, and
meetings, and Congress received significant input from public
health officials, medical experts, emergency managers,
biotechnology companies, and stakeholders from across our
Nation. These actions culminated with the passage of the
Pandemic and All-Hazards Preparedness Act of 2006. I am very
proud to have authored this important bipartisan law and to
have worked with many of my colleagues on this committee,
including Senators Kennedy and Enzi, on this bill and other
important pieces of legislation.
Through the Pandemic and All-Hazards Preparedness Act,
Congress empowered the Department of Health and Human Services
with the tools it needs to protect the American people more
effectively and efficiently in response to a public health
emergency. Since 2006, the Department has made progress in
implementing this law. I hope one good story that we will see
come out of this situation is that the tools that Congress gave
the Department are being put to good use in responding to H1N1.
For example, this law established the Office of the Assistant
Secretary for Preparedness and Response, or ASPR, to unify the
Department's preparedness and response programs. Since its
inception, ASPR has carried out significant preparedness and
response planning, and is now playing a critical role in the
current public health emergency by helping to coordinate
response efforts with Federal, State, and local public health
partners. In addition, the National Biodefense Science Board,
which was also created by this law, provides important advice
and guidance to HHS on matters related to public health
emergency preparedness and response. With the passage of this
law in 2006, HHS now has additional authority to make sure we
are prepared and can respond to an emergency like the one we
are experiencing today.
In particular, in the Pandemic and All-Hazards Preparedness
Act, Congress created the Biomedical Advanced Research and
Development Authority, or BARDA, to speed up the development of
countermeasures--such as vaccines or treatments--to protect
Americans against a potential chemical, biological,
radiological, or nuclear terrorist attack, or other public
health emergency such as a pandemic flu. The Pandemic and All-
Hazards Preparedness Act authorized over a billion dollars for
BARDA. But, despite my best efforts, Congress has failed to
provide this full funding.
Thankfully, even without full funding, BARDA has been able
to identify promising countermeasures, fund the advanced
research and development necessary for making these products
available, and has supported their acquisition, stockpiling,
and deployment. I believe firmly that, thanks to BARDA and the
investment we have made over the last few years, our Nation is
now much better positioned to quickly respond to the H1N1 flu
outbreak and other potential pandemics.
I am ready to work with the Administration and my
colleagues to do what we need to do to make sure that we fight
the spread of the H1N1 flu as much as possible and protect the
health of Americans, especially the most vulnerable of our
society. While we have immediate needs at hand to address, we
must also not lose sight of the ongoing work that must be done
if our Nation is going to be fully prepared for future public
health emergencies or a bioterrorist attack.
This outbreak should be a wake up call to all of us for why
we cannot let our guard down. We must continue to invest in
BARDA and other tools so that we can tackle not only today's
public health emergency but also what we may have to confront
in the future.
I thank the Chair.
Senator Brown. Thank you, Senator Burr.
Senator Mikulski.
Statement of Senator Mikulski
Senator Mikulski. I know we are all looking forward to
hearing Drs. Besser and Fauci.
I wanted to reiterate what my colleague, Senator Burr, has
said.
First of all, I just want to thank Dr. Fauci and Dr. Besser
for what they do, not only in response to this now critical
international situation, but we have turned to Dr. Fauci time
and time and time again. When there was an outbreak of an
unknown disease in the bath houses of California and then a new
disease came on the scene called AIDS, we turned to NIH, the
institute on viruses. There was Dr. Fauci. When we were hit by
anthrax in this capital, who did we turn to? We turned to Dr.
Fauci.
Now once again, we are turning to Dr. Fauci, and I mean not
only him as a talented public servant, but him as a metaphor
for our public servants. If anything this shows us why we need
to maintain the integrity of our public health infrastructure
and honor the integrity of our public and civil servants. We
are very good at funding emergencies. We love emergency
hearings. We like getting all juiced up and funding things, but
it is the faithful funding of our public health infrastructure
and supporting them on days where there is not an emergency
that prepares them to be ready for an emergency.
Now, as we respond to this, working with our President and
our international partners, I would hope that when the
appropriations comes up, we not only look at the emergency
funding for swine flu, but you know you cannot respond to an
emergency unless you have the right people in place and a
public health infrastructure that works. I would hope we would
look forward to funding it.
My colleague from North Carolina that we have worked with
on these issues has talked about BARDA, but it is across the
board.
We are glad to see you once again. I am relieved that the
country can turn to you once again, and we are grateful that
you have remained in civil service at NIH. You could have some
cushy job in some university where you could be flying around
to international conferences and on tons of boards and
commissions. If only we could take your salary and put a bunch
of zeroes behind it. We want to thank you for being you and we
want to thank you for the metaphor for all those talented
people who work every day so we can be ready to respond to the
emergency.
Senator Brown. Thank you, Senator Mikulski.
Our two witnesses are Dr. Richard Besser, Acting Director
of the Centers for Disease Control and Prevention in Atlanta.
He is with us by video from Atlanta. Also, Dr. Anthony Fauci is
Director of the National Institute for Allergy and Infectious
Diseases at the National Institutes of Health in Bethesda.
Thank you both for your public service. Thank you both for,
as Senator Mikulski said, answering the call for public health.
There are few higher callings in our country for the last many
decades than devoting your life to public health and making
such a difference in so many people's lives and so poorly paid
and so underfunded, so often as public health overall, not just
pay but in the services that it provides.
Dr. Besser, we will begin with you by video from Atlanta.
Thank you for joining us. Thank you for your patience. Proceed
please.
STATEMENT OF RICHARD E. BESSER, M.D., ACTING DIRECTOR, CENTERS
FOR DISEASE CONTROL AND PREVENTION,
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES,
ATLANTA, GA
Dr. Besser. Thank you very much. Good afternoon, Mr.
Chairman and members of the committee. I am Dr. Richard Besser,
Acting Director of the Centers for Disease Control and
Prevention. I appreciate the opportunity to update you on the
current steps we are taking to respond to this unique and
serious influenza outbreak.
First, I want to say our hearts go out to the people in the
United States, in Mexico, and around the globe who have been
directly impacted, in particular to the family of a child in
Texas whose death was the focus of media reports this morning.
People are concerned and we are concerned as well.
We are responding aggressively at the Federal, State, and
local levels to understand the complexities of this outbreak
and to implement control measures. Our aggressive actions are
possible, in many respects, because of the investments and
support of this committee and the Congress and the hard work of
State and local officials across the country.
Flu viruses are extremely unpredictable, making it hard to
anticipate the course of this outbreak with any certainty. We
do expect increases in the number of cases, the number of
States that are affected, and the severity of illness. Amid
this uncertainty, we hope to be clear in communicating what we
do know, make clear the uncertainties, clearly communicate what
we are doing to protect the health of Americans and help
Americans understand the steps that they can take to protect
their own health and that of their communities.
Influenza arises from a variety of sources, and in this
case we have determined that there was a novel 2009 H1N1 virus
circulating in the United States and Mexico that contains
genetic pieces from four different virus sources. Additional
testing is being done on this virus, including a complete
genetic sequencing.
CDC has determined that this virus is contagious and is
spreading from human to human, similar to seasonal influenza,
likely through coughing, sneezing, touching of hands that are
infected, and so forth. Sometimes people may be infected by
touching something with flu virus on it and then touching their
mouth or nose.
There is no evidence to suggest that this virus has been
found in swine in the United States, and there have been no
illnesses attributed to handling or consuming pork. There is no
evidence that you can get this new influenza from eating pork
or pork products.
I want to reiterate that as we look more intensely for
cases, we are finding more cases. We fully expect to see not
only more cases but also a greater spectrum of severity of
disease. The specific numbers are less important in
understanding the outbreak than the more general patterns that
we will use to help guide our interventions.
Aggressive actions are being taken here, as well as abroad.
We are working closely with State and local public health
officials around the United States on this investigation and to
implement appropriate control measures. We are providing both
technical support on epidemiology and laboratory support for
confirming cases. We are also working closely with the World
Health Organization and the Pan American Health Organization,
and the governments of Mexico and Canada on this outbreak
investigation. There is a tri-national team on the ground right
now in Mexico trying to better understand the outbreak and to
enhance surveillance and laboratory capacity so that we can
better address critical questions such as why cases in Mexico
appear to be more severe than initially seen in the United
States. We are working closely with HHS and other Federal
partners to ensure that our efforts are coordinated and
effective.
CDC has issued numerous health advisories for individuals,
health care practitioners, schools, and communities, and these
continue to evolve as our understanding of the situation
changes. For example, on Monday, CDC issued a travel health
warning for Mexico, recommending that travelers postpone
nonessential travel to Mexico. CDC is also evaluating
information from other countries and will update travel notices
as necessary. As always, persons with flu or flu-like symptoms
should stay at home and not attempt to travel.
In fact, a key message from CDC is that there is a role for
everyone to play when an outbreak is occurring. It is a matter
of shared responsibility. At the individual level, it is
important for people to understand how they can prevent
respiratory infections. Frequent hand-washing or use of alcohol
hand gels is an effective way to reduce transmission of this
virus. If you are sick, stay at home, and if your children are
sick, have a fever, or flu-like illness, they should not go to
school. If you are ill, you should not get on an airplane or
other public means of transportation. Taking personal
responsibility for these things will help reduce the spread of
this new virus as well as other respiratory illnesses.
It is important that people think about what they would do
if this outbreak deepens in their community. It is about
planning, leaning forward that will help our communities be
ready. Communities, businesses, schools, and local governments
should plan now for what to do if cases appear in their
communities. For example, parents should prepare for what they
would have to do if faced with temporary school closures.
We also have additional community guidance so that
clinicians, laboratory scientists, and other public health
officials will know what to do should they see cases in their
community. All of these specific recommendations, as well as
other regular updates, are posted on the CDC Web site,
www.cdc.gov.
CDC maintains the Strategic National Stockpile of
medications and other materials for the eventuality that they
may be needed in a situation just as the one that we are
facing. As part of our pandemic preparedness efforts, the U.S.
Government has purchased extensive supplies of antiviral drugs
and our preliminary testing indicates that this virus is
susceptible to the drugs that we have been stockpiling.
We are releasing one-quarter of the States' share of
antiviral drugs and personal protective equipment to help
States prepare to respond to the outbreak, along with the
necessary FDA emergency use authorities to facilitate their
effective use. Distribution has already begun, starting with
the States in which we already have confirmed cases. The
Department of Defense and individual States have also
stockpiled these antiviral drugs.
Whenever we see a novel strain of influenza, we immediately
begin to work toward the development of a vaccine in case one
needs to be produced. Dr. Fauci will be talking more about
this. The CDC is working to develop a vaccine seed strain
specific to this novel virus, the first step in vaccine
manufacturing. We have initiated steps so that should we need
to manufacture a vaccine, we can work toward that goal very
quickly. Rapid progress will be possible through the combined
forces of CDC, NIH, FDA, BARDA, and manufacturers.
Finally, it is important to recognize through the strong of
the Congress, there have been enormous efforts in the United
States to prepare for this kind of an outbreak and a pandemic.
Our detection of this strain in the United States came as a
result of that investment, and our enhanced surveillance and
laboratory capacity are absolutely critical to understanding
and mitigating this threat. While we must remain vigilant
throughout this and subsequent outbreaks, it is important to
note that at no time in our Nation's history have we been more
prepared to face this kind of challenge. As we face the
challenges that are undoubtedly going to come our way in the
weeks ahead, we look forward to working closely with the
committee to best address this evolving situation.
I want to thank you for holding this hearing, and I look
forward to answering any questions you may have.
[The prepared statement of Dr. Besser follows:]
Prepared Statement of Richard E. Besser, M.D.
Good afternoon, Chairman Kennedy, Ranking Member Enzi and other
distinguished members of the committee. I am Dr. Richard Besser, Acting
Director of the Centers for Disease Control and Prevention. I thank you
for the opportunity in updating you on current efforts the U.S.
Government is taking to respond to the ongoing novel 2009 H1N1
influenza outbreak. Our hearts go out to the people in the United
States, in Mexico, and around the globe who have been directly
impacted. People around the country and around the globe are concerned
with this situation we're seeing, and we're concerned as well. We are
responding aggressively at the Federal, State, and local levels to
understand the complexities of this outbreak and to implement control
measures. It is important to note that our Nation's current
preparedness is a direct result of the investments and support of the
Congress and the hard work of State and local officials across the
country.
It is important for all of us to understand that flu viruses--and
outbreaks of many infectious diseases--are extremely unpredictable. We
know that as our investigation proceeds, what we learn will change. We
expect changes in the number of cases, the number of States affected,
and the severity of illness. Our goal in our daily communication--to
the public, to the Congress, and to the media--is to be clear in what
we do know, explain uncertainty, and clearly communicate what we are
doing to protect the health of Americans. An equal priority is to
communicate the steps that Americans can take to protect their own
health and that of their community. As we learn more, these
communications and recommendations will evolve.
Influenza arises from a variety of sources; for example, swine
influenza (H1N1) is a common respiratory disease of pigs caused by type
A influenza viruses. These and other animal viruses are different from
seasonal human influenza A (H1N1) viruses. From laboratory analysis
already performed at CDC, we have determined that there is a novel 2009
H1N1 virus circulating in the United States and Mexico that contains
genetic pieces from four different virus sources. This particular
genetic combination of H1N1 influenza virus is new and has not been
recognized before in the United States or anywhere else worldwide.
Additional testing is being done on the viruses, including a complete
genetic sequencing.
CDC has determined that this virus is contagious and is spreading
from human to human. It appears to spread with similar characteristics
as seasonal influenza. Flu viruses are thought to spread mainly from
person to person through coughing or sneezing of people with influenza.
Sometimes people may become infected by touching something with flu
viruses on it and then touching their mouth or nose. There is no
evidence to suggest that this virus has been found in swine in the
United States, and there have been no illnesses attributed to handling
or consuming pork. Currently, there is no evidence that you can get
this novel 2009 H1N1 influenza from eating pork or pork products. Of
course, it is always important to cook pork to an internal temperature
of 160 degrees Fahrenheit in order to ensure safety.
I want to reiterate that as we look for cases, we are seeing more
cases. We fully expect to see not only more cases, but also greater
severity of illness. We've ramped up our surveillance around the
country to try and get a better understanding of the magnitude of this
outbreak.
Let me provide for you an update in terms of the public health
actions that are being taken here as well as abroad. On the
investigation side, we are working very closely with State and local
public health officials around the country. We're providing both
technical support on the epidemiology as well as laboratory support for
confirming cases. We are also working with the World Health
Organization, the Pan American Health Organization, and the governments
of Mexico and Canada on this outbreak. There is a tri-national team
that is working in Mexico to better understand the outbreak, and answer
critical questions such as why cases in Mexico appear to be more severe
than we have seen in the United States to date. We are working to
assist Mexico in establishing more laboratory capacity in-country; this
is very important because when you can define someone as a truly
confirmed case, what you understand about how they acquire disease
takes on much more meaning.
In terms of travel advisories, CDC continues to evaluate incoming
information from the World Health Organization, the Pan American Health
Organization, and other governments to determine the potential impact
of the outbreak on international travel. On Monday, April 27, CDC
issued a travel health warning for Mexico. With this warning, we
recommend travelers to postpone non-essential travel to Mexico for the
time being. CDC is also evaluating information from other countries and
will update travel notices for other affected countries as necessary.
As always, persons with flu or flu-like symptoms should stay at home
and should not attempt to travel.
CDC has and will continue to develop specific recommendations for
what individuals, communities, clinicians, and other professionals can
do. It is important that people understand that there's a role for
everyone to play when an outbreak is occurring. At the individual
level, it is important for people to understand how they can prevent
respiratory infections. Very frequent hand-washing is something that we
talk about time and time again and that is an effective way to reduce
transmission of disease. If you're sick, it's very important to stay at
home. If your children are sick, have a fever and flu-like illness,
they shouldn't go to school. And if you're ill, you shouldn't get on an
airplane or any public transport to travel. Taking personal
responsibility for these things will help reduce the spread of this new
virus as well as other respiratory illnesses.
It is important that people think about what they would do if this
outbreak deepens in their community. Communities, businesses, schools,
and local governments should plan now for what to do if cases appear in
their communities. Parents should prepare for what they would do if
faced with temporary school closures, as we are recommending temporary
school closures when cases are identified.
We also have additional community guidance so that clinicians,
laboratorians, and other public health officials will know what to do
should they see cases in their community. All of these specific
recommendations, as well as other regular updates, are posted on the
CDC Website--www.cdc.gov.
We will continue to provide support to States and communities
throughout this outbreak. In addition to the epidemiologic and
laboratory support that CDC provides, CDC maintains the Nation's
Strategic National Stockpile of medications that may be needed in this
outbreak. As part of our pandemic preparedness efforts, the U.S.
Government has purchased extensive supplies of antiviral drugs--
oseltamivir and zanamivir--for the Strategic National Stockpile.
Laboratory testing on the viruses so far indicate that they are
susceptible to oseltamivir and zanamivir. We are releasing one-quarter
of the States' share of antiviral drugs and personal protective
equipment to help States prepare to respond to the outbreak, along with
the necessary emergency use authorities to facilitate their effective
use. Distribution has been prioritized for the States where we already
have confirmed cases. In addition, the Department of Defense has
procured and strategically prepositioned 7 million treatment courses of
oseltamivir.
Whenever we see a novel strain of influenza, we begin our work in
the event that a vaccine needs to be manufactured. The CDC is working
to develop a vaccine seed strain specific to these viruses--the first
step in vaccine manufacturing. This is something we often initiate when
we encounter a new influenza virus that has the potential to cause
significant human illness. We have isolated and identified the virus
and discussions are underway so that should we need to manufacture a
vaccine, we can work towards that goal very quickly. HHS has also
identified the needed pathways to provide rapid production of vaccine
after the appropriate seed strain has been provided to manufacturers.
As this progresses, HHS operating divisions and offices including CDC,
NIH, FDA, and ASPR/BARDA will work in close partnership.
In closing, we are simultaneously working hard to understand and
control this outbreak while also keeping the public and the Congress
fully informed on the situation and our response. We are working in
close collaboration with our Federal partners including our sister HHS
agencies and other Federal departments. While much has happened to
date, this will be a marathon, not a sprint, and even if this outbreak
is a small one, we can anticipate that we may have a subsequent or
follow-on outbreak several months later. Steps we are taking now are
putting us in a strong position to respond.
The government cannot solve this alone, and as I have noted, all of
us must take constructive steps. If you are sick, stay home. If
children are sick, keep them home from school. Wash your hands. Take
all of those reasonable measures that will help us mitigate how many
people actually get sick in our country.
Finally, it is important to recognize that there have been enormous
efforts in the United States and abroad to prepare for this kind of an
outbreak and a pandemic. The Congress has provided strong support for
these efforts. Our detection of this strain in the United States came
as a result of that investment and our enhanced surveillance and
laboratory capacity are critical to understanding and mitigating this
threat. While we must remain vigilant throughout this and subsequent
outbreaks, it is important to note that at no time in our Nation's
history have we been more prepared to face this kind of challenge. As
we face the challenges in the weeks ahead, we look forward to working
closely with the committee to best address this evolving situation.
Senator Brown. Thank you, Dr. Besser.
Dr. Fauci.
STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE
FOR ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF
HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, BETHESDA,
MD
Dr. Fauci. Mr. Chairman, members of the committee, thank
you again--and I reiterate what Dr. Besser said--for calling
this hearing. Thank you very much, all of you, for your kind
words. I sincerely appreciate it. Thank you for the opportunity
to discuss the public health threat that the Nation and the
world are facing with regard to outbreak of the potentially
pandemic 2009 H1N1 flu virus.
Thank you also for the extraordinary support that you and
the committee have given to us at HHS in the development of the
pandemic influenza preparative efforts. I can say quite
sincerely and honestly that we would not be where we are right
now in our high level of preparedness were it not for this
committee.
As you have just heard, the number of influenza cases
caused by this novel virus has continued to grow in the United
States and internationally. Our colleagues at the CDC, the WHO,
and international health authorities have done an outstanding
job in tracking this potential pandemic virus and in
implementing control measures. What I will do over the next
couple of minutes is describe very briefly the research
response at the NIH that is synergistic with and complementary
to the efforts of our sister agencies, CDC, FDA, as well as
other organizations.
As you know, over the last several years, we have launched
a major research effort that builds on longstanding programs in
seasonal influenza to improve our preparedness for the
possibility of pandemic influenza. Although we have focused a
good deal of attention recently on the H5N1 influenza, the so-
called bird flu, it has always been clear that the next
pandemic threat could come from another virus altogether.
Indeed, such a threat is now upon us.
We have rapidly ramped up the research agenda that
underpins the development of countermeasures for all influenza
subtypes, including potentially pandemic strains.
Basic research has given us fundamental information about
how influenza viruses re-assort. I know many of you have heard
that word, ``re-assort.'' What does that mean? This means that
viruses exchange their genes within a cell to yield a new
hybrid virus such as the one that we are now seeing.
We have also learned how viruses evolve and how different
viruses cause disease. It is these kinds of studies that lead
to the translation in clinical research that we need to develop
new tools to diagnose, treat, and prevent diseases and prevent
notably with vaccines.
Vaccines, of course, are essential tools for the control of
any form of influenza. Basic research of advances have allowed
for the rapid isolation and genetic sequencing of the currently
circulating 2009 H1N1 virus and has given us important insights
and technologies into the design of potential vaccines for this
virus. The CDC should be congratulated in the extraordinary
rapidity in which they did this.
Using our multifaceted research infrastructure, we are now
working with our partners of HHS, CDC, FDA, and industry on the
various stages in making a vaccine against this novel
threatening virus. An immediate priority is the development and
testing of a reference virus strain that will be made into seed
viruses, as we call them, that will be used in the production
of pilot lots by our partners in the private sector.
This process has already begun as part of our pre-arranged
plan that Senator Burr referred to. Our clinical trials
infrastructure, called the Vaccine and Treatment Evaluation
Units, are at the ready right now to quickly evaluate the pilot
lots when they become available to determine three things: the
safety, the ability to adduce a response that you would predict
would be protective, and the determination of the appropriate
dose that we will ultimately use in a vaccine. All systems are
go for this step-wise process.
Antiviral medications also are an important counterpart to
vaccines as a means of controlling influenza outbreaks through
both treatment and prophylaxis. Thankfully, the currently
circulating 2009 H1N1 flu virus is sensitive to the two major
antiviral drugs in our Strategic National Stockpile, Tamiflu
and Relenza. However, experience tells us that drug resistance
can occur, and NIH is working to develop with CDC and test the
next generation of flu antivirals. CDC already has new and
sensitive diagnostics available and other new diagnostics are
being developed by NIH grantees and contractors.
In closing, I would like to emphasize that our longstanding
collective efforts at HHS to prepare for an influenza pandemic
with research, with a sufficient supply of effective vaccines
and antiviral drugs, with public health measures, efficient
infection control, and clear public communication has given us
a head start in this serious situation that we are facing
today. Again, we appreciate very much the support that you have
given us to get to this level of preparedness. I would be happy
to answer any questions that you may have. Thank you.
Senator Brown. Thank you, Dr. Fauci.
Dr. Besser, thank you again. You had said that the CDC's
Division of the Strategic National Stockpile has released one-
quarter of the antiviral drugs and personal protective
equipment and respiratory protection devices to those, I
believe, 10 States that have had any kind of evidence of anyone
who has contracted the virus.
Run through, if you would, what happens once these
antivirals reach the State. Are they disseminated at hospitals,
community health centers, public health departments? Where do
they go? How is that determined? Run through that process, if
you would.
Dr. Besser. Thank you, Senator, for that question.
Actually we are distributing antivirals and other supplies
to all 50 States, plus the other large cities that participate
as independent recipients. We are targeting those areas that
have been infected first.
The reason we are doing that is as a forward-leaning,
aggressive move. At this point, it is too early to say whether
this virus will cause severe disease in this country, how many
people will be affected, and whether local supplies of drugs
and other supplies will run low. We are in the process of
moving 25 percent of each State's allocation to the State
control.
Now, we exercise this all the time. States have plans and
we report annually to the public on the status of planning and
exercising around stockpile distribution. We turn over the
Federal supplies to the State in their receipt staging and
storage site. They are then responsible for the next stage of
distribution down to where those drugs would be used.
Now, at this point with the number of cases we are seeing
with the supply of oseltamivir and zanamivir that are around
the country, we are not seeing shortages for use in treatment.
Should that be the case, States have plans and we would be able
to distribute that in the way that they have been planning. As
you would expect, States will vary depending on whether they
are a rural State or mainly a predominantly urban State. Those
plans are in place and have been exercised.
Senator Brown. President Obama sent a letter to Congress
asking for an additional $1.8 billion to help fund a plan to
build drug stockpiles and monitor future cases of the disease.
Can you give me a general outline of how this money will be
spent, and why it is so vitally important?
Dr. Besser. Senator, I will need to get back to you for the
record on that, but I can tell you that when we are in
emergency response mode, when we are helping the State and
locals and responding globally, it is very resource-intensive.
At that time, resources are not to matter. It is the safety and
health of people here and elsewhere. I know that a large
portion of those funds are to support the ongoing emergency
response capabilities and ensure we have flexibility and are
not hampered in that regard. For additional components of that
funding, I would like to get back to you for the record.
Senator Brown. Thank you, Dr. Besser.
Dr. Fauci, why is the virus proving to be fatal in so many
cases in Mexico but less so here in the United States and
elsewhere in the world?
Dr. Fauci. Well, I will tell you a bit about that, and then
Dr. Besser may want to chime in.
It is still very unclear what people are interpreting as
the differences between a virus in Mexico and what it is doing
in Mexico and what it is doing in the United States. From a
molecular virus-type standpoint, it appears to be essentially
identical to the virus here. The numbers of cases in Mexico are
larger than the numbers of cases in the United States, probably
even much, much larger. We do not know what the true
denominator is. Mainly we are hearing reports of cases that are
reported of people who are very sick, a certain proportion,
varying numbers, 100, 200, or more who have died, not all of
them at all confirmed with that. In the United States, the
numbers at this point are less, and as the CDC--and I will have
Dr. Besser go into this. We should expect that we are going to
see more serious disease over the next days to weeks or even
beyond.
I think it is such a dynamic situation, Mr. Chairman, that
we cannot say necessarily that there is an absolutely
fundamental difference. It may be just that there are so many
more cases in Mexico and we are still in the evolution of more
cases in the United States. I will turn now to Dr. Besser and
have him amplify that.
Senator Brown. Dr. Besser, any thoughts on that?
Dr. Besser. Yes, Senator. Thank you, Dr. Fauci.
This is a critically important question. Is there truly a
difference between what is taking place in Mexico and what is
taking place here in the United States? It is premature to say
that there truly is a difference. It may be that we are earlier
in the course of the introduction of this virus into our
communities and that as it progresses, we will see more severe
disease.
There may be differences in terms of treatment practices in
Mexico. Our team that is part of the tri-national effort is
looking at such factors as how long was the time between onset
of symptoms and beginning of treatment. What were the treatment
practices? What medications were used? Were there additional
treatments that may have impacted adversely in that treatment?
Are there other factors related to the population, related to
the environment? There are many things that need to be looked
at, and people are very aggressively trying to address those
questions while, at the same time, we are working here to study
transmission in our communities.
The best news would be if we were to find that this virus,
as it goes from person to person to person, loses some of its
strength, some of its virulence. We do not have evidence of
that at this point, but that is one of the questions we need to
look at.
But you asked, I think, the fundamentally most important
question that we are trying to address.
Senator Brown. Thank you. One real quick question. Then I
will call on Senator Burr.
How many Americans typically die from the flu every year?
Dr. Fauci. The number that you hear is about 36,000, at
least tens of thousands. It is a number that changes a bit from
year to year, and about 200,000 excess hospitalizations each
year in a seasonal flu.
Senator Brown. Tens of thousands. That number is annually?
I mean, for the last many, many years, there have always been
tens of thousands of Americans die from some influenza.
Dr. Fauci. They are mostly in elderly people and people who
have compromised, what we call, host defenses or compromised
immune function.
Senator Brown. Some 200,000 Americans have gone to the
hospital, more or less, annually because of influenza?
Dr. Fauci. Right.
Senator Brown. Thank you.
Senator Burr is recognized for 5 minutes.
Senator Burr. Thank you, Mr. Chairman.
Dr. Besser, I think it is clear that our ability to
diagnose this flu strain is absolutely essential. Let me ask
two questions of you. What are our capabilities regarding
point-of-care diagnostics, and have we begun to procure and
deploy any type of rapid testing diagnostics?
Dr. Besser. Thank you, Senator Burr.
First, I would like to say that the investments that we
have made in our State and local laboratory capacity, through
things such as the laboratory response network as part of
overall preparedness and as part of pandemic preparedness
have--it is an incredibly important network of laboratories,
more than 160 labs across the country that use common
diagnostic testing that assures that if a test result from
North Carolina comes back positive, we will have confidence
that it is the same as if we had done it here in Atlanta.
We are in the process now of distributing H1N1 diagnostic
kits to all of the States. Right now, those kits are available
in California and New York. We are rolling these out. We are
making sure that they work well as we scale that up. By the end
of the week, every affected State will have this test kit in
their laboratory, and by early next week, we will have this in
all of our State laboratories. This is part of our efforts to
shorten the time between identification of a potential case of
flu and being able to confirm that.
In terms of the issue of point-of-care tests, we do not
have a point-of-care test for this strain. I need to say that
the reason we were able to diagnose this case, the initial case
of swine flu--and it was a case of swine flu--was because of
the pandemic preparedness efforts. There was a study going on
in San Diego at a Department of Defense site, a naval site,
that was developing point-of-care tests, and it was a step as
part of the investments Congress had made in preparedness. They
were developing a test for point-of-care, and they identified
through that a strain that looked different. They sent that
strain to CDC and we were able to determine it was a novel
strain of influenza that had components that were related to
strains in affected swine. We shared this information with the
international community, as we always do, and we were able to
see that the strains that Mexico had sent to Canada were the
same strain that we had identified in San Diego.
The work going on to develop point-of-care tests--and we
agree that point-of-care testing is a very important piece.
Those efforts bore fruit here in the early detection of this
novel outbreak of influenza.
Senator Burr. Thank you, Dr. Besser.
Dr. Fauci, do we expect this virus to go dormant at some
point?
Dr. Fauci. The one thing that we have learned about
influenza, Senator Burr, is that it is quite unpredictable, in
fact, extraordinarily unpredictable. Any possible scenario. It
could take off more. It could go dormant. It could lay low over
the summer and come back in the fall. That is the reason why we
really are preparing for any of those options. We are preparing
always for an unpredictable course, which is very
characteristic of influenza, particularly a virus that you have
actually never seen before or had experience with before.
Senator Burr. One could say this has been very
unpredictable, a late season eruption. It seems to be, if the
accounts are correct, in the most severe cases this is an upper
respiratory distress. Would that be accurate?
Dr. Fauci. It starts off as a standard type of flu with
fever, headache, muscle aches, some diarrhea and GI tract
involvement. Then in the people who get seriously ill, it
rapidly progresses to serious pulmonary involvement, which we
call acute respiratory distress, which is the thing that people
get at the point when they are dying. I am sure Dr. Besser can
give you more details about the cases in Mexico. That is the
general thing that happens. It starts off as an influenza type
of an illness, which just progresses rapidly in people who get
seriously ill. The cases in our country, as you know, at least
the ones that are being reported now, relatively speaking have
been the typical type of mild flu.
Senator Burr. I understand that the data set that we have
right now is fairly limited from the standpoint of knowing how
many cases, and therefore how many deaths.
Dr. Fauci. Right.
Senator Burr. Can you find comparisons to at least the
initial stages of this flu strain and its affects on humans and
the 1918 strain? Some news accounts suggest that those who have
died were in the lower age groups, which is counter to what we
typically see in a flu patient. Again, the data set is much
smaller right now.
Dr. Fauci. Yes. I will defer the question to Dr. Besser.
But in general, we tend to be careful about making these
kinds of comparisons because that immediately sets off alarm,
even though we always assume the worst scenario.
The individual manifestations I will hand to Dr. Besser who
has the experience of the numbers and what we are getting
reported on a daily basis.
Rich.
Dr. Besser. Thanks, Tony. I appreciate it.
We are gathering data still from Mexico to understand the
various presentations. The presentations that Dr. Fauci was
talking about of fulminant presentation of infection going on
to a white-out of the lungs and respiratory failure--that is
the picture of 1918 that we hear about. Getting a handle on how
often that is being seen versus patients who have flu-like
symptoms who progress, progress, progress and then go into
failure or develop a secondary bacterial infection is going to
be very important.
We have yet to see in this country any of that rapid
progression. When we look at the cases here that have been
hospitalized--and there are only five hospitalized cases so
far--we are seeing the types of patients who typically have a
problem with seasonal flu, and that is: people who have
underlying medical conditions, may have immune problems or are
taking drugs that could suppress the immune system or those who
are at the extremes of age, that setting. That is a typical
pattern for seasonal flu.
We are not seeing the evidence here yet of high attack
rates and increased severity in the healthy adult population.
That is an area we are really looking at, the 10 to 50 age. If
we start to see fulminant disease in that area, if we start to
see increased severity and high rates of hospitalization in
that range, that would be very concerning.
Senator Burr. The last question. The Chairman has been very
patient with me.
Is there any reason for us to believe that the annual
influenza vaccine that millions of Americans took this year
could play a role in moderating this current strain?
Dr. Fauci. If you look at the laboratory, what we call, in
vitro cross-reactivity, does the response of the seasonal
influenza H1N1 that is part of the three virus vaccines that go
into what we get on a seasonal basis, there does not appear to
be any laboratory indication that you would predict would be
protective. However, we have experience with vaccines that
there are some things that might be unmeasurable and subtle,
such as cell-mediated immunity that you do not measure or
certain types of immunological responses. You would not expect
or predict that that vaccine that we took would protect against
this. But there are some subtle things that we need to pursue
to see that there may be some things below the radar screen
that might be beneficial.
Senator Burr. Thank you.
Senator Brown. Thank you, Senator Burr.
Senator Dodd is recognized.
Senator Dodd. Thank you very much, Mr. Chairman, and I
thank both of you. Let us underscore the comments of the others
about the tremendous value that both of you provide on these
issues and so many others we have had to grapple with over the
years.
I am not sure to whom I want to address this. I will start
with Dr. Fauci. The first question I have is about public
health lab personnel. I know the State budgets are such that it
puts a lot of strain on them today. The number of people--I
think something like 500 public health lab staff over the last
year or so have lost their jobs because of budget pressures of
the 6,500 that are out there. I know the States are cutting
back. In my own State, the lab staff of 100 has been cut in
recent years.
Could you give us any indication as to whether or not, in
the coming days here, we are going to see some sort of an
additional resource allocation so the States and the lab
personnel will be in place so we have the workforce to help us
at this point?
Dr. Fauci. The CDC works very closely with the State and
territorial officials. I am not sure there is an answer to your
question. Dr. Besser would be more on the line of being able to
answer that.
Senator Dodd. Doctor.
Dr. Besser. Thanks. Thanks, Dr. Fauci.
Clearly, a critical part of our preparedness and our
response is those at the front lines, State and local public
health. It has been very concerning to us as we have been
hearing reports of more than 10,000 State public health
employees who are at jeopardy of losing their jobs, in large
part due to the economy.
One of the reasons we are as prepared as we currently are
for a potential pandemic is the investments that have been made
in State and local public health, in the infrastructure, in the
laboratories, in the health communicators, in those people who
are doing surveillance and investigating cases, those who are
communicating to the public. This infrastructure allows us not
only to respond to a potential pandemic, but to the everyday
public health challenges that we face.
We have been pushing and emphasizing to our State
colleagues the importance of planning and exercising. We do
this at the Federal level and we have been holding their feet
to the fire of State grantees. If they are getting money from
the Federal Government, they need to be exercising and they
need to be showing us how they are exercising and how they are
using those exercises to improve their systems.
I can tell you that it is absolutely impossible to require
States to do exercising at a time when they are laying off
their personnel. They just do not have the capability to do
their jobs and continue the preparedness efforts.
In terms of resources from the Federal Government to the
States, I would need to get back to you on that. I do not have
details on how the supplemental request is being directed. But
I can tell you that what we hear from our State laboratory
colleagues, from our State public health colleagues is that
those systems are in jeopardy of being lost.
Senator Dodd. Again, I appreciate that, and I would hope at
least on a matter like this that it would not take this kind of
a moment. It seems to me when you are dealing with potentially
pandemic issues, they do not confine themselves geographically.
In our States where we are relying on States to hire people to
have in place, it seems to me in a matter like this, that this
becomes more of a national policy rather than a State policy.
Obviously, having the help of States means a lot. The fact that
10,000 people we do not have in place seems to me rather
precarious. Just going out and doing that today--imagine if you
had to do it today how hard that would be. I do not know where
you would find 10,000 people necessarily to fill these jobs.
I would urge you to get back to us on that, and I presume
you are communicating this to the Administration and others.
Let us know if there is anything we need to do from this
standpoint to support that effort. It seems to me this ought to
be more a permanent place somehow, a combination, whether you
do State, local, Federal, whatever, to keep having personnel on
hand. I would appreciate that. If you could get back to us, I
would appreciate that, as well, Doctor.
I will bring up a parochial issue for you, if I can. As I
understand it right now, there is currently no vaccine
available for H1N1. Is that correct?
Dr. Fauci. Well, we have to be careful when we say H1N1. We
have an H1N1 vaccine in our seasonal flu package of three
vaccines that we vaccinate every year. There is not a vaccine
for this particular 2009 H1N1 flu that we are in the process of
trying to develop.
Senator Dodd. So that is my question. Again, there is a
company in Connecticut called Protein Sciences, which has been
very involved with the CDC and has had a very responsive
reaction. A vaccine company, a small company. They have had an
application pending since 2007 with BARDA for the manufacture
of a recombinant flu vaccine. The Mexican government have had
them down there. They have been hired to come in and help deal
with the situation. They just cannot get an answer to their
application with BARDA here in the United States.
I just want to take the opportunity of this gathering
here--from BARDA--I guess CDC or Dr. Besser might be the right
one to raise this question with to see if we can get some
answer for them. This is not a parochial issue for a company,
but a company that has developed--they think with minor
changes, they could have in 5 to 6 weeks 30,000 doses a week
available of the product they have been producing.
Are you familiar with this, Dr. Besser, at all, what I am
talking about?
Dr. Besser. Senator, can you hear me?
Senator Dodd. Yes, I can now.
Dr. Besser. Very good. Senator, let me take this issue back
to our colleagues at BARDA and ask them to give a direct
response on that.
Senator Dodd. I appreciate that. Again, I apologize. It is
parochial but it is larger than that. It is a company that
claims with minor variations they could produce a product in 5
or 6 weeks at 30,000 doses a week that would address this
particular issue.
Dr. Fauci.
Dr. Fauci. We will do what Dr. Besser said and bring it
back to BARDA.
I am familiar with the company. They have been interacting
and having scientific discussions with us at the NIH. I am
familiar with the product, and we will bring it to the
attention of BARDA.
Senator Dodd. Is there any reason to be encouraged by what
they are doing?
Dr. Fauci. It is a very interesting approach. It is a
recombinant process where instead of getting the whole virus
itself and trying to make a vaccine from the whole virus, they
take very specific components and in a recombinant DNA fashion
make the two important components of a vaccine, the H and the
N. So I am familiar with the work. It is very interesting work.
Senator Dodd. Thank you very much. Thank you, both. Thank
you, Mr. Chairman.
Senator Brown. Thank you, Senator Dodd.
Senator McCain is recognized.
Statement of Senator McCain
Senator McCain. Thank you, Mr. Chairman.
Dr. Fauci and Dr. Besser, is there enough day-to-day data
to show that H1N1 influenza is slowing or accelerating?
Dr. Fauci. I will leave that to Dr. Besser since the CDC is
tracking it. Rich?
Dr. Besser. Thank you, Senator. At this point, it is very
difficult to say. What we are looking at is an increased number
of cases from day to day. Whenever you start an outbreak
investigation, you are going to see additional cases from the
process of doing surveillance and looking. The early cases that
we were seeing were not very severe infection, and if we had
not increased surveillance and asked people to be looking for
these cases, these would not come to the attention frequently
of their physicians or to public health.
It is too early to say where we are, whether this is
ramping up greatly. It is our feeling that there is increased
spread in this country and that there are increasing cases, but
it is too soon to say what that really looks like. Each day we
are reporting our cases and we are trying to do it at the same
time to avoid some of the confusion around case numbers that
frequently occurs.
Similarly, in Mexico, it is very difficult to get a handle
on the rate of cases and whether they are increasing, staying
the same, or starting to decline.
Senator McCain. There is no doubt in either one of your
minds that this originated in Mexico. Right?
Dr. Besser. I could not hear that question.
Senator McCain. That H1N1 originated in Mexico, and that
the recorded cases--many of them in the United States--in fact,
the first recorded death tragically was an infant that was from
Mexico and came to Texas. Right?
Dr. Besser. Yes, sir. The first case had traveled from
Mexico.
Senator McCain. Have we considered, if the influenza
continues to increase in intensity, the option of closing our
borders?
Dr. Besser. As we have been doing our planning for pandemic
preparedness--and there has been much planning going on over
the past 5 years or more--the initial strategy, in particular,
for bird flu, was to try and identify the first cases outside
of our borders and to swoop in, as part of an international
team, to try and quench this, to try and treat the initial
cases and contacts and limit the spread so it would not leave
where it was occurring.
If it started to spread from there, we had a strategy of
trying to keep it or delay the entry from our borders. Modeling
data showed us that if we were able to implement some pretty
strict entry screening, we might be able to delay the entrance
into our country for a few weeks to allow us to prepare so that
we would be ready to take care of patients that we would see on
our borders.
We have also learned from the modelers and from experts who
have dealt with SARS during the large SARS outbreak----
Senator McCain. Doctor, I do not mean to interrupt. I do
not mean to interrupt, but I have a question.
Dr. Besser [continuing]. Primary borders and is spreading
from country to country. There is very little value in
intensifying border screening. It is a major use of resources
that could be used in much more productive control efforts.
In my discussions with the Director-General of the World
Health Organization, Dr. Margaret Chan, she led the response to
SARS in Hong Kong, and there they put in place intensive
efforts. Her recommendation to me and her recommendation to the
global community from engaging with the experts in influenza is
that that was not a productive effort during SARS, that cases
were not identified in that way, and that control efforts could
be directed in ways that would be much more likely to be
productive.
Senator McCain. Yet, countries like Singapore and others
are screening people aggressively for people with fever and
others. Is there a scenario that you can see where this
influenza reached a point where we would be required to close
the border with Mexico?
Dr. Besser. Senator, Singapore is, in a sense, how we would
have been had this arisen in Singapore. We might be looking to
see if we could screen and delay the entry of cases from
Singapore into our shores. I would envision that Singapore does
not expect that they are going to be able to keep this out of
Singapore, but if they can delay, they can be more prepared and
be able to manage the situation better.
There are times at which we would look at using border
entry as a way of looking for containing infections and
delaying entry into our shores. This would be the case if we
had a novel strain or a novel type of infectious disease that
was originating outside our borders to allow us time for that
preparation.
At this point, we have this virus spreading across our
country, and what it appears to be is spreading from person to
person without a lot of difficulty, largely with an infection
that is not very severe. The ability to control that by using a
border strategy would not be effective.
Senator McCain. I thank you. Thank you, Mr. Chairman. Thank
you for your good work.
Senator Brown. Thank you, Senator McCain.
Senator Casey is recognized.
Statement of Senator Casey
Senator Casey. Mr. Chairman, thank you very much for
chairing this hearing.
Dr. Besser and Dr. Fauci, we are grateful for your work,
your presence here, your testimony, and for your work going
back many years.
I wanted to focus on two or three areas, but certainly two.
One is capacity and the other is with regard to children.
First, on the capacity question--and this is a tough
question because I am sure you do not have time to do a full-
blown survey of this, but just in terms of capacity state-by-
state or looking at the States as a whole, do you see any
shortfall or any deficiency with regard to what States can do
in two areas? One is just in hospital capacity or bed capacity,
and the other is in terms of any kind of antiviral drugs or any
other medical capacity. Can either of you give us a sense of
that? I know it may be redundant, but I think it is important
to emphasize.
Dr. Fauci. I think Dr. Besser in his interaction with the
States and the territorials would be better to answer that.
Richard.
Dr. Besser. Thank you, Dr. Fauci, and thank you for that
question, Senator.
In terms of State capacity, there is variability. There is,
I would say, dramatic variability. If you look at the
investments that States put into public health, there is
dramatic variability. There will be States that require more
assistance than others. There are States that are really
providing direction for other States. We have built an ability
for States to provide direct state-to-state support for
response.
In the area of hospital capacity, there has been study
after study coming out of the Institute of Medicine that has
been showing that we have very little in the way of excess
capacity in our systems, whether we are looking at our
emergency rooms or we are looking at bed capacity. There is a
lot of working being done much by ASPR, the Office of the
Assistant Secretary for Preparedness and Response, work done by
the Agency for Health Care Research and Quality to provide
guidance around how would you do medical surge capacity,
looking at appropriate standards of care should your regular
capacity be outstretched. That will be helpful. Should this
turn into a strain that was much more severe and requiring more
intensive hospital care, our hospital capacity is not very
great.
In terms of antivirals, we see a similar situation. We
report out each year or every other year on States' capacity to
receive and distribute and dispense antiviral medication, and
you will see, if you look at that report, a variation in terms
of the score. Some of that represents differentials again by
investment within those States so that some States are relying
almost exclusively on Federal dollars, but some of it is that
not all States put the same attention to the issues of
preparedness and response. We have seen issues of complacency.
It has been 3\1/2\ years since our country suffered the
devastating impact of Hurricane Katrina, and in many areas we
see complacency. So there is a difference.
There are differences in States' abilities to purchase
antivirals, and so you will see that there was differential
utilization of the Federal contract to have purchased Tamiflu.
We are nowhere near taxing our reserves of Tamiflu, but we will
find that some States will be exclusively relying on the
Federal stockpile and other States will have their own
stockpiles as well.
Senator Casey. Well, thank goodness we are not being fully
tested yet in terms of capacity, but I know it is something we
are concerned about for the near-term and the long-term.
Second, with regard to children, we hope what we will see
in the next couple of days and weeks is that children are not
disproportionately adversely impacted. We know now that the
first fatality was, I guess, a 23-month-old.
What can you tell us about the approach we have to take
with regard to children, understanding that they are not just
smaller versions of adults? We hear that a lot in our health
care debates. Is there a particular strategy we need to be
focused on with regard to children in terms of the threat posed
by this flu, or is there not? Is there no difference in how we
approach it? Doctor?
Dr. Fauci. Dr. Besser is a pediatrician. So we will ask him
that question.
Dr. Besser. Thank you, Senator. Thank you, Dr. Fauci.
As a pediatrician and as a parent of two young children,
this is something I think about all the time. Your words about
children not being small adults resonate. Frequently when it
comes to drug development, they are treated like small adults,
and so we do not see licensed products for children in the same
way that we see them for adults. There are many gaps in that
regard. We are forced, in a time of emergency, to use emergency
authorization to utilize drugs that are only licensed for
adults--to use those in children. So that is a gap in our
preparedness.
There is a major gap in terms of our capacity should we see
increased impact on the health of children and an increased
need for hospitalization.
This is an important area. The American Academy of
Pediatrics has a disaster preparedness committee that is
focusing on these issues and trying to draw more attention to
them. I think that this is an area that definitely requires
additional attention.
Senator Casey. Thank you very much to both of you. Thank
you for your work.
Senator Brown. Thank you, Senator Casey.
Senator Roberts is recognized.
Statement of Senator Roberts
Senator Roberts. Thank you very much, Mr. Chairman. Thanks
to Dr. Fauci and to Dr. Besser.
We are holding a hearing today to discuss the current H1N1
flu situation. I want to emphasize the H1N1 designation as
opposed to what some call the swine flu. I was instructed not
even to say that, let alone point it out.
I would like to say that this committee has done much to
help better prepare us for a response to an outbreak of this or
any other virus. One of the efforts I am most proud of is the
legislation that I introduced with Secretary of State Clinton
when she was a Senator from the State of New York. We
introduced the Influenza Vaccine Security Act, portions of
which were included in the overall Pandemic and All-Hazards
Preparedness Act. That is a mouthful, but it was signed into
law in December 2006. Those provisions that were signed into
law should really help us prepare for any vaccine development
distribution and tracking that may well occur due to this
virus.
We have also taken important actions on this committee
through the Bioterrorism Preparedness Act reauthorization and
through general oversight to ensure that these agencies
involved are better prepared.
I do have to say, I am just not pleased with the 24-hour
news cycle on this issue. We should not unnecessarily be
creating fear among the American public and some of our trading
partners. If you watch the newscasts on this issue, you would
think in some cases a pandemic was already occurring. That
simply is not the case. Bottom line: The American people need
to be aware and able to protect themselves from the H1N1 virus,
but I do not think we need to scare or terrify the public.
Since we are talking about the media, I also want to point
out what I said earlier, that I represent a State that is a
major agriculture producer. Every time some reporter or some
politician calls this the swine flu, they are doing a
disservice to the agriculture producers in Kansas and also
throughout the Nation. Let us call it what it is, H1N1 virus,
and quit trying to blame it on farmers and ranchers and current
production practices. These claims just do not hold water.
A very clear example, Mr. Chairman, of this is Egypt's
decision to cull their entire swine herd despite any indication
of this virus in their swine or human population. There is no
evidence of the existence of this virus in the U.S. swine
herd--zero--backed up by the World Organization for Animal
Health. Our swine herd and pork products are safe, and I
encourage everyone here, including both doctors, to enjoy two
strips of bacon tomorrow with your breakfast.
Finally, Mr. Chairman, the emergence of this new virus
further demonstrates our need. I know Dr. Besser talked about
complacency. We also need to be prepared to react to disease
outbreaks and undertake the necessary research that allows us
to stay one step ahead of them.
On this front, the Department of Homeland Security
announced in January that it intends to build a new National
Bio and Agro-Defense Facility--the acronym for that, by the
way, is NBAF--in Manhattan, KS. This facility will do research
on existing and emerging diseases. It is the kind of research
that we need to protect the American people, and our DHS
Secretary has said it is a top priority. And it is. I will be
urging our colleagues to support funding--let me repeat that--
to support funding--for the construction of this facility so
that we can move forward on this important research.
I thank the chair.
Dr. Fauci. Thank you, Senator Roberts, for those comments.
They are very well taken. And the name that is now being used,
as you pointed out, is 2009 H1N1 flu. It is important to say
2009 because we do not want people to get confused with the
H1N1 that is a seasonal flu. Your point about calling it swine
flu is very, very well taken, and as Dr. Besser pointed out in
his opening statement, there is no danger in eating pork to get
this particular virus. It would not be appropriate to call it
swine flu.
Senator Roberts. Well, just have a pork chop as well.
[Laughter.]
I would point out that we have the regular flu every
season. Everybody gets a flu shot. Unfortunately, people get
sick and some meet very untimely deaths. This is a different
thing, but we are approaching it in a different way and it
should be labeled correctly. And I appreciate your comments,
sir.
Senator Brown. Thank you, Senator Roberts.
CNN just reported that the World Health Organization just
raised the alert level from 4 to 5. What might that mean, Dr.
Fauci?
Dr. Fauci. I will give you my quick comment, and then turn
it over to Dr. Besser.
It is very likely related to the fact of the increased
evidence of spread in different places. If you look at the
categorization of the levels, that is the level you go to when
you get a more enhanced spread.
I will have Dr. Besser comment more on that.
Senator Brown. Anything briefly you want to add, Dr.
Besser?
Dr. Besser. Yes, thank you. Two comments. That indicates a
recognition of community outbreaks. That is the difference
between phase 4 and phase 5. The important thing for us to
recognize here as Americans is that the label does not matter.
It is what we do, and our actions are driven by what is taking
place here in this country, in our communities. The recognition
of 4 to 5 is of more relevance to countries around the world,
especially less-developed countries that have not been able to
prepare in the way that the wealthier countries have been able
to get ready. I do see that as major should this virus spread
to countries with less resources.
Senator Brown. Thank you.
Senator Reed is recognized.
Statement of Senator Reed
Senator Reed. Thank you very much, Mr. Chairman.
Dr. Fauci and Dr. Besser, thank you for your excellent
work.
Let me raise an issue which may already have been
addressed. I will either make a point or reaffirm a point, and
that is that at the local level the capacity with personnel,
with resources to do what we all know has to be done, even if
they receive adequate Tamiflu or other clinical support, is not
going to be there. I spoke to Dr. David Gifford, our health
director in Rhode Island, today and his major concern is that
even with additional Federal spending, there will not be the
resources at the local level to hire the personnel, the nurses,
the 24-hour hotlines, etc. If I am repeating some of my
colleagues, I apologize, but your comments would be
appreciated.
Dr. Fauci. We will ask Dr. Besser to answer that. We did
discuss it just a bit ago, but I am sure he will be able to
quickly summarize it for you.
Senator Reed. Thank you.
Dr. Besser. There is excellent data from the Trust for
America's Health looking at the impact currently of the
economic downturn on State and local public health capacity. It
is very concerning. We discussed that without strong State and
local public health, it is impossible to respond to emerging
threats such as the one we are currently facing.
Senator Reed. Thank you very much. Again, I think your
comments suggest to us that we have to target resources not
only to vaccine research and to other clinical approaches, but
to some of the more mundane operational approaches of people
and hotline operators, etc.
Dr. Fauci, let me ask a question. We are in the process, I
believe, of preparing a vaccine. I have heard estimates of
taking up to 16-plus weeks to get it online. Would that vaccine
be simply dedicated to the H1N1 flu, or would it try to
anticipate the seasonal flu? If that is the case, do you have
strategy of one that is better than the other, or how will you
proceed?
Dr. Fauci. Right now, we are in very active discussions of
how we are going to in parallel--if we could possibly not
interrupt what we do with the seasonal flu, as well as on a
parallel track, get what we call a monovalent, or a single
individual vaccine for this 2009 H1N1 strain.
Senator Reed, I want to make sure that there is not a
misunderstanding because you used the words ``16 weeks.'' Let
me clarify that, because there is a process that is staged in
how you develop a vaccine. The first thing that is going on
right now is that the CDC has isolated the virus and made it
available for a reference strain, of which you then get what we
call a seed virus to grow up to get a pilot lot to begin to
test the vaccine for the right dose, the safety, whether it
induces an immune response. The couple-of-month process that
that generally takes is not having a lot of vaccine at your
disposal to distribute. The process of vaccine development
really started right from the point that the CDC isolated that
virus.
Senator Reed. Well, I think that is an important point to
make, Dr. Fauci. I do not want either of us to leave here with
the suggestion that in X number of weeks we will have a vaccine
for everyone who needs it.
Dr. Fauci. Exactly. That is a very good point.
Senator Reed. Thank you, Dr. Fauci.
Let me go back also to the issue that Senator Casey raised
about children and with respect to immunization and vaccine.
Are you going to target--or is part of your strategy to target
certain groups to receive this H1N1 vaccine, or is it going to
be available, have you thought about, across the board?
Dr. Fauci. I will answer part of it and then give the rest
to Dr. Besser.
Again, with your permission, Senator Reed, I want to
emphasize the difference between the process of developing a
vaccine and administering a vaccine. It is very, very
important. There is no talk about administering. We are in the
process of trying to get it online.
With regard to the various categories of who you give it
to, I will yield that to Dr. Besser.
Dr. Besser. Thanks, Dr. Fauci.
That is a very important question, who should get a
vaccine? As we have been doing pandemic planning for avian flu,
we have had discussions around who should get an avian flu
vaccine when that is available.
In the scenario that Dr. Fauci is talking about in terms of
the process for manufacturing a vaccine, there is a period of
time there that allows for real community engagement so that
the public can be involved in the discussions around that. In
1976, we all remember the issues around swine flu vaccine, and
we do not want to repeat that. We want to make sure that there
is engagement with the broader public in this decision. There
are issues around who is at most risk of dying or having
adverse events from this flu that we do not have the answers
to. That information will be very useful in defining the risk
groups for this particular infection. Apart from the science,
which can say who is at risk, there is a societal decision that
would need to be made. There is a policy decision, and clearly,
we would want to engage broadly in that process.
Senator Reed. Thank you all, gentlemen. Thank you, Dr.
Fauci. Dr. Besser, thank you.
Senator Brown. Thank you, Senator Reed.
Senator Merkley is recognized.
Statement of Senator Merkley
Senator Merkley. Thank you much, Mr. Chair.
I wanted to step back a moment because I keep seeing in the
testimony and other places that each year in America on average
10,000 to 30,000 individuals die of influenza. What is it about
this particular strain, as it appeared and developed, that
creates so much attention? I mean each year we have many
different strains appear. Many deaths result. It is, obviously,
a concern for all of us that we work on steadfast. This
particular strain has leapt into the public mind in a
spectacular way. We are all very concerned, but I want to
understand how it differentiates from the many mutations that
occur annually and appear in our population.
Dr. Fauci. When we think in terms of seasonal flu, what it
generally does from year to year is it drifts a little. That is
the word we use. There are mutations that it changes a bit from
year to year, which generally necessitates what you see each
year of a modification of the vaccine that we annually
administer on a seasonal basis.
When a virus changes a bit, it is fundamentally the same
virus with a little bit of differences. Generally what we see
are H3N2's, H1N1's or B. This virus is an entirely new virus
that we have never seen before. There has been what we call re-
assortment of the genes. It has viral genes from a swine, viral
genes from human viruses, and viral genes from a bird. It has
the potential of a pandemic. We have never seen it before.
There is no background immunity in society against that, and it
has the potential to cause widespread disease. That is the
difference between this virus and a virus that might change
just a little bit from season to season.
Senator Merkley. Does the makeup of the genetic code of the
virus give us some clues as to how it may have come to be?
Dr. Fauci. At this point, no. What we do know is that when
you have these re-assortants--they are called re-assortants
because the genes sort of rearrange themselves and join
together. This is very unusual because, one, it is a re-
assortant, but it is also what is called a triple re-
assortment. The molecular analysis has not yet given us a clue
of how or why that happened.
Having said that, I will have Dr. Besser comment because
the CDC was absolutely wonderful in how quickly they got on top
of this virus. So I will leave the other comments.
Dr. Besser. Thank you, Dr. Fauci.
I do not have much to add on that, but I do want to comment
on why people are so much more worried about this virus and
this situation. A number of things.
First, the comment about 36,000 flu deaths a year. I think
that is tragic, and I think that a large proportion of those
are preventable. And if people had the same concern looking at
seasonal flu as we have today about the emergence of this new
strain with pandemic potential, tens of thousands of lives
could be saved.
Right now, we are faced with a period of uncertainty, and
people have fear. Many people in their minds think back to what
they have read and seen about 1918, and that is driving some of
that fear. Some of the comments around fear being paralyzing,
we do not want this to be driven by fear. We want to inform
people. We want people to be concerned, and we want to change
that concern into preparedness and action.
The virus that has been isolated contains four parts, and
as Dr. Fauci said, it has components from many different
viruses that have been seen elsewhere, including a fourth
component that came from Eurasian swine flu.
We are going to continue to share the strains of virus. The
network that NIH has, the research community, is the place
where we will continue to learn more about this and learn more
about how do these viruses arise. Is there any way in which we
can prevent that from occurring in the first place? Is there
any potential for a vaccine that would take care of the entire
flu problem? That is where our biomedical research is so
critically important.
Senator Merkley. Dr. Besser, you mentioned that if we had a
high level of attention to influenza in general, we could have
a huge impact on the tragic loss of 36,000 lives a year. Do you
have some specific thoughts about additional work we should do
to take on that influenza challenge?
Dr. Besser. Thank you for that question.
Some of it has to do with behavioral change, and the
measures that we are promoting right now, the measures of hand-
washing, the measures of personal responsibility when you are
sick of doing what you can to not make other people ill. I know
many schools give an award to children who do not miss a day
the entire year. I think of that as the Typhoid Mary Award
because what it encourages is children to go to school when
they are sick, and they get a certificate for it.
I think we need to encourage the exact opposite behavior
and make it possible for people to go to work if their child is
sick and know that their child will be well cared for. For many
people, they do not have that choice. If they keep their child
home, that means they are not going to work and they are not
getting paid. There are things we need to do as a society to
promote and support responsible behavior. There are things
individuals need to do as well, and we need to learn how do you
get people to view the issue of transmission of a respiratory
infection in the workplace in the same way we currently view
exposure to passive smoke.
Senator Merkley. I thank you both for your expertise and
for your attention to helping us address this issue. Thank you.
Senator Brown. Thank you, Senator Merkley.
Senator Burr has a last couple of questions, but I want to
follow up on Senator Merkley's question, the Typhoid Mary Award
from the Centers for Disease Control notwithstanding, because I
thought that was exactly the right question to ask. You made
the statement that if we showed the same vigilance and
attention annually for the seasonal flu as we are showing for
the 2009 H1N1, we would save tens of thousands of lives. I
totally support and agree on hand-washing and some of the other
things you said, personal responsibility.
Are there structural things that the public health system
should be doing differently, more thoroughly to pre-empt, to
prevent some of these more regular, if you will, seasonal flu
deaths?
Dr. Besser. There have been efforts taken in terms of
looking at vaccine recommendations. There has been in many
circles a demonization of immunizations, and in order to
address annual flu, it requires annual immunization. Our
infrastructure for administering an annual shot is not as good
as it is for, say, school immunization where there is an entry
point that you can ensure that every child has been immunized
before they start school. We do not really have that mechanism
for annual flu vaccination.
I think we need to think creatively about that, how
seriously do we feel this problem should be addressed, and what
should be done in terms of requiring people to take measures to
prevent influenza each year.
Senator Brown. Could I ask you and Dr. Besser--I assume you
have done some of this, but would you put together for this
committee and share it with me personally and anybody on the
committee. We will start with the committee--your thoughts for
future years on how to--just thinking, focused on putting aside
this potential public health problem right now, but for future
years about how, in terms of both infrastructure--and
infrastructure meaning CDC, local public health departments,
all that--and in terms of personal responsibility what we
should do in the future to better deal with these 36,000--
30,000-some deaths every year, if we can reduce those numbers
and how we would do it, and put together a document for us that
this committee might be able to use in a preventive way in the
future?
Dr. Besser. We would be glad to, Senator.
Senator Brown. Good. Thank you.
Senator Burr.
Senator Burr. Thank you, Mr. Chairman.
I do not want to speak for Dr. Besser. I think it starts
with making sure that the vaccination program for the seasonal
flu is much more productive from the standpoint of the American
people's willingness to participate at all ages. I think that
when you look at the level of participation and then the
infrastructure that it requires to be in vaccine production in
this country, you understand why several years ago we started
in a big hole with Dr. Fauci's efforts to try to regenerate a
vaccine research business, much less the vaccine production
side of this. I look forward at another time, Dr. Fauci, to
talking with you in depth about some of the multipurpose
manufacturing facilities that we can construct that give us the
ability in short order to produce the type of vaccines from the
standpoint of quantity that we are going to need for a true
pandemic or other potential threats.
Any concern, Tony, that you have that the cultivation
through egg-based production might not work? Is that our focus
as to how we would cultivate?
Dr. Fauci. Yes. Right now, a part of the planning process,
you know, a substantial amount, will be through the classic,
tried, true, and used egg cultivations. There are companies, as
you know, through the efforts that you and others and your
colleagues put in to get these programs going, that are trying
to push the envelope and convert ultimately to a cell-based.
There will be a substantial amount of egg-based involved.
I always have concern. The field of vaccinology, although
it does great things, is somewhat fragile in the sense of
things can go wrong and there are land mines. When you do try
to grow up vaccines, most of the time you are very successful
and it is very reliable, but there could be some glitches. I do
not anticipate that there will be. I think the critical issue
that we will be facing with the development of a vaccine is how
well and quickly it grows. If it grows well when we make those
seeds and grow them up, then I think we will be in relatively
good shape.
Senator Burr. Can I assume that the course of treatment
will be designed for one vaccination shot?
Dr. Fauci. Well, no. We do not know that. That is a very
important point, Senator. The question is, is it going to be
one or two shots, and that is why we are doing those trials of
what the right dosage and the dose regimen is. When you get a
vaccine for a virus to which you have had no prior exposure,
not infrequently you need to do more than one dose, two doses
as a possibility. We see that sometimes with children because
they have never had the kind of exposure or experience that we
as adults have had with influenza. There is certainly
possibility, if not likelihood, that there will be more than
one dose.
Senator Burr. It makes it quite challenging----
Dr. Fauci. It does. Indeed, it does.
Senator Burr [continuing]. From the standpoint of the
number of eggs.
Dr. Fauci. Right.
Senator Burr. The last thing, and I would ask this to both
you and Dr. Besser. Let us assume for a minute that the strain
does go dormant this summer at some point. How do we plan for
next fall, and given that the flu strains are so unpredictable,
are there any additional needs that NIH has from Congress or
CDC has from Congress as it relates to next fall's preparation
that we need to begin to talk about now?
Dr. Fauci. We will definitely be coming back to you. The
leadership at HHS has been fully now briefed on all of these
issues that will come up, and we are in very active discussions
about those things. Regarding next fall, I will kick it over to
Dr. Besser.
One of the things that is going to be interesting is what
happens in the southern hemisphere over the summer because that
often--you know, if you make the assumption that it is going to
go low for a while, what is going to happen on the other side
of the globe in predicting what might ultimately happen.
I will have Dr. Besser comment about that.
Senator Burr. Before we go to Dr. Besser, just for the
purposes of all of us, it is possible that you could have a
mutation over our summer and potentially have a different
strain in the fall and we plan for the original vaccine strain?
Dr. Fauci. There is always that possibility. What impact it
would have on the vaccine versus things like virulence and
ability to spread is not predictable. Any of those combinations
could occur. Obviously, with influenza, which is a very mutable
type virus, there is always the potential of that happening.
That could happen in a way that does not necessarily impact the
vaccine but impacts spread and virulence.
Also, I would like Dr. Besser to have the opportunity to
comment on that.
Senator Burr. Dr. Besser.
Dr. Besser. Thank you, Dr. Fauci. [audio interference] and
your comment about the southern hemisphere is very important.
[audio interference] relationships with many things with many
[audio interference] in the southern hemisphere [audio
interference] surveillance [audio interference] are there
changes that are being seen. During the summer, there would
need to be very important discussions and policy decisions
around, do we move forward. In discussions so far, the issues
of could the virus just go away, fizzle out, that is possible.
Could it go away and come back stronger, as was seen in 1918?
That is also possible. We will most likely be in a situation
[audio interference] dealing with infectious diseases and
emerging infectious diseases in particular.
Senator Burr. Mr. Chairman, let me take this opportunity to
thank both doctors for not only their willingness to be here
today, but the expertise that they bring to the country and to
our public health infrastructure. It is absolutely essential
that we do everything we can to provide them with the tools to
do what they do and for us not to substitute ourselves for
them. I think Senator Mikulski made probably the most important
statement at the beginning. Let us put ourselves in a position
where we are rewarded because of how well we planned, not our
ability to respond to an emergency. I think this is one time we
will get our money's worth if in fact, we do that planning.
Thank you both.
Senator Brown. Thank you, Senator Burr.
One last question probably for Dr. Besser. Would you just
tell us what are the signs and symptoms of the 2009 H1N1 virus,
what people should look for, and what they should do if they
see any symptoms?
Dr. Besser. Thank you, Senator.
The symptoms of the 2009 H1N1 virus are no different than
seasonal flu. We wish that there was a telltale sign that we
could say to people. Individuals would look for fever. They
would look for malaise, fatigue, body aches, respiratory
symptoms such as cough. They may have some intestinal symptoms,
some nausea, some diarrhea. Individuals who have those symptoms
who have traveled to Mexico are in a much higher likelihood
group for having this new strain of flu. Individuals who have
flu-like symptoms and have underlying medical conditions should
see their doctors or contact their doctors and see whether they
should come in to be seen. Other individuals who have mild
infection who have been in contact with diagnosed cases should
as well contact their doctors in terms of management. There is
no telltale symptom. It is the symptoms that we look for each
year during the flu season.
Senator Brown. Thank you, Dr. Besser. Thank you for joining
us. Thank you for your public service.
Dr. Fauci, thank you again for joining us and for your
public service.
This hearing certainly again underscores the importance of
a good public health infrastructure, which we are all working
toward. I thank you all for your involvement and your good work
on public health. This committee stands ready to work with the
Administration in dealing with this.
The committee is adjourned.
[Additional material follows.]
ADDITIONAL MATERIAL
Response by Richard E. Besser, M.D. and Anthony Fauci, M.D. to
Questions of Senator Kennedy, Senator Enzi, and Senator Murray
QUESTION OF SENATOR KENNEDY
Current CDC guidelines recommend that healthcare workers use fit-
tested N95 respirators when treating patients infected (or potentially
infected) with the H1N1 influenza in order to protect against
respirable exposure. We understand that some in the infection control
community have been urging CDC to change its recommendation to provide
for droplet precautions, instead of airborne transmission precautions,
and to recommend the use of surgical masks instead of N95 respirators
by healthcare workers who come into close contact with patients. Both
NIOSH and OSHA, the two agencies primarily responsible for workplace
safety, have strongly supported at least the need for N95 respirator
use by health care workers.
Question 1. Is CDC actively considering changing its
recommendations for the protection of health care workers involved in
the care of patients who are suspected or confirmed to have the H1N1
virus? Can you assure the committee that CDC will consult closely with
OSHA, NIOSH and representatives of workers before any changes are made
to the recommendations for protecting health care workers from the H1N1
virus?
Answer 1. When the novel influenza A (H1N1) outbreak began, CDC
issued ``Interim Guidance for Infection Control for Care of Patients
with Confirmed or Suspected Novel Influenza A (H1N1) Virus Infection in
a Healthcare Setting,'' which recommended that ``All health care
personnel who enter the rooms of patients in isolation with confirmed,
suspected, or probable novel H1N1 influenza should wear a fit-tested
disposable N95 respirator or higher. Respiratory protection should be
donned when entering a patient's room.'' The interim guidance noted
that ``this recommendation differs from current infection control
guidance for seasonal influenza, which recommends that healthcare
personnel wear surgical masks for patient care. The rationale for the
use of respiratory protection is that a more conservative approach is
needed until more is known about the specific transmission
characteristics of this new virus.''&
CDC is continually evaluating our guidance as we learn more about
this virus, and we will provide updates to our guidance as appropriate
based on the best available science. Staff from across CDC--including
NIOSH staff--were involved in drafting the interim guidance relating to
protecting health care workers, which was issued early in this
outbreak, and they have been involved in evaluating this guidance as we
have learned more about the virus. CDC has and will continue to
communicate with OSHA and labor unions regarding this guidance.
QUESTIONS OF SENATOR ENZI
Question 1. Dr. Fauci, there are concerns regarding our
capabilities to produce enough vaccines if this flu outbreak becomes a
pandemic. Has the NIH prioritized funding for vaccine research that
explores new cell-based technologies rather than egg-based technologies
that would allow us to ``scale up production'' or more quickly
manufacture a greater volume of vaccine?
Answer 1. The National Institute of Allergy and Infectious Diseases
(NIAID), a component of the National Institutes of Health (NIH),
supports and conducts research on the development of new and improved
influenza vaccines (including the use of cell-based technologies), and
basic immunology research that underpins all vaccine research and
development.
Although egg-based manufacturing methods have been used
successfully for more than 40 years, they are logistically complex and
can lead to delays if the vaccine strain of influenza virus will not
grow efficiently. Furthermore, egg-based production cannot be rapidly
expanded to meet the expected demand that a pandemic event will
generate. To address these concerns, NIAID continues to conduct
research that will help to increase U.S.-based pandemic influenza
vaccine production capacity, and lead to the further development of new
vaccines and manufacturing methods that are faster and more flexible
for influenza vaccine production. While NIAID supports basic and
applied research toward cell-based influenza vaccine production, the
Department of Health and Human Services, through the Biomedical
Advanced Research and Development Authority (BARDA), now leads efforts
to advance cell-based influenza vaccine production as a viable
alternative to egg-based techniques.
NIAID also supports innovative research on new methods that could
allow for ``scale up'' production, or ``stretch'' the existing supply
of influenza vaccines. These methods include recombinant DNA
technologies that yield subunit vaccines, in which influenza virus
proteins are produced in cultured cells and used in a vaccine; DNA
vaccines, in which harmless influenza genetic sequences are injected
into an individual to stimulate an immune response against influenza
proteins; and approaches that use harmless transport viruses to deliver
influenza virus proteins via an injection and stimulate an immune
response. While these candidate vaccines and approaches have not yet
reached the licensing stage, they hold promise as novel methods for
controlling influenza in the future.
In addition, NIAID supports basic and translational research to
develop new and improved adjuvants. An adjuvant is a substance that
augments or boosts a vaccine's effectiveness so that less vaccine is
needed to produce an immune response. Results from NIAID-supported
clinical trials of avian influenza vaccine candidates indicate that one
promising adjuvant increased the immune response and could
significantly decrease the amount of antigen required for each dose and
expand the total supply of this vaccine. NIAID is considering clinical
evaluations of this adjuvant in a 2009-H1N1 vaccine candidate. Several
other promising adjuvants also are currently under development. These
novel adjuvants are still in the testing phase and are not currently
licensed in the United States.
While studies to develop prototype 2009-H1N1 influenza vaccines
that rely on experimental strategies hold promise, such ``next-
generation'' vaccines will require additional safety and efficacy
testing before they can be deployed. Since the candidate vaccines and
adjuvants described above are not yet at the licensing stage, they are
unlikely to reach the public before more traditional types of vaccines
become available for the 2009-H1N1 influenza virus. Because of the
urgency of addressing influenza outbreaks and preparing for possible
pandemics, it is crucial to advance traditional vaccinology as well as
to support basic and applied research on innovative vaccine strategies.
NIH and NIAID are committed to this two-pronged approach to be as well-
prepared as possible to respond to urgent public health needs.
Question 2. Dr. Fauci, has the NIH invested in new technologies
that will result in therapies for flu that are not susceptible to drug
resistance?
Answer 2. Antiviral medications are an important counterpart to
vaccines as a means of controlling influenza, treating infection after
it occurs and, under certain circumstances, preventing infection prior
to or immediately after exposure. Although the 2009-H1N1 virus is
currently sensitive to oseltamivir (Tamiflu) and zanamivir (Relenza),
it is important to recognize that resistance to influenza antiviral
medications frequently emerges. In fact, over the past 2 years, the
circulating seasonal H1N1 influenza viruses have become oseltamivir-
resistant, even while other influenza viruses have remained sensitive
to the drug.
NIH has been working to develop and test the next generation of
influenza antivirals. Three new drugs are now in clinical testing: a
long-acting neuraminidase inhibitor; an inhibitor of the enzyme that
replicates viral genes; and a drug that prevents the virus from
entering human lung cells. NIH soon will evaluate how well these
candidate antiviral drugs block the 2009-H1N1 strain. If they are
determined by FDA to be safe and effective, these antiviral drugs will
increase the arsenal of approved therapeutics available to physicians,
expanding our options against influenza strains that are resistant to
currently available drugs. NIH also is screening numerous additional
compounds for activity against influenza, including the current H1N1
strain.
NIH also supports an extensive research portfolio on human
immunology. This research focus represents an important strategy for
tackling drug resistance, as the ability to prevent or reduce infection
by enhancing the body's immune response has the potential to improve
outcomes and reduce disease burden even if a pathogen is drug
resistant.
Question 3. The National Strategy for Pandemic Influenza designates
the U.S. Department of Health and Human Services as the leading agency
for pandemic preparedness. Is it also the leading agency for response?
There have been multiple reports from several agencies. If this becomes
a pandemic, will we have a central command? Who is in charge?
Answer 3. As stated in the National Response Framework, HSPD-5, and
other guiding documents, the Secretary of Homeland Security would serve
as the leader of the Federal response. The Department of Homeland
Security (DHS) through the Federal Emergency Management Agency (FEMA)
is responsible for the coordination of the overall Federal response
during an influenza pandemic, including development of a common
operating picture for all Federal Departments and Agencies, and
ensuring the integrity of the Nation's infrastructure, domestic
preparedness and response capabilities, domestic security and entry and
exit screening for influenza at the borders. DHS will work closely with
all Federal partners, including the Department of Health and Human
Services (HHS), that have responsibilities in preparing for and
responding to a pandemic.
Each Federal Department is responsible for coordination of pandemic
influenza response efforts within its authorized mission under the
National Response Framework and its own agency authorities. Lead
departments have been identified for the public health and medical
response (HHS), international activities (Department of State) and the
overall domestic incident management and Federal coordination (DHS/
FEMA).
The Secretary of Health and Human Services will fulfill the major
responsibility of overseeing the public health and medical response
during a pandemic under section 2801 of the Public Health Service Act
and under Emergency Support Function (ESF)-8, including coordination of
domestic disease containment and control activities. Among other
responsibilities, HHS will lead the procurement, stockpiling,
deployment and distribution of vaccines, antiviral drugs and other
life-saving medical countermeasures from the Strategic National
Stockpile and coordinate the use of Federal public health and medical
personnel.
There is close cooperation between the DHS Principal Federal
Officials for Pandemic Influenza and the HHS Senior Health Officials
for Pandemic Influenza in this lead role. In support of domestic
incident management during a pandemic, DHS has organized the Nation
into five pandemic influenza regions (Regions A through E) and the DHS
Secretary has pre-designated one National Pandemic Influenza Principal
Federal Official (PI PFO) and five Regional PI PFOs for each of the
five pandemic regions. In support of this DHS structure, the HHS
Secretary has pre-identified one National and five Regional Pandemic
Influenza (PI) Senior Health Officials (SHO) to lead and guide HHS
support to States during an influenza pandemic and to support the DHS
PI PFO Team with public health and medical expertise in preparation for
and during an influenza pandemic. These are senior departmental
officials including Public Health Service (PHS) Flag Officers who are
dedicated to the response. During a pandemic, HHS PI Senior Health
Officials will deploy to the five Pandemic Regions to support the DHS
PFOs with public health and medical expertise, to coordinate HHS
strategic decisionmaking and provide liaison between the PFO and HHS
activities and assets deployed in the region. We convene a monthly
teleconference meeting and a quarterly in-person meeting in Washington,
DC, and also conduct joint training and exercises to coordinate
activities in this leadership role.&
On a regional level, the HHS Regional Health Administrators, often
with their DHS colleagues, lead regular regional meetings and exercises
with the State health directors and State, local and tribal emergency
preparedness personnel as well as continuing engagement with the
National Governor's Association pandemic influenza exercises.
Question 4. Is the Public Health and Social Services Emergency Fund
adequately funded to respond to the threat of a flu pandemic?
Answer 4. On April 30, 2009, the Administration submitted a
proposal requesting $1.5 billion in supplemental appropriations for
H1N1 response and preparedness activities. On June 2, 2009, the
Administration submitted an additional and contingent request for
additional resources to prepare the Nation in the event of a potential
H1N1 influenza pandemic. On June 25, 2009, Congress appropriated $7.65
billion to HHS for pandemic influenza preparedness and response in an
fiscal year 2009 supplemental to respond to the novel H1N1 influenza
pandemic. In addition to the immediate H1N1 response, this funding
allows HHS to prepare for the potential future outbreaks or emergence
of a new flu strain and provides additional funding in the event of an
escalation of the H1N1 virus or other influenza strain. The funding
includes $200 million for the Centers for Disease Control and
Prevention (CDC) and $350 million to support State and local
activities.
The FY 2010 Budget builds on the supplemental request with another
$584 million for HHS, including $276 million in no-year funds and $308
million in annual appropriations. The no-year funds requested for
fiscal year 2010 will go toward the Department's continuing efforts to
prepare for future outbreaks by supporting ongoing contracts to develop
vaccine technology and production capacity and to develop the next
generation of antivirals, diagnostics, and ventilators. The annual
funds in fiscal year 2010 will be used to expand domestic and
international surveillance and detection capabilities, accelerate
research and development of rapid diagnostic tests, improve pandemic
preparedness and response capabilities, and support international
efforts to strengthen public health and vaccine infrastructure.
Question 5a. Dr. Besser, do we have the necessary tools to test
people quickly and accurately crossing our borders to monitor the
migration of pandemic flu?
Answer 5a. CDC's Quarantine System has the capability to assess
reported symptoms of illness in travelers. However, we are not able to
determine immediately whether the cause of a person's illness is the
novel H1N1 virus or some other common virus such as the seasonal H3N2
influenza virus or adenovirus, for example. Definitive diagnosis of
novel influenza H1N1 virus infection requires special laboratory tests
that are not available at the border crossings. It is also important to
remember that people infected with any influenza virus don't show
symptoms during the first 24 to 48 hours after infection, and may not
develop an elevated temperature during their entire illness.
Question 5b. How quickly are you able to determine the health
status of that person?
Answer 5b. The laboratory tests that are authorized for use to
confirm if a person has the novel H1N1 virus can only be performed at
CDC and a few laboratories in each State. It can take several hours or
even days to get results, depending in part on how far the specimen
needs to be transported for testing and the urgency of the situation.
Question 5c. Can you test for the flu virus on the spot?
Answer 5c. We do not have the capacity to identify the novel
influenza H1N1 virus or any other specific influenza virus on the spot.
Rapid tests that identify influenza A and B are available and can be
performed by trained staff anywhere. However, in addition to being
unable to identify specific virus subtypes (i.e., they can't
differentiate between normal seasonal influenza viruses versus the
novel H1N1 virus), these rapid tests can miss as many as one-third of
influenza infections. Said in another way, among people that are
infected with influenza, the rapid tests may not detect influenza in
many of those people. Subtyping of influenza A viruses (i.e. testing to
see if an influenza A virus is the novel influenza H1N1 or a seasonal
influenza strain) requires specialized testing at laboratories with
highly sophisticated technology and specially trained staff.
Question 6a. Dr. Besser, in the Senate version of American Recovery
and Reinvestment Act, $870 million was included for pandemic flu, but
was stripped and replaced with general funding for prevention and
wellness that totaled $1 billion.
Do you have the flexibility and authority to direct funding from
the stimulus towards the Swine Flu response?
Answer 6a. The spending plan for Section 317 Immunization under the
Recovery Act has been approved by HHS and OMB. The 317 ARRA plan
overarching goal is to reach more unvaccinated persons across the
lifespan, including influenza vaccines. Section 317 grantees are in the
process of finalizing spending plans for the operations dollars and
some of these funds could be used for the novel H1N1 preparedness if
determined a priority by the State. In addition, there is still a small
portion of Recovery Act 317 funds that have not yet been designated
that could be used for H1N1. CDC continues to work with HHS to develop
plans for the remaining $650 million under the Prevention and Wellness
Fund.
Question 6b. Is there adequate and consistent funding for pandemic
flu?
Answer 6b. We thank Congress for its strong support of pandemic
influenza preparedness. The level of readiness and public health
response to the current novel H1N1 epidemic would not have been
possible without the help Congress has provided. However, now that the
United States is in a response mode, higher, sustained levels of
funding are needed.
Effective, well-tested preparedness and response programs can
protect public health and minimize illness, death, and the social and
economic disruption. These programs depend on dependable public health
resources available at international, Federal, State, and community
levels. CDC bases continued successful preparedness and response on the
following indicators:
Early recognition and reporting of a human outbreak
through the use of laboratory and epidemiologic disease surveillance
resources, including H1N1 rapid test kits to laboratories throughout
the United States and in other nations.
Rapid assistance with the necessary resources and actions
to contain outbreaks and reduce and delay further spread of disease.
When available, adequate and successful provision of
vaccine to provide prophylaxis to at-risk populations.
Adequate and successful provision of antiviral medications
to treat affected populations.
Question 7. In fiscal year 2008 the Public Health and Social
Services Emergency Fund received $804 million in appropriations and
$570 million for fiscal year 2009, with a total amount of $1.3 billion
for the fund. Is the Public Health and Social Services Emergency Fund
adequately funded to respond to a flu pandemic?
Answer 7. On April 30, 2009, the Administration submitted a
proposal requesting $1.5 billion in supplemental appropriations for
H1N1 response and preparedness activities. On June 2, 2009, the
Administration submitted an additional and contingent request for
additional resources to prepare the Nation in the event of a potential
H1N1 influenza pandemic. On June 25, 2009, Congress appropriated $7.65
billion to HHS for pandemic influenza preparedness and response in an
fiscal year 2009 supplemental to respond to the novel H1N1 influenza
pandemic. In addition to the immediate H1N1 response, this funding
allows HHS to prepare for the potential future outbreaks or emergence
of a new flu strain and provides additional funding in the event of an
escalation of the H1N1 virus or other influenza strain. The funding
includes $200 million for the Centers for Disease Control and
Prevention (CDC) and $350 million to support State and local
activities.
The fiscal year 2010 Budget builds on the supplemental request with
another $584 million for HHS, including $276 million in no-year funds
and $308 million in annual appropriations. The no-year funds requested
for fiscal year 2010 will go toward the Department's continuing efforts
to prepare for future outbreaks by supporting ongoing contracts to
develop vaccine technology and production capacity and to develop the
next generation of antivirals, diagnostics, and ventilators. The annual
funds in fiscal year 2010 will be used to expand domestic and
international surveillance and detection capabilities, accelerate
research and development of rapid diagnostic tests, improve pandemic
preparedness and response capabilities, and support international
efforts to strengthen public health and vaccine infrastructure.
QUESTIONS OF SENATOR MURRAY
Question 1. Dr. Besser, as you know, the earlier detailed potential
pandemic warnings are issued the better the response and the greater
the potential degree of containment. Does the CDC utilize or rely upon
systems that provide the earliest possible detection of infectious
disease threats?
Answer 1. The GDD Operations Center, a component of the CDC's
Global Disease Detection Program and physically located within the
Emergency Operations Center at CDC Headquarters in Atlanta, serves as
CDC's central analytical clearinghouse and coordination point for
international outbreak information gathering and response. Information
about outbreaks worldwide is collected from many sources, including GDD
Regional Centers in Thailand, Kenya, Guatemala, China, Kazakhstan, and
Egypt; CDC programs; and a wide range of public and private sources,
including the World Health Organization, the U.S. Department of State,
USAID, DOD, DHS' National Biosurveillance Integration System,
Georgetown University's Project Argus, the Global Public Health
Information Network, and other governmental and non-governmental
organizations. Information is analyzed using the expertise of
scientists from across CDC to assess all of the information received,
determine the public health threat posed by a given event, and guide
the appropriate level of response.
It is important to understand the process of how reports of
individual infectious cases eventually progress into determinations of
disease epidemics. CDC uses several reporting systems and every month
receives hundreds of reports of unexplained respiratory illness
throughout the world. For example, media scanning systems reported more
than 800 and 600 such outbreaks in March and April 2009, respectively.
The media reporting systems used by CDC are very useful for alerting us
to potential events of international importance; however, the
information in the reports must be further investigated. CDC follows up
on significant reports and consults with country officials,
specifically looking for trends and patterns, particularly of severe
illness, among such reports before classifying them as unusual or
epidemic. Given the numbers of news reports received and the limited
information available in those reports, it is not possible to predict
which events will become significant until there is a definitive
pattern in the disease or the country's government mounts a response.
Highly fatal conditions such as viral hemorrhagic fevers are much
easier to using these alerting systems.
Further complicating the analysis of novel respiratory illnesses is
the ongoing disease burden caused by seasonal influenza, a wide number
of common respiratory pathogens, viral pneumonias, environmental
contaminants, and other diseases that may seem to be notable or
``novel'' in countries with less-than-optimal disease surveillance
capacity.
It is always possible that individual cases of a disease may
circulate before established disease patterns appear. We can reasonably
compare the current situation to the SARS outbreak of 2003. During
SARS, individual cases existed for months before public health
authorities could see the pattern. Looking retrospectively, one media
scanning system had reported the occurrence of undiagnosed pneumonia
during the early phase of the outbreak, but its significance was not
appreciated at the time until there were more cases and international
spread.
Since CDC went into full activation on this outbreak, we have seen
extraordinary leadership from the World Health Organization and our
global partners. In addition, Mexican and Canadian health authorities
have been extremely transparent in their actions and collaboration with
CDC.
Question 2a. Health officials have expressed particular concern
about this flu strain because reports from Mexico indicate that it can
cause severe disease in young adults. That's different from what
happens with the seasonal flu, which tends to be most severe in older
adults and young children.&
Do you know why young healthy adults are being hit so hard by this
virus?&
Answer 2a. As of May 22, infections with this novel H1N1 virus have
been reported mainly in younger people. However, we do not know whether
this is because older people may have some pre-existing protective
antibody to this virus, or whether it is merely that the virus has not
yet spread significantly to this segment of the population. A recent
antibody study was conducted by CDC involved analyzing stored serum
samples from over 350 people in various age groups ranging from 6
months to over 60 years of age. Results from this study showed that
about one-third of adults older than 60 years of age had cross-reactive
antibody against the novel H1N1 flu virus. However, we do not know if
such antibodies provide any protection against the novel influenza A
(H1N1). A possible explanation for the pre-existing antibodies in
adults is that they may have had previous exposure, either through
infection or vaccination to an influenza A (H1N1) virus that was more
closely related to the novel H1N1 flu virus than are contemporary
seasonal H1N1 strains. The findings described above were reported in
the MMWR May 22, 2009/58(19); 521-524.
Question 2b. What are you doing to investigate why the virus hits
this group so hard?
Answer 2b. As part of CDC's H1N1 response, we are continuing to
monitor trends in the reporting of influenza-like illness and are
conducting multiple studies to identify risk factors for developing
severe illness following infection with the novel H1N1 influenza virus.
An article was published in the MMWR on May 22d (58(19);521-524)
showing the results of a recent antibody study conducted by CDC, as
mentioned in the response to the previous question. Other studies are
under way that will examine how long people shed the virus, how long
people can be infectious, how easily the virus is spread, and how
transmission of the virus takes place.
Question 3. How long it will take to develop and test a new vaccine
for this H1N1 strain and the next generation of antivirals Dr. Fauci
mentioned? Are they tracking the virus to monitor whether it is
changing over time?
Answer 3. A key goal of the HHS Pandemic Influenza Plan (Nov. 2005)
is to provide pandemic influenza vaccine to every American within 6
months of the onset of an influenza pandemic. To achieve this goal, HHS
through the Biomedical Advanced Research and Development Authority
(BARDA) invested in the expansion of domestic vaccine manufacturing
infrastructure to increase surge capacity, the advanced development of
new cell-based influenza vaccines, antigen-sparing adjuvant
technologies, the establishment and maintenance of a national pre-
pandemic influenza vaccine stockpile, as well as in next-generation
recombinant approaches that may shorten the time necessary to
manufacture a pandemic vaccine.
From the results of these initial investments, HHS is able to
forecast that the earliest that H1N1 vaccine would be available is
autumn 2009, if epidemiological and viral reasons warrant the
implementation of an H1N1 immunization program. The forecast is based
on the current timelines we developed with HHS agencies, vaccine
manufacturing partners, and the availability of clinical study results
that may inform vaccine formulation. HHS already has multiple active
contracts to obtain pandemic vaccine.
There are no new influenza antiviral drugs that have completed
phase 3 development. However, a neuraminidase inhibitor that can be
given intravenously is under study and consideration for Emergency Use
Authorization (EUA) in severely ill patients with influenza. In
addition, some studies are under discussion to look at combinations of
the licensed antivirals for influenza to explore whether combination
therapy might be a more effective way to combat the virus and decrease
emergence of drug resistance.
There is an international surveillance network that continues to
isolate and characterize influenza viruses that are causing disease in
the general population. These efforts are headed up by the CDC here in
the United States and by the WHO internationally. It was this
surveillance network here in the United States that initially
discovered the 2009-H1N1 virus in San Diego. The monitoring and
characterization of 2009-H1N1 virus isolates continues, and the network
is watching for changes in the virus over time.
Question 4. What steps is CDC or other U.S. agencies taking to work
with other countries to monitor the global spread of disease and
monitor changes in the virus and severity of the outbreak?
Answer 4. CDC is working very closely with public health officials
around the world to respond to novel H1N1 influenza. As of May 19,
2009, CDC has deployed a total of 34 staff to Mexico (including 16
currently deployed) including experts in influenza epidemiology,
laboratory, health communications, emergency operations including
distribution of supplies and medications, information technology and
veterinary sciences. These teams are working under the auspices of the
Pan-American Health Organization/World Health Organization (PAHO/WHO)
Global Outbreak Alert and Response Network and a tri-lateral team of
Mexican, Canadian and American experts. The teams are working to better
understand the outbreak, including clinical illness severity and
transmission patterns, and answer critical questions such as why cases
in Mexico initially appeared to be more severe than those that were
first seen in the United States. In addition, CDC's Emergency
Operations Center is hosting liaisons from PAHO, the European Centre
for Disease Prevention and Control (ECDC) and the China CDC to
facilitate coordination and collaboration. Staff deployments to
Guatemala and Costa Rica have also been supported by CDC.&
CDC is providing both technical support on the epidemiology as well
as laboratory support for confirming cases. We are also assisting
Mexico to establish more laboratory capacity in-country, a critical
step in identifying more cases on which to base our epidemiological
investigation into the spread and severity of this new virus.
Additionally, CDC's Global Disease Detection Program, commonly
known as GDD, has not only been vital in dealing with the current
situation but has also laid a foundation for the United States to
respond to infectious disease outbreaks globally. Established by
Congress in 2004, GDD develops and integrates epidemiologic,
laboratory, surveillance, veterinary, medical, and public health
programs and resources. GDD's Regional Center in Guatemala is providing
evidence that this new virus is expanding south of Mexico. It is also
serving as a regional laboratory for influenza A testing and is
processing samples from suspected cases and identifying those that need
further investigation, including additional testing at CDC
laboratories. Other GDD Centers in Kenya, Thailand, Kazakhstan, Egypt,
and China have increased their surveillance and laboratory testing
activities for respiratory diseases and influenza-like illnesses and
are sharing valuable surveillance information for those illnesses.
These GDD Centers are also providing regional leadership.&
As a WHO Collaborating Center for Influenza, CDC is providing its
real-time RT-PCR protocol and kit for detection and characterization of
H1N1 influenza free of charge to domestic and international public
health institutions, and is providing laboratory testing of specimens
which are not able to be characterized in their country of origin. As
of May 18, 2009, 250 labs in 142 countries have requested these kits;
119 have been provided (either delivered to the recipient or are in
customs awaiting pick-up or additional documentation), and CDC is
working to provide the other shipments as quickly as possible.
In addition to our close collaboration with WHO and affected
country governments, CDC is working closely with other U.S. Government
agencies such as the Department of Defense, Department of State and
USAID. CDC has had staff assigned as a liaison to USAID working first
specifically on influenza planning and now on response, and staff
within CDC's Emergency Operations Center are in daily contact with
USAID experts in Washington. Finally, CDC overseas field staff are
sharing information and working closely with our embassies and USAID
missions overseas in terms of preparedness and response in their host
countries.&
Response to Questions of Senator Burr by Richard E. Besser, M.D.
Question 1. The Pandemic and All-Hazards Preparedness Act (P.L.
109-417) unified HHS' preparedness and response programs under a re-
named Assistant Secretary for Preparedness and Response (ASPR);
however, this office was not represented at the April 29 hearing.
How is CDC collaborating with ASPR to respond to the current
influenza outbreak?
Answer 1. The Office of the Assistant Secretary for Preparedness
and Response (ASPR) has provided ongoing strategic guidance and support
throughout long-term planning for influenza pandemics. As the Federal
response to the current novel H1N1 epidemic continues, ASPR and CDC are
working together to meet both immediate and longer term challenges.
Examples of how ASPR and CDC are collaborating include the following:
Planning for development, production, and use of a
pandemic vaccine.
Communication with partners, stakeholders, and
policymakers on pandemic planning and emergency response.
Engagement with other Departments and Agencies on
technical and policy issues.
Participation in HHS and ESF-8 strategic planning.
Collaboration with BARDA on medical countermeasure
acquisition.
Interaction through CDC and HHS LNOs at respective
Emergency Operation Centers.
Development of guidance for Faith-Based and Community-
Based Organizations.
Review of PREP Act application to 2009 H1N1.
Collaboration with BARDA on joint management of contracts
for development of point-of-care and hospital-based influenza
diagnostic devices; this investigational point-of-care device detected
the first case of novel H1N1 in April 2009.
Collaboration with BARDA on achieving FDA approval of a
PCR diagnostic test for detecting seasonal and non-seasonal influenza,
now being used to detect the novel H1N1 under an EUA.
Question 2a. How will CDC work with ASPR in the coming months to
ensure our Nation is prepared for the upcoming influenza season?
Answer 2a. CDC and ASPR will continue to work together with vaccine
manufacturers, distributors, other Federal agencies, and public health
stakeholders to ensure adequate supplies of seasonal vaccine for the
2009-2010 season.
Each year, CDC and ASPR work closely with other organizations to
plan the Vaccination Education Campaign for the influenza season, which
will begin in September 2009. National Influenza Vaccine Week (NIVW),
scheduled for the last week in November 2009, has become an
increasingly important part of the campaign, emphasizing the importance
of continued influenza vaccination through the latter part of the
season. Over the years, the Education Campaign has been a cost-
effective initiative that has reached ever-increasing numbers of
people, including those within vulnerable groups. CDC will continue its
efforts to make those populations most vulnerable for complications
from seasonal influenza aware of the annual vaccination
recommendations.
CDC will continue to partner with its Immunization Grantees to make
seasonal influenza vaccine available to those populations through
existing programs (Section 317 Immunization Program; Stimulus Funds,
and the Vaccines for Children Program).
Because of the novel H1N1 epidemic this summer, CDC and
ASPR are working with partners to ensure that educational messages are
flexible to meet potential changes in the influenza virus as the season
progresses, such as changes in populations recommended for vaccination.
CDC and ASPR will work to distribute new point-of-care
devices in strategic locations in the United States and around the
globe to assist in early detection of first cases of the novel H1N1
infections.
CDC and ASPR will utilize the Influenza Reagent Resource
(IRR), a CDC-supported reagent stockpile and virus library, to provide
viruses and testing reagents to vaccine, antiviral, and test
developers. In addition, the IRR will distribute testing kits to U.S.
and international laboratories to allow for characterization of
influenza viruses. As of May 18, the IRR has distributed to 95 sentinel
U.S. laboratories and 253 international laboratories.
Question 2b. More specifically, what steps will CDC take to ensure
that our Nation is prepared in the event that a more virulent form of
the 2009 H1N1 virus resurfaces during the 2009-2010 flu season?
Answer 2b. As of May 20, 2009, evidence-based information CDC is
receiving indicates that the current novel H1N1 epidemic (1) continues
to spread among populations in the United States and globally, and (2)
is causing influenza illness similar in severity to seasonal influenza
viruses, except in some people who have underlying illnesses. It is
difficult to predict whether the 2009 H1N1 virus will resurface in a
more virulent form during the 2009-2010 influenza season. However, CDC
is taking critical preparedness steps in case this happens--or in case
another novel influenza virus emerges as a pandemic influenza
candidate. These steps include the following:
While the H1N1 epidemic continues, CDC is analyzing
initial lessons learned and ways the agency might apply these lessons
to a more severe epidemic or a pandemic.
CDC has developed candidate seed vaccines to use in
testing and development of a monovalent H1N1 vaccine.
CDC is working closely with State and local partners (both
public and private) to address concerns or gaps that may occur in the
2009-2010 influenza season.
CDC is working with the World Health Organization,
ministries of health in many countries, and other global partners to
identify and address potential challenges before they occur.
HHS and CDC are working with influenza vaccine
manufacturers to monitor the status of the production of seasonal
influenza vaccine and consider implications of the development of an
H1N1 vaccine on seasonal flu vaccine supply.
CDC is working with HHS, States and vaccine manufacturers
to plan for the distribution of vaccine during the 2009-2010 influenza
season, including the seasonal trivalent influenza vaccine and a
possible H1N1 vaccine.
CDC is working with its Advisory Committee on Immunization
Practices (ACIP) to review its seasonal influenza vaccination
recommendations and identify any necessary policy reviews/
recommendations that will be needed, such as revised vaccination
recommendations based on seasonal flu vaccine supply, or
recommendations related to the implementation of a simultaneous H1N1
vaccination program. A special session devoted to influenza and, in
particular, novel influenza A (H1N1), has been added to the June 2009
ACIP meeting to allow discussion by ACIP members and CDC subject matter
experts of issues related to epidemiology, virology, possible
development of a new vaccine, program implementation, possible use of
pneumococcal vaccines during a pandemic, and use of antiviral drugs.
The ACIP meeting agenda is posted and updated regularly at http://
www.cdc.gov/vaccines/recs/acip/meetings.htm#agendas.
CDC is in the process of developing its annual influenza
vaccination communication campaign and is consulting with its partners
to plan for the inclusion of H1N1 in the annual campaign as
appropriate. CDC will be conducting communication research during the
upcoming months that will inform the development of messages and
educational materials for the public.
CDC will continue to monitor H1N1 and other influenza
virus strains, and will perform influenza disease and antiviral
resistance surveillance during the summer and annual influenza season
both in the northern and southern hemispheres to determine the severity
and spread of the influenza viruses circulating in the United States
and inform disease control measures.
CDC will be closely monitoring events in the southern
hemisphere this summer to inform disease control measures in the
northern hemisphere during the fall and winter months.
CDC will be providing reagents to U.S. and international
laboratories through the Influenza Reagent Resource. This will provide
a stockpile of diagnostic reagents to assure that adequate testing is
performed to monitor changes in the virus that might indicate a vaccine
mismatch or might indicate rising antiviral resistance.
Response to Questions of Senator Burr by Anthony Fauci, M.D.
Questions 1a and 1b. On April 29, CDC and NIH testified that the
Department was working to develop a vaccine seed strain specific to the
2009 H1N1 influenza, which is the first step in manufacturing a
vaccine. Has the decision been made to proceed with manufacturing a
vaccine specific to the 2009 H1N1 influenza strain?
(a) If so, does the Department plan to pursue a monovalent vaccine
or fold this new vaccine into the seasonal flu vaccine?
(b) If a decision has not yet been made, when will HHS make that
decision and will there be sufficient time to manufacture a vaccine for
the upcoming flu season if that is the approach the Department pursues?
Answer 1a and 1b. A key goal of the HHS Pandemic Influenza Plan
(Nov. 2005) is to provide pandemic influenza vaccine to every American
within 6 months of the onset of an influenza pandemic. To achieve this
goal, HHS through the Biomedical Advanced Research and Development
Authority (BARDA) invested in the expansion of domestic vaccine
manufacturing infrastructure to increase surge capacity, the advanced
development of new cell-based influenza vaccines and antigen-sparing
adjuvant technologies, the establishment and maintenance of a national
pre-pandemic influenza vaccine stockpile, as well as, in next-
generation recombinant approaches that may shorten the time necessary
to manufacture a pandemic vaccine.
Question 2. If HHS has decided not to proceed with manufacturing a
vaccine, what are the implications for the upcoming flu season?
Answer 2. From the results of these initial investments, HHS is
able to forecast that the earliest that H1N1 vaccine would be available
is autumn 2009, if virus transmissibility and disease severity warrant
the implementation of an H1N1 immunization program. The forecast is
based on the current timelines BARDA developed with other HHS agencies,
vaccine manufacturing partners, and the availability of clinical study
results that may inform vaccine formulation. HHS has multiple active
contracts to obtain pandemic vaccine including H1N1 vaccine and
adjuvants. On May 22 HHS Secretary Sebelius announced $1.1 B in support
of vaccine development by HHS agencies and the acquisition of vaccine
components--H1N1 bulk antigen and adjuvants--to establish an initial
stockpile of H1N1 vaccine using all remaining HHS pandemic influenza
funds. More H1N1 vaccine may be acquired during the summer months
provided new funding becomes available. In September 2009 decisions on
whether to acquire additional H1N1 vaccine from vaccine manufacturers
may be made based on the results of clinical studies that will inform
vaccine formulation, H1N1 virus spread that will inform whether an
immunization program is needed, and the availability of funds. If a
vaccination program is initiated, then vaccine may be available in late
October 2009 for immunization in the United States. Vaccination in
States will follow the availability of vaccine for several months
thereafter.
[Whereupon, at 4:38 p.m., the hearing was adjourned.]