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The Smallpox Vaccination Plan: Challenges and Next
Steps
Bill Number: Oversight Hearing
Hearing Date: January 30, 2003
Witness:
Jon Abramson, MD
on behalf of the American Academy of Pediatrics
Washington, DC
Testimony:
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.
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