[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

=======================================================================

                                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

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


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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

                               __________

                               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

                              ----------                              


                       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.]

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