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[Senate Hearing 108-146]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 108-146

        THE SMALLPOX VACCINATION PLAN: CHALLENGES AND NEXT STEPS

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             FIRST SESSION

                                   ON

    EXAMINING THE FEDERAL ROLE AND ITS IMPLEMENTATION OF A NATIONAL 
 SMALLPOX VACCINATION PROGRAM, FOCUSING ON PREVENTION AND PREPAREDNESS 
                               STRATEGIES

                               __________

                            JANUARY 30, 2003

                               __________

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

84-743              U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2003
____________________________________________________________________________
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  JUDD GREGG, New Hampshire, Chairman

BILL FRIST, Tennessee                EDWARD M. KENNEDY, Massachusetts
MICHAEL B. ENZI, Wyoming             CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee           TOM HARKIN, Iowa
CHRISTOPHER S. BOND, Missouri        BARBARA A. MIKULSKI, Maryland
MIKE DeWINE, Ohio                    JAMES M. JEFFORDS (I), Vermont
PAT ROBERTS, Kansas                  JEFF BINGAMAN, New Mexico
JEFF SESSIONS, Alabama               PATTY MURRAY, Washington
JOHN ENSIGN, Nevada                  JACK REED, Rhode Island
LINDSEY O. GRAHAM, South Carolina    JOHN EDWARDS, North Carolina
JOHN W. WARNER, Virginia             HILLARY RODHAM CLINTON, New York

                  Sharon R. Soderstrom, Staff Director

      J. Michael Myers, Minority Staff Director and Chief Counsel

                                  (ii)

  

                            C O N T E N T S

                               __________

                               STATEMENTS

                       Thursday, January 30, 2003

                                                                   Page
Gregg, Hon. Judd, a U.S. Senator from the State of New Hampshire.     1
Gerberding, Julie L., M.D., Director, Centers For Disease Control 
  and Prevention, Atlanta, GA; and Anthony S. Fauci, M.D., 
  Director, National Institute of Allergy and Infectious 
  Diseases, Bethesda, MD.........................................     7
Frist, Hon. Bill, a U.S. Senator from the State of Tennessee.....    13
Schuler, William J., CEO, Portsmouth Regional Hospital on behalf 
  of the Federation of American Hospitals, Portsmouth, NH; 
  William J. Bicknell, M.D., Boston University School of Public 
  Health, Boston, MA; Jon Abramson, M.D. on behalf of the 
  American Academy of Pediatrics, Washington, DC; Martha Baker, 
  R.N., Co-chair, Service Employees International Union (SEIU) 
  Nursing Alliance, Washington, DC; and Kim Bush, President, 
  Vaccines Division, Baxter Healthcare Corporation, Washington, 
  DC.............................................................    26

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Julie L. Gerberding, M.D.....................................    47
    Anthony S. Fauci, M.D........................................    52
    William Schuler..............................................    55
    William J. Bicknell, M.D.....................................    59
    Jon Abramson, M.D............................................    64
    Martha Baker.................................................    66
    Baxter Healthcare Corporation................................    69
    Patrick M. Libbey............................................    74
    Response to questions of Senator Gregg from:
        William Schuler..........................................    76
        William Bicknell, M.D....................................    77
        Jon Abramson, M.D........................................    81
        Martha Baker.............................................    82

                                 (iii)

  

 
        THE SMALLPOX VACCINATION PLAN: CHALLENGES AND NEXT STEPS

                              ----------                              

                       THURSDAY, JANUARY 30, 2003

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:00 a.m., in 
room SD-430, Dirksen Senate Office Building, Senator [chairman 
of the committee] presiding.
    Present: Senators Gregg, Frist, DeWine, Kennedy, Dodd, 
Mikulski, Jeffords, Reed, and Clinton.

                   Opening Statement of Senator Gregg

    The Chairman. Good morning, everybody. I understand Senator 
Kennedy is at the Estrada hearing of the Judiciary, so he may 
or may not be arriving later. I know a number of other members 
are coming but since everybody is here, I thought we could 
start a little early, which is a nice way to begin.
    Today we are taking on the issue of how we address the 
smallpox vaccination question for our society. This has become 
a critical question of healthcare and of national protection. I 
view this obviously as an issue of national security.
    The way I see it, and I have spent a considerable amount of 
time on this even before we had the problems that we are 
confronting today, is that if we are able as a society to put 
ourselves in a position of being ready for a smallpox attack, 
the likelihood of it occurring will be significantly less. It 
would be unlikely that the terrorists would use the smallpox 
virus against us if they knew that the damage that they were 
going to cause was going to be dramatically reduced because a 
large number of Americans had been immunized and were not going 
to be impacted by their attack. So I think it is one of these 
situations where if we are able to prepare properly, we will 
never have the event.
    On the other hand, if we do not prepare properly, the event 
is a possibility. We know that our enemies, the people who have 
already struck at us and harmed us, would use this weapon if 
they had it. We regrettably are not sure who does have it by 
now and we therefore need to prepare ourselves.
    I congratulate the administration for its aggressive 
initiative in this area and it is nice to have today before us 
the two leaders in the administration on this issue.
    I think there are three issues which I would like this 
hearing to focus on. No. 1 is how we deal with vaccinating the 
general public. No. 2 is how we deal specifically with 
vaccinating children. And number three is how we deal with the 
very, I think, important issue of compensation. I do not 
believe we can get people to participate in a general 
vaccination program or even in a targeted vaccination program 
unless we have set up a structure so that, in those rare 
instances where there is harm caused as a result of the 
vaccine, people understand that they are going to be able to 
receive at least pecuniary protection. So that becomes a major 
element of this question.
    Just for the record, when other members decide to be here 
the way we are going to proceed in this committee is that we 
are going to have opening statements by myself and Senator 
Kennedy and should the majority leader, and I am assuming the 
majority leader will be here, he will obviously be granted the 
opportunity for an opening statement. Then we are going to go 
to five-minute questioning periods and the order of questioning 
will be determined by the order of arrival.
    [The prepared statements of Senators Gregg, Enzi, and 
Mikulski follow:]

                  Prepared Statement of Senator Gregg

    I would like to thank all of our witnesses for taking the 
time to come here today to discuss the implementation of the 
Administration's smallpox vaccination plan.
    While smallpox no longer occurs naturally, some in the 
intelligence community are concerned that countries like Iraq 
and North Korea may possess samples of the virus. Highly 
contagious and easily dispersed in the air, smallpox virus can 
be a deadly weapon in terrorist hands.
    Congress and the Administration have responded to this 
potential threat by purchasing 300 million doses of smallpox 
vaccine and by developing a plan to protect the American people 
against such an attack.
    In accordance with this plan, the smallpox vaccine would be 
offered to 500,000 health care workers, expand to 10 million 
emergency responders, and extend to the rest of the population 
as early as 2004.
    As a strong advocate for making the smallpox vaccine 
available to the general public, I think the plan was 
thoughtful and on the mark. Americans, after consulting with 
their doctors, should be allowed to make voluntary, informed 
decisions to receive the vaccine for themselves and their 
families.
    The more people who are vaccinated against smallpox, the 
lower the rate of transmission of the disease, and the greater 
likelihood that such an outbreak could be contained. Also, the 
fewer people who are susceptible to the disease, the less 
likely an enemy is to use it against us.
    Health care worker vaccinations began on Friday, January 
24. The National Institute for Allergy and Infectious Diseases, 
the CDC, and its state and local partners should be commended 
for planning the pre-event smallpox vaccination program and for 
helping it become operational so quickly.
    As with any comprehensive program rolled out under such 
exigent circumstances, there are some questions and concerns.
    These areas include logistics; provider education and 
training, including screening for contraindications and 
treating adverse reactions; and preventing the vaccine's 
inadvertent transmission.
    There has also been no pediatric testing of the smallpox 
vaccine--only on adults. Most adults don't want the vaccine for 
themselves, so much as to protect their children. Children are 
not small adults, and we need to make sure that our stocks of 
smallpox vaccine are safe and effective for children--
notwithstanding recent positive testing in adults.
    I am also sympathetic to the concerns of our health care 
and emergency workers who volunteer to be vaccinated. They will 
be on the front line in responding to any smallpox attack, and 
we must ensure that their health and safety is protected, and 
that persons who suffer serious adverse reactions to the 
vaccine have appropriate recourse.
    While some have called for a new federal ``no fault'' 
workers' compensation program to cover smallpox-vaccine related 
injuries, we need to remember that states already have such 
systems already in place.
    Vaccinated workers are not the only group of people who 
could be injured; co-workers, family members, patients, and 
others could become infected inadvertently. These persons could 
not file a claim under any state workers' compensation program.
    I'm looking forward to hearing our witnesses on this issue, 
and will continue to work with the Administration, my friends 
across the aisle--and especially our health care and emergency 
workers--to address this important issue.
    We need to ensure that the children and families of these 
workers are protected.
    Finally, we need to know what Congress must do to ensure an 
adequate supply of smallpox vaccine, the development of a safer 
smallpox vaccine, and the development of vaccines to address 
other biological threats.
    In light of these issues, some have urged that the smallpox 
vaccination program be delayed. I strongly disagree. 
Considering the potential threat to our nation posed be a 
smallpox attack, we must continue to move forward.
    Even the Institute of Medicine (IOM), which was charged by 
the CDC to provide advice on how best to implement the program, 
does not recommend that it be delayed. In his testimony before 
the Labor, HHS Appropriations Subcommittee yesterday, the Chair 
of the IOM's Committee on Smallpox Vaccination Program 
Implementation, Dr. Brian Strom, made this point clear.
     . . . by recommending that CDC ``proceed cautiously,'' the 
[IOM] committee never implied that CDC was proceeding too 
quickly or without due caution, as has been somewhat misstated 
in some of the press reports on the committee's 
recommendations. The committee did not recommend that the 
vaccination program be delayed or slowed down. The committee 
only encouraged CDC to facilitate local implementation at the 
pace that safety would allow. CDC has acknowledged that these 
are its intentions, and the committee believes that CDC will 
proceed accordingly.
    That is the purpose of today's hearing: To ensure that the 
smallpox vaccination plan continues to proceed safely and 
efficiently. I look forward to hearing from our witnesses.

                   Prepared Statement of Senator Enzi

    Thank you Mr. Chairman. On December 13, 2002 the President 
announced a plan to better protect Americans against the threat 
of a smallpox attack by hostile groups or governments. The 
Administration's smallpox vaccination program is an important 
tool in our fight against bioterrorism. While there is no 
reason to believe that smallpox presents an imminent threat, 
the deliberate release of the smallpox disease is now 
considered a possibility. Now is the time to take precautions 
to deal with this dangerous possibility.
    The Administration has carefully considered the risks of a 
smallpox attack as well as the risks of the smallpox vaccine. 
Their plan represents a targeted, prioritized response to both 
risks. The program recommends vaccination for those civilians 
who would be most critical in responding to a smallpox 
outbreak.
    Approximately 500,000 health care and public health workers 
will be asked to volunteer for the vaccine during Phase I of 
the program. This initial group includes health care workers 
who would treat smallpox cases and public health response teams 
who investigate initial smallpox cases and implement control 
measures. Up to 10 million health care workers and first 
responders subsequently will be offered the vaccine on a 
voluntary basis during Phase II. Pre-attack vaccination of 
these health care workers and first responders will allow them 
to better protect the American public in the event of a 
smallpox attack. These health care workers and first responders 
will be at the front-line of our battle against bioterrorism. 
We must see that they are properly armed.
    Yet the armor--the smallpox vaccine--carries its own risks 
and side effects. In the past, about 1,000 people for every 
million people vaccinated for the first time experienced 
serious, but not life-threatening. reactions. Rarely. people 
have experienced potentially life-threatening reactions. Based 
on past experience, The CDC estimates that between 1 and 2 
people per million people vaccinated will die as a result of 
the life-threatening reactions to the vaccine. Because the 
vaccine contains the live vaccinia virus, the vaccinated 
individual can also potentially infect others.
    Careful screening, education, and training on the 
administration of the vaccine will help to minimize 
complications and secondary exposure. I am very interested in 
hearing our witnesses discuss effective screening, education 
and training measures. I am very proud to have been an original 
cosponsor of the Needlestick Safety and Prevention Act, which 
was enacted to significantly reduce the risk that health care 
workers will contract a bloodborne disease in the course of 
their work. I am very interested in hearing our witnesses 
discuss the needles used to give the smallpox vaccine and 
ensuring its safe administration.
    I'm interested in hearing more about how the CDC and NIH 
are preparing for the possibility of a smallpox attack--both 
initially if our first response if not sufficient. 
Contemplating these scenarios is chilling, but very necessary 
if we are to be prepared for any eventuality.
    While proper screening, education and training can reduce 
complications and secondary exposer, they cannot entirely 
eliminate vaccine risks. Concerns about liability for adverse 
reactions may inhibit manufacturers from making the vaccine. 
Liability concerns may also inhibit health care entities and 
health care professionals from administering, the vaccine. 
Concerns about compensation for adverse reactions may inhibit 
health care workers from getting the vaccine.
    The Administration's smallpox vaccine program is dependent 
on the voluntary participation of manufacturers, 
administrators, health care workers and first responders. We 
must appropriately address these liability and compensation 
concerns to ensure that the Administration's program is 
successful.
    Section 304 of the Homeland Security Act was enacted to 
allay liability concerns so as to encourage the manufacture and 
administration of vaccines. Section 304 designates 
manufacturers and health care entities and workers who 
administer the vaccine to be federal employees for purposes of 
administering the vaccine. The Federal Tort Claims Act (FTCA) 
makes federal employees immune from liability for torts 
committed within the scope of their employment. The federal 
government would then assume tort liability for smallpox 
vaccine related injuries and deaths pursuant to the FTCA. The 
FTCA does not permit jury trials or punitive damages. 
Furthermore, an individual most prove negligence in order to 
recover under the FTCA.
    The Department of Health and Human Services has issued 
guidance on Section 304. However, questions remain about 
liability and compensation for vaccine-related injuries and 
illnesses. Some have argued that the liability protection 
afforded by Section 304 is not adequate. Others have argued 
that the compensation afforded by Section 304 is not adequate. 
Successful implementation of the Smallpox Vaccine Plan requires 
satisfaction of these seemingly inconsistent goals First, we 
must clarify what Section 304 does--and does not--do.
    We need answers to the following questions:
    Who and what activities fall under the liability shield of 
Section 304?
    Does Section 304 preclude recovery, under state workers' 
compensation laws?
    If not, will state worker's compensation cover vaccine-
related injuries and Illnesses?
    Are there individuals who could sustain vaccine-related 
injuries, either directly or indirectly, with no recourse for 
compensation?
    These answers are needed to identify gaps in the 
compensation structure for vaccine-related injuries. Once these 
gaps are identified, we can discuss appropriate measures to 
fill them.
    However, we must be careful to maintain the integrity of 
state workers' compensation systems. State workers' 
compensation laws provide a ``no-fault'' remedy for work-
related injuries and illnesses. In exchange, workers' 
compensation damages are limited and are the exclusive remedy 
against an employer. A new federal workers' compensation system 
upsets the delicate balance created by state workers' 
compensations systems and usurps state autonomy in this area.
    I look forward to hearing from our witnesses about the 
challenges and next steps for the smallpox vaccination program. 
I look forward to working with my Colleagues and the 
Administration to address these challenges so that we may take 
an important step in our fight against bioterrorism.
    Thank you Mr. Chairman.

                 Prepared Statement of Senator Mikulski

    Thank you for holding this hearing, Chairman Gregg. I look 
forward to hearing from the experts about their concerns with 
the Administration's smallpox vaccination plan.
    I have serious concerns that the Administration is rushing 
into this plan, without taking care of doctors and nurses on 
the front lines, and without plans to communicate with the 
public and health care professionals in the event of a smallpox 
attack.
    Vaccine safety is critical. Brave doctors and nurses on the 
front line are volunteering for a smallpox vaccine. They put 
themselves and their families at risk to protect our country in 
a smallpox attack. We owe it to them to make sure they can get 
medical care if they need it, their families will be able taken 
care of if they are injured, and they will not be sued for 
treating their patients.
    There are serious problems with this plan. The federal 
government has done a poor job communicating with the public 
and health professionals. One in five nurses surveyed last week 
did not know that vaccination given within a few days of 
exposure will prevent smallpox. This is unacceptable.
    Let's take lessons learned from the anthrax attacks that 
killed two Marylanders. The government must speak with one 
voice about the risks and benefits of the vaccine. The 
Institute of Medicine (IOM) agrees. IOM recommended that the 
federal government designate one person, a scientist like Dr. 
Fauci or Dr. Gerberding, to be the national spokesperson on 
smallpox.
    The federal government must have a plan to communicate with 
the public, medical professionals, and public health officials. 
Who coordinates with governors? What happens when a case of 
smallpox is diagnosed? Quarantine? Vaccinations? There must be 
clear answers to these questions.
    Vaccinations have begun. I am concerned that the 
Administration has rushed vaccination with out enough attention 
to vaccine safety. How safe is safe? Who set the standard for 
safe? Are safer vaccines in the pipeline?
    There is no compensation to the families for nurses or 
doctors who are seriously injured or die from this vaccine. 
There is no guarantee that first responders can get medical 
care if they get sick. Doctors and nurses are not getting 
vaccinated for personal protection. They are getting vaccinated 
to protect the public. The federal government must protect the 
protectors.
    Questions about liability have not been resolved. Unless 
hospitals, doctors, and nurses are protected from lawsuits, 
this plan will fail.
    States and hospitals are bearing these costs without any 
help from the federal government. The costs to implement this 
plan will be staggering. States will spend about $85 per 
vaccination at a time when states are already strapped for 
cash. States will have to cut back on other bioterrorism 
improvements like building better labs and hiring extra disease 
detectives.
    Hospitals are being asked to bear much of this burden. 
Johns Hopkins in Maryland will reassign immunized doctors and 
nurses so they don't treat patients for a couple of weeks to 
make sure patients do not get sick. These staffing 
reassignments will be especially hard on hospitals because of 
the nursing shortage.
    I am looking forward to hearing from our witnesses today, 
especially Dr. Gerberding and Dr. Fauci. There are many 
questions that must be answered before this country is 
adequately prepared for smallpox.
    The Chairman. At this time I would like to hear from the 
representatives from the government, Dr. Fauci and Dr. 
Gerberding. We will begin with Dr. Gerberding.

   STATEMENTS OF JULIE L. GERBERDING, M.D., M.P.H, DIRECTOR, 
 CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA; AND 
ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY 
             AND INFECTIOUS DISEASES, BETHESDA, MD

    Dr. Gerberding. Good morning and thank you very much for 
having this opportunity to update you on the current status of 
the smallpox vaccination implementation program.
    As you know, smallpox is a devastating, disfiguring and a 
deadly disease. This disease has a mortality rate of 30 
percent. Fortunately, we were able to eradicate it, at least 
the natural disease, but we know that there are countries and/
or entities that have the smallpox virus and could use it for 
purposes of a biological attack on the United States. We do not 
know the quantitative risk of an attack but we know it is not 
zero and we need to prepare to protect the American people 
should that occur.
    In December President Bush announced the policy for 
immunization of Americans against smallpox. He was very 
specific in his policy. The recommendation was that we protect 
the military troops and that we protect those civilians who 
would be in a position to respond to initial cases of smallpox 
and protect the country in emergency situations, and that would 
include emergency medical service workers, healthcare 
providers, and others who would be part of our overall 
emergency response team. The highest priority in this is to 
protect the smallpox preparedness teams, which are the public 
health workers and the clinicians who would take care of the 
very first cases of smallpox.
    We have plans in place and let me just show you on the next 
graphic the progress that has been made over a relatively short 
time frame. In November no States had approved plans for mass 
vaccination of the American public and no States had plans for 
immunization of smallpox response teams or emergency personnel. 
By this month, all States have approved plans for how they 
would in emergencies immunize their citizens and all States 
have plans for how they would immunize the smallpox response 
teams. So we have made considerable progress very fast in terms 
of our planning.
    Let me explain to you on the next graphic how we will roll 
out this immunization program. The States receive $918 million 
in supplemental resources for terrorism preparedness and 
response. By June of this past year they had received the 
entire allocation. In December, as I mentioned, the president 
announced his policy and in January, specifically last Friday 
on January 24, the first stage initiated civilian vaccination 
of emergency response teams.
    As of today, 22 States and two counties have received 
127,200 doses of smallpox vaccine. Thirty-eight States and two 
counties have requested a total of 205,700 doses of vaccine. So 
the States have, I think, made a heroic effort to become 
prepared and are initiating right now vaccination primarily of 
the vaccinators who will staff the vaccine clinics but over the 
next several weeks we anticipate that these efforts will be 
scaling up and ultimately expanding to achieve a level of 
preparedness that will allow us to initiate a wider vaccine 
campaign should we need to in case of an emergency.
    It is important to respect at this point that the president 
specifically did not recommend vaccination of the general 
public at this point but charged us to make vaccine available 
to those who insist on having it in an orderly fashion over the 
next several months. And I remind you that although Secretary 
Thompson has been able to ensure that we have a dose of 
smallpox vaccine if we need it in an emergency for every man, 
woman and child in America, right now we do not have licensed 
vaccine sufficient in quantity or supply to immunize beyond the 
groups that I have already mentioned that were included in the 
president's initial recommendations.
    So we have, I think, stepped up and scaled up our efforts 
but I wanted to also explain what would happen if we had a case 
or a suspect case of smallpox today because I think our 
capacity to respond to this has significantly improved over the 
last several months.
    If we had a case today two things would happen. First of 
all, laboratory samples would quickly be sent to the Laboratory 
Response Network and to CDC so that we could confirm it was a 
case and at the same time, individuals would be getting on an 
airplane from CDC carrying this kit, which contains 1,500 doses 
of vaccine, and they would initiate the initial round of 
vaccine around the suspect case to take the earliest step 
possible to prevent spread to others.
    So I think we have exercised this plan through multiple 
false alarms and we appreciate that the most important 
component of detection really is identification of the first 
case early enough to initiate this level of response, but our 
preparedness has continued to improve regularly over the last 
several weeks. Thank you.
    The Chairman. Thank you.
    [The prepared statement of Dr. Gerberding may be found in 
additional material.]
    The Chairman. Dr. Fauci?
    Dr. Fauci. Thank you very much, Mr. Chairman, for calling 
this hearing, for giving me the opportunity to testify before 
you. I am just going to spend a few minutes talking about the 
vaccine that is being used in the program announced by the 
president and executed by the CDC, talk a little bit about the 
toxicities.
    Dr. Gerberding told you quite well that this is a very 
serious disease with a 30 percent mortality, with no treatment. 
However, what is important is that we have a very, very 
effective vaccine and that vaccine, as you know, historically 
has been responsible for eradicating smallpox in the United 
States and worldwide.
    The vaccine that we are using in the currently implemented 
program is called Dryvax. It is, in fact, a vaccine that you 
and I got when we were children and that, in fact, was used in 
the United States and a version of this, different 
modifications, throughout the world. It is greater than 95 
percent effective.
    However, we know historically, particularly from the 1968 
cohort data, that for every million individuals vaccinated 
there will be between 14 and 52 life-threatening adverse events 
and between 49 and 935 nonlife-threatening serious events with 
one to two deaths. This has been in primary vaccinees. An 
important point, as we know, that if you were previously 
vaccinated the chance of your getting an adverse event is 
considerably less than among primary vaccinees.
    What do we do when we do get an adverse event? The time-
honored approach is to administer a substance called Vaccinia 
Immune Globulin, which is derived from the plasma of people who 
have been formerly vaccinated. Currently we have enough 
Vaccinia Immune Globulin or VIG to take care of the projected 
adverse events that we might expect in the program that is 
being implemented now through the CDC. By this summer we will 
have enough VIG to cover the projected adverse events were we 
to vaccinate 300 million people, which we have no intention of 
doing, only in the event of an attack.
    Also, there are experimental approaches like Cidofovir, 
which is an antiviral drug, that is now in our stockpile to use 
to complement the VIG if, in fact, the VIG fails.
    We are also pursuing something we feel is very important 
from a research standpoint, is to develop a vaccine with 
considerably less toxicities. One of these, called Modified 
Vaccinia Ankara, is actually a vaccine that has been used 
successfully in Germany for a couple of decades during their 
smallpox vaccine program. It is clearly quite a safe vaccine. 
It is an attenuated vaccinia virus. What we do not know for 
sure is its efficacy in epidemic conditions. We are pursuing 
this aggressively together with other attenuated forms and 
hopefully within the next couple of years we will have a 
considerable amount of this were we ever to need it.
    Let me spend the next just minute or so talking to you 
about the broader approach that we are taking in the effort of 
research to counter the microbes that we might be met with in 
the future, including smallpox but also anthrax, botulism, and 
others. We have a research program anchored in our strategic 
plan and a research agenda to cover both Category A and B 
agents and we talked to you about the Category A and B agents, 
the top six in the Category A, and then a larger number of B 
and C agents.
    That program is anchored on the classical NIH approach of 
basic research but with a new paradigm, a paradigm of taking 
that research and accelerating the translation of that research 
into identifiable products in the form of vaccines, 
therapeutics and diagnostics, with the clear collaboration of 
industry, and that is what the president was referring to in 
one of the points he made in the State of the Union Address 
when he referred to Project BioShield, which would be a major 
incentive, one component of it, for industry to get involved.
    And finally, in this last slide I want to emphasize that 
the ultimate goal or vision is to develop universal or wide-
ranging antibiotics, antimicrobials, antivirals that can be 
used against all classes of biological pathogens, to develop 
new platforms for vaccine development and other 
countermeasures, to modulate the immune system that we might 
bolster up capability when we do not know exactly what the 
microbe is, and also to develop molecularly based diagnostics.
    At the end of the day we believe this will have two major 
accomplishments. One will be that it would effectively defend 
us against the microbes of bioterror. But also, since bioterror 
agents are really emerging and reemerging diseases that 
resemble very much the naturally occurring diseases, so that 
what we learn for biodefense will have important implications 
for decades and decades to come in our approach toward emerging 
and reemerging diseases.
    Thank you very much, Mr. Chairman. I would be happy to 
answer questions.
    The Chairman. Thank you, Doctor.
    [The prepared statement of Dr. Fauci may be found in 
additional material.]
    The Chairman. Let us assume that any outbreak of smallpox 
anywhere in the world is a terrorist attack. That is a 
reasonable assumption since the disease has been eradicated. So 
is it not also reasonable to assume that if there is an attack, 
it is not going to occur at one place? It is going to have been 
planned. It will be a multiphased attack. It will involve maybe 
who knows how many people that have been infected traveling on 
what would be very populated areas, either public 
transportation or going to public events. Since smallpox is 
such a huge threat because it can be spread so easily, it would 
be quickly disseminated amongst large numbers of people and 
moved about the country and possibly about the world, depending 
on where the attacks occurred.
    So I think is it not unreasonable to presume that we are 
not simply going to have a single outbreak; that if an attack 
occurs, that we are going to have dramatic multiple outbreaks, 
and that they will be spread out across large areas, large 
population centers, and be very hard to contain? Is that not a 
reasonable assumption?
    Dr. Fauci. Quite a reasonable assumption. There could be 
all of the above. There could be minor moderate or there could 
be multifocal. One would think logically that if there is a 
bioterrorist-led attack with smallpox, that it would be 
something that would have maximum effectiveness in impact, 
negative impact on us. So whether it happens or not, we 
absolutely need to be prepared for it.
    The other important point that you alluded to, Mr. 
Chairman, that is really quite critical to the whole 
preparedness effort is that our experience over decades and 
decades has been against naturally occurring smallpox. We do 
not have any experience of what would happen, for example, on 
an aerosolized multifocal attack throughout the United States 
and otherwise, and that is the reason why, as Dr. Gerberding 
mentioned, we have to have that core of preparedness.
    The Chairman. Which leads me to the second question. Why do 
we presume that vaccinating a small percentage of the 
population would allow us to effectively deal with an attack, 
which would be focussed on the general population and would be 
moving extremely quickly? Is it not inevitable that if we are 
going to keep this attack from occurring that the general 
population has to have been protected before the event occurs?
    Dr. Gerberding. I think that what we are trying to do here 
is balance protection of the general population ahead of an 
attack with what we know to be very harmful consequences of 
this vaccine. And what we have said right now is that it is 
absolutely necessary that we have the preparedness capacity to 
initiate a mass vaccine program if we needed to.
    Initially the recommendations from our experts were that 
the number of people who needed prevent immunization was quite 
small. That number has grown over time as we have begun to 
appreciate that we need to have this level of preparedness in 
every community for the reasons that you, I think, correctly 
outlined.
    But it is also important to appreciate that while this is a 
devastating disease, it is not as infectious as people imagine. 
It is actually not very efficiently spread compared to 
something like measles or influenza. Most, although not all, 
but most of the transmission occurs after people are quite ill 
and when people are ill, their home and the risk that they 
present for spread is primarily to their household contacts.
    There are a few people who disseminate before they are in 
that stage. These are the coughing people or people with very 
profound presentations of the illness. But the experience with 
the people who eradicated this infection over the last several 
decades is that you can contain the infection through an 
incredibly aggressive immunization program if you have the army 
of people available to go out and do that level of vaccination.
    If there is an aerosol exposure to this virus in the 
country there are people who will not be safe from the first 
exposure to smallpox. We know that. That is an honest 
statement. But once we have identified that there is an 
exposure, we will be able to protect most people by 
implementing an immunization program. And as we have more 
licensed vaccine and more capacity to immunize safely larger 
groups of people, we will need to look again at whether our 
initial recommendation should be expanded.
    The Chairman. Do we have the capacity to identify an 
aerosol exposure outside of having people get very sick?
    Dr. Gerberding. As you probably have heard, recently there 
has been deployment of technology that is in the expansion 
phase right now that allows detection of microbes in the air. 
This is a project that EPA is doing in conjunction with CDC, 
HHS and others to detect the organism before it could have a 
chance to cause disease. This capacity is evolving. We look 
forward to improvements in the technology over time but we are 
aiming to be able to detect aerosols before they cause disease 
in the human population.
    The Chairman. But we do not have that capacity relative to 
smallpox right now, do we?
    Dr. Gerberding. We have a limited capacity to do that right 
now for smallpox.
    The Chairman. Limited. How limited?
    Dr. Gerberding. Well, I feel a little uncomfortable about 
discussing exactly where these systems are deployed right now 
but I would be happy to get back to you for the record with 
what we know about it and we can confer with our colleagues 
from EPA.
    The Chairman. OK.
    Dr. Fauci, you mentioned the other vaccine initiatives 
which you are pursuing under this BioShield that was announced 
Tuesday evening. You listed the six Category A or you mentioned 
that there are six Category A. Maybe you could identify what 
those six are and what the status is on each one relative to 
our capacity to protect the society.
    Dr. Fauci. I would be happy to, Mr. Chairman. The six are 
smallpox, anthrax, botulism toxin, tularemia, plague, and the 
hemorrhagic fevers, particularly Ebola.
    We are discussing smallpox. You know quite well where we 
are now with smallpox. The only additional thing is what I 
alluded to, is that we do not want to stop here. We want to go 
to the next generation of much safer attenuated smallpox. That 
would fit under one of the BioShield concepts of being able to 
let industry know that were they to get involved with us in 
making the investment to try and develop a safer form of a 
vaccinia smallpox vaccine, that we would essentially assure 
that that would be purchased even if we had to stockpile it.
    Anthrax, we have a couple of contracts that are now 
directed at developing a safer, better, more effective and easy 
to use anthrax. The current anthrax vaccine is based on taking 
the supernatant or the material in a culture from the growing 
anthrax microbes and using that as the vaccine. It requires six 
immunizations over 18 months. It is not a convenient way to 
make someone protected by vaccination. We are working right now 
on a recombinant what we call protective antigen referred to as 
RPA, which is the next generation of anthrax vaccine, and we 
hope within a shorter period of time, within a period of a year 
to two, to have sufficient quantities of that to essentially 
replace what we are having now with the first generation of 
anthrax.
    Botulism toxin, the approach to botulism toxin is 
fundamentally to develop anti-toxin against it. We have limited 
supplies of a horse-derived anti-toxin that has been used for 
the naturally occurring botulism, usually in children, which 
when children usually from contaminated from food get botulism 
toxin poisoning, they wind up going into respiratory difficulty 
because it paralyzes the muscles' ability to actually breathe. 
That is one of the more devastating effects of this particular 
microbe and its toxin.
    We are processing rapidly the stores of horse anti-toxin 
that we have now that has to be converted from crude gross sera 
into the anti-toxin in its more concentrated form. That is 
going to take a considerable period of time. That is another 
thing we need to accelerate.
    The next generation is to make what we call a monoclonal 
antibody or a very specific antibody that is generally tailored 
and manufactured in an animal but can be converted to a 
humanized form. Once we succeed in that Mr. Chairman, we could 
stockpile an unlimited quantity of that.
    We have Ebola, one of the hemorrhagic fevers, we have very 
good news with Ebola in that we have developed at the NIH and 
others are also involved in this, an Ebola vaccine that has 
been tested in a monkey model and has protected essentially 100 
percent of a group of a dozen or more monkeys that were 
deliberately challenge with Ebola intraperitoneally, and we are 
going into phase one trials now in humans in calendar year 
2003.
    The other two--plague. Plague is a variation disease. We 
have antibiotics that are good against plague. We do not have a 
very good vaccine against plague. We used to have one. It is 
now at the point where it is getting on clinical hold with the 
FDA, so we will have to develop a better one than that.
    And then also tularemia, we have good antibiotics against 
it but we need to get a better vaccine. So those are the----
    The Chairman. Are you doing anything in the chemical area, 
such as with VX gas?
    Dr. Fauci. Not directly, but there are certain aspects of 
chemical and radiation that the NIH will do vis a vis certain 
types of effects on the nervous system, etc, but we are not 
directly specifically doing research. The CDC has a program. 
Also, the Department of Defense also has a program on that and 
we are collaborating with them.
    The Chairman. I want to come back to that but, as I said in 
my opening statement, whenever we have the good fortune to be 
joined by the majority leader, since we are fortunate enough to 
have him on the committee, it is going to be the new 
established tradition of this committee to recognize the 
majority leader when he does arrive and give him the 
opportunity to make any statements or ask any questions.

                   Opening Statement of Senator Frist

    Senator Frist. Thank you, Mr. Chairman and I thank both of 
you for being with us today for an issue that is close to my 
heart and one that I have had the opportunity of working with 
both of you over the last several years.
    I want to welcome both of you formally to the committee and 
thank the chairman for holding this very important meeting. Let 
me just make three quick points and then I ask some questions.
    First of all, I think that it is absolutely critical that 
we support President Bush's plan to vaccinate healthcare 
workers, public health officials, and first responders. The 
range of reasons is clear. From 10 to as many as 14 countries 
have developed offensive biological weapons programs; 
Therefore, it is imperative that we have individuals who are 
going to be first called if something happens right now 
vaccinated. Who are the American people going to turn to if a 
child comes home with smallpox? It is going to be those first 
responders and public health officials.
    It is also incumbent upon us to give the American people an 
opportunity to make an informed decision about being vaccinated 
with a licensed vaccine. This policy introduces the challenges 
that have been addressed and will continue to be addressed.
    I say this because 3 or 4 years ago we would have been 
talking about this as a pure public health initiative. Now, 
this preparation is apart of national security.
    The second point that we must address through legislation 
is liability concerns. Two months ago, the president 
acknowledged this concern. We have to address the fears that 
one may not be compensated if injured from the smallpox 
vaccination--a barrier to immunization. I think the smallpox 
compensations concerns must be addressed by the U.S. Senate, 
and the House and the entire Congress.
    My third point is that this process is part of a long-term 
strategy. This process began with the public health initiatives 
that have gone on for many years. It has been accentuated by 
the bioterrorist threats that we in this building and in 
Washington, DC have seen in a very real way. We must increase 
our knowledge of the use of biological weapons and 
microorganisms as weapons of mass destruction.
    In that long-term strategy, we have to look once again at 
the liability issues and compensation measures for the future 
countermeasures. It comes down to improved communications, 
improved surveillance, improved infrastructure, and in improved 
capacity-building.
    I wanted to make those three points and then I will fall 
back in line for questions here shortly, but once again I want 
to thank both of you for being with us.
    The Chairman. Well, I did State that the tradition was 
going to be that you could also ask questions.
    Senator Frist. No, that is fine.
    The Chairman. OK, then we will go to Senator Reed.
    Senator Reed. Thank you very much, Mr. Chairman. Thank you 
for holding the hearing. Thank you, Dr. Gerberding and Dr. 
Fauci.
    Three critical issues and the leader illustrated many of 
them--safety, cost and compensation. And Dr. Fauci, you talked 
a great deal about the safety but let me for a moment talk 
about cost.
    The State health departments now are challenged to engage 
this program. They also have on-going responsibilities for the 
vaccination, immunization in my children. In my State about 
$250,000 they are committed to in a tough budget time.
    I wonder if there is any thought, Dr. Gerberding or Dr. 
Fauci, to help out the States with this program directly with 
aid and assistance.
    Dr. Gerberding. Thank you. When we distributed the $918 
million to the State and local health governments in June we 
had specific capacities that they were expected to accomplish 
with that allocation. Some of those capacities included 
developing an infrastructure that would allow delivery of 
products in national pharmaceutical stockpile, such as vaccine, 
but we did not include a specific smallpox vaccine program in 
those expectations.
    Since that time obviously we recognize we need to have this 
program get implemented as safely and as expeditiously as we 
can. The States are doing this, in part, with the 
infrastructure support that we have given them. We will be 
making another allocation of $918 million in August, assuming 
the budget evolves as predicted. And we have some 
infrastructure capacity because of the immunization programs 
that you have already mentioned. And, of course, the vaccine 
itself is free.
    But there are gaps in what the States have now and what is 
needed to actually implement this program. We do not know 
exactly what those gaps are. We have never done this before and 
it is very difficult to predict a priori what is actually 
needed.
    There have been all kinds of analyses done to look at this, 
some of them from an economic framework where you are factoring 
all the direct and indirect costs like gasoline to get to the 
clinic, and so on and so forth. But another way of looking at 
it is the way I think most people doing budget look at it, and 
that is what is actually needed to fill the gap between what 
you have and what you are going to have to spend to make the 
program work.
    When we looked at our own economic assessment and then 
tried to identify the gaps in what we are giving people and 
what they need to do the program, we estimated that per person 
on average across the country, the gap would be somewhere 
between $10 and $15 and we picked $13 for planning purposes but 
we recognize as we go forward we are going to have to be 
looking at that very carefully and that is not going to be the 
same in all jurisdictions. In part there is an economy of 
scale, so as you immunize more and more people, the cost per 
person you vaccinate will become less and less. In some places 
where the immunization programs are spread out, the gap may be 
greater.
    And, as I said, the bottom line is we recognize there is a 
gap. We do not know how it is. Right now we are focussing on 
looking for how we can provide somewhere around $13 per person 
who is immunized.
    Senator Reed. Given that gap, are you also going to look 
closely at the maintenance of effort on other vaccine programs, 
immunization programs, so that we do not have the situation 
where the States are literally robbing Peter to pay Paul?
    Dr. Gerberding. Absolutely. We are very concerned about the 
overall situation of public health at the State and local 
level. This is, as Senator Frist mentioned, a system that has 
suffered from long-term neglect and the investments that we are 
making right now are helping but we are dealing with a very 
fragile public health system and we are concerned that all of 
the efforts that we are putting into terrorism preparedness 
right now must serve a duel function. We must make sure that 
these investments also support on-going public health issues, 
such as vaccination of children or long-term imperatives that 
are part of our overall mission.
    Senator Reed. Let me ask a question with regard to 
compensation. Is CDC or anyone looking at the relationship 
between workers compensation programs in the various States and 
someone contracting, a healthcare worker, for example, 
contracting a side effect based on the vaccination? And also 
the private insurance coverage for a situation like this, is 
that being thought through carefully?
    Dr. Gerberding. We believe that we must make sure that the 
people who participate in this program have appropriate and 
fair compensation if they are injured as a result of it and we 
will do whatever we can to make this program successful in that 
light.
    We have been working with the Association of State and 
Territorial Health Officers to assess what is the current 
status of compensation programs and it varies very much from 
State to State. It also varies from facility to facility or 
employer to employer. Many people do have good coverage. Some 
people do not. And many people are concerned that they could 
fall through the cracks of compensation.
    So we are very concerned about this and we are obviously 
trying to learn as much as we can about what gaps exist in this 
program so that we can identify options for filling them.
    Senator Reed. Mr. Chairman, I have one additional question, 
if I may?
    The Chairman. Go ahead.
    Senator Reed. My understanding is that the reporting of 
adverse events is a relatively passive system. It requires 
someone to take the initiative to report it. With respect to 
the safety considerations, are you looking at a more active 
monitoring of immunizations and adverse reactions, something 
more than you have at the moment? And maybe Dr. Fauci, you can 
comment on that. I would assume you want to validate those 
statistics of two deaths in a million, etc.
    Dr. Gerberding. We have several ways of monitoring side 
effects in this program and trying to do this as safely as 
possible really is our overriding priority. We have a 
mechanism; as people come into the vaccine clinics they are 
enrolled in a confidential secure system that operates into a 
database through the Internet. So we will know on a regular 
basis, basically a daily basis, who is participating in the 
vaccine program.
    Once you are in the program, it is necessary to come back 
to have your vaccine site checked to make sure that it was 
effective and that you did develop the pustule there that 
indicates you are protected. So when people come back for that 
seven-day time point, it is the perfect opportunity to actively 
determine whether or not they have experienced any side effect 
or any complication. This is particularly important for the 
more common and less serious side effects.
    In addition to that, some States are doing a more proactive 
survey of individuals and we have a mechanism in hospitals for 
healthcare workers that is being developed at CDC right now so 
that when the infection control nurse or the infection control 
staff check the arms of the healthcare workers who have been 
vaccinated on a daily basis, they can put that information into 
a data system that monitors that yes, the vaccine site is fine, 
there is no spread, there is no threat to patients, and the 
dressing is appropriate, and so forth.
    Finally, for the serious complications, the life-
threatening complications that Dr. Fauci mentioned, we have the 
control over the release of the VIG, the antidote. So in order 
for people to receive the antidote, CDC and our colleagues have 
to know about it, and that is a perfect trigger for us to go 
and investigate, evaluate, learn something, decide whether the 
complication truly is vaccine-related or not.
    And all of this information is regularly presented to our 
Data Safety Monitoring Board, which meets for the first time 
tomorrow, and that is a group of experts who will be monitoring 
the safety of the program as we go forward to try to make sure 
that we are doing everything we need to be doing at CDC to 
protect our volunteers, as well as the patients that they may 
be taking care of.
    Senator Reed. Do you have a comment, Doctor?
    Dr. Fauci. Yes, just a small complementary comment, 
Senator. The information that we will be getting from the 
program that Dr. Gerberding just described will really be very 
important because the data that I showed on my slides is over 
three decades old. It comes from the 1968 cohort. And although 
things are similar, they are not really exactly the same. The 
data I showed you were in primary vaccinees. At least half of 
the people who will be coming into the program for the smallpox 
response teams and the emergency first responders, at least 
half of those will have already been vaccinated. So the 
incidence of toxicities in those individuals will be 
considerably lesser.
    On the other hand, as people say appropriately, in the year 
2002 there are more people that would have immunosuppressive or 
contraindicating conditions. Even though we will be 
aggressively when someone comes in to volunteer, asking them do 
you have a transplant, are you on glucocorticoids, do you have 
eczema or atopic dermatitis, we do not know when those factors 
balance where the 2002 numbers are going to fall in. So that is 
the reason why what Dr. Gerberding is saying is critical and 
important.
    I might also add from a historical standpoint the fact that 
the CDC controls the Vaccinia Immune Globulin, as Dr. 
Gerberding mentioned, is a good indication of how many people 
will actually need it. If you go back 20 some odd years, the 
CDC controlled the administration of Pentamidine for 
pneumocystis carinii pneumonia and it was that monitoring of 
how many people were asking for Pentamidine that was one of the 
big kick-offs and the red flags that we were dealing with the 
very incipient phase of the HIV epidemic.
    Senator Reed. Thank you, Doctor.
    Thank you, Mr. Chairman.
    The Chairman. Dr. Frist?
    Senator Frist. Thank you, Mr. Chairman.
    Dr. Fauci, Congress provided liability protection to the 
smallpox vaccine manufacturers and administrators in the 
Homeland Security Act. When we drafted that legislation, we did 
it specifically for the smallpox vaccine. Your list of 
bioterrorists agents includes tularemia, smallpox, anthrax, 
Ebola, the other hemorrhagic viral fevers, plague. Recognizing 
that each of those agents have had bioweapons programs designed 
around them--which most people do not realize--leads me to 
think that something further than just smallpox vaccine should 
have this liability coverage. Otherwise, every time an agent is 
used, whether it is anthrax here on Capitol Hill and New York 
and Florida or tularemia, or plaque or Ebola, we are going to 
have come back and legislate each and every time. That is not 
very appealing to me as a legislator. We need to address the 
piecemeal liability issue, and I would like for you to comment 
on that.
    The second issue from my opening statement that I want you 
to explore a little bit further is the overall infrastructure 
of our vaccine manufacturing base. The very present risk of 
increased liability exposure when there is such a low rate of 
return to those same manufacturers. Government is not in the 
business of manufacturing a broad range of vaccines, nor should 
we be, nor are we capable of really doing that. At the same 
time, when you have huge liability risk and the potential of 
being literally put out of business, prudent companies, even if 
it is in the national interest, are not going to be focussing 
their business on this critical issues.
    Since the 1970s when I started medical school, we have seen 
a constant decline in the number of vaccine manufacturers from 
say, 12 or 14. I would argue that such a decline in the 
manufacturing base is due to liability concerns. We now have 
four manufacturers in the world making vaccines and only two 
that are actually American companies today that make the 
licensed vaccines.
    At the same time, every year, I or Senator Gregg or one of 
us must go to the floor and comment on the fact that we have 
childhood vaccine shortages. But if we have shortages with 
childhood vaccines which are being used, it is clearly going to 
be difficult for companies to develop vaccines for the 
increasing threat or risk that we have with these agents that 
we have not really thought very much about, including botulism 
toxin. As we sit here, we know that Saddam Hussein has over 
6,000 liters of botulism toxin, the most powerful poison in the 
world.
    We do not have the vaccine infrastructure to develop new 
bioterrorism vaccines today, no matter how good the science is 
at the NIH. We have an obligation to lower the barriers that 
prevent the development of a vaccine infrastructure. I would 
argue much of the infrastructure is disappearing due to a lack 
of a market or a guaranteed market, coupled with this huge 
liability. This is where public health again becomes part of 
the national security problem.
    Could you comment on how you see that playing out? The 
problem is crystal clear to me and it is crystal clear to you, 
but how you see this vaccine infrastructure, national security 
risk and liability playing out?
    Dr. Fauci. You said it very well, Senator, and we really 
appreciate the leadership that you and your colleagues have 
shown with the Homeland Security taking care of the liability. 
But as you so appropriately pointed out, that is one microbe 
and we are talking about the big picture of vaccines.
    Just very briefly, the infrastructure and the lack of 
incentive for companies to either stay in the vaccine field or 
what we hope, to come into the vaccine field because we have so 
many new challenges with biodefense, is exactly what you said. 
The infrastructure has diminished at the same time as they have 
gotten out of the field and there is a concern about liability.
    Addressing the infrastructure component, that was one of 
the issues that we described to you a couple of days ago vis a 
vis the BioShield and getting an incentive so that at the end 
of the day they would know that when they are getting ready to 
go to their board of trustees or their stockholders and say we 
have a good idea, we have some funding from the NIH, we have 
some collaborations with the CDC, but we want to go forward, 
but we do not have any guarantee that anybody is going to use 
this. That is one of the three-pronged components that the 
president announced the other night about Project BioShield.
    We would say we would have a guaranteed assurance that if 
you do get involved and build that infrastructure, that there 
will be a purchase of that material even if we do not ever use 
it and we stockpile it. That addresses building up the 
infrastructure and the confidence of industry that if they work 
with the Federal Government there will be something there not 
only that they will not lose money on it but they could get a 
modest profit out of that.
    Senator Frist. Did you comment on Bioshield in your opening 
statement?
    Dr. Fauci. I just alluded to it briefly.
    Senator Frist. I don't know if Bioshield was mentioned or a 
sentence in the State of the Union or not, but for me, this 
initiative really caught my attention. And the size of it was 
how much? $6 billion. And that is----
    Dr. Fauci. It is less the size of the amount than it is 
what is described as--and you know very well but sometimes the 
general public does not quite understand what it is--it is a 
permanent and indefinite appropriation authority where the 
authority exists that when the secretary of HHS and the 
secretary of DHS come to the realization that we really do need 
a product, the president can then have a finding to say we 
really need to do that. So we could draw out of this mandated 
authority to be able to actually put however much money one 
needs to do that purchase.
    Now clearly the liability issue is a complex issue. It was 
addressed specifically for smallpox. For some but not all of 
the products and the biodefense countermeasures that we are 
talking about, since the Federal Government will essentially be 
the sole purchaser of several but not all of those, that could 
fall and would fall under the Federal Tort Claims Act that 
would cover that component of the liability.
    But I agree with you there are gaps there that we need to 
address and we would be very happy to work together with you in 
addressing them.
    Senator Frist. Thank you, Mr. Chairman.
    The Chairman. This is a huge issue and we do have to get on 
it quickly because we are simply not going to get the vaccine 
industry back up unless we do something in the areas liability 
and compensation.
    Senator Mikulski?
    Senator Mikulski. Thank you, Senator Gregg.
    Senator Frist, I am just so glad that you have found the 
time to be able to--usually majority leaders are not. So good 
to have you here.
    To Dr. Gerberding and Dr. Fauci, welcome. Doctor, I do not 
know you as well as I know Dr. Fauci but look forward to 
getting better acquainted.
    Right now I think there is great fear about smallpox. I 
think there is fear about an attack on the United States and 
being exposed to smallpox but I also think there is now a lot 
of fear around the vaccine to prevent one getting smallpox and 
the fear centers on either dying or having some type of grim 
chronic condition--paralysis, blindness, things that as 
physicians, you could even share with us.
    I want to pick up then on the liability because part of my 
overall questions will be how do we contain the fear, even if 
there is an attack?
    Regarding the liability issue, if a nurse or an emergency 
medical person, first responder, gets the vaccine and they get 
sick where the consequences particularly are chronic, number 
one, who pays for their medical care? And number two, who 
would, say with blindness, then pay for on-going compensation? 
Would the Federal Government pay for that? Who pays for that, 
for their medical care and, of course, their own lost income?
    Dr. Gerberding. Right now the existing mechanism is that we 
are relying on the workers compensation programs that exist 
through the State or the employer and whatever private 
insurance the individual has. Some of these programs are 
comprehensive; some are not.
    Senator Mikulski. Well, how can we move to uniformity? 
Because if we go to your private health insurance, many have 
the exclusion related to an attack of war and smallpox, we are 
not talking about an accidental exposure. This is war where we 
would be exposed to smallpox. So therefore we would be in 
litigation over will the insurance company pay? So that seems 
flawed.
    Workman's compensation is uneven around our country because 
there are 50 different State programs. Have you looked at all 
50 and would all 50 cover this particular situation?
    Dr. Gerberding. Right now I have information from 34 
States. We do not have the information back from all 50. Part 
of it is a State issue but in addition, there are differences 
in how employers within each State provide coverage. Some are 
self-insured and some are not.
    Senator Mikulski. Doctor, would it make your job easier, 
because I have noticed a very tepid response to even the 
voluntary request. In Connecticut only four doctors showed up 
and these are very informed people, far more informed than 
dealing with the general public.
    Do you feel that a national program, tightly written, 
targeted--we are not talking big loopholes or big lawyer fees 
or whatever--do you think that that would get more compliance 
and more rapid compliance?
    Dr. Gerberding. Senator, I believe that we need to do 
whatever it takes to remove the barriers to this program. We 
must have the preparedness capacity that we need to protect 
people. I am not sure I understand what all the barriers are 
and you have mentioned compensation as being one; I think fear 
is another.
    Senator Mikulski. Doctor, we need to understand the 
barriers and we need to understand them quickly. In other 
words, if you have a tepid response, and I think you would 
agree it has been tepid in terms of who is willing to get the 
vaccines now. You do not have thousands of people saying I want 
it because I am ready to serve America, but I am going to be 
protected myself. We are talking about very dedicated people--
nurses, doctors, emergency people. Hasn't the response been 
tepid?
    Dr. Gerberding. Actually I was able to say earlier in my 
testimony that so far, the States have requested--we have 
delivered 127,000 doses at the States' request, so the States 
are expecting to immunize that number of people. What the rate 
of immunization will be remains to be seen.
    What we know is happening right now is that just the 
vaccinators are getting vaccinated so that they will be 
prepared to immunize everyone else. I do not think we are going 
to know for sure how many people are stepping up to the plate 
and when until the program progresses.
    Senator Mikulski. That is up till today. You have only 
heard from 34 States if their workman's compensation would 
cover what we would call medical personnel and of those 34 
States, would they cover both medical treatment and income 
compensation?
    Dr. Gerberding. Of the 34 States that I have information 
on, one State has said it would not.
    Senator Mikulski. So 33 said it would?
    Dr. Gerberding. That there would be at least partial 
coverage, and most are checking to get a comprehensive decision 
from their attorney general.
    Senator Mikulski. You know, if there is blindness or 
paralysis, partial coverage does not cover it.
    Dr. Gerberding. I understand.
    Senator Mikulski. So what would we do about the other part?
    Dr. Gerberding. This is the concern that I share with you. 
There are gaps and we have to find ways to address those gaps.
    Senator Mikulski. Well, I know that my time is just. Just a 
follow-on.
    If a patient gets sick because of they were exposed to a 
nurse or a doctor who has taken the vaccine but inadvertently 
causes one of their patients or someone being carried in an 
ambulance to get smallpox, what is the compensation for the 
patient?
    Dr. Gerberding. Right now the compensation program is not 
available for contacts of people who have been vaccinated and 
are exposed.
    Senator Mikulski. So we have a big job ahead of us. Thank 
you.
    The Chairman. Senator Jeffords?
    Senator Jeffords. Dr. Gerberding, what were the elements in 
choosing which States and counties would receive these initial 
doses of vaccine?
    Dr. Gerberding. What happened was CDC issued guidance for 
States to develop their plans and as the plans were submitted 
this past January, they were reviewed according to the 
completeness of the various elements. As they were approved, 
then States were given permission to request the doses of 
vaccine that they needed to initiate their program.
    As of today all States have approved plans. In one State, 
and I forget which one it is, there is some minor contingency 
that has to be cleared up before we could release vaccine. But 
the vaccine will be made available to every State when they 
request it.
    Senator Jeffords. I know that Vermont was selected. What 
did that mean?
    Dr. Gerberding. It means that the State of Vermont 
contacted CDC and said please ship us vaccine; we are ready to 
go.
    Senator Jeffords. Again what is the plan for evaluating the 
implementation of the smallpox program in the initial stage?
    Dr. Gerberding. I am sorry; I missed your question.
    Senator Jeffords. For evaluation of implementation of the 
smallpox program, what is the plan?
    Dr. Gerberding. The plan is quite comprehensive. In 
addition to monitoring the safety and the mechanisms that I 
described earlier, which include following people who have 
chosen to be vaccinated and using another system for 
identifying people with severe effects, several States are 
working on a program to contact the people who could have been 
vaccinated but chose not to be, to understand why they chose 
not to be included in the program and are we aware of all the 
barriers to participation?
    Senator Jeffords. Dr. Fauci, yesterday you mentioned that 
we need to be prepared against genetic manipulation of some of 
these bacteria and viruses that could be used in a terrorist 
attack. I am concerned that there could be potentially 
unlimited variations of these bacteria or viruses. Could you 
elaborate on these issues and how we can be prepared?
    Dr. Fauci. Yes, Senator. That is an excellent question that 
we continually struggle with.
    The kinds of genetic manipulations fall into two broad 
categories. One is much easier to do than the other. The easy 
one for anyone to do would be to genetically mutate the microbe 
so that it resists or avoids the currently used antibiotics 
against it. The approach to that would be, and that is part of 
our strategic plan, is to have at least two and generally three 
alternatives antibiotics or antivirals that act at different 
parts of the replication or metabolic cycle of a microbe so 
that if it is changed in one way, you will have an alternative 
antimicrobial against it. We have a broad plan to do that.
    The anchor of that plan is to essentially sequence, the 
same way we have sequenced the human genome, to get the full 
sequences of virtually every microbe that could be a potential 
bioterror, the microbes on our various Category A, B, and C 
agents. That is one approach.
    The other approach is a little bit more--in fact, a lot 
more difficult for anybody to do, is to manipulate the microbe 
so that it avoids or counteracts the effect of a vaccine. So 
if, for example, someone were to take a smallpox and 
genetically manipulate it so that if it gets into you it would 
mute or dampen your body's ability to respond appropriately 
even if you were not vaccinated, that falls under the category 
of enhancers of the immune system so that when you develop a 
vaccine, you develop a vaccine that so induces a specific 
response against the microbe that it would overcome even the 
genetic manipulation to try and weaken the body's immune 
system.
    So those are the two strategies. As you say, there are 
infinite possibilities of being able to mutate. However, only a 
few of those would have an impact of being able to still 
maintain the capability of the microbe to infect and hurt you 
because some mutations actually put the microbe out of 
business.
    Senator Jeffords. During the recent mad cow disease scare 
in Europe there was a great deal of concern about prions and 
what role they played in the disease. These are not bacteria or 
viruses, I believe.
    Dr. Fauci. No, they are not.
    Senator Jeffords. Can you tell us more about these? And do 
we need to be concerned about them in our fight against 
bioterrorism?
    Dr. Fauci. We have a lesser concern about the prions, which 
are a protein that actually can self-replicate itself. That is, 
as you alluded to correctly, a protein that is responsible for 
animal diseases and there is a version of it in humans, ovarian 
Jakob Creutzfeldt disease it is called, a big word that does 
not mean much except that that is the name of the disease.
    We are doing research on prion disease at the NIH. We are 
doing it in other parts of the Federal research enterprise. It 
is fundamentally not under the auspices of what we would 
consider a high probability bioterror event. Just by the very 
nature of what it is, I mean if somebody wants to in a 
bioterror way attack our agricultural system with animals in 
the sense of inserting into our animal stock something that 
would cause economic difficulty, as opposed to hurting people, 
but nonetheless this is something that we do have research on, 
but it is not in the big, broad umbrella of a high priority 
biodefense.
    Senator Jeffords. Thank you.
    Dr. Fauci. You are welcome.
    The Chairman. Senator Clinton?
    Senator Clinton. Thank you, Mr. Chairman, and thank you for 
calling this important hearing. I think there are obviously 
going to be a lot of unanswered and maybe at this point in time 
unanswerable questions in the face of these new challenges.
    I greatly appreciate the work that both CDC and NIH are 
doing to develop an adequate supply of medications for those 
who might have side effects, who suffer injuries, lost work 
time, and other consequences as a result of the vaccinations. 
And I do believe we need some kind of system to ensure that 
they are taken care of and compensated.
    I cannot help but add that of course if we had a universal 
healthcare system this would not be as big a concern, but we 
are going to continue to patch away at the old broken system 
and it is just going to get creakier and creakier and squeakier 
and squeakier and leakier and leakier and I think that the 
threat of terrorism, combined with advances in the knowledge of 
the human genome which are going to tell us that we are all 
vulnerable and susceptible to something, should prove to be a 
spur to our dealing with this issue on a much broader level. 
But in the meantime I hope that we will take seriously the 
challenges of providing adequate compensation.
    I have had a different but related experience with respect 
to the World Trade Center health effects on the workers and 
volunteers most directly involved. We did, with bipartisan 
support, set up a program at Mount Sinai to begin to screen 
those people and we had our first report of the outcomes of 
those screenings and we have very high percentages, in some 
cases 50 percent to 80 percent, of decreased pulmonary and 
respiratory capacity, adult-onset asthma, and many other 
issues. And some of the people who were construction workers, 
utility workers, etc. do not have adequate insurance and do not 
have the capacity to either be screened or taken care of. So I 
just think this has to be put into a broader context.
    And from my perspective there is another related issue 
which we have heard about in the news, which is that if we 
underfund this massive vaccination effort, then State and local 
public health departments will be picking up the costs and some 
are already saying that they cannot continue their other work, 
the routine immunizations and other kinds of public health 
work, as well.
    So I am very much looking forward to working with the 
chairman and Majority Leader Frist, along with Senators 
Kennedy, Mikulski, Durbin and myself and our colleagues in the 
House to try to come up with a package of legislation that does 
address these very legitimate issues.
    If I may, Dr. Fauci, I know that there is not anyone who 
knows more and has worked harder on the HIV/AIDS challenge and 
it is clear that we now have not just with HIV/AIDS but with 
other conditions, including eczema in our population, a lot of 
immunosuppressed people, people who are more vulnerable to the 
side effects, and this is a concern that we all have because of 
not only those directly vaccinated but the potential contagion 
effect.
    What will the impact of these immunodeficiencies have on 
the number of injuries, deaths and side effects, as best as you 
are able to extrapolate?
    Dr. Fauci. Thank you for that question, Senator Clinton. It 
depends on the immunodeficiency. For example, if someone has a 
transplantation, they have a kidney or a lung or a pancreas or 
what have you, it is very clear and easy that they know they 
have it, so they would be immediately excluded from any pre-
event vaccination program. Obviously if there is a massive 
attack, we would be vaccinating them if they came into contact 
with a person, but we make sure we have a lot of Vaccinia 
Immune Globulin around.
    We would have to do, and that is part of the program, 
serious questioning to go through the list--eczema, atopic 
dermatitis. Are you on glucocorticoids? Are you taking steroids 
for anything? Do you have an immune-suppressed disease that is 
being treated, like lupus or rheumatoid arthritis? Do you have 
cancer chemotherapy? All of those kinds of things.
    There are other things that obviously are of concern, is 
HIV. We need to question people, is there any possibility that 
you may be at risk for HIV, and if you are, to clearly go and 
get an HIV test. HIV is one of the immunosuppressive diseases 
that we have and if someone is far advanced in HIV, then just 
inadvertently, without knowing it, if they get vaccinated they 
could be in trouble.
    So that is the reason why it is very clear in a vaccination 
program, which is why a pre-event program where you have the 
time to go through those multiple menus of contraindications 
would be very helpful in averting vast majority of inadvertent 
vaccinations for someone who would have a contraindication. So 
we share your concern.
    Senator Clinton. Thank you.
    Dr. Gerberding, I recognize that there are studies of 
smallpox vaccine safety in children currently in progress in 
Cincinnati and Los Angeles; is that right?
    Dr. Gerberding. I would have to defer to Dr. Fauci on that.
    Senator Clinton. Is that right, Dr. Fauci?
    Dr. Fauci. The studies are not going on, Senator. As part 
of the vaccine program for the dilutional study of the Dryvax, 
which is now the product that is being used in its undiluted 
form in the program that Dr. Gerberding described, in the 
dilutional study, if we were going to widely use diluted 
Dryvax, you have three general components of people. Those who 
have been previously vaccinated, that study is done. Those who 
have never been vaccinated before, that study was done. The 
third component was in children but when the clinical trial to 
determine if it actually was still immunogenic in children, was 
there any specific unexpected toxicities in children, even 
though you would not predict it because that is exactly the 
vaccine that you and I got when we were children, but 
nonetheless we needed to do the clinical trial.
    When the clinical trial went before the IRB the Cincinnati 
group felt that it was a reasonable approach; let us do it. The 
UCLA group said you know, we cannot determine on the basis of 
the codes that guide you as to whether or not you can do 
research in children whether the risk/benefit ratio for a 
child, given the current threat, we just cannot make that 
determination as to whether or not we should go ahead with the 
trial.
    So what they did is that they sent it back to the secretary 
and there is a code of regulation that says they need to do 
that. The secretary then took the problem, sent it before the 
Office of Human Research Protection. They had a public comment 
period. Many of the comments came in with concern that for 
children, particularly infants, since they have a greater 
incidence of serious effects, that they felt that it should not 
go on.
    In the meantime it became clear that we were not going to 
be using Dryvax on children anyway because the program would be 
excluding children because it would be for health workers, 
first responders, etc. For that reason the clinical trial in 
children with Dryvax has now been called off and we are not 
going to do a clinical trial in children for this particular 
product.
    Senator Clinton. Thank you.
    The Chairman. Thank you, Senator.
    I would like to keep this going but I know you folks have 
to get back and actually take care of America, so we are going 
to let you go, but this issue of what we do with children is 
critical. The compensation issue, also absolutely critical. And 
Senator Frist, as our majority leader and doctor, has put forth 
some really excellent ideas in the area of vaccines generally 
and how we are going to try to get our whole vaccine industry 
backup, which would include provisions on compensation and 
liability.
    So we will pursue those at a later date with you, but we 
are definitely going to be moving on that. I quite honestly 
hope we move on Senator Frist's ideas fairly quickly. So we 
thank you very much for your time. We appreciate it and keep up 
the good work.
    If we can get the next panel to step forward?
    Our next panel, and we appreciate their participation, 
represents a variety of folks who are on the front lines of 
this issue, coming from various walks of life and who have 
substantive interest in and concerns about how we proceed with 
the smallpox vaccination process.
    I would ask that you submit your formal statements and if 
you could keep your general comments concise and to the point 
so that we could get right into the questions, that would be 
very helpful.
    Let me begin. We will go from right to left from my side 
because on the right is a gentleman from New Hampshire who I 
have known for many years. He is a good friend, a neighbor, and 
somebody who is a specialist of the first order in managing 
hospitals. So let us begin with you, Bill.

  STATEMENTS OF WILLIAM J. SCHULER, CEO, PORTSMOUTH REGIONAL 
  HOSPITAL ON BEHALF OF THE FEDERATION OF AMERICAN HOSPITALS, 
   PORTSMOUTH, NH; WILLIAM J. BICKNELL, M.D., M.P.H., BOSTON 
 UNIVERSITY SCHOOL OF PUBLIC HEALTH, BOSTON, MA; JON ABRAMSON, 
     M.D. ON BEHALF OF THE AMERICAN ACADEMY OF PEDIATRICS, 
WASHINGTON, DC; MARTHA BAKER, R.N., CO-CHAIR, SERVICE EMPLOYEES 
 INTERNATIONAL UNION (SEIU) NURSING ALLIANCE, WASHINGTON, DC; 
 AND KIM BUSH, PRESIDENT, VACCINES DIVISION, BAXTER HEALTHCARE 
                  CORPORATION, WASHINGTON, DC

    Mr. Schuler. Good morning. I am William Schuler, president 
and CEO of Portsmouth Regional Hospital, of HCA, Hospital 
Corporation of America, and our trade association. I would like 
to thank Chairman Gregg, Ranking Member Kennedy and others on 
the Senate Health and Education, Labor and Pensions Committee 
for providing me this opportunity to discuss the smallpox 
vaccination plan from the perspective of a community hospital.
    Portsmouth Hospital, our trade association, the Federal of 
American Hospitals, fully support the administration's decision 
to provide voluntary smallpox vaccinations to healthcare 
workers. We particularly applaud the chairman, ranking member 
and other members of the committee for their continued advocacy 
of the voluntary vaccinations. There seems to be widespread 
recognition that the proper implementation safeguards will 
produce an environment where our Nation's hospitals can provide 
the safest care and work setting for our patients, our 
employees, and our families. By vaccinating these core 
caregivers, we enable them to step forward with the assurance 
of their own immunity to provide this vital care.
    Portsmouth's role in the vaccinations. While we applaud the 
direction in which we are heading, hospitals are concerned that 
much of the responsibilities for implementing the vaccination 
plan appear to be filtering to the hospital level. In my 
testimony I will highlight the critical issues facing a 
community hospital, how we are handling them, and where we feel 
guidance and assistance is needed.
    First, it may be helpful to describe the stages of the pre-
event vaccination initiative from a hospital perspective. I 
will refer to three stages. Stage one is the vaccination of the 
smallpox response teams and front-line healthcare workers. This 
stage is currently under way. In stage two, vaccinations will 
be offered to all healthcare workers, EMS, first responders, 
fire-fighters and police. Stage three, the vaccinations will be 
offered to the general public.
    At Portsmouth we arrived at a core group of 40 providers 
for stage one. We began our efforts to recruit volunteers in 
November, with the physicians first being invited to a 
classroom-style presentation by the chief of staff, infectious 
disease physicians, myself and others. Approximately 25 
physicians volunteered immediately. A similar presentation was 
offered the following week to hospital nursing and ancillary 
staff; an additional 30 clinicians were added to the volunteer 
roster.
    Ultimately the 40 volunteers were chosen because they had 
been previously vaccinated against smallpox, screened for 
contraindications, and provided with additional educational 
resources. In March we anticipate these volunteers will visit 
area clinics at staggered intervals to receive the vaccination.
    Now allow me to touch on some of the concerns with the 
implementation plan. As the vaccination process proceeds to 
stages two and three, Portsmouth faces increasing medical and 
staffing challenges. According to a study by the CDC, 36 
percent of adults receiving vaccine for the first time will 
likely be sufficiently ill to miss work, school, or 
recreational activities or have trouble sleeping. Nationwide, 
this amount of absenteeism, superimposed on winter illness and 
critical nursing-wide shortages, will surely exacerbate an 
already tenuous staffing shortage.
    To ensure the support of normal hospital operations, we 
must follow staggered vaccination schedules. We anticipate up 
to 10 employees may require time off. We should be able to 
cover this level of absenteeism without impacting patient care. 
In future stages, however, additional staff members are 
vaccinated and these staffing issues become of major 
significance.
    According to CDC guidelines, hospital responsibilities 
include not only education, screening for contraindications, 
identification of volunteers but also daily vaccination site 
assessment and the evolution of takes. This means that the 
hospitals must provide daily staffing for a 21-day vaccinee 
site assessment clinic. In stage one we should be able to 
absorb the financial staffing burden. However, it might be a 
burden not so easily managed in the future.
    Furthermore, in stage two the logistics for staffing 
education, site care, assessment and recordkeeping will 
certainly require Federal and State support. They are not 
activities that a local community hospital can easily absorb. 
Consideration for extra funding to the State public health 
departments would enable them to play a much greater role than 
we have seen to date and will ease the vaccination-related 
staffing issues expected to be shouldered by the hospitals.
    Community healthcare systems will be severely stressed in 
stage three. Using the published rates of vaccine-related 
complications, the 50,000 vaccinees in our service area could 
lead to 5,000 office visits and up to 500 hospital admissions, 
an untenable demand for a medical community with a 200-bed 
hospital like ours. We will need a system where specialists 
would help with the evaluation of the more severe vaccine 
reactions, discussing and coordinating home care for all but 
the most ill. This system has been discussed at the State level 
and is yet to be developed. Mass vaccinations will create a 
volume of ill patients that in most communities will be 
unprecedented and profoundly difficult to manage.
    With regard to communication and planning, I will tell you 
that the communication between the State OEM and the local 
emergency personnel has been suboptimal. In the early stages 
local emergency personnel, fire and police were not adequately 
informed of the CDC vaccination plans or the responsibilities 
for such a plan. Initially, hospital and community 
representatives' responsibilities were to be quite limited. As 
the planning stage unfolded, responsibilities originally 
assigned to the OEM were given to both hospitals and the 
community.
    We have communicate this issue to State leaders and have 
learned that New Hampshire OEM, like many other States, has not 
received additional funding from FEMA. At a time when State and 
municipal budgets are also stressed, there is an understandable 
reluctance to take on additional responsibilities without 
funding. In short, the State's OEM is relying too heavily on 
staffing resources at the local hospital level for planning and 
implementation. In order to strengthen the overall postevent, 
the State OEM requires additional funding, staffing and other 
resources.
    We appreciate the recent classification of section 304 of 
the Homeland Security Act that appears to resolve many of the 
liability concerns. However, further clarification on liability 
may be needed in the scope of employment issues.
     Specifically it is not clear if the current guideline 
provides protection for vaccinated person who inadvertently and 
outside of the scope of one's employment spread the infection 
caused by a smallpox vaccine outside the participating 
hospital. We look forward to working with Congress and the 
administration to achieve full protection intended under 
section 304.
    It is vitally important that the healthcare workers are 
protected from personal expense and loss of wages as a result 
of adverse reactions to voluntary vaccination and we hope that 
this will occur.
    Finally, in a time of national emergency requiring 
implementation of mass immunizations, healthcare resources will 
be severely strained. It is in these limited circumstances that 
certain aspects of the healthcare laws and regulations may not 
be in the best interest of patients and healthcare workers in 
our hospital. I have laid out an example in my testimony in 
response to anthrax exposures occurring in Florida, New York, 
Washington, DC. and other States.
    As you know, EMTALA requires hospitals to provide medical 
screening to all patients requesting medical treatment. In the 
event of mass vaccination potential smallpox exposures, 
hospital emergency departments could be overwhelmed by the 
worried well. Any hospital following the recommendations of the 
State health department, as outlined in our testimony would 
have to be subject to potential liability under EMTALA.
    In addition, when hospitals are coping with mass 
vaccination clinics and potential complications generated, the 
completion of the usual hospital forms, such as notices of 
HIPAA privacy rights and advanced beneficiary notices, may not 
be possible or practical. We hope that the committee will 
consider how to mitigate the consequences of these regulatory 
dilemmas in a time of national crisis.
    In closing, I would like to commend the committee for its 
commitment to the safety and well-being of the first responders 
and their families. Portsmouth Regional Hospital and the 
federation look forward to working with the committee to 
implement the administration's voluntary smallpox vaccination 
plan. Thank you.
    The Chairman. Thank you.
    [The prepared statement of Mr. Schuler may be found in 
additional material.]
    The Chairman. Dr. Bicknell?
    Dr. Bicknell. It is an honor and pleasure to be here this 
morning, Mr. Chairman and members of the committee. I am going 
to touch on certain high points of my written testimony.
    I am a physician with a public health degree. I was 
commissioner of public health in Massachusetts at one time. I 
sit currently on the Massachusetts Statewide Smallpox Work 
Group. Most recently I have been a proponent of careful 
selective, progressive and ultimately widespread pre-exposure 
vaccinations as the best way to protect the Nation against the 
threat of a bioterrorist attack using smallpox as a weapon. And 
even though Dr. Gerberding and Dr. Fauci are not here, I think 
they and the Nation have made tremendous strides in the last 
year in this area.
    National security, economics, and economic disruption, 
medicine, public health, and labor-management issues often get 
confused as we discuss smallpox. This is complicated by serious 
misunderstanding of the facts, confusion of fact and opinion, 
and finally, there is honest disagreement about what is right 
and what is not right. And, of course, as we have heard 
earlier, this is all in the context of all the other 
bioterrorist threats.
    I want to touch on six points and then if there is time, 
elaborate later. The president's three-phase plan is extremely 
sound. Implementation today, I feel, is seriously flawed. 
Finishing phase two is an urgent national priority, 
particularly given the course of world events. Until phase two 
is done, we are not protected. And I would say that although 
there is wide recognition in this room about national security 
issues, in the public health and medical community the concern 
that Senator Frist expressed just has not hit home. That 
message has to get out that this is a national security issue; 
it is not just a medical or public health issue.
    We have all the gadgetry, tools and manpower to do this. 
What we do not have is the organizational structures. They are 
not yet in place.
    There is dangerous misinformation about key aspects of 
smallpox transmission and control. This needs to be corrected. 
Let me give you a couple of examples. I would take exception to 
what Dr. Gerberding said that mostly you are sick and you go 
home. And I would distinguish between Dr. Gerberding, who I 
think we would all agree is not a terrorist, and if she got 
sick she would go home, but I could be a terrorist. I had to 
present to my university president, who is known as somewhat of 
a bear, and I had a fever of 103.5. I presented. If I am a 
motivated terrorist I will get up and walk around. And, in 
fact, as you become infectious it is not visible. You start to 
feel better. There is no obvious rash and you are highly 
infectious.
    We have to plan for a worst-case event, not what happened 
in the smallpox years of eradication when we had high levels of 
population immunity, not very mobile populations, and nobody 
was a terrorist. They were just plain old people getting sick. 
This is a very different State of affairs.
    Now let us talk about some of the risks of vaccination. I 
think there is misinterpretation and misinformation out there. 
I do not want to give the sense that smallpox vaccination is 
like a sugar cube but let us look at it with care. We are 
talking about adults, not kids at the moment. I understand your 
issue of kids and I will get to that in a moment.
    If you look at the historical data, U.S. military since 
World War II, 1963 data, around 14 million people. 1968 data, 
14 million people, Israeli military experience, Israeli 
civilian experience, U.S. civilian experience since the 1980s, 
I believe you will find that there are two adult deaths. Both 
of these people were in 1968 and would have been screened out. 
One had aplastic anemia, one leukemia. In 1968 we had nine 
deaths; seven were in children, a 16-year-old girl, and a 62-
year-old woman. We are not vaccinating children at the moment 
and we are planning to carefully screen. We would not have 
vaccinated the two people who did die.
    What is happening with the U.S. military as of this moment? 
As of January 25, over 2,000 military hospital workers have 
been vaccinated, including staff at Walter Reed, which has a 
hematology oncology ward, transplant unit, a neonatal intensive 
care unit, all where you do not want accidental spread. It has 
not happened. Vaccinated workers continue caring for patients 
using the semi-permeable membrane dressing--I have some here--
long sleeves and scrupulous hand-washing.
    The semi-permeable membrane dressing makes an already rare 
event--114 cases of transmission to other people happened in 
1968 after 14 million vaccinations. You do not do kids, drop 
that by 70 to 90 percent. You add this dressing; that reduces 
it by 90 to 95 percent. This is a controllable thing.
    What has happened in the military? The success rate of 
vaccination has been for people who are first-time vaccinees, 
97 percent successful, revaccinees 99 percent.
    What about sick leave? Four percent of first-time vaccinees 
take a day or two off. One and a half percent of revaccinees 
take a day or two off. Complications have been minor and are 
occurring at the levels that have been historically expected.
    Full data on the military are classified in terms of 
numbers--I do not know them; CDC and FDA do--but I have been 
told that those numbers are getting very large and the rates of 
complications, side effects and time off in the larger number 
of troops approximates that that is happening in the 2,000 
health workers.
    So I think we need to put the risk of adult vaccination in 
perspective. It would be absurd to promise but it would not be 
surprising to find out when phase two is done and we have done 
10 million, we might have zero, one or two deaths, not the 
hundreds of deaths that we are thinking of. So I think we need 
to get that very much in perspective.
    CDC needs a clear, concise, strategic statement that 
articulates the president's plan and establishes a rationale 
and framework for implementation. It is just not clear now to 
people out there. And then within that document there need to 
be simple, and I would emphasize simple, pre- and postexposure 
guidelines. They are not simple now. They are too complex and 
if we had to act now we would have chaos, confusion and 
casualties. We need to be prepared to move in a big hurry and 
this requires not just advanced planning but the elegance that 
comes from simplicity.
    Finally, I think we may have made some fundamental mistakes 
in assessing what public health and the public health system is 
all about. I am working with Ken Bloem, who you may know. He 
has led major teaching hospitals in Chicago, Palo Alto and 
Washington and we feel the public health system is by its very 
nature and culture not an emergency response system and never 
has been. We may need a different structure, perhaps an 
integrated Federal-State incident command structure with 
emergency medical services and the acute medical care system 
taking the lead role for mitigating the adverse events of a 
bioterrorism attack. And in this conceptualization, public 
health, particularly laboratories and epidemiologic 
intelligence, play a supportive but not a directive role.
    The side effects of children I think need to be put in 
perspective. I have a two-and-a-half-year-old grandson and he 
is at the center of my life but I do not think we should 
vaccinate him yet. The reasoning goes like this. The bad 
complications and deaths and a lot of the less bad ones mostly 
are in kids under 10. The worst one, encephalitis, is really 
bad, hits kids under 10 in this country--our data is very clear 
on that--mostly under 10, almost exclusively. Most of the 
deaths almost exclusively under 10. There is no treatment for 
this. It is rare but about 25 to 30 percent die and another 10 
or 15 percent have permanent brain damage.
    Children are the ones who get accidentally infected with 
each other. It is rubbing up in a sandbox. We are not doing 
kids; that eliminates that.
    Complications are common of the less severe kind--one in 
9,000, one in 10,000. That means there is going to be a 
complication in virtually every city in town.
    Post-attack you can isolate kids. If we have phase two 
completed and a mechanism in place that we can vaccinate in 
schools and churches and gymnasiums rapidly, we can protect 
children very rapidly and avoid the complications they will 
experience by preexposure attack.
    The four-day window, we have heard a great deal about the 
four-day window. That is a myth. It does not exist. If you are 
vaccinated within 4 days you may get less severe illness; there 
is no evidence you can prevent it. And that is all over the 
place; that is just wrong.
    The visible rash. Let me just read you something. Happened 
in 1913. ``One person with smallpox arrived in the country and 
traveled by train. In the initial phase of the disease nobody 
noticed the rash on his face. Almost everyone who traveled with 
him from Queensborough to Manchester got smallpox--the ticket 
collector and those who went on to Stallybridge.'' Something 
like 100 people being infected from a single case, and this was 
not a terrorist. Suppose you were a terrorist; you could do a 
better job.
    Most doctors, if they are properly trained, will be able to 
quickly identify a case. That is wrong. That can never, ever 
happen. Smallpox does not look like much until day three or 
four and it will be missed and then there will be 
overdiagnosis. This is another compelling argument for getting 
the president's plan done, at least through phase two and I 
would hope phase three, and I would like to extend it, move 
from it is okay if you are adult to it is urged if you are an 
adult.
    Ring vaccination. There is tremendous evidence that ring 
vaccination, as proposed until very recently--it came off the 
website over the weekend, guideline B--ring vaccination many 
thoughtful people feel, as it has been proposed, will not work. 
What will work is vaccinating with a little kit the friends and 
neighbors of the first case, gear up for local mass 
vaccination, vaccinate in the area locally. If there is a 
second case in another geographic area move to national mass 
vaccination. That will work and that will only work if we 
finish phase two and have 10 million done.
    In conclusion, I would say this. We are potentially 
prepared but we are not there yet. And until the plan is done 
through phase two, we will not be there.
    Finally, as with the interstate highway program and the 
space program, I think the BioShield initiative is going to 
have all kinds of other unintended positive benefits and I 
think these hearings are a great first step along the way and I 
would be pleased to answer questions. Thank you very much.
    The Chairman. Thank you, Doctor.
    [The prepared statement of Dr. Bicknell may be found in 
additional material.]
    The Chairman. Dr. Abramson?
    Dr. Abramson. Good morning, Mr. Chairman and members of the 
committee. I am Jon Abramson. I am chair of the Department of 
Pediatrics at Wake Forest University School of Medicine. I am 
here today in my role as chair of the Committee on Infectious 
Disease for the American Academy of Pediatrics. I appreciate 
the opportunity to participate in the hearing on the smallpox 
vaccination program.
    This committee has asked us to respond to three very 
important questions. We provided written testimony and our own 
policy from the American Academy of Pediatrics that you can 
read. Today I will focus my remarks on the questions concerning 
implementation of the president's smallpox vaccination plana 
and what needs to be done to ensure that the plan maximizes 
protection afforded to children. During the allotted time I 
will cover three main points.
    The American Academy of Pediatrics' recommendations are 
based on the information provided to us by the government that 
the risk of smallpox, though not zero, is small. Should the 
risk assessment change, then our answers to these questions may 
change.
    No. 2, voluntary vaccination of the general public is the 
least scientifically defensible policy, no matter what the 
level of risk a smallpox attack.
    No. 3, the safety and effectiveness of the various smallpox 
vaccines, particularly the recently developing tissue culture-
derived vaccine, needs to be studied in children.
    The American Academy of Pediatrics believes that the 
general public, particularly children, should not be offered 
the smallpox vaccine at this time. This recommendation is based 
on weighing the relative high rate of serious adverse events, 
including death, caused by the smallpox vaccine versus the low 
risk of a smallpox attack. Infants and children are 
particularly vulnerable to the complications caused by the 
smallpox vaccine because of their high incidence of atopic 
dermatitis and of immune deficiencies that have not yet 
manifested or been diagnosed.
    Currently the AAP favors a ring vaccination policy that 
includes a plan for rapid distribution of smallpox vaccine and 
development of strategies for urgent vaccination of large 
numbers of the population, rather than a voluntary or mass 
vaccination program. However, if the risk of attack was felt to 
be high or an attack occurred, then a recommendation to 
vaccinate everyone except those with high-risk 
contraindications would make sense.
    Unfortunately, the concept of a pre-event voluntary 
vaccination for the public, while appealing on the surface, 
makes the least sense from a public health and scientific 
standpoint and in actuality is a misnomer. Under a voluntary 
vaccination scenario, children whose parents did not want them 
to get the vaccine would accidentally be inoculated by those 
who did receive the vaccine.
    It is important to point out that before 1972 when smallpox 
vaccine was routinely given to everyone who did not have a 
known contraindication, approximately 25 percent of those who 
developed serious side effects were those unintentionally 
inoculated with the vaccine. While the use of semi-permeable 
dressings can reduce the risk of spread of the vaccine virus, 
these dressings are unlikely to be practical for large-scale 
vaccination because they are expensive, cause allergic 
reactions in some people, and compliance with their use will 
vary greatly. Thus, many unintentionally vaccinated children 
could end up with adverse consequences from the vaccine, some 
of which would be very serious, including death.
    To answer the question about what needs to be done to 
ensure that children are eligible to receive the smallpox 
vaccine, I need to point out that recent studies have shown 
that the currently available licensed 30-year-old Dryvax 
vaccine can effectively be administered to adults. However, no 
pertinent recent clinical trial has been done or will be done 
to ascertain if this is true for children.
    Furthermore, the new culture-derived vaccine currently 
being developed has never been tested in adults or children. We 
are aware of planned studies of adults of this new vaccine but 
know of no such planned studies in children. Children are not 
little adults and their distinct physiologic responses must be 
studied before large numbers of children are exposed to the 
vaccine.
    Both the American Academy of Pediatrics and the Advisory 
Committee on Immunization Practices of the CDC have clearly 
stated these studies need to be done in children. Congress in 
1998 passed the Food and Drug Administration Modernization Act 
to make sure that children would no longer have to receive 
drugs that had not previously undergone testing to assure 
safety and effectiveness in children.
    As a pediatrician and a father, I cannot imagine that we 
are willing to potentially use the smallpox vaccine in greater 
than 70 million children and not know that it will be safe and 
effective in preventing disease. Nor can I imagine if a 
smallpox attack did occur that we are willing to let millions 
of children be part of an emergency experiment.
    The enormous cost of the smallpox vaccination program will 
also have an impact on the health of children. Public health 
officials have indicated that the vaccination plan will divert 
public health funds from other programs, such as routine 
childhood immunization and dental clinics or worse yet, may 
close public health facilities altogether to accommodate the 
cost of the smallpox initiative. The AAP strongly urges 
Congress to ensure that these other vital public health 
programs that protect against on-going and preventable diseases 
are not sacrificed for a currently nonexistent disease; that 
is, smallpox.
    We are looking forward to continuing this dialogue with you 
to assure that the appropriate research, therapeutic 
provisions, and policies are in place to protect children 
against the threat of biologic, chemical and nuclear attack 
while continuing the programs that are needed to maintain the 
health of our children.
    Thank you and I would be happy to answer any questions.
    The Chairman. Thank you.
    [The prepared statement of Dr. Abramson may be found in 
additional material.]
    The Chairman. Ms. Baker?
    Ms. Baker. Good morning, Chairman Gregg, Ranking Member 
Senator Kennedy and other committee members.
    My name is Martha Baker. I am a registered nurse at Jackson 
Memorial Hospital in Miami, FL, one of the largest public 
hospitals in this country, and I am a national co-chair of the 
Service Employees International Union Nurse Alliance.
    As a trauma nurse I work on the front lines of medicine, 
providing every patient who comes through the door with the 
best care possible. If a smallpox outbreak occurs I want to do 
no less for someone suffering from that terrible disease. If 
there is a bioterrorism threat, healthcare workers like me want 
to be ready to respond.
    Unfortunately, the administration's smallpox vaccination 
plan lacks important safeguards and a lot of healthcare workers 
are hesitant to roll up our sleeves and put the health of our 
patients, our loved ones, and ourselves at risk without better 
support.
    The prestigious Institute of Medicine has suggested better 
safeguards. The American Public Health Association has called 
for compensation for vaccine victims, liability protection, and 
adequate resources to safely implement the plan. The National 
Association of County and City Health Officials say the lack of 
adequate funding for this program is diverting resources away 
from their efforts to make sure we are prepared for other 
bioterroristic threats.
    The USA Today reported last week that more than 80 
hospitals have opted out of the smallpox program. In 
Connecticut, as someone mentioned earlier, where the program 
was launched on January 24, only four healthcare workers showed 
up for vaccines after workers' concerns about the plan were 
unanswered. Out of 10,000 employees at my hospital, 49 people 
have volunteered, and that is before screening has taken place.
    Everyone agrees that this is a risky vaccine. Past 
experience and recent studies have shown that out of every 
million people, up to one-third may experience flu-like 
symptoms and need to miss few days of work. A thousand may have 
serious reactions, 14 to 52 will have life-threatening 
complications, and as many as one or two may possibly die. One 
of the ER docs I work with had a life-threatening reaction to 
the smallpox vaccine when she was a child; she got the 
encephalitis. So it is important to everyone to remember that 
these statistics are not just numbers. If we vaccinate 500,000 
healthcare workers, one of us may be expected to die.
    Healthcare workers across America are wrestling with the 
known risks of the vaccine while knowing that the 
administration's program does not adequately protect us and our 
patients. The Homeland Security Act protects the drug companies 
that produce the vaccine and the hospitals who administer it 
from liability but if someone gets sick as a result of the 
vaccine, they will be lucky to get a get well card from our 
elected leaders. I think we can do better than that and I hope 
you do, too.
    First, we need better screening to try and limit adverse 
reactions from ever happening. For example, pregnancy and HIV 
are two contraindications for this vaccine that can be easily 
identified but the current civilian program does not provide 
for that testing. By contrast, servicemen and women who are 
candidates for the smallpox vaccine are being offered those 
tests free of charge.
    Second, as the Institute of Medicine has recommended, we 
need a more proactive approach to monitoring those vaccinated--
their patients, their coworkers, their household members--to 
make sure we catch and provide medical treatment for any 
adverse events as early as possible and so other workers and 
the public as we go into phase two can learn from our 
experiences. The passive CDC surveillance plan will not be 
effective enough.
    Better screening and surveillance will reduce the cost of 
providing medical treatment and covering lost wages for people 
who are harmed by this vaccine, which is our third concern. 
People with more serious adverse reactions will need a fair 
compensation program that is easily accessible, recognizes the 
no-fault likelihood of injury, and covers the cost of medical 
care and lost income. The Childhood Vaccine Injury Compensation 
Fund provides a good model as a common-sense program that 
works.
    Workers compensation programs will not provide an adequate 
safety net. Many states won't cover workers because the vaccine 
is voluntary. It will not provide any protection at all for 
patients or family members. Even those who are eligible may not 
get all of their medical expenses covered and are likely, after 
perhaps a couple of years of fighting, to receive only a 
percentage of their usual earnings.
    Other concerns include protecting workers who choose not to 
get vaccinated from discrimination, providing adequate 
resources for State and local health departments so they can 
implement a safe plan, and getting the FDA to license sheathed 
bifurcated needles to deliver the vaccine safely and 
consistently with the Needle Stick Safety and Prevention Act. I 
actually have those safe and unsafe needles here.
    We are pleased that Chairman Gregg and Majority Leader 
Frist and Senator Kennedy have agreed to work together on 
legislation that could address many of our issues. We had hoped 
that we would not be asked to volunteer for this vaccine until 
better safeguards were already in place but now that 
vaccinations have started, we urgently need Congress to pass 
and fund legislation that closes the gaps that several of us 
have referred to and put forth the very safest plan possible.
    On behalf of the Nation's largest healthcare union I am 
grateful for this opportunity to express the concerns of the 
front-line healthcare workers. Thank you.
    The Chairman. Thank you very much.
    [The prepared statement of Ms. Baker may be found in 
additional material.]
    The Chairman. Mr. Bush?
    Mr. Bush. Mr. Chairman, members of the committee, thank you 
for the opportunity to speak today about the smallpox vaccines 
and about the threat of bioterrorism.
    I am Kim Bush and I am the president of Baxter BioScience 
Vaccines, a subsidiary of Baxter International. Baxter is a 
U.S.-based global healthcare company that provides critical 
therapies for people with life-threatening conditions.
    Today Baxter has five licensed vaccines worldwide in a 
broad pipeline with more than a dozen vaccines at various 
stages of development. Baxter, in conjunction with Acambis, is 
playing a major role in the production of 155 million doses of 
smallpox vaccine for the U.S. government.
    The development of a new vaccine from discovery to final 
licensed product may take as many as 10 years or more. In the 
case of our current smallpox effort, this innovative public-
private partnership has been able to dramatically compress the 
time frame to meet the national security needs. This is 
possible because the FDA, other government agencies and 
manufacturers truly did decide that producing a new smallpox 
vaccine was not and could not be business as usual.
    Mr. Chairman, the willingness or the ability of the private 
sector to become engaged are not barriers to the development of 
biodefense vaccines. Indeed, I believe the new BioShield 
legislation may become an excellent accelerator to that 
engagement.
    Baxter, like a number of other companies, can meet many of 
today's biodefense needs, like those identified in the 
president's State of the Union Address. The question is under 
what conditions and with what incentives can these capabilities 
be optimized? And let me share with you some issues associated 
with that question.
    Every healthcare company, like Baxter, must make some very 
difficult choices relative to which R&D projects to fund. Often 
vaccines emerge as a less appealing choice because other 
medical or pharmaceutical products have longer term, more 
predictable market potential. Also, growing concerns about 
intellectual property protection, very serious liability 
issues, and the cost of meeting regulatory requirements and 
compliance must be considered.
    Making vaccines, which involves production from living 
organisms, is a costly, difficult, and very complex process. In 
addition, a vaccine that will be stockpiled and used only in an 
emergency is not likely by itself to create a sustainable 
business model. The realities of highly unpredictable needs, 
shifts in government policy and funding, and changes in 
perceived threats make matters even more challenging.
    In light of this, it is critical that the Nation's 
biodefense priorities be more clearly stated so that industry 
can adapt and respond more effectively. At the same time, we 
would like to see the government proactively bring together the 
skills and the expertise of the vaccine industry necessary to 
assure the security of the American public.
    Enhancement of the procurement system would be beneficial. 
Highly regulated procurement systems that work very well under 
normal circumstances do not necessarily provide incentives or 
easy to manage processes for manufacturers to provide vaccines 
to the U.S. government efficiently.
    In addition, consideration might be given to enhancing the 
regulatory system such that it deals with the abnormal and the 
unpredictable as effectively as it did with the smallpox 
situation. The FDA deserves enormous credit for already 
initiating this process, as exemplified by some of its newest 
clinical trial rules.
    Mr. Chairman, Baxter believes that liability exposure is 
one of the most serious impediments to new biodefense vaccine 
development. There is no liability protection for vaccine 
manufacturers beyond the Homeland Security legislation for 
smallpox. In addition, as has already been discussed, there is 
no comprehensive mechanism to provide compensation to persons 
who may suffer an injury.
    Another important need is continued adequate intellectual 
property protection here and abroad. We would like to work with 
Congress and the administration to seek ways to assist 
developing nations in improving access to healthcare 
technologies but without undermining the strong intellectual 
property protections that are the engine that drives discovery.
    The vaccine industry needs to be healthy and vibrant. We 
must address the challenges of rising development costs, 
downward pricing pressure, the high cost of regulatory approval 
and compliance, and the constant threat of predatory lawsuits. 
In recent years we have seen vaccine shortages and a continued 
decline in the number of vaccine manufacturers. Today in the 
U.S., as was mentioned earlier, there are only four major 
manufacturers and to our knowledge, to our knowledge, there are 
no stand-alone manufacturers of licensed vaccines and I think 
this demonstrates how difficult it is to build a sustainable 
business enterprise solely on a vaccine portfolio.
    In closing, we have the following recommendations for the 
government. First, establish and clearly communicate the 
Nation's biodefense priorities and time lines. Second, 
establish an in-depth working knowledge of industry 
capabilities to align those capabilities more effectively with 
national interest. There was a mention earlier of 
infrastructure. It might surprise you there is probably more in 
place than you may be aware of. Third, enhance the procurement 
process to embrace fast decision-making for critical biodefense 
contracts. Fourth, use the Homeland Security Act as a template 
for expanding manufacturer product liability coverage. And 
finally, provide incentives that promote a healthy vaccine 
industry by adapting existing programs to take into account the 
very unique and complex nature of vaccine development and 
manufacturing.
    As a manufacturer committed to assisting in this effort, we 
would be pleased to work with this committee, others in 
Congress and the relevant government agencies to ensure that 
vaccine development for biodefense truly is seen as not being 
business as usual.
    We certainly appreciate the opportunity to share our views 
with you here today. Thank you.
    The Chairman. Thank you, Mr. Bush.
    [The prepared statement of Mr. Bush may be found in 
additional material.]
    The Chairman. This question is directed to Ms. Baker but I 
would be interested in anybody else's response to this. This 
compensation issue--compensation and liability, which go hand 
in hand in my opinion--is obviously at the core of getting a 
vaccine industry up and running and getting vaccines back in 
the marketplace and getting people to take advantage of the 
vaccines once they are there.
    I understand that what you are basically saying is that you 
want a no-fault system where people would get recovery for loss 
of wages and medical costs. Is that what you think is needed so 
that a person, once they have shown through whatever trusts has 
been set up, following State workers comp or a VIC fund model, 
once the person has been identified as having an illness which 
is directly related to the vaccine, that that person would then 
have the right under a no-fault process to receive compensation 
that would cover loss of medical costs and loss of income at a 
reasonable rate?
    Ms. Baker. Yes. Healthcare workers, like I said, we work 
where we work because we are glad to step up to the plate and 
help with whatever emergencies are happening. And we actually 
surveyed our members. They are nearly 100 percent ready to do 
it. It is when they start looking and getting the facts that it 
becomes a scary process.
    We want the screening obviously to happen. That is an 
important part. That will eliminate the high----
    The Chairman. We all understand the screening.
    Ms. Baker. So the screening and the monitoring and the 
compensation for loss of wages and medical care, obviously. And 
workers comp is a battle.
    The Chairman. Right, I understand. What I am more 
interested in, is if we are thinking of how we would set up a 
system, I see workman's comp as a template but I am trying to 
get the parameters of what the recovery should be. If we are 
talking medical costs and loss of compensation, some 
percentage, as long as the illness is proved to have been 
caused by the smallpox vaccine, that seems to me to be a 
reasonable template. In exchange for that, you limit liability, 
obviously.
    You said, Bill, that there are a number of regulatory 
events out there that still stand in the way of you doing this 
that are just not consistent with this type of a national 
security issue. Could you name a few of those?
    Mr. Schuler. I have referred to EMTALA and HIPAA in terms 
of in a time of crisis if stage three comes out and there is 
massive vaccination, hospitals are going to have to move very 
quickly to pass along information and to sometimes redirect 
patients so they can get adequate care. And I think during this 
defined period of crisis it would be very important for the 
healthcare workers to be somewhat shielded from violating these 
acts in an effort to take care of patients.
    The Chairman. I do not know whether we have given the 
secretary of HHS or the president the right to waive those 
regulatory events in the case of a national emergency, declared 
national emergency or not, but I think that is worth checking 
into and I appreciate your bringing it to our attention. We 
will check into it.
    It was interesting to hear Dr. Abramson and Dr. Bicknell, 
who are about as far apart as you can get on the issue of 
whether this is a threat. We are not going to resolve that in 
the minute that I have left for my questions but clearly that 
is an underlying concern, Dr. Abramson taking the position that 
the threat is not high enough to justify the exercise and Dr. 
Bicknell taking just the opposite position, that the threat is 
high enough to justify a great deal, and that gets to a public 
policy issue which we are not going to resolve now but I do 
want to note that this is an issue.
    Senator Kennedy?
    Senator Kennedy. Thank you very much, Mr. Chairman. I 
apologize that I was not here for the earlier part of the 
hearing. We were down at the Judiciary Committee with some 
nominees.
    Now as I understand it, there has been a very slow process 
where the States have been signing on for the administration's 
program. I understand now that, I guess, California, 
Connecticut, and Vermont have started. New Jersey intends to 
start either tomorrow or in the next couple of days, 
Massachusetts mid-February, but it is very slow-going. And even 
in Connecticut I think Ms. Baker had indicated the small number 
of people that--it might have started but it extraordinarily 
limited in its coverage.
    And I think Senator Gregg has pointed to one of the real 
problems and challenges, and that is what kind of risks are we 
facing or ask people to take and what can they do about it? As 
I understand now, most of the private insurers will not 
compensate the workers if they take it and have an adverse 
reaction, but that has been the position of most of the private 
insurance companies. So you have an option about suing the 
government, and that is not a very satisfactory situation.
    So basically people look into it and they are talking about 
the kinds of risks that you have talked about, Ms. Baker, and 
there is still a lot of questions that are out there and it 
seems to me it was suggested at least in the questioning of our 
chairman that unless we are going to develop some kind of 
compensation fund that is going to help meet the needs of 
people, as you have described it, we are just not going to get 
it done.
    In my own State, Cooley Dickinson Hospital in Western 
Massachusetts--the only reason I keep remembering it is because 
it is where I landed after my plane crashed and it probably 
saved my life--they have indicated that they will not 
participate under the present system. When I heard about that I 
asked my staff to look up other hospitals and there is a score 
of hospitals, more than 80 hospitals in 22 States--Medical 
College of Virginia, Richmond, Vanderbilt University, 
Children's Hospital, Philadelphia, Grady Memorial in Atlanta. 
All across the country the list goes on, included in the 
record.
    So it seems to me that whatever we are going to do, we have 
to get this up and going, is what I am hearing from our panel. 
They have talked about different other features.
    Do most of you believe that that is fairly essential before 
we are going to get a real active program in place? Ms. Baker? 
I will hear the panel quickly and then I have just one or two 
other questions I would like to hear from the panel on.
    Ms. Baker. Right, the risks can probably be debated, as Dr. 
Bicknell said. We have history to rely on only at this point, 
perhaps, but that alone is a risky enough decision to make. To 
think that you are going to step up and do something that you 
will have no safety net is another serious risk. And I think if 
that one can be eliminated and safely taken care of, and I do 
not know why hospitals would want to participate if they are 
going to just take on a huge burden.
    Our hospital, Jackson Memorial, has agreed to pay 7 days, 
100 percent AD time on the front end if someone is sick, but 
then it puts you in the predicament of after that, workers comp 
kicks in at 66 percent, so it is still a problem that there is 
not adequate compensation. That certainly has to make the 
person, whether it is the hospital or the healthcare worker, 
more willing to participate if there are some safety nets in 
place financially.
    Senator Kennedy. Others want to make a brief comment?
    Dr. Abramson. The only other point I want to make is that 
though I think the controls in the hospital setting will be 
good, if we accidentally inoculate one of our patients, that 
patient has no recourse and that has a sense of unfairness to 
it.
    Senator Kennedy. And the pressures hospitals generally are 
under at this time in terms of the cutbacks, the additional 
kinds of pressures that they are under.
    Very quickly, Mr. Bush, are you, in terms of the production 
of the smallpox vaccine, are you on time? Is Acambis on time 
and on budget?
    Mr. Bush. Yes, we are making very good progress.
    Senator Kennedy. I was interested to hear Dr. Abramson and 
Dr. Bicknell and I want to welcome Dr. Bicknell from 
Massachusetts, Boston University. When you talked about your 
higher-ups I know just what you were talking about. No one else 
did but Dr. Silber is a good friend of mine, a supporter and a 
great guy but he--I understood what you were saying.
    Let me just quickly because our time is moving about, both 
of you support giving out the vaccine to the public, anyone 
that wants it. We get asked about that. Just very quickly I 
would ask maybe the panel that and then my time is already up.
    Dr. Abramson. We are not in favor of giving it out to the 
public for the reasons I stated. I am particularly concerned 
that daycare is a whole different scenario than it was 30 years 
ago. If we have adults, even if we just do adults, those adults 
are taking care of our children in daycare. I think the chances 
of cross-inoculation, the worker to the child, is substantial 
and these parents have not volunteered their children to be 
inoculated.
    So in a low-risk situation, which is what we have been told 
as I sit on the Advisory Committee on Immunization Practices--
we have been told the risk is not zero but small--under that 
scenario we are not in favor.
    Dr. Bicknell. I would like to say a couple of things. I 
think the threat issue is an important one and it seems to me 
that the determination of threat is not something that 
physicians can do, public health people can do. That is a 
national determination. And if the threat is nontrivial, then 
the question becomes what to do.
    I would agree completely with Dr. Abramson that I think 
pre-event, pre-attack vaccinating children is not merited. I 
think the point about daycare is a very good one. I think that 
could be handled. I do, though, think once we have the data--we 
will have an enormous amount of data. We have military data 
now. In a few months we will have lots of data. We will go to 
10 million. We will really know the risks of transmission.
    The transmission, 114 contacts from 14 million people 
vaccinated. I think if daycare is a threat area, let us 
segregate, plan about that, make sure that people do use the 
dressing, urge maybe that daycare do not participate, whatever 
it may be. But the more vaccination of adults that is done 
before the fact, the easier it is to control afterwards. There 
is absolutely no doubt about that.
    And in adults I think the historical data shows and I think 
we will find as the data emerges from the military and others 
that we are dealing with a vaccine that is not going to be 
killing adults the way that we have been hearing about or even 
having the serious adverse events.
    So I would urge after we get phase two, make it widely 
available to the adult population with appropriate protections. 
And if people are working and living with high-risk people, 
hey, do not do those.
    Senator Kennedy. I would just give others who want to make 
a comment a brief comment.
    Mr. Schuler. I think is important also to get through at 
least phase two and then provide the public with the choice in 
terms of whether they can proceed or not.
    The Chairman. Does anybody else want to comment on Senator 
Kennedy's question?
    Senator Kennedy. Thank you, Mr. Chairman.
    The Chairman. Senator Dodd?
    Senator Dodd. Thank you very much, Mr. Chairman. I 
apologize, as well, for not being down at the outset of the 
hearing and let me thank all of you for being here. We are 
having a hearing down the hall with the deputy secretary of 
State and the United States ambassador to the United Nations on 
the Iraq issue, so it is a not unrelated subject matter 
obviously as we start talking about weapons of mass destruction 
and how we respond to them here. So at one end of the hall here 
we are talking about the threats and the other end of the hall 
here we are talking about how we respond to them, at least from 
a medical standpoint.
    Just an observation or so. One is obviously when you have a 
hearing like this and we are talking about Connecticut being 
the first State, obviously we had a lot of news back in the 
State about the reactions from healthcare workers and Ms. 
Baker, you are correct; we had a very small number of people, a 
lot of comments about the risks being posed. That in and of 
itself, I sort of regret that was the case. On the one hand I 
applaud it because it was obviously warning people about some 
things, but I worry about this kind of information as we have 
hearings such as this and people do not distinguish at various 
phases of this and we end up having the negative impact of a 
lot of people walking away from something they should probably 
do at some point, at least adults, anyway, beyond the 
healthcare workers and the first responders, and so forth.
    So it is going to be important that we get in front of this 
issue as quickly as we can so that we can start to ease the 
natural concerns people would have about subjecting themselves 
voluntarily to a medical procedure which could raise medical 
risks for them. So it is going to be very, very important that 
our discussions and our debates and the legislation that the 
chairman and Senator Kennedy and Senator Frist are talking 
about can have an early hearing, Mr. Chairman, and an early 
discussion and debate so we can start offering some positive 
information to the public generally about the direction we are 
heading in. That is the first point I wanted to make.
    I note in my prepared remarks, Mr. Chairman, about the 
Vaccine Injury Compensation Program that we have already used 
for children injured by childhood vaccines that we put in 
place. It might not be a bad idea to look at that as a model 
for this program, as well. Do you want to comment on that? When 
I get to the questions I would be interested in what the panel 
might think, particularly you, Dr. Abramson, Dr. Bicknell, 
about whether or not if you are familiar with that program, 
whether or not something like that would be worthwhile.
    The question I would like to get to, and I am sorry that I 
was not here for Dr. Fauci, who raised some of these concerns, 
but in his testimony he mentioned the difficulty that 
individuals with compromised immune systems and others, such as 
children, pregnant women, and the elderly would face in the 
event of a bioterror event involving smallpox. He also 
mentioned that a helpful development of medicine, such as 
Vaccinia Immune Globulin if I am pronouncing that correctly--
VIG is a lot easier--could greatly reduce the risk of 
complications for these individuals. And I want to know if you 
might comment, Dr. Abramson particularly, on that point.
    And recent studies have shown obviously that currently 
available licensed Dryvax, if that is how you pronounce that, 
vaccine can be safely and effectively administered to adults. 
However, no recent pertinent clinical trials have been or will 
be done using this 30-year-old frozen vaccine to ascertain 
whether this is true for children.
    Senator DeWine and I authored legislation dealing with the 
pediatric clinical trials and testing, which I presume you are 
familiar with, Dr. Abramson, and maybe others on the panel are, 
as well, which has done some remarkably good work in a 
relatively short period of time. So we are interested in having 
more testing being done.
    I heard your response obviously to the issue of whether or 
not childcare workers and so forth ought to be vaccinated with 
the dangers of cross-contamination and I support your point 
entirely. But I also would like to get some sense out of this 
that we are heading in a direction where as we develop these 
vaccines, develop them in the diluted versions of them 
potentially that would have the same beneficial impact on those 
who are receiving them, that we would not exclude children. In 
the past they have recommended that children under the age of 
three--I think that was the age, or one--was it one? That was, 
I thought, more of a question that at least early on was more 
of a process question than a health question. Obviously that 
may be different.
    I wonder if you might generally comment on those particular 
issues--the VIG possibility and whether or not we can get to a 
point relatively quickly where we can produce products here 
that would be safe for the general population with obviously 
some risks involved, and whether or not this program we have 
adopted for children where trials are being used as a way of 
protecting them from the potential implications would work 
here, as well.
    Dr. Abramson. I think you good points, Senator Dodd, and 
let me try to comment on them.
    The Vaccinia Immune Globulin, VIG, is effective. We hope to 
have enough doses in another year or so that we could handle 
all the complications if we had to immunize the Nation. But it 
is not effective, unfortunately, against the encephalitis. So 
that is the one complication for which VIG does not work.
    The American Academy of Pediatrics is very concerned that 
these studies are not being done in children; so the decision 
was made not to do the Dryvax dilutional studies in children. 
What would happen if we had an attack tomorrow? Well, the 
problem is that we do not have enough Dryvax to give out to the 
Nation and we would have to start diluting it and we wouldn't 
know what we were doing and that is of great concern to us.
    I also am unaware--I have talked to Acambis and maybe Mr. 
Bush can clarify this, but when I last talked to them there 
were clear studies that would be done of the new vaccine which 
should hopefully be safer. The technology in doing it clearly 
should make it safer. There were studies planned in adults; 
there were no studies planned in children.
    We have to get away--that was the whole point of the FDAMA 
Act--get way from thinking that we can use these drugs and 
vaccines in children and not study them. It is just not a safe 
thing to do. We have many instances of where something works 
fine in adults and does not work fine in children.
    Senator Dodd. You do support, I presume, the rulemaking 
authority we have sought here to require that products be 
tested for children?
    Dr. Abramson. That is a whole debate that is going on right 
now and you know what has happened in the courts, of course. I 
think I will let Mr. Bush----
    Mr. Bush. Yeah, let me clarify a couple of things. You 
commented on the Dryvax. The Dryvax is in limited quantity. 
That was the older generation vaccine. That is being used now, 
my understanding, and when that is done, the new generation, 
the next generation product that is currently going into the 
national pharmaceutical stockpile will begin to be used.
    That product is made in a new generation cell technology 
that makes for a much purer vaccine. You could debate how much 
safer that makes a vaccine and I think there are three critical 
components. One is the way it is made, the purity. The strain 
that is selected. In this case the strain was selected from the 
New York City Board of Health strain. However, it was clonally 
adapted so that this strain is a little bit less virulent than 
what we have seen in the past.
    In addition, to the doctor's point, we need to make sure 
that we do clinical trials on this. The only true indicator of 
safety, not the only true but the best indicator will be the 
clinical trials. Phase one is already done. Phase two is in 
progress. Phase three is already under design with the FDA and 
Dr. Manath with Acambis would have to speak to design for the 
pediatric trials.
    Senator Dodd. Well, are you going to do that? Is that part 
of the deal?
    Mr. Bush. That is part of the whole development contract.
    Senator Dodd. The children will be? There are going to be 
trials done for children?
    Mr. Bush. That I cannot answer for sure. That is why I say 
I would have to defer to the medical director at Acambis. He is 
driving that.
    The Chairman. Well, I think it was Dr. Fauci's point 
earlier that they decided not to do the Dryvax because they 
knew it was going to be replaced by the Acambis product, but 
when they got the Acambis product they were going to do 
childhood testing.
    Mr. Bush. Yes, we can clarify that. We can get back to you 
and clarify that for the record. I honestly do not have that 
information.
    Senator Dodd. I would appreciate that. In fact, I would 
like the answer but more importantly, I would like you to tell 
them we would like them to do it.
    Mr. Bush. OK. I will share that information.
    Senator Dodd. Any other quick comment on--sorry, go ahead.
    Dr. Bicknell. I think Dr. Fauci said that if we went 
nationwide because of an attack we will have enough Vaccinia 
Immune Globulin on hand by mid-year of this year, so we are 
really, really close on that.
    Senator Dodd. Just a quick comment on the--what did I call 
it again? The program we established, Mr. Chairman, the VICP, 
childhood vaccine, the Vaccine Injury Compensation Program. 
That is a model for some of the discussion that has gone on 
already.
    Dr. Abramson. I think the American Academy of Pediatrics 
thinks that would be a very good model for compensating people 
who were injured by vaccines, the whole concept of everybody 
putting themselves at a little bit of risk for the public good 
and if something does happen like when we were using oral polio 
and you had vaccine-related paralysis, then somebody would be 
compensated for that is a very good model.
    Senator Dodd. Any disagreement with that conclusion?
    Mr. Bush. No, I was just going to comment on that. I think 
part of the issue is a technical issue around whether the 
product is licensed or not and, as you know, that program is 
set up now for licensed vaccines being used in children.
    The issue you have right now when Dryvax runs out until the 
new generation vaccine is licensed by the FDA, which will be 
2005, you basically will not have a licensed vaccine available 
to the public even if they wanted it. And once it is licensed, 
then you could get a prescription or request from a physician 
to have that done.
    But in a sense, what the government would do is tax itself 
because the government has prescribed use of that vaccine, so 
it would need to fund that. But it is certainly a model to look 
at as we go down the road.
    Senator Dodd. Anything else?
    Dr. Bicknell. This raises a very interesting point if I 
read it correctly, that if there were an attack tomorrow or the 
next day and we would, in fact, dip into the Acambis stock that 
has been produced already and is barely going into phase three 
trials, a lot of people could be very nervous about taking it 
because it would be kind of a very early investigational new 
drug and compensation would not cover.
    So that would be a very important loophole to plug. It is 
an unlikely event but we could very well be faced with having 
to use a vaccine that is still in kind of the middle stages of 
development and we would certainly not want to have liability 
issues out there at that moment when we have an attack in 
progress.
    Senator Dodd. Good point.
    Mr. Bush. I would just like to echo that point. It is very, 
very important. And all the way from the manufacturers to the 
practitioners, that is a real issue.
    Senator Dodd. Absolutely.
    Mr. Bush. We really do not have a choice in that the old, 
old vaccine, some of the material that has been around and is 
being kept in case we had a massive attack today, is unlicensed 
very old, some of it made 30, 40, 50 years ago, may still be 
viable, probably could be used. The Dryvax has a good record, 
has been tested, but is in limited quantity, is not made any 
longer.
    And then you will be into next generation cell culture 
vaccine and there is a possibility if something happened, this 
product--Dryvax, the licensed product--would be gone and for a 
year or a year and a half you would have to use an IND 
unlicensed product and that is why we as a manufacturer 
continue to bring up the issue of liability, and the clinical 
trial part of this is very, very important as we move forward.
    Dr. Bicknell. There could easily be a window before phase 
three is done when there is lots of Acambis about but it is 
really not----
    Mr. Bush. But let me make one other comment, too, and this 
is with permission of Dr. Manath from Acambis, that the trials 
have gone well. There have been no unexpected situations, 
nothing that they did not expect to see, nothing unusual. It 
just takes time to work through these clinical trials because 
we do have to do it in the proper way under FDA guidance, 
working very closely with them. They have been outstanding in 
support of the process but it will take some time to do that.
    But again this is a vaccine that is being made different 
but in terms of its strain is very close to the Dryvax strain, 
so we would not expect a lot of differences in this.
    Senator Dodd. Well, it raises the issue--I do not know 
whether we ought to be talking about some set of procedures for 
the FDA, sort of an aside approach, to be looked at in these 
potential emergency situations, on a different track when the 
situations warrant it, such as this case is, to be looking at 
maybe an expedited process or something else. It is something 
you have to be careful about so it does not become the 
mainstream, but if you had cases like this, it seems to me it 
is in our interest to have some sort of an expedited procedural 
process that would allow for some procedures to occur here that 
offer some protections.
    Mr. Bush. Yes, and let me say again I would like to 
reiterate even though I am not personally involved in the 
trials, I do know that the FDA, CDC and the agencies have been 
extremely supportive of the process.
    Senator Dodd. Yes, we know that.
    Mr. Chairman, thank you.
    The Chairman. Thank you, and I thank the panel. One of the 
purposes of this hearing was to begin to have some discussion 
on the issue of liability. I do think Section 304 of the 
Homeland Security Act addresses a lot of what we have just 
discussed right here, but we will have to check on that.
    In addition, independent of what we may hope, the fact is 
that the people who appear to know what they are talking about 
tell us the threat is out there and so we have to get ready for 
it and we have to deal with it and this panel has been very 
helpful in giving us some ideas on how to do that, as was the 
prior panel, and we appreciate your taking time to help us out.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

            Prepared Statement of Julie L. Gerberding, M.D.
    Good morning, Mr. Chairman and members of the Committee.
    I am Dr. Julie Gerberding, Director of the Centers for Disease 
Control and Prevention (CDC) and Administrator of the Agency for Toxic 
Substances and Disease Registry (ATSDR).
    Thank you for the opportunity to testify today about the efforts 
underway to assure the nation is prepared in the event of an attack 
using smallpox virus as a weapon.

                              THE DISEASE

    Smallpox is a serious, contagious, and sometimes fatal infectious 
disease. There is no specific treatment for smallpox disease. 
Prevention strategies involve vaccination of exposed or potentially 
exposed individuals. Smallpox outbreaks have occurred from time to time 
for thousands of years, but the disease was eradicated after a 
successful worldwide vaccination program. The last case of smallpox in 
the United States was in 1949. The last naturally occurring case in the 
world was in Somalia in 1977.
    Regardless of the mode, magnitude or duration of any terrorist 
attack, smallpox would be expected to spread from person to person 
following its introduction. Much is known about the natural 
transmission of smallpox. Generally, direct and fairly prolonged face-
to-face contact is required to spread smallpox from one person to 
another. Smallpox also can be spread through direct contact with 
infected bodily fluids or contaminated objects, such as bedding or 
clothing. Rarely, smallpox has been spread by virus carried in the air 
in enclosed settings, such as buildings, buses, and trains. Humans are 
the only natural hosts of variola, the virus that causes smallpox. 
Smallpox is not known to be transmitted by insects or animals.

                              THE VACCINE

    The smallpox vaccine is the only way to prevent smallpox. The 
vaccine is made from a virus called vaccinia, which is another ``pox''-
type virus related to smallpox virus. The vaccine helps the body 
develop immunity to smallpox. It was successfully used to eradicate 
smallpox from the human population. We have had a lot of experience 
with the smallpox vaccine and know it is very effective: it was used to 
eradicate smallpox from the world. It is safe in most people, but in 
some people it is associated with life-threatening adverse events. This 
risk of serious adverse events has made it more difficult to find the 
right balance between preparedness and not placing people at risk 
unnecessarily.
    Routine vaccination of the American public against smallpox stopped 
in 1972 after the disease was eliminated in the United States. 
Vaccination was stopped because the risk of the vaccine was felt to 
outweigh the risk from the disease.
    Until recently, the U.S. government provided the smallpox vaccine 
only to a few hundred scientists and medical professionals annually who 
work with smallpox and similar viruses in a research setting.
    The stockpiling of smallpox vaccine was an important priority 
before September 11, 2001, and smallpox vaccine was already in 
production at that time. The events of the fall of 2001 heightened 
concern that terrorists may have access to the virus and attempt to use 
it against the American public. In response to these events, the 
Department of Health and Human Services (HHS) increased its order for 
vaccine, accelerated production, and began working to develop a 
detailed plan for the public health response to an outbreak of 
smallpox. The United States currently has sufficient quantities of the 
vaccine for every single person in the country in an emergency 
situation.

                       SMALLPOX RESPONSE PLANNING

    A single report of a smallpox case in the United States will 
require an aggressive outbreak control effort to contain spread of the 
disease. In partnership with State and Local Health authorities, DHHS/
CDC is in the process of establishing a smallpox preparedness and 
response program that: Enhances community awareness and clinician 
expertise about smallpox disease and smallpox vaccination through 
education and training; Performs disease surveillance and laboratory 
analysis to rapidly detect a single case of smallpox and any subsequent 
cases; Implements public health interventions, based on careful 
consideration of epidemiology and mode of transmission of smallpox, in 
the safest possible manner; Provides vaccination and follow-up service, 
on a voluntary basis, immediately to those individuals who respond to a 
smallpox emergency (including, but not limited to, those who will treat 
the victims, provide security, vaccinate the population, and perform 
disease case investigations), then, based on knowledge gained, expand 
the program to include those responders who would be occupationally at 
risk during a smallpox outbreak; Provides for the capability to rapidly 
vaccinate a greater number of responders or the entire population 
should a case occur or threat levels of a possible smallpox terrorist 
attack increase.

Response to an Attack
    States need to be prepared to rapidly implement aggressive smallpox 
containment activities, including the ability to vaccinate their entire 
populations. On October 28, 2002, CDC issued post-event smallpox 
planning guidance to the 50 states; the District of Columbia; the 
commonwealths of Puerto Rico and the Northern Marianas Islands; 
American Samoa; Guam; the U.S. Virgin Islands; the republics of Palau 
and the Marshall Islands; the Federated States of Micronesia; and the 
nation's three largest municipalities (New York, Chicago and Los 
Angeles County). To date, all 62 jurisdictions have developed plans 
that are undergoing review by CDC.
    In addition, we are also working collaboratively with other nations 
(Canada, France, Germany, Italy, Japan, Mexico, and the U.K.) in the 
Global Health Security Action Group (GHSAG) to provide a coordinated 
and collaborative response to a bioterror event. In particular, we are 
working closely with Canada and Mexico, as a smallpox outbreak in 
either could necessitate a rapid response in the U.S.

               INCREASING PREPAREDNESS PRIOR TO AN ATTACK

President's Plan
    On December 13, 2002, President Bush announced a plan to better 
protect the American people against the threat of smallpox attacks by 
hostile groups or governments. This announcement is a vital step in 
ensuring that we are prepared to respond to a single reported case of 
smallpox. The President's decision will provide the public health and 
emergency response system with a cadre of vaccinated individuals who 
would respond in the event of outbreak of smallpox. The President's 
announcement identified the need for the public health system to 
provide smallpox vaccine to the following:

Smallpox Response Teams
    HHS has been working with state and local governments to form 
volunteer state and local Smallpox Response Teams that can provide 
critical services to their fellow Americans in the event of a smallpox 
attack. To ensure that Smallpox Response Teams can mobilize immediately 
in an emergency, health care workers and other critical personnel are 
being asked to volunteer to receive the smallpox vaccine. Pre-attack 
vaccination of Smallpox Response Teams will allow them, in the event of 
a smallpox attack, to immediately administer the vaccine to others and 
care for victims. In the initial phase of vaccination, vaccine will be 
offered to core members of public health and health care response 
teams. Then vaccination will expand to include health care workers and 
others who may be first responders.

Department of Defense and State Department Personnel
    The President also announced that the Department of Defense (DOD) 
will vaccinate certain military and civilian personnel who are or may 
be deployed in high threat areas. Some United States personnel assigned 
to certain overseas embassies will also be offered vaccination.

Members of the General Public
    The federal government is not recommending that members of the 
general public be vaccinated at this time. The government has no 
information that a smallpox attack is imminent, and there are 
significant side effects and risks associated with the vaccine. HHS is 
in the process of establishing an orderly process to make unlicensed 
vaccine available to those adult members of the general public without 
medical contraindications who want to be vaccinated either in 2003, 
with an unlicensed vaccine, or in 2004, with a licensed vaccine. A 
member of the general public may also be eligible to volunteer for an 
on-going clinical trial for next generation vaccines.

             IMPLEMENTATION OF SMALLPOX PREPAREDNESS PLANS

    On November 22, 2002, CDC asked states how they intend to vaccinate 
individuals most likely to respond to a smallpox attack. CDC requested 
pre-attack plans that contain information on the number of people 
comprising each Smallpox Response Team, information on where vaccines 
would be administered, the number of health care facilities identified 
to participate, and the number of clinics needed to support this 
effort. States were also asked to address vaccine logistics and 
security, vaccine safety monitoring, training and education, data 
management, and communications in their plans.

Status of State Pre-Attack Vaccination Plans
    States have worked diligently to develop plans to vaccinate and 
have begun implementing them. My oral testimony will address the 
current status of their implementation.
    The plans indicate that approximately 450,000 public health and 
healthcare personnel may be offered the smallpox vaccine. Vaccination 
is voluntary and eligible individuals will make their own decisions as 
to whether or not to receive the vaccine. There are no negative 
ramifications employment ramifications for anyone who chooses not to be 
vaccinated. About 1,500 clinics around the nation will be set up to 
deliver the vaccine to those who choose to receive it. In addition, 
state health officials have identified over 3,300 health care 
facilities that will participate in the program.

                   DISTRIBUTING VACCINE TO THE STATES

    The National Pharmaceutical Stockpile (NPS) Program ensures the 
availability and rapid deployment of life-saving pharmaceuticals, 
antidotes, other medical supplies, and equipment necessary to counter 
the effects of nerve agents, biological pathogens, and chemical agents. 
The NPS Program stands ready for immediate deployment to any U.S. 
location in the event of a terrorist attack using a biological toxin, 
chemical or radiological agent directed against a civilian population 
at the request of the locality.
    The week of January 20, 2003, CDC delivered kits with enough 
vaccine and needles for 21,600 public health and healthcare workers to 
Connecticut, Nebraska, Vermont and Los Angeles County. As of January 
22, 2003, 20 states (including 1 county) requested nearly 100,000 doses 
of vaccine. These were the first shipment of vaccine to state and local 
governments under the President's plan to protect the American people 
from an intentional release of the smallpox virus. Under the program, 
smallpox vaccine is being offered to those most likely to respond to a 
potential outbreak of the disease. Each state notifies CDC when it is 
ready to receive its shipment of smallpox vaccine to begin pre-event 
vaccination of public health and healthcare workers. Once CDC receives 
a request for smallpox vaccine from a state, the order is forwarded to 
the National Pharmaceutical Stockpile for processing and shipment. CDC 
is providing smallpox handling instructions, cold chain management 
guidance, and all appropriate documentation. CDC will deliver Dryvax 
smallpox vaccine, packaged and shipped in increments as small as one 
vial (100 doses). CDC will validate all delivery information prior to 
shipment and will release vaccine after validation of temperature 
monitoring information.

                         TRAINING AND EDUCATION

    Because smallpox vaccine has not been used routinely in the United 
States since the early 1970s, many of today's healthcare providers are 
not familiar with the disease, the vaccine, or the vaccine's potential 
side effects. This makes training of those administering and those 
receiving the vaccine necessary to ensure that this program is 
implemented as safely as possible. Anyone considering vaccination must 
receive information on conditions that are contraindications to 
vaccination (e.g., certain skin conditions, compromised immune systems, 
pregnancy, allergies to components of the vaccine, or household 
contacts with a condition listed above). CDC has held 19 training and 
education sessions on smallpox that reached an estimated 800,000 
clinicians, members of the public health workforce, and members of the 
general population. Training has been conducted in classrooms, via 
satellite, over the Internet, through videotaped sessions and CD-ROM, 
and over the telephone. Thirty different training products, in a wide 
variety of media formats, currently are available.

Training for Response Team Members
    Training and education for Smallpox Response Team members will be 
critical. In order to prepare for their participation in a smallpox 
response effort, all Smallpox Response Team vaccination candidates will 
be asked to watch a video distributed by CDC and will receive a packet 
of information describing the purpose of the national smallpox 
preparedness program. The response team members will receive general 
information about smallpox disease and the vaccine, including pre- and 
post-vaccination worksheets to provide instructions for anticipating 
and monitoring any potential side effects, as well as fact sheets on 
various methods of treatment for side effects resulting from 
vaccination. Prior to vaccination, each vaccine recipient will be 
required to fill out a patient medical history and consent form to 
confirm the absence of contraindications and to confirm the patient's 
consent in receiving the vaccine.

Training for Clinicians
    Clinicians must be able to detect the first symptoms of a potential 
case of smallpox. During vaccination of response team members, 
clinicians will be an important resource for volunteers who are making 
a decision about whether or not they want to accept the smallpox 
vaccine. CDC has an ongoing initiative to educate clinicians about 
smallpox, done in conjunction with experts from a variety of medical 
professional organizations, including the Infectious Disease Society of 
America, the American Academy of Dermatology, the American College of 
Emergency Medicine (within a consortium of other emergency clinician 
organizations), and several primary care organizations. We are planning 
to help these organizations repackage information from CDC, and 
distribute it to their constituents in the format most appropriate for 
their members. In addition, CDC has established ongoing communication 
with 66 professional organizations that represent front-line clinicians 
to determine the smallpox training and education needs of their 
members. Within the next month, CDC is planning a national mail-out of 
critical clinician information to the nation's hospital and clinical 
community through each state's licensing board. In addition, we 
anticipate hundreds of thousands of clinicians will participate in 
CDC's upcoming Public Health Training Network program on ``Clinical 
Management of Adverse Events Following Smallpox Vaccination: A National 
Training Initiative'' scheduled for February 4, 2003. To supplement 
this extensive campaign to educate clinicians, CDC is also utilizing 
its normal means of getting information to clinicians, including the 
Health Alert Network, the secure Epi-X program, and the Morbidity and 
Mortality Weekly Report (MMWR). CDC has also contracted to establish a 
24-hour-a-day, 7-day-a-week hotline for clinicians to call with 
questions about smallpox vaccinations.

Training for Laboratorians
    CDC is providing smallpox training for laboratorians, including 
detailed instructions on the differentiation of smallpox from other 
rashes. On January 29, 2003, CDC will broadcast nationally a training 
program entitled, ``Smallpox and Vaccinia Laboratory Testing: A 
National Training Initiative.'' The program presents detailed 
information, specific to those who perform testing and those who use 
laboratory services, such as physicians, nurses, epidemiologists, and 
state medical officers. They will also be given specific information on 
the laboratory role in diagnosing adverse events associated with 
smallpox vaccination. In addition, CDC has developed ``Agents of 
Bioterrorism: A Guide for Clinical Laboratories,'' which includes 
information for clinical laboratorians about handling specimens 
suspected of containing smallpox. This guide will be distributed to the 
state public health laboratories within the next two weeks. The state 
public health laboratories can customize the guide with state-specific 
information and deliver it to the clinical laboratories in their area.

Education for the Public and the Media
    CDC has, and will continue to use, weekly (and as warranted) media 
briefings, media advisories, access to smallpox vaccine experts, and 
public information materials to create awareness of the smallpox 
vaccination recommendations, the purpose of the recommendations, and 
the risks associated with smallpox vaccine. In addition, CDC is using 
its website to provide easy access to a wide range of smallpox 
education materials, including materials designed specifically to meet 
the needs of different audiences such as members of the public, health 
care providers, people for whom smallpox vaccination is recommended, 
and state and local health departments. We have been, and will continue 
to work with, state and local health departments and other partners to 
help ensure our messages and materials are visible and readily 
available. CDC also operates a 24-hour-a-day, 7-day-a-week public 
information hotline that is accessible in English and Spanish.

    PREVENTING, DIAGNOSING, TREATING, AND MONITORING ADVERSE EVENTS

    Ensuring that we can implement this program as safely as possible 
has been central to our planning. The first part of this effort is to 
carefully educate and screen those considering vaccination. We have had 
a great deal of experience with this vaccine and have information on 
who is at risk of serious adverse events (e.g., those who have certain 
skin conditions, have compromised immune systems, are pregnant, have 
allergies to components of the vaccine, or have a member of their 
household with a condition listed above). Second, we will, with state 
and local health departments and the healthcare community, ensure that 
we diagnose, manage, and treat adverse events promptly and correctly. 
Third, we will very carefully monitor adverse events to ensure that we 
know of any unexpected patterns or types of adverse events on a real-
time basis and can quickly modify the program to decrease the risk of 
adverse events if necessary. Included in this effort is education about 
what to expect after vaccination, when to be concerned about an adverse 
event, and where to go for help.
    The Smallpox Vaccine Adverse Events Monitoring and Response System 
will monitor the occurrence of clinically significant, especially 
serious, adverse events (AEs). It will also serve to identify any 
unexpected adverse events. This process will help to build state 
capacity for assessment of adverse events.

Diagnosing and Treating Adverse Events
    CDC will provide technical assistance to state health departments, 
including screening to identify and exclude persons with 
contraindications and help in implementing proper clinical procedures. 
There will be a designated telephone hotline for state health 
departments. CDC will monitor state tracking of clinically significant 
AEs. CDC will also inform states of any adverse event reports 
transmitted directly to CDC.
    Efforts are underway to work with healthcare providers to assure 
they are educated about the smallpox vaccination program and smallpox 
vaccine AEs. This includes recognizing possible AEs and managing and 
treating any AEs among their patients. Standard algorithms are under 
development to assist physicians in proper identification and treatment 
of these patients.
    Vaccinia Immune Globulin (VIG) is a product used to treat certain 
serious adverse reactions caused by smallpox vaccine. Sufficient 
quantities of VIG are available now to treat all anticipated adverse 
events resulting from the current vaccination program. New VIG is being 
produced and delivered to the National Pharmaceutical Stockpile for 
distribution, if needed, as the vaccination program expands. An effort 
is underway to produce new lots that will meet the standards for 
intravenous immune globulin. Cidofovir is a drug used to treat viral 
infections in persons with HIV/AIDS. It may be helpful in treating 
vaccinia reactions in cases where VIG does not work.
    The state will inform CDC of VIG and/or Cidofovir requests. A CDC 
clinical team will then assess the request with the state and treating 
physician. CDC Drug Services and the National Pharmaceutical Stockpile 
will coordinate release of VIG and Cidofovir. The treating physician 
will then designated as a co-investigator on the Investigational New 
Drug (IND) protocol.

Reporting
    CDC is working with the states to develop an active surveillance 
system to detect serious adverse events following smallpox vaccine. CDC 
intends to implement recommendations that all health care workers have 
their vaccination sites monitored in the hospital daily, which will 
contribute information on serious illnesses that occur in all 
vaccinees. In addition, CDC will use the Vaccine Adverse Event 
Reporting System (VAERS), a national surveillance system administered 
by CDC and the Food and Drug Administration (FDA), to monitor smallpox 
AEs. The data collected through VAERS will be analyzed to identify any 
new or rare vaccine side effects, increases in rates of known side 
effects, associations with specific vaccine lots, or patient risk 
factors.

Post-vaccination Surveillance
    Post-vaccination surveillance will be conducted for people 
receiving the smallpox vaccine. This surveillance will assist in 
determining the rates of common AEs, assessing impact on time lost from 
work, and evaluating vaccinee satisfaction with the immunization 
program. This will be done by telephone survey 10 and 21 days post-
vaccination.

Data and Safety Monitoring Board
    CDC has established a Data and Safety Monitoring Board to provide 
advice to the CDC and program managers on selected aspects of pre-event 
smallpox vaccination program implementation.
    The committee will review reported adverse events to determine 
whether rates of serious events are within expected limits; whether 
recommendations for screening out persons with contraindications are 
being properly observed; whether adverse events following vaccination 
are causally or only coincidentally linked to vaccination; and whether 
the adverse events experienced necessitate a substantial change in the 
way the program is run.

                             IOM COMMITTEE

    Through the Institute of Medicine's (IOM) Committee on Smallpox 
Vaccination Program Implementation, the IOM is providing advice to the 
CDC and program managers on selected aspects of pre-event smallpox 
vaccination program implementation. The IOM Committee released its 
first report on January 17, 2003.
    The committee is making recommendations to CDC and state and local 
vaccine program managers to improve: CDC guidance designed to identify 
potential vaccine recipients at high risk of vaccine adverse events and 
complications; CDC measures to ensure the early recognition, 
evaluation, and appropriate treatment of adverse events and 
complications of smallpox vaccination; CDC plans for collecting and 
analyzing data on vaccine immunogenicity, adverse events, 
complications, and vaccine coverage; the informed consent process for 
vaccine recipients; professional education and training materials; 
communication plans for public health and medical professionals and the 
public; state smallpox vaccination implementation plans; and the 
achievement of overall goals of the smallpox vaccination program (e.g., 
vaccine coverage rate, equity of access, adverse reaction rates, etc.).

                               CONCLUSION

    Assuring the nation is prepared in the event of an attack by a 
hostile group or government is one of the highest priorities for the 
administration. HHS and CDC are dedicated to assisting the states in 
increasing smallpox preparedness. We greatly appreciate all the work 
the states and local jurisdictions have done to develop plans and begin 
to implement them. We look forward to continuing to support states' 
efforts to protect the American people.
    Thank you for the opportunity to testify before you today on this 
important public health issue. I would be happy to answer any of your 
questions.

              Prepared Statement of Anthony S. Fauci, M.D.

    Mr. Chairman and Members of the Committee, thank you for inviting 
me here today to discuss the implementation of the President's smallpox 
vaccination plan, which is intended to protect the American people 
against the threat of a smallpox attack. Because of the long-standing 
expertise of the National Institute of Allergy and Infectious Diseases 
(NIAID) of the National Institutes of Health (NIH) in biomedical 
research on emerging and reemerging infectious diseases, including 
smallpox and other potential bioterror agents, the Institute has been 
designated by President Bush to play a leading role in the nation's 
fight against bioterrorism. As Director of the NIAID, I am committed to 
bringing all of our research expertise to bear on the full 
implementation of this important effort.

                   SMALLPOX VACCINE IMPLEMENTION PLAN

    On December 13, 2002, the President announced a plan to prepare and 
protect the American people against the threat of a possible smallpox 
attack by hostile groups or governments. Under the plan, the Department 
of Health and Human Services (DHHS), through the Centers for Disease 
Control and Prevention (CDC), will work with state and local 
governments to form volunteer ``Smallpox Response Teams'' who can 
provide critical services to their fellow Americans in the event of a 
smallpox attack. To ensure that these teams can mobilize and perform 
effectively in an emergency, it is recommended that health care workers 
and other critical personnel volunteer to receive the smallpox vaccine. 
The President also announced that the Department of Defense will 
vaccinate certain military and civilian personnel who are or may be 
deployed in high threat areas. Some U.S. personnel assigned to certain 
overseas embassies also will be offered vaccination. It should be noted 
that the Federal government is not recommending vaccination for the 
general public at this time.

                          SMALLPOX THE DISEASE

    Smallpox is a serious, contagious, and sometimes fatal disease. The 
symptoms of smallpox infection appear approximately 12 to 14 days 
(range: 7 to 17 days) following exposure. Initial symptoms include high 
fever, fatigue, and head and back aches. A characteristic rash, most 
prominent on the face, arms, and legs, follows in 2-3 days. The rash 
starts with flat red lesions (a ``maculopapular'' rash) all beginning 
at the same time. These lesions become pus-filled and begin to crust, 
forming scabs that separate and fall off after about 3-4 weeks. 
Individuals are generally infectious to others from the time period 
immediately prior to the eruption of the maculopapular rash until the 
time of the shedding of scabs, but are most infectious during the first 
7 to 10 days of rash. The mortality of smallpox infection is 
approximately 30 percent, although mortality is likely to be much 
higher in those with compromised immunity, such as individuals with HIV 
infection and those receiving cancer therapies or drugs to prevent the 
rejection of transplanted organs. Smallpox patients who recover 
frequently have disfiguring scars over large areas of their body, 
especially their face; some are left blind. There is no licensed 
treatment for smallpox disease, and the only known prevention is 
vaccination.
    A massive vaccination program led by the World Health Organization 
(WHO) eradicated all known smallpox disease from the world in the late 
1970's, a resounding success story for vaccination and public health. 
The last case of smallpox in the U.S.A. was in 1949, and use of the 
vaccine in this country was discontinued in 1972. In 1980, WHO 
recommended that all countries stop vaccinating for smallpox. At the 
present time, small quantities of smallpox virus are stored in two 
secure facilities in the United States and Russia explicitly for 
research purposes, but it is believed that unrecognized stores of 
smallpox virus exist elsewhere in the world.
    Prior to its eradication, smallpox was considered one of the most 
devastating infectious diseases known to mankind. Today, with the real 
possibility that smallpox may be used as an agent of bioterrorism, it 
may be once again poised to threaten public health worldwide.

                          SMALLPOX THE VACCINE

    The ``Smallpox Response Teams'' and ``first responders'' identified 
in the President's Smallpox Vaccination Plan will receive FDA-licensed 
Dryvax smallpox vaccine in the undiluted form. This vaccine was made by 
Wyeth Laboratories and approximately 15 million doses have been in 
storage since 1982, when the company stopped making the vaccine. 
Historically, Dryvax smallpox vaccine has proven to be 95% effective in 
preventing smallpox infection. In unvaccinated people exposed to 
smallpox, the vaccine can lessen the severity of, or even prevent, 
illness if given within 3 days after exposure.
    The vaccine is freeze-dried, live vaccinia virus, a poxvirus 
related to smallpox virus it is not a dead virus like many other 
vaccines. The vaccine is delivered in an unusual way, using a technique 
called scarification whereby the material is pricked into the skin 
using a two-pronged needle. Successful vaccination is measured by the 
development of a clear-cut pustule 6-8 days after vaccination. This is 
known as a ``take.'' The blister dries up and a scab begins to form, 
and by the third week the scab falls off, leaving a scar. The 
immunization site remains contagious for vaccinia until the scab dries 
up completely and falls off. For that reason, the vaccination site must 
be cared for carefully to prevent the virus from spreading. 
Approximately one week after vaccination, many people experience fever, 
malaise, myalgia, soreness at the vaccination site, and swelling of the 
lymph nodes in the area of the vaccine, particularly under the arms.
    In order to determine whether the existing supply of Dryvax vaccine 
(15 million doses) retained its potency and could even be diluted to 
expand the stock, a series of clinical trials were performed. In this 
regard, NIAID conducted a study on adults who had not been previously 
vaccinated to determine whether Dryvax could be diluted effectively to 
make more doses of this smallpox vaccine available. This clinical trial 
showed that the existing U.S. supply of smallpox vaccine was still very 
potent in its undiluted form and could be diluted five-fold and retain 
its potency, effectively expanding the number of doses of smallpox 
vaccine in the United States to 75 million. A report describing these 
findings appeared in the April 25, 2002, issue of The New England 
Journal of Medicine. The Dryvax vaccine also is being studied by NIAID 
in previously vaccinated populations to determine whether any residual 
immunity exists from earlier vaccinations.
    In addition to Dryvax, NIAID is sponsoring clinical trials of 
another vaccine against smallpox developed by Aventis Pasteur. Eighty 
million doses of Aventis Pasteur's smallpox vaccine, a different 
formulation of the vaccinia smallpox vaccine, have been in storage for 
40 years. NIAID-supported studies performed through its Vaccine 
Treatment and Evaluation Units will determine the safety and 
preliminary efficacy of various concentrations of Aventis Pasteur's 
smallpox vaccine in adults. To further ensure adequate supplies of 
smallpox vaccine, DHHS has contracted with Acambis, Inc. to produce a 
cell culture based smallpox vaccine for licensure.

         SMALLPOX VACCINE RESEARCH CHALLENGES AND OPPORTUNITIES

    While the Dryvax smallpox vaccine is currently the most effective 
weapon against a possible smallpox attack, it still poses risks, even 
in healthy populations. Fortunately, most individuals experience only 
mild symptoms. However, serious reactions to smallpox vaccination are 
well documented in studies dating back to the 1960s when smallpox 
vaccination was routine in the United States. Those data indicate that, 
for every 1 million people vaccinated, there are 14 to 52 life-
threatening adverse events such as post-vaccinial encephalitis with 1 
to 2 deaths. In addition, there are 49 to 935 serious, but not life-
threatening events. Moreover, because smallpox vaccination ceased in 
the U.S. more than 25 years ago, there is limited experience with this 
vaccine in the era of HIV infection, organ transplantation, and 
immunosuppressive therapy.
    The protection of all populations, including immunocompromised 
individuals, pregnant women, and children is the next critical 
important step in addressing the smallpox threat. NIAID is carefully 
examining alternatives to Dryvax including modified vaccinia Ankara 
(MVA), which may be a viable ``second generation'' smallpox vaccine for 
individuals at high risk of complications from the current Dryvax 
smallpox vaccine.
    Several of the complications of smallpox vaccination can be treated 
with Vaccinia Immune Globulin (VIG), which is derived from the plasma 
of volunteers who previously have received a smallpox vaccination. DHHS 
currently has more than enough VIG to cover the adverse events that are 
projected to be associated with vaccinating the smallpox response teams 
and first responders under the President's smallpox vaccination plan. 
Furthermore, the CDC has contracted for additional supplies of VIG to 
ensure an adequate stockpile of this product by this summer to cover 
the severe adverse events that might be expected for over 300 million 
vaccinees.
    Assessments of MVA vaccine candidates in multiple animal models, 
including immunosuppressed animals, are providing important data on the 
safety and efficacy of the vaccine. In addition, historical data from 
people who received an MVA vaccine in Germany in the 1970's adds to the 
body of scientific data. Importantly, the clinical trials conducted in 
Germany at the time included children, who are known to be at risk for 
adverse events associated with the conventional vaccinia-based vaccine. 
MVA vaccine also has been tested recently as an experimental vaccine 
vector for the delivery of other vaccine candidates, including HIV and 
cancer vaccines. These studies suggest that the vaccine may be safe in 
immunocompromised individuals.
    In late 2002, the NIAID issued a Request for Proposals (RFPs) 
intended to provide resources for the initial development of MVA 
vaccine candidates. NIAID intends to issue a second RFP during the 
summer of 2003, entitled ``Production and Acquisition of MVA Vaccine.'' 
The objective of the second RFP will be to manufacture, formulate, fill 
and finish, and test, in accordance with current Good Manufacturing 
Processes (cGMP) regulations, up to 30 million doses of MVA vaccine to 
constitute the U.S. government's stockpile for emergency use under 
Investigational New Drug (IND) status and to provide a licensure plan 
to include the conduct of expanded human safety studies required for 
licensure and the conduct of pivotal animal protection studies. A third 
contract solicitation for the acquisition of a licensed product is 
being planned for 2005, under the auspices of the CDC.
    In addition, the NIAID Vaccine Research Center on the NIH campus in 
Bethesda, MD, is conducting a clinical trial to determine the safety of 
MVA and to compare the immunogenicity of MVA and Dryvax. This study is 
being conducted in healthy volunteers who have not been previously 
immunized with vaccinia; a future trial with vaccinia-experienced 
subjects is being planned. NIAID also is looking ahead to develop 
``third'' generation smallpox vaccines, including recombinant protein 
vaccines.
    NIAID is also evaluating drugs for use against smallpox virus. 
NIAID-supported scientists have developed a form of the antiviral drug 
cidofovir that can be administered orally. Injectable cidofovir already 
has been approved by the Food and Drug Administration (FDA) for 
treating CMV retinitis in individuals with HIV/AIDS and has shown 
activity against smallpox and related viruses in laboratory and animal 
studies. Preliminary data from these experiments suggest that cidofovir 
may be helpful in controlling the progression of serious vaccinia-
related complications. To illuminate this issue, NIAID worked last year 
with colleagues at the CDC, the FDA and the Department of Defense (DoD) 
to develop an Investigational New Drug application to evaluate 
cidofovir in the treatment of smallpox. NIAID continues to explore the 
development of additional therapeutic interventions against smallpox 
and other potential bioterror agents.

                          BIODEFENSE RESEARCH

    Smallpox is only one of a number of potential bioterror threats to 
our nation. In 2002, NIAID convened two Blue Ribbon Panels to provide 
objective scientific advice on NIAID's biodefense research activities 
involving smallpox as well as other potential agents of bioterror. As a 
result of these deliberations, the Institute has developed two research 
agendas: one focuses on the CDC's Category A agents, which include 
smallpox, while the second focuses on NIAID's Category B and C Priority 
Pathogens. Guided by the recommendations outlined in these agendas, 
NIAID developed a total of 52 biodefense initiatives to stimulate 
research in Fiscal Years 2002 and 2003; 36 are new initiatives and 16 
are significant expansions. During this same time period, NIAID has 
seen a 30 percent increase in the number of grant applications; the 
vast majority of these are in response to our biodefense initiatives.
    In Fiscal Year 2002, several NIAID initiatives encouraged industry 
partnerships and focused on the development of new diagnostics, 
vaccines and therapeutics for CDC Category A agents. These types of 
research initiatives have been well received. As a result, NIAID has 
expanded and reissued many of these collaborative efforts in Fiscal 
Year 2003, and plans to do the same in Fiscal Year 2004. In addition, 
the new initiatives will be broadened to address NIAID's Category B and 
C Priority Pathogens.
    A number of significant advances in understanding, treating and 
preventing potential agents of bioterror have already been realized. 
For example, NIAID-supported scientists determined how anthrax toxin 
gains entry into a cell and demonstrated how the toxin can be 
effectively blocked from entering the cell, suggesting that the 
development of specific anthrax toxin-blocking compounds could be a 
viable approach to treating anthrax disease. Furthermore, intramural 
researchers at NIAID's Vaccine Research Center are working on the 
development and pre-clinical testing of an Ebola vaccine, while others 
have discovered a single gene mutation in the plague bacterium, 
Yersinia pestis, which may have been responsible for the emergence of 
the ``Black Death'' in the 14th century.
    NIAID also has expanded genomic sequencing of potential agents of 
bioterrorism, including anthrax and plague, and has recently awarded 
contracts to two companies designed to spur development of a new 
anthrax vaccine. Similarly, the Institute has new initiatives planned 
to encourage development of vaccines against plague and therapeutic 
strategies against Botulinum toxin.
    In Fiscal Year 2003, NIAID will establish a nationwide network of 
Regional Centers of Excellence for Biodefense and Emerging Infectious 
Disease Research and pursue an initiative to design, build, and 
renovate a system of Regional and National Biocontainment Laboratories 
to serve as national resources for biodefense research and product 
development. These facilities will include a small number of Biosafety 
Level-4 (BSL-4) laboratories, the level of containment necessary to 
study highly pathogenic organisms.

                               CONCLUSION

    The threat of resurgent smallpox is real and its potential is 
devastating; however, the President's Plan moves us in the right 
direction to address this threat head-on. We will continue to work 
closely with the Administration, including our colleagues within HHS, 
to fully implement the President's smallpox vaccine action plan. In 
addition, NIAID will continue to bolster our biodefense research 
efforts, which span basic, clinical and product development research, 
and infrastructure development. With a strong research base and 
talented investigators throughout the country, we fully expect that 
NIAID's research programs will provide the elements essential to 
enhance significantly our nation's defenses against the threat of 
bioterrorism.
    Thank you for the opportunity to testify. I will be happy to answer 
any questions.

                 Prepared Statement of William Schuler

    Good morning, I am William Schuler, President and CEO of Portsmouth 
Regional Hospital, of HCA, Hospital Corporation of America. I would 
like to take this opportunity to thank Chairman Gregg, Ranking Member 
Kennedy, and others on the Senate Health, Education, Labor and Pensions 
Committee for providing me this opportunity to discuss with you the 
implications and concerns raised by the Federal Government's smallpox 
vaccination plan from the perspective of a community hospital.
    Portsmouth, HCA and our trade association, The Federation of 
American Hospitals, fully support the Administration's decision to 
provide voluntary smallpox vaccinations for healthcare workers. We 
particularly applaud the Chairman, the Ranking Member and others on the 
Committee for their continued advocacy of voluntary vaccinations. There 
seems to be widespread recognition that proper implementation and 
safeguards will produce an environment where our nation's hospitals can 
provide the safest patient care and work setting for our patients, our 
employees and their families.
    We believe that advanced voluntary vaccinations will provide the 
best protection to our providers in an identified smallpox outbreak, 
and will strengthen the ability of nurses, doctors and others 
throughout the nation to deliver the care that would be needed-care 
that would likely stretch for weeks and months following a smallpox 
epidemic. By vaccinating these core caregivers, we enable them to step 
forward with the assurance of their own immunity to provide this vital 
care.

                   PORTSMOUTH'S ROLE IN VACCINATIONS

    Portsmouth Regional Hospital, a 209-bed full service facility, is 
the seventh largest hospital in New Hampshire. In 1998, we served as 
one of the four facilities in the country chosen by the US Department 
of Justice to participate in Operation TOPOFF, a nationwide exercise to 
test healthcare preparation for mass casualties.
    Under the President's smallpox vaccination plan, the Department of 
Health and Human Services (HHS) will work with state and local 
governments to form volunteer Smallpox response teams comprised of 
healthcare workers and first responders. Understandably, much of the 
efforts have filtered to the hospital level. As I describe how this 
vaccination plan is proceeding, I will highlight the critical issues 
facing a community hospital, how we are handling them, and where we 
feel further guidance and assistance is needed. These issues include: 
1) Staffing; 2) Treatment of vaccine-related adverse effects; 3) 
Communication, Planning and Funding; 4) Liability and Compensation; and 
5) Regulatory Requirements.
    Allow me to begin by describing the stages of the vaccination 
initiative:

                         PRE-EVENT PREPARATIONS

Stage I
    Step 1--One ``pilot'' clinic that will consist of a very small 
group of clinical individuals from two hospitals in the central region 
of the state, as well as five to seven members of the Public Health 
department vaccination team. (Imminent)
    Step 2--Five or six vaccination clinics at sites that have not yet 
been designated. Approximately forty core, prescreened healthcare 
workers from Portsmouth Regional Hospital will be vaccinated at this 
time, twenty nurses and twenty physicians. (March)

Stage II
    Vaccinations will be offered to all healthcare workers, EMS, First 
Responders, including Firefighters and Police. We are not aware of any 
policy or guidance from any level of government on this step or how 
many workers will be vaccinated. (End of summer if plan progresses)

Stage III
    Vaccinations will be offered to General Public. Public would, at 
that time, receive vaccine from their primary care providers.

                        POST-EVENT PREPARATIONS

    Community Clinics--A collaborative effort led by the state Office 
of Emergency Management (OEM), facilitated by a community team of Fire, 
Police, State Department of Health and Human Services employees, and 
hospital representatives. This team is charged with the formulation of 
a workable plan in which vaccination of an entire community, consisting 
of fifty to one hundred thousand people in our catchment area could be 
achieved in ten days following a smallpox outbreak in the United 
States.
    At Portsmouth Regional Hospital, recruitment of volunteer 
physicians and clinical staff, including nurses, radiology 
technologists, respiratory therapists, and others began in our facility 
in mid-November, 2002. Physicians were the first to be invited to a 
classroom-style presentation by the Chief of Staff, Infectious Disease 
Physician, Infection Control Practitioner, Emergency Room Medical 
Director and myself. The physicians assumed the leadership role in the 
development and implementation of the voluntary vaccination plan. 
Educational booklets and volunteer rosters were distributed to the 150 
physician attendees. Approximately twenty-five physicians volunteered 
immediately. A similar presentation was offered the following week to 
hospital nursing and ancillary staff, as well as staff from physician 
offices, local nursing homes and visiting nurse associations. An 
additional thirty clinicians were added to the volunteer roster. From 
our volunteer roster, we arrived at a core group of forty providers for 
Stage I vaccination, all from the hospital's Inpatient and Emergency 
Department staff. These volunteers were chosen because they had 
previously been vaccinated against smallpox, screened for 
contraindications and provided with additional educational resources. 
In March, we anticipate that this core staff will visit area clinics at 
staggered intervals to receive the vaccination.

                                STAFFING

    As the smallpox vaccination process proceeds into Stages II and 
III, Portsmouth faces increasing medical and staffing challenges. 
According to a study recently reported on by the CDC, 36% of adults 
receiving the vaccine for the first time will likely be sufficiently 
ill to miss work, school, or recreational activities or have trouble 
sleeping. Nationwide, this amount of absenteeism, superimposed on 
winter illnesses and a critical nationwide nursing shortage, will 
surely exacerbate an already tenuous staffing shortage. Provisions must 
be allowed for staggered vaccination schedules of clinical staff to 
ensure support of normal hospital operations. Although our core team of 
forty staff has all previously received the smallpox vaccine without 
complications, we anticipate that approximately ten employees may 
require some time away from their duties. At this stage, we should be 
able to cover this level of absenteeism without impacting patient care. 
However, in future stages, as additional staff members are vaccinated, 
including those who have not had the vaccine before, these staffing 
issues will become of major significance.
    According to the CDC guidelines, hospital responsibilities include 
not only program education, screening for contraindications, and 
identification of healthcare workers to be offered vaccine, but also 
daily vaccination site assessment and management, and evaluation of 
'takes'. Such site assessment means that hospitals must provide daily 
staffing for a twenty-one day vaccine site assessment clinic. At this 
stage of vaccinations (Stage I) at Portsmouth, we would likely be able 
to absorb the financial and staffing burden. However, such a burden 
might not be so easily managed in a much larger hospital with a much 
larger pool of vaccinees.
    Furthermore, in a Stage II setting, when a greater number of 
healthcare workers, EMT's, firefighters and police are vaccinated, the 
logistics for staffing, education, site care, assessment and record 
keeping will require state and federal support. They are not activities 
that a local community hospital can absorb with existing staffing. 
Consideration for extra funding to State Public Health departments 
would enable them to play a much greater role than we have seen to date 
in education, screening and post-vaccination site care, and will ease 
the vaccination-related staffing issues which are currently expected to 
be shouldered by the hospitals.

              TREATMENT OF VACCINE-RELATED ADVERSE EFFECTS

    If and when mass vaccination (Stage III) within the community 
occurs, it is important to recognize that community health care systems 
will be severely stressed. Using published rates of vaccine related 
complications, the 50,000 vaccinees in our designated service area 
could potentially lead to 5,000 office visits and up to 500 hospital 
admissions--an untenable demand for a medical community and a 200 bed 
hospital like our own. We anticipate the need to coordinate a system 
where specialists would help in the evaluation of the more severe 
vaccine reactions, discussing and coordinating homecare for all but the 
most ill. This system has been discussed at a State level in theory 
only, but has yet to be developed. We will hardly be unique in this 
regard. Mass vaccination will create a volume of ill patients that in 
most communities will be unprecedented and profoundly difficult to 
manage.

                  COMMUNICATION, PLANNING AND FUNDING

    Major issues remain regarding communication and division of labor. 
Communication between the State OEM and local emergency personnel has 
been sub-optimal. In the early stages of Community Clinic planning, 
local emergency personnel (fire and police) were not adequately 
informed about the CDC vaccination plans, or their responsibilities in 
such a plan. Initially, hospital and community responsibilities were 
stated to be quite limited. As planning unfolded, responsibilities 
originally assigned to the OEM were given to the hospital and 
community.
    We have communicated this issue to State leaders, and have learned 
that the New Hampshire OEM, like many other states in the country, has 
received no additional funding from FEMA. The New Hampshire OEM remains 
funded only through the Bioterrorism Grant and the New Hampshire 
Department of Health and Human Services. At a time when state and 
municipal budgets are already stressed, there is an understandable 
reluctance to take on additional responsibilities without funding. 
Furthermore, as is happening nationwide, New Hampshire is looking for 
millions of dollars in cuts from the Department of Health and Human 
Services in order to balance the State's budget. As a result, the 
state's OEM is relying too heavily on the staffing resources at a local 
hospital level for planning and initiation. In order to strengthen 
overall post-event planning, the State OEM requires additional funding, 
staffing, and resources.

                       LIABILITY AND COMPENSATION

    We, as a nation, must ensure that healthcare workers are protected 
from personal expense and lost wages as a result of adverse reaction to 
voluntary vaccination. Initially, hospitals and affiliated 
organizations, such as physician offices, had significant concerns 
about their protection from liability in the case of adverse outcomes 
from vaccination, or the rare, yet potentially devastating, inadvertent 
spread of the vaccinia virus to other healthcare workers or patients. 
We understand and appreciate the recent clarification of Section 304 of 
the Homeland Security Act that appears to have resolved many of these 
liability concerns. The guidance clarified that a hospital 
participating in the vaccination program is a covered entity, 
regardless of where its smallpox response team is vaccinated. The 
declaration goes a step forward by clarifying that all members of a 
participating hospital's team are covered, whether employees or not, 
such as non-employed medical staff.
    However, further clarification of liability may be needed on the 
``scope of employment'' issue. Specifically, it is not clear if the 
current guidance provides protection for vaccinated persons who 
inadvertently, and outside of the scope of one's employment, spread the 
infection caused by the smallpox vaccine outside the participating 
hospital. We look forward to working with the Congress and the 
Administration to achieve the full protection intended under Section 
304.
    Significant concerns also remain regarding first party compensation 
claims for health care workers and first responders. The only avenue to 
address compensation as a result of illness, under current law, would 
be through State Workers' Compensation Law, which provides coverage 
after three days of vaccine-related absence. However, since the 
vaccination is voluntary, and not a condition of employment, it remains 
unclear whether this would be an option for our employees. Furthermore, 
our hospital does not feel that our volunteer health care workers 
should be asked to absorb the first three days of absence from their 
own sick leave banks, nor should hospitals be responsible for payment 
of this sick time directly. In addition, not all private practice 
physicians subscribe to workers' compensation. Therefore, we would 
suggest that Congress develop an additional fund, similar to the 
National Vaccine Injury Compensation Program, to ensure that no 
volunteer health care worker goes without compensation due to smallpox 
vaccine-related complications. Providing such compensation would help 
us significantly in the recruitment of additional health care workers.

                        REGULATORY REQUIREMENTS

    Finally, in a time of national emergency requiring the 
implementation of mass immunizations, health care resources will be 
severely strained. In these limited circumstances, certain aspects of 
current healthcare laws and regulations may not be in the best interest 
of the patients and health care workers in our hospitals.
    For example, in response to anthrax exposures occurring in Florida, 
New York, Washington, D.C. and other states, some state departments of 
health issued directives regarding the handling of patients who feared 
they had been exposed to anthrax or other biological agents. One 
hospital was instructed to put a sign outside of the emergency 
department directing patients to an alternative site. In another 
instance, a state health department told asymptomatic patients who 
feared anthrax exposure that they did not need medical screening until 
laboratory results from source letters or packages were received. As 
you know, EMTALA requires hospitals to provide medical screening to all 
patients requesting medical treatment. In the event of mass 
vaccinations or potential smallpox exposures, hospital emergency 
departments could be overwhelmed by the ``worried well.'' Any hospital 
following the recommendations in the two examples above would have been 
subject to potential liability under EMTALA.
    In addition, when hospitals are coping with mass vaccination 
clinics and the potential complications generated, the completion of 
the usual complement of hospital forms such as notices of HIPAA privacy 
rights and Advance Beneficiary Notices may not be possible or 
practical. We hope that the committee will consider how to mitigate the 
consequences of these regulatory dilemmas in a time of national crisis.

                               CONCLUSION

    In closing, I would like to commend the Committee for its 
commitment to the safety and well being of first responders and their 
families. Portsmouth Regional Hospital, HCA and the Federation of 
American Hospitals look forward to working with the Committee to 
implement the Administration's voluntary smallpox vaccination plan.
    I would like to emphasize four key points--first, as the 
immunization program progresses to Stage II and Stage III, staffing 
shortages are likely to become particularly acute. Extra funding to 
State Public Health departments would enable them to play a much 
greater role than has been seen to date in education, screening and 
post-vaccination site care, and will ease the vaccination-related 
staffing issues which are currently expected to be shouldered by the 
hospitals. Second, further clarification on hospital liability as it 
pertains to ``scope of employment'' issues may be necessary. Third, 
Congress should consider developing an additional fund, similar to the 
National Vaccine Injury Compensation Program, to ensure that all 
volunteer health care workers have access to compensation in the event 
of smallpox vaccine-related complications. Fourth, although not the 
primary focus of today's hearing, Congress may want to review the 
consequences, in limited national emergency circumstances, of 
regulatory issues such as EMTALA and completion of the paperwork 
requirements for HIPAA and Advanced Beneficiary Notices.
    Thank you for providing me this opportunity to testify. I will be 
happy to answer any questions the Committee may have.

            Prepared Statement of William J. Bicknell, M.D.

    Mr. Chairman, members of the committee, colleagues and guests, it 
is an honor to be invited to testify before the Health, Education, 
Labor and Pensions Committee. My name is William J. Bicknell, I am a 
physician with a public health degree, have served as Commissioner of 
Public Health in Massachusetts, am Board Certified in Public Health and 
Preventive Medicine and have been a Professor of Public Health and 
International Health at Boston University's Schools of Public Health 
and Medicine for over 20 years. Most recently I have been a proponent 
of careful, selective, progressive and, ultimately, widespread, pre-
exposure vaccination as the best way to protect the nation against the 
threat of a bioterrorist attack using smallpox as a weapon.
    Issues of national security, economics and economic disruption, 
medicine, public health, and labor/management issues often get confused 
as we discuss smallpox. This is complicated by misunderstanding of the 
facts, confusion of fact and opinion and, finally, honest disagreements 
as to the correct course of action. And, as we consider smallpox, it is 
important to remember that it is just one of a number of bioterrorist 
threats.

                                CONTEXT

    First let me provide some context. Smallpox (Variola) is very 
contagious with a 30% overall fatality rate in persons who have not 
been vaccinated. 60% to 80% of survivors are disfigured. There is no 
treatment. It is a terrible disease and an excellent weapon. The threat 
is widely believed to be real but cannot be quantified. However, as the 
consequences of a terrorist release of smallpox on an unprepared nation 
have the potential to be devastating, preparation is essential.
    Many of us were vaccinated years ago. This decreases the likelihood 
of vaccine complications and may provide some very limited immunity to 
smallpox. From a personal or public health perspective the only 
significant benefit of vaccination 10 or more years ago is a further 
reduction in the already low rate of vaccine complications in adults. 
More about this shortly. The important point is anyone who has been 
vaccinated over 10 years ago cannot count on being protected from 
smallpox.
    The nation is far better prepared today for a smallpox attack than 
it was even a few months ago. The three phase plan announced by the 
President in December is prudent and makes excellent sense. A 
tremendous amount has been accomplished and Drs. Fauci and Gerberding 
deserve to be congratulated for their leadership and excellent work. We 
now have sufficient vaccine to protect everyone and Vaccinia Immune 
Globulin (VIG) to treat the treatable complications of vaccination. The 
President's policy, as announced in December, if it is fully and well 
implemented and if we move rapidly with no discernable pause from Phase 
I to Phase II, will give us the ability to rapidly control a terrorist 
generated outbreak of smallpox. But we are not yet ready. Before 
addressing the remaining issues and problems, I would like to summarize 
some facts about smallpox vaccination.

                        VACCINATION--SOME FACTS

    Smallpox was eradicated in the 1970s after many years of great 
effort. At that time the immunity level of the general population was 
very high and most people in Africa and Asia were far less mobile than 
our population today. Today's American population is substantially non-
immune and highly mobile. No one has any experience in dealing with an 
outbreak of smallpox in this very different and dangerous context. The 
unquantifiable but real risk of attack and our highly mobile and 
substantially non-immune population requires us to plan for a worst-
case scenario, not a desirable or not too bad scenario. Managing less 
is easier. However, terrorists can do their job well. We know this. 
Planning for less than a worst case could be disastrous.
    As we consider the possibility of attack, we must think beyond the 
tragedy of deaths and disfigurement and recognize the consequences of 
substantially shutting down commercial activity for weeks or more. In 
addition to domestic disruption, it would be reasonable for other 
countries to ban all arrivals from and departures to the United States. 
If panic, civil unrest and martial law were to ensue, the adverse 
consequences to the United States will be immense, horrible and 
incalculable. My most fundamental message to the Committee is we must 
rapidly complete Phase I and, without pause and with contemporaneous 
evaluation of Phase I results, move rapidly and without delay into 
Phase II of the President's plan. In my judgment, basic protection of 
the nation will not be sufficient until Phase II is completed.
    As Dr. Henderson, former director of the worldwide smallpox 
eradication program, said in 1999: ``One can only speculate on the 
probable rapidity of spread of the smallpox virus in a population where 
no one younger than 25 [now 30] years of age has ever been vaccinated 
and older persons have little remaining residual immunity.''
    Does vaccination work? Yes, it is very effective and prevents 
smallpox. Dr. Henderson and his colleagues demonstrated this 
dramatically with great benefit to mankind.
    The vaccine (vaccinia virus): We have enough for everyone living in 
the United States. The new Acambis product is expected to have a 
similar risk profile to the ``old'' recently relicensed Dryvax product. 
Newer vaccines that may be safer are still 2 or more years away. Drs. 
Fuci, Gerberding and Monath know far more about this than I. They too 
are far more qualified than I to comment upon the likelihood and risks 
of genetically engineered smallpox variants.
    How safe is the vaccine? 14,168,000 persons were vaccinated in 
1968, with 9 deaths, 7 of them in children. The 2 deaths in persons 
over 10 were a teen (age 16) with aplastic anemia and an adult (age 62) 
with leukemia. Using today's guidelines we would not vaccinate any 
children, and we would screen out and not vaccinate the teen and the 
adult. Deaths in children and sick adults can be expected not to occur 
today. In 1968 there were 114 cases of accidental vaccination of others 
with 1 death (a child). Mostly these were child-to-child transmissions 
(70%) and the balance (26%), with 2 or 3 exceptions, were between 
parent/grandparent and child. There is substantial historical evidence 
of safety in adults from the US military since World War II, the 
Israeli Military in the early to mid 1990s, and the recent Israeli 
civilian experience, There have been no reports of vaccine related 
deaths.
    However, we do not have to rely entirely on historical data or 
recent Israeli experience. As of January 27, over 2000 military 
hospital workers have been vaccinated, including staff at Walter Reed. 
This very sophisticated, modern hospital has a hematology/oncology 
ward, transplant unit and neonatal intensive care unit. These are all 
areas where you would not want to accidentally spread vaccinia virus 
from recently vaccinated workers to patients. This has not happened. 
Vaccinated health care workers continued caring for patients using 
semi-permeable membrane dressings, long sleeves, and scrupulous hand 
washing. The semi-permeable membrane dressing reduces the shedding of 
vaccinia virus from the vaccination site into the environment by 95% to 
99%. In addition, patient contact with recently vaccinated workers was 
minimized in the hematology/oncology ward, transplant unit and neonatal 
intensive care unit.
    Primary or first-time vaccinees receive 3 jabs of the special 
bifurcated needle and 97% have a successful vaccination or take rate. 
Persons who had been vaccinated years ago (revaccinees) receive 15 jabs 
and have a 99% take rate. Sick leave day(s) off are taken by 4% of 
primary and 1.5% of revaccinees. Almost all sick leave has been 1 to 2 
days off with 1 day being the most common. The military use the semi-
permeable dressing for hospital workers but not for troops who use a 
band-aid. This is consistent with the CDC guidelines. Complications 
have been minor and are occurring at the expected rates.
    Full data on our military are still classified as to numbers but 
CDC and FDA have this information and, in terms of complications and 
absenteeism, there is nothing to suggest anything much different from 
the above.
    It is very important to remember that many of the military are 
first-time vaccinees, a group at higher risk of vaccine complications 
than revaccinees, and similar to a well screened group of civilian 
health workers. In only a few weeks we will have recent hard, current 
data on serous complications, minor complications and absenteeism. 
However, everything to date suggests that the widely reported fears of 
some health workers either for themselves, their fmailies or for their 
patients are not well founded.
    As our recent experience with adult first-time vaccinees is 
somewhat limited, the plan to vaccinate 500,000 military and 500,00 
civilian first responders will expand our experience base and, I 
believe, put to rest many fears. We are observing and evaluating as we 
go. We can contemporaneously, without pausing, adjust policy if the 
risks are greater than expected. Otherwise, we can and should rapidly 
move to 10,000,000 in Phase II, continue collecting data, recalibrate 
if needed, and finally make vaccination available to the general adult 
public. Anything less than completing Phase II is half-built 
protection. If a hospital, city or state chooses to do less, it is at 
higher risk, becomes a preferred target and weakens national defense.
    It is worth remembering that those at greatest risk of vaccine 
complications are also at greatest risk of dying from smallpox. Thus, 
the more we do careful screening, education and vaccination pre-attack, 
the more the most vulnerable among us will be protected.

                    CHILDREN & SMALLPOX VACCINATION

    Fatality rates from smallpox in children can approach 50%. Children 
are one of our most cherished assets. Gareth, my 2 and 1/2 year old 
grandson is certainly at the center of my life. So why not vaccinate 
children now, before an attack? The reasoning goes like this:
    1--The worst complications and the most deaths from vaccination, 
including deaths in otherwise healthy children, occur in children under 
10.
    2--Arguably the worst complication--Post Vaccinal Encephalitis 
(PVE)--cannot be predicted and cannot be treated. This is rare and 
occurs most commonly in young children (15 of 16 cases in 1968). In 
1968, 4,900,000 children under 10 were vaccinated for the first time, 
only 15 got PVE (0.0003%), but 4 died (26%) and 4 had complications 
including brain damage and paralysis of the arms and legs.
    3--Children are most likely to be accidentally infected or 
accidentally vaccinated by others. In 1968, with a total of 14,168,000 
vaccinations (39% primary vaccinees) there were only 114 reported cases 
of accidental vaccination of others with 90 of these cases (79%) 
occurring in children. Children are most commonly infected by another 
child (70% of cases) or by an adult caregiver. 96% of the cases where 
one person accidentally vaccinated another were either child-to-child 
or between caregiver and child. Only one occurred in a hospital setting 
where a recently vaccinated nurse cared for a child with active eczema. 
This is also a good example of why it makes sense to use the semi-
permeable membrane dressing and schedule recently vaccinated staff not 
to care for patients, such as eczema and immune disorder patients, at 
high risk of accidental immunization.
    4--Complications in children, ranging from mostly minor to, very 
rarely, severe, are quite common. For a mother often any complication 
is seen as severe, even though in the grand scheme of things it may be 
inconsequential. My own son had a smallpox vaccination complication in 
the 1960s, I don't remember it, his mother does! Based on 1968 data, 
children under 1 can expect to experience 1 complication for every 
8,900 vaccinated, for children from 1 through 9 years of age the 
expected complications would be about 1 in 12,000. This is a lot of 
complications even though the vast majority would not be severe.
    5--Post-attack, children are far easier to isolate than adults. In 
a smallpox emergency we would say stay home until your local 
vaccination point is ready in somewhere between 1 and 5 days. 
Hopefully, this will be closer to 2 or 3 days. Then children will be 
rapidly vaccinated and protected before they are infected. The benefits 
of vaccination would now greatly exceed the risks.
    6--The more adults that are vaccinated pre-attack, the less likely 
it is there will be widespread transmission and transmission to 
children post-attack. In my judgment, this is a good reason to modify 
Phase III of the President's plan and move from allowing adults in the 
general public to be vaccinated to encouraging adults to be vaccinated.
    What would I do for my family? I want the adults vaccinated or 
revaccinated so long as they had no contraindications. I'd say no for 
any children under 10. And I would want a tested and proven mechanism 
in place for rapid post-attack vaccination of every remaining 
unvaccinated adult and all children so that smallpox deaths would be 
reduced to a minimum (In a post attack scenario there are very few 
contraindications to vaccination.). In my judgment this approach offers 
the best protection with the least risk, pre- and post-attack, for 
children, adults and the nation.

                          A NOTE ABOUT MODELS

    There are many mathematical simulations or models of a smallpox 
attack extant. They are confusing to many. However, it is my 
understanding, with the possible exception of one model, that, when the 
assumptions are well understood and corrections are made so that the 
populations being considered are comparable, the results from various 
models are remarkably similar and favor the President's plan. If and as 
further modeling takes place and is used to inform policy and to test 
the feasibility of alternative program structures at the federal and 
state levels, it is vital that models be reality based and 
comprehensible with clear and explicit assumptions. The work of Ed 
Kaplan (Yale), Larry Wein (Stanford) and David Craft (MIT) is exemplary 
and their expertise represents a real national resource in this area.

                         JURISDICTIONAL ISSUES

    These are non-trivial. The Homeland Security Act may have 
eliminated these concerns at the federal level, but perhaps not. At the 
state and local levels, jurisdictional issues remain. A colleague (Ken 
Bloem--He has led several leading academic medical center hospitals 
across the country) and I have been working on a concept that 
recognizes the unique problems in coordinating a response to 
bioterrorism events in the United States. Our constitutional division 
of responsibilities between the federal government and the states is 
only one complication. There are overlapping agency jurisdictions at 
the federal, state and local levels and we have a highly unusual blend 
of private and public organizations whose activities must be 
coordinated.
    We are considering an approach that would use an incident command 
structure with incident commanders who may not be traditional public 
health professionals, but would simultaneously be federal and state 
employees reporting directly to the governor of a state and to a deputy 
or under-secretary in Homeland Security. These issues are not the 
subject of this hearing but they are of vital importance and I mention 
them only to highlight their importance. We now have all the material 
things needed to control a smallpox attack. It is time to imaginatively 
and realistically address the organizational and human issues that are 
essential for an effective response.

                               LIABILITY

    I will not address liability as great progress has been made in 
this area and others are far more expert than I.
    SERIOUS MYTHS & MISCONCEPTIONS
    1--The smallpox vaccine is so dangerous it should not be used 
before an actual case of smallpox occurs--WRONG.
    There are differences of opinion. However, the historical data and 
current experience demonstrate that with careful screening, the use of 
the semi-permeable membrane dressing and limiting vaccination to 
healthy adults, the risks of severe vaccine complications and 
particularly deaths can be reduced to extremely low levels. These 
levels are far below the levels of many avoidable risks we all accept 
on a daily basis and far lower than what many health professionals are 
anticipating.
    It is essential to distinguish between vaccine side effects in 
children under 10 and all others as well as between first-time vaccines 
and repeat vaccinees. Children under 10 are at highest risk, repeat 
adult vaccinees are at lowest risk. Deaths in healthy adults, whether 
previously vaccinated or not, can be expected to be extremely low.
    2--A contagious smallpox patient is always visibly sick with a rash 
so there is no risk to health workers if a person infected with 
smallpox is not obviously sick with a rash--WRONG.
    CORRECT--Transmission can occur without a visible rash, with the 
person not feeling well but not so sick as to preclude travel and 
walking around.
    3--Vaccinating within a 2, 3 or 4-day window after exposure may/
will prevent disease--WRONG.
    CORRECT--Vaccination within 5 days of exposure may prevent death, 
and probably results in less serious disease (lower fatality rate), but 
there is little to no evidence that vaccination after exposure prevents 
disease.
    4--If doctors are just properly trained they will be able to 
quickly identify the first case or two of smallpox--WRONG.
    First case(s) will be diagnosed late: Smallpox doesn't look like 
much until day 3 or 4. Confirming may take another day or two. Once the 
first case is confirmed, there will be over-diagnosis. No amount of 
training can prevent this. As rapid diagnosis cannot be assured, and it 
would not be surprising if it took longer than 3 or 4 days, this is an 
additional compelling reason for rapidly completing Phase II of the 
President's plan.
    5--Identifying individual cases, tracing contacts with targeted 
vaccination of contacts, isolation and quarantine (Often called ``Ring 
Vaccination'') is the preferred strategy to contain a smallpox attack--
WRONG.
    In any serious terrorism scenario, this will not work. See the 
comparison of post-attack ring vaccination and immediate mass 
vaccination by Kaplan, et al. With ring vaccination, we can also 
anticipate failure of quarantine, serious disruption of commerce and 
quite possibly civil unrest. As the first case or two are identified 
and obvious case contacts are vaccinated, we should simultaneously ramp 
up for local mass vaccination in the area of the first case(s) and be 
ready for more widespread national mass vaccination if a case occurs in 
a second geographic area.
    All of the above have substantial implications for planning pre- 
and post-attack national control strategies.
    I submit as part of my written testimony a recent article by Dr. 
Ken James and myself that carefully reviews and considers many of the 
issues I have been raising during this hearing. It proposes a framework 
not only for the US but also for other countries to consider as they, 
too, face the possibility of smallpox. I also include a recent article 
by Warren Kaplan, Esq. that, although using Massachusetts as an 
example, takes a national perspective on federal and state legal issues 
as they impinge upon mounting an effective response to the bioterrorism 
threat.

                    THE PREFERRED NATIONAL STRATEGY

    1--Pre-Attack: Implement the President's plan in a timely manner 
with real-time evaluation of Phase I results as we move immediately to 
Phase II. There is no argument for delay and protection is not adequate 
until Phase II is complete. I would more actively encourage vaccination 
of the general population once first responders have been vaccinated. 
This will decrease post-attack transmission, decrease panic and make 
post-attack control much easier. I would also consider using the semi-
permeable membrane dressing for everyone who is vaccinated not just 
hospital workers. Why not decrease the risk of accidental vaccination 
to the lowest possible levels?
    2--Post-Attack: With one or two cases in the nation, I recommend: 
A) in the area where the first case(s) occur immediately vaccinate 
obvious contacts and simultaneously initiate mass vaccination; B) 
mobilize for national mass vaccination; and C) move to national mass 
vaccination if there are any cases in a new geographic area. .

                           REMAINING PROBLEMS

    Clear, concise, accurate information to the public and to the 
medical and public health community is needed. This is getting better 
but further improvement is essential. Open, honest, direct and 
forthright communication including acknowledging uncertainty and errors 
are essential to gain and maintain the trust of the public in 
government.
    Although we have all the material to control an outbreak of 
smallpox, administratively, we are far from ready. Mass vaccination 
tomorrow would be chaotic. Who is in charge and who should do what are 
often not clear. Plans should emphasize simple methods and procedures 
that recognize we will be vaccinating in a big hurry. To do this well 
requires not just advance planning, but the elegance that comes from 
simplicity.
    Finally, the public health system is, by its nature and culture, 
not an emergency response system and never has been. We need to 
consider an integrated federal-state incident command structure with 
Emergency Medical Services and the acute care system taking the lead 
role for mitigating the adverse health impact of any bioterrorism 
event. In this conceptualization, public health, particularly 
laboratories and epidemiologic intelligence, would play an essential 
supportive, but not directive, role.
    Of the utmost importance, if smallpox or some other bioterrorist 
threat becomes a reality, we must be certain our plans will work. 
Therefore, we must move to rapidly complete Phase II of the President's 
plan, and whatever our ultimate organizational structure, we must 
realistically and regularly test our post-attack plans.

                               CONCLUSION

    This is a terrorist threat we have anticipated and can largely 
prevent. The nation has made tremendous strides in the past 16 months. 
The President's plan is sound, takes the teeth out of the smallpox 
weapon and decreases the smallpox risk for us and the rest of the 
world. But we must keep moving. We can simultaneously be prudent, avoid 
needless risk and move ahead rapidly.
    Putting the President's smallpox control plan into effect is but 
one step in a long and arduous journey on the road to improved national 
protection against a variety of bioterrorist threats.
    Finally, as was the case with the interstate highway program and 
the space program, I believe we can look forward to many positive and 
unanticipated benefits to our bioterrorism preparedness initiatives.
    Thank you for offering me the opportunity to testify. I welcome 
questions.

                PREPARED STATEMENT OF JON ABRAMSON, M.D.

    Good morning, Mr. Chairman and members of the Committee, I am Jon 
Abramson, MD Chair, Wake Forest University Physicians, Physician-in-
Chief, Brenner Children's Hospital and Weston M. Kelsey Professor and 
Chair of Pediatrics at Wake Forest. I am also the Chair of the 
Committee on Infectious Diseases of the American Academy of Pediatrics 
(AAP). The AAP is an organization of 57,000 primary care pediatricians, 
pediatric medical subspecialists and pediatric surgical specialists 
dedicated to the health, safety and well-being of infants, children, 
adolescents and young adults. On behalf of the Academy, I would like to 
thank you for the opportunity to present this statement.
    In December, the AAP applauded President Bush's announcement that 
the government did not recommend routine smallpox immunizations for the 
general public. At the same time, we urged the government to do all it 
could do to examine the needs of children.
    This Committee has asked the AAP to respond to three very important 
questions about the President's smallpox vaccination plan. Everything 
that I say today in response to these questions is based on the 
information that the government has provided about the risk of a 
smallpox attack (i.e., the risk while not zero, is very small). Should 
the risk assessment change, then our answers to these questions might 
well be different.
    What is the best approach for implementing the Administration's 
plan to make smallpox vaccine available to the general public?
    The AAP has carefully analyzed this question and we believe that 
the general public, particularly children, should not be offered the 
smallpox vaccine at this time. This recommendation is based on weighing 
the relatively high rate of serious adverse events, including death, 
caused by the smallpox vaccine versus the low risk of a smallpox 
attack.
    During any general public smallpox vaccination campaign infants and 
children would be particularly vulnerable to complications of 
vaccination for the following reasons:
    1) High prevalence of atopic dermatitis.
    2) Immune deficiencies that have not yet manifested or been 
diagnosed in the infant (e.g., primary immune deficiency) or child 
(e.g., HIV-infected children who have a delayed presentation).
    3) Greater risk in infants of serious complications due to the 
smallpox vaccine.
    4) Greater risk of unintended inoculation (e.g., self-inoculation 
of an eye, cross-inoculation between children in a child care center, 
some of whom will have contraindications to smallpox vaccination such 
as atopic dermatitis).
    Currently, the AAP favors a ring-vaccination policy that includes a 
plan for rapid distribution of smallpox vaccine and development of 
strategies for urgent vaccination of large numbers of the population 
rather than a voluntary or mass vaccination program. However, if the 
risk of an attack was felt to be high or if an attack occurred, then a 
recommendation to vaccinate everyone, except those with high risk 
specific contraindications (e.g., a patient who recently received a 
bone marrow transplant), would make sense. Unfortunately, the concept 
of a pre-event voluntary vaccination program for the public, while 
appealing on the surface, makes the least sense from a scientific and 
public health standpoint.
    Some have proposed that vaccination of the general public will 
decrease the spread of smallpox in the event of an attack. However, 
those of us in the public health community know that voluntary 
vaccination programs (without incentives) have not yielded vaccination 
rates at levels high enough to prevent outbreaks of disease. It is very 
unlikely that vaccination rates for smallpox will exceed the rates 
needed to prevent outbreaks and, therefore, this particular argument 
for vaccination of the general public is not based on sound, known 
public health principles. Ring vaccination is an effective method for 
containing this disease, if it occurs, while minimizing risks.
    The words voluntary vaccination is a misnomer. Under a voluntary 
vaccination program scenario many infants, children and adults, who did 
not want to get the smallpox vaccine, would accidentally be inoculated 
by those who did receive the vaccine. It is important to point out that 
before 1972 when smallpox vaccine was routinely given to everyone who 
did not have a known contraindication, 25% of those who developed 
serious side effects were those unintentionally inoculated with the 
vaccine. Moreover, although the use of semi-permeable dressings can 
reduce the risk of spread of the vaccine virus, these dressings are 
unlikely to be practical for large-scale vaccinations because they are 
expensive, cause allergic reactions in some people and compliance with 
their proper use will vary. Thus, many children whose parents did not 
wish for them to get the vaccine could end up with adverse consequences 
from the vaccine, some of which would be very serious - including 
death.
    What more needs to be done to deal with liability and compensation 
concerns?
    To answer this question I speak not only from the viewpoint of the 
AAP, but also as the Chair of the Wake Forest University School of 
Medicine physicians group. Over the past few months our medical center 
has struggled with trying to come up with a smallpox vaccination 
program that would allow us to implement President Bush's request that 
we immunize a group of healthcare workers at various hospitals to care 
for children or adults who are exposed to or develop smallpox. There 
are a number of troublesome issues that arise from this request 
including concerns about liability and compensation.
    Recent statements from the administration have clarified that the 
federal government's intent is to assume liability risk for physicians 
and hospitals that participate in this program. However, this does not 
provide injury compensation for patients or household contacts that are 
accidentally inoculated. This is very problematic. For example, if I as 
part of the healthcare team suffer a serious adverse event, I am 
covered by the workmen's compensation program. However, if I 
accidentally inoculate one of my children at home or a patient I am 
caring for in the hospital and they develop a serious side effect they 
are not covered. We urge Congress to correct this problem by enacting a 
``no fault'' mechanism, similar to the successful National Childhood 
Vaccine Injury Compensation Program, to compensate those injured 
directly or indirectly by the smallpox vaccine. Furthermore, it is 
important that those receiving the smallpox vaccine be adequately 
informed about the risks associated with the vaccine including issues 
surrounding liability and compensation.
    What needs to be done to ensure that children are eligible to 
receive the smallpox vaccine?
    Recent studies have shown that the currently available licensed 
Dryvax vaccine can be safely and effectively administered to adults. 
However, no recent pertinent clinical trials have been or will be done 
using this 30-year-old frozen vaccine to ascertain whether this is true 
for children. Furthermore, the new tissue culture-derived vaccine that 
is currently being developed has never been tested in adults or 
children. We are aware of planned studies in adults for this new 
vaccine, but know of no such planned evaluation of the vaccine in 
children.
    Surveillance studies done prior to 1970 when undiluted Dryvax 
vaccine was routinely used suggest that children have a higher 
incidence of adverse effects from the vaccine than adults do. Children 
are not 'little adults', and their distinct physiological responses 
must be studied before being exposed to the vaccine. Both the Committee 
on Infectious Diseases of the AAP and the Advisory Committee on 
Immunization Practices (ACIP) of the CDC have clearly stated that these 
studies need to be done in children similar to the testing that is done 
for other childhood vaccines.
    In 1998, Congress passed the Food and Drug Administration 
Modernization Act (FDAMA) to make sure that children would no longer be 
subjected to receiving drugs that had not previously undergone testing 
to assure safety and effectiveness in children at various ages. Are we 
really willing to make and potentially use millions of doses of 
smallpox vaccine to prevent smallpox in children and not know if it 
will be safe and effective in preventing the disease? If a smallpox 
attack did occur are we really willing to let millions of children be 
part of an emergency experiment? The AAP and ACIP have clearly stated 
that these studies should be done and we hope that Congress will assure 
that they are. The AAP strongly recommends that Congress take immediate 
action to assure that they are.
    The National Association of County and City Health Officials, have 
estimated that the total cost of the vaccination program, including 
purchase of the vaccine, training personnel, screening potential 
vaccine recipients, and data collection, could be as much as $1 
billion. Local health officials have indicated that the vaccination 
plan will divert public health funds from other health programs 
including childhood immunization clinics and control of tuberculosis 
and pertussis. The AAP strongly urges Congress to ensure that these 
other vital public health programs that are needed to protect against 
ongoing and preventable diseases are not sacrificed to protect the 
population against a potential, but currently non-existent disease 
(i.e., smallpox).
    The American Academy of Pediatrics is eager to work with Congress 
and the Administration to assure that the appropriate research, 
therapeutic provisions and policies are in place to protect children 
against the threat of a biologic, chemical or nuclear attack, while 
continuing the programs needed to maintain the health of our children. 
Thank you for your consideration and I would be happy to engage in a 
dialogue and answer any questions that you have.

                   Prepared Statement of Martha Baker

    Good morning Committee Chairman Gregg Ranking, Member Kennedy and 
other Members of the Senate HELP Committee.
    My name is Martha Baker. I have been a registered nurse for 23 
years. I work in the Trauma Intensive Care Unit of Jackson Memorial 
Hospital in Miami, Florida, and I'm a national leader of the 1.5 
million member Service Employees International Union, the largest 
health care union in the country. I am also president of SEIU Local 
1991 and cochair of the SEIU Nurse Alliance, which is made up of 
110,000 nurses across the country. In addition to nurses, our union 
represents doctors, laboratory technicians, EMTs, orderlies, dietary 
workers, laundry workers, environmental services workers, and other 
occupations within the health care sector. Many of these employees work 
in occupations that would likely be defined as ``first responders'' in 
the event of a smallpox attack.
    As a trauma nurse, I deal with emergencies every day and work on 
the frontlines of medicine, providing every patient that comes through 
the door with the best care possible. If a smallpox outbreak occurred, 
I'd want to do no less for someone suffering from that terrible 
disease. That's why--if there is a bioterrorism threat--it makes sense 
that health workers should take steps now so we're ready to respond. 
Unfortunately, problems with the Bush Administration's smallpox 
vaccination plan are making a lot of nurses like me hesitant to roll up 
our sleeves and put the health of our patients, our loved ones, and 
ourselves on the line.
    Dr. Fauci and Dr. Gerberding, have already discussed the scientific 
details of this vaccine. Suffice it to say, everyone agrees that this 
is a very dangerous human vaccine. When the vaccine was routinely being 
administered up until 1972, for every 1 million vaccinated, 1,000 
people suffered serious side effects, 14-52 people suffered life-
threatening complications and one or two died.
    The question we face today is whether our elected leaders in 
Washington could be doing more to make sure the vaccine program is safe 
and effective. The prestigious Institute of Medicine says better 
safeguards are needed. The American Public Health Association has 
called for compensation for vaccine victims, liability protection, and 
adequate resources to safely implement the plan.
    Many hospitals across the country are speaking with their feet. The 
USA Today reported last week that more than 80 hospitals have decided 
to opt out of the program. The majority of states have not yet ordered 
the vaccine. And in Connecticut, only four doctors showed up to get 
vaccines after nurses' concerns about the plan went unanswered.
    I'd like to talk about the issues workers and management at my 
hospital faced when we tried to figure out how to safely implement this 
plan.
    First, everyone wanted to be sure we weren't doing anything to put 
our patients at risk.
    Jackson Memorial is one of the largest public hospital in the 
country. On any given day, we care for hundreds of patients. Some are 
pregnant women, newborn infants, and children. Many of them are 
battling cancer or are HIV positive. If I or anyone in my household has 
these conditions, the Centers for Disease Control and Prevention says I 
shouldn't take the vaccine. So how can we be sure our patients are 100 
percent safe in the care of nurses, doctors, or other caregivers who 
get vaccinated? In June, the Advisory Committee on Immunization 
Practices (ACIP) recommended against direct patient care for about 
three weeks. In October, the same panel said patient care is safe. 
While the medical experts debate the issue, the nurses I work with just 
want to know--Am I going to infect someone in my care?
    Nurses, doctors, and management at our hospital decided that any 
volunteer who could accidentally expose vulnerable patients to the 
virus in the vaccine should be put on administrative leave until they 
were no longer shedding the live virus in the vaccine.
    In our hospital--as in just about every hospital across the 
country--understaffing is a constant issue. Too few nurses are already 
under pressure to provide quality care to patients who are sicker than 
ever before. Recent studies suggest that the smallpox vaccine will make 
up to 1 in 3 nurses too sick to work for a few days--and those are just 
the people with normal reactions.
    Staff at our hospital will be vaccinated in stages, so we don't 
create a staffing crisis that compromises care. And if workers at our 
hospital get sick for a few days as a result of the vaccine, management 
has agreed to treat it as an on-the-job injury so they won't face any 
loss of income.
    Next, we thought about our own health and the health of our 
families.
    The Washington Post reported last week on a survey that showed how 
little nurses know about smallpox and the vaccine. I can tell you from 
my own experience that it's true. So we knew we had to make sure 
everyone is provided with good information by holding training sessions 
on work time so they can make an informed decision. We're also going to 
closely monitor people who are vaccinated and make that information is 
available as we go along so other workers can benefit from our 
experience. The lack of proper surveillance and reporting is a critical 
missing piece of President Bush's vaccination plan. It would be a shame 
if the 10 million ``first responders'' who are set to get vaccinated 
after health care workers don't have access to the knowledge we gain 
during the first phase of this plan. This is why we support the 
Institute of Medicine recommendations for ``active'' monitoring of 
those vaccinated, and not the ``passive'' monitoring CDC currently 
recommends.
    Many health workers being asked to volunteer for this vaccine are 
women who have children at home, are pregnant, or could be pregnant. 
Latex allergies and other skin disorders are more common among health 
care workers. And certainly advanced treatments mean many people, 
including nurses and other health workers, are living with cancer, HIV, 
or other disorders that put them at a higher risk of adverse reactions 
from the smallpox vaccine.
    Our hospital is providing free and confidential testing for any 
volunteers who want to be sure they aren't pregnant or infected with 
HIV before they volunteer for this vaccine. Our service men and women 
in the military who are candidates for the vaccine are being offered 
such protection, but as of yet, the federal government has not agreed 
to pay for such tests for civilian health worker volunteers, Spending a 
relatively small amount on preventative testing can reduce the cost of 
any compensation fund, as adverse effects are less likely if people at 
high risk are identified and screened out. Not everyone will need 
testing but there must be mandatory screening with free voluntary 
testing where such follow-up is indicated. Not only must testing be 
confidential, but smallpox responders must be protected against any 
discrimination or retaliation on the job if they refuse to be 
vaccinated.
    Most nurses are used to vaccinations. We see how sick people get at 
this time of year and counsel our patients about getting their flu 
shots. Health care workers fought for access to the Hepatitis B 
vaccine. So in a way, getting another vaccination is all in a day's 
work. And since the average age of nurses is 47, many of us got a 
smallpox vaccine when we were children.
    But there's a reason why our country stopped vaccinating children 
against smallpox. The risks outweighed the benefits. People were 
getting sick and a few were dying from the vaccine. A doctor I work 
with had one of the life-threatening reactions to the vaccine that 
everyone is talking about--she got encephalitis when she was vaccinated 
as a child.
    The situation is potentially much more precarious today. Back in 
1972, few people lived with weakened immune systems, and less than 5 
percent had eczema; both groups that are now considered high risk and 
should not be exposed to the vaccine. Today, it is estimated that 
between 30 million and 50 million Americans fit a high-risk category. 
This includes people who are receiving chemotherapy, have had organ 
transplants, are pregnant or are planning to become pregnant, have 
allergies to some antibiotics or latex, are taking high doses of 
steroids, have, or have ever had eczema (now estimated at up to 22 
percent of the population), or are infected with the AIDS virus.
    The risks of this vaccine are real. Health care workers around the 
country are asking: What if me or one of my patients or one of my 
children is one of the unlucky few who gets sick?
    Unfortunately, there is no good answer to that question. This is 
why careful screening and free, confidential testing--as well as 
active, on-going medical surveillance of vaccine volunteers and their 
patients, co-workers, and household members--is essential. Health care 
workers and those close to them must have immediate access to free 
medical treatment if needed. If serious reactions occur, 
countermeasures must be in place to perhaps prevent a life threatening 
response, including the immediate availability of Vaccinia Immune 
Globulin (VIG).
    The Homeland Security Act protects the drug companies who produced 
the vaccine and the hospitals who administer it from liability. If 
workers, their patients, or their family members get sick as a result 
of the vaccine, they'll be lucky if they receive a ``get well'' card 
from our elected leaders. I think we can do better than that--and I 
hope you do, too.
    Nurses at my hospital had a voice in how our smallpox vaccination 
plan will be implemented because we have a union. But most health care 
workers aren't so lucky. Without action by Congress, the safety of this 
plan for workers and our patients will depend a lot on where you live 
and which hospital you work in.
    Even our hospital hasn't been able to answer the question of what 
will happen if one of us, or one of our patients, or someone we live 
with gets really sick from this vaccine. At Jackson Memorial we are 
fortunate since our employer has agreed to pay for up to seven days of 
administrative leave for those of us who have less severe reactions. 
But what happens after that is an unknown. Where can health care 
workers or others suffering injury or illness from the vaccine or 
exposure to the vaccine turn to for coverage of medical care and lost 
wages.
    State and federal workers' compensation programs do not provide an 
adequate safety net. We have already heard that some state workers' 
compensation programs won't cover us and others won't do enough. Some 
workers' compensation programs may not cover the claims of workers who 
have adverse reactions because they have voluntarily agreed to be 
vaccinated. Some state workers' compensation laws do not require 
coverage for all workers. Since workers' compensation only applies to 
injuries that are work-related, it won't provide any protection for 
patients or family members who could be at risk.
    Even where applicable, workers will not be fully compensated. Most 
workers' compensation programs replace only two-thirds of workers' 
earnings. There are also limits on the maximum weekly benefits, which 
means that more highly paid health care workers cannot receive anything 
approaching adequate replacement of their lost income. In addition, 
there are caps on medical care, posing a particular problem for workers 
who suffer a severe side effect. Clearly, for most civilian responders 
and others who become ill from exposure to the vaccine, the workers' 
compensation program will not be there for us.
    So where do we turn for coverage of our medical costs and lost 
wages if we become ill from the vaccine--either directly or indirectly? 
Since health care and emergency workers are being asked to step forward 
to help protect our nation against a possible smallpox attack, we 
believe the federal government has a responsibility to make sure that 
no one vaccinated or harmed as a result of the vaccinia virus has to 
worry about paying for medical treatment or recovering lost wages. In 
the case of more severe adverse reactions, there must be a fair 
compensation program that is easily accessible, recognizes the no-fault 
likelihood of injury, and covers the cost of medical care and lost 
income.
    If smallpox is a threat, then we need to prepare for it in a way 
that doesn't make the problem worse. It has been SEIU's view that the 
national smallpox program should not proceed until all necessary 
protections and safeguards are in place. But now that vaccinations have 
started, Congress urgently needs to pass and fund legislation that 
closes the gaps in the Administration's smallpox plan that could put 
everyone at risk.

                    THE NEED FOR FEDERAL LEGISLATION

    This is why SEIU and other unions representing health care and 
emergency workers have developed a legislative proposal that speaks to 
the safeguards that we believe must be in place in order to carry out a 
successful, safe smallpox responder program. I have attached the full 
proposal, but briefly we believe a safe, effective smallpox program 
must include the following:
    Sufficient federal funding to allow all states through state and 
local public health agencies, in cooperation with hospitals and other 
health care entities, to have the needed resources to carry out and 
coordinate all aspects of a comprehensive smallpox program. States 
should not have to siphon funds now being used to strengthen state and 
local public health infrastructure to fund the smallpox program. States 
must ensure there are the following:
    1. Mandatory education that is available prior to vaccination for 
all potential smallpox responders, their household members, and co-
workers who may be exposed to the vaccinia virus.
    2. Mandatory Medical Screening and voluntary testing program that 
provides free and confidential screening and testing for pregnancy. 
HIV, and other conditions that could put volunteers at high risk of 
side effects. Workers who choose not to receive the vaccine should not 
face discrimination or retaliation on the job.
    3. Medical Surveillance and Treatment of volunteers, patients, co-
workers. and household members for any adverse effects of the vaccine. 
Treatment must be available at no cost to those suffering adverse 
reactions to the vaccine as well as protections to ensure no lost wages 
or benefits if they are required to take time off from work. A federal 
compensation program must available for those suffering from more 
serious adverse reactions. For those responders or others who have no 
health insurance, there must be some provision, such as temporary 
Medicaid coverage to ensure that treatment costs are covered. In 
addition, the Institute of Medicine has recommended a much stronger 
system of reporting adverse reactions tot he vaccine.
    Compliance with the Needlestick Safety and Prevention Act of 2000. 
Only the safest and most effective bifurcated needles should be used to 
administer the only smallpox vaccine. A sheathed bifurcated needle is 
available for the smallpox vaccine. We urge that the FDA expeditiously 
expand their current license for safer bifurcated needles so that they 
can be used as part of this national smallpox program and included as 
part of vaccine kit.
    A National Smallpox Vaccine Injury Compensation Program. This 
program would cover costs for medical care, lost wages, and pain and 
suffering for those who face more severe reactions to the vaccine or as 
a result of exposure to the vaccinia virus. We already have a model for 
this in the childhood vaccine injury compensation act, which is a no-
fault, easily accessible compensation program.

                               CONCLUSION

    SEIU, along with the other health care unions, are very pleased 
that Chairman Gregg, Majority Leader Frist and Senator Kennedy have 
agreed to work together in crafting legislation that we believe will 
meet many of these points raised above. We look forward to working with 
you to assure our nation's smallpox program includes the protections 
that health care workers, emergency workers, patients, and household 
members need and deserve. Given that smallpox vaccinations have already 
begun, we hope that you will move quickly to introduce legislation and 
to appropriate the necessary funds to make it a reality. On behalf of 
SEIU, we are grateful for this opportunity to express the concerns of 
frontline health care responders. Thank you.

          Prepared Statement of Baxter Healthcare Corporation

    Mr. Chairman, members of the Committee, thank you for the 
opportunity to speak today about smallpox vaccine and the threat of 
bioterrorism.
    I am Kim Bush, President of Baxter Bioscience Vaccines. Baxter 
International Inc. is a global health care company that, through its 
subsidiaries, provides critical therapies for people with life-
threatening conditions. Baxter's Bioscience, Medication Delivery and 
Renal products and services are used to treat patients with some of the 
most challenging medical conditions including cancer, hemophilia, 
immune deficiencies, infectious diseases, kidney disease and trauma. 
With 2002 sales of over $8 billion, and approximately 48,000 team 
members in 110 countries, Baxter is a global leader in developing 
innovative medical therapies that improve the quality of life for 
people around the world.
    Baxter has a total of five licensed vaccines worldwide, and a broad 
pipeline of vaccines with more than a dozen vaccines at all stages of 
development from pre-clinical to pre-launch, including influenza and 
various meningococcal combination conjugates. Baxter's NeisVac-C 
meningococcal vaccine was approved in the U.K. in 2000 and is now 
licensed in 29 countries. Our newest next generation influenza vaccine 
has been approved for Phase III clinical trials this year in the U.S.
    Baxter Healthcare Corporation, in conjunction with Acambis Inc., is 
participating in the production of 155 million doses of smallpox 
vaccine for the U.S. Government.
    Mr. Chairman, I would like to make the point that what has happened 
in the case of the smallpox vaccine partnership between Baxter/Acambis 
is extraordinary to the point of being unprecedented. As you may be 
aware, although smallpox vaccine has been around for many years, the 
process used by Baxter and Acambis--growing the vaccinia virus in cell 
culture--is entirely new insofar as large-scale production is 
concerned.
    Under optimal circumstances, the development of a new vaccine from 
the beginning through product delivery to the ultimate end user is a 
process that may take 10 years and in some cases has taken much longer. 
In the case of our current smallpox effort, however, through an 
innovative public-private partnership, this time frame has been 
dramatically shortened and compressed so that the needs of national 
security can and have been met. At the same time, neither product 
quality nor the need to demonstrate safety and effectiveness in 
clinical trials is being compromised. That is a remarkable feat made 
possible because the FDA and all of the other government agencies along 
with the manufacturers decided this was not ``business as usual.'' I am 
not sure many Americans know or appreciate the long hours, weeks of 
intensive and exhaustive fact-finding, and all the other hard work and 
collaboration that went into this contracting process. If they did, I 
am sure they would be very proud--as I am--of what our civil service 
and political leadership can accomplish in partnership with the private 
sector when an urgent need arises. It took only 58 days to complete the 
decision making process to award a $400 million contract. That is 
unprecedented!
    At the same time, we believe there are some lessons from this 
experience and we appreciate this opportunity to share with you some 
thoughts and ideas based on our experience as to how the country can 
enhance its ability to prepare for and respond to other bioterrorism 
threats. It is unfortunate that a disease that scientists and health 
care workers throughout the world devoted decades to eradicating may 
now be a bioterrorist threat. We therefore must use whatever scientific 
and medical tools at our disposal to defend against the unthinkable.
    We believe a number of issues need to be considered and resolved if 
we are to have a truly meaningful and productive public-private 
partnership in defending against bioterrorism. I can assure you that 
the barriers are not in the willingness or ability of the private 
sector to become engaged.
    For example, Baxter currently has the capability to make vaccines 
for numerous bioterrorism threats. Now--today--we have the technical 
ability to produce and deliver vaccines for smallpox (2nd generation 
and next generation/MVA), as well as vaccines that utilize recombinant, 
cell culture and conjugate technology and can protect against a variety 
of both viral and bacterial diseases. We can respond to pandemic 
threats including influenza, with our proprietary cell culture based 
production technology that eliminates the need for egg-dependent growth 
platforms and decreases the risk of adverse reactions. Beyond that, 
another 5 to 10 vaccines are possible if we select the right partners. 
In short, Mr. Chairman, Baxter, like a number of other companies, is 
technically able to meet many of the country's vaccine needs. The 
questions are under what conditions and with what incentives can these 
capabilities be optimized and what are the factors working against 
them? Let me share with you some of the issues we and industry are 
dealing with.

    UNCERTAINTY OF MARKET CONDITIONS FOR ANTI-BIOTERRORISM PRODUCTS

    Inside a company such as Baxter, proposals to fund vaccine projects 
must compete against each other as well as against non-vaccine projects 
for R&D dollars. To put it simply, when you do the math, vaccines often 
come out as a less appealing choice for investment than other medical 
or pharmaceutical products. If you add to this the current and growing 
attacks on intellectual property protection, particularly as it 
pertains to health needs of developing countries--along with liability 
issues facing the industry and the costs of meeting regulatory 
requirements--it's not hard to understand why vaccines are viewed by 
some in less and less favorable terms as an investment priority.
    New vaccine development decisions are risky in and of themselves. 
Bioterrorism products present even more difficult challenges because 
such products, especially if they are vaccines, may represent one-time-
only opportunities and the market is extremely unpredictable. Certainly 
a product that is to be stockpiled and used only in case of emergency 
is not one that can by itself create a sustainable business model or 
warrant a huge R&D expenditure. That is even more true when we factor 
in the reality that shifts in government policy or perceived threats 
could change priorities and funding initiatives overnight. Today's 
urgent need may become tomorrow's minor concern, or vice versa.
    Beyond that, for a manufacturer of vaccines that often take months 
to move through the production process, scheduling and anticipating 
needs are critically important. Also, just as for up-front decisions 
regarding product research and development, expensive manufacturing and 
production funding priorities and resource allocation decisions also 
take place in an environment of competing and sometimes conflicting 
demands.
    Against this backdrop, it is critical that needs be clearly stated. 
This is not always the case for government needs. Numerous different 
agencies have responsibility to foster research related to 
bioterrorism. That is a good thing and, indeed, there is a lot going 
on. However, from the perspective of industry their activities are not 
always coordinated or visible. Sometimes the procurement process lacks 
transparency--RFPs are issued and announcement dates come and go, 
sometimes without good communication as to the reasons for delay or 
what the issues are. Highly regulated procurement systems that work 
well under normal circumstances and are set up to procure standard 
material goods or to support small business R&D, do not necessarily 
provide incentives for large, capable manufacturers of complex 
biopharmaceuticals--nor are these standard procurement practices 
necessarily the fastest way to get products, especially 
biopharmaceuticals, into the hands of the U.S. government.
    Another factor adding to the risk is our awareness of the fact 
that, in some cases, what the government is willing or able to pay for 
a product may be determined according to the appropriations available, 
not the value of the product to be purchased or the cost structure of 
the manufacturer. Hence, when investment decisions for R&D programs or 
manufacturing are being made by vaccine producers, we must consider the 
possibility that the government agencies may be bound by artificial 
limits in terms of determining what constitutes a fair price for the 
final product.
    To create improved incentives to invest in new bioterrorism 
vaccines, it would be very helpful to hear a clearer and more 
coordinate message from the federal government as to the definition of 
its needs.
    Mr. Chairman, I would also like the Committee to be aware that the 
vaccine industry today is somewhat splintered in the sense that--on the 
one hand you have a small number of large integrated manufacturers--
and, on the other, a host of small companies including some small 
start-ups, that have really focused on a particular niche or technical 
capability. From our standpoint, it would seem very beneficial to the 
government to gain a greater understanding of the strengths of all 
these different companies, and put together a comprehensive composite 
picture of how all of these companies might be used in varying 
partnerships or consortia to bring forth the best possible result in 
the shortest possible time.
    Currently, the way the system works, the government will issue an 
RFP and ultimately award the work to one prime contractor. It may very 
well be that alternative processes might foster partnerships and 
collaborations between companies with strengths that complement each 
other. I can say from our own Baxter experience that our partnership 
with Acambis in producing smallpox vaccine has been optimal for the 
government and certainly has worked well for our two companies. Yet, 
that partnership came about only through a series of events and pre-
existing relationships that would not normally occur and were almost 
serendipitous. We think the government could be much more proactive in 
terms of acquiring a broader knowledge of the industry's capabilities 
and using that knowledge to foster public-private partnerships. This 
could more readily harness the diverse talents and capabilities of the 
private sector to achieve the best possible results in the shortest 
possible time.
    Accordingly, Mr. Chairman, we recommend that all of the government 
agencies that are involved in biodefense preparation develop a process 
for working in a more collaborative fashion to establish and 
communicate clear national research and development targets, thoroughly 
educate themselves on the capabilities of the industry, foster 
partnerships among different companies, and establish an RFP process 
that has an overriding goal of getting the best product in the shortest 
possible time. That is what occurred in the case of the smallpox 
contract with truly remarkable results and we think that process can be 
replicated for other bioterrorism research initiatives.

                          IMPACT OF REGULATION

    The current regulatory system for drugs and biologics was 
established around the concept of assuring that the American people 
have safe and effective medicines to treat or prevent the wide range of 
medical conditions that can afflict people in a normal lifetime. 
Biologic products such as vaccines, because they are made from living 
organisms and are generally injected into healthy people, are subject 
to particular scrutiny under our existing regulatory setup--and 
justifiably so.
    The question I raise today, however, is whether a regulatory system 
that works well and is set up to deal principally with conventional and 
often predictable health needs is positioned to deal with the abnormal 
and the unpredictable. Can it be better adapted to expedite the 
availability of medicines to counter organisms that have been 
weaponized or are highly exotic and almost never encountered during 
normal times? Certainly, in the case of the smallpox contract, we have 
seen that the regulatory system can quickly adapt when faced with an 
issue of overriding national interest.
    The FDA has also moved forward in giving the vaccine industry 
better guidance in the critical area of designing clinical trials for 
products to protect against bioterrorism threats. The FDA and the 
industry agree that, because of ethical and safety concerns, Phase III 
efficacy trials are not possible in the case of vaccines, therapeutics 
or drugs to treat bioterrorism agents if such trials would require 
challenging human subjects with a deadly organism or highly toxic 
substance. Accordingly, the FDA has been developing alternative testing 
methods to be used when human studies are not feasible--because the 
product being tested is intended to deal with chemical, biological, 
radiological, or nuclear substances. The FDA deserves enormous credit 
for undertaking this initiative, which was underway even before 
September 11, 2001. This new rule that was made final on May 30, 2002, 
should provide industry with clear guidance on how to construct 
clinical trials.
    There are still some issues remaining for which regulatory 
solutions remain elusive. Let me give you one example. Tick-borne 
encephalitis (TBE) is a viral infection of the central nervous system 
that can lead to a number of serious neurological problems and in a 
small number of cases, death. TBE is common in Europe, Eastern Europe 
and East Asia. It currently is not known to exist in the United States. 
Some bioterrorism experts have expressed concern that this virus could 
be weaponized, and there is also interest on the part of the U.S. Army 
in having a vaccine to protect troops that might be stationed in places 
where TBE is prevalent.
    Baxter has a vaccine for TBE that has been approved and marketed in 
Europe for many years. It would be preferable if the U.S. Army uses 
that vaccine for our troops to have FDA approval. For that to happen, 
however, Baxter would have to invest millions of dollars to conduct 
large and lengthy clinical trials to gain U.S. regulatory approval of a 
vaccine already licensed in Europe. Baxter might make such an 
investment if there was a high probability of having a U.S. purchaser 
but, otherwise, it would not make sense to seek U.S. licensing of a 
vaccine to prevent a disease that does not exist in the U.S. and for 
which there is no medical need.
    Mr. Chairman, we are very encouraged by the steps taken so far by 
the FDA to assist industry in moving forward with anti-bioterrorism 
research projects, and we are hopeful the agency will build upon this 
process to identify and address additional needs as they become 
apparent. We do hope to find ways to address issues such as with the 
TBE vaccine that, because of unusual circumstances, falls outside of 
the range of solutions that can be sought within the usual regulatory 
process. We recommend that there be better collaboration between 
international agencies that might help eliminate duplication of 
regulatory efforts and harmonize high standards for licensing quality 
products.

            ISSUES RELATING TO LIABILITY AND RISK MANAGEMENT

    Mr. Chairman, Baxter believes that liability exposure is one of the 
most serious impediments to new vaccine development, especially in the 
area of preparing for a bioterrorist threat. This is because, unlike 
the situation with childhood vaccines, there is no comprehensive regime 
in place today designed to provide rapid and predictable compensation 
to persons who may have suffered a vaccine-related injury from 
bioterrorism vaccines.
    As you may be aware, when Baxter and Acambis first entered into the 
contract with HHS to produce smallpox vaccine, the indemnification 
protection that was made available to us was a hastily cobbled together 
extension of a 1950s Executive Order--originally developed for 
Department of Defense contractors. Under this system, should our 
smallpox vaccine be used and result in adverse patient reactions, 
Baxter and Acambis would have to go through the lengthy, costly and 
difficult process of defending all lawsuits brought against us, and pay 
all claims until our insurance was exhausted. Then, and only then, 
would the government step in and take responsibility for the claims. 
This system exposes a manufacturer to tremendous legal costs and 
creates enormous difficulties in negotiating an insurance portfolio 
with private insurers, not to mention the uncertainty of how the 
government might exercise its discretion in indemnifying claims.
    This system is less than optimal and provides a strong disincentive 
to get involved in future vaccine contracting even assuming that the 
Executive Order could protect companies contracting for vaccines other 
than smallpox.
    The language included in the Homeland Security Bill relating 
specifically to smallpox is a significant improvement over the 
Executive Order. Under that legislation, if HHS makes the appropriate 
declaration concerning the need to immunize all or some of the public 
against smallpox, then the government will, in effect, stand in the 
shoes of the manufacturer for purposes of defending lawsuits and paying 
claims.
    The system set up in the Homeland Security bill makes far more 
sense and we recommend that it be extended to all bioterrorism vaccine 
development programs undertaken by the government. We believe that, if 
a vaccine is developed and manufactured at the request of the 
government to specifications set forth by the government, and is 
delivered to the government to be used only when, where and how the 
government specifies, and given only to those individuals that the 
government determines should get the vaccine, then the government 
should bear the responsibility in paying the claims of those who have 
experienced injury or adverse reactions.
    We strongly urge Congress to look at the smallpox liability 
language in the Homeland Security bill as a template for handling 
liability issues for future bioterrorism vaccine development.

                    INTELLECTUAL PROPERTY PROTECTION

    Another point I would like to touch on is the need to continue to 
assure adequate intellectual property protection. In combination with 
adequate market opportunities, patents are the means by which 
manufacturers can recover the cost of development and fund future 
research projects. As I had previously mentioned, it usually takes 10 
years to bring a vaccine to the marketplace. Thus, upon entry into the 
market following regulatory approval, most vaccines only have less than 
ten years of remaining patent protection. Manufacturers rely on this 
relatively short period of protected sales to recoup the considerable 
costs of research, development, and clinical trials. In recent years, 
especially with respect to diseases affecting developing countries, we 
have seen an effort to require compulsory licensing or otherwise 
undermine patent protection as a way of making medications affordable 
for those nations, many of which are poor. I should add that, in many 
instances, developing nations are also in tropical regions, and many of 
the targets of both conventional vaccine research and bioterrorism 
preparation are on diseases of tropical origin.
    As a company strongly committed to improving access to healthcare, 
Baxter understands the laudable goals of those who want to make 
medications more available to developing nations. At the same time, we 
need to recognize that the vaccine industry cannot afford to develop 
products for the diseases affecting those areas, including diseases 
that can be weaponized, if it cannot rely upon strong protections for 
the inventions and know-how that create those products.
    As the U.S. continues the process of developing a trade agenda for 
the WTO and related negotiations, we strongly urge Congress and the 
Administration to seek ways to assist the poorer nations in improving 
access to health care technologies without undermining the strong 
intellectual property protections that are, in the final analysis, the 
engine that drives discovery of those technologies in the first place.

             CREATING A SOLID BASE FOR THE VACCINE INDUSTRY

    Finally, Mr. Chairman, if the vaccine industry is to make a 
meaningful contribution to the defense against bioterrorism, the 
industry must be healthy and vibrant. That is not universally the case 
today. To the contrary, rising development costs, downward pricing 
pressure, high costs of regulatory approval and compliance, and the 
constant threat of predatory lawsuits have combined with the inherent 
difficulties of manufacturing vaccines to create a situation where the 
industry is having trouble meeting the country's basic needs for 
regular childhood and seasonal vaccines--let alone meeting the 
country's needs on an emergency basis for innovative vaccines to combat 
bioterrorism threats.
    Unlike mass-produced pills and tablets, which are synthesized from 
chemicals according to a standard recipe and are manufactured in a 
highly mechanized and predictable fashion, vaccines are produced from 
living organisms--including viruses and bacteria and cell cultures and 
other living systems. Despite the best efforts of vaccine 
manufacturers, there can often occur a great deal of variation and 
unpredictability in the way these organisms grow and behave. In some 
cases these organisms are cloned or are the result of recombinant DNA 
technology. The process of making a vaccine from beginning to end can 
take many months, with many opportunities for unexpected and unwanted 
variations to occur. Building facilities to mass-produce vaccines 
requires investments of hundreds of millions of dollars. In other 
words, making vaccines is a costly, lengthy, difficult and a complex 
process.
    In recent years we have seen shortages of vaccines that guard 
against measles, mumps, rubella, pneumonia, meningitis, diphtheria, 
tetanus, pertussis, chicken pox and adult influenza. We have witnessed 
a constant decline in the number of vaccine manufacturers--for U.S. 
licensed vaccines, there were 26 different manufacturers in 1967. Today 
in the U.S. there are only four major manufacturers. To our knowledge 
there are no stand-alone manufacturers of licensed vaccines in the U.S. 
which demonstrates how difficult it is to build a sustainable business 
enterprise solely on a vaccine portfolio.
    Mr. Chairman, shortages and contraction are not indicators of an 
industry in the best of health. If America wants to build a dynamic 
biomedical infrastructure to serve as a bulwark against bioterrorism, 
we cannot do so on a fragile foundation.
    The market for vaccines today, both in the U.S. and around the 
world, is one that is focused on, if not obsessed with, getting the 
lowest possible prices. Given the financial issues facing many 
governments and the problems facing many developing countries, that's 
not hard to understand. But what we must also understand is that the 
natural and inevitable result of downward pricing pressure is that many 
vaccines have now become low margin products and, as such, have the 
ability to contribute only marginally to the funding of future research 
and development for vaccine initiatives.
    We have developed an attitude as a country that vaccines should be 
cheap, readily accessible and treated as an entitlement. Vaccines have 
done such an effective job for so many years, there has been a tendency 
to take them for granted, and there is a general lack of appreciation 
in the public of how difficult it is to produce vaccines and of the 
complex and formidable regulatory environment that faces these 
products. We recognize clearly the need to ensure consumer safety with 
vaccine products, especially as in many cases these products are given 
to individuals who are not yet ill. However, the overall attitude 
towards emerging vaccines for bioterrorism threats cannot be ``business 
as usual'' or these products will never be available. As one 
manufacturer capable of and committed to assisting in this effort, we 
would be pleased to work with this committee, others in Congress, the 
FDA, and other relevant agencies to determine the best ways to re-tool 
this process to expedite the development and availability of essential 
vaccines.

                     CONCLUSION AND RECOMMENDATIONS

    In closing, we believe that government can take a number of steps 
to improve the investment climate and willingness of private companies 
to make a greater commitment to research on bioterrorism vaccines and 
drugs.
    We are hopeful that industry can gain a clearer picture of the 
government's needs and develop a collaborative process to meet those 
needs. To assist in that process, we strongly encourage government 
agencies involved in biodefense to establish and communicate clear 
national research and development targets, and work to better 
understand and coordinate the capabilities of the private sector to 
achieve those targets. We also hope that the contracting process will 
be structured in a way that reflects the urgency of the situation, and 
has the overriding objective of getting the best product in the 
shortest possible time, at a cost which is reasonable to both the 
government and the contractor. Obviously, the FDA must be a full 
partner in that process so that it can think about and address issues 
that would not normally be raised in the process of approving drugs and 
biologics for more conventional uses. International regulatory 
harmonization of high standards would be especially useful.
    With respect to liability and risk management, we hope Congress 
will look closely at the smallpox liability language in the Homeland 
Security bill as a template for handling liability issues for future 
bioterrorism vaccine development. This is critical because we expect 
that many of the new vaccines that will be developed as part of this 
effort will--unlike the smallpox vaccine--have no previous history and 
therefore will raise much more speculative questions of liability than 
is the case with smallpox. Getting private insurance we expect will be 
next to impossible, so some different mechanism must be in place.
    Finally, Mr. Chairman, we hope that future policy in the area of 
vaccines will reflect an understanding of the difficulties and 
complexity of the vaccine manufacturing process, the need for strong 
intellectual property protection, and the enormous financial investment 
and risks created for the industry due to liability issues and 
regulatory compliance. The overall facts and data concerning the 
vaccine industry in the U.S. do not paint a picture of a completely 
healthy industry. To the contrary, there are some fairly serious 
warning signs based on the overall contraction of the industry and the 
shortages of recent years.
    We appreciate this opportunity to share our views with the 
Committee and would be happy to answer any questions you might have.

                     Statement of Patrick M. Libbey

    On behalf of the National Association of County and City Health 
Officials (NACCHO), I thank you for the opportunity to provide initial 
comments on the national smallpox vaccination program from the 
perspective of local public health agencies. This program has multiple 
practical complexities. We expect that new questions and concerns will 
continue to arise as states and localities gain experience. We look 
forward to working with the Committee on a continuous basis to identify 
new issues and lessons learned as implementation proceeds.
    NACCHO represents the nation's nearly 3000 local public health 
agencies. Many will be involved in planning and implementing smallpox 
vaccination in their communities, particularly as the program extends 
into its second phase of vaccinating up to ten million first 
responders, as the President has announced. This program has serious 
and far-reaching implications for local public health practice. Our 
message, based on the classic admonition, ``First, do no harm,'' is 
straightforward. It is, ``Slow down and stay small.''
    We all must respect the sense of urgency conveyed by the President. 
However, we also believe that, in light of the President's statement 
that there is no imminent risk of a smallpox outbreak, we owe it to our 
communities to proceed carefully and take the time to evaluate Our 
vaccination activities as we go. We must also understand and document 
clearly the consequences of the necessary diversion of resources from 
other critical public health work to smallpox vaccination.

Localities Need More Assistance and Flexibility in Implementing 
        Smallpox Vaccination
    Planning is well underway for the initial phase of vaccinating 
500,000 volunteer medical and public health response teams. Local 
public health agencies that will play a role in this phase are 
encountering many questions. Among these are the presence or absence of 
liability protection for entities engaged in vaccination and the 
availability of compensation for vaccinated persons who lose work time 
or incur medical care costs as a consequence. The Homeland Security Act 
and state workers' compensation laws do not adequately address these 
concerns, which remain substantial barriers.
    Local public health agencies also need consistent guidance in 
several areas. They need accurate, uniform guidelines for clinical 
practice. They need guidance for communicating with potential 
vaccinees. They need guidance for communicating with their communities, 
particularly in explaining the program as the President has established 
it and in explaining the particular course of action that their state 
has adopted. It is appropriate and expected that state plans for 
initial vaccinations will vary, but it is essential that local public 
health officials be able to explain why the types and numbers of people 
who will be asked to volunteer for vaccination vary markedly among the 
states.
    It is also essential that the federal government take the time to 
evaluate the initial experience of vaccination. This should include: 
monitoring side effects; identifying unexpected logistical barriers to 
vaccination; consulting more thoroughly with the next larger cohort to 
be vaccinated; and instituting measures for quality assurance. CDC has 
undertaken a training program that relies on distance-based training 
and a ``train the trainer'' model for administering vaccinations. It is 
essential to evaluate the effectiveness of that training, so that there 
is greater assurance that vaccines are administered and ``takes'' are 
evaluated properly. We do not believe it will be appropriate for any 
community to move forward with vaccinating a larger population until we 
have identified what training methods are effective and implemented 
them to prepare the larger number of vaccinators that will be required.

Implementation of Vaccination of Up to Ten Million First Responders 
        Will Take More Time and Resources Than are Now Planned
    The logistics for vaccinating the first 500,000 volunteers 
nationally remain incomplete, but we are confident that states and 
localities can master them. However, those same plans and logistics 
will not work when the objective expands by a factor of 20 to encompass 
up to ten million first responders. The broader program cannot be 
successful unless we take the time not only to apply the lessons 
learned in the first phase of the program, but also to tackle 
significantly greater logistical problems. We have only begun to 
identify the potential issues. These include: Who will provide 
vaccinations and how will they be indemnified? How do we get vaccine to 
a larger group of vaccinators and assure its proper storage, handling 
and administration? How do we train vaccinators? How do we ensure that 
emergency and routine first responders can be vaccinated without 
disrupting essential community services? Local public health agencies 
have long experience in mounting immunization programs, but the unique 
characteristics of the smallpox vaccine raise a host of new questions. 
We must take the time to answer them before we can expect to launch an 
effective vaccination program.
    We also need to assess the costs of such a program. We know that 
they will be great. States and localities already are diverting 
significant resources to smallpox vaccination and there is no endpoint 
in sight. We are greatly concerned about two effects of such a 
diversion. First, staff hired through the state and local grants for 
bioterrorism preparedness cannot also pursue the other important 
preparedness activities that are now underway. We already see these 
activities slowing or halting in many locations. A disproportionate 
amount of resources may be spent on smallpox vaccination for an 
indefinite time, at the expense of other bioterrorism and emergency 
preparedness programs.
    Second, the magnitude of a program to vaccinate ten million 
persons, and possibly also other members of the general public, will 
drain general public health resources at an alarming rate for an 
unknown period of time. In some jurisdictions, new staff have been 
hired with federal bioterrorism preparedness funds because they have 
the skills to improve public health capacities in the five focus areas 
of the cooperative agreements, including epidemiology, communication, 
and the application of information technology. These staff cannot 
readily be transferred into smallpox vaccination, which requires a 
different set of competencies. In many other jurisdictions, existing 
staff has taken on the additional job of preparing for bioterrorism. In 
either case, it is inevitable that existing staff in maternal and child 
health, immunization, or other clinical programs will be diverted even 
more into smallpox vaccination. This will further disrupt essential 
community services. We recommend a more measured, thoughtful 
implementation, whereby the capacity for smallpox vaccination is 
incorporated more gradually into routine public health practice. We 
cannot afford to exact a sudden, dramatic toll on routine disease. 
prevention and health promotion activities.

The Scope of Smallpox Vaccination Should be Limited
    We have grave reservations about offering smallpox vaccination on 
demand to members of the general public, in the absence of a heightened 
threat assessment. Smallpox vaccine is inherently less safe than 
immunizations we advocate and offer routinely. We are greatly concerned 
about both inflicting harm unnecessarily and compromising our 
effectiveness in routine immunizations. Adverse reactions to smallpox 
vaccine will be well publicized and we would expect such publicity to 
have a chilling effect on both childhood and adult immunization 
efforts. Our best chance to minimize this effect is to limit explicitly 
the use of smallpox vaccine, thereby distinguishing it from routine 
immunizations, and to ratchet up our ongoing public education about the 
relative risks and benefits of routine childhood and adult 
immunization.
    For all these reasons, we urge a slower, measured approach to 
smallpox vaccination. We urge that the program be kept at minimal 
levels and grow only as rapidly as threat assessment demands, so as not 
to disrupt other basic community health protections or cause 
unnecessary harm.
      Response to Questions of Senator Gregg From William Schuler
    Question 1. In your statement, you cite hospital staffing as a real 
concern as the smallpox vaccination program moves into the second and 
third phases. What are your thoughts as to how or what needs to be done 
to address this issue?
    Answer 1. In a Stage 2 clinic, where all healthcare providers and 
first responders are vaccinated, the number of absences could be 
devastating. Offering the vaccine to only 20% of the staff at a time, 
in five clinics at staggered three week intervals should allow for a 
number of vaccine related absences which would not likely debilitate 
hospital operations.
    The number of patients with adverse reactions from a Stage 3 clinic 
would overwhelm hospital resources. Triage of all but the most acute 
vaccinia adverse reactions in an offsite facility would help to 
eliminate congestion in emergency rooms. Provisions for staffing and 
resources to provide home care or care in a dormitory-type setting for 
all but the most acutely ill would alleviate unprecedented volume of 
inpatient bed needs.
    Question 2. Communication between federal, state and local agencies 
is imperative to making this vaccination program a success. In your 
view, have communications between your hospital and the relevant 
federal, state, and local agencies been sufficiently adequate? As we 
continue to move forward with the plan, do you have any ideas on how 
communications could be improved?
    Answer 2. As mentioned in the testimony, early in the planning 
process, communications and guidance to local authorities (fire, 
police) was extremely limited. With the progression of time, this 
communication has improved and responsibilities delineated to a 
workable level. A Federal oversight program in the development of 
community post-event vaccination Clinic Response Team would have 
facilitated a quicker start, and would have eliminated some, if not all 
of the initial confusion. As we move further into planning and closer 
to a finished, workable plan, it is clear that hospital representatives 
in a community planning group could benefit from a state or Federal 
level group board meeting in order to bring share relevant and timely 
information at the community level planning meetings.
    Question 3. In the absence of knowing whether or not your health 
care workers would be covered by dew Hampshire's workers' compensation 
program, you urged that a federal ``no fault'' program be created to 
compensate workers for smallpox vaccine-related injuries. It is my 
understanding that the State of New Hampshire has recently said that it 
would, in fact, cover all smallpox vaccine-related adverse events. As 
such, do you still believe such a federal compensation program is 
necessary--at least with respect to health care workers already covered 
under the state's program?
    Answer 3. A Federal baseline for coverage would allow for, and 
facilitate, uniformity between states. In New Hampshire, we are very 
fortunate to have lawmakers who recognize the importance of protection 
to the front line volunteers. It is unlikely that all states will 
follow New Hampshire's lead. Given complexity of smallpox vaccination 
program (e.g., multi-state transport of vaccine, multi-agency 
directives. CDC, State Departments of Health, healthcare organization 
ownership beyond state of administration) a federal program would be 
appropriate. The Federal program could be developed to offer coverage 
of all participants (self-employed physicians, non-employed volunteers, 
others) and those who develop vaccine-related illness including co-
workers, spouse/household members, etc.
    Response to Questions of Senator Gregg From Bill Bicknell, M.D.
    Question 1. Though we are focusing much of today's efforts on 
implementing the current three-phase vaccination plan, what do you 
believe needs to be done to strengthen our public health care system in 
order to be able to adequately respond to a smallpox outbreak?

(See also my answer to Question 5 below)

    1. All states should either have a diagnostic laboratory that can 
rapidly identify smallpox or have an arrangement with a laboratory in a 
nearby state.
    2. Vaccine for post attack use should be pre-positioned at the 
state level with the national stockpile used to replenish supplies as 
post-attack vaccination gets underway. A clever terrorist will assure 
multiple infections in many different geographic areas across the 
country. For those who choose not to get vaccinated pre-attack, as well 
as for children (see below), getting the vaccine as close to their arms 
as possible for very rapid use post-attack is just common sense.
    3. Plans for post-attack vaccination should be sufficiently 
detailed that each person or family group knows where they are to 
report for vaccination. Far more and far smaller vaccination clinics 
will need to be planned if we are to vaccinate the entire country in 5 
to 10 days post-attack. This means a town like mine. Marshfield, with a 
population of about 25,000, needs 3 to 5 sites such as public school 
gyms and places of worship Volunteers need to be identified and trained 
to staff and operate these vaccination sites and occasional trial runs 
need to done to test the system and work out the kinks.
    4. Distribution to local clinics from state stockpiles can be done 
by state and local police.
    5. So long as we complete Phase II of the President's plan and, I 
would hope move from being, permissive to encouraging the adult 
population to be vaccinated in Phase III, little more than the above 
needs to be done. There will be very few cases of actual smallpox 
because we will have quickly halted transmission by implementing 
widespread mass vaccination in all geographic areas where there is 
disease. I would strongly recommend, as soon as there is smallpox in 
two different geographic areas, the nation more immediately to 
vaccinating the entire country.
    6. Consideration could be given to converting old armory's and 
other large spaces, possible recently closed hospitals, to temporary 
low intensity, hospital/nursing care facilities. Frankly, for smallpox, 
I don't think this will be needed and staffing would be very difficult 
and Would have to come in large part from already short-staffed acute-
care hospitals. If there is a smallpox event. I foresee rapid discharge 
of hospital patients and stopping admissions of all but the most urgent 
cases. This will free up large numbers of staffed beds with trained 
personnel who have access to laboratory and other support services 
needed to take care of the ill.
    7. As the state epidemiologists and their staffs are likely to be 
called upon to help interpret data in any bioterrorism event, they need 
to be trained in a very different kind of data analysis and 
interpretation. Specifically, they need to learn how to deal with very 
incomplete, fragmentary and conflicting data in the context of no 
option for wait and see. This is absolutely antithetical to the mind 
set and culture of most everyone in public health, epidemiologists 
included. Whether or not such an approach would be accepted and would 
work is an open question. However, although there are certainly 
exceptions, many of the current breed of epidemiologists in public 
health agencies and in academia are simply not equipped to deal with 
the realities of imminent death, limited data and the need for 
immediate decisions.
    8. The national smallpox post-attack plan (Guide B, Vaccination 
Guidelines for State and Local Health Agencies) was removed from the 
CDC website on Monday January 26. I leave emailed to you a separate 
long communication about this that I sent to CDC on February 19. States 
have made their post-attack plans according to the guidelines which 
have been withdrawn and now states and local authorities are without 
published national guidance in case of an attack. This needs to be 
corrected rather urgently. At present, what would happen after a 
smallpox attack is not at all clear.
    It is my sense, without hard data, that this is not just a CDC 
problem. Rather it may be compounded by and reflect poor communications 
between HHS and CDC. Effective communication with the public before, 
and particularly after, a bioterrorism event requires near seamless, 
collegial relationships characterized by mutual trust and respect 
between the leadership and key staff of HHS, CDC and doubtless HSA. 
Almost certainly staff is limited in every agency and everyone has too 
much to do. Bioterrorism, including smallpox, is a dynamic threat, If 
an attack comes, it will likely be different from what we have 
anticipated. Therefore, easy, open and fast internal communications 
will be essential to effectively marshalling and coordinating the best 
possible national response. But it is my understanding that, whatever 
the public posture, the day-to-day communications between HHS and CDC 
may not be what they should be. Now is the time for building a culture 
of teamwork, collegiality, mutual trust and respect. Whether in 
Washington or Atlanta the players need to invest time in pulling 
together with a real emphasis on clarity, simplicity and realistic 
expectations. Finally, an effective response to an attack is further 
complicated by a common federal problem, lack of realization that it is 
the states and medical providers within the states that are the 
implementers. Today, the states and providers are not marching well to 
a confused drummer, nor will they in the future.
    Question 2. What are your thoughts on testing the smallpox vaccine 
for safety and efficacy in children?
    I believe the current vaccine (DRYVAX) has been adequately tested 
in children and there is no need to test it further. It was used in 
millions of children and we know the side effects and we also know it 
is effective and there is nothing to suggest that children's immune 
response today is different from what it was 30 or more years ago.
    New vaccines, and the only relevant products at this moment are the 
two Acambis vaccines which are slightly different from each other, 
should undergo Phase I and Phase II trials in children. Although I am 
not an expert immunologist, I believe with Phase I and II trials in 
children and Phase I, II and III trials in adults we would have 
sufficient data to license for use in children in a post-attack 
situation.
    If use in children was to be permitted pre-attack, then Phase III 
trials in children would be appropriate.
    Question 3. Once the new Barter-Acambis vaccine has been FDA-
licensed and manufactured in sufficient amounts, do you believe that it 
should be made available to children? If not, why?
    Assuming the risk profile is very similar to DRYVAX, and there is 
little reason to think otherwise, I would be very hesitant about making 
the vaccine available for use in children under 10. It is in this age 
group that very severe reactions and deaths, though rare, are most 
likely to occur. As children can be readily isolated and rapidly 
vaccinated post-attack, so long as we have Phase II of the President's 
pre-attack plan fully in place. I feel the nation's younger children 
are well protected without being immunized pre-attack. This underscores 
the importance of fully completing Phase II of the President's pre-
attack plan.
    Another reason not to vaccinate young children is 70% of the cases 
of accidental vaccination of others comes from child to child contact. 
Accidental vaccinations will happen to children without regard to their 
or their parents wishes and some of these children are likely to have 
contraindications to vaccination. Reactions in those accidentally 
vaccinated can be very serious. In 1968, when 14,168,000 persons of all 
ages were vaccinated, the nation experienced 50 very serious reactions 
and one death in persons under 10 years old that were accidentally 
vaccinated by contact with another deliberately vaccinated person.
    On balance, I'd be in favor of lowering the age of permissive 
vaccination in Phase III of the President's plan to 10. I would be very 
hesitant to go lower based on the information available to me at this 
moment.
    Vaccinating children before an attack poses particularly difficult 
questions. The risks of vaccination are definitely greater in children 
than adults. This will almost certainly be true but not easily proven 
with the new Acambis products. The risk of death from smallpox is 
greater in younger children. The ease of isolating children prior to 
vaccination in a post-attack scenario is easier for children than for 
adults. The risk of attack is unknown, non-trivial and certainly 
greater than zero. Children under 10 face a heightened risk of very 
serious and sometimes lethal complications. For some of these 
complications, there is no treatment. Taken together, these factors 
make widespread vaccination of children before an attack very 
problematic. In children, if there is a good post-event vaccination 
plan in place for every community, the risk of vaccination need only be 
taken if there is an actual attack. After an attack the vaccine risk is 
far outweighed by the risk of death from smallpox.
    In my written testimony (the relevant part is pasted just below) I 
review the arguments for not vaccinating children under 10 with DRYVAX 
and I suspect we will find the Acambis products to have a similar risk 
profile in adults. To get any idea of the serious risks in children of 
the new Acambis products would require huge numbers, tantamount to 
widespread vaccination. If we complete Phase II of the President's 
plan, we are in a position to rapidly vaccinate children after an 
attack and minimize deaths from smallpox and not unnecessarily expose 
children to an untreatable, often lethal, vaccine complication (Post 
Vaccinal Encephalitis) as well as other serious and also sometimes 
fatal complications.

      FROM MY WRITTEN TESTIMONY--CHILDREN AND SMALLPOX VACCINATION

    Fatality rates from smallpox in children can approach 50%. Children 
are one of our most cherished assets. Gareth, my 2\1/2\ year old 
grandson is certainly at the center of my life. So why not vaccinate 
children now, before an attack? The reasoning goes like this:
    1. The worst complications and the most deaths from vaccination, 
including deaths in otherwise healthy children, occur in children under 
10.
    2. Arguably the worst complication--Post Vaccinal Encephalitis 
(PVE)--cannot be predicted and cannot be treated. This is rare and 
occurs most commonly in young children (15 of 16 cases in 1968). In 
1968, 4,900,000 children under 10 were vaccinated for the first time, 
only 15 got PVE (0.0003%), but 4 died (26%) and 4 had complications 
including brain damage and paralysis of the arms and legs.
    3. Children are most likely to be accidentally infected or 
accidentally vaccinated by others. In 1968, with a total of 14,168,000 
vaccinations (39% primary vaccinees) there were only 114 reported cases 
of accidental vaccination of others with 90 of these cases (79%) 
occurring in children. Children are most commonly infected by another 
child (70% of cases) or by an adult caregiver. 96% of the cases where 
one person accidentally vaccinated another were either child-to-child 
or between caregiver and child. Only one occurred in a hospital setting 
where a recently vaccinated nurse cared for a child with active eczema. 
This is also a good example of why it makes sense to use the 
semipermeable membrane dressing and schedule recently vaccinated staff 
not to care for patients, such as eczema and immune disorder patients, 
at high risk of accidental immunization.
    4. Complications in children, ranging from mostly minor to, very 
rarely, severe, are quite common. For a mother often any complication 
is seen as severe, even though in the grand scheme of things it may be 
inconsequential. My own son had a smallpox vaccination complication in 
the 1960s, I don't remember it, his mother does! Based on 1968 data, 
children under I can expect to experience 1 complication for every 
8,900 vaccinated, for children from 1 through 9 years of age the 
expected complications would be about 1 in 12,000. This is a lot of 
complications even though the vast majority would not be severe.
    5. Post-attack, children are far easier to isolate than adults. In 
a smallpox emergency we would say stay home until your local 
vaccination point is ready in somewhere between 1 and 5 days. 
Hopefully, this will be closer to 2 or 3 days. Then children will be 
rapidly vaccinated and protected before they are infected. The benefits 
of vaccination would now greatly exceed the risks.
    6. The more adults that are vaccinated pre-attack, the less likely 
it is there will be widespread transmission and transmission to 
children post-attack. In my judgment, this is a good reason to modify 
Phase III of the President's plan and move from allowing adults in the 
general public to be vaccinated to encouraging adults to be vaccinated.
    What would I do for my family? I want the adults vaccinated or 
revaccinated so long as they had no contraindications. I'd say no for 
any children under 10. And I would want a tested and proven mechanism 
in place for rapid post-attack vaccination of every remaining 
unvaccinated adult and all children so that smallpox deaths would be 
reduced to a minimum (In a post attack scenario there are very few 
contraindications to vaccination.). In my judgment, this approach 
offers the best protection with the least risk, pre- and post-attack, 
for children, adults and the nation.
    Question 4. What are your thoughts about using an adverse event 
tracking or reporting system to gain more data or information on the 
frequency, and types of adverse events and our experiences dealing with 
those events?
    I think adverse event reporting is a good idea. However, what we 
really need to know are the severe adverse events. I would define 
severe as anything requiring hospitalization or that results in death. 
The lesser events are of academic but not really of public policy 
interest or relevance. I think the DOD is doing an excellent job of 
rapidly tracking analyzing and publicizing adverse events. We should 
learn from the DOD.
    Question 5. In your written statement you suggest, ``that it is 
time to imaginatively and realistically address the organizational and 
human issues that are essential for an effective response.'' Could you 
expand upon these thoughts and offer a few specific recommendations for 
its to consider?
    Ken Bloem and I have given this question a great deal of thought. 
Public Health by experience, tradition and culture is not an emergency 
service. Almost nothing is done in real time, with limited, conflicting 
and ambiguous data. Public Health collects, analyses and plans for the 
next event. It seeks consensus and works across and within very diverse 
communities with many different points of view. Building consensus and 
avoiding risk is at the heart of today's public health culture. This is 
not wrong but it is antithetical to mounting and managing a response to 
bioterrorism where rapid action, on limited data, that does not respect 
individual rights, is likely to be essential. I had personal experience 
with this when I managed a bioterrorism-like event in Massachusetts in 
the 1970s suing the state emergency powers and would be pleased to 
provide more details, specifics and lessons learned.
    Ken and I feel that the public heath apparatus should be supportive 
but not have a primary role in bioterrorism response. Support from the 
pubic health laboratories and almost certainly the state 
epidemiologists will be desirable. However, overall management should 
not rest within public health. Primary responsibility for responding to 
the publics needs will and should rest with the acute care delivery 
system particularly hospitals and larger clinics. Rather than have 
event management in the hands of pubic health, we feel each state 
should have trained and designated incident commanders for 
bioterrorism. The incident commander would be both a state and a 
federal employee for purposes of the incident and report directly to 
the governor of the state and the appropriate under-secretary in the 
Department of Homeland Security. The incident commander could be a non-
physician appropriately trained or a physician with a strong background 
in both management and emergencies. In some jurisdictions the incident 
commander could be a public health professional. Dual federal-state 
reporting and employment finesses the problem of constitutional 
authority and largely avoids the need to amend many state emergency 
power laws. This approach uses what pubic health has to offer in an 
appropriate and reasonable way. It avoids asking public heath to do a 
job that it is not suited to do by organizational structure, culture, 
tradition and temperament. It is as simple as not using a screw driver 
to hammer a nail.
    Mr. Bloem and I are preparing an article for publication on this 
approach and will go into the legal, political, technical and 
managerial implications in some detail. As we complete this article, we 
will be pleased to share this with you and discuss with interested 
committee members and staff.
    Question 6. Today, few physicians are properly trained to recognize 
and quickly identify smallpox--what recommendations do you have, 
considering the practical and financial limitations, to better prepare 
our health care providers for this task?
    Your question suggests that physicians can be trained to quickly 
recognize smallpox. Unfortunately this is not the case. I would do no 
more than is being done. Early detection of smallpox by training 
physicians is just not going to happen. This is a necessary consequence 
that flows from how smallpox disease manifests itself, not blindness, 
ignorance or resistance on the part of physicians and other health 
workers. Perhaps the most common presenting complaint of patients to 
the medical community is feeling lousy with a fever. That's smallpox 
and many, many other things too. A few days later a very non-specific 
and unimpressive bump or lump will show up on the face or shoulders or 
arms. These bumps do not look like smallpox. They look like a bump or 
two that even the most discerning diagnostician might at most note but 
is very unlikely to call smallpox. 24 to 48 hours later, after about 4 
or 5 days of being infectious, the patient is likely to be recognized 
as possibly having smallpox.
    It is reasonable to have posters in outpatient departments and 
emergency rooms. It is a good idea for the prevention, control, 
recognition and management of smallpox to be part of medical school and 
residency training curricula. Beyond that, don't waste your time or 
money.
    Many thanks for giving me the opportunity to answer these 
questions.
    Please feel free to contact me at any time about smallpox or 
related issues.
        Response to Questions of Senator Gregg From Jon Abramson
    Question 1. Children are not small adults, shouldn't we make sure 
that the smallpox vaccine supple is safe and effective for children, 
regardless of the positive results obtained through adult testing?
    Question 2. What can and should be done to ensure that our stocks 
of smallpox vaccine can be used safely and effectively in children?
    Answer. Because these two questions are closely aligned we are 
collectively responding to the questions as presented.
    The AAP would concur that the smallpox vaccine supply should be 
made safe and effective for children regardless of the positive results 
obtained through adult testing. As stated in the AAP's testimony and 
smallpox vaccine policy statement----

        [c]hildren are not ``little adults'', and their distinct 
        physiological responses must be studied before being exposed to 
        the vaccine. Both the AAP and the Advisory Committee on 
        Immunization Practices (ACIP) of the CDC have clearly stated 
        that these studies need to be done in children similar to the 
        testing that is done for other childhood vaccines.

    We can not predict how soon a smallpox attack might occur and 
therefore whether the tissue-derived smallpox vaccine currently under 
development will be available when needed. Thus, we need to ensure that 
the diluted Dryvax smallpox vaccine is also tested for safety and 
effectiveness in children at the same time that the Acambis vaccine is 
also studied in children. Moreover, these clinical trials in children 
should not wait for the completion of the adult clinical trials.
    Question 3. In your written statement you bring attention to the 
issues of smallpox vaccine-related adverse events in infants and 
children and recommend that they should not be offered the vaccine at 
this time. You also cite several medical conditions (HIV, primary 
immune deficiency) that may not be fully manifested in the young 
infant. How would we deal with these issues should the country need to 
employ a ring-vaccination program? For example, under those urgent 
conditions time may not be available to perform HIV or other screening 
tests.
    Answer. Under pre-event circumstances we do not believe children 
should be vaccinated for the reasons already described in our testimony 
and smallpox vaccine policy statement. If the risk of smallpox 
increases to the degree that widespread vaccination of children is felt 
to be warranted, the risk of serious adverse event from the vaccine 
would have to be compared to the risk of infection. In at least some 
circumstances, it is likely that the risk of disease would be greater 
than the potential risk of vaccination.
    Question 4. Until we know the new Baxter-Acambis smallpox vaccine 
works and that there are sufficient doses, we will have to rely on the 
Dryvax vaccine to protect our children in the event of an outbreak. 
Since the Dryvax vaccine will have to be diluted, don't we need to know 
if such a vaccine is still safe and effective in children--regardless 
of the positive results obtained through adult testing? If clinical 
trials are developed to re-study the Dryvax vaccine in children, what 
are your thoughts on how such a trial should be structured?
    Answer. The clinical trials as initially proposed by the National 
Institute of Allergy and Infectious Diseases (NIAID) at the National 
Institutes of Health (NIH) and regulated by the Food and Drug 
Administration was appropriately structured. The protocol for this 
research study entitled ``A Multicenter Randomized Dose Response Study 
of the Safety, Clinical and Immune Response of Dryvax Administered to 
Children 2 to 5 Years of Age'' is articulated in the October 31, 2002, 
Federal Register Notice. However, in a letter dated, January 24, 2003, 
to the Harbor-UCLA Medical Center one of the sites of the clinical 
trial, the FDA and the Office for Human Research Protections determined 
that----

        bioterrorism preparedness plans have evolved such that, under 
        current plans, the potential to use diluted Dryvax in children 
        will no longer exist. In the absence of plans to use diluted 
        Dryvax in children, the Secretary, HHS and the Commission. FDA 
        have determined that there is no justification for this 
        particular clinical investigation to proceed.

    We believe that the decision is not correct for the reasons noted 
in the last paragraph of our answer to question 1 and 2 and as noted in 
our response to the Federal Register notice that further details our 
view on the clinical trials.
    The American Academy of Pediatrics appreciates the opportunity to 
continue to work with you to assure that the appropriate research, 
therapeutic provisions and policies are in place to protect children 
against the threat of a biologic, chemical or nuclear attack. We look 
forward to continuing to work with you and your staff.
        Response to Questions of Senator Gregg From Martha Baker
    Question 1. In a January 26, the International Association of 
Industrial Accident Boards and Commissions, a not-for-profit trade 
association representing most of the government agencies charged with 
the administration of workers' compensation systems throughout the U.S. 
and other countries, issued a press release stating that:
    ``The IAIABC conducted an informal survey of experts in workers' 
compensation agencies. None of the experts expressed any doubt about 
the workers' compensation coverage for a worker who suffers an adverse 
health reaction to a smallpox vaccination done in connection with their 
work States like Kentucky, Connecticut and Wisconsin have issued 
opinions on the issue, which confirm coverage for injuries caused 
through this work related vaccination program.
    ``Administrative law judges contacted by the IAIABC expressed no 
reservations over coverage in current law.
    ``Thus, it appears that workers should have a basis for a claim 
against workers' compensation in most states, just as for any other 
disease in that state.''
    If state workers' compensation programs will most likely provide 
medical care and benefits for lost wages for vaccinated workers, why 
would it be necessary to create a new federal compensation system for 
them?
    While it is correct that the International Association of 
Industrial Accident Boards and Commissions (IAIABC) is the leading non-
profit organization of state workers' compensation commissions, its 
executive director. Gregory Krohm, who issued the January 26, 2003 
press release, stated that he did so on his own initiative, after 
mistakenly deciding that the leading medical studies on smallpox 
vaccinia, cited by MAID Director Anthony Fauci and CDC Director Julie 
Gerberding were out of date and inapplicable to a US population with 
higher percentages of immune-compromised individuals. \1\
---------------------------------------------------------------------------
    \1\ Interview with with Gregory Krohm, Executive Director, 
International Association of Industrial Accident Boards and 
Commissions, February 10, 2003.
---------------------------------------------------------------------------
    Moreover, Mr. Krohm conducted his ``survey'' himself, by calling 
``at least a dozen [workers' compensation] administrators'' whom he 
knew. Mr. Krohm stated that he told one of the people lie ``surveyed,'' 
Robert Snashall, Chairman of the New York State Workers' Compensation 
Board. ``I do not see any basis for alarm. I don't like to scare people 
if there's no basis for being afraid.''
    Neither Chairman Snashall, nor the New York State Workers' 
Compensation Board has issued any statement on workers' compensation 
coverage of smallpox. Indeed, major workers' compensation insurers in 
New York State have repeated the statements of American Insurance 
Association assistant general counsel, Bruce Wood:

        ``I do not see where comp would pay for either the vaccine or 
        for the adverse effects of an inoculation. My question is: 
        Where's the injury? For comp to be implicated there needs first 
        to be an injury. Simply inoculating workers as a purely 
        prophylactic exercise, where there has not been an injury, is 
        not covered. Would comp pay for the effects of any other 
        inoculation? No.'' \2\
---------------------------------------------------------------------------
    \2\ ``Smallpox Vaccine Program Creates Dilemma for WC Insurers.'' 
Risk and Insurance.com, February 10, 3003; ``Vaccine Raises Claim 
Issues,'' Business Insurance, January 13, 2001.

    Mr. Krohm also admitted that statutory waiting period requirements 
ranging from 7-42 days in state workers' compensation programs would 
make it impossible to compensate anyone who became too ill to work 
after being vaccinated.
    While Mr. Krohm maintains that any worker requiring medical care 
after vaccination will receive it under workers' compensation, he 
concedes that such cases may well have to be decided by workers' 
compensation administrative law judges. Indeed, the one example cited 
in his press release of January 26, quotes the Kentucky workers' 
compensation board, which states. ``Ultimately, if a healthcare worker 
suffers a vaccination related reaction and files a contested claim, 
compensability under Kentucky's workers' compensation law would have to 
be decided by an administrative law judge.''
    The Association for State and Territorial Health Officers (ASTHO) 
did a survey of state workers' compensation programs in January, 2003, 
with the intent of determining the extent of coverage by state workers' 
compensation programs for injuries resulting from the smallpox 
vaccination. Of the 30 state workers' compensation programs contacted 
by state health departments, only 6 responded that they would provide 
coverage to all workers.
    However, it is clear from this data that there is wide disparity in 
what states are saving, with an overwhelming number raising many issues 
about the ability or willingness to cover injuries resulting from the 
smallpox vaccine. Some are saying that if the vaccination is voluntary 
and not ``required'' than it would not be covered. Others are saying 
while state compensation programs may say yes. ``hospitals and counties 
are paving their own costs of workers' comp, and some of them have said 
no to any coverage.'' Still others raise the fact that because of 
waiting periods, workers will not be covered unless, for example, they 
are out for more than 10 days. For your information, we have attached 
is a copy of the ASTHO study.
    Similarly, an AFL-CIO survey of 41 State Workers Compensation 
programs as of 2/25/03 reports the following:

        12 states have stated they will provide coverage for smallpox 
        injuries

        states expect to provide coverage based on case law, but have 
        no official statement guaranteeing coverage

        9 states will not cover smallpox injuries

        4 will not cover for private sector workers, but will cover 
        state workers

        11 are still reviewing to decide whether they will provide 
        coverage

    We might add that your question notes that Wisconsin said they will 
cover work-related vaccine injuries, but an AFSCME local in LaCrosse 
was told that their workers' compensation coverage will not apple in 
the event of an injury.
    Aside from all the questions about workers' compensation made 
abundantly clear from the ASTHO survey, state workers' compensation 
laws do not cover all workers, including many nurses and doctors who 
work as private contractors.
    Volunteering for vaccination should not be a game of maybe you 
will, maybe you won't. Workers need to know what relief they, or their 
families. Will receive if someone should become ill. Just as the 
Department of Defense provides full medical care and lost wage 
compensation to military and civilian personnel in its smallpox 
vaccination program, a federal smallpox compensation fund is required 
to provide for the necessary medical care and lost wages for civilians 
persons suffering reactions to the vaccine.
    Question 2. Isn't it true that the federal smallpox workers' 
compensation program proposed by SEIU, AFSCME, AFL-CIO, and others 
would provide more generous compensation than would be available under 
any of the existing state compensation programs?
    As described above, there are significant gaps in state workers' 
compensation coverage that will deny necessary medical care and lost 
wages to civilians who agree to serve the Nation by receiving the 
smallpox vaccine. The American Insurance Association, whose member 
companies provide workers' compensation insurance, has stated that 
adverse reactions arising from the federal smallpox vaccination program 
do not even qualify as compensable injuries.
    Since the federal smallpox program has been ordered by the 
President, acting in his capacity as Commander-in-Chief to protect the 
Nation, and since the special circumstances and reactions to the 
vaccine all result from the federal program, a federal compensation 
program is required to close all of the gaps in state workers' 
compensation programs that will very necessary medical care and 
compensation to affected workers and patients. We also believe that 
rather than compare our proposed federal compensation program to 
workers' compensation, it is important to look at what DoD is providing 
in terms of compensation to military personnel who are injured by the 
vaccine.
    Patients or household members who become ill as a result of contact 
with a first responder who has received the smallpox vaccine will, 
under no circumstances, be eligible for any coverage under state 
workers' compensation laws. Their only recourse is under the Federal 
Tort Claims Act, as specified by Section 304 of the Homeland Security 
Act. As the Committee is no doubt aware, such claims are virtually 
impossible to win since they require proof of negligence in the 
manufacture or administration of the vaccine. What we have here are 
adverse consequences that are a known result of the vaccine. In these 
circumstances, no one is likely to recover under the FTCA. Moreover, 
few, if any courts will find negligence under the circumstance 
described by the President in his declaration of December 13, 2002 and 
the Secretary of Health and Human Services Declaration of January 24, 
2003.
    Question 3. Why should we create a workers' compensation program 
that gives preferential treatment to smallpox vaccine injuries over 
other kinds of injuries?
    The federal smallpox vaccination is not, as CDC Director Julie 
Gerberding has stated, a public health program. It is a national 
security program conducted in time of war. Just as the Armed Forces of 
the United States are fully protected with all necessary medical care 
and compensation for themselves and their household members to defend 
the Nation against a terrorist smallpox attack, so each civilian who 
volunteers to serve the Nation at the request of the President of the 
United States must be fully protected with all necessary medical care 
and compensation. Moreover, full medical care and compensation must be 
provided to household members and patients who become ill as a result 
of exposure to a person vaccinated under this federal program. To do 
anything less is to jeopardize the safety and security of the American 
people.
    Question 4. Having reviewed the proposal put forth by SEIU, et al., 
I noticed that there is no prohibition on workers from seeking recovery 
under both this new federal and a state workers' compensation program.
    Is that intentional, or would this new federal compensation program 
be the exclusive remedy?
    If a state's workers' compensation program does coyer such 
injuries, shouldn't a worker be required to go through that state's 
compensation program?
    We agree that if a state workers' compensation program does cover 
such injuries that it would be the first source of benefits. An injured 
worker would only seek recovery from a federal compensation program for 
health costs and lost wages and benefits if the state workers' 
compensation program does not cover any or all of the health costs or 
lost wages and benefits. It is not our intention that an injured worker 
should receive double payment. However, we strongly believe a federal 
compensation program must be in place to ensure that any injured 
worker, and in case of death, receives appropriate payment, if not 
covered from any other source, for health care costs, lost wages and 
benefits, and pain and suffering.
    Question 5. The proposal put forth by SEIL'', et al., would require 
employers to give employees up to four days of paid leave for workers 
who don't feel well after being vaccinated.
    Why can't regular sick leave take care of this? Why should we give 
more rights to this group of people to get a special type of sick 
leave?
    Should an employee who develops a sinus infection while serving 
with the Army Reserve over the weekend get a special type of sick 
leave?
    As stated in the response to Question 3 above, the federal smallpox 
vaccination program has been ordered by the President of the United 
States to protect the Nation in time of war. Just as all military and 
civilian personnel vaccinated under the DoD's smallpox program receive 
all necessary medical care and compensation, so, too, should all 
civilians who are first responders.
    Many first responders do not have sufficient sick leave. It is also 
important to note that the reactions caused by the smallpox vaccine are 
not naturally occurring diseases like a sinus infection. All available 
medical and epidemiological research makes it clear that certain 
illnesses are predictable and direct consequences of receiving or 
coming in contact with one who has received the federally administered 
smallpox vaccine. \3\
---------------------------------------------------------------------------
    \3\ Kent A. Sepkowitz, M.D., How Contagious Is Vaccinia? N Engl J 
Med 348;5, January 30, 2003.
---------------------------------------------------------------------------
    With specific reference to the Army Reserve, it is our 
understanding that an Army Reserve individual DOES get a ``special type 
of sick leave'' if injured during his or her service. If a Reserve 
soldier suffers an injury or illness related to his or her service, 
then he or she is placed on active duty but unable to perform status 
until the injury is healed to the degree that he or she could return to 
active duty. At that point, he or she is returned to Reserve status and 
to their civilian job. If the injury does not heal, the person can be 
discharged from the military with a disability--thus allowing access to 
VA for long-term treatment.
    With the example of the sinus infection, the person would probably 
not get this special status because a sinus infection would not prevent 
the person from fulfilling, their active duty requirements--nor would 
it be possible unambiguously to determine that the infection was caused 
in the line of duty over the weekend.
    However, if a Reserve soldier contracted a significant illness, 
including having an adverse reaction to the smallpox vaccine, during 
their 2 week service (where it would be clear that they sot sick during 
their service) they would be retained on active duty. (There is a big 
differences between a sinus infection and adverse reactions to the 
vaccine, which are known.) They would be treated at a military hospital 
until they are able to perform their duties again--at which point they 
would return to civilian service. Anyone who is genuinely injured due 
to their service in the Reserves is in fact given a ``special type of 
sick leave''. Furthermore, DoD has decided that if a spouse or child of 
a reservist gets sick, the reservist will be put on active duty so that 
DoD insurance care-taking can be extended to the family member. We 
should be doing no less for civilian responders who are injured as a 
result of the smallpox vaccine and have right to paid ``sick leave'' 
after volunteering to help their country during a period of crisis.
    Question 6. The proposal put forth by SEIU, et al., prohibits 
discrimination or retaliation in the workplace based upon an 
individual's refusal to be vaccinated. As part of this, it imposes an 
appeal process and protections similar to those provided to 
whistleblowers under the Energy Reorganization Act. However, the 
proposed anti-discrimination provisions do not deal with 
whistleblowers.
    How is a proposal designed to protect whistleblowers applicable or 
even appropriate in this case?
    Why should we create legislation--one which creates a new private 
cause of action against employers--to address a practice that we have 
no evidence has even occurred?
    Congress has routinely enacted legislation to prevent employers 
from retaliating against employees who assert their rights under the 
Constitution, federal statutes, regulatory and executive orders. \4\
---------------------------------------------------------------------------
    \4\ See e.g. Civil Rights Act of 1964, as amended, 42 USC 
Sec. 1983; Black Lung Benefits Act, 30 USC Sec. 938; FLSA, 29 USC 
Sec. 215(a)(3); Workforce Investment Act, 29 USC Sec. 2938(4); OSHA, 29 
USC Sec. 660(c); Equal Employment Opportunity Act; 32 USC Sec. 12203; 
and Family & Medical Leave Act, 29 USC Sec. 2615.
---------------------------------------------------------------------------
    When he announced the federal smallpox program on December 13, 
2002, the President was very clear that the program must be a voluntary 
program. No individual may be compelled to receive a smallpox 
vaccination unless he or she freely decides to do so. The Institute of 
Medicine, in its January 17, 2003 Letter Report to CDC Director 
Gerberding stated:

        ``It is easy to imagine situations whereby a potential vaccinee 
        will not feel free to decline vaccination. A potential vaccinee 
        might not wish to disclose fears about the risk of the vaccine, 
        particularly in regard to one's own or a personal contact's HIV 
        or pregnancy status, or even the fear of treating a smallpox 
        victim. While in large hospitals or public health departments, 
        other vaccinees might be available to volunteer for sevice, in 
        small hospitals, a potential vaccinee might be the only worker 
        with a specific, essential expertise and to decline could put 
        the hospital or clinic at risk of incomplete coverage in the 
        case of a smallpox outbreak. To decline vaccination could lead 
        to rumors about the health status of decliners or their family 
        members. Thus, a vaccinee who would otherwise decline to 
        Volunteer for vaccination might feel coerced into 
        participation.'' \5\
---------------------------------------------------------------------------
    \5\ IOM Letter Report, January 17, 2003, p. 12.

        ``Vaccinees should not feel any pressure to receive the 
        vaccine, for fear that a medical condition that they do not 
        want to disclose may be discovered by the vaccination clinic or 
---------------------------------------------------------------------------
        potentially, by their employer.''

    Pressures to vaccinate sufficient numbers of first responders at 
hospitals throughout the country have been great, however, and there 
have already been news reports citing retaliatory action taken against 
maritime workers who refused to be vaccinated. \6\ Consequently, it is 
necessary to protect employees against potential discrimination that 
could well arise if they refuse to participate in the vaccine program. 
State workers' compensation laws routinely protect employees filing 
claims from employer retaliation. Similarly, Congress saw fit to 
protect energy workers and mass transportation workers from the actual 
and perceived threats of employer retaliation. The federal smallpox 
vaccination program is too important to the security of the Nation not 
to be administered in a manner which fully protects individual rights 
and the public's health. Indeed, the Institute of Medicine has also 
cited the need to protect individual rights in the smallpox program by 
requiring a comprehensive process of informed consent. The 
antidiscrimination provisions proposed are vital component of that 
effort because the dangers of vaccinating people who should not receive 
the vaccinia far outweigh the burden to an employer who discriminates 
against workers for exercising their rights.
---------------------------------------------------------------------------
    \6\ NY Times, TX news reports.
---------------------------------------------------------------------------
    There are numerous safety and health, environmental and other 
statutes that include antiretaliation provisions and procedures for 
work-related activities. These include the Energy Reorganization Act, 
the Surface Transportation Act, the Mine Safety and Health Act and many 
others. These statutes coyer a range of different kinds of protected 
activities (e.g. whistleblowing, exercising rights, refusing hazardous 
work). The Department of Labor has been given responsibility for 
enforcing these various provisions. We suggested the Energy 
Reorganization Act as an example since it includes an administrative 
mechanism for considering and deciding complaints, rather than 
requiring court litigation, a process that we believe is too 
cumbersome. For smallpox vaccination legislation, we would propose that 
anti-retaliation protection be provided for workers who decline to 
participate in the program and for workers who suffer adverse effects.
    Question 7. The proposal put forth by SEIU, et al., requires that 
``only the safest and most efficacious needles meeting the requirements 
of OSHA's BBP standard may be used.'' The proposal also requires the 
FDA to issue a license for the use of a sheathed-bifurcated needle 
before the commencement of the vaccine program.
    Doesn't this proposal go beyond the requirements of the BBP 
standard by requiring the use of a specific-FDA approved needle?
    The proposal would also extend OSHA's BBP standard to state and 
local public employees, including those states that are not OSHA state-
plan states. This is a significant extension of OSHA's jurisdiction. 
Are there any existing OSHA requirements that extend to state and local 
public employees in non-OSHA plan states?
    In April 2002, the FDA approved the licensing of bifurcated needles 
with integrated safety features by a company called Univec. The needle 
is identical to the Precision conventional bifurcated needle, except 
that it is attached to a needle hub (like a conventional syringe) and 
has a sliding sheath safety feature.
    Univec is currently selling these needles to health departments and 
others to use to practice giving smallpox injections. In an 
unscientific survey of SEIU nurses, these nurses prefer the safer 
Univec needle over the conventional Precision product. First, the 
needle is much easier to hold (remember, 30 years ago nurses did not 
wear latex gloves, which makes it that much more difficult to hold the 
small conventional bifurcated needle). Secondly, the needle has a 
sliding sheath mechanism, similar in design to other safer needles on 
the market that meet OSHA's definition of a needle with integrated 
safety features.
    Even though the FDA licensed this safer bifurcated needle, this 
needle was not licensed as part of the complete kit submitted by Wyeth 
to the FDA. Therefore, this safer bifurcated needle cannot be used to 
administer the smallpox vaccine according to the FDA. For the safer 
needle to be legally used, we are told by FDA staff that Wyeth would 
need to submit a supplement to their smallpox vaccine application and 
seek such approval from FDA.
    What we are seeking in legislation is the requirement that the 
safer bifurcated needles be used in the administration of the vaccine 
if it is approved by the FDA for this purpose and if it is available to 
the states. As part of this national security program, CDC has 
purchased and distributed 50 million conventional needles as part of a 
vaccine kit without giving health departments, hospitals and health 
care workers the opportunity to use a safer device. It would also 
appear to make little sense to distribute a safer device as part of a 
vaccine kit only for the private sector and state and local health care 
facilities in OSHA state-plan states. Consequently, we recommend that 
the safer bifurcated needle be made available to all health facilities, 
both public and private, administering the vaccine. We are not asking 
for a change in the OSHA standards to accomplish the goal of using 
safer needles as part of this unique national program. If licensed by 
FDA as part of the vaccine kit, CDC can simple use the sheathed needles 
as part of the kit rather than the unsheathed.

    [Whereupon, at 12:20 p.m., the committee was adjourned.]

```