Advisory
Commission on Childhood Vaccines
Meeting and Conference Call
March
7 - 8, 2007
Members
Present
Don L. Wilber, M.D., Chair
Marguerite E. Willner, Vice-Chair
Tawny Buck
Loren G. Cooper, J.D.
Jaime Deville, M.D.
William P. Glass, Jr., J.D., via conference
call
Robin Stavola, via conference call
Jeffrey M. Sconyers, J.D.
Tamara Tempfer, R.N-C, M.S.N., P.N.P.
Ex-Officio
Members Present
Marion Gruber, Ph.D. for
Norman Baylor,
Ph.D., Center for Biologics and Evaluation
Research, Food and Drug Administration
(FDA)
Dr. John Iskander, M.D., M.P.H., Acting
Co-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)
Dr. Kenneth Bart, M.D., M.P.H., for
Dr. Bruce Gellin,
M.D. Director, National Vaccine Program
Office (NVPO)
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
Welcome
and Opening Remarks
Dr.
Don Wilber convened the 65th quarterly
meeting of the Advisory Commission of
Childhood Vaccines (ACCV) and welcomed
all participants. Since this is his last
meeting as ACCV Chair, he thanked Cheryl
Lee, Tamara Overby and Dr. Geoffrey Evans
for coordinating the ACCV meetings and
obtaining information for the ACCV. He
also thanked Loren Cooper and Marguerite
Willner for serving as Chairs of ACCV
Workgroups. The minutes of the October
24, 2006 meeting were approved.
Report
from the ACCV Futures Work Group: Marguerite
E. Willner, ACCV Member
Ms. Marguerite Willner stated that the
ACCV Futures Workgroup (Workgroup) was
formed to create a robust agenda for every
ACCV meeting. More specifically, it was
formed in response to the ACCV’s
belief that the National Vaccine Injury
Compensation Program (Program) needs to
be improved and modernized and, therefore,
the ACCV should hold more meetings and
each meeting held should be more productive.
Ms. Willner noted that, in particular,
many ACCV members were interested in following
up presentations made to the ACCV by petitioners’
attorney, Cliff Shoemaker, and others
who advocated extending the statute of
limitations. Many ACCV members felt the
Program should be inclusive, rather than
exclusive, and its success should be measured
by how many vaccine-injured people file
claims in the Program and receive compensation,
rather than by how many do not or cannot.
Ms.
Willner reported that the Workgroup was
composed of six of the nine ACCV members.
Of the six, two were new members: Tawny
Buck and Jeff Sconyers; and four were
veteran commissioners: Dr. Don Wilber
(ACCV Chair), Loren Cooper, Dr. Jaime
DeVille, and Ms. Willner (ACCV Vice-Chair).
She also noted that the Workgroup was
careful to keep the three non-Workgroup
members informed of its work.
Ms.
Willner mentioned that the Workgroup members
devoted a substantial amount of time and
effort to create the legislative recommendations
to be presented today. Not only did they
review hundreds of pages of literature,
they met at least three times by conference
call and met in Washington for a two-day
face-to-face meeting on February 5th and
6th .
On
February 5th, the Workgroup invited various
Program participants and stakeholders
to attend a “Roundtable Discussion”
during which the Workgroup solicited their
views on the past, present, and future
of the Program and ways to improve it.
Invited
guests included: Chief Special Master
Gary Golkiewicz of the U.S. Court of Federal
Claims; Jackie Noyes, former ACCV chair,
and Karen Hendricks of the American Academy
of Pediatrics; Sarah Depres from Congressman
Waxman’s Congressional Oversight
Committee on Government Reform; Tom Powers,
a plaintiffs’ attorney currently
representing petitioners in the Autism
Omnibus Proceeding; and Randy Moss, partner
of the law firm of Wilmer Hale who has
represented vaccine manufacturers. Each
guest provided valuable insight, and Ms.
Willner thanks each for their participation.
On
February 6th, the Workgroup deliberated
privately and subsequently developed the
following set of legislative recommendations
which are summarized in the Workgroup
Report distributed this morning. Ms. Willner
noted that each recommendation received
unanimous Workgroup support and was now
ripe for public discussion and ACCV action.
Ms. Willner then proceeded to address
each of the Workgroup’s twelve recommendations,
solicit a ACCV and public discussion,
and hold a vote.
Dr.
Wilber noted that these are general recommendations
and those receiving a favorable vote will
be sent to the Secretary of HHS, who may
then decide to ask his staff to develop
specific legislative language to be sent
to Congress. Dr. Wilber thanked the Workgroup
for its hard work.
Ms. Stavola stated at the outset that,
after consulting the attorney who filed
her claim, Mr. Stanley Kops, she is in
favor of Recommendations Nos. 1 through
5, 11, and 12; she’s uncertain about
#7; and she is not in favor of Nos. 8-10.
(IMPORTANT
NOTE: See attached 3/23/07 ACCV Letter
to Secretary Leavitt for specific language
of each Workgroup recommendation and outcome
of ACCV vote [ATTACHMENT
1].)
-
Allowing Payment of Interim Fees and
Costs to Petitioners’ Attorneys.
Ms.
Willner said that the Workgroup felt
that it is important to recommend amending
the Act to provide for the payment of
interim fees and costs to petitioners’
attorneys because it significantly affects
the quality of representation petitioners
receive. She noted that when the National
Childhood Vaccine Injury Act of 1986
(Act) was passed, Congress contemplated
that all claims would be resolved within
8 months and, win or lose, petitioners’
attorney fees and costs would be promptly
paid. Today, however, most claims take
years to process and require the use
of expensive expert witnesses. During
these years, petitioners’ attorneys’
go without pay. This unduly burdens
both petitioners and their counsel.
The Workgroup, therefore, feels it would
be much more fair to petitioners and
their counsel to amend the Act to provide
for the payment of interim fees and
costs to petitioners’ attorneys
after the entitlement decision is made.
The
ACCV voted unanimously in favor of this
recommendation.
-
Procedure for Paying Fees and Costs
Solely to Petitioner’s Attorney.
Ms. Willner stated that when the Program
pays fees and costs to petitioners’
attorneys, the check now must be made
payable to both the petitioner and his
attorney. While normally this is not
a problem, there have been some extraordinary
circumstances, such as when the petitioner
cannot be located, that this requirement
has unfairly prevented the attorney
from being paid. Therefore, to avoid
this result, the Workgroup recommends
amending the Act to provide that in
certain extraordinary circumstances,
the special master or court may order
that the award check for fees and costs
be made payable solely to the petitioner’s
attorney.
The
ACCV voted unanimously in favor of this
recommendation.
-
Increased Benefits Caps for Death and
Pain and Suffering.
Ms. Willner said that the Workgroup
recommends increasing the $250,000 benefit
cap for death and the $250,000 benefit
cap for pain and suffering to account
for inflation. Both benefit caps would
be retroactively increased since 1988
to account for inflation and would increase
annually to account for inflation using
the Consumer Price Index-All Urban Wage
Earners (CPI-U) as envisioned by Congress
in the original Act in 1986.
The
ACCV voted unanimously in favor of this
recommendation.
-
Allowing Compensation for Family Counseling
Expenses and Expense of Establishing
and Maintaining Guardianships, Conservatorships,
or Trusts.
Ms. Willner stated that the Workgroup
wanted to make sure that counseling
was made available to the families of
those who had suffered a vaccine injury
or death. Thus, it recommends amending
the Act to provide compensation for
reasonable and necessary, non-reimbursable
expenses that have been or will be incurred
for family counseling relating to a
vaccine injury or death.
Similarly,
the Workgroup believes that the Program,
and not petitioners, should incur the
significant expenses associated with
setting up legal and financial vehicles
necessary for the care of a petitioner
who has prevailed in a Program case.
Accordingly, it recommends amending
the Act to provide compensation for
reasonable and necessary, non-reimbursable
expenses that have been or will be incurred
establishing and maintaining a guardianship,
conservatorship, or trust, approved
by the Court, for the benefit of a person
who has suffered a vaccine-related injury.
The
ACCV voted unanimously in favor of this
recommendation.
-
Appointment of Adult with Vaccine-Related
Injury to ACCV.
Because approximately 50% of petitions
are now filed by adults on their own
behalf, Ms. Willner stated that the
Workgroup recommends amending the Act
to permit the Secretary of HHS to appoint
an adult who has personally suffered
a vaccine injury to one of the two ACCV
posts currently reserved under the Act
for parents or legal guardians of a
child who has been injured by a vaccine.
Prior
to the vote, Mr. Glass suggested adding
language which would also allow the
Secretary to appoint the spouse of a
vaccine-injured adult to one of these
posts. Accordingly, the Workgroup amended
the recommendation as stated in its
Report to allow, but not require, the
Secretary to appoint an adult who has
personally suffered a vaccine-related
injury, or the guardian or family member
of such an adult, to one of the two
posts reserved for the legal representative
of a child who has suffered a vaccine-related
injury or death.
The
ACCV voted unanimously in favor of this
amended recommendation.
-
Clarification: A Petitioner Who Establishes
a Vaccine-Related Injury and Death is
Entitled to Both Death and Injury Benefits.
Ms. Willner stated that the Workgroup
wishes to clarify that a petitioner
who establishes a vaccine-related injury
and death is entitled to both death
and injury benefits under the Act as
written. Ms. Willner mentioned that
this issue is currently being litigated
by DOJ. The Workgroup, however, believes
it is unwarranted and unfair to interpret
the Act in such a way as to provide
the same $250,000 death benefit to someone
who dies instantly after receiving a
vaccine as someone who dies years after
suffering a vaccine-related injury and
illness.
Prior
to the vote, there was a discussion
in which Ms. Stavola voiced her attorney’s
concerns, which were allayed by Mr.
Glass and Ms. Willner.
The
ACCV voted unanimously in favor of this
recommendation.
-
Parent Petitions for Compensation.
Ms. Willner stated that the Workgroup
believes that Program should be made
available to parents and other third
parties with vaccine-related damage
claims. The Workgroup, therefore, recommends
amending the Act to require a parent
or other third party to file a petition
in the Program before filing or maintaining
a civil action against the vaccine manufacturer
or administrator in state or federal
court for damages, including claims
for loss of consortium, society companionship
or services, loss of earnings, medical
and other expenses and emotional distress.
This recommendation was premised upon
on the Workgroup’s belief that
third party claimants would have a better
chance of receiving compensation in
the Program than in the tort system.
Prior
to the vote, Ms. Stavola stated her
opposition to the portion of the recommendation
which requires a parent or other third
party to file a petition with the Program
before filing a civil suit.
The
ACCV voted 8 to 1 in favor of this recommendation.
-
Clarification of Definition of Manufacturer.
Ms.
Willner reported that the Workgroup
recommends clarifying the definition
of manufacturer by enlarging the current
definition to include any corporation,
organization, or institution whether
public or private that manufactures,
imports, processes or distributes any
component or ingredient of any vaccine
on the Vaccine Injury Table (Table).
She added that this clarification would
provide liability protection under the
Program to manufacturers of thimerosal
or any other ingredient in a licensed
vaccine listed on the Table.
Prior
to the vote, a discussion ensued during
which Ms. Willner and Ms. Cooper explained
that this, along with the following
two recommendations, were the Workgroup’s
adaptation of certain provisions in
the Frist Bill. They are interrelated
and purport to accomplish the same thing,
that is, to eliminate collateral litigation
surrounding the issue of whether the
Program should capture claims alleging
that a single ingredient or component
of a vaccine caused an injury or death.
In other words, it opens the Program
to this type of claim.
Ms.
Cooper noted that if this kind of recommendation
is not made, manufacturers may not be
able to procure the components needed
to make vaccines. Ms. Willner noted
that, as a practical matter, this recommendation
simply codifies what is in practice
today, as evidenced by the Autism Omnibus
Proceeding, where the Program has been
made available to claims that Thimerosal
causes autism.
Mr.
Glass stated that he would vote “no”
out of deference to certain parents
group who opposed the Frist Bill.
The
ACCV voted 7 to 2 in favor of this recommendation.
-
Clarification of Definition of Vaccine-Related
Injury or Death.
The
Workgroup recommends that the definition
of vaccine-related injury or death be
clarified so that a component or ingredient
approved for use in a Table vaccine
by the FDA is not to be considered an
adulterant or contaminant for purposes
of the Act.
Prior
to the vote, a discussion ensued. Ms.
Willner and Mr. Sconyers reiterated
that the idea behind this recommendation
is to make the Program more accessible
to those with component-injury claims.
In other words, as long as a vaccine
listed on the Table has been made according
to its FDA product license, then any
claim that an ingredient or component
caused an injury or death is covered
by the Program, as it cannot be considered
an adulterant or contaminant. On the
other hand, the Program would not cover
an ingredient or component that the
FDA has not approved in the product
license.
Ms.
Cooper further explained that when the
FDA approves a vaccine, it looks at
different things, including all of the
ingredients that go into the vaccine.
So if there is an ingredient or component
that has been approved by the FDA, by
definition that can't be considered
an adulterant or a contaminant. Therefore,
if the injury is alleged to have been
a result of that component, then it
doesn't fall outside the scope of a
vaccine-related injury.
Dr.
Gruber stated that the proposed wording
in italics includes any component or
ingredient listed in a vaccine’s
product license application or product
label. Product license application is
a regulatory term. The terms, “active
ingredient, inactive ingredient, component,
byproduct, and residual,” have
certain definitions. The ACCV needs
to be sure that it is using the appropriate
terms.
Mr.
Sconyers stated that the Workgroup intended
to present an idea, not develop the
definitive legislative language. The
idea is that a component that is part
of the approved formulation can’t
be an adulterant. Dr. Evans stated that,
if the Secretary wants to develop this
suggestion into a legislative proposal,
the Department would certainly ask the
FDA for its views and any necessary
language would be incorporated.
Again
Ms. Willner noted that ever since the
Leroy decision, the vaccine court has
held that allegations of injury from
vaccine components or ingredients must
go through the Program. So, as a practical
matter, this recommendation simply codifies
an existing practice.
Mr. Glass stated that he does not want
to vote “no” to this recommendation,
but he doesn’t fully understand
it and couldn’t explain it to
somebody. He then offered a motion to
table this recommendation until the
next meeting. His motion was not seconded.
The
ACCV voted 7 to 2 (1 no; 1 abstention)
in favor of this recommendation.
-
Add Definition of Vaccine.
The
Workgroup recommends adding a definition
of vaccine to the Act. The Act does
not now define “vaccine,”
and the Workgroup felt that adding one
consistent with its other definitional
clarifications for “manufacturer”
and “vaccine-related injury or
death” has merit. Here again,
we wanted to define vaccine in such
a way that ingredients or components
are not adulterants or contaminants
for purposes of the Act.
Prior
to the vote, Mr. Glass stated that he
thinks that defining vaccine is out
the ACCV’s purview, and that the
ACCV should just recommend to the Secretary
there is a need for a definition of
“vaccine.” Mr. Sconyers
asked Mr. Glass if he would like to
offer a motion that the ACCV advise
the Secretary to adopt a definition
of vaccine that is consistent with the
other provisions of the Act. Mr. Glass
agreed with this suggestion. Ms. Willner
stated the ACCV would ask the Secretary
to add a definition of vaccine to the
Act that includes all components and
ingredients listed in the vaccine product
license application and product label.
Mr. Glass offered a motion to substitute
Ms. Willner’s suggestion for the
definition above.
The
ACCV voted 8 to1 in favor of this amended
recommendation.
-
Extending the Statute of Limitations
(SOL) for an Injury.
As
the Workgroup’s primary goal was
to expand access to the Program, Ms.
Willner emphasized that extending the
statute of limitations (SOL) was the
most important issue it faced. The Workgroup
carefully studied this issue and agreed
to recommend that the current 3-year
SOL be extended to 8 years to correspond
to the 8 years of retroactive coverage
currently provided under the Act when
a new injury or vaccine is added to
the Table.
For
vaccine-related injuries, the SOL would
be extended from three to eight years,
but the Program would be the exclusive
remedy for anyone who files a claim
during the extended 5-year period. In
other words, anyone who files a petition
during the extended period cannot “opt
out” to file a civil action. However,
the opt-out remains available to anyone
who files within the current 3-year
SOL. The Workgroup recognized that those
who failed to timely file under the
current SOL, cannot opt out anyway –
so they give up nothing for the benefit
of having 5 additional years to file
a claim.
Prior
to the vote, Mr. Glass asked for some
explanation of this provision. Mr. Sconyers
replied that the Workgroup has proposed
that the SOL be extended from its current
three years to eight years, which matches
the look-back period when either vaccines
or injuries are added to the Table,
but that for the additional 5-year period,
the remedies under the VICP be exclusive
(i.e., no opt-out for this period).
Mr.
Glass noted that this provision would
benefit parents because it opens the
Program up to those parents with claims
that do not meet the current SOL. He
stated that he didn't like that the
Program would be the exclusive remedy
for the 5-year period. Mr. Sconyers
stated that this recommendation reflects
a range of views on the Workgroup, and
is a compromise. It probably isn't exactly
what any one member of the Workgroup
would have designed from the start.
Ms.
Buck stated that she had the same concerns
as Mr. Glass about the opt-out, but
that she wanted to reiterate what Mr.
Sconyers just said. It is a reflection
of a compromise. Ms. Stavola asked Tawny
to explain what she meant by stating
that it was a compromise. Ms. Buck replied
that she would like to see the SOL extended
without the Program being the exclusive
remedy. Some of us thought that the
SOL should be extended to the age of
majority, while others didn’t
think that it should be extended at
all. So, the Workgroup wanted to come
up with a compromise that is better
than what we have now.
Ms.
Willner agreed, telling Mr. Glass and
Ms. Stavola that “It is better
than nothing. If our goal is to improve
access, it does that, period.”
The
ACCV voted unanimously in favor of this
recommendation.
-
Extending the SOL for a Death.
For vaccine-related deaths, the Workgroup
recommends extending the SOL from 2
to 8 years following the death, with
the Program being the exclusive remedy
during the extended 6-year period. In
other words, those who file during the
extended period cannot opt out of the
Program to file suit in civil court.
Also, the SOL would be extended from
4 to 8 years after the first symptom
of the vaccine injury from which the
death occurred, with the VICP being
the exclusive remedy for years 4 through
8. Again, these proposed extensions
would benefit those now barred from
filing claims with the Program, or in
civil court, because they have missed
the Program’s SOL.
Prior
to the vote, Ms. Buck stated that she
would like to see a more generous SOL,
but this provision provides better access
than what parents have now. It gives
more people access to the VICP, so it
is a good compromise.
The
ACCV voted unanimously in favor of this
recommendation.
Discussion of VICP Outreach Activities:
Tamara Overby, MBA, Chief, Policy Analysis
Branch, DVIC
Ms.
Overby stated that she is making this
presentation because the ACCV Workgroup
has requested information about the outreach
efforts of the National Vaccine Injury
Compensation Program (VICP). She discussed
the VICP outreach activities in 2006 and
plans for 2007.
In
2004, DVIC began the process of developing
outreach materials. Before that time,
there were not any brochures or booklets
that described or gave information about
the VICP in a succinct and easy to understand
way. From 2004 to 2006, DVIC worked on
developing documents which were easier
for the public to understand than previously
used materials. In 2004, DVIC awarded
a contract to the Media Network, a communications
company, to test the draft VICP materials
with various populations. They tested
the materials with parents, attorneys
and health care providers, both English-
and Spanish-speaking, to determine if
the materials conveyed the intended messages.
As
a result of this 2-year project, in February
2006, DVIC published the VICP brochure
and booklet in English and Spanish. The
brochure is intended to provide an overview
of the VICP, whereas the booklet is intended
to provide in-depth information in a question
and answer format about the VICP. There
have been 800 booklets in English, 900
brochures in English, 65 booklets in Spanish,
and about 38 brochures in Spanish have
been distributed by the HRSA Information
Center.
In
2006, the VICP website was extensively
revised to make the language easier for
the public to understand. Before the revisions,
the text of the website consisted of language
from the legislation which created the
VICP. This legislative language is hard
for the average person to understand.
The website was also reformatted to make
it more user-friendly. Individuals can
send DVIC questions by clicking on the
“Ask HRSA” box, and responses
are sent to them via the website. The
website address changed to www.hrsa.gov/vaccinecompensation.
In
terms of other outreach activities, DOJ
has taken on sole responsibility for these
efforts exhibiting at medical and legal
conferences. In 2005, HRSA changed its
policy on programs attending outside professional
gatherings. Last year, DOJ exhibited at
the National Academy of Physicians Assistants
Conference, the Texas Bar Association
Conference, and the American Academy of
Pediatrics Conference.
Another
effort includes the use of Vaccine Information
Statements, which contain contact information
about the VICP, and are distributed by
the Centers for Disease Control and Prevention
(CDC). This is one of the primary ways
that parents and individuals receive information
about the VICP.
Regarding
future outreach strategies, DVIC and DOJ
will continue the 2006 efforts. DVIC plans
to develop press releases any time a new
vaccine or injury is added to the VICP.
The meningococcal vaccine was added to
the VICP effective February 1. Once the
Federal Register notice is published announcing
that this vaccine has been added to the
VICP, HRSA will issue a press release.
A press release will also be released
announcing that the 2-year filing deadline
of July 1, 2007, is approaching for flu
claims alleging injuries up to 8 years
prior to the July 1, 2005, effective date
of VICP coverage.
On another front, DVIC plans to proactively
seek speaking engagements at annual conferences
of legal and medical organizations. In
the past, staff have spoken at the National
Immunization Conference, the American
Bar Association, and the National Bar
Association. DVIC will continue efforts
to publish information about the VICP
in the AARP newsletter.
DVIC
will pursue cost effective and efficient
ways of distributing the VICP brochure
and booklets. DOJ plans to continue to
exhibit at professional meetings. In 2007,
DOJ will exhibit at the Western Institute
of Nursing, the American Academy of Nurse
Practitioners, the American Bar Association,
the California Bar Association and the
American Academy of Nursing conferences.
DVIC may also exhibit this year because
HRSA appears to be revising its attendance
at outside meetings policy. DVIC is open
to any suggestions that ACCV members have
and is always looking for creative and
cost efficient ways to do outreach.
Dr.
Deville asked if DVIC has ever exhibited
at the American Academy of Pediatrics
(AAP) and the Society of Pediatric Research
(SPR) meetings. Dr. Evans replied that
the AAP has probably been one of the most
frequent meeting locations over the years,
particularly in the 1990’s. Dr.
Deville asked if DVIC could explore getting
in to a long term relationship with the
AAP, so that the VICP has a presence at
those meetings. If HRSA does change its
policies in the future and funding is
available, DVIC would certainly pursue
participating in the AAP annual conference,
rather than the more specialized pediatric
research meetings.
Dr.
Deville asked whether DVIC and DOJ participate
only as an exhibitor or also presents
updates about the VICP in presentations
when exhibiting at meetings. Exhibits
are often overlooked. Dr. Evans replied
most of the time DVIC and DOJ are exhibitors.
This is also an opportunity for the pediatric
staff to receive continuing medical education
credit and network. In the early '90s,
Dr. Evans stated that he was an invited
speaker at the “Meet the Red Book”
session, which was a wonderful way to
get information about the VICP to the
pediatric community. This meeting usually
has thousands of attendees and is a good
forum for information exchange. In terms
of speaking engagements, there has been
interest and efforts on our part to be
invited to speak about the VICP. The American
Academy of Family Physicians has been
a difficult entry for the VICP, but will
keep trying. It is tough to get in the
plenary sessions, but it is easier to
be invited to speak at workshop sessions.
Of course, the audience attendance is
much more limited. Dr. Evans stated that
a list of organizations where DVIC has
spoken can be provided to the ACCV.
Dr.
Deville asked if DVIC could explore ways
of getting into partnerships, perhaps
with AAP, to mail the VICP brochures to
pediatricians' offices, since a low number
of them have been distributed, especially
the Spanish version. Dr. Evans replied
that DVIC will check with several organizations
to determine their policies for distributing
materials to their members between now
and the next meeting.
Mr.
Sconyers asked DVIC to describe the change
in HRSA’s exhibiting policy. Ms.
Overby stated before 2005, bureaus within
HRSA had their own exhibiting budgets
and determined which conferences they
would attend. Sometimes, the bureaus within
HRSA were exhibiting at the same meeting.
Therefore, HRSA’s leadership decided
to centralize exhibiting activities, including
the budgets, for better use of resources.
Instead of two bureaus going separately
to these conferences, HRSA would exhibit
as one entity. The leadership would determine
which meetings the bureaus were allowed
to go to. Therefore, the number of meetings
for exhibiting was reduced from about
100 to ten, and the ten were not meetings
attended by VICP’s target audiences.
Mr.
Sconyers stated that the VICP should find
ways to attend more meetings, both legal
and pediatric, because knowledge of the
program is limited. It would be better
for people who have been injured and potentially
able to file a claim to know more about
the VICP. Ms. Overby agreed and acknowledged
that DVIC needs to be conducting more
outreach activities on a regular basis.
However, if HRSA’s policy doesn't
change, DVIC still has to find ways to
get the word out. DVIC is definitely trying
to think of creative and cost efficient
ways to promote the availability of the
VICP.
Mr.
Sconyers asked about the audience for
the VICP booklets and brochures. Ms. Overby
replied that the booklets and brochures
were designed for parents, health care
providers who administer vaccines, and
attorneys. Mr. Sconyers questioned DVIC’s
expectations about distributing these
materials to patients, anyone receiving
the vaccine, or any pediatrician who is
treating a patient with signs of vaccine-related
injury. Dr. Evans responded the Vaccine
Information Statements (VIS’s) are
a superb mechanism for publicizing the
availability of the VICP, at least in
theory. By law, they should be given every
time a covered vaccine is administered.
Then, if more information about the VICP
is needed, the patient could contact the
VICP using the information on the VIS
and the brochure or booklet would be sent
to them at that time.
Mr. Sconyers asked how did people come
to receive the brochure or booklet. Ms.
Overby replied that people who have received
the brochure or booklet have found out
about the VICP and the HRSA Information
Center sent the materials to them. DVIC
is not sure of their source of information.
Ms. Buck stated that it would be interesting
to know how they heard about the VICP.
Presentations should be made to parent
groups, at schools, to school nurses,
and people who are dealing with kids and
their shots.
Ms. Cooper suggested that DVIC could request
national organizations to distribute the
materials to their networks. One organization
would be the American Public Health Association.
She stated that the members are concerned
that there is not enough awareness about
the VICP and that there may be certain
populations that are being underserved
at this point. Having these materials
available at clinics or wherever parents
are showing up could be very helpful.
Mass mailings don't work, but working
with national organizations may be a more
cost effective way to do it. Dr. Iskander
suggested that another more targeted group
would be the Association of Immunization
Managers. Each state has an adverse event
reporting coordinator.
Dr.
Evans said that these are wonderful ideas,
and DVIC will contact these organizations.
It is a immense challenge to get children
and adults immunized. Sometimes people
promoting immunization are not oriented
to thinking about vaccine safety and liability.
They are trying to convince people of
the importance of vaccines, and it presents
a dilemma for them, in terms of how one
conveys both of these kinds of messages.
Dr. Deville said that he agrees and DVIC
must reach the healthcare providers. He
stated that for example, in the last two
months, he has seen two patients after
they received the MMR (measles-mumps-rubella)
vaccine. One patient developed encephalitis
which was probably associated with the
mumps component of the vaccine, and the
other one had arthritis probably from
the rubella component of the vaccine.
In both cases, he spoke with the pediatricians
who referred these patients, and these
doctors had no idea about the VICP. They
were completely unaware of it. Ms. Stavola
suggested placing the brochure on the
AAP website under professional education
and resources. Dr. Wilber responded that
he has significant experience with AAP
and that they would be very willing to
participate in making it available nationally.
Ms.
Overby stated that a few years ago, DVIC
staff looked into how healthcare providers
could earn continuing education credits
learning about the VICP. It was much more
involved than first thought. Dr. Iskander
stated that Vaccine Adverse Event Reporting
System (VAERS) has struggled with these
same issues. VAERS has published several
continuing education articles and has
reached health professionals in this manner.
The process has become more difficult
over the years, but it is not an impossible.
He suggested that this information could
be made available through the CDC information
line, so that they can either refer calls
to the VICP or be able to provide information
about the VICP. He asked Ms. Overby if
there was any attempt to develop a message
or core messages or develop a scientifically
or evidence-based framework for doing
outreach. VAERS has taken very similar
approaches to what DVIC has done. Ms.
Overby rephrased his question for clarification
and stated that DVIC would like to develop
an overall communication strategy, but
does not have expertise in-house, and
would like to award a contract to do this
initiative. However, currently DVIC does
not have the money to do so.
Dr. Evans stated that it was his understanding
that reporters of serious events to VAERS
are advised of the availability of the
VICP in the initial follow-up at two months,
as well as the 12-month letter. This is
another way that the public is made aware
of the VICP.
Dr. Iskander stated that there is always
the issue of wanting to keep VAERS and
the VICP as separate systems to avoid
misunderstandings and to try to limit
the frustration of people who think they
are accessing both systems by accessing
one. However, the two programs still could
use some of the same types of outreach
forums. There probably are messages that
can be developed that would appeal to
different audiences, specifically tag
lines that could raise awareness of the
VICP. He stated that he experienced a
lot of these challenges at VAERS over
the years.
VAERS was able to commission a nationally
representative survey of providers to
obtain quantitative information of overall
levels of knowledge and the risk factors
for knowing about the system (i.e., which
providers are more likely to know about
it). According to the survey, pediatric
providers had much better knowledge of
VAERS than adult providers. This type
of survey,which takes some resources to
complete, can be used to help determine
how to best direct resources, such as
which conferences to attend.
He stated that he was not citing VAERS
as a model or success story, but is sharing
experiences that will hopefully benefit
both programs.
Ms.
Tempfer stated that so many health care
providers rely heavily on the Internet
for information. Medscape, a part of WebMD,
offers continuing education unit credit
programs all the time. They are always
looking for new programs to put on their
site. Dr. Deville suggested sending a
letter to the pediatric organizations
asking them to add a vaccine safety session
to their meetings.
Dr.
Wilber asked for public comments and there
were not any comments.
After
the discussion, Dr. Wilber stated to Mr.
Paul Glass that we had notification of
your father's passing, and as a representative
of this committee, just let me convey
the thoughts and prayers from all the
committee members as well as the staff.
Mr. Glass thanked Dr. Wilber and stated
that several people called with prayers
and thoughts, and he appreciated everybody's
concern.
Report from the Division of Vaccine
Injury Compensation: Dr. Geoffrey Evans,
M.D., Director, DVIC
Dr.
Evans welcomed everyone to the 65th quarterly
meeting of the Advisory Commission on
Childhood Vaccines (ACCV). He pointed
out the new covers for the ACCV Meeting
Book and that it is symbolic of the work
of Cheryl Lee and Tamara Overby. He stated
that there are several standout pictures
on the cover, such as the little girl
and boy that are in the second to the
right vertical column, Jenna and Joshua,
who are Jean Suthard's children, and Elijah
Overby, Tamara’s son, who is in
the second column from the left towards
the bottom. For phone messages, the conference
control center phone number is 301-443-2585,
and the conference center's fax is 301-443-2559.
If you need any materials photocopied,
please see Cheryl in the back.
Dr.
Evans stated that following his presentation
on the DVIC, the agenda items for today’s
meeting include: an update from the Department
of Justice by Mark Rogers, and a presentation
on the Vaccine Adverse Event Reporting
System, including the requirements for
the reporting of adverse events by Dr.
Ann McMahon. In addition, our ex officio
members will be providing updates -- Dr.
Kenneth Bart from the National Vaccine
Program Office, Dr. John Iskander from
the Immunization Safety Office at the
CDC, Dr. Barbara Mulach from the National
Institute of Allergy and Infectious Diseases,
NIH, and Dr. Marion Gruber from the Center
for Biologics Evaluation and Research,
FDA.
In
your blue folders, there are several documents.
On the right side is the obituary notice
for Mr. William Paul Glass. Dr. Evans
shared his condolences for the recent
passing of Mr. Glass’s father. On
the left side are four articles. The first
reconfirms the original CDC recommendation
after reviewing the safety data on rotavirus
vaccine, which was introduced in February
2006. There are articles on safety issues
also under Tab G in the meeting book.
The second article is entitled, “Merck
to Stop Pushing to Require Shots”,
and the third and fourth articles are
to be read in conjunction with Dr. McMahon's
presentation on the VAERS later this morning.
He
presented the statistics for the VICP
under Tab D in the meeting book. Under
claims filed, the significant trends are
that autism claims have dropped and continue
to do so. In terms of non-autism claims,
the VICP has been receiving an average
of about 140 to 160 over the past several
years. So far this Fiscal Year, 58 claims
have been filed and if it keeps on this
pace, about 180 claims will be filed by
the end year’s end. This potential
increase is not surprising because influenza
vaccines were added to the VICP effective
July 1, 2005, and claims for this vaccine
are now starting to be filed. This vaccine
is given to many more people than other
routine childhood vaccines.
By
adding influenza vaccine, the VICP covers
a third more of the vaccines that are
distributed in the U.S. Now, the VICP
covers 95 to 96 percent of vaccines distributed.
In terms of awards, the average is $58
million for petitioners' awards and $4
million for attorneys’ fees and
costs per year. The balance of the Vaccine
Injury Compensation Trust Fund (Trust
Fund) is between $2.4 and $2.5 billion.
It is increasing at the rate of over $200
million per year and will continue to
increase, especially since the flu vaccine
has been added to the VICP and the amount
of doses of this vaccine distributed and
administered continues to increase. He
expects that if 110 to 120 million doses
of flu vaccine are given per year, which
is the target, then Trust Fund revenue
and interest will probably approach $300
million against average outlays of $58
or $60 million per year.
He
stated that on December 20, 2006, the
President signed into law the “Tax
Relief and Health Care Act of 2006,”
which added meningococcal and human papillomavirus
(HPV) vaccines to the VICP, by imposing
a 75 cent excise tax on each dose that
is administered. The effective date of
that excise tax is February 1, 2007. As
a reminder, in order for a vaccine to
be covered by the VICP, an excise tax
must be imposed and the CDC must recommend
the vaccine for routine administration
to children evidenced by publication in
the Morbidity and Mortality Weekly Reports
(MMWR).
In
the case of meningococcal vaccines, and
there are two types of vaccines: the polysaccharide
vaccine and the more recently licensed
conjugate vaccine for young children.
The routine use recommendation was published
in the Morbidity and Mortality Weekly
Report in May 2005. With the imposition
of the excise tax, meningococcal vaccines
are officially covered as of the effective
date of February 1.
In
terms of the HPV vaccine, Dr. Iskander
stated that the routine use recommendation
for HPV would be published on March 12.
Once that is done, both prerequisites
will have been met. The Secretary will
publish a notice of coverage in the Federal
Register notifying the public of this
new addition to the Vaccine Injury Table
(Table). Once the notice is published,
it is listed in the last box of the Table.
All newly-added vaccines are included
in this last box until a final rule is
published. Only after publishing a notice
of proposed rulemaking, a 180-day public
comment period, and publishing a final
rule, will the new vaccine have a separate
and distinct listing on the table, including
the listing of any injuries or conditions
found to be associated with the vaccine.
Once a vaccine or injury is added to the
Table, there is eight years of retroactive
coverage based on the effective date of
coverage. Individuals have two years to
file these claims, in addition to the
regular statute of limitations.
For
HPV, claims going back eight years would
be for injuries sustained during clinical
trials. Individuals participating in clinical
trials for covered vaccines are able to
file claims with the VICP, assuming they
have not received compensation for their
injuries previously. However, the VICP
has never had a claim for injuries sustained
during clinical trials. Now, the VICP
covers 16 vaccines.
In
other legislative news, on February 17,
Representatives Dave Weldon and Carolyn
Maloney reintroduced a bill entitled the
“Mercury Free Vaccines Act of 2007.”
The bill requires that influenza shots
given to children under age three and
pregnant women contain no more than one
microgram of mercury, beginning with the
2007-2008 influenza season. In addition,
this bill requires that all other routinely
administered childhood vaccines contain
no more than one microgram of mercury
by July 1. A copy of this bill is in Tab
E3, and the “Tax Relief and Health
Care Act of 2006” is in Tab E2.
In
terms of meetings, in October 25, Dr.
Indira Jevaji, a DVIC pediatric medical
officer, attended the Advisory Committee
Immunization Practices (ACIP) meeting
in Atlanta. Of note, the ACIP recommended
the use of Zostavax, a vaccine recently
licensed by FDA for prevention of herpes
zoster in older adults. This vaccine is
recommended for individuals that are 60
or older. Because it is not recommended
for routine use in children, this vaccine
will not be covered by the VICP. In addition,
Dr. Jevaji attended the ACIP meeting a
few weeks ago. During that session, in
addition to updates on vaccines and thimerosal,
there were updates on VAERS reports of
intussusception following use of the new
rotavirus vaccine, and of GBS after meningococcal
conjugate vaccine. Information about two
of these topics are under Tab G in the
meeting book.
In
addition, ACIP appears to be getting closer
to expanding the immunization recommendation
for influenza vaccine beyond five years
of age, up to 18. The ACIP did not vote
to do so, but keeps discussing it. There
are some members of the ACIP who would
like to have universal use of influenza
vaccine and that would certainly increase
excise tax revenues considerably. Since
more companies are producing the vaccine
now, and this is something that will probably
happen.
Dr. Wilber asked if adults who receive
the flu vaccine are covered by the VICP,
even though one of the two prerequisites
for adding a vaccine to the VICP is that
it be recommended for routine administration
to children. Dr. Evans replied that anyone
of any age who received a VICP covered
vaccine can file a claim.
Finally, in terms of points of contact,
individuals can write the National Vaccine
Injury Compensation Program at 5600 Fishers
Lane, Parklawn Building, Room 11C-26,
Rockville, Maryland 20857. The HRSA Information
Center number is 1-800-338-2382. The VICP
website address is www.hrsa.gov/vaccinecompensation.
HRSA has done an excellent job of making
the website much more user friendly, and
there is a great deal of current information
about the VICP on it. As the VICP changes,
new information is added.
Lastly,
in terms of public comment, anyone who
would like to formally participate in
ACCV meetings should contact Ms. Cheryl
Lee. Notices are published in the Federal
Register notifying the public of the meetings.
Mr.
Sconyers stated that the ACCV received
a letter from the Secretary thanking us
for the recommendation that there be a
periodic scientific review of the Vaccine
Injury Table, and that a scientific panel
be established for that purpose. He inquired
about the status and whether there been
such a panel established. Dr. Evans replied
that a panel has not been established.
Traditionally, the Institute of Medicine
has been the body that has performed these
studies, and would probably be one of
the first choices for the Department to
do further studies. To re-study the Table
and all the vaccines that have been added
since the Table was last studied, probably
would cost about $2.5 to $3 million. DVIC
does not have this amount of money in
the budget. At this point in time, this
is probably the most significant unmet
need of the VICP.
Mr.
Sconyers stated that updating the Table
on a regular basis and on the basis of
good science is crucial. The ACCV would
like to support the program’s efforts
to request funding.
Another
item from the prior minutes was that DVIC
would provide the ACCV with a report of
the compensable and non-compensable cases
and time frames for adjudication of claims.
Ms. Lee replied that she sent Mr. Sconyers
these statistics to the Workgroup. Mr.
Sconyers responded that he would like
these statistics to be a part of the regular
statistics report. He stated that from
Fiscal Year 1999 and beyond, the rate
at which non-autism cases are filed and
the rate at which they are adjudicated
are different. Basically, the adjudication
rate is not keeping pace with the filing.
He would like to know how the VICP can
improve the rate at which cases are resolved.
He stated that he thinks claimants experience
long delays, and it isn't good for the
credibility of the VICP. Dr. Evans responded
that in 1999, DVIC received 300 hepatitis
B claims because the retrospective deadline
was approaching in the summer of that
year. The Court has not been able to adjudicate
these cases because of the lack of information
about conditions allegedly related to
hepatitis B vaccine. The Court has grouped
these claims by the injuries alleged and
is now just starting the adjudication
process. DVIC understands the point of
trying to increase the efficiency of the
process. Over the years, DVIC has reported
that, on average, it takes two to three
years to adjudicate a claim. These hepatitis
B claims will extend this average. The
claims that can proceed are adjudicated
in a fairly efficient manner. Mr. Sconyers
said that at the June meeting that he
would like to discuss which claims are
delayed and why.
Report from the Department of
Justice: Mark Rogers, Deputy Director,
Torts Branch, Civil Division, Department
of Justice
Staffing
and Hiring
Deputy
Director Mark Rogers returned from active
duty in the Marine Corps, and gave the
presentation for the Office of Vaccine
Litigation, Department of Justice (DOJ).
Since October, 2006, DOJ has hired two
new attorneys, Vo Johnson, in attendance,
and Robin Broderick. They are replacing
two attorneys who have left DOJ. DOJ is
hiring one more attorney.
Litigation
Mr.
Rogers anticipates an increase in DOJ’s
workload based on two factors: 1) autism
litigation will begin in earnest in June,
and, 2) an expected increase in influenza
claims because the statute of repose will
expire in July, 2007 (as of July 1, 2005,
trivalent influenza vaccines were added
to the Table), which is two years after
the flu vaccine was added to the Vaccine
Injury Table.
All
cases
The
data is consistent with a steady state
of approximately 200 petitions being filed
annually; that number excludes autism
petitions. Since the last meeting, and
for this first part of the fiscal year,
69 cases were resolved. Of those, 32 cases
were compensated. Of those, 25 cases were
settled. Mr. Rogers explained that settlement
means that the parties agreed upon a resolution,
alternative to litigation. Crediting the
Office of Special Masters, as well as
counsel for petitioners and respondent,
Mr. Rogers highlighted the benefits of
settlement as an alternative to litigation.
There were seven entitlement decisions
for the petitioner; three of those were
death cases where the respondent conceded
the case. Thirty seven cases were dismissed;
seven of those were for procedural reasons,
including jurisdiction. The statute of
limitations is a leading basis for those
dismissals, as are cases alleging a vaccine
that is not listed on the Table. Four
cases were withdrawn; one was non-autism
while the other three alleged autism.
There were 26 decisions where the Special
Master found that causation had not been
established. Of those, only eight involved
a hearing. Mr. Rogers explained that,
in many cases, petitioners do not request
a hearing. In other words, petitioners
request that the case be decided on the
record without a hearing.
Mr.
Rogers offered historical data spanning
the last five years to show that the computed
average adjudication time of a case is
1,026 days, which translates to approximately
2.8 years for an average case to be resolved
in the Program. The median adjudication
time, which removes outlying cases, is
2.2 years, which signals that there are
more outliers at the long end of the cases.
Mr. Rogers opined that the outliers consist
of hepatitis B claims that are currently
being resolved. The hepatitis B claims
were initially filed as a group two years
after hepatitis B was added to the Table,
under the two year statute of repose.
The claims, which are now six-seven years
old, were essentially dormant until very
recently. Mr. Rogers noted a lack of capacity
in the Office of Special Masters and within
the Program to process such a voluminous
surge in filings. The claims are finally
being processed, which accounts for the
skewed statistics.
Mr.
Rogers also presented statistics reflecting
average case adjudication time for 2000
through 2005. For 2000, average adjudication
time was 2,437 days, which captured the
very end of the retrospective cases, cases
where the vaccine was administered from
the beginning of the Act through history.
Because of the large volume of claims
filed, those claims took nearly ten years
to process. For 2001, average adjudication
was 1,195 days; for 2002, average case
adjudication took 970 days; 2003, it was
1,005; for 2004, it was 1,006; and for
year 2005, it was 1,033. Mr. Rogers acknowledged
that the time period is climbing and emphasized
DOJ’s desire to process claims faster.
Citing to the hepatitis B claims currently
being processed, Mr. Rogers suggested
that the median may represent a more significant
statistic. According to DOJ’s computation,
the average award is $961,000 per case.
Autism
There
are approximately 4,750 claims pending
in the Autism Omnibus Proceeding; approximately
300 have been resolved by dismissal or
withdrawal. Two additional Special Masters
have been appointed to oversee the proceedings
along with Special Master Hastings: Special
Master Campbell-Smith and Special Master
Vowell. Mr. Rogers expressed his current
understanding of the proceedings. The
first trial is scheduled to begin in June.
The first trial will comprise the first
of the three component causation theories
proposed by petitioners. The Special Masters
have decided that all three special masters
will hear the evidence of the first causation
theory in the context of one “test”
case, Cedillo, with Special
Master Hastings issuing his decision on
that petition. The first theory, in essence,
is that thimerosal containing vaccines
in combination with the MMR vaccine causes
autism spectrum disorder.
Over
the next three months, Special Masters
Vowell and Campbell-Smith will each take
another representative single case, and
hear the evidence specific to that case.
Thus, there will be three trials on petitioners’
first theory of causation. The goal is
to have three decisions by the three Special
Masters, then proceed through the appeals
process, if appropriate. Mr. Rogers’
understanding of the strategy is to develop
case precedent, known as stare decisis,
which would provide the parties with some
knowledge into how the cases should proceed.
Mr. Rogers did not know whether or not
the Special Masters would issue their
decisions simultaneously; presently, Mr.
Rogers was aware that they intended to
review the evidence as to their respective
fact patterns, then render a decision.
As for future trials, Mr. Rogers understood
that the three Special Masters would convene
three similar hearings for each of the
petitioners’ next two theories of
entitlement. Petitioners’ Steering
Committee filed their expert opinions
in Cedillo on February
20, 2007, and the government’s were
due on April 24, 2007.
Hepatitis
B vaccine
Regarding
the hepatitis B litigation, Mr. Rogers
advised that there were approximately
400 cases, which, in large part, comprise
the 700 total cases that are in backlog.
He reiterated that these cases are currently
being decided. While he hopes that these
cases will be resolved by the end of the
calendar year, Mr. Rogers considered that
prediction somewhat optimistic. Mr. Rogers
explained that those cases were divided
into eight subgroups according to particular
injuries alleged. Some representative
groups include demyelinating disorders,
GBS, and CIDP, which have largely been
resolved. As a representative group, sixty-six
cases comprise the neurodevelopmental
cases. Of that group, seven have been
resolved. One was resolved in favor of
the petitioners, while five were dismissed,
and one settled. Thus, thirty-seven claims
remain active; the Special Master has
started to take evidence and convene status
conferences. Twenty-two claims are still
waiting for processing at this point.
Appeals
There
is one case before the Supreme Court on
a writ of certiorari. In the Program,
where a party loses before the Federal
Circuit Court of Appeals (Federal Circuit),
the party may petition the Supreme Court
for review. The petition for writ of certiorari
was filed by petitioners in the case of
Pafford v. HHS. There,
the Federal Circuit upheld a Special Master’s
determination that petitioners had not
proven causation. The key issue involved
evidence of another cause.
At
the Federal Circuit, two cases, both appealed
by petitioners, are pending: Walther
v. HHS and Marks v. HHS.
In Walther, the Special
Master held that petitioner’s medical
expert was not credible and the Court
of Federal Claims affirmed. Oral arguments
were held on November 8, 2007, and the
decision is pending. In the Marks
case, the Special Master held that petitioner’s
claim was not supported by medical records
or opinion. The Court of Federal Claims
affirmed. That appeal was filed last month.
Three
cases were decided by the Federal Circuit
since the last ACCV report: Aull
v. HHS, Wiley v. HHS,
and Markovich v. HHS.
Of these, all three were appeals filed
by petitioners. In Aull,
the Federal Circuit affirmed the Special
Masters’ dismissal of a vaccine
petition because petitioner had pending
a simultaneous state civil action against
the vaccine manufacturer or vaccine administrator
for a vaccine-related injury. Under the
Vaccine Act, a party cannot maintain those
simultaneous actions. In the Wiley case,
the Federal Circuit affirmed a Special
Master’s dismissal of a time-barred
case – a case filed too late under
the Vaccine Act. The Markovich
case also involved the interpretation
of the Vaccine Act’s three year
statute of limitations.
The
Federal Circuit issued a published decision
affirming the Special Master’s dismissal
of the petition. The key issue was when
the three-year (or 36 month) limitations
period starts to run under the Vaccine
Act. The Special Master held that the
limitations period begins with the first
sign or symptom of manifestation of onset
of a condition, regardless of whether
it is recognized as a sign or symptom
of an injury at that time. Petitioners
argued that the first sign or symptom
of manifestation of onset means something
that is manifest, i.e., something that
is understood to be a sign or symptom
of a vaccine injury. The Special Master
and Court of Federal Claims rejected petitioners’
argument, the Federal Circuit affirmed,
holding that the standard is objective,
not subjective.
At
the Court of Federal Claims level, Mr.
Rogers reported that there are five cases
pending. All five petitions for review
were filed by petitioners and dispute
a finding of no causation. In other words,
petitioners disagree with a Special Master’s
decision. Four cases were decided by the
Court of Federal Claims since the last
ACCV report. In emphasizing that these
appeals were filed by petitioners, Mr.
Rogers explained that respondent only
seeks appeal under criteria where it is
important in advancing Program goals.
In Sauer v. HHS, petitioners
voluntarily dismissed their case; thereafter,
they discovered additional evidence and
requested that the Special Master re-open
the case.
The
Special Master found that petitioners’
claims were untimely. On appeal, the Court
of Federal Claims reversed, and stated
that the petitioners claim should be re-opened.
In the remaining three cases, the Court
of Federal Claims ruled for the respondent.
In Avera v. HHS, the
Court declined to adopt a “forum
rule” (Washington, DC hourly rates)
argument or allow the payment of interim
attorneys’ fees, which the Court
found to be unavailable under the Vaccine
Act. In Way v. HHS, the
Court of Federal Claims upheld a Special
Master’s dismissal of a petition
for failure to prove causation. In Smith
v. HHS, the Court of Federal
Claims upheld a Special Master’s
dismissal of a petition as time-barred.
Civil
Litigation
Mr.
Rogers reported on a decision issued in
the Rivard v. AHIP case,
which was filed outside of the Program,
in the Superior Court of New Jersey. Mr.
Rogers summarized that petitioners filed
a claim in state court alleging that the
oral polio vaccine contained a monkey
virus, SV-40, and that the monkey virus
caused a brain tumor in their child. The
defendant argued that plaintiffs’
claim should have been filed in the Vaccine
Program. Plaintiffs maintained that their
claim belonged in state court because
the monkey virus was a contaminant that
should not have been in the vaccine and
could have been eliminated had the defendants
exercised due diligence in manufacturing
the vaccine. The trial court agreed with
the plaintiffs’ arguments. The appellate
court reversed on appeal and ruled consistent
with defendant manufacturers that the
case should have been filed in the Vaccine
Program first. In short, the appellate
court held that the monkey virus was a
normal component incidental to the manufacturing
process. It was not intentionally added
to adulterate or to contaminate the vaccine.
Mr. Rogers offered his view that the Rivard
ruling takes the thimerosal cases a step
further, and reflects a tendency by civil
courts to find that these cases are properly
before the Vaccine Program.
Overview of the Vaccine Adverse
Event Reporting System and the Requirements
for Reporting of Adverse Events: Dr. Ann
McMahon, M.D. M.S., Division of Epidemiology,
Center of Biologics Evaluation and Research,
Office of Biostatistics and Epidemiology,
Food and Drug Administration (FDA)
Dr.
Ann McMahon provided an overview of the
Vaccine Adverse Event Reporting System
(VAERS). Post-licensure safety surveillance
is necessary because pre-licensure trials
have limitations, such as the size and
duration of the clinical trials, and the
population in these trials which may be
limited by age, co-morbidity or severity
of various conditions. There are often
exclusions in the pre-licensure trials;
and therefore, certain subpopulations
are not included in the clinical trials.
VAERS
was established as one of the changes
made to the U.S. vaccine safety infrastructure
in the National Childhood Vaccine Injury
Act of 1986 (Act). It was established
in 1990. It is a passive surveillance
system operated collaboratively by the
CDC and FDA. Reports to VAERS are submitted
by health professionals, vaccine manufacturers
and the public.
What
are some of the strengths of VAERS? VAERS
detects rare adverse events. It has a
large surveillance area, the United States,
and in some instances, international surveillance.
The data are often available in a timely
fashion. This tool can be used for hypothesis
generation which is generally the way
that it is used at the FDA and CDC.
VAERS
also has its weaknesses. VAERS is often
missing data or has inaccurate data. There
is underreporting to VAERS. Accuracy rates
are not known. VAERS is better at detecting
events that occur in close time proximity
with vaccination, than events with long
latency periods. There is a lack of an
accurate denominator or number of people
that are vaccinated. There is also a lack
of a control group. All of these weaknesses
result in the near inability to assess
causality.
The serious adverse events reported to
VAERS, as defined by 21 CFR 600.80, are
death, life threatening events, initial
hospitalization or prolongation of hospitalization,
events with significant or persistent
disability/incapacity, congenital anomalies
or birth defects, and medical events that
may require intervention to prevent one
of those from occurring.
What are the reporting requirements to
VAERS? In 21 CFR 600.80, the requirements
for vaccine manufacturers are the following.
Licensed manufacturers with approved Biologics
License Applications (BLAs) are required
to report serious and unexpected adverse
events regardless of presumed causation
from U.S. and foreign sources. Unexpected
means if it is not included in the product's
label. Other adverse events are also required
to be reported if they occur in the U.S.
Adverse events from studies, where there
is a reasonable possibility that the adverse
event was caused by the product, are also
required to be reported. When must adverse
events be reported by the manufacturers
of biologic products? A 15-day alert reports
are required for both serious and unexpected
adverse events, and quarterly for three
years after licensure, and then annually
for other adverse events.
What events are required to be reported
to VAERS by health care providers? The
Act requires that health care providers
report any event listed in the manufacturer's
package insert as a contraindication to
further doses of the vaccine, and any
event in the reportable events table that
occurs within the specified time period
after immunization.
What is the efficiency of reporting to
VAERS? There were two different manuscripts
published on this subject several years
ago. They were done using different tools.
“The Reporting Sensitivities of
Two Passive Surveillance Systems for Vaccine
Adverse Events” paper by Steven
Rosenthal, M.D., M.P.H. and Robert Chen,
M.D., M.A. in the American Journal of
Public Health, December 1995 compared
the rate of reporting of various adverse
events after various vaccines in VAERS
divided by a denominator, which is described
in the paper. Then, they compared that
rate with rates published in the literature
of these adverse events that were associated
with one or another vaccine. They came
up with a reporting efficiency number
for these various adverse events.
For
example, they found that vaccine associated
polio after oral poliovirus vaccine had
a reporting efficiency of 68 percent,
which is relatively high, whereas rash
after measles-mumps-rubella vaccine had
a reporting efficiency of less than one
percent. Generally, the observation could
be made that the more severe the vaccine
associated event is, then the higher the
reporting efficiency. However, this observation
is clouded by issues, such as whether
there is stimulated reporting by other
events that are occurring during this
period of time. For example, publicity
may have been given to one event and one
vaccine more so than another.
Another
paper looked at reporting efficiency in
a slightly different way. The “Enhancing
Vaccine Safety Surveillance: A Capture-Recapture
Analysis of Intussusception after Rotavirus
Vaccination” by Thomas Verstraeten
paper in the American Journal of Epidemiology
in 2001 looked at intussusception after
vaccination with the rotavirus vaccine
(trade name: Rotashield). This study looked
at the number of cases reported to VAERS
and compared to the number of cases that
were found in clinical trials that had
been ongoing during the same period of
time. They found that the VAERS reporting
efficiency was 47 percent for intussusception
after Rotashield.
How
does the FDA use VAERS? There are a number
of quantitative methods for signal detection
in a system such as VAERS. Several that
are used frequently in the Vaccine Safety
Branch at the FDA are the following: 1.
Comparison of reporting rates to VAERS
with background rates. Reporting rates
are derived from number of adverse events
reported to VAERS and some estimate of
the number of persons vaccinated. Background
rates are commonly derived from reports
in the literature, but other methods are
also used, such as querying health maintenance
organization databases. 2. The FDA also
uses "data mining" to identify
adverse events reported to VAERS more
commonly after one product than after
others. It is important to be aware in
applying any of these quantitative methods
that the results can be impacted by reporting
artifact or biases in reporting. In addition,
it is important always to use medical
knowledge and independent confirmation
of results of quantitative methods."
So
data mining is a term that is often used
in this context to refer to identifying
events reported more commonly for one
product as compared to another product.
So using a database with numerators, such
as VAERS which does not have denominators,
what can be done to quantify proportionality?
There are different ways of doing data
mining. Proportional reporting ratios
and empirical Bayesian geometric means
are methods used by FDA. Medical knowledge
and review of the reports after the numbers
are generated is usually necessary.
Other
than those means, how does the FDA generate
hypotheses in VAERS? There are a wide
range of possibilities. For example, only
one case could be used if it is a positive-rechallenge
case, or a case where someone had an adverse
event after one dose of vaccine and had
the same adverse event after a second
dose of vaccine. This might be very compelling,
and it might generate a hypothesis. Or
there may be a clustering of adverse events
occurring eight to 12 days after vaccination.
When looking at clusters of adverse events,
background rates must be considered because
some adverse events may be extremely common,
such as depression, versus adverse events
that are quite rare, like aplastic anemia.
It
is important to consider the health impact
of an adverse event, both the severity
of the event and the number of people
impacted, in determining a public health
response. Additionally, it is important
to consider both potential costs and benefits
of any public health intervention. The
interventions that might be considered
if appropriate are: updating the package
insert, sending a “Dear Doctor Letter”
or public health advisory; presenting
at professional meetings; publishing peer-reviewed
articles; designing and implementing a
risk management program; and rarely, withdrawing
the product. Dr. McMahon thanked Dr. Robert
Ball and Dr. Miles Braun for their help
with the presentation, and asked if anyone
had questions.
Mr.
Sconyers had questions about how is VAERS
publicized to likely reporters, such as
pediatricians, how do they know about
VAERS, and how do they know that they
have a requirement to report certain things.
Dr. McMahon replied that information about
VAERS is sometimes publicized in journals.
Dr. John Iskander replied that there are
a variety of strategies that are used
annually. “Dear Doctor Letters”
can contain VIS with information about
VAERS. Information about VAERS can be
exhibited at meetings. Certain resources
that are very commonly used by pediatricians,
for example, the American Academy of Pediatrics
Red Book (Red Book) contain a sample VAERS
form and contains information about adverse
event reporting. All of the ACIP statements
now contain standard language and recommendations
about adverse event reporting. Again,
VAERS is certainly amenable to constructive
suggestions about new and different and
innovative ways of promoting reporting.
Dr. Evans replied that there is an entity
called the Reportable Events Table (RET),
which probably confuses more than helps
some people. If you look at the back of
the Red Book, it combines both the Vaccine
Injury Table (Table), as well as the RET.
The VAERS RET is very similar to the VICP
Table, but has slightly different time
intervals based on the Act. It is a reminder
that anything that is on the RET must
be reported to the VAERS. It also includes
those events that are in the Contraindication
section of the package inserts. Also,
more recently, the harmonized schedule
that is published in the January edition
of Pediatrics and family practice journals
now has a footnote which reminds practitioners
that any clinically significant events
that occur after any vaccines should be
reported to VAERS. Hopefully, this may
have boosted the awareness of practitioners
of the importance of getting reports to
VAERS.
Mr. Sconyers asked whether any of the
FDA adverse event responses have occurred.
Dr. McMahon replied these responses have
been implemented at various times. The
peer reviewed publications of VAERS and
adverse events are done all the time.
Presentations at professional meetings
are also done all the time. “Dear
Doctor Letters” are done when required.
Package insert label are reviewed regularly,
and changed as needed. Dr. Gruber replied
that last year, FDA updated the package
insert for the Menatra (a meningococcal
vaccine) to include the Guillain Barre
Syndrome reporting.
Mr. Glass wanted to know whether health
care providers required to report and
if unexpected events required to be reported
by them. Dr. McMahon replied that the
rule about serious and unexpected events
is in 21 CFR 600.80, and refers to the
manufacturers. But unexpected events,
that is, events that are not in the label,
are not required to be reported by health
professionals. Mr. Glass questioned the
reasoning for that, or the benefit of
not reporting them? Dr. Evans replied
that health care providers are required
to report events listed in the contraindications
section of the manufacturer's package
insert and events on the reportable events
table. There is not any punitive action
if they don't report these events, but
by law they are required to be report
them. Language was added, and it appears
in all the footnotes of the Reportable
Events Table, sometimes bolded and underlined,
that anything that is clinically significant
that occurs after any vaccine should be
reported, whether by a parent or a physician.
However, passive reporting systems, historically,
suffer from underreporting, despite best
efforts.
Dr. Iskander replied that FDA/CDC have
never quantified it precisely. In fact,
most of the events reported to VAERS are
voluntary rather than mandatory reporting.
Ms. Buck inquired about how does VAERS
identify who made a report, whether it
is a manufacturer or a member of the public.
Dr. McMahon replied that who filed that
report is on the reporting form.
Update
from the National Vaccine Program Office:
Dr. Kenneth Bart, M.D., M.P.H., National
Vaccine Program Office
Dr. Bart stated that on April 10-11, the
National Vaccine Program Office and the
four agencies that are responsible for
vaccine safety -- NIH, HRSA, CDC, and
FDA -- are planning a vaccine safety evaluation
meeting focusing on post-marketing safety
surveillance. It will be announced in
the Federal Register and is a public meeting.
The purpose of the meeting is to discuss
the ideal vaccine safety evaluation system.
The meeting will focus on vaccine safety
methodologies, what we can do to improve,
and how we can enhance the vaccine safety
evaluation process. This is a follow-up
to a meeting which occurred in the year
2000 for pre-marketing surveillance. This
meeting was sponsored by FDA, and examined
what is done prior to the formal licensing
of a vaccine to demonstrate the accumulation
of data on safety of a vaccine.
The
meeting will look at strengths and limitations
of each agency’s vaccine safety
monitoring tools. International speakers,
the European Regulatory Agency, countries,
such as the U.K. and Denmark, that have
large and in some cases country-wide databases
accessible to them have been invited.
Interest is focused on the strengths and
limitations of these systems. These systems
and ongoing research will be systematically
reviewed over the two days of the meeting.
Invitations
have been sent to ACCV members. Please
come to the meeting and invite interested
others to attend as well. If you are going
to make a presentation, you should inform
the organizers in advance, so that time
is made available for your presentation.
Register on-line because of the security
procedures on the NIH campus.
Agenda Item: Update on the Immunization
Safety Office (ISO), Centers for Disease
Control and Prevention (CDC): Dr. John
Iskander, M.D., M.P.H., Acting Co-Director,
ISO, CDC
Dr.
Iskander stated that Dr. Robert Davis,
who has addressed the committee previously,
has accepted a position with Georgia Kaiser
Permanente effective March 12. As of February
26, Kristin Pope and Dr. Iskander are
serving as acting co-directors of the
Immunization Safety Office, CDC. Dr. Iskander
provided a brief background about himself.
He has worked in vaccine safety at CDC
for the past seven years and has served
as project officer and team leader for
VAERS, and most recently was Associate
Director for Science. Kristin Pope is
a senior policy analyst who has worked
at CDC since 2000, and has worked with
immunization safety since 2003 on a variety
of challenging policy and management issues.
ISO
research agenda development, as outlined
by Dr. Davis at the last ACCV meeting,
will be proceeding. An external scientific
consultant panel will meet in Atlanta
May 10-11. Their recommendations will
be only one of several inputs that will
be considered in drafting a research agenda.
The National Vaccine Advisory Committee
(NVAC) will be involved in the latter
stages of the research agenda development
process. In February 2007, a progress
update was presented to the NVAC, and
there were several constructive suggestions
that ISO will consider implementing.
The
Advisory Committee on Immunization Practices
(ACIP) met in February. This was a relatively
short meeting, and at the same time, a
meeting with a great deal of safety related
content presented. A joint ISO and National
Center for Immunization and Respiratory
Disease analysis was presented which indicated
that the risk of intussusception after
vaccination with Rotateq was not elevated
in either the seven- or 21-day period
following vaccination. Using the Vaccine
Safety Datalink (VSD), no cases of intussusception
have been detected after about 28,000
doses were given. This implies that the
risk with Rotateq, if there is a risk,
is less than that seen with Rotashield.
The open question is whether there might
be a risk on the order of one in 100,000
or even rarer, which will take ongoing
analyses and accumulation of dose experience
to determine. Details of this analysis
are posted at The
Advisory Committee on Immunization Practices
(ACIP) web site, and will also be
published in a forthcoming Morbidity
and Mortality Weekly Report (MMWR).
Additional
safety issues discussed at the ACIP included
an update on Guillain-Barre Syndrome following
the meningococcal conjugate (Menactra)
vaccine. Post-licensure safety summaries
of Tdap and zoster vaccines and a status
report on the VSD’s autism case
control study were discussed. Medimmune
presented safety data on FluMist, the
nasal spray influenza vaccine, which indicated
that children between one and five years
of age with prior history of wheezing
or asthma may be at risk to wheeze again
following Flumist. Published data from
VAERS previously indicated that wheezing
episodes reported following Flumist were
associated with previous wheezing. Currently,
Flumist is licensed only for healthy 5
to 49-year-olds. However, Medimmune is
interested in expanding use to children
under age five and has a BLA pending with
FDA.
Dr.
Iskander reported that both he and Melinda
Wharton will be presenting on behalf of
CDC at the NVPO post-marketing surveillance
meeting in April.
A
safety update on human papillomavirus
(HPV) vaccine was provided at the ACIP
meeting as well. To date, reporting to
VAERS has been very vigorous, which we
expect for a vaccine which is both new
and of a novel type, and perhaps being
given by providers who are not as experienced
as pediatric providers with giving vaccines.
Relatively, few serious adverse events
have been reported to date. There has
been discussion about syncope (fainting)
following vaccination, but this seems
to be an issue of vaccination in general,
especially vaccination of adolescents
of both genders. There doesn't seem to
be anything disproportional about these
episodes happening after HPV. Media attention
has focused primarily on concerns about
mandates. About 18 states are considering
legislation regarding mandates.
Dr.
Deville asked about the kinds of adverse
events have been reported, particularly
in the older adolescents, after Tdap vaccine
has been given. Dr. Iskander replied that
the overall safety profile looks quite
favorable with local and systemic reactions
of a self-limited nature, comprising up
to 90 to 99 percent of the reports. The
issues which came to ISO’s attention
were administration errors, product mix-ups
because of Tdap, DTaP, TD, and variety
of vaccines that can be said or abbreviated
in similar ways with similar packaging.
None of those have resulted in any serious
clinical outcomes, but it is an issue
involving both immunization program administration
and vaccine safety. About five percent
of the reports have involved fainting
or near fainting episodes, without documented
serious outcomes (such as intracranial
bleeding) having occurred.
Dr.
Deville asked if Dr. Iskander has seen
a significant amount of arm swelling in
the adolescents receiving Tdap. Dr. Iskander
replied that whole limb swelling has been
observed with booster doses of DTaP given
to children getting their pre-school shots,
which sounds quite frightening, but in
practice resolves spontaneously and is
very difficult to study because parents
rarely even bring their children in for
medical attention when this happens. It
has also been observed with a variety
of vaccines, including Td, (tetanus and
diphtheria toxoids), and hepatitis B vaccines.
CDC's Clinical Immunization Safety Assessment
(CISA) Centers have undertaken a couple
of studies to determine the pathophysiology
of this. So far, there have been a variety
of theories and no clear cause has been
found, and the continued observation has
been that these reactions seem to occur
following a variety of vaccines. They
peak in their clinical presentation within
about 48 hours, and they resolve spontaneously,
and do not have ongoing sequelae.
Dr.
Deville asked about those cases where
adolescents have been given the DTaP vaccine
accidentally, and if there is a higher
incidence of adverse events. Dr. Iskander
replied that this issue as been looked
at preliminarily. To date, the information
doesn't suggest that those vaccine mix-ups
have resulted in any serious consequences.
The concern is that people exposed to
the higher diphtheria toxoid content in
DTaP, especially people vaccinated more
recently with diphtheria toxoid containing
vaccines, might be more at risk for serious
local reactions.
There
have been now some post licensure observational
studies that have been done--one in Canada
and one in New Hampshire--which looked
at intervals between diphtheria toxoid
containing vaccines as short as 18 months
to two years. It doesn't appear that there
is any increased risk of serious local
reactions with these shorter intervals.
This suggests that using Tdap for a pertussis
outbreak could be a reasonable strategy
to pursue, where the potential benefits
of a vaccine are more apparent.
Dr.
Wilber explained the difference between
DTaP and Tdap vaccines. DTaP is given
to children and Tdap is given to adults
and adolescents. Dr. Iskander stated that
on the vaccine schedule, “D”
indicates a higher diphtheria toxoid content.
The “d” indicates that there
is less diphtheria toxoid content. Menactra
contains diphtheria toxoid, not as an
immunizing antigen, but as a carrier protein,
and it is a “D”. There has
been a lot of concern about different
schedules of vaccines containing diphtheria,
tetanus and acelluar pertussis.
Dr.
Deville asked about problems being reported
in children receiving a fourth dose of
Hepatitis B even though it is recommended
that they get only three doses of vaccine.
They get the first dose at birth, and
then, they could potentially get their
second, third and fourth doses with the
Pediarix, which is a vaccine containing
Diphtheria and Tetanus Toxoids, Acellular
Pertussis, Hepatitis B and Inactivated
Poliovirus Vaccine for children. Dr. Iskander
responded that the ISO is aware of this
concern. He said that he is not aware
of any analyses done by VAERS looking
specifically at the fourth dose given
and that fourth dose would fall within
what is allowed under the general recommendations
on immunization. It may be that with a
newer combination vaccine many providers
move to a schedule or change products
so a fourth dose would be eliminated.
Dr. McMahon replied that Soju Chang, who
works with VAERS, has been looking at
something related to this issue.
Dr. Evans stated that Rotateq, a rotavirus
vaccine, has been licensed for a year,
and the VICP has not received a claim
alleging injuries from this vaccine yet,
although some may be filed soon with cases
of intussusception being reported through
VAERS. On the Vaccine Injury Table, there
are two boxes that contain rotavirus vaccine.
Box XI contains the general category of
rotavirus vaccine with no condition specified.
Rotateq is covered under this category.
Box XII contains the live, oral, rhesus-based
rotavirus vaccine (trade name: Rotasheild)
with the injury of intussusception, which
is no longer in effect because Rotashield
withdrew its vaccine from the market in
1999. In the near future, the VICP may
publish a technical change notice to remove
Box XII, and then, only the general category
of rotavirus vaccine will remain on the
Table. The VICP will certainly look at
ongoing data being gathered and make a
decision about whether there is any proven
evidence of a relationship between Rotateq
and intussusception. With Rotateq, there
is no presumption of causation at this
point.
Update on National Institute of
Allergies and Infectious Diseases: Dr.
Barbara Mulach, Ph.D., National Institute
of Allergy and Infectious Diseases (NIAID),
National Institutes of Health
Dr.
Babara Mulach stated that in December
2006, scientists at the Vaccine Research
Center (VRC) within NIAID began a small
Phase I study of an H5N1 avian influenza
DNA vaccine. This clinical trial will
enroll 45 volunteers between the ages
of 18 and 60. Unlike conventional flu
vaccines, which are developed by growing
the influenza virus in eggs and then administered
as a weakened or killed form of the virus,
DNA-based vaccines contain only portions
of the influenza virus' genetic material.
This vaccine is aimed at newer clade II
strains of the H5N1 virus that currently
pose a threat in Indonesia. To read the
full press release, please visit The
National Institute of Allergy and Infectious
Diseases (NIAID) web site.
The
National Children's Study has issued a
request for proposals to award contracts
to up to 20 new study centers. This study
seeks to examine the effects of environmental
influences on human health and development
by enrolling a representative sample of
more than 100,000 infants from across
the United States and following them from
before birth until age 21. The study is
led by a consortium of federal agencies:
the U.S. Department of Health and Human
Services—including the National
Institute of Child Health and Human Development
(NICHD) and the National Institute of
Environmental Health Sciences at the NIH,
and the Centers for Disease Control and
Prevention—and the Environmental
Protection Agency. The National Children's
Study has received an appropriation of
$69 million from Congress for fiscal year
2007 to support the implementation of
the study. Detailed information is available
on the National
Children's Study web site.
The
following are new NIAID publications-
1) NIAID Biodefense Research for CDC
Category A Agents-2006 Progress Report
is now available in hard copy or on the
NIAID web site; 2) The Jordan Report:
Accelerated Development of Vaccines 2007
will be available soon (Spring 2007).
Hard copies of this report (as well as
the web link) will be made available to
the ACCV when the document is completed.
Dr.
Deville asked about the status of the
DNA-based avian flu vaccine research and
kinds of immunogenicity seen in preliminary
avian flu studies. Dr. Mulach replied
that the Vaccine Research Center (VRC)
has been doing several different products
with their DNA platform. So far, in animal
studies, the VRC has seen immunogenicity
and safety. But with the avian flu, there
is the added complication of not really
knowing what an avian influenza clade
II vaccine might draw in immune response.
In animal studies, it has shown promise.
The VRC is really trying to see whether
a DNA vaccine strategy can be used, then
it will be fairly easy to change what
is put into the DNA vaccine. This will
make it very versatile in terms of the
evolution and the changing of the strains
that are actually circulating.
Dr.
Deville stated the concern with this approach
will be the same concern that resulted
in the failure of the HIV vaccine which
was that responses are extremely weak.
Dr. Mulach responded that the VRC is investigating
the use of prime boost strategies with
their DNA vaccines. There are a lot of
strategies that can be used and this is
just a first indication of what it is
might be possible. With the avian flu
vaccines, it has been difficult to get
a strong immune responses to begin with,
so there may be multiple strategies that
are examined in the future. Currently,
the VRC is focusing on a very limited
population for safety and initial immune
response. Dr. Deville asked about the
number of people involved in the study.
Dr. Mulach replied that 50 people are
involved in the study so far.
Dr.
Wilber asked about the clade. Dr. Mulach
responded that clade is the different
strain of influenza that is circulating.
Dr. Wilber asked is it H5N1 also. Dr.
Mulach replied it is H5N1, but it is called
clade II which is what people are concerned
about now. In Indonesia, the clade II's
are circulating. The concern is with clade
I vaccines that were made a couple of
years ago because the further away you
get from what is circulating, then, there
is going to be less of an immune response.
NIH and HHS are looking at multiple types
of avian flu vaccines to determine what
works the best. It may be ultimately that
there is some mixture, but it is important
to understand the different clade vaccines.
Update
on Food and Drug Administration Vaccine
Activities: Dr. Marion Gruber, Ph.D.,
Center for Biologics and Evaluation Research,
Food and Drug Administration (FDA)
Dr. Gruber stated that on January 25,
2007, the FDA’s Vaccines and Related
Biologics Product Advisory Committee (VRBPAC)
met to discuss whether the data that were
submitted to the biologics license application
(BLA) for Pentacel, a new combination
vaccine that includes diphtheria, tetanus,
acellular pertussis, inactivated polio
and haemophilus influenza type b antigens,
would support the safety and the effectiveness
of this product in the indicated population.
The proposed indication is for prevention
of diphtheria, tetanus, pertussis, poliomyelitis
and invasive disease caused by Haemophilus
influenza type B, in infants and
children six weeks through six years of
age.
FDA
noted in its presentation to VRBPAC that
the response to pertactin (one of the
pertussis antigens present in the vaccine)
was statistically inferior following Pentacel
relative to the control DTaP vaccine and
the response to the Hib component showed
inconsistent results derived from 2 clinical
studies performed. In its discussions,
the committee took into consideration
data from Canadian post-marketing experiences
with the product. The committee voted
in favor of the safety of Pentacel. While
the committee voted that the data were
adequate to support the efficacy of Pentacel,
some members expressed concern regarding
the efficacy of the Hib and pertussis
component. Members suggested post-licensure
evaluation of the effectiveness of the
Hib and pertussis components of Pentacel.
Dr.
Gruber stated that it is her understanding
that if this vaccine is licensed, there
will be an ACIP workgroup that will further
review the safety and immunogenicity data
of this vaccine to develop recommendations
to update the recommended childhood immunization
schedule.
On
February 27, 2007, the VRBPAC met to make
recommendations on the safety and effectiveness
of an H5N1 inactivated influenza vaccine
manufactured by sanofi pasteur and to
have discussions on clinical development
of influenza vaccines for pre-pandemic
uses. The BLA for the H5N1 A/Vietnam/1203/2004
vaccine, an influenza virus with pandemic
potential and manufactured by sanofi pasteur,
is the first U.S. license application
for a vaccine against H5N1 influenza virus
strain. This vaccine, if licensed, will
be the first vaccine available against
H5N1 strain in the interim until other
influenza vaccines against H5N1 are developed
and licensed. VRBPAC recommended approval
of this vaccine for use during a pandemic
or in situations of high risk exposure.
On
February 28, 2007, VRBPAC considered which
influenza viruses should be included in
vaccines for use in the 2007-2008 influenza
season. Based on surveillance data, responses
to current vaccines and availability of
strains, VRBPAC recommended trivalent
influenza vaccines, consisting of three
different types - two influenza A types
and one B type. There will be a strain
change regarding the H1N1 subtype A, the
H3N2 subtype A will stay the same, and
the B-like virus will also stay the same
compared to the 2006-2007 season. These
recommendations for influenza vaccine
composition to be used in the upcoming
2007-2008 season in the U.S. are identical
to those recommended by the World Health
Organization when they met February 14,
2007. Dr. Gruber stated that she tried
to get information on the projected amounts
of influenza vaccine doses that will be
available, but data were not available
to her.
There
are several BLAs under review, namely
those for Pentacel and the H5N1 influenza
vaccine. FDA also has a BLA for Flumist,
a live attenuated influenza virus vaccine
currently indicated for use in persons
five to 49 years. Medimmune seeks to extend
the currently licensed age indication
to the pediatric population (i.e., children
less than five years). The FDA also has
a BLA for a live attenuated smallpox vaccine
for immunization of persons who are at
risk for smallpox infection.
Dr.
Wilber asked about when FDA will make
a decision about the BLA for expanding
the use of Flumist to a broader pediatric
population. Dr. Gruber replied the BLA
is currently under review, and the FDA
has certain time lines that have to be
met. So if approved, it would happen in
early summer. However, the availability
of this vaccine for the coming season
is not known. With Flumist, there are
also still issues under discussion. Dr.
Iskander mentioned wheezing after receipt
of this vaccine. Therefore, the data have
to be further analyzed to determine the
age range for use of this vaccine. Dr.
Iskander stated that wheezing is a very
common condition in young children, but
that has to be balanced against the fact
that the efficacy and effectiveness of
this vaccine in young children appear
to be very, very good, and would potentially
be an improvement over inactivated vaccines.
This is going to be another risk versus
benefit calculation.
Dr.
Evans stated that any pandemic vaccine
will be a monovalent vaccine. According
to the excise tax language that Congress
passed in 2004, only trivalent influenza
vaccines are covered by the VICP. Therefore,
the avian influenza vaccines that Drs.
Barbara Mulach and Marion Gruber discussed
for the stockpile, or for general distribution
if there ever should be an emergency,
would not be vaccines covered by the VICP
unless Congress were to expand the excise
tax language.
Dr. Wilber asked if VRBPAC was reviewing
data about the serologic markers which
did not meet non-inferiority criteria
for the Hib and pertussis components for
Pentacel. Dr. Gruber responded that for
Pentacel, efficacy is inferred by determining
the adequacy of pre-defined immune endpoints.
The antibody response to the Hib components
showed inconsistent results derived from
2 clinical studies performed. For the
Hib antigen, there is a correlated of
protection. Even though two different
clinical trials gave inconsistent results
based on statistically predefined criteria,
in both cases the antibody response was
above what is considered protective. For
the pertussis antigen, no correlate of
protection has been established. The response
to pertactin, one of the pertussis components
present in the vaccine, was statistically
inferior following Pentacel relative to
the control DTaP vaccine.
Dr.
Deville asked another question about the
Pentacel vaccine. He stated that for years,
there have been attempts to mix the acellular
pertussis vaccine with Hib, and for the
most part these have failed. How is this
vaccine different? Which antigen of pertussis
doesn't show similar titers to the one
in the licensed vaccine? Dr. Gruber replied
there are different pertussis components
in various licensed vaccines. They are
all different. In this case, there are
several pertussis components included
in Pentacel, and one of them is pertactin,
and the antibody response to the pertactin
component was statistically inferior.
Dr. Deville stated that it is believed
to be the most protective antigen by many.
Dr. Gruber responded that she thinks opinions
differ on this issue. Some people believe
it is really the pertussis toxin component
which is the most protective component.
However, she stated that Dr. Deville raised
important issues that the FDA is grappling
with in terms of reviewing this data.
There has been an issue when the Hib vaccine
is mixed with other antigens because there
has been suppression in the immune response
to the Hib components, which is why some
companies do not develop these Hib combination
vaccines. It is difficult to know why
the immune response of the Hib component
is the way it turned out to be in the
clinical trials.
Dr. Deville stated that there are two
issues. One is the Haemophilus influenza
disease, which for the most part has been
eliminated from this country. If we introduce
a vaccine that is not as immunogenic,
that might create a problem, especially
with travelers to other parts of the world.
These children might not be as protected.
Dr. Gruber replied that the FDA is currently
discussing this concern. This is an issue
that was raised at the VRBPAC meeting.
Also, an ACIP workgroup is going to be
formed to analyze this issue. One consideration
is to conduct post-marketing studies in
the US to determine the efficacy of the
Hib component to see if there has been
a surge in Hib disease. However, it might
not be feasible to do these studies given
the low incidence of Hib disease currently
in the United States.
Dr.
Iskander stated that what would make such
studies difficult would be the greater
than 99 percent reduction in Hib disease
in the U.S. The other factor that would
make it potentially difficult is that
there is a lot of non-type Haemophilus
disease based on data from 2007 the National
Immunization Conference. Non-typable is
a type. Non-typed means it is Haemophilus,
but the category that it fits into is
not known. According to the data, 70 percent
of isolates across the country are not
typed at all. There are eight active surveillance
sites, but even if data from all sites
were combined it is uncertain whether
an increase of disease, if indeed occurring,
would be detected.
Dr.
Deville asked for an update on the status
of the pneumococcal vaccine and the herpes
simplex vaccine. Dr. Gruber replied that
she could not provide an update on these
vaccines because of the confidentiality
issues. Mr. Sconyers asked whether there
have been Canadian studies on the effectiveness
of Pentacel and specifically on the pertussis
effectiveness. Dr. Gruber replied, that
post-marketing surveillance is ongoing
in Canada. That data was presented at
that VRBPAC meeting and it was reassuring.
However, there is the question of the
comparability of the subject population,
the geographic areas, the density of population
in Canada versus the United States. There
are questions of whether one can apply
the Canadian experience to the United
States.
Mr.
Sconyers asked about what does the Flumist
protect against and how does it account
for seasonal variation. Dr. Gruber responded
that it will have the same seasonal influenza
strains as those in the inactivated vaccine.
Selection
of ACCV Chair and Vice Chair: Dr. Don
Wilber, M.D.
Tawny
Buck nominated Jeff Sconyers to be the
ACCV Chair and Dr. Jaime Deville to be
Vice Chair. Mr. William Paul Glass seconded
both nominations. Dr. Wilber called for
a vote and the ACCV unanimously supported
these nominations. Dr. Evans thanked the
three retiring members, Loren Cooper,
Marguerite Willner and Dr. Wilber, for
their service and informed them that they
would be receiving certificates in the
mail from the Secretary of Health and
Human Services.
Public Comment: Dr. Wilber
There were not any comments from the public.
Future Agenda Items: Dr. Wilber
Dr. Wilber asked about future agenda items.
Mr. Sconyers replied that the ACCV Workgroup
did a lot of work and did set aside several
issues for discussion in the future. They
include vaccine safety, questions about
access of minorities and underserved groups
to the VICP, and effectiveness of outreach
programs. Therefore, he suggested that
a subsequent workgroup be formed, an include
one of the new members.
ATTACHMENT
1
Don
L. Wilber, M.D.
Oklahoma City Clinic
600 National Avenue
Midwest City, OK 73110
March
23, 2007
The Honorable Michael O. Leavitt
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear
Secretary Leavitt:
The
Advisory Commission on Childhood Vaccines
(ACCV) is a nine member advisory commission
appointed by the Secretary of Health and
Human Services (Secretary), as required
by § 2119 of the Public Health Service
Act, to advise and make recommenda¬tions
to the Secretary on matters related to
the implementation of the National Vaccine
Injury Compensation Program (Program).
The
National Childhood Vaccine Injury Act
of 1986 (the Act) created the Program.
The Act’s overarching public health
policy objective was to eliminate vaccine-preventable
disease by encouraging the use of vaccinations.
Toward that end, the goal of the Program
was to stabilize the nation’s vaccine
supply by creating a federal cause of
action whereby the U.S. government assumes
liability for injuries or deaths resulting
from the administration of certain vaccines
mandated for childhood use. Thus, the
direct beneficiaries of the Program were
to be vaccine manufacturers (industry),
vaccine administrators (healthcare providers)
and those claiming vaccine-related injuries
(petitioners).
For
petitioners, the Program was to be an
appealing “no-fault” alternative
to the tort system in which the process
of receiving compensation would be faster,
less adversarial, and more compassionate.
The House Report on the Act called for
a compensation program that administers
awards “quickly, easily, and with
certainty and generosity.”
For
industry, the Program was to provide a
broad measure of liability protection
by requiring any person claiming a vaccine-related
injury to file a petition in the Program
before “opting out” to directly
sue a manufacturer or provider in state
or federal court.
The
Program is privately funded by the imposition
of a 75-cent excise tax per disease prevented
(per dose) which is paid by the vaccine
consumer, collected by the manufacturer,
and deposited into the Vaccine Injury
Compensation Trust Fund (Fund). The un-obligated
balance of the Fund is expected to reach
almost $2.6 Billion by year end, which
far exceeds current Program obligations.
The
Program is administered jointly by the
Department of Health and Human Services
(Health Resources and Services Administration),
the Department of Justice, and the U.S.
Court of Federal Claims (Court). The Program
was to be “fair, simple and easy
to administer” and “to compensate
persons with recognized vaccine injuries
without requiring the difficult individual
determinations of causation of injury.”
Accordingly, the Act provides for informal
procedural rules, limited discovery, and
requires petitions to be decided within
240 days (8 months).
On
average, 125 petitions are filed with
the Program each year.1
For Fiscal Years 2002-06, on average,
about 44% of all claims received compensation;
compensated claims took, on average, 3.3
years to process, even though 67% are
settled. For the same period, claims which
were dismissed took, on average, 2.4 years
to process. Since the inception of the
Program in 1988, the average post-1988
Act injury award is $961,738 and the average
fee paid to petitioners’ attorneys
is $37,460 which is about 4% of the average
annual award paid to petitioners.
The
statute of limitations (SOL) for filing
a petition in the Program is three years
from the date of the first symptom of
the injury, even if the petitioner reasonably
would not have known at the time that
the vaccine had caused the first symptom.
Thus, the Program stands in stark contrast
to most state SOLs which do not run against
a plaintiff until he is aware of both
the injury and its cause and
which suspend the SOL for minors and the
disabled.
At
its March and October 2006 meetings, the
ACCV heard presentations highlighting
concerns about the Program’s SOL.
To respond to these concerns and to study
other proposals to improve the Program,
the “ACCV Futures Workgroup”
(Workgroup) was formed to develop a specific
set of recommendations to present to the
full ACCV for action at its next public
meeting.
The
Workgroup was composed of six ACCV members
and was chaired by the ACCV Vice Chair,
a representative of the general public.
As ACCV Chair and a physician representative,
I was also a member of the Workgroup along
with another physician representative,
a representative of the general public
who is the parent of a vaccine-injured
child, a general attorney representative,
and an attorney who specializes in representing
vaccine manufacturers.
The
Workgroup met regularly from November
2006 to March 2007. It carefully studied
and discussed both internal and external
proposals to improve the Program, and
reviewed hundreds of pages of documents,
and sought the advice of outside experts.
For
example, on February 5th, the Workgroup
held a Round Table Discussion to solicit
the ideas and feedback from representatives
from the Congressional Oversight Committee
on Government Reform, the Court , the
American Academy of Pediatrics, an attorney
with expertise in both constitutional
law and experience representing the vaccine
industry, and a plaintiffs’ attorney
who is also a member of the Petitioner’s
Autism Steering Committee. (For list of
attendees and agenda, please see pages
9-10.)
The
Workgroup’s efforts yielded significant
results – it developed and garnered
support for a list of 12 legislative recommendations
to improve the Program.
At
the March 7th ACCV meeting, the Workgroup
presented the following list to the full
ACCV, stressing its conclusion that the
Program must be made more accessible and
inclusive. After discussion and public
comment, the ACCV voted overwhelmingly
to support all 12 recommendations -- with
8 receiving unanimous support. The summary
of these recommendations and the voting
outcomes is enclosed.
This
result, along with the fact that this
is the first time in over eight years
that the ACCV has felt compelled to proactively
create and send to the Secretary an affirmative
set of recommendations, underscores both
the value and urgency with which the ACCV
commends them for your consideration.
In
conclusion, Mr. Secretary, we urge you
to adopt these recommenda¬tions as
your own and present them as legislative
proposals to Congress at your earliest
convenience. We firmly believe that passing
such legislation will ensure that this
Program remains viable and above reproach.
The
ACCV wants you to know that it greatly
appreciates your leadership and support,
and we await your reply.
Sincerely,
(signature)
Don
L. Wilber, M.D.
Chair, ACCV |
1
There are currently about 4,800 autism
claims awaiting adjudication in the
“Omnibus Autism Proceeding”.
Recommendations
to Amend the National Childhood Vaccine
Injury Act
Presented
by the ACCV Futures Workgroup
to the
Advisory Commission on Childhood Vaccines
for Action
on March 7, 2007
The ACCV Futures Workgroup, having itself
unanimously agreed to support them, presented
the following list of 12 recommendations
to amend the Act to the full ACCV for
a vote at its public meeting on March
7, 2007. (Voting results are noted in
red.)
-
Allowing Payment of Interim Fees and
Costs to Petitioners’ Attorneys.
After
the special master or court has determined
that a petitioner is entitled to compensa¬tion,
the petitioners’ attorney may
seek an award for reasonable fees and
costs incurred in the proceeding. The
“interim award” shall be
promptly paid by the Secretary pursuant
to the special master’s or court’s
order and without need of a final disposition
of the case.
ACCV
VOTE: UNANIMOUSLY SUPPORTED.
-
Procedure for Paying Fees and Costs
Solely to Petitioner’s Attorney.
When
a special master or court awards attorneys’
fees or costs, it may order them payable
solely to the petitioner’s attorney
if the petitioner expressly consents
or the special master or court determines
that (i) the petitioner cannot be located
or refuses to respond to a request by
the special master or court for information
and there is no practical alternative
means to ensure that the attorney will
be reimbursed for such fees and costs
expedi¬tiously, or (ii) there are
other exceptional circumstances and
good cause for paying such fees and
costs solely to the petitioner’s
attorney.
ACCV
VOTE: UNANIMOUSLY SUPPORTED.
-
Increased Benefits Caps for Death and
Pain and Suffering.
Increase
the $250,000 benefit cap for death and
the $250,000 benefit cap for pain and
suffering to account for inflation.
Both benefit caps would be retroactively
increased since 1988 to account for
inflation and would increase annually
to account for inflation using the Consumer
Price Index - All Urban Wage Earners
(CPI-U), as envisioned by Congress in
the original National Childhood Vaccine
Injury Act of 1986.
ACCV
VOTE: UNANIMOUSLY SUPPORTED.
-
Allowing Compensation for Family Counseling
Expenses and Expense of
Establishing and Maintaining Guardianships,
Conservatorships, or Trusts.
The
Act shall provide compensation for reasonable
and necessary, non-reimbursable expenses
that have been or will be incurred for
(a) family counseling determined to
be reasonably necessary and that results
from the vaccine-related injury and/or
death for which the petitioner seeks
compensation; and (b) compensation for
reasonable and necessary non-reimbursable
expenses, including attorneys’
fees, that have been or will be incurred
to establish and maintain a guardianship,
conservatorship, or trust, approved
by the U.S. Court of Federal Claims,
for the benefit of an individual who
has suffered a vaccine-related injury.
ACCV
VOTE: UNANIMOUSLY SUPPORTED.
-
Appointment of Adult with Vaccine-Related
Injury to ACCV.
Amend the Act to permit, but not require,
the Secretary to appoint an adult who
has personally suffered a vaccine-related
injury, or the guardian or family member
of such an adult, to one of the two
ACCV posts reserved for the legal representative
of a child who has suffered a vaccine-related
injury or death.
ACCV
VOTE: UNANIMOUSLY SUPPORTED.
-
Clarification: A Petitioner Who Establishes
a Vaccine-Related Injury and Death is
Entitled to Both Death and Injury Benefits.
Amend
42 USC § 300aa-15(a)(2): In the
event of a vaccine-related death, an
award of $250,000 for the estate of
the deceased, in addition to the
benefits provided in Sections 15(a)(1),
15(a)(3) and 15 (a)(4). (new words in
italics)
ACCV
VOTE: UNANIMOUSLY SUPPORTED.
-
Parent Petitions for Compensation.
Amendment
to require parent or other third party
to file a petition in the Program before
filing or maintaining a civil action
against a vaccine manufacturer or administrator
in a Federal or State court for damages
relating to a vaccine-related injury
or death, including but not limited
to damages for loss of consortium, society,
companionship or services, loss of earnings,
medical or other expenses, and emotional
distress, and no court may award damages
in such an action unless the action
is joined with a civil action brought
by the person whose vaccine-related
injury is the basis for the parent’s
or other third party’s action.
ACCV
VOTE: 8 FOR; 1 AGAINST (parent rep.):
SUPPORTED.
-
Clarification of Definition of Manufacturer.
Enlarges
the current definition of manufacturer
(42 USC § 300aa-33(3)) to include
any corporation, organization, or institution
(public or private) which manufactures,
imports, processes, or distributes any
component or ingredient of any
vaccine set forth in the Vaccine Injury
Table.
ACCV
VOTE: 7 FOR; 2 AGAINST (parent rep.
and petitioners’ attorney rep.):
SUPPORTED.
-
Clarification of Definition of Vaccine-Related
Injury or Death.
Clarifies
that a component or ingredient approved
for use in a Table vaccine by the FDA
is not to be considered an adulterant
or contaminant for purposes of the Act.
(42 USC § 300aa-33(5))
New
Definition: Vaccine-related injury or
death means an illness, injury, condition,
or death associated with one or more
of the vaccines set forth in the Vaccine
Injury Table, except that the term does
not include an illness, injury, condition,
or death associated with an adulterant
or contaminant intentionally added to
such a vaccine. For purposes of
the preceding sentence, an adulterant
or contaminant shall not include any
component or ingredient listed in a
vaccine’s product license application
or product label. (new words in italics)
ACCV
VOTE: 7 FOR; 1 AGAINST (parent rep.);
1 ABSTENSION (petitioners’
attorney rep.): SUPPORTED.
-
Add Definition of Vaccine to 42 USC
§ 300aa-33.
The
Act currently contains no definition
of “vaccine.” To complement
the above clarifications – that
ingredients and components are not adulterants
or contaminants for purposes of this
Act – the Workgroup recommends
that the Secretary add a definition
of “vaccine” to the Act
that includes all components and ingredients
listed in the vaccines’ product
license application and product label.
ACCV
VOTE: 8 FOR; 1 AGAINST (parent rep.):
SUPPORTED.
11
and 12. Extending the Statute of Limitations
(“SOL”).
The
Workgroup’s goal was to expand
access to the Program; therefore,
it recommends extending the SOL to
correspond to the 8 years of retroactive
coverage when a new vaccine or injury
is added to the Vaccine Injury Table:
-
For vaccine-related injuries:
Extend
the SOL from 3 to 8 years, but make
the Program the exclusive remedy for
any petitioner who files during the
extended period (no opt out). There
would be no change in the current 3
year SOL, including the right to opt
out. However, the Program would be the
exclusive remedy for any petition filed
during the extended 5-year period (year
3-8).
ACCV
VOTE: UNANIMOUSLY SUPPORTED.
-
For vaccine-related deaths:
Extend
the SOL from 2 to 8 years following
a death, with the Program being the
exclusive remedy for the extended 6-year
period (no opt out); and extend the
SOL from 4 to 8 years from injury, with
the Program being the exclusive remedy
from year 4-8 (no opt out).
ACCV
VOTE: UNANIMOUSLY SUPPORTED.
ACCV
Futures Workgroup Round Table Discussion
February
5, 2007
The Jefferson Hotel
Washington, D.C.
Participants:
ACCV
Workgroup Members:
Marguerite
Evans Willner, Workgroup Chair, ACCV Vice-Chair
Tawny
L. Buck
Loren
G. Cooper, J.D.
GlaxoSmithKline Biologicals, SA
Jaime
G. Deville, M.D.
Department of Pediatrics Infectious Diseases,
University of California
Jeffrey
M. Sconyers, J.D.
Children’s Hospital & Regional
Medical Center
Don
L. Wilber, M.D., ACCV Chair
Oklahoma City Clinic
Invited Guests:
Sarah
Despres
Congressman Waxman’s Congressional
Oversight Committee on Government Reform
Chief
Special Master Golkiewicz
U.S. Court of Federal Claims
Karen
Hendricks
Asst. Director, Government Affairs, American
Academy of Pediatrics
Randy
Moss, J.D., WilmerHale
Tom
Powers, J.D., Williams, Love O’Leary,
Craine & Powers, P.C.
Staff: DVIC, Healthcare Systems
Bureau, HRSA
Cheryl
Lee, Principal Staff Liaison
Tamara
Overby, M.B.A., Chief, Policy Analysis
Branch
Staff: HHS Office of the General
Counsel
Elizabeth
Saindon, J.D., Senior Attorney
ACCV
Futures Workgroup
Agenda
Monday, February 5, 2007
9:30 Welcome
Topics:
-
The Original Purposes, Policies, and
Goals of the National Childhood Vaccine
Injury
Act of 1986 (“the Act”)
-
How have the Act and the Table changed
over the last 20 years?
Legislative
Changes to the Act and Agency Rule-Making
Changes
to the Vaccine Injury Table (“the
Table”) (Tamara Overby, M.B.A.)
-
How has the Act been interpreted by
the courts over the last 20 years?
Althen
and Capizzano (relaxed standards of
proof)
-
What impact have these changes had on
petitioners, industry, the Vaccine Injury
Compensation Trust Fund, and those entrusted
with implementing the Program?
-
Does the Act currently fulfill its promises
to stakeholders?
to
petitioners: to provide a no-fault
compensation program in which awards
can be made “quickly, easily,
and with certainty and generosity”
to
industry: to provide a broad measure
of liability protection
to the public (including petitioners):
to perfect vaccines, monitor adverse
events, promote
public health by ensuring a stable vaccine
supply and improving immunization rates
-
Do differing perceptions concerning
the purpose of compensating vaccine-associated
injuries threaten the Program?
-
Does the “Table” reflect
a tension among competing interests
with incompatible goals
and values and disproportionate political
power (Congress, government agencies,
the
general public, petitioners, and industry)?
-
Does the Program provide an “appealing
alternative” to the traditional
tort system?
If not, what are the implications?
-
Discussion of legislative solutions.
5:00
Adjourn.
__________________________
Jeffrey Sconyers, J.D.
ACCV Chair |
________________________
Dr. Jamie Deville
ACCV Vice-Chair
|
__________________________
Geoffrey Evans, M.D.
Executive Secretary, ACCV |
__________________________
Date |
This
information reflects the current thinking of the United States Department
of Health and Human Services on the topics addressed. This information is
not legal advice and does not create or confer any rights for or on any
person and does not operate to bind the Department or the public. The ultimate
decision about the scope of the statutes authorizing the VICP is within
the authority of the United States Court of Federal Claims, which is responsible
for resolving claims for compensation under the VICP.
|
|