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
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