Advisory
Commission on Childhood Vaccines
Meeting and Conference Call
March
9, 2006
Minutes
Members Present
Don L. Wilber, M.D., Chair
Suzanne H. Vaughn, Vice-Chair, via conference
call
Robert P. Fuller, M.D., via conference
call
Loren G. Cooper, J.D
Jaime Deville, M.D., via conference call
William P. Glass, Jr., J.D.
Robin Stavola
Marguerite E. Willner
Ex-Officio
Members Present
Marion Gruber, Ph.D. for
Norman Baylor, Ph.D., Center for Biologics and Evaluation Research, Food and
Drug Administration (FDA)
Robert L. Davis, M.D., M.P.H., Director, Immunization Safety Office, Centers
for Disease Control and Prevention (CDC)
Barbara Mulach, Ph.D., for
Carole Heilman, Ph.D./National Institute of Allergy and Infectious Diseases
(NIAID), National Institutes of Health (NIH) (via conference call)
Acting
Executive Secretary
Geoffrey Evans, M.D., Director, Division
of Vaccine Injury Compensation (DVIC),
Healthcare Systems Bureau (HSB), Health
Resources and Services Administration (HRSA)
Staff
Liaison
Cheryl Lee, DVIC, HSB, HRSA
Introduction
Dr. Don Wilber convened the 63rd quarterly
meeting of the Advisory Commission of Childhood
Vaccines (ACCV) and welcomed all participants.
The minutes of the
September 14 and December 12, 2005 meetings
were approved.
Report from the Division of Vaccine Injury
Compensation (DVIC): Geoffrey Evans, M.D.,
Acting Director
Dr. Evans welcomed Dr. Robert Davis to
the ACCV as the new Centers for Disease
Control and Prevention’s (CDC) ex-officio
member. He has replaced Dr. Frank DeStefano
as Director, Immunization Safety Office,
Office of the Chief Science Officer. Previously,
Dr. Davis served as an Epidemic Intelligence
Service Officer with CDC, and as an epidemiologist
with the state of Washington’s Department
of Health. While serving on the Group Health
Cooperative in Seattle, he was one of the
original project officers for the Large-Linked
Database project, which is currently called
the Vaccine Safety Datalink. He is an acknowledged
leader in the field of immunization safety.
Dr. Evans reported that the National Vaccine
Injury Compensation Program (VICP)
Post-1988 Statistical Report has been changed
based on feedback from the public. The
Awards Paid section has been changed to
report separate totals for petitioners’awards
and attorneys’ fees for compensable
cases. Previously, this section incorporated
attorneys fees and costs into the petitioners’ award
total. More footnotes have been included
in the new report to aid in understanding
the new format.
The VICP’s Claims Filed and Compensated
or Dismissed by Vaccine Report has also
been changed. The new format consolidates
data on the number of claims filed for
injuries and deaths and the number of claims
compensated and dismissed by vaccine as
reported by petitioners. Previously, this
information was provided in two separate
reports. Hopefully, this change will make
it more user-friendly. Footnotes have been
provided to explain the changes.
Dr. Evans provided program statistics
from the March 8 Monthly Statistics Report.
Currently, the trend of autism filings
has continued to decrease, and the non-autism
claims have increased slightly from 180
to 190. This is likely due to the addition
of influenza vaccines to the VICP, which
became effective on July 1, 2005.
The average award paid for Fiscal Years
(FY) 1990 – 2006 is approximately
$61 million for petitioners, and $4 million
annually for attorneys fees and costs.
As of December 31, 2005, the balance in
the Vaccine Injury Trust Fund (Trust Fund)
was over $2.2 billion. Currently in FY
2006, the Trust Fund has received approximately
$35 million in revenue, of which $15 million
was excise tax collections, and $20 million
in interest.
Dr. Evans reported on the recent approval
of a vaccine license this year. On February
3, the Food and Drug Administration approved
a new live oral rotavirus vaccine that
will be administered to infants in a three
dose series between the ages of 6 to 32
weeks. RotaTeq ® is the trade name,
and is manufactured by Merck. Rotavirus
infection is the leading cause of diarrhea
in infants and young children causing about
20 – 60 deaths per year in the U.S.
A previous rotavirus product, Rotashield®,
was withdrawn from the U.S. market in 1999,
due to cases of intussusception found associated
with the vaccine. There is no indication
that this adverse event is associated with
Rotateq after being confirmed by the largest
clinical trial leading up to vaccine licensure
in many years.
As a general category, rotavirus vaccines
are already covered under the VICP under
category XI with no corresponding injury
or condition specified. On the Vaccine
Injury Table (Table) there is a second
category XII for the live oral rhesus-based
rotavirus vaccine, Rotashield, with the
corresponding injury of intussusception.
HRSA has revised the VICP website to make
it more user-friendly. The new website
address is http://www.hrsa.gov/vaccinecompensation.
The old website address, www.hrsa.gov/osp/vicp,
will also allow access to the updated website.
Dr. Evans reported on meetings attended
by DVIC staff. On February 21-22, he represented
HRSA as an ex-officio member at CDC’s
Advisory Committee on Immunization Practices
(ACIP) meeting in Atlanta. The ACIP endorsed
universal immunization of U.S. infants
with the newly licensed oral rotavirus
vaccine, Rotateq. In addition, they unanimously
recommended the expansion of the routine
use of influenza vaccines in children from
6 to 23 months to 6 to 59 months of age.
Household contacts of children up to age
5 years are included in this recommendation.
Several ACIP members expressed strong
support for approving a recommendation
that influenza vaccine be given to healthy
individuals of all ages. There are programmatic,
logistical, financial, and other factors
at this time that make this change unfeasible.
However, language is included in the current
recommendation that a strategy of universal
influenza immunization vaccination be evaluated
by ACIP in the future.
Dr. Evans provided additional information
on adding vaccines to the Table. When a
new vaccine is added to the Table, there
is a two-year window in which to file a
claim for injuries that occurred up to
eight years before the effective date of
coverage for the newly added vaccine. When
hepatitis B vaccine was added to the VICP
in 1997, nearly 350 claims were filed in
1999. Since the influenza vaccine will
be given to larger numbers of people, it
is expected that many more influenza claims
could be filed with the VICP. The filing
deadline is July 1, 2007.
On February 21-22, Dr. Robert Weibel served
as the HRSA representative to the National
Institutes of Health’s Autoimmune
Diseases Coordinating Committee at the
Conference on Developing New Standards
of Autoantibody Measurement at the National
Institute of Standards and Technology in
Gaithersburg, Maryland. The conference
reviewed current assays for determining
rheumatic and vascular diseases and auto-antibodies
for diabetes mellitus, cancer, cardiovascular
and celiac disease. The goal of the conference
was to establish new standards for measuring
autoantibodies for prevention, diagnosis
and treatment of these diseases.
Update on the National Institute of Allergy
and Infectious Diseases (NIAID) Vaccine
Activities: Barbara Mulach, Ph.D.
Last fall, NIAID completed the H5N1 avian
influenza vaccine study, which involved
evaluating the vaccine in healthy adults.
At the end of March, the results of this
study will be published in the New
England Journal of Medicine. (not a
U.S. Government Web site)
NIAID has also been involved in the avian
influenza vaccination studies on healthy
elderly and children to get preliminary
data on the immunogenicity and safety of
this vaccination for these populations.
This week, several clinical trials of
this vaccine with and without different
adjuvants are beginning in order to determine
if there is a way to boost the immune response
and the ability to extend the vaccine as
much as possible. Recruitment for these
trials is underway at several sites, including
the University of Maryland. More information
on the trials can be viewed at the U.S.
National Institutes of Health, Clinical
Trails Web site.
Report from the Department of Justice
(DOJ): Vincent Matonoski, J.D., Acting
Deputy Director for the Torts Branch, Civil
Division
Staffing and Hiring
Mr. Matanoski noted that Deputy Director
Mark Rogers remains on active duty with
the Marine Corps, in Africa. He announced
that the Office of Vaccine Litigation has
recently hired two attorneys, who will
replace two attorneys who left the office
in August 2005. One is already onboard
and the other attorney should be entering
on duty in April or May 2006. These new
hires are important to the office because
the Court of Federal Claims (CFC) has hired
three new special masters, which will increase
that office’s ability to handle cases
by about 40 percent. The Department of
Justice (DOJ) wants to make sure that the
office has resources available so that
cases can continue to move quickly through
the system.
Litigation
Autism
DOJ continues to see a trend downward
in the number of autism cases filed. It
is anticipated that there will be less
than 20 cases filed per month by the end
of this Fiscal Year (FY). There were 42
autism cases filed between December 1,
2005 and February 28, 2006. This is out
of a total of 75 cases filed during the
aforesaid period. Approximately 4700 autism
cases have been filed in the Program.
Petitioners’ interests in the Omnibus
Autism Proceeding are represented by a
steering committee of several attorneys.
The committee has filed a brief in which
it has been requested that petitioners
be allowed until the end of 2006 before
being required to put on their cases.
In January 2006, the steering committee
presented a preliminary list of 15 potential
experts they may use to assist them in
proving causation. These experts come from
a variety of fields, including epidemiology,
biostatistics, chemistry, and pediatrics.
The committee has indicated that the number
of experts may be increased or decreased.
Influenza vaccine
There were 8 influenza (flu) vaccine cases
filed between December 1, 2005 and February
28, 2006. A slight increase in the number
of flu vaccine-related cases is being seen,
but it is expected that the bulk of such
cases will be filed in July 2007, two years
from the date the flu vaccine was added
to the Vaccine Injury Table.
Other case activity
Of the remaining cases filed during the
above time period, four were hepatitis
B vaccine-related cases and 25 were related
to other vaccines. There were 39 dispositions
of cases during this period, and 15 of
those resulted in decisions finding petitioners
entitled to compensation. In 4 of those
cases, respondent had contested petitioners’ entitlement
to compensation, but the court found entitlement
anyway. In the remaining 11 cases, the
disposition resulted from either a stipulation
of settlement, or a proffer by respondent
of an award of compensation, or a concession
of entitlement by respondent. Twenty-four
cases were dismissed without compensation.
The bases for the dismissals varied. Many
of them occurred because petitioners requested
that the special master decide the case
on the record as it stands. In most of
those instances, petitioners felt that
they did not have enough evidence to go
forward and obtain compensation, but they
wanted a decision nevertheless – the
petitioners understood that the decision
was probably going to result in decision
against them, but they preferred to have
the decided at that time, rather than continue
further with the litigation of their claim.
Appeals
During the aforesaid period, there were
8 appellate decisions in the CFC. Five
of these decisions were in cases that had
been dismissed by the special master, and
these dismissals were affirmed by the CFC.
In the three other appeals, the CFC reversed
the special master’s dismissals of
the cases and remanded the cases to the
special master for further findings in
light of the CFC’s decision.
Settlements
Many vaccine cases are resolved through
mutually agreed upon settlements. In FY
2006, there have been 18 settlements. There
are 13 settlements currently pending final
approval. In every case settled, the 15-week
time frame established for finalizing settlements
and sending a stipulation to the petitioner
has been met, which is good news for everyone
concerned.
Vaccine Safety Datalink (VSD)
Pursuant to an agreement between petitioners’ counsel
in the autism cases and respondent, petitioners
have been given permission to look at certain
VSD data concerning the Thimerosal Screening
Analysis. This data is resident in the
Research Data Center in Greenbelt, Maryland,
and is handled by the National Center for
Health Statistics. Petitioners have identified
2 experts who will perform the research
on this data. The research will not be
done until petitioners and their experts
sign an agreement not to disclose any personal
information found during the research.
In January 2006, several petitioners’ counsel
met with members of CDC, including
Dr. Robert Davis and Dr. Tanya Popovich,
the Associate Director for Science at the
CDC, both of whom have experience with
and are knowledgeable about the VSD. They
presented a great deal of information about
how the VSD works, the type of information
it contains, and how quickly it can be
used to do research. Mr. Matanoski feels
that the conclusion to be reached based
on the information presented at the meeting
is that the VSD is not a “real time” research
tool – one cannot use the VSD to
pose a scientific question and receive
an answer in a short period of time. Rather,
it would take several years to get an answer
using the VSD as a research tool. The VSD
is not something that is feasible for a
petitioner under the Act to use to get
evidence to support a case that already
has been filed and which is subject to
statutory deadlines.
The VSD can be used to set a research
agenda by determining the types of research
questions that may be posed to the VSD.
Information gleaned from Vaccine Act cases
and the kinds of questions that are coming
up in vaccine cases would be funneled into
the decision-making process in setting
the research agenda. This could be another
piece of information that those who are
setting the research agenda could consider
in deciding which questions to put to the
VSD data. While the VSD will not give an
answer for a case that is currently pending,
it could give answers out into the future.
Snyder v. HHS
The CFC decision in Snyder has the potential
to affect the litigation of vaccine cases.
In that case, petitioner’s medical
records contained entries noting a potential
vaccine association with an injury. Petitioner
went forward with the case without presenting
any medical expert evidence. Respondent
did present a medical expert to address
petitioner’s claim. The special master
found that petitioner had not proven that
the vaccine caused her alleged injury and
dismissed the case. On appeal to the CFC,
the judge found that the medical record
entries were more compelling to him than
was the expert opinion of the respondent.
This is a very unusual decision, in that
an appellate judge does not normally step
in and do his or her own fact finding.
The decision will affect respondent’s
litigation of other vaccine cases because
medical records are often seen which contain
conclusory assertions of a connection to
a vaccine for a patient’s illness
or condition. Sometimes these assertions
are based on a temporal association alone.
The petitioner may come in and say to the
treating physician, “I was injured
by rubella vaccine,” and the physician
writes this statement in his records. That
is what happened in Snyder. In the past,
it has been left up to the special master
to consider such entries and determine
whether they should be given any weight.
Based on the weight given, such entries
by the CFC judge in Snyder, respondent
may be compelled to look behind medical
record entries and investigate them by
deposing or interviewing the individual
who made the notation to determine the
basis for it. Did the person really believe
that the vaccine caused the problem or
were they noting something based solely
on the patient’s report? Was the
association based solely on the temporal
relationship or was there some other reason?
Was there a clinical sign or reason that
was thought to be compelling in that particular
case? Respondent may be forced to investigate
such entries in the medical records to
ensure that they are not misinterpreted,
either by the parties or the court. One
of the ways that Snyder has already affected
the litigation of vaccine cases is that
recently, a petitioner’s attorney
who was under a court order to provide
an expert opinion to support a petitioner’s
claim, instead filed a report stating that
he was going to rely solely on petitioner’s
medical records, and would not be providing
an expert opinion in the case, citing Snyder.
It remains to be seen how the litigation
of vaccine cases will be affected by the
Snyder decision, given that it just came
down in early February 2006, but Mr. Matanoski
wanted to make the ACCV aware of the potential
effect.
Capizzano v. HHS
The Federal Circuit has not issued its
decision yet in Capizzano. The case was
argued in the beginning of November 2005.
Dr. Evans asked Mr. Matanoski to discuss
the significance of the case, in light
of the Circuit’s decision in Althen.
Mr. Matanoski explained that Althen did
not, in respondent’s view, change
the actual causation standards under the
Vaccine Act. In fact, it could not change
those standards because a panel sitting
alone cannot change the existing precedent
of the Circuit. That would require an en
banc decision. If the language of Althen
is parsed, one can see that the standard
articulated in that decision is word-for-word
the standard that was used in Grant v.
HHS, which was a 1992 Federal Circuit decision
that set the standard for actual causation
cases. Althen reiterated that standard.
What has been taken away from Althen is
perhaps something read between the lines
of the holding based on comments in the
decision. There are comments such as “close
calls go to petitioner.” That seems
to have been interpreted to mean that the
standard of causation may have eased a
bit for petitioners. Clearly the standard
that was articulated is the same one that
has been in place for 14 years. Also, by
saying that “close cases go to the
petitioner” the Circuit cannot mean
that petitioners can meet their burden
of proof by less than a preponderance of
the evidence, which is the legally applicable
standard in causation in fact cases filed
under the Act.
Capizzano involved the dismissal of a
petition because the special master found
that petitioner failed to meet her burden
of proving causation in fact. It was decided
before the Circuit’s decision in
Althen, but after the CFC’s decision
in that case, which struck down the so
called “Stevens standard.” The
special master did not use that standard
in deciding Capizzano.
In respondent’s view, the decision
in Capizzano determined whether or not
petitioner had satisfied her burden of
proving causation in fact by applying the
precedent set in Grant, and so it should
not be disturbed in light of Althen. The
result would not have been any different
if Althen had been decided before the decision
was made in Capizzano.
Mr. Matanoski believes that the decision
ought to withstand scrutiny at the appellate
level, but it remains to be seen how the
Circuit will decide the case.
Vaccine Injury Compensation Programs Worldwide:
Geoffrey Evans, M.D.
Dr. Evans provided information on worldwide
vaccine injury compensation programs. His
research began by individually surveying
existing vaccine injury compensation programs
in preparation for a VICP-sponsored workshop
held in 2000. Managers from over a dozen
programs in Canada, Western Europe and
Asia attended the 2-day workshop in Washington.
Survey results were presented the following
year at the European Vaccine Manufacturer’s
Association in Brighton, UK. More recently,
Dr. Evans contacted each of the programs
to update the 2000 survey information.
This updated information was presented
in November 2005 at the 3rd Congress of
the Asociacion Espanola de Vacunologia
in Madrid. One additional program, Finland,
came to his attention while obtaining the
new data. Today’s presentation mirrors
what was presented at the Madrid meeting.
There are many similarities and differences
in the various programs. They came about
because of important public policy questions.
First, what do you do when there are victims
of unpredictable reactions to properly
manufactured and administered vaccines?
Second, who is responsible for compensating
people who experience vaccine injuries?
Should they be compensated? If so, who
should pay for it? Should it be the vaccine
company who may have manufactured the product
correctly, but unanticipated the adverse
effects of product, or the government who
is responsible for protecting public health,
or other sources (private health insurance
or excise tax on vaccines)?
In the U.S., medical injuries and malpractice
claims were handled in the civil tort system
where negligence needs to be proven. Either
the product was inadequately made, or it
was administered negligently, or the patient
was not warned of the possible side effects.
However, the problem arises when there
is no fault on the part of the manufacturer
or the administrator.
Historically, outside the U.S., adult
victims were commonly covered in most industrial
accident programs which did not contain
coverage for disability compensation. Children,
however, were not covered under these programs,
and there was no compensation for severe
disabilities, loss of future earnings,
and permanent injury or death.
Dr. Evans provided information on 14 vaccine
injury compensation programs in other countries
which were detailed by category in a 2-page
table handout. In 1953, the German Supreme
Court ruled that people who were injured
by compulsory vaccine (at that time it
was smallpox vaccine) were entitled to
compensation. In 1960, Germany and France
were providing compensation for the vaccine
injured. In the 1970s, the following countries
established compensation programs due to
DTP vaccine concerns: Japan, Switzerland,
Denmark, New Zealand, Sweden, and United
Kingdom. In the 1980s, Finland, Quebec,
United States, and Taiwan started compensation
programs, and in 1990, Italy and Norway
formed programs.
The reasons for the enactment of compensation
programs varied. Basically, programs were
created because people believed that the
government had a responsibility to compensate
those who were injured by vaccines. Another
reason these programs were created was
that injuries caused by vaccines are unique
and should be dealt with separately from
other types of injuries (i.e., from industrial
accident injuries). In the U.S., Japan,
and the U.K., concerns over injuries from
the DTP vaccines resulted in public pressure
to create a compensation program. Other
reasons included trying to avoid costly
trials, and providing more consistency
in liability law outcomes and compensation.
In Italy and some other countries, the
medical community pressured the government
to create a compensation program.
All countries, except Sweden and Finland,
were enacted through administration on
the national level. Germany and Switzerland
enacted their programs on the state level
which is responsible for determining eligibility
in compensation outcome decisions, and
deciding which vaccines are recommended
for use. Japan enacted their program on
a state and local level. New Zealand has
a compensation system that requires its
citizens to participate and give up their
rights to sue for injuries, whether from
drugs, vaccines, or other products or services.
Participation in this program is mandatory.
Individuals in high-risk professions pay
more to the “Accident Rehabilitation
and Compensation Insurance Corporation,” which
is setup as a quasi-governmental private
enterprise.
Sweden’s compensation program called
the “Pharmaceutical Insurance” started
in 1978 by companies marketing pharmaceutical
products. Compensation is not decided under
their judicial system. Finland has a program
similar to Sweden. Denmark switched to
a private insurance system in 2004.
The eligibility criteria for the compensation
programs varies from country to country.
The criteria reflects the specific needs
and vaccine recommendations found in these
countries. Most countries specify the type
of vaccines that are given, whether it
is compulsory, recommended, or voluntary;
the date of vaccination, injury, or filing
of the claim; and the type and severity
of the continued effects of the injury.
Some specify the setting where the vaccine
is given, such as public, clinic, doctor’s
office, type of employment of healthcare
worker, and citizen requirements.
The vaccines covered in these programs
are usually recommended for routine use.
Few countries have compulsory immunization.
Most of the compensation programs covered
vaccines given to children or those who
are required to get vaccines for certain
occupations and travel. France provides
coverage for specific vaccines required
for healthcare workers and health profession
students. In Italy, persons who received
the typhoid vaccine for professional reasons,
and who traveled outside the country became
eligible for compensation due to the 1992
legislation enacted which covered contaminated
blood products.
In the U.S., there are no Federal vaccination
mandates. There are 50 different state
laws and nearly all of the 14 vaccines
covered under the VICP are mandated in
these states.
Some of the countries have different filing
deadlines and limit coverage to a certain
time period. In the U.K., claims could
at one point be filed for injuries dating
back to 1948. In the U.S., a pertussis
vaccine claim was filed with the VICP dating
back to 1918. There were also cases filed
from vaccines administered in the 1930s
and 1940s. Japan and Norway have no time
limits for filing, and Germany’s
deadlines are determined by their Cantons.
In terms of compensable injuries, most
countries are not very specific other than
the U.S. In Taiwan, they used the U.S.
Vaccine Injury Table to compensate injuries
until two years ago. Currently, they require
that the injury have a certain level of
severity and have lasting effects. Often
the decision to compensate is based on
temporal association as well as current
knowledge of vaccine reactions.
In most countries, claims are usually
filed with the administrative entity at
the national level and eligibility for
compensation is determined at the same
level. Decisions about compensation are
done through an administrative process
using internal reviews with some outside
consultants. Some countries employ more
formal evaluations bodies consisting of
health and legal professionals as prescribed
by law to evaluate their claims.
In Quebec, the process for reviewing a
claim consists of each party choosing a
physician who will support their causation
theories, and then both of these physicians
choose a third physician in order to obtain
a majority vote.
Most programs do offer flexibility in
making causation decisions. Other than
that,
Dr. Evans was not able to determine more
precisely the criteria upon which these
decisions are made. Usually, if there is
a suggestion in the literature of some
significance and there is a reasonable
temporal association, causation will be
determined in favor of the injured party.
Many of the western European countries
have very different healthcare systems
than in the U.S. Many have universal health
insurance that covers people from when
they are born until they die.
All programs allow claimants the right
to appeal decisions against compensation.
Almost all provide four categories of basic
compensation similar to the benefits listed
under industrial accident programs. The
U.K. is the exception and has a provision
for tax free lump sum payment of 100,000
pounds to ease the present and future burdens
of those suffering from vaccine damage
and their families. The types of benefits
covered by most programs include: (1) medical
costs for laboratory testing, therapy,
hospital care; (2) disability pensions
that can be based on lost earnings and
long-term care costs, or based on the severity
of the injury; (3) lost earnings for adults
to care for a disabled child; and (4) damages
for pain and suffering.
France is very specific about compensation
for emotional distress and loss of consortium.
Other programs provide additional benefits
based on the severity of the injury and
degree of inconvenience and discomfort.
They all provide some type of death benefit,
either for the family to pay funeral costs
or for loss of income. Germany and Denmark
apply provisions of their industrial injury
pension laws to vaccine injury victims.
Some countries also allow individuals to
supplement payments obtained from other
forms of social assistance, while others
disallow such practices. Japan allows an
individual to obtain both government and
social assistance benefits and private
insurance if available. In the U.S., individuals
are compensated for unreimbursed expenses.
The funding sources for vaccine injury
compensation programs differ among countries.
About half are funded from the national
treasuries. Private insurance provides
funding for programs in Sweden, Finland,
and Denmark. Some programs are funded by
vaccine manufacturers.
Most of these programs allow the filing
of civil actions in addition to obtaining
compensation. However, some programs preclude
individuals from obtaining benefits from
both systems or reduce the amount of benefits
obtained through civil action by the amount
of benefits received under governmental
programs. Denmark, Germany, U.K., and Switzerland
do not allow civil suits to be filed.
There is great variability in the number
of claims filed. In the U.K. and Japan,
public awareness was high and affected
the number of claims filed. The data from
Japan reflects an increase in claims due
to more public awareness and the Urabe
mumps vaccine causing cases of aseptic
meningitis, which has lead to a significant
percentage in compensation. Other factors
affected the number of claims filed including
population size, numbers of vaccines administered,
the types of injuries covered, and the
willingness of the public to utilize government
programs versus other options.
Dr. Evans concluded that vaccine injury
compensation programs outside of the U.S.
are working well, but there is not much
awareness of their existence. All exist
solely in industrialized countries. The
Pan American Health Organization has expressed
interest in creating compensation programs
for developing countries. However, in order
to have a compensation program, a country
must be able to afford to buy vaccines.
Update from the National Vaccine Program
Office (NVPO) and the Interagency Vaccine:
Kenneth Bart, M.D., M.P.H., Consultant
Dr. Bart submitted the following summary
after the ACCV Meeting.
Advisory Committee on Immunization Practices (ACIP)
On February 21-22, the ACIP conducted
their meeting in Atlanta, Georgia. Agenda
items that were discussed included general
recommendations on immunization, the status
of Tdap vaccine recommendations, the status
of human papillomavirus vaccine, recommendations
for the rotavirus vaccine, and influenza
activities. Hepatitis B vaccine recommendations
were published in the Morbidity and Mortality
Weekly Report on December 25, 2005. Major
updates to the recommendation include implementation
of universal vaccination of newborns before
hospital discharge, and vaccination of
children and adolescents who were not previously
vaccinated.
National Vaccine Advisory Committee (NVAC)
On February 7-8, NVAC met and presentations
were made by CDC and FDA staff on the
supply and demand of influenza vaccine,
vaccine safety, and vaccine financing.
Helen Darling, President, National Business
Group on Health made a presentation on
immunization coverage and insurance coverage
for vaccination. Harry Hull, an epidemiologist
with the State of Minnesota provided
a talk about the recent polio outbreak
among unvaccinated populations. Dr. Robert
Davis, Director of the Immunization Safety
Office at the CDC, spoke about vaccine
safety and the prevention of adverse
events and how genomic medicine could
change the way in which medical professionals
and the public evaluate the safety of
vaccines. The genomic approach to vaccine
safety determination is modeled on the
method utilized by pharmaceutical manufacturers
in identifying predisposing genetic factors
that could be exacerbated by the use
of a particular medication. John Agwunobi,
Assistant Secretary of Health, HHS spoke
about the increasing burden of vaccine
financing and discussed strategies with
ACIP. The Subcommittee on Safety heard
a presentation from the National Institutes
of Allergy and Infectious Diseases on
current research to identify nucleotide
polymorphisms that could predispose a
vaccine recipient to an adverse event.
Cost Effectiveness of Vaccine
An economic evaluation of the impact
of seven vaccines (DTap, Td, Hib, polio,
MMR, hepatitis B, and varicella) routinely
given as part of the childhood immunization
schedule found that vaccines are very
cost effective. Routine childhood vaccination
with these seven vaccines, which prevent
over 14 million cases of disease and
over 35,500 deaths over the lifetime
of children born in any given year, resulted
in annual cost saving of $10 billion
in direct medical costs and over $40
billion in indirect societal costs. (Published
in the Archives of Pediatric and
Adolescent Medicine in December 2005).
Vaccine Liability 50 years After the
Cutter Incident: Paul A. Offit, M.D.
Dr. Paul Offit is a virologist in the
Division of Infectious Diseases, Children's
Hospital of Philadelphia, University of
Pennsylvania, School of Medicine. He provided
a discussion of his book entitled, “The
Cutter Incident: How America’s First
Polio Vaccine Led to the Growing Vaccine
Crisis.”
In the 1940’s and 1950’s,
polio disease was a highly contagious and
occasionally fatal disease. In 1952, 58,000
cases of polio were reported, and 65 percent
of these cases occurred in children between
5 and 9 years of age. The polio virus affected
the central nervous system, specifically
the cells that are responsible for the
motion in the enervating muscles. Usually,
children became paralyzed in their legs,
and occasionally, it caused paralysis in
their arms. The virus also affected the
cranial nerves that are necessary for breathing.
Children who experienced breathing problems
from this condition were place in iron
lungs, which were negative pressure ventilators.
They typically died from aspiration pneumonia.
As a consequence, there was a tremendous
amount of public and private interest to
develop a vaccine to prevent polio.
Jonas Salk, M.D. developed the first polio
vaccine based on research done by John
Enders of Harvard University. He grew the
polio virus in monkey kidney cells, and
then purified it using formaldehyde. Hence,
the vaccine was referred to as the formaldehyde-inactivated
polio vaccine. In Dr. Salk’s theory
of inactivation, he reasoned that there
were a million of infectious particles
per dose, which is per milliliter. He found
that if a million particles were treated
with formaldehyde at a certain acidity
level at a certain temperature, then over
3 days, the amount of infectivity would
be reduced from a million infectious particles
to one infectious particle. He thought
that if you treated the virus with formaldehyde
for another three days, there would be
another million fold reduction in the virus
leading to only one infectious particle
per million milliliters. If you treated
the virus for another 3 days there would
be one infectious particle per trillion
milliliters resulting in complete inactivation
of the virus.
With the help of Eli Lilly and Parke-Davis,
in 1954, a polio vaccine was created for
a large clinical trial that was headed
by Thomas Francis, University of Michigan.
Three doses of vaccine were given to 420,000
children, and 200,000 children were inoculated
with placebo, and 1.2 million children
served as observed, uninoculated controls.
This was the largest clinical trial of
a vaccine ever performed. About 1.8 million
children participated in the trial. The
polio vaccine proved to be effective. However,
it was not effective against type one polio
virus because the Federal government at
the time required a substance called merthiolate
(currently called thimerosal) to be added
to the vaccine. Merthiolate destroyed type
one virus and made it less effective against
the virus.
On April 12, 1955, the Salk vaccine was
released, and merthiolate was removed from
the vaccine. At that time, the Laboratory
of Biologists Control within the National
Institutes of Health (NIH) was responsible
for the release of vaccines. The following
vaccine companies distributed the Salk
vaccine: Eli Lily, Parke-Davis, Wyeth,
Pitman-Moore, and Cutter. The polio vaccines
were released and never tested pre-licensure.
On April 28, 1955, the New York Times published an article entitled, “One
Firm’s Vaccine Barred; 6 Polio Cases
Are Studied.” This article discussed
polio cases that involved paralysis which
occurred in the arm that was inoculated
within two weeks of receiving this vaccine.
All of the cases occurred following inoculation
with the vaccine from one company. This
vaccine was made at the Cutter Laboratories
in Berkeley, CA.
A study by Neal Nathanson, was published
in the American Journal of Hygiene, examined
eight lots of polio vaccine that were released
by Cutter Laboratories and found that two
of the lots were high-risk and the instance
of paralysis following the administration
of this vaccine was about eight fold greater
than in other lots.
In Idaho, polio vaccines were made available
free of charge to all first and second
graders by the National Foundation for
Infantile Paralysis who funded the 1.8
million children clinical trial and is
currently known as the March of Dimes.
Thirty-two thousand school children were
immunized in two weeks, and 20 children
were paralyzed, and 3 were killed by the
Cutter vaccine.
Dr. Manley Shaw, an orthopedic surgeon,
provided retrospective examination of medical
records and conducted interviews with parents
of 425 children who received the Cutter
vaccine in Boise, Lewiston and Pocatello,
Idaho. Thirty-two percent of the children
had symptoms of abortive polio (i.e., headaches,
stiff neck and back, residual paralysis),
which is roughly the rate of abortive polio
that occurs after natural infection. Therefore,
it is likely that every dose in the two
high risks lots administered in Idaho contained
live polio virus. About 120,000 children
were inoculated with the vaccine that contained
the live polio virus, because these children
excreted the virus in their stools resulting
in another 100,000 family members and community
contacts being infected. At least 70,000
developed abortive polio; at least 164
people were permanently paralyzed, and
10 people were killed by the vaccine.
Within 3 months, investigators determined
that the problem with the Cutter virus
was caused by the filtration method used
to separate the cells from the virus. The
polio virus and cell debris would come
through a tube and then Cutter would try
to filter out the cell debris in the porous
glass. The filtered virus would come out
of another tube. In this case, the filtration
was not good enough and some dead cells
or cell debris actually ended up in the
final preparation before it was treated
with formaldehyde. Then, the polio virus
particles hid within that cell debris and
was not accessible to the killing effects
of formaldehyde. Some of the dead polio
cells were found in the final vaccine batch,
and were not effected by or killed by the
formaldehyde process.
In essence, Dr. Salk’s theory of
straight line inactivation that was based
on studies used in his laboratory did not
come true in practice. It is possible that
the line did not remain straight, but that
it curved up toward the baseline. There
were some good things that resulted from
this medical tragedy. Second, the safety
tests on vaccines were improved. Better
test results revealed whether there was
live virus in the vaccine, and there were
better filtration requirements.
The first was the birth of vaccine regulation
in the U.S. Vaccine regulation within NIH
moved from the Laboratory of Biologics
Control to the Division of Biologics Standards.
The number of professional regulators increased
from 10 part-time to 150 full-time people.
In the early 1970s, the control of the
vaccine regulation was transferred from
NIH to the FDA, at the Centers for Biologics
Evaluation and Research.
One of the first assignments of the Epidemic
Intelligence Service (EIS), CDC was the
first national response to the medical
emergency resulting from the Cutter incident,
which gave tremendous credibility to the
EIS. As a result, more funds were quickly
garnered to the CDC.
In 1955, the Salk vaccine was released
in the U.S. and uptake was very slow. The
immunization rate was only about 40 percent
because the U.S. was not very good at immunizing
its citizens and of fear resulting from
the Cutter incident. Nevertheless, the
Salk vaccine reduced the number of cases
of polio during the years it was used.
The Salk vaccine was replaced by Sabin’s
oral polio vaccine which was a live, weakened
form of the virus itself and caused people
to get polio in rare instances. Therefore,
in 1998, the U.S. switched to a fully inactivated
polio vaccine schedule.
Anne Gottsdanker was five and a half years
old when she was paralyzed after receiving
the Cutter polio vaccine. Her mother, Josephine
Gottsdanker, sued Cutter Laboratories for
damages caused by their vaccine. The attorney
who handled her case was Melvin Belli,
probably the most famous tort attorney
at the time. Mr. Belli sued Cutter for
negligence because they failed to exercise
ordinary care in manufacturing that vaccine.
He also sued them for breach of an implied
warranty because it was implied that a
vaccine designed to prevent paralysis shouldn’t
have caused paralysis.
The jury in the Gottsdanker case was provided
with information that Cutter Laboratories
was not the only vaccine company experiencing
problems inactivating the virus. Records
provided in the case through the Freedom
of Information Act revealed that the following
vaccine companies had live virus in their
vaccines when they thought they had fully
inactivated the virus: Eli Lilly, Parke-Davis,
Wyeth, and Pitman-Moore. Eli Lilly and
Parke-Davis were the biggest companies,
and it took them a while to figure out
a way to inactivate the virus in the vaccine.
The other companies (Wyeth, Pitman-Moore,
and Cutter) were smaller companies.
Wyeth’s polio vaccine also caused
more cases of polio than expected in the
normal population. A study written by Neal
Nathanson, Alexander Lang, and Bill Jackson
at CDC, called “An Epidemiological
Analysis of the Occurrence of Poliomyelitis
in Association with Certain Lots of Wyeth
Vaccine,” was never published. Wyeth
made a lot of vaccine – lot 236 – that
caused paralysis and the death of at least
one child in Buck’s County, PA. For
this reason lot 236 was quietly withdrawn
from the market.
On April 28, 1955, Cutter withdrew all
of its polio vaccines from the market.
A couple of weeks later all polio vaccines
were withdrawn and more re-tested based
on more sensitive tests. However, Wyeth’s
vaccine lot #236 continued to be withdrawn
from the market, even after the other vaccines
were returned.
In the case of Gottsdanker v. Cutter Laboratories,
the jury found Cutter not guilty of negligence,
but guilty of breech of implied warranty.
The jury based their verdict on the view
that in the process of medical advances,
especially commercial scale manufacturer,
there is expected to be trial and error
in creating a safe vaccine. The rationale
was that Cutter, as well as other vaccine
companies were experiencing the same problems
with there vaccines. However, the judge
in the case stated that if the vaccine
was the proximate cause of harm, then you
must find Cutter liable for their vaccine.
This case was a precedent for liability
without fault or negligence for pharmaceutical
companies. This was the first time that
liability without fault was extended to
a pharmaceutical company. The thought was
why Anne Gottsdanker should have to buy
insurance to protect her from paralysis
caused by polio vaccine. An article was
published in the Yale Law Journal by Guildo
Calabresi. He stated that society will
be better off if vaccine companies could
be held liable without fault for their
products. He reasoned that vaccine companies
are in a better position to provide insurance
by increasing their price for the vaccine.
However, difficult vaccines continued to
be developed, tested, and sold. The measles-mumps-rubella
vaccine experienced many trials and error
before it became a safe vaccine.
In 1974, the Kulenkampff paper was published
in the Archives of Diseases of Children in London. Thirty-six pertussis vaccine
cases were reported, of which 22 cases
were children who had received the whole
cell pertussis vaccine. They subsequently
developed brain damage (mental retardation
and seizure disorder). Kulenkampff argued
that the whole cell pertussis vaccine could
cause permanent brain damage. This caused
many lawsuits in the U.S., and the pertussis
vaccine was blamed for unexplained coma,
Sudden Infant Death Syndrome, Reye Syndrome,
retardation, seizure disorders, and paralysis.
The results of the lawsuits caused the
price of the pertussis vaccines to increase
from .17 cents per dose to $11.00 per dose.
The increase was due to the cost of liability.
The number of vaccine companies producing
pertussis vaccine decreased from eight
to one, which was Lederle Laboratories.
In the mid-1980s, the parents of a child,
Kevin Toner claimed that the pertussis
vaccine caused transverse myelitis, and
filed suit against Lederle Laboratories.
The jury was responsible for determining
causality, and had difficultly doing so
because there was no evidence that the
pertussis vaccine increased the incidents
of transverse myelitis. They ended up awarding
the parents of Kevin Toner $1.3 million
dollars. At that time, pertussis vaccine
business in the U.S. was only $3 million
dollars.
In other vaccine cases, juries continued
to awarded big settlements against vaccine
manufacturers. They determined that the
drug, Bendectin, an anti-nausea drug used
in the 1950 – 1970’s, caused
birth defects. Twenty seven studies did
not show a causal relation. However, the
jury awarded a $4.7 billion dollar settlement.
They found that breast implants can cause
cardiovascular disease, even though six
studies have shown that is does not. In
the Fen-phen case, a jury awarded $21 billion,
and in the Vioxx case, the award the jury
recommended caused Merck to lose about
two-thirds of their capitalization.
To assist vaccine companies with liability
protection, the Federal government created
the “National Childhood Vaccine Injury
Act of 1986, as amended.” The Vaccine
Injury Table was established and it lists
injuries/conditions that are presumed to
be caused by vaccines. The program is funded
by revenues in the Vaccine Injury Trust
Fund, which are earned by excise taxes
on vaccines.
Dr. Offit explained how several vaccines
were taken off the market due to fears
from the public that it caused a condition
that was not supported by scientific studies.
GlaxoSmithKline developed a vaccine to
treat Lyme disease. Lyme disease is a bacterial
infection that can cause permanent joint,
central nervous system, or heart abnormalities.
It affects about 23,000 people a year in
the U.S. The vaccine contained the outer
surface protein of Lyme bacteria.
The Lyme vaccine was tested pre-licensure
on 20,000 people who were followed for
2 years. The vaccine was recommended for
use in only adolescents and young adults
living in high risk areas (New Jersey,
Pennsylvania, etc.) who engaged in high
risk activities.
There were a number of lawsuits filed
against the Lyme vaccine. One lawsuit filed
in Philadelphia alleged that the vaccine
caused chronic arthritis. There were no
pre-licensure studies to support the causal
relationship. Tremendous negative publicity
about the perception that the vaccine caused
chronic arthritis drove the vaccine off
the market. Children who acquired Lyme
disease would have to endure it since there
was no vaccine available to treat the disease.
Dr. Offit stated that he feels that this
vaccine would be available if it was covered
by the VICP.
The Group B Strep vaccine was also removed
from the market. Group B Strep disease
is a bacterial infection that affects about
2,000 children per year in the U.S. It
has caused about 100 deaths. The disease
causes meningitis, which is an inflammation
of the lining of the brain and spinal cord.
It typically attacks children in the first
week of life.
In the late 1980s, studies were conducted
on Group B Strep by Carol Baker at Baylor
University in Houston, Texas. The results
of the study revealed that if the complex
sugar is stripped from the Group B strep,
the level of antibodies in the serum could
be transferred from mother to child, therefore,
protecting the baby against Group B Strep.
A vaccine was never developed.
In conclusion, Dr. Offit expressed concern
that the many autism claims being filed
in Federal and state court will be decided
by juries that will rule in the petitioners
favor. He worries that the parents who
sue vaccine companies for loss of consortium
and medical monitoring may be successful
one day. Currently, there are trace amounts
of thimerosal in a number of vaccines,
and Dr. Offit believes if these claims
are successful it would cause vaccines
companies to re-formulate their vaccines
with even less amounts of thimerosal, which
may cause some vaccine manufacturers to
go out of business.
Dr. Offit stated that certain vaccines
that would protect against diseases are
off the market because they are not covered
in the VICP. He believes that if someone
files a claim in the program, they should
not be able to opt out to file a claim
in state court.
Public Comment Period: Argument to Amend
the VICP to Toll the Statute of Limitations
to the Age of Majority for Vaccine Injured
Children: Clifford J. Shoemaker, J.D.
Clifford J. Shoemaker, J.D. is an attorney
with the law firm of Shoemaker & Associates,
Vienna, VA. He has represented a number
of individuals filing claims with the VICP
over the years. Mr. Shoemaker stated that
he is a vaccine advocate, and is in favor
of safe and effective vaccines. His sister
contracted paralytic polio when she was
nine years old, and is in a wheelchair
today because there were no vaccines available.
Mr. Shoemaker’s vaccine litigation
career began during his last year in the
Marine Corps in 1977. He represented people
injured after receiving the swine flu vaccine.
Mr. Shoemaker feels that the VICP has
improved since its inception, and that
it should be a model for tort reform. However,
he is requesting that the current statute
of limitation be amended to allow for tolling
to the age of majority for vaccine injured
children. Specifically, he is proposing
to amend the National Childhood Vaccine
Injury Act of 1986, as amended, section
300aa-16(a) (2) to add the following language
at the end of the paragraph after the word “injury”: “provided,
however, that if the injured party is a
minor, then the 3-year limitation of actions
shall be tolled until the injured party
reaches 18 years of age.”
Currently, the statute of limitations
for filing a claim in the VICP is within
three years after the first symptom of
the vaccine injury. For a death, a claim
must be filed within two years of the death,
and four years after the start of the first
symptom of the vaccine-related injury from
which the death occurred. When a new vaccine
is covered by the VICP, or when a new injury/condition
is added to the Vaccine Injury Table (Table),
claims must be filed within two years from
the date the vaccine or injury/condition
is added to the Table for injuries or deaths
that occurred up to 8 years before the
Table change.
Mr. Shoemaker stated that he is recommending
that the statute be amended because it
is difficult to identify vaccine-related
injuries in babies and infants. In some
cases it takes years to diagnose a condition
where the symptoms may have started years
earlier. There are times when the child’s
doctor specifically tells the parents that
an injury is not related to a vaccine,
even in cases that are conceded by HHS.
He also stated that children should not
be punished for the failure of their parents
to bring a claim on their behalf, especially
when the parents are often overwhelmed
with the job of caring for an injured child.
Every state has a tolling provision for
minors and the disabled. For instance,
Agent Orange and radiation exposure cases
have no deadlines for filing a claim.
Mr. Shoemaker mentioned that the goals
of the VICP are to prevent civil litigation
by providing compensation for all injured
children, and assuring public confidence
and trust in vaccination programs. Mr.
Shoemaker also stated that his goal is
to have kids diagnosed with autism compensated
by the VICP.
One of the first efforts at tort reform
in vaccine cases was started by Secretary
Califano of the Department of Health, Education,
and Welfare who provided compensation to
individuals who experienced Guillian Barre
Syndrome after receiving the Swine flu
vaccine. These individuals did not have
to prove a theory of liability. At the
time, the Federal government was sued instead
of the vaccine manufacturers and these
cases were filed in Federal court. Trials
were handled by only judges. This program
laid the groundwork for the vaccine program
established today.
NOTE: After reviewing the minutes
of his presentation, Mr. Shoemaker requested
the
following “afterthought” be
included: Almost all of the countries that
have vaccine compensation programs (as
reported by Geoff Evans, MD) have more
liberal statutes of limitations than the
United States. This represents a black
mark on the way the United States is handling
these unfortunate, but rare, victims of
childhood vaccinations.
Report from the ACCV Workgroup on Standards
for Adding Injuries | 
