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**National Vaccine Advisory Committee (NVAC)**

**June 7--8, 2007, Meeting Minutes**

[Meeting Overview]{.underline}

The Committee heard presentations on a variety of issues on both days of
the meeting and received reports from Subcommittees and Working Groups
during the second day of the meeting. Presentation topics included
preparations and expectations for the 2007--08 influenza season,
development of the National Vaccine Plan, and a review of funding
through the renamed Strategic Issues in Vaccine Research Program.
Additionally, developments in the international arena from the recent
World Health Assembly and the status of the Omnibus Autism Proceeding in
the U.S. Court of Federal Claims were covered. In addition to reports
from agency, department, and advisory committee liaisons, the second
meeting day featured reports from the Vaccine Financing Working Group
and the Adolescent Immunization Working Group as well as each of the
Subcommittees---Subcommittee on Immunization Coverage, Subcommittee on
Vaccine Development and Supply, Subcommittee on Vaccine Safety,
Subcommittee on Communication and Public Engagement, and Subcommittee on
Public Communication, Consultation, and Participation.

[Committee Members in Attendance]{.underline}

> Gary L. Freed, M.D., M.P.H.---*Chairperson*
>
> Jon R. Almquist, M.D.
>
> Guthrie S. Birkhead, M.D., M.P.H.
>
> Cornelia Dekker, M.D.
>
> Mark Feinberg, M.D.
>
> Jaime Fergie, M.D., F.A.A.P.
>
> Lance K. Gordon, Ph.D.
>
> Alan R. Hinman, M.D.
>
> Sharon G. Humiston, M.D., M.P.H.
>
> Calvin Johnson, M.D., M.P.H.
>
> Charles Lovell, Jr., M.D., F.A.C.P.
>
> Andrew T. Pavia, M.D.
>
> Laura E. Riley, M.D.
>
> Adele E. Young, Ph.D.

[Executive Secretary]{.underline}

> Bruce G. Gellin, M.D., M.P.H., Director, National Vaccine Program
> Office (NVPO)

[NVAC Ex Officio Members]{.underline}

> Neal Brandes, United States Agency for International Development
> (USAID)
>
> George Curlin, M.D., National Institutes of Health (NIH)
>
> Geoffrey Evans, M.D., Health Resources and Services Administration
> (HRSA)
>
> Jeffrey Kelman, M.MSc., M.D., Centers for Medicare & Medicaid Services
> (CMS)
>
> Captain (USPHS) Anne Schuchat, M.D., Centers for Disease Control and
> Prevention (CDC)
>
> Ronald Valdiserri, M.D., M.P.H., Department of Veterans Affairs (VA)

[Liaison Representatives]{.underline}

> Jon S. Abramson, M.D., Advisory Committee on Immunization Practice
> (ACIP)
>
> Wayne Rawlins, America\'s Health Insurance Plans (AHIP)
>
> David Salisbury, CB, FRCP, FRCPCH, FFPHM, United Kingdom Department of
> Health

[Committee Members Absent]{.underline}

> Jerome O. Klein, M.D.
>
> Mary Beth Koslap-Petraco, M.S., C.P.N.P.
>
> Trish Parnell

[Invited Speakers]{.underline}

> Dr. David Bell, HHS
>
> Ms. Emily Marcus Levine (HHS/OGC)
>
> Dr. Gina T. Mootrey, CDC
>
> Dr. Jeanne Santoli, National Center for Immunization and Respiratory
> Diseases (NCIRD)
>
> Dr. Benjamin Schwartz, NVPO
>
> Dr. Raymond A. Strikas, NVPO

**Opening Session---Dr. Cornelia Dekker**

Dr. Cornelia Dekker welcomed Committee members on behalf of Dr. Gary L.
Freed, who was unable attend the first day of the meeting, and indicated
that she would be chairing the meeting in his stead. Dr. Dekker then
invited all participants to introduce themselves and asked Committee
members to indicate any new conflicts of interest since the Committee
last convened. As a final administrative item, the Committee unanimously
approved the minutes from its February 7--8, 2007, meeting.

**Welcome From HHS Assistant Secretary for Health**

ADM John O. Agwunobi, Assistant Secretary for Health, added his welcome
and thanked Dr. Dekker for acting as chairperson in Dr. Freed\'s
absence. He informed the Committee that he would meet with Dr. Freed on
June 8 to discuss NVAC\'s progress. He also indicated that Dr. Bruce G.
Gellin would update the Committee on NVPO\'s activities as well as
provide an overview of HHS activities.

Dr. Agwunobi then expressed his gratitude to NVAC for its service to the
Nation, describing its work as the \"point of our spear\" in disease
prevention. He acknowledged that despite the tremendous return on
investment demonstrated by vaccination, investment in immunization is
not emphasized accordingly, an issue that the HHS is working to address.
However, he also recognizes that the vaccine financing system is
evolving, and significant opportunities exist at the State, local, and
private levels to provide guidance on improving vaccine financing. For
this reason, he indicated his anticipation of the report from the
Vaccine Financing Working Group. In addition to financing issues,
vaccine safety remains a high-priority issue from the HHS perspective.
He closed by thanking the Committee once more, this time on behalf of
his children.

[]{.mark}

**National Influenza Vaccine Summit---Dr. Gina T. Mootrey, CDC**

The Committee next heard from Dr. Gina T. Mootrey about the National
Influenza Vaccine Summit, held this year on April 19--20. The Summit has
been held yearly since 2001 and is cosponsored by the American Medical
Association (AMA) and the CDC. Designed as a forum to discuss influenza
vaccine issues with a broad stakeholder base, the recent meeting
attracted 190 people representing 74 organizations.

Dr. Mootrey began by sharing one of the meeting highlights, which is
manufacturers\' estimated production of influenza vaccine for the
2007--08 season----at up to 132 million doses, it is the largest
projected vaccination production to date. One point made at the summit
is that increasing the number of doses of seasonal influenza vaccine is
good preparation for a pandemic event. In addition, the meeting featured
presentations on initiatives to increase public awareness and vaccine
uptake. The NFID Pediatric Influenza Immunization Coalition presented
its plans for a series of messages, events, and public relations
materials to educate families and providers and thereby increase
pediatric coverage. The American Lung Association presented its Faces of
Flu campaign and discussed with the CDC the possibility of either
expanding the Flu Clinic Locator program or developing another mechanism
to publicize and increase access to clinics.

Dr. Mootrey noted that in presentation on 2007 ACIP influenza,
recommendations showed that age and risk groups for whom routine
vaccination is recommended has not changed compared to the 2006
recommendations, which translates to 220 million people (73 percent of
the population) being recommended for annual influenza vaccination. At
the summit, there was discussion about moving toward universal influenza
vaccination. Accordingly, the statement from the summit emphasizes
vaccination for all people, including school-age children, as opposed to
limiting vaccination to high-risk groups.

Another perennial topic of interest at the summit is vaccine
distribution and perceptions of differential distribution. This year,
manufacturers provided CDC\'s 2006--07 influenza vaccine distribution
data, which are intended to enhance the visibility of influenza vaccine
distribution for State and local health officials to assist in their
management of influenza vaccine. These data were mapped to a number of
variables, including State, ZIP Code, national drug code number of
doses, and provider type. Dr. Mootrey shared the distribution data by
provider type, which show that private providers have the greatest
vaccine distribution at 43 percent. She contrasted the relative
stability of this percentage through the course of the vaccine season
with that of other providers for whom there was either an increase or
decrease in distribution over time.

Dr. Mootrey then noted the influenza vaccine legislation being
considered at both the State and Federal levels. Within the Federal
Government, the types of legislation proposed are on the topics of
distribution/priority groups, pandemic influenza, appropriations, and
thimerosal, while State-level legislation is broken down into finer
categories. At the summit, there was a great deal of concern about
legislation targeting specific provider groups, which was perceived as
amounting to preferential treatment. Summit participants expressed a
desire to have further action in this area, which led to creation of a
related action item.

Another agenda item that received much discussion at the summit was the
presentation of recipients of the 2006 Summit Immunization Excellence
Awards, who were chosen for their efforts to increase demand for
vaccination through partnerships with the community, with healthcare
workers, and with schools, respectively. Dr. Mootrey profiled each of
the awardees:

-   Getaflushot.com is a winter season flu shot campaign that provided
    an example of a nontraditional partnership; in this case, with the
    Oregon Food Bank. Over the course of 3 weeks, 9 free flu shot
    clinics administered 625 shots to individuals who provided money or
    food to the food bank.

-   The Virginia Mason Health System is in its second year of a
    mandatory vaccination campaign. This large healthcare system in
    Seattle, Washington, employs 480 physicians and 5,000 full-time
    equivalents. The campaign was implemented after the company held a
    series of workshops on improving delivery of vaccine to its staff
    from the current rate of 30 to 50 percent. The mandatory program
    includes physicians, vendors, volunteers, and contingent labor, and
    although staff could request exemption on religious or medical
    grounds, they had to wear a mask at work the entire flu season if
    their request was approved. In addition, the system used some
    innovative delivery sites, including drive-through clinics and
    Seattle Seahawks sports events to increase uptake. In the last 2
    years, the health system has had 98-percent compliance with the
    immunization policy.

-   The Maryland Elementary School Influenza Vaccination Project is a
    statewide school influenza vaccination project targeted to 5- to
    11-year-olds beginning in the 2006 flu season. With support from
    MedImmune, the CDC, and the State of Maryland, the project did not
    place any charges on parents or local schools. Vaccines were
    administered under two models: One in which children received
    vaccination during schools hours and the other in which parents
    brought their children to school during nonschool hours to receive
    vaccination. Although the models have not yet been compared in terms
    of effectiveness, the aggregate project result was distribution of
    more than 114,000 vaccine doses, with some counties vaccinating more
    than 40 percent of children in the target age group.

Increasing vaccine coverage through other activities, such as the
National Influenza Vaccination Week, was also a topic of discussion at
the summit. The result was that participants called for simple, clear
messaging to be disseminated to avoid confusion.

Action items resulting from the 2007 Summit are to (1) improve coverage
of healthcare workers, (2) encourage an informal legislative task force
that will educate legislators about vaccination as they review proposed
legislation, and (3) develop a single, consistent statement on when and
whom to vaccinate that is consonant with CDC recommendations. In
closing, Dr. Mootrey shared with the Committee the final summit
statement, which encourages that \"influenza vaccine be administered to
all people...who want to reduce their likelihood of becoming ill with
influenza or transmitting influenza to others.\"

***Discussion***

Committee members initiated discussion by offering feedback on the
summit statement on influenza vaccination. Dr. Guthrie S. Birkhead
expressed concern that the statement might cause some confusion as it
does not even allude to high-risk groups. Dr. Dekker added her concern
that the language in the summit statement about continuing immunization
\"until the vaccine supply is used up\" suggests a goal of exhausting
the vaccine supply rather than preventing influenza. Dr. Mootrey
welcomed their input.

Dr. Jaime Fergie inquired whether the Virginia Mason Health System
encountered legal challenges with their mandatory vaccine campaign. Dr.
Mootrey replied that their position has been upheld in ongoing
discussions with labor unions. She added that a few individuals left the
system in the first year the policy took effect, but there were no staff
departures for this reason in the subsequent year. Dr. Adele E. Young
then asked whether demonstrated sustainability is a criterion of the
Summit Immunization Excellence Awards. Dr. Mootrey affirmed that the
project\'s sustainability is considered in award decisions and
highlighted that the Virginia Mason campaign is in its second year and
is planned to continue.

Discussion turned to the influenza vaccine distribution data. Dr.
Birkhead asked whether there was any explanation for the vaccine
distribution patterns over time (for example, it appeared that state
health departments had delayed distribution compared to other sectors)
and if strategies to rectify the instability had been considered. Dr.
Greg Wallace responded that the CDC has shared these data with
manufacturers and is working with them on balancing distribution. In one
case, a manufacturer put language into its contract about treating
provider groups equally and reporting to the CDC on how this was
accomplished. Dr. Gellin noted that Dr. Mootrey presented aggregate data
for manufacturers and distributors, which led him to ask if there are
some companies that stand out in distribution inequity. Dr. Wallace said
that this is indeed that case, and the CDC is working with these
companies in particular.

Dr. Andrew T. Pavia asked when the CDC might be able to provide
real-time rather than retrospective vaccine distribution data, given
that the former would be more helpful to stakeholders. Dr. Wallace
responded that the CDC did provide aggregate, national-level data to
grantees on a weekly basis in the past season, but limited staffing and
resources present challenges to continuing this service. Dr. Jeanne
Santoli added that although the CDC cannot provide this national-level
data in real time, there are local-level data available during the
influenza season to help public health officials remain informed in
their communication with the media and the public. However, the past
season was the first year that the data were complete and available all
year, and only 40 domestic grantees requested access. CDC is aware of
the need to increase public awareness of the resource. She also reported
that CDC has surveyed current data users to assist with the development
of guidance on data use and managing supply problems. Dr. Gellin
concluded that the issue of distribution data and the CDC\'s system may
need to be addressed again at NVAC\'s fall meeting as Committee members
likely have questions that are difficult to answer at this juncture.

The Committee then considered the role of NVAC in the National Influenza
Vaccine Summit. Dr. Mootrey indicated that NVAC has no formal
relationship with the summit although Dr. Raymond A. Strikas from NVPO
does participate in summit calls. She suggested that a more active role
for NVAC would be desirable; for instance, to propose agenda items or to
send members to attend in an official capacity. Dr. Anne Schuchat
affirmed the need for NVAC involvement in the summit because it has
evolved into a strategic policy group.

**Action Item:** The Committee responded with a motion, unanimously
approved, to send an NVAC representative to the 2008 National Influenza
Vaccine Summit.

**World Health Assembly Pandemic Influenza Preparedness Resolution---Dr.
David Bell**

Dr. David Bell began by providing background to the resolution. (A copy
was provided to Committee members in their agenda books.) In January
2007, Indonesia ceased sharing its human H5N1 specimens with the WHO
surveillance network on the grounds that the country does not receive
any benefit related to its sharing; namely, vaccines produced with the
samples. Because Indonesia has the largest umber of human specimens of
the H5N1 virus of any country, the inability to monitor evolution of
virus there is of great concern. Although there were attempts to resolve
the crisis in early 2007, no new agreement was reached, and the issue
surfaced as a major topic of the World Health Assembly on May 23, 2007.

Debate during the assembly centered around the Indonesians\' assertion
that the 1992 Convention on Biologic Diversity, which the United States
signed but did not ratify, upholds its argument. They also pointed to
the International Treaty on Plant Genetic Resources for Food and
Agriculture as a model of the type of agreement they are seeking. The
treaty\'s key provision relevant to this debate is that countries who
share a plant genetic resource with the international community will
receive a portion of the monetary benefits generated through commercial
use of that resource via a fund that promotes sustainable agriculture in
the country of origin. In rebuttal, the WHO\'s chief legal counsel
invoked language from the 2005 International Health Regulation that
requires States to facilitate the transport of \"biological substances
and diagnostic specimens, reagents and other diagnostic materials for
verification and public health response purposes.\"[^1] However, the
Iranian delegate, arguing on behalf of Indonesia, countered that because
the 1992 convention predated the 2005 IHR, their argument stood.

The assembly did succeed in crafting a compromise resolution that
reiterates key principles on international sharing and lays out next
steps for the WHO, but it by no means offers a final resolution. The
document proposes multiple revisions to the WHO terms of agreement for
the surveillance network, including (1) sharing viruses within the WHO
network in a timely fashion but directing requests for use of virus
outside the network to the home country; (2) developing new mechanisms
for sharing commercial product benefits, particularly with developing
countries; (3) increasing the number of vaccines that are available at
an affordable price; (4) increasing production; and (5) establishing an
international stockpile of vaccines. Perhaps the most controversial of
these proposals is to commission a study of the extent to which a virus
or gene can be considered a biological resource over which countries can
claim sovereign rights.

Dr. Bell stated that although the debate is limited for now to the
influenza virus, there is the potential for a new agreement that extends
to all microbes, including specimens in other outbreak investigations.

Dr. Bell reported that the U.S. Government currently is engaged in
discussing what position to take on this issue and considering
implications for public health as well as trade and patenting.
Historically, the United States has held positions in the international
arena that favor intellectual property rights over public good, so a
divergence from that stance would require a new negotiating position for
the Government. For the present time, however, the issue remains
unresolved, and Dr. Bell indicated that it is likely to be faced by the
World Trade Organization and the World Intellectual Property
Organization, among others. In the midst of the debate, of course, the
challenge of protecting public health remains.

***Discussion***

Dr. Gellin opened the discussion by reiterating that the U.S. Government
is engaged in this debate at the highest levels. Thus, while it is not
clear that NVAC needs to take any action on the issue, he wanted members
to be updated on the recent events.

Dr. Wayne Rawlins expressed apprehension that the direction of the
discussion could portend epidemics that are entrepreneurial activities
resulting in delayed vaccine administration. Dr. Bell stated that this
is a possible scenario; alternately, the result could be that when
selecting strains for vaccine development, researchers will be limited
to those that are not embroiled in legal battles. He cautioned that the
impact of the final outcome easily could spread beyond the H5N1 virus.
Dr. Jon S. Abramson commented that the original H5N1 virus is not
patented and questioned the legal basis of patenting variations of the
existing virus. Dr. Bell responded that this is the very issue on which
patent office lawyers are working; they are currently trying to
determine whether the H5N1 variation is different enough to render it
unique.

Dr. George Curlin asked if the assembly discussion referenced genes or
only the virus strains. Dr. Bell replied that assembly attendees, who
are not scientists, used the term \"samples\" but also made imprecise
references to genes and sequences. Dr. Bell said he considers it likely
that any sharing decisions would affect genetic sequences in the same
way as viruses. Dr. Curlin then stated that the NIH Influenza Genome
Sequencing Project has a public database containing hundreds of
thousands of influenza strains. Though some of those strains may no
longer be relevant for commercial development, he is concerned about the
status of those viruses given the current of the discussion. Dr. Bell
replied that there is awareness of Dr. Curlin\'s concerns, and NIH
representatives are heavily involved in the discussions.

In response to Dr. Mark Feinberg\'s question about how the debate may be
resolved, Dr. Bell outlined the process that will lead to an WHO
executive board meeting on the topic in 6 months\' time. The WHO will
begin with a meeting on the proposal to revise the terms of reference
for laboratories; all other proposals for the revised agreement will be
addressed at an intergovernmental meeting in October, with a report to
the executive board in January and to the World Health Assembly in May
2008. Dr. Bell expressed doubt that the WHO can adhere to this ambitious
timeline, a sentiment that Dr. Pavia shared based on the fact that past
international agreements of similar complexity have taken over a decade
to resolve. Dr Pavia also commented that given the anticipated profound
impact of the WHO\'s decision on influenza and other vaccine
development, it would be advisable for NVAC to receive future updates,
particularly on the issues of (1) intellectual property as it affects
vaccine development, (2) patenting of genes, and (3) transport of
organisms.

**2007--08 Influenza Season---Dr. Jeanne Santoli**

Dr. Jeanne Santoli presented on expectations for the 2007--08 influenza
season. Notable highlights of the 2007 ACIP recommendations are the
change to the vaccine composition to include the new H1N1 component and
continued recommendation against the use of adamantanes because of
resistance prevalence. Although there is no change in recommended groups
for vaccination, the recommendation\'s revised format emphasizes the
permissive component. Another significant change is the recommendation
to give young children two doses in the second influenza season if they
only received one in the first season. This change is based on new data
suggesting that young children receive less benefit if they do not
receive two doses of vaccine both years, and this is true when the
vaccine strain changes as well as when it does not.

Another highlight of the recommendations is the emphasis on the need to
continue vaccination beyond the traditional months of October and
November. Surveillance data for 30 seasons of U.S. influenza activity
show that peak disease activity in the United States occurred in January
or later for 80 percent of the seasons and February or later for 60
percent of the seasons. The recommendation is to vaccinate as soon as
possible and continue vaccination beyond January, and there is no longer
a specific statement that October and November are optimal vaccination
months. Providers will be encouraged to suggest flu vaccine at all
visits, and media campaigns will similarly be encouraged to extend
campaigns beyond December. Finally, Dr. Santoli highlighted the
recommendation\'s emphasis on vaccinating healthcare workers. Notably,
the recommendations now include strategies to achieve higher rates of
immunization and proposed changes for the Joint Commission on
Accreditation of Healthcare Organizations policy.

Dr. Santoli emphasized that influenza recommendations are not static,
and a number of major changes have been made in the recommendations over
the last 7 years, including expansion of the adult and child populations
recommended for vaccination. Within the next 5 years, it is possible
that the recommendations will be expanded to all school-age children and
their caregivers, with universal vaccination on the horizon as well.
Consideration of issues around vaccination of school-age children will
occur at a meeting scheduled for September 10--11, 2007, which will be
preceded by a working meeting to examine the evidence base, identify
data gaps, and discuss implementation.

Dr. Santoli then reviewed the influenza vaccine supply estimate and
cautioned that while it does exceed the 2006 supply by 10 million doses,
production at this level depends on demand, which is gauged by the
ordering process, for which data are not yet available. Nevertheless,
the number of estimated doses still could rise because another
manufacturer has applied for a vaccine license, which would increase the
number of doses. Supplies of p-free, injectable vaccine for young
children are expected to be the same this season as last, but an
increased quantity of the live attenuated influenza vaccine (LAIV) is
projected, pending approval of MedImmune\'s application for lowering the
age indication.

Dr. Santoli next described CDC\'s public relations campaign for the
upcoming influenza season, which has three major goals: (1) Promote
vaccination to ACIP-recommended groups, (2) generate vaccine demand
among the general public, and (3) change attitudes regarding the
vaccination season. In addition to directed messages at the usual target
population, CDC is focusing on a growing population share of working
adults, commuters and travelers, and mothers. Core campaign elements
will extend beyond traditional avenues (print materials, etc.) to
include new media; i.e., healthcare Weblogs.

A key precursor to CDC\'s communications campaign is formative research
with urban-based focus groups on late-season messages and vaccine
mismatch messages. Participants comprise Blacks and Whites and include
individuals who normally receive vaccines (\"doers\") as well as those
who do not (\"nondoers\"). Dr. Santoli shared some preliminary results
from the study.

-   Participants remember past messages regarding vaccination season and
    still think of October and November as the prime vaccination months.

-   Messages about the timing of disease peak raised questions among the
    groups about immunity \"lasting\" through season and the freshness
    of the vaccine.

-   Emphasis on the permissive component raised skepticism, particularly
    whether there will be enough and whether this is simply a marketing
    ploy.

-   Messages about vulnerable household contacts were highly motivating
    to \"nondoers.\"

She also reported that participants found an article on vaccine mismatch
to be too difficult to comprehend despite the fact that it was written
for a lay audience. This experience underscores the challenges in
developing clear communication to the public about vaccine mismatch.

CDC\'s communication campaign will launch during Vaccine Week. Planned
activities include flu mobile stops (based on the CMS Part D bus tour)
to promote late-season vaccination messages, public relations releases
and media tours, and release of an online toolkit and calendar.

***Discussion***

In response to Dr. Peggy Rennels\' inquiry about why mothers in
particular are being targeted, Dr. Santoli clarified that the center is
interested in reaching out to mothers as they are often the ones who
make healthcare decisions for the family; nevertheless, the intent is to
include all family members in the campaign. She also clarified, in
response to questions from several participants, that high-risk groups
(i.e., pregnant women and healthcare workers) will not be excluded from
the campaign though not targeted specifically. Dr. Alan R. Hinman
suggested that publishing the effectiveness of the Virginia Mason Health
System\'s program could be a catalyst for increased coverage among
healthcare workers. Finally, regarding expansion of the campaign to
include messages about LAIV, Dr. Santoli confirmed that the center is
preparing appropriate materials in the event that the LAIV
recommendations are expanded.

Ms. Sarah Landry lauded changes in the CDC campaign regarding the timing
of the vaccination season. However, she noted that this presents
inconsistencies with pandemic flu guidance that is disseminated to
States---in past seasons, States were required to perform mass
immunization flu drills before the end of November. She suggested that
this pandemic influenza guidance be modified in the next iteration to
reinforce the message of vaccination season expansion. Dr. Santoli
affirmed the importance of her point and said that CDC is working to
better coordinate routine flu season messages with pandemic flu
messages.

**Update on Omnibus Autism Proceeding in the U.S. Court of Federal
Claims---Ms. Emily Marcus Levine**

Ms. Emily Marcus Levine briefed the Committee on the Omnibus Autism
Proceeding in the U.S. Court of Federal Claims. She began by summarizing
the case development, which began in 2001. Since that time, over 5,100
parents filed petitions with the National Vaccine Injury Compensation
Program (VICP) alleging that the measles, mumps, and rubella (MMR)
vaccine, the thimerosal contained in other covered vaccines, or a
combination of these two factors caused autism spectrum disorders in
their children. Under normal circumstances, VICP petitions are heard
individually, but given the number of petitions filed on a similar
issue, they were moved into an omnibus vehicle with a petitioners\'
steering committee formed to represent claimants. In 2006, the chief
special master altered the format of the omnibus proceeding to
accommodate the petitioners\' wish to pursue the three causation
theories independently with three special masters each presiding over a
test case with respect to each of the causation theories. Ms. Levine
noted that resolution of these cases has been delayed beyond the initial
anticipated timeframe to accommodate petitioners' discovery requests.
Also in the intervening period, some petitioners chose to drop their
case or to pursue cases against vaccine manufacturers in the civil
courts. Therefore, of the cases filed, 4,800 still await adjudication.

Three test cases representing each causation claim have been chosen, and
experts selected from both sides. Ms. Levine informed the Committee that
despite petitioners\' argument against it, the presiding special master
ruled that the hearings are subject to the Supreme Court's *Daubert*
decision, which states that expert testimony on scientific matters must
be scientifically reliable. The first test case is for the combination
causation theory and will be heard beginning on June 11, 2007. Hearings
for the remaining two causation theories have not yet been scheduled.
Ms. Levine stated that three separate decisions on each of the causation
theories are expected. If the petitioners are not satisfied, each of the
decisions may be appealed up to the Supreme Court.

Given the expected number of attendees at the public hearing, other
methods of access have been made available: Via phone, audio broadcast
on the Web, or transcripts on a 1-day delay. Ms. Levine directed
Committee members to the U.S. Court of Federal Claims Web site at
<http://www.uscfc.uscourts.gov/OSM/OSMAutism.htm> for more information
on the case and for instructions on how to access the hearings.

***Discussion***

[]{.mark}

Dr. Abramson expressed pleasure that the scientific bar for expert
testimony is being set high. He then inquired whether petitioners can
take their case outside of the VICP after following the prescribed
appeal process. Ms. Levine responded that petitioners will have two
options: To pursue their case individually through the VICP or pursue
litigation against manufacturers in the civil courts as some have
already elected to do. Dr. Abramson further asked if decisions made in
these cases will set a strong legal precedent. Ms. Levine clarified that
special masters\' decisions are not precedent setting; such decisions
must come from the Federal Circuit. In addition, limitations on civil
actions in the Vaccine Act dictate that the findings of special masters
are not admissible in subsequent civil cases.

Dr. Pavia inquired whether, given the complexity of the legal
proceedings, there will be a way for interested parties to obtain an
intelligent summary of the proceedings either daily or weekly. Ms.
Levine responded that this may be possible through the Vaccine Safety
Research Office listserv. Dr. Gellin agreed to raise the possibility
within the HHS to determine any legal barriers to fulfilling Dr.
Pavia\'s request. Ms. Levine also informed the Committee that the Court
provides frequent updates on its Web site, but the daily agenda has not
been publicized.

Dr. David Salisbury referenced a petition by the U.S. Government to the
High Court in London to release four academic reports on measles
virology used in a failed class action litigation against manufacturers
of the MMR vaccine. The litigation failed because public funding was
withdrawn on the basis that there was not sufficient evidence to justify
the case coming before the court. However, the documents produced as
evidence remained under the court\'s jurisdiction. The petition by the
U.S. Government was to release the documents to them to be used in the
omnibus case, and a decision was expected on June 6. On the second day
of the meeting, Dr. Salisbury reported that the court had agreed to
release the reports to Secretary Michael Leavitt.

Ms. Jennifer Zavolinsky reported that Every Child by Two recently held a
briefing for journalists on the omnibus proceedings, with several
experts providing an overview of the issue. Transcripts of the briefing
are available and can be sent to NVAC members. She added that she
expects related articles to be published in The Washington Post, The New
York Times, and USA TODAY in the next few weeks.

**NVPO Strategic Issues in Vaccine Research Funding Program---Dr. Ben
Schwartz**

Dr. Ben Schwartz reported on the renamed Strategic Issues in Vaccine
Research (SIVR) Program, formerly the Unmet Needs Program. The new name
is intended to be more descriptive of the program goal, which remains
unchanged. He began his report with the results of the FY 2007 proposal
review process. Agency scientists submitted 54 proposals, which were
reviewed in a two-step process that was streamlined for FY 2007. A total
of 31 projects were funded from a pool of over \$4 million, with an
average award of \$129,000. Of these projects, 19 were continuation
projects in one of the previous year\'s priority topic areas, and 12
projects are new proposals in one of the 5 priority areas for 2007
established with NVAC input: Vaccine safety, adolescent vaccination,
vaccine economics and financing, public engagement, and improved
diagnostic tests for vaccine-preventable diseases (VPDs). Notably, nine
of the new projects included interagency collaborations, a real success
of the program.

Dr. Schwartz then described some of the new proposals funded within each
new priority area.

-   Adolescent vaccination: The program funded a proposal to evaluate
    the scientific basis for adolescent MMR vaccination. The
    applicant\'s thesis is that for a cohort of individuals susceptible
    to mumps, additional vaccination may be needed to provide immunity.

-   Vaccine safety: One funded proposal---a collaboration among the CDC,
    NIH, and FDA---is to study the genetic basis for vaccine safety.
    Another collaboration project between CMS and FDA is to rapidly
    assess flu vaccine safety by weekly analysis of Medicare database
    for adverse events.

-   VPDs: A new proposal was funded to develop a rapid human
    papillomavirus (HPV) antibody test that will assist developing
    countries to determine efficient use of an expensive vaccine.

-   Public engagement: The funded proposal in this area is on
    communication targeted to Native American and Asian youth.

-   Vaccine economics and financing: The funded proposal in this area is
    on the impact and cost-effectiveness of HPV vaccination.

Dr. Schwartz concluded that as a whole, the 12 new projects will advance
the field incrementally but do not represent a single large focus.
Instead, the program is supporting research in many different areas. He
also highlighted the distribution of proposals across topic area, noting
that

a small number of proposals were received in the areas of public
engagement and vaccine economics and financing relative to the other
topic areas.

Relevant to its supported research projects, the SIVR Program has a goal
to improve monitoring, evaluation, and information sharing. Implementing
6-month and end-of-project progress reports, updates 1 and 2 years
postcompletion (i.e., publications and followup activities), and an
SIVR-sponsored seminar series are under consideration.

Dr. Schwartz closed by soliciting Committee member input to the program
in the response to the following questions:

-   Should the program retain the same priority topics?

-   Are there comments on the revised review process or suggestions for
    improvement?

-   Should the review timeline be maintained or moved earlier in the
    calendar year?

With regard to the issue of timeline, Dr. Schwartz commented that
investigators do not receive funding until May of the fiscal year under
the current review timeline. Thus, he proposed moving the process
earlier in the year so that solicitation occurs in late August and the
review is held in early December. He added that some NVAC members
already have indicated their willingness to come to Washington for a
separate review meeting in the fall instead of waiting until the
regularly scheduled NVAC meeting in February 2008.

***Discussion***

The Committee discussed each of the questions on which the SIVR Program
sought its feedback. On the issue of priority setting, Dr. Dekker
advised that discussion begin with the Subcommittee meetings and that
full Committee discussion occur following reports from the Subcommittee
chairs, where initial suggestions could be shared. Some questions
emerged regarding the parameters for the priority-setting activity, and
subsequent discussion clarified the following points:

-   NVAC is not limited to five priority areas. However, there has been
    discussion at the program level about decreasing the total number of
    priorities as well as focusing the topic areas.

-   Subcommittees should limit their discussion of priorities to topics
    that fall within their purview, understanding that important issues
    outside the focus of the Subcommittee will need to be raised in the
    full Committee discussion.

-   The Committee should focus on identifying topics that need to be
    addressed, and NVPO will work on matching the topic area to the
    appropriate agency.

-   International research on vaccine is important to the program and
    may be included in proposed priority topics.

Dr. Abramson raised the topic of research on prevaccination in
anticipation of an H5N1 pandemic, characterizing this as a strategic
issue that he is not sure is being formally addressed by any one agency.
Dr. Gellin responded that the agencies represented at NVAC likely have a
number of activities that are not known to NVAC members. He suggested
that during the agency reports the following day, NVAC members
articulate questions that they have about specific activities, and the
agencies can map their responses accordingly.

Discussion continued with feedback from Dr. Sharon G. Humiston and Mr.
Neal Brandes on the streamlined review process; both members lauded the
process as much improved. With regard to the proposal for earlier
initiation of review, Dr. Schuchat commented that the applicants could
get an earlier start on their proposals if the Committee established
clear priority areas for FY 2008 during this meeting. Dr. Hinman agreed,
noting that Dr. Schwartz\'s presentation underscored the impact of the
priorities on proposal topics.

Dr. Lance K. Gordon asked whether publishing the solicitation earlier in
the calendar year is expected to shorten the timeframe between proposal
submission and initiation of funding. Dr. Schwartz clarified that he
expects the greatest decrease in time elapsed between the review and
investigators receiving their funding. Dr. Curlin commented that an
earlier timeline will also benefit the interagency funding process,
which is driven by the calendar year.

**Action Item:** The Committee suggests that the streamlined review
process be used again in the FY 2008 review. Dr. Hinman made a motion to
alter the review schedule timeline as follows: Solicitation publication
in late August, proposals due in mid-October, and a review committee
meeting in December. His motion was seconded and unanimously approved.

In response to a question about whether the program foresees an increase
in its funding, Dr. Gellin stated that the NVPO increasingly has to make
the case for the impact of the program, which is partly what motivated
the program\'s name change. The NVPO continues to highlight program
accomplishments, but the budget has not been expanded. Dr. Pavia
suggested a good rationale for an increased program budget would be
demonstrated return on the initial investment through the program\'s
support of vaccine research.

Dr. Gordon sought information on whether the program\'s consideration of
improvements to monitoring, evaluation, and information sharing includes
a mechanism for NVAC to receive project progress reports. Dr. Schwartz
replied that these improvements are just now being considered but agreed
that keeping NVAC informed of the success coming out of the program is a
good idea, particularly given the Committee\'s participation in the
proposal review process. Dr. Hinman shared the opinion that 6-month
progress reports would be useful to keeping NVAC updated although Dr.
Schuchat cautioned that 6-month progress reports may not yield very
interesting information because awardees will be in the very early
stages of their work. Dr. Gellin concluded that Committee members are
interested in receiving feedback on the impact of the program and that
real-time results may not be necessary to do this.

Dr. Young asked whether, given the limited number of proposals submitted
in the areas of public engagement and vaccine economics and financing,
the program should include other agencies in the solicitation. Dr.
Schwartz responded that the SIVR Program has been targeted to the HHS,
USAID, and DoD as a result of the legislation that created the NVPO. He
noted that there have been improved proposals in these areas from FY
2006 to FY 2007, and they are continuing to discuss methods to stimulate
interest in these topic areas. As there was further interest among
Committee members about which agencies were submitting proposals and
being funded, Dr. Gellin offered to provide members with a list of the
FY 2007 proposals organized by submitting agency.

On the topic of collaboration, Dr. Humiston suggested two additional
collaboration vehicles: (1) Designating an NVAC working group as a
Federal agency that CDC could collaborate with and/or (2) allowing a
Federal agency to collaborate with an academic economist to increase the
number of financing research proposals.

On a separate point, Dr. Curlin stated that the original program was
intended to emphasize its function as a source of funds for emergency
needs and unanticipated issues in the vaccine area; for example, program
funds were tapped for pertussis research on an emergency basis. Dr.
Schwartz allayed Dr. Curlin\'s concern that the name shift signaled a
movement away from this role by affirming that the program\'s philosophy
has remained the same.

At the close of this discussion, the full Committee adjourned, and
members broke into their assigned Subcommittee meetings, which
constituted the remainder of the meeting for the day.

**Report From the Chair**

Dr. Freed opened the second day of the meeting with thanks to Dr. Dekker
for chairing in his absence while he attended his son\'s graduation
ceremony. He commented that he was struck during the ceremony by the
historic nature of immunization and the fact that many of those students
and their parents would not have been there if not for the reduction of
morbidity and mortality brought about with the advent of mass
immunization. This realization underscored to him the importance of
NVAC\'s work.

**Agency, Department, Advisory Committee, and Liaison Reports**

**VICP---Dr. Geoffrey Evans**

Dr. Geoffrey Evans reported that the VICP has been receiving
approximately 160 non-autism claims per year. He attributed the recent
increased number of influenza vaccine claims to the upcoming 2-year
deadline of July 1 for filing of claims dating back 8 years (from July
1, 2005, the effective date of coverage) whenever a new vaccine is added
to the VICP. Nevertheless, there have been fewer influenza vaccine
claims than expected given the fact that tens of millions of doses are
administered each year.

**Advisory Commission on Childhood Vaccines (ACCV)---Ms. Marguerite
Willner**

The ACCV is an independent advisory commission created by the National
Childhood Vaccine Injury Act to advise and make recommendations to the
Secretary on matters related to the implementation of the NVICP. Ms.
Marguerite Willner reported that the ACCV recently heard from members of
the public about concerns with the program. Although the program was
designed to provide a simple mechanism for compensation, the public
expressed concern that the claims take too long to process. Another
subject of criticism was the statute of limitations for a claim, which
is 3 years from the first symptom of manifestation of injury. Ms.
Willner stated that the Workgroup was very concerned with this short
timeframe that could be considered unfair for developing children, in
which it may be difficult to identify developmental delays.

In response to these and other concerns, the ACCV formed a Workgroup to
develop a set of legislative recommendations to improve the program.
This Workgroup comprised a diverse group of representatives although Ms.
Willner noted that the major activist organization on behalf of
vaccine-injured children declined participation. During regular meetings
over the course of several months, the Workgroup reviewed ideas and
feedback from petitioners, constitutional lawyers, and the American
Academy of Pediatrics, among others. The Workgroup\'s product was 12
legislative recommendations to improve the program that received
overwhelming support at the next meeting of the full ACCV, with 8 of the
recommendations unanimously approved. Based on these results, the ACCV
wrote a letter to Secretary Leavitt (provided in Committee agenda
books)---Ms. Willner added that this marks the first occasion since the
program\'s initiation that the ACCV has felt compelled to do so. The
letter contains the 12 legislative recommendations approved by the
Committee and urges Secretary Leavitt to bring them before Congress.

***Discussion***

Dr. Hinman expressed concern that parents were not involved in the
Workgroup\'s discussions and asked if their lack of involvement might
hinder reformation of the Act, especially since the act was created
primarily through the efforts of parents. Dr. Evans responded that there
has been less participation in the political process by the main
activist group because there have been no major changes to the act since
the 1980s. Ms. Willner added that her conversations with representatives
from this group reveal that they would rather the act be repealed than
reformed. After some further discussion, Committee members requested
follow-up at the next meeting regarding Secretary Leavitt\'s response to
the ACCV\'s recommendations.

**CDC---Dr. Melinda Wharton**

Dr. Melinda Wharton provided the Committee with the following updates:

-   There has been a leadership change in CDC\'s Immunization Safety
    Office since the last NVAC meeting, and it is now under the
    direction of Dr. John Iskander and Ms. Kristin Pope.

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-   The HHS has submitted a report requested by Congress on the size of
    the Section 317 Program. It is now being publicly circulated, and a
    report can be ordered for NVAC to review.

-   The process for distributing public sector vaccines is progressing
    well and is expected to be ongoing for the next year.

-   The next ACIP meeting is June 27--28, 2007. The agenda includes
    discussion of the influenza and HPV vaccines as well as
    post-exposure use of the hepatitis A vaccine and the adult
    immunization schedule. A vote on recommendations for LAIV also may
    occur.

-   CDC is planning a preteen vaccine campaign targeted to parents and
    health care providers of 11- to 12-year-olds receiving immunization.

**NVPO---Dr. Bruce Gellin**

Dr. Gellin reported that the office continues to be involved in pandemic
flu preparedness, including the National Implementation Plan (a Homeland
Security Council plan) issued over a year ago. Within it are over 300
action items, usually to be carried out with partners. A report card on
agencies\' preparedness mapped to the plan is being compiled. There has
also been a lot of discussion in the office about seasonal influenza
prioritization, with the next round of guidance from the infrastructure
advisory committee expected in the coming week. Dr. Schwartz elaborated
that an interagency working group has developed draft guidance on
influenza vaccine prioritization that is published on the Federal
Register. It is being vetted by the public and stakeholders through
public engagement meetings, and the Federal Register notice solicits
public comments as well. The guidance will be revised as needed based on
these comments, and Dr. Schwartz stated that input from NVAC would be
appreciated.

***Discussion***

Dr. Abramson asked whether there is discussion in the Government about
priming in anticipation of a pandemic event. Dr. Gellin affirmed that
this is an active part of pandemic influenza discussions. In fact, at
the recent Vaccines and Related Biological Products Advisory Committee
meeting on H5N1, participants discussed the scientific basis for
priming.

**CMS---Dr. Jeffrey Kelman**

Dr. Jeffrey Kelman reported that there are no immunization policy
changes in Medicare part B, which continues to cover postexposure
vaccines under the standard fee schedule and the three preventive
vaccines (influenza, pneumococcal, and hepatitis B and A for moderate-
to high-risk individuals). Both influenza and pneumococcal vaccines are
covered without a copay or part B deductible. For these vaccines,
Medicare also has stringent requirements for provider qualifications;
for instance, mass vaccinations are allowed. All other vaccines are
covered under part D, for which Dr. Kelman reported two new
developments:

-   An administration fee will be included in part D beginning in 2008.
    A memo with operational guidance for implementation was included in
    the agenda books.

-   Part D plans now will be required to include all commercially
    available vaccines in all formularies, which should greatly
    facilitate vaccine access for Medicare beneficiaries.

***Discussion***

One participant referred to a recent recommendation by the Medicare
Payment Advisory Committee that all ACIP-recommended vaccines be covered
under Medicare part B and asked Dr. Kelman to comment on the timeline
for Congress to consider this recommendation. Dr. Kelman affirmed that
the recommendation has been sent forward to Congress and that this is
the time at which Congress is considering it.

**USAID---Mr. Neal Brandes**

Mr. Brandes reiterated a previous offer for a colleague of his from the
Global Alliance for Vaccine and Immunizations (GAVI) to brief the
Committee. He then briefly described events surrounding the withdrawal
of rotavirus vaccine from the market, an event that the Unmet Needs
Program quickly responded to with a small investment in surveillance.
The program also facilitated collaboration between the public sector
(NIH, CDC, USAID) and private partners. Mr. Brandes credited the program
for its work in this regard and reported that GAVI has indicated it will
again purchase rotavirus vaccine.

***Discussion***

Dr. Hinman suggested that Committee members may be interested in hearing
a general presentation on global financing for vaccines. He stated that
beyond GAVI, which has a significant role, a new international financing
approach has been introduced and is having a major impact on worldwide
immunization efforts. Dr. Gellin agreed that this is a worthwhile topic
and suggested that it may be a good presentation to the Vaccine
Financing Working Group.

**Department of Veterans Affairs---Dr. Ronald O. Valdiserri**

Dr. Ronald O. Valdiserri discussed vaccination at the VA on a number of
fronts. For seasonal influenza vaccination, VA pharmacists have been
asked to place vaccine orders for the 2007--08 season, and they
anticipate purchasing 2.6 million doses. Performance targets for vaccine
coverage are 75 percent of all veterans over 49 years of age as well as
75 percent of veterans under age 49 who have a chronic illness. He cited
the VA\'s comparatively strong performance in healthcare worker
vaccination; the most recently available data are for the 2005--06
season, in which 53 percent of VA healthcare staff received vaccination.
The target for 2006--07 was 60 percent and was increased to 65 percent
for the 2007--08 season. Dr. Valdiserri directed Committee members to
the VA Web site for more information about seasonal flu activity.

The HPV vaccine has been approved by the medical advisory panel of the
VA Pharmacy Benefits Management group. The advisory panel also developed
criteria for its use, which will be disseminated to VA providers through
a letter from the panel. The Committee agenda book includes a monograph
on the HPV vaccine written by the VA pharmacy benefits management group.
Dr. Valdiserri also informed the Committee that Zostavax is currently
available for use on a non-formulary basis at all VA medical facilities.
Inclusion into the VA formulary and development of criteria for use will
occur after CDC issues final ACIP recommendations in September 2007.

***Discussion***

Dr. Pavia expressed disappointment that the VA raised this season\'s
goal for flu vaccination for healthcare workers only to 65 percent,
particularly given previous successes. Dr. Valdiserri responded that he
was not directly involved in the goal-setting process so could not
adequately comment on why that number was chosen; however, he noted that
given that the overall national average is 40 percent, he did not think
that most would view this goal as less than ambitious.

Dr. Feinberg then initiated a discussion of the VA\'s formulary
inclusion process for new vaccines by asking whether it is VA policy to
wait for final publication of ACIP recommendations before including a
vaccine in their formulary. Dr. Valdiserri responded that while it may
not be policy, it does seem to have been the process that was used with
HPV and Zostavax. Dr. Abramson asked why the VA waited for publication,
given that the preliminary recommendations were available soon after the
ACIP met. Dr. Valdiserri clarified that Zostavax vaccine is currently
available to VA patients on a non-formulary basis. Dr. Hinman then
stated that given reports at this meeting that most insurance plans
begin the process of covering new vaccines on publication of ACIP\'s
preliminary recommendation, he would like to encourage the VA to adopt a
similar policy with regard to new vaccines. Dr. Freed concluded that it
would be helpful if Dr. Valdiserri provided NVAC at its next meeting
with a formal explanation of the VA\'s formulary inclusion process and
how it is tied to publication of the preliminary or final ACIP
recommendations.

*Note:* Dr. Valdiserri offered further clarification to the Committee
via e-mail following the meeting (Addendum).

**America\'s Health Insurance Plans---Ms. Barbara Lardy**

Ms. Barbara Lardy opened with mention of a recent AHIP accomplishment:
Publication of a checklist on pandemicflu.gov for health insurers. In
January, they will host a pandemic flu simulation exercise for multiple
stakeholders. AHIP also recently hosted a Webinar on emerging vaccines
and heath insurance benefit design. Finally, AHIP is establishing a
process to recognize healthcare plans that improve their immunization
rates in all populations (children, adolescents, and adults). The goal
is to award those making gains, not necessarily plans that already stand
out for high levels of immunization.

**Update on National Vaccine Plan---Dr. Raymond A. Strikas and Dr. Alan
Hinman**

Dr. Strikas informed the Committee that recent activities with regard to
the National Vaccine Plan have occurred during and between two
interagency meetings held in spring 2007. A number of recommendations
emerged from the March 20 meeting, including a unanimous recommendation
to extend the plan timeline to obtain true stakeholder involvement. In
discussions subsequent to the meeting, the Assistant Secretary of Health
clarified the following points:

-   The process of updating the plan should engage Government and
    non-Government stakeholders to define challenges and opportunities,
    which he acknowledged may take three or more budget cycles.

-   The plan should consider diseases for which there is no vaccine
    (i.e., HIV, tuberculosis, malaria) as well as the role of adjuvants
    and other means of improving current vaccines.

-   The process should reference HealthyPeople (HP) 2020 goals
    (available in 2009), where possible, as well as the HP 2010 goals.

-   The plan should define funding needs rather than allow funds to
    define the plan\'s goals.

Following these discussions with the Assistant Secretary for Health, the
NVPO undertook a review of WHO global immunization and vision strategy
goals as well as the immunization priorities of other English-speaking
countries. The major message taken away from this analysis was that the
common elements in each set of plans reveal that international groups
have come to similar conclusions about vaccination priorities.

At the next interagency meeting on June 5, participants undertook review
and revision of a summary table containing all immunization priorities
offered by agencies and offices to date. The summary table is sorted
according to the four goals of the 1994 plan: (1) Develop new and
improved vaccines, (2) ensure safety and effectiveness, (3) better
educate public and health professionals, and (4) achieve better use of
existing vaccines. The goals were then further sorted to areas and
issues; e.g., stable manufacture and supply. For planning purposes, lead
and contributing agencies were identified for each priority. As the next
step, the NVPO will work with lead and contributing agencies to identify
and develop actions for each issue as well as to develop milestones that
correlate to HP 2010 and, when possible, HP 2020. They will then
establish a task force to draft a discussion document.

Discussion of stakeholder involvement also featured in the June meeting,
and Dr. Strikas shared with the Committee the current thoughts on an
approach to this involvement. After completing the priority table with
introduction and annotation, they want to obtain NVAC review and
comments. Then, in a to-be-determined process, they hope to engage other
expert stakeholders, followed by a broader group of stakeholders,
including the general public.

Dr. Hinman added that while progress is being made, there was a good
deal discussion about how to organize the priority goals. Eventually,
the group settled on organizing them by outcomes as was done with the
1994 plan. However, he emphasized that the group is not wedded to the
headings presented by Dr. Strikas, and there may be other important ones
to include; for instance, vaccine financing.

***Discussion***

Dr. Freed asked when NVAC should expect to review the discussion
document. Dr. Strikas replied that the hope is within the next 4 to 6
weeks. Discussion ensued about the details of how NVAC would conduct its
review. After some consideration, it was agreed that the best approach
would be to form a task force consisting of, at a minimum, the
Subcommittee chairs and the chair of the Vaccine Financing Group to
formally review the document via conference call although all NVAC
members would receive the document via e-mail. NPO staff will arrange
these calls for the task force, but all Committee members will receive
conference call information so they can participate if they wish.

Discussion then turned to the challenges in creating a National Vaccine
Plan. Dr. Walter A. Orenstein, who is part of the group working on the
plan, stated that one failing of the 1994 plan was its universality. He
noticed that at the June 5 meeting, the group continued to add
priorities rather than subtract some. To ensure the effectiveness of the
current plan, he recommended a two-document plan, with one that covers
all vaccination areas and a second focused on high-priority areas. Dr.
Strikas indicated that NVPO will be asking lead agencies to focus on
prioritization.

**Report: Subcommittee on Public Communication, Consultation, and
Participation---Dr. Sharon Humiston**

Dr. Humiston reported that the NIS module on public communication is out
and in formative testing. In other news, the Subcommittee has finalized
the Adolescent Vaccination Working Group\'s recommendations for
communications.

**Report: Subcommittee on Vaccine Safety---Dr. Andrew Pavia**

The Subcommittee on Vaccine Safety met jointly with members of the
Subcommittee on Public Communication, Consultation, and Participation.
Dr. Pavia reported that the meeting focused on development of the
Immunization Safety Office\'s (ISO) research agenda and NVAC\'s role in
the process. In February 2005, the Institute of Medicine (IOM) released
its recommendations for the ISO research agenda in a report titled
\"Vaccine Safety Research, Data Access, and Public Trust.\" In sum, the
report encouraged a research agenda development process that increases
the transparency of the ISO.

In response to these recommendations, the ISO has proposed a
coordinated, three-phase agenda development process that features
extensive public input, including a scientific review by NVAC. The
process is expected to take place during an 18-month timeframe in
2007--08. The ISO is currently drafting a research agenda and has
already sought input from an external scientific group. Other
constituencies from whom they are requesting input include CDC programs
external to the ISO and other HHS agencies, the DoD, and non-Federal
partners. Following this first phase, the NVAC will conduct a scientific
review between October 20007 and July 2008. The third phase comprises
ISO\'s response to the review and finalization of the revised agenda.

Dr. Pavia stated that it is important for NVAC\'s scientific review
process to be well thought out and unbiased to avoid criticisms. Based
on their discussion of the process, the Subcommittee recommended that
the panel include immunization safety experts, medical and scientific
experts in related disciplines, and key immunization stakeholders. The
Subcommittee also considered the ISO\'s proposed charge to the reviewers
and concluded that NVAC will need to add topics to the charge for the
ISO\'s consideration. The next step for the Subcommittee is to formally
develop the composition of the panel and nominate members. Meanwhile,
the ISO will create a clear charge to the review panel to continue to
refine the public role (in concert with the Subcommittee) and work with
the NVPO to develop a mechanism for industry consultation.

***Discussion***

Dr. Freed asked when the Vaccine Safety Subcommittee will be conducting
its review and when the full Committee will do its review and provide
comments. Dr. Pavia responded that he expects the ISO will take several
months to put together the draft agenda, and the Subcommittee expects to
conduct its review between March and June of 2008, with the report to
the full Committee occurring after that. Dr. Pavia added that it is
likely the review process will require support from a Government
contractor.

**Report: Subcommittee on Vaccine Development and Supply---Dr. Ben
Schwartz**

Subcommittee Chair Dr. Dekker asked Dr. Schwartz to report on the
Subcommittee\'s meeting, which focused on how vaccines\' schedules are
established and changed. Dr. Schwartz briefly reviewed vaccine schedule
development, which is based on the results of prelicensure trials and
the schedule that the manufacturers submit for FDA approval.
Postlicensure, additional data may be generated to suggest that more or
fewer doses are needed. The Subcommittee\'s discussion focused on what
infrastructures exist that can generate data assessing vaccination
schedules and how these data potentially can be used to lead to schedule
changes.

The first aspect of the Subcommittee\'s discussion was the value of a
more parsimonious schedule, including fewer injections, fewer adverse
events, lower costs, less stress to vaccine supply, as well as the
potential risks of such changes, including a reduced schedule that may
not be consistent with scheduled visits or combination vaccines, and
confusion among parents and providers. Dr. Schwartz referenced the
recent United Kingdom schedule changes for the PCV, meningococcal, and
HIB vaccinations. These changes were based on immunogenicity and
surveillance data provided to the Joint Committee on Vaccines and
Immunisation (the United Kingdom\'s ACIP counterpart) by the Health
Protection Agency (HPA), a government-funded scientific institute, and
the Vaccine Evaluation Consortium (VEC), an organization whose mission
it is to research near-term vaccines.

Dr. Schwartz noted that the United Kingdom has greater flexibility than
the Unites States to establish and change schedules for three reasons:
(1) European Union licensure allows varying schedules for member states,
(2) HPA and VEC data contribute to the Joint Committee decisions to
establish and change schedules, and (3) the Joint Committee has been
willing to recommend \"off label\" uses outside of the approved
licensing schedule. Nevertheless, consideration of changes to the PCV
schedule in the United States may be warranted. Dr. Schwartz noted that
since the licensure of this vaccine, data have been generated on the
immunogenicity of two or three infant doses and a booster, the impact of
vaccination on invasive disease (in ecological studies and case control
efficacy studies), and the impact of vaccination on carriage. These data
have contributed to the new two-dose plus one booster schedule adopted
in the United Kingdom as well as Quebec.

Dr. Schwartz then stated that, from the perspective of HHS, a high bar
is set for data to justify changing vaccination schedules, given that
effective disease prevention is the highest priority. He also described
current mechanisms to generate postlicensure data; these include
immunogenicity studies and, to a lesser extent, epidemiology and
surveillance data. There are concerns about potential bias in the latter
forms of data, and these results are less informative than randomized
controlled trials. The current U.S. infrastructure for evaluating
vaccines comprises the NIH Vaccine Treatment and Evaluation Units and
CDC surveillance and epidemiological studies. At the Subcommittee\'s
meeting, there were no suggestions by agency representatives about
additional evaluation infrastructure. Finally, he noted that the U.S.
process to consider vaccination schedule changes is based on
recommendations from the ACIP as well as the FDA-licensed schedule,
which is considered strong guidance. He concluded that the
Subcommittee\'s discussion was robust but produced no recommendations
from agencies on changes to facilitate evaluation or potential
modification of vaccine schedules and no specific recommendation for
consideration by NVAC.

Dr. Schwartz briefly described a second topic of Subcommittee
discussion: Priorities for vaccine development and research. The
Subcommittee agreed to an NIH proposal to collaborate on planning a
meeting to discuss vaccine research priorities as part of the revision
of the National Vaccine Plan. The Subcommittee also discussed the
relative value of analyzing vaccine development priorities and decided
to include reflections on the impact of further public health work on
vaccine development priorities in the NIH meeting.

Dr. Schwartz closed by stating that the Subcommittee considered the
request for feedback from research priorities from the SIVR Program and
suggested a topic area that emphasizes standardized vaccine assays as
well as assay development.

***Discussion***

Dr. Abramson commented that although the United States has not been as
timely as the United Kingdom with changing the PCV schedule, there is an
ACIP PCV Working Group looking at current dosing recommendations. He
agreed with Dr. Schwartz\'s conclusion that a high bar has been set for
changes to the vaccination schedule. He also clarified that the ACIP has
made off-label recommendations in the past; for instance, in vaccination
of pregnant women. Dr. Schwartz clarified that the goal of the
Subcommittee was not to supplant ACIP\'s work but to understand how data
may be generated to assist ACIP in decisionmaking. Dr. Feinberg
encouraged consideration of a more collaborative vision for schedule
changes, especially with regard to industry. He noted that
immunogenicity studies need industry-supported laboratories and also
that changing a vaccine label is the manufacturer\'s responsibility. Dr.
Schwartz replied that industry contributed to the Subcommittee\'s
discussion, but it was focused more on areas where public health
agencies can contribute.

The discussion then turned to more specifics regarding label changes and
the role of various players in this process. In the course of
discussion, it was clarified that changes to a vaccine license
application have to be proposed by the license manufacturer while
recommendations in use come from ACIP. Dr. Freed commented that if a
reduction in dosage must be initiated by the manufacturer, there would
appear to be a proprietary disinterest to do so. Dr. Feinberg responded
to this comment by affirming that vaccine manufacturers have a shared
interest in the best interests of public health and that industry would
respond favorably to schedule changes that improve public health. Mr.
Dick Tardif provided an example of a company that is pursuing reducing
dosage for preexposure to anthrax, noting that they are doing so at a
financial loss but motivated by increased public health benefit from the
reduced dosage. Dr. Pavia shared his experience that changing a label
presents significant financial challenges to a country and suggested
consideration of a mechanism to decouple label indications from schedule
changes.

Dr. Salisbury raised the point that clinical trials to establish
licensing frequently exclude children whom it is desirable to include in
immunization recommendations (i.e., children with a history of
seizures); thus, the recommendation to vaccinate such children on the
basis of expert opinion actually constitutes an off-license
recommendation. He pointed to the more fundamental issue of finding ways
to get rid of perverse disincentives that lead to granting of licenses.
Dr. Abramson responded that when companies do not have economic reasons
to obtain labeling, it is necessary to rely on expert opinion, which may
not be avoidable. He argued that the need is for a more consistent
system.

**Immunization Coverage---Dr. Jon R. Almquist**

Dr. Jon R. Almquist opened his report with a summary of Dr. Laura
Riley\'s presentation to the Subcommittee on American College of
Obstetricians and Gynecologists\' (ACOG) education vaccination efforts.
ACOG\'s multipronged approach has resulted in publication of several
monographs on immunization and a comprehensive vaccination \"wheel\" for
physician office use; hosting a full-day course on immunization at the
annual ACOG meeting; a survey to assess member attitudes about
vaccination practice; and publication of statements on statement on HPV,
meningococcal, rubella, and hepatitis B immunizations to promote the
practice of immunization in obstetrical/gynecological practices. In
addition, one ACOG district has developed a 2-hour CD-ROM on the HPV
vaccine and the office infrastructure needed to support an immunization
practice. ACOG is considering national dissemination of this CD-ROM
accompanied with continuing medical education credits.

Dr. Almquist then provided an update on publication of NVAC\'s report on
immunization information systems (IIS). Two related peer-reviewed
publications are in review: One at *Health Affairs* provides a
description of the role of IIS in electronic medical recordkeeping, and
the full report is under review at the *Journal of Public Health
Management Practice*. He reported that the NVPO sought the
Subcommittee\'s input on how to implement the report\'s charge to host a
meeting of stakeholders to evaluate means to improve IIS participation.
The Subcommittee encouraged NVPO to host the meeting no later than fall
2007 and requested that NVAC review the meeting results.

The Subcommittee heard from Mr. James Singleton on CDC\'s strategic
planning for vaccine coverage assessment. He noted that the current
system is costly and yet has almost no data on older children and
adults. There is also a need for validation for self-report survey data,
which the program does not have enough funds to support. As a result of
this report, the Subcommittee recommended an increase in resources to
support immunization assessment.

The Subcommittee also discussed vaccine payments (both timing and
amount) and sought the perspectives of AHIP and the National Business
Group on Health (NBGH), an organization that represents 65 million
employees and half of the Fortune 500 companies. The primary message the
Subcommittee heard was that immunization is a very low priority to
company benefit managers. NBGH is working to change this through
educational materials for constituents that include ACIP recommendations
for adult vaccination and encourages buyers to consider vaccination
coverage when they look for a benefit plan.

Dr. Almquist concluded with the following Subcommittee suggestions for
new SIVR Program priority areas: Improving adult immunization rates and
improving immunization assessment and IIS. He closed by recognizing Dr.
Hinman, outgoing Subcommittee chair, for his tireless leadership and
dedication to the work of the Subcommittee.

***Discussion***

Discussion began on the topic of vaccination by obstetricians and
gynecologists. Dr. Abramson asked Dr. Riley whether obstetricians might
be open to giving postpartum women one dose of the HPV vaccine. She
responded that it is a challenge for obstetricians to begin an
immunization program at all; thus, the focus of ACOG\'s education
efforts is simply to encourage providers to do some immunizations. Dr.
Pavia pointed to the barriers to establishing vaccination programs in
obstetricians\' and gynecologists\' offices and suggested that ACOG\'s
survey is a good opportunity to gain data on their experience and
publish the findings, a suggestion that Dr. Riley embraced. Dr. Freed
suggested adding this as a strategic priority under adult immunization.

The Committee then considered the Subcommittee\'s recommendation to
increase resources and funding for CDC\'s immunization assessment
program. Ms. Landry encouraged NVAC to seriously consider the
Subcommittee\'s recommendation, pointing to a recent struggle for the
section 317 coalition to demonstrate missing coverage, given the dearth
of good data. Dr. Pavia raised some concern that, given the low level of
funding for the program, decisions were being made to assess coverage in
one area to the detriment of another. He was particularly concerned
about losing valuable pediatric data in order to fund the adolescent
module of the NIS. Dr. Lance Rodewald clarified that the program has not
stopped collecting key pediatric data; however, in order to fund the
NIS-Teen module, they did forgo collecting pediatric data on 22 cities
that were oversampled. He cited the need for not only national-level
data but also program-level data (in States and among providers). Dr.
Pavia noted that this seems to be a theme; that is, the United States
does not have the capacity to evaluate vaccine coverage at the same
level of sophistication as in the United Kingdom.

Lengthy discussion ensued regarding the potential source of funds for
expanding the immunization assessment program\'s budget. Dr. Freed was
particularly keen to determine to whom the Committee should direct its
recommendation for increased funding. Over the course of the discussion,
it was clarified that the program receives funding through three
sources: An evaluation line, the Vaccines for Children Program, and the
Section 317 Program. Dr. Rodewald suggested that the Section 317
Program, which currently has only a small investment in the program, may
be a reasonable source for increased funding.

Dr. Hinman suggested that the committee could simply make a statement
that adequate resources need to be made available to appropriately
assess our programs, but Dr. Freed expressed concerned about making
vague recommendations. Members agreed that it would be desirable for the
assessment program to articulate an adequate level of funding to cover
their activities.

**Action Item:** The Committee requested a report from the CDC
assessment program at its February 2008 meeting on resources needed to
ensure evaluation of coverage and impact of vaccination, particularly in
light of expanded recommendations.

Ms. Amy Pisani suggested that NVAC may be able to obtain evaluation
funds information through a Congressionally commissioned report by CDC.
She explained that the coalition is helping Congress to draft a request
from information on vaccination infrastructure needs at CDC. Dr. Freed
suggested that both approaches be pursued independently to increase the
possibility that there will be action on the recommendation.

**Feedback on SIVR Program Priorities**

Dr. Hinman reminded the Committee of the SIVR Program request for their
feedback on research priority areas. Although not all Subcommittees
addressed this request, at least three additions were suggested. Dr.
Hinman said that given concerns about the addition of new priorities,
there might need to be some discussion of how to consolidate the list.

**Action Item:** The SIVR Program should add Subcommittees\' suggestions
to the existing priority list, consolidating where appropriate, and
circulate it to the Committee for feedback.

**Adolescent Immunization Working Group Update---Dr. Lance K. Gordon**

Dr. Gordon reported that the working group has been very active, with
monthly conference calls since the February NVAC meeting. There have
also been a number of subgroup conference calls convened to address
issues identified in the Working Group\'s problem statement white paper,
\"The Promise and Challenge of Adolescent Immunization.\" After a May 11
meeting to solicit public comment on the white paper, the full NVAC
Committee approved the manuscript. Details of authorship remain to be
resolved, but the manuscript is expected to be submitted to *J.A.M.A.*
in the near future.

During the past few months, the Working Group has been developing
recommendations in response to the challenges outline in the white
paper, with the goal of having a draft addressing the full range of
adolescent immunization issues ready by October 2007. Their approach has
been to assign each of the issues identified in the problem statement
paper to members of the Working Group, who then take responsibility for
drafting recommendations. To date, the Committee has made the most
progress on school mandates, given concerns that events surrounding
approval of the HPV vaccine would overtake a careful policy
consideration. The result of the Committee\'s work in this area is a
draft white paper on school mandates, and they hope to follow the same
approval path as was done for the problem statement white paper. The
plan is to circulate the paper among Committee members in the next few
weeks for review and comment and then issue a notice for public comment
on the Federal Register. In addition, the paper has been sent to three
independent reviewers whose comments will be consolidated with those
from NVAC and the public. Also in development are recommendations on
public communication and financing for adolescent vaccination, the
latter in coordination with the Vaccine Financing Working Group.

He closed with a report that the NIS-Teen reached 5,000 families with
adolescents (age 13 to 17). This survey module is expected yield
valuable data on what vaccines have been received by this population as
well as reasons vaccines were not received. The Working Group is looking
forward to publication of these results in August.

***Discussion***

Dr. Abramson sought clarification on whether the Working Group is
developing \"mandates\" or \"principles.\" Dr. Gordon clarified that
their work is to ensure that the appropriate infrastructure is in place
(i.e., supply, payment system, etc.) prior to the establishment of
mandates by other bodies. Dr. Freed likened the Working Group\'s
activities to laying a roadmap so that if mandates are under
consideration, the road forward to implementation is clear.

**\
Vaccine Financing Working Group Update---Dr. Guthrie S. Birkhead**

Dr. Birkhead reviewed the establishment of this ad hoc working group
charged over 1 year ago. The group was formed to address the crisis in
the delivery system caused by the addition of new vaccines to the
immunization schedule. This crisis threatens to greatly reduce or
eliminate the private provider\'s role in delivery, fragment the medical
home, and increase stress on the public sector, particularly the Section
317 Program. Although the problem is not readily visible yet as there
has not been a resurgence of VPDs from failure to vaccinate or
recognition of morbidity not prevented by vaccines as a major problem,
the goal of the Working Group is to prevent such outcomes. The Working
Group comprises nine NVAC members, five NVPO representatives, and
representatives from AHIP, NBGH, academia, CDC, and CMS as well as a
health economist. As part of the Working Group\'s charge, it delivers
specific and targeted policy options on two or three key topics per year
to the full NVAC for discussion and recommendations.

To date, the Working Group has focused primarily on childhood
immunization and is engaged in data gathering from NVAC Subcommittees
and stakeholders, the AMA/AAP Vaccine Finance Congress, meetings with
CMS, and interviews with vaccine manufacturers. In addition, studies
conducted by CDC in the areas of vaccine finance are expected to yield
useful information. In the public sector, the group\'s focus is on the
Medicaid administration fee, which is not adequate to cover the expense
of vaccination, and the 317 program, which is not keeping pace with the
need. In the private sector, the Working Group is concerned with issues
such as inventory costs for new vaccines and the inadequacy of insurance
coverage.

Dr. Birkhead reviewed the potential conclusions and recommendations from
the white paper that the Working Group is drafting, which is expected to
be presented to the full Committee at its February 2008 meeting. The
goal of the paper is to ensure universal access to all ACIP-recommended
vaccines for children and adolescents without financial barriers. One of
the major conclusions of the paper is that the current private and
public sector mixed system for delivering pediatric vaccines does have
the potential capacity to deliver all recommended vaccines to a
pediatric and adolescent population; thus, the current system should be
reinforced and strengthened, with one potential means being financial
incentives. With regard to providers, the Working Group has concluded
that a system should be in place to reduce outlays of practice capital
for providers who want to establish inventories of new vaccines and that
reimbursement should include coverage for nonvaccine costs such as
storage and insurance against loss.

Based on these and other conclusions, the Working Group has both
recommendations that can be implemented under existing legislation and
others that would require new legislation. These recommendations include
the following:

-   The maximum allowable reimbursement rates for administration costs
    for Medicaid children receiving vaccines through the Vaccine for
    Children program should be revised.

-   Provider-insurer contracts should allow for increases in vaccine
    prices and incorporation of new vaccines midcontract.

-   Vaccine manufacturers and third-party distributors should work with
    providers to reduce financial liability for initial inventories of
    new vaccines.

-   Section 317 funding should be increased in accordance with new
    vaccine recommendations.

The Working Group will also recommend that NVPO convene a meeting of key
stakeholders, including manufacturers and insurers, to evaluate (1) tax
credits as incentives for insurers and employers to eliminate
underinsurance, (2) insurance mandates for first dollar coverage of
recommended vaccines and their administration, and (3) a universal
Federal vaccine purchase or universal Federal reimbursement for
vaccines.

Dr. Birkhead closed his presentation with a description of ongoing
Working Group activities. On June 27, the Working Group will update ACIP
on its activities. In fall and winter of 2007, practice and cost survey
results are expected, to be followed by a stakeholder meeting on the
results, and the Working Group is planning an interview survey of
insurers. Finally, the Working group is in continued discussion with CMS
on administration fees and is encouraging the Vaccine Economics
Evaluation Projects Steering (VEEPS) Committee to design the methodology
for the definitive study of actual costs of vaccination that is under
development in CDC.

***Discussion***

Dr. Freed began by expressing his appreciation to Dr. Birkhead for his
extraordinary organization and dedication as chair of the Working Group
as well as his efforts to include a variety of perspectives in the
group\'s deliberations.

One participant inquired whether the VEEPS Committee will look only at
pediatric vaccine costs or also adolescent and adult immunization costs;
she suggested that segmenting the study by population could be useful.
Dr. Birkhead said that although the Working Group has focused on
pediatric and adolescent immunization, every mechanism they are working
on logically expands to adults. She also referenced a recent RAND report
and suggested learning from other preventive models on how to move adult
immunization forward; for example, tobacco control initiatives. By
getting CPT codes for patient counseling and referral, doctors were
willing to counsel patients to stop smoking. Dr. Birkhead agreed to
disseminate the RAND report to the Working Group.

In response to a question from Dr. Young regarding use of the term
\"commission\" with regard to vaccine cost surveys, Dr. Birkhead
clarified that the Working Group did not commission any surveys, nor did
NVAC/NVPO fund them. He explained that CDC\'s evaluation program has a
standing arrangement with contractors who conduct surveys, and Dr.
Rodewald as the CDC liaison to the Working Group was able to communicate
some of the Working Group ideas to these contractors.

With no further discussion or public comment, Dr. Freed thanked all
participants for their attendance and adjourned the meeting at 12:55
p.m.

Appendix: Subcommittee Minutes

**Subcommittee on Immunization Coverage---Chair: Dr. Jon R. Almquist**

**Attendees:** Guthrie S. Birkhead, NVAC; Stuart Feldman, sanofi
pasteur; Alan R. Hinman, NVAC; Elizabeth Greenbaum, National Business
Group on Health; Charles Lovell, Jr., NVAC; Walter A. Orenstein, Emory
University; Laura E. Riley, NVAC; Lance Rodewald, CDC; James Singleton,
CDC; Raymond A. Strikas, NVPO; Adele E. Young, NVAC; Jennifer
Zavolinsky, Every Child by Two; Christine Maisano, notetaker.

***ACOG Immunization Education Efforts---Dr. Laura E. Riley, NVAC***

Dr. Laura E. Riley reported that in September 2006, the American College
of Obstetricians and Gynecologists (ACOG) began a 3-year, CDC-funded
effort to educate its members regarding recommended immunization
practices. The initial effort was born from a survey suggesting that
obstetricians are not immunizing their patients, largely due to lack of
education. An ACOG task force comprising obstetricians and gynecologists
in infectious disease formed to address this issue and later obtained
CDC funding. Task force efforts will culminate in several products: An
educational monograph on immunizations in general, an immunization
information \"wheel\" (intended to be mounted in patient exam rooms) for
physician reference, and a monograph on starting an immunization
practice in an existing obstetrical/gynecological practice, with a focus
on financing and reimbursement issues.

Dr. Riley reported that the ACOG task force worked with NVAC\'s
Adolescent Immunization Working Group to write a committee opinion on
what should occur during an adolescent well visit to her gynecologist,
which includes immunization. Also notable is the day-long postgraduate
immunization course given by two obstetricians at the last ACOG annual
meeting. It is a goal of ACOG to make this course available to its
members in all future annual and district meetings. Another potential
course of continuing medical education credits in vaccination for ACOG
members is a program developed by the Georgia ACOG district. This CD/DVD
is a 2-hour module on the HPV and general immunization practice for
obstetricians and gynecologists. ACOG is looking into the possibility of
distribution of the program nationwide.

Finally, Dr. Riley stated that the previously limited measurement of
obstetrician and gynecologist immunization practice and the recent
approval of the HPV have motivated ACOG to survey a standing member
cohort regarding their immunization practices. The questions are on HPV
and general immunization knowledge, at what point in their education
practitioners received or did not receive immunization education (to
identify which physician cohorts may have not received appropriate
education), and what barriers exist to obstetricians and gynecologists
initiating immunization practice.

***Discussion***

In response to a member\'s questions regarding the monographs, Dr. Riley
clarified the following points: (1) The monograph on establishing an
immunization practice is comprehensive and covers all potential barriers
(i.e., storage and handling) to doing so. (2) The monographs currently
are not accompanied by continuing medical education credits.

Dr. Hinman asked whether ACOG has considered how to encourage its
members to be VFC providers as he suspects most
obstetricians/gynecologists will focus on HPV vaccination and not the
entire vaccination schedule. Dr. Riley confirmed that most of the
constituency will focus on HPV to the exclusion of other vaccines and
may even send patients to other providers for HPV vaccination. Jennifer
Zavolinsky of Every Child by Two added that anecdotes from the recent
ACOG meeting suggest that some providers are asking patients to obtain
the HPV vaccine from their pharmacy and then come to the office to have
it administered.

Dr. Young suggested using a PalmPilot format as opposed to the wheel,
but Dr. Riley explained that funding was a limiting factor. In addition,
the task force is looking to the upcoming survey results to indicate
obstetrician/gynecologist needs with regard to educational materials. As
an aside, she noted that obstetricians/gynecologists seem to read
educational materials published by ACOG.

Dr. Strikas asked whether the obstetrics/gynecology certification exam
contains immunization questions. Dr. Riley replied that it does not but
that the recertification exam does and, furthermore, that ACOG committee
opinions always are on the recertification exams.

***Strategic Issues in Vaccine Research Priorities---Subcommittee
Discussion***

Dr. Almquist led the group in consideration of priorities for the SIVR
Program. Throughout the discussion, Dr. Hinman encouraged specific
recommendations and also attention to not adding too many new
priorities. Dr. Orenstein proposed that adult immunization is in need of
greater attention. After some discussion, the recommendation was honed
to improving adult immunization rates. Dr. Strikas proposed the addition
of improving immunization coverage assessment, including improvement to
IIS. Subcommittee members supported putting forth both of these
suggestions to the full Committee.

***Update on NVAC Progress Report on Immunization Information
Systems---Dr. Alan Hinman, NVAC***

Dr. Hinman stated that the full IIS report has not yet been made
available to NVAC members because the original intent was to publish the
report in a medical journal (i.e., *Health Affairs*), and publication in
another setting could disincentivize journal publication. However, when
approached, the *Health Affairs* editors were not interested in
publication of a committee report, stating a preference for an article
on immunization information systems in relation to electronic health
records. Dr. Hinman wrote this piece per their recommendations, and it
is under review. A second journal, the *Journal of Public Health
Management and Practice*, was approached about publishing the committee
report. They tentatively agreed to do so in a supplement, and this
publication is under HHS clearance. In short, the full report cannot be
published until both of these pieces are either published or rejected.

***HHS/NVPO Plans for Implementation of NVAC Progress Report on
Immunization Information Systems---Dr. Ray Strikas, NVPO***

Dr. Strikas stated that two NVPO action items are apparent in the NVAC
Progress Report on IIS. They call for the NVPO to convene meetings of a
broad range of stakeholders to consider two deliberate the pros and cons
of two issues: (1) Legislative and other approaches to increase provider
participation in an IIS and (2) provider performance incentives based on
the completeness of immunization data available in an IIS. Dr. Strikas
solicited the Subcommittee\'s recommendations for how the NVPO should
move forward to address these items. After some discussion, the
Subcommittee recommended the following to NVPO:

-   One meeting should be convened to address both goals.

-   The desired outcome is a document enumerating the pros and cons in
    each area to be presented to NVAC for consideration (likely at its
    February meeting).

-   The final recommendations should be circulated widely to
    stakeholders.

The Subcommittee had a separate discussion about patient identification
in an IIS, with Dr. Charles Lovell raising the concern that multiple
patient identifiers could hinder information sharing. Dr. Hinman
explained that for communication within States, this is not a concern as
each State assigns unique identifiers to registry members. However, he
conceded that Dr. Lovell\'s concerns are real for interstate
communication and recommended national-level approaches to overcoming
this communication difficulty. Dr. Hinman added that another major
problem is that interstate agreements about electronic information
sharing are captured in memos of agreement and vary from State to State.
Dr. Strikas indicated that there is a pilot project analyzing each
State\'s information sharing laws with the goal of identifying
similarities that might lead to a more generic agreement.

***Strategic Planning for Vaccine Coverage Assessment---Mr. James
Singleton, CDC***

Mr. Singleton\'s presentation was to inform the Subcommittee about
vaccine coverage assessment activities at CDC and to solicit their
feedback on the directions and priorities developed to date. He stated
that the program must be engaged in strategic planning, given the many
challenges inherent in vaccine coverage assessment, and highlighted the
increasing number of wireless-only households as particularly daunting
to survey research that has traditionally relied on publicly available
lists of land-line phone numbers. On the other hand, the multitude of
survey platforms now available presents new opportunities for the
program. The program\'s budget is currently 0.6 percent of the total CDC
vaccine program budget, with some support through a Public Health
Service evaluation line item and additional support for the National
Immunization Survey (NIS), the program\'s major activity, through the
Vaccine for Children Program.

The program develops its vaccine assessment goals with input from
multiple groups, including an external review committee chaired by Dr.
Orenstein. This input guides the program in developing its goals as well
as prioritizing assessment activities. Mr. Singleton stated that the
program\'s primary goal is to reduce health and societal burden of
vaccine-preventable diseases. This and the program\'s numerous other
goals are accomplished through fielding of the NIS of
noninstitutionalized children age 19 to 35 months in all 50 States. The
core survey is enhanced with modules on specific topic areas; the 2007
modules are on socioeconomic status and parental concerns. Mr. Singleton
stated that the program is currently engaged in survey methods research
to decrease bias, increase cost efficiency, and address the challenge of
wireless-only and phoneless households. The program also is working on
integrating with the IIS. The program also receives coverage data from
schools and child care that are provided directly to CDC.

The NIS-Teen, which uses the same sampling frame as the NIS, is a new
initiative to gather data on adolescent immunization. This survey
assesses children over age 11 through a telephone interview that is
matched with provider vaccination histories. Expansion of this survey to
that State and grantee level is a high priority for the program in 2008.
Finally, the program collects information on adult immunization through
the National Health Interview Survey and the new NIS Adult survey,
fielded for the first time in 2007 to gain more timely and detailed
information. Results from the 2007--08 waves of these and other
State-level surveys will be published beginning in September 2007.

Mr. Singleton closed his presentation with a review of the program\'s
strategic directions and preliminary priorities that were informed by
the external review as well as meetings of the CDC Vaccine Assessment
Work Group. He emphasized that while there are a number of pressing
issues to be considered, limited program resources constrain
implementation. Thus, the program has prioritized recommendations, with
the following emerging as top priority for the NIS:

-   Maintain annual NIS by 56 grantee areas with provider record check.

-   Obtain State-specific estimates for adolescent vaccination.

-   Continue NIS methods research.

He also shared high priorities for adult and local assessment and lower
rated priority areas for the program as a whole.

***Discussion***

Dr. Orenstein commented that the external review panel he chaired was
struck with the small proportion of CDC\'s vaccination budget devoted to
evaluation. He suggested consideration of increasing the resources
channeled to this important activity. The review panel also determined
that national data are not as useful as State-based data, which can be
used to motivate action. Finally, the panel recommended improvement of
coverage assessment for adults and favored improving the NIS-Adult.

Discussion turned to the problem identified with telephone surveys, with
Dr. Lovell suggesting household surveys instead. Mr. Singleton responded
that although household surveys are used to some extent, they are very
expensive. He added that good local IIS would obviate the need for
telephone surveys. Thus, the program is energized to improve efficiency
through beginning with the IIS sampling frame. Dr. Hinman encouraged
expanding the number of States in which the IIS is used as the sampling
frame.

In response to Dr. Almquist\'s question regarding validation, Mr.
Singleton responded that there has been little validation of these
self-reported data, which is why this is a high priority for the
program. To date, only influenza vaccine data have been validated, but
there has been no time to validate self-reports on the receipt of newer
vaccines such as Zostavax.

Dr. Young asked for clarification of the types of technical assistance
and support the program gives for within-State assessment. Mr. Singleton
replied that some States want to conduct county-based assessments to
identify communities at risk, and the program would like to promote
successful approaches used in other States; e.g., Oregon. In addition,
the section 317 grantees are now required to evaluate at least one
program component, and CDC provides technical assistance for these
evaluations to ensure that they are being conducted in the best possible
manner.

The Subcommittee considered the topic of funding raised by Dr. Orenstein
and agreed that 0.6 percent of the total vaccine program budget does not
appear to be adequate for funding assessment, particularly given the
many priority areas that are not being covered due to limited resources.
After considering other potential funding sources, the Subcommittee
concluded that NVAC should recommend increased funding for CDC\'s
vaccine coverage assessment program.

[]{.mark}

***Immunization Payment Policies---Ms. Elizabeth Greenbaum, National
Business Group on Health***

The NBGH is engaged in advising its members about what they should do in
the interests of employee health. The group\'s membership represents
approximately 56 million employees and over half of Fortune 500
companies. Ms. Greenbaum informed the Subcommittee that research shows
that employers follow the lead of health plans with immunizations.
However, immunization receives limited attention as a health plan line
item because it is not expensive and does not demand constant management
such as pharmaceutical benefits. Immunization is particularly neglected
in large companies with unstable work forces. Influenza vaccines are the
most widely covered (at a self-reported rate of 75 percent), and half of
NBGH members report providing onsite opportunities for vaccination.

In a new publication, \"A Purchaser\'s Guide to Clinical Preventive
Services,\" the NBGH presents ACIP recommendations for adult
immunization as the medical standard of care. The NBGH also provides its
members with suggested language on immunization for health plan
contracts. She concluded that vaccination remains a low priority for
benefit managers, who typically concern themselves with benefits
specifically requested by employees.

***Discussion***

Dr. Rodewald commented that the vaccine delivery system requires
providers to pay up front for vaccines and asked whether there can be
steps to mitigate this impact on doctor office financial resources. Ms.
Greenbaum replied that the NBGH is well aware of this problem but noted
that employers are not responsible for negotiating contracts with
providers, and, furthermore, they are not even aware of this problem. In
response to a question form Dr. Orenstein, she stated that it is
unlikely employers would be willing to advance funds for provider
inventory. Dr. Lovell suggested consideration of beneficiaries
purchasing vaccines from their pharmacy and then returning to the
provider to have them administered. This suggestion was met with concern
about the temperature instability of vaccines and the potential to miss
vaccination opportunities. Ms. Greenbaum added that when a beneficiary
purchases a vaccine, it is unclear whether it is covered under the
health or pharmacy benefit. Also, many plans limit coverage for
immunization to the context of a yearly well visit, so it would be
difficult for people to prepurchase their vaccine in anticipation of the
visit.

The group then considered the \"lag time\" between publication of ACIP
recommendations and active coverage for recommended vaccination. Ms.
Greenbaum noted that employers can choose to cover prevention at first
dollar through high-deductible plans and health savings accounts. A
representative from sanofi pasteur then commented that if employees are
providing prevention at first dollar, they need to be assured that the
insurance plan will actively cover the vaccine because a lag in
reimbursement is unfair to the purchaser. Dr. Hinman stated that AHIP
representatives have indicated that most plans begin processing coverage
of vaccines based on preliminary ACIP recommendations rather than
waiting for formal publication. Dr. Almquist added that any delays in
the system represent an ethical problem.

Dr. Almquist lauded the NBGH\'s publication and asked how this resource
will be used. Ms. Greenbaum clarified that it is intended to be used by
purchasers to inform them as they search for a health plan. In response
to Dr. Hinman\'s question about increasing the prominence of
immunization for employers, Ms. Greenbaum pointed to their purchaser\'s
guide that provides specific contract language on vaccinations for
employer use. It also provides prioritization options for vaccination if
employers cannot afford to cover all recommended immunizations.

With no further comments, the meeting adjourned at 4 p.m.

**Subcommittee on Vaccine Development and Supply Report--- Cochairs: Dr.
Cornelia L. Dekker and Dr. Jerome Klein**

Attendees: Jon S. Abramson, CDC; Norman W. Baylor, FDA; George Curlin,
NIH; Lance K. Gordon, Representative Member; Sarah Landry, GSK;
Marie-Michele Leger, AAPA; Alison C. Mawle, CDC; Matthew R. Moore, CDC;
Larry Pickering, CDC; Jennifer Salesa, NVAC; David Salisbury, Department
of Health (UK); Anne Schuchat, CDC; Benjamin Schwartz, NVPO; Greg
Wallace, CDC; Laura York, Wyeth Vaccines Research; Andrea Savoye,
notetaker.

Subcommittee Cochair Dr. Dekker welcomed participants and turned the
meeting over to Dr. Schwartz, who had arranged the speakers for this
session. Three speakers were chosen to provide their perspectives on
infrastructure changes and capabilities necessary to review, research,
and recommend changes to manufacturer dosing recommendations.

***United Kingdom Perspective---Dr. David Salisbury, Principal Medical
Officer, Department of Health, United Kingdom***

Dr. Salisbury provided an overview of the systems in the United Kingdom
that work together to reduce the incidence and consequences of infection
from preventable diseases with vaccine and the process by which a
manufacturer\'s timing or dosing recommendations may be overridden.

The Joint Committee on Vaccination and Immunisation (JCVI) is a
multidisciplinary committee consisting of short-lived subgroups (i.e.,
groups are dissolved when the topic they were formed to research has
been resolved) with specific criteria for avoiding conflicts of
interest. Recommendations from the JCVI go to the Department of Health
Ministers for decisions on resource allocations.

The HPA provides the Department of Health with the scientific support
and advice necessary to support the recommendations. HPA is accountable
to the government but has no political oversight. It is not a
policymaking body.

The VEC, which receives funding through the Department of Health,
conducts research on near-term vaccines and sets up studies with
information about dosing and how a new vaccine would fit into the
existing vaccine schedule. This group determines whether there is added
value to further studies of new vaccines. Manufacturers supply them with
the materials needed for their studies, and VEC has open discussions
with the manufacturers during the process. In general, manufacturers do
not see this process as a threat. In the case of the meningococcal C
(MenC) vaccine, testing done by the VEC served as a shortcut to
licensing for the manufacturer.

Manufacturers in Europe now sometimes build flexibility regarding a
vaccine\'s dosing schedule into their licenses; e.g., to be administered
at 2, 4, and 6 months or as recommended by the proper national
authority. MenC was originally licensed with a three-dose schedule. VEC
produced data that showed two doses of the MenC vaccine provide the same
level of protection as three doses in the first year of life.

In the United Kingdom in 1986, there was low participation in the
pertussis vaccination program. The manufacturer information was
overdetailed and included some false contraindications. Doctors were
advising mothers not to have their children immunized against pertussis.
The product information list was eventually updated, but the vaccine was
operationally difficult to administer, and because many children were
not receiving all of the doses, there was not good protection from
pertussis during this time. After some research, a dosing schedule
different from the product license was recommended and accepted.
Coverage increased, and protection improved.

The Hib vaccine infant program was introduced in the United Kingdom in
1992. The United Kingdom had age-specific attack rates comparable to
those in the United States. At the time, manufacturer dosage
recommendations did not include a booster. From 1999 to 2001, the United
Kingdom experienced an increase in disease, due in part to vaccine
formulation. Government data from 2002 to 2004 showed improvement in
disease impact with an additional dose of the Hib vaccine. The
manufacturer began production of a new Hib/MenC vaccine. The United
Kingdom vaccine schedule now includes this vaccine at 12 months.

***Immunogenicity and Effectiveness---Dr. Matthew R. Moore, CDC***

Dr. Matthew R. Moore presented a potential framework for evaluating
reduced-dose vaccinations. The assumption for making reductions to
dosage is that the effectiveness of fewer doses of the vaccine, however
measured, would be equivalent to a full schedule. Consideration would
need to be given to the risks of making a change, including reduced
effectiveness and unintended messages and consequences; e.g., public
confusion and concern. Some potential benefits of safely reducing a
vaccine dose could include greater compliance, reduced costs, fewer
injections, and an improved vaccine supply.

Data for evaluating a reduced dose for a specific vaccine could include
the following:

-   Controlled clinical trials;

-   Immunogenicity studies;

-   Carriage studies;

-   Ecologic studies;

-   Effectiveness studies; and

-   Breakthrough cases.

Dr. Moore presented information from current trials, studies, and cases
that may be relevant to dose reduction discussions in the future. He
noted that if considering a dose change, serious thought would need to
be given to the tools used to answer the necessary questions.

Dr. Moore also presented some initial recommendations from the ACIP
Working Group on Pneumococcal Vaccine. In general, the group felt it was
premature to present a permissive dosing recommendation to the full
ACIP. Some of the group\'s comments included the following:

-   ACIP is cautious about deviating from license scheduling.

-   Manufacturers are unlikely to apply for a new license with a reduced
    schedule.

-   Members would like to see more data on the risk of disease among
    children age 6 to 12.

-   Providers may be confused by a permissive recommendation.

***Discussion***

Dr. Salisbury noted that given the United Kingdom\'s system of medicine,
they are more likely to have better completion rates and less slippage.
Families are notified of appointment dates and times according to the
national vaccination schedule. In the United States, where families are
largely responsible for making their own appointments, there may be more
slippage, and with a reduced dose vaccine schedule, effectiveness may be
compromised.

Dr. Schuchat noted that cost saving may not be a certain byproduct of
vaccine dose reduction and that cost should not be the prime motivator
in seeking a reduced dose schedule.

***FDA/CBER---Regulatory Perspective---Dr. Norman W. Baylor, Director,
Office of Vaccines Research and Review, Center for Biologics Evaluation
and Research, FDA***

Dr. Norman W. Baylor provided comments related to altering vaccine dose
schedules from a regulatory perspective. He advised Subcommittee members
to submit data for review, noting that the ideal standard for regulatory
approval is an efficacy study. He suggested that optimally a dose
schedule would be proposed and the study would be designed around it,
noting that adding visits to the current vaccination schedule would be
cumbersome. Other comments included the following:

-   Case studies would need to be followed up with a prospective study,
    and immunogenicity studies need correlates.

-   Time is needed to generate information and to see a true change in
    disease incidence.

-   Changes to the vaccine schedule must be based on more than cost.

-   Licensing is a regulatory decision.

***Discussion***

Dr. Curlin noted that the most powerful data to consider is experience
based, not clinical trials. He also stressed that ACIP does not consider
cost when making recommendations that will have an impact on public
health. He commented that the NIH is able to do trials but does not have
the capabilities to undertake studies.

One member noted that optimal usage of a vaccine might change after its
introduction; e.g., 5 years out. Dr. Moore noted that ACIP is looking at
the current list of vaccinations and making recommendations as to
whether they should be renewed, retired, or revised. They may make
recommendations that are not approved by the FDA.

Dr. Schwartz recommended working to eliminate the two-tier system. He
noted that as new vaccines are added to the vaccine schedule, costs and
the number of injections will become more significant issues.

Dr. Schuchat noted that some States were unable to provide coverage for
underinsured children and that they may move toward purchasing off-label
vaccines from Canada to meet their needs.

Dr. Schwartz asked Subcommittee members for their suggestions regarding
NVAC\'s further role under this topic. Dr. Dekker suggested that those
interested join Dr. Schwartz in a campaign to move money to NIH to
expand the Vaccine Trials Unit\'s public health recommendations.

***Vaccines for the 21^st^ Century---Dr. Alison C. Mawle***

Dr. Alison C. Mawle discussed the issue of whether CDC should be
involved in establishing priorities for new vaccines. In 1985, NIH
compiled a report for the IOM regarding establishing priorities for new
vaccine development. This report identified 14 vaccines for accelerated
development. (Approximately half have been developed.) The report was
updated in 2000. To determine vaccine development priority, the 2000
report recommended a quantitative and unbiased model. Vaccines should be
able to go to production within 20 years and have a realistic cost
schedule. The recommendations were not ranked but grouped by four
levels:

-   Level I Saves money and quality-adjusted life years (QALYs)

-   Level II Costs less than \$10,000 per QALY saved

-   Level III Costs more than \$10,000 and less than \$100,000 per QALY
    saved

-   Level IV Costs more than \$100,000 per QALY saved

Level I is labeled as most favorable and included cytomegalovirus and
influenza vaccines. Level IV is labeled less favorable and included
*Borrelia burgdorferi* and *Coccidioides immitis* vaccines.

Dr. Mawle mentioned that the National Vaccine Plan is being updated and
that there are public health needs that should possibly be highlighted.

***Discussion***

A member inquired whether manufacturers pay any attention to the
recommendations. Dr. Gordon noted that the 1985 volume had an enormous
impact on public health priorities of the time. It drove discussions and
was used to support funding decisions. The report included data on
software to assist with further analysis and also discussed the
readiness of various technologies. He noted that for some reason, the
2000 report has had much less impact.

Dr. Curlin indicated he is not in favor of establishing a vaccine
priority list because of unpredictable public health needs. The NIH is
working with four agencies to draft a collective research agenda for the
National Vaccine Plan. He asked whether he might use the Subcommittee to
develop a planning group to bring the various pieces of the work
together. Dr. Dekker approved of the idea.

***Conclusion***

Dr. Dekker asked the Subcommittee members to brainstorm for
recommendations to the SIVR Program. Suggestions included the following:

-   Put more funds into assay development (e.g., standardize assays and
    look at potency).

-   Improve diagnostic testing for preventable diseases.

-   Look into vaccines in late-stage development.

-   Look into the effectiveness of the pertussis vaccine.

-   Look at flu vaccines that are substantially different. (Note: HHS is
    looking at ways to increase the flu vaccine\'s immunogenicity.)

**Subcommittee on Vaccine Safety---Chair: Dr. Andrew Pavia**

**Subcommittee on Public Communication, Consultation, and
Participation---Chair: Dr. Sharon Humiston**

Attendees: Janet Angbazo, The George Washington University School of
Public Health; Bob Ball, FDA; Kenneth Bart, NVPO; Roger Bernier, NCIRD;
Karen Broder, ISO; Emma English, NVPO; Mark Feinberg, NVAC; Jaime
Fergie, NVAC; Deborah Gust (by phone), CDC/NIP; Calvin Johnson, NVAC;
David R. Johnson, sanofi pasteur; Erica Johnson, APCO; Christine Layton,
RTI; Trish Parnell (by phone), NVAC; Amy Pisani, Every Child By Two;
Kristin Pope, ISO; Laura E. Riley, NVAC; Amy Smith, sanofi pasteur;
Dixie Snider (by phone), CDC; Dick Tardif, ORISE; Melinda Wharton, CDC;
Lois Goodstein, notetaker.

Dr. Pavia began the joint Subcommittee meeting by welcoming attendees
and outlining the key topics for consideration during the meeting,
including the Subcommittee\'s role in the CDC/ISO research agenda review
and expanded opportunities for public input in vaccine safety issues.

***CDC\'s Immunization Safety Office Development of a Research
Agenda---Dr. Karen Broder, ISO/CDC***

Dr. Karen Broder reviewed the mission of the ISO---to assess the safety
of vaccines received by children, adolescents, and adults---and the
IOM\'s recommendations for ISO\'s research agenda. The goal is to
develop a comprehensive, scientifically robust research agenda with
extensive internal and external input. The ISO hopes to carry out the
agenda using current infrastructure, novel collaborations, and
extramural research. Dr. Broder then presented CDC\'s response to IOM
recommendations for the development of the agenda, delineating its scope
and integration with other vaccine safety initiatives. She explained the
three-phase development process and its 18-month timeline: The ISO
develops the agenda, NVAC facilitates the review, and the ISO responds
to the feedback and finalizes the agenda.

In phase 1, the proposed development process comprises five input
venues: ISO external scientific consultancy charged with identifying
emerging vaccine safety research questions, CDC programs outside ISO,
other HHS agencies, DoD, and non-Federal partners.

Dr. Broder delineated both the 2007 and 2008 CDC deliverables to NVAC,
culminating in the draft ISO research agenda. She updated the progress
so far in phase 1, noting that the report from the external scientific
consultants, who met in Atlanta in May, is already in preparation.
Questions for consideration were around the mechanism of manufacturer
input, the constituency of the implementation of a scientific review of
the agenda, and the reasonableness of the charge to the reviewers. Dr.
Broder reviewed the background of the IOM recommendations, the guiding
principles for the ISO research agenda development, and the breakdown of
the consultancy process into brainstorming sessions. She concluded her
presentation with a list of the individual external consultants,
external liaisons, and members of the research agenda development team.

***Discussion***

Discussion followed about the proposed timeline and its appropriateness.
Dr. Broder indicated that there would be progress updates and stressed
the importance of prioritizing the research topics. As noted by Dr.
Humiston, vaccine safety is a fast-moving field, and today\'s focus is
different from that of the future. Ms. Pope added that the ISO is
challenged with matching resources and managing its day-to-day
activities; the agency wants to give NVAC the best product for review.
Dr. Kenneth Bart, asking what industry really feels, noted the necessity
of a useful timeline and a quality agenda that can be invested in. Both
people and money are necessary to accomplish this.

Dr. Pavia raised the issue of communicating with non-Federal partners
and suggested summer conference calls in order to give feedback to CDC.
It is important for people to know that there will be updates, and he
suggested the establishment of a vaccine safety listserv. Dr. Broder
indicated that updates would be provided to non-Federal partners.

Dr. Roger Bernier introduced the question of cocreation: Are we
conceiving of this development process as a cocreation of participants
or as something we created and are bringing to someone else for review?
Are NVAC and CDC cocreators? According to Dr. Pavia, NVAC\'s role is as
a reviewer, not the creator. Dr. Broder added that the ISO expects to
work closely with scientific partners and that this is not a cocreation
with the public at large. Dr. Bernier noted that cocreation has to be
addressed by both CDC and NVAC---once as they develop the agenda, once
as they review it. In response to the question of the extent of NVAC\'s
coreview, Ms. Pope offered that there is a broad ownership, but the ISO
has tried to keep its focus on the research agenda as a springboard for
other agencies. Dr. Bart noted that input is needed from others; both
scientific and nonscientific partners need to have cocreationist roles.

Subcommittee members discussed two issues that needed clarification. Dr.
Bernier noted that people have many different purposes for planning:
Roadmaps, building morale, and raising money. Prioritizing the ISO\'s
purposes is essential. Dr. Calvin Johnson asked for clarification on the
timeline, which seems like a sequential paradigm. He suggested perhaps
giving a name---rather than a number---to each phase.

As a final comment, Dr. Pavia said that the Subcommittee needs to
consider the constituency of the review panel by the time the draft
comes to NVAC. He reiterated his suggestion of a series of monthly
conference calls to establish the process for finalizing. Dr. Feinberg
suggested ongoing review on the part of ISO, which Dr. Broder confirmed.

Three presentations on alternative methods of obtaining public input
followed.

***Public Input on Immunization Safety: CDC Experiences and Lessons
Learned---Ms. Kristin Pope, ISO/CDC***

Ms. Pope reviewed selected methods for obtaining public input and
lessons learned and discussed considerations for public input into the
ISO research agenda development. She delineated public inquiries and
both unsolicited and solicited input. Examples of the former are
individual public inquiries (e.g., CDC-INFO, VAERS), Congressional
requests, and media interviews. Solicited input included a review of the
CDC vaccine safety monitoring activities (2004), which comprised a blue
ribbon panel and Web-based public comment. As another example of
solicited input, the autism listening sessions in 2004 yielded a broad
range of feedback from 225 participants, whose comments addressed
several different areas. A summary report was posted on the CDC Web
page. Another example of solicited public input is the use of individual
expert consultants conducting thimerosal studies. This was a
labor-intensive endeavor that involved the consultants in all aspects of
the study.

Many lessons were learned from the autism session; specifically, the
expectations of the public were different from those convening the
meeting. The public was more interested in having an exchange of ideas
than just sharing their thoughts, Ms. Pope stressed, and the need to
have clear expectations as to the purpose of the input is critical. The
ISO has also learned that highly technical and scientific issues are
difficult for the general public to address without significant advance
preparation that includes a plan for followup and response.

Ms. Pope noted that different responses are garnered from various
categories of the public: Advocacy groups, an informed public, and the
\"person on the street.\" The ISO is concerned about gaining consensus
from competing groups.

The ISO is operating under certain assumptions for public input:

-   They want external input regarding urgent and emerging vaccine
    safety issues in order to develop the research agenda.

-   They want the input to be relevant to contribute to the ISO research
    agenda priorities.

-   They want a transparent, documented process that is respectful of
    the public as well as CDC scientists.

-   They want the input to be manageable within ISO resources and
    timeframe.

Ms. Pope concluded her presentation with some questions for
consideration, including the usefulness of approaches to obtaining input
at different stages of agenda preparation.

***The Public and Immunization Safety Research---Dr. Deb Gust, NCIRD***

Dr. Deb Gust presented via telephone. She identified what we do know
(e.g., one-third of parents do not agree that they have enough
information to make a good decision about immunizing their child) and
what we could do; e.g., ensure that information is presented before the
child\'s immunization visit. Dr. Gust offered two important points about
public engagement and vaccine safety:

-   The reason for public engagement should be clear. Should
    solicitation of public input come before the basic educational needs
    of parents are met?

-   Public input is not a substitute for educating and better
    communicating with parents about immunizations.

What type of input should we solicit from public? Parents want to be
reassured about the vaccine\'s safety.

Dr. Gust identified potential methods to solicit input, noting that
using mixed methods is optimal as it has no disadvantages. She concluded
her presentation by emphasizing the importance of people feeling that
their opinion counts.

***Discussion***

Discussion centered on the need for bringing nonexperts into the
discussion in an area in which there are professionals with subject
matter expertise. Dr. Bernier noted that nonexperts help experts---who
may not be representative of the public\'s values---to understand what
the public\'s values are. Nonexperts have a different kind of knowledge,
a new perspective, in contrast to experts, who have a more narrow
vision. People bring necessary local knowledge and the perspective of
their town and their community to the discussion.

***Citizen and Stakeholder Engagement in Research on Vaccine
Safety---Dr. Roger H. Bernier, NCIRD***

Dr. Bernier identified the potential goals for vaccine safety research
related to the work needed, from identifying the needs and creating a
plan to designing policies based on results. He noted that we have not
progressed very far regarding immunization policy since 1991.

Noting that there is a trust issue at stake, Dr. Bernier stressed that
the product is not a roadmap for the ISO. Rather, the product is
increased trust. A new reality is that if maintaining public trust is
the problem, then working together is the solution. What work does the
vaccine safety research group have that it can share with the public? It
is essential for this process to be more participatory through
cocreation. Building trust---not using persuasion---is the goal.

Benefits of public engagement are as follows:

-   Improved quality of decisions;

-   Increased support and ease of implementation (a sense of ownership);
    and

-   Improved well-being and sense of efficacy derived from public
    participation.

Dr. Bernier also noted the disadvantages of public engagement (e.g.,
increased time to decisionmaking, decreased Government control over
contents) and compared the length of time of a unilateral decision
versus that where public participation is involved. In delineating both
what public engagement is and is not, Dr. Bernier noted that there is
more than one definition. The key is understanding the levels of public
participation, which exist on a spectrum: Inform, consult (by using
two-way communication such as focus groups), involve (by using
give-and-take), collaborate (by using joint resources, partnerships),
and empower (by delegating). CDC has been functioning largely on the
left of the spectrum.

Public engagement done poorly is unsafe; it can subtract from our trust
account and add to the cynicism and distrust in society. We want to be
sure that we can pass the readiness test before we can expect public
engagement.

An examination of the growth of public engagement at HHS and CDC shows
that the agency is making itself accountable. Dr. Bernier noted the
programs that already exist that involve the public; specifically, he
cited DoD\'s Congressionally Directed Medical Research Programs. In the
National Breast Cancer Coalition peer review program, for example,
consumer reviewers are essential and provide a unique perspective to the
proposed research in question. Involving the public in research is not a
new idea.

***Discussion***

The issue of trust was again central to the discussion. Ms. Pope noted
that the trust factor has been around a specific group of people with a
specific concern and that public engagement is needed because of the way
our society functions. Dr. Pavia reiterated that our goal is to gain
public trust and get good ideas, and Dr. Fergie commented that most
people do trust CDC. There is a need to involve the silent majority in
public participation.

In summary, Dr. Pavia noted the consensus that some representation of
the public on a review panel is desirable and that there is rich ground
for doing research without the obstacle of fear. As to methodology, the
panel is just one of many approaches. Questions still under discussion
are, What are our goals? Which of the input approaches fit what we are
doing? What method should we choose? Why do we want to do this?

**Action Items:** The Subcommittee\'s next steps are to establish the
review panel, develop its clear charge, clarify the role of the public,
and delineate industry involvement. These steps will involve Dr.
Humiston and her Subcommittee. There will be periodic phone calls
between the ISO and NVPO as there remains some concern about the CDC
timeline.

The Subcommittee meeting was adjourned.

**Addendum:**

Clarification of issues surrounding the placement of vaccines on the VA
formulary.

Provided by Dr. Ronald Valdiserri

1\. By what process does VA place vaccines on the formulary? What are
the implications of formulary versus non-formulary status?

> The Medical Advisory Panel (MAP) of the Pharmacy Benefits Management
> group determines whether drugs and vaccines are on or off of the VA
> formulary. Although the MAP gives serious consideration to guidelines
> from other federal agencies and the federal Advisory Council on
> Immunization Practices (ACIP), there is no policy, per se, that
> placement of a vaccine on the VA formulary must await  final ACIP
> recommendations.
>
> When a vaccine, like Zostavax, is non-formulary, it does not mean that
> it is unavailable to veteran patients. Nor are there any differences
> in patient co-pays with respect to drugs or vaccines being on or off
> formulary. What it does mean is that some level of approval, beyond
> the physician\'s order, must take place.

2\. How did the VA set the goal of 65% as its 2007-2008 performance
target for flu vaccination for health care workers?

> The first time that data were collected on vaccination of VA health
> care workers for influenza was FY 05-06 when the vaccination rate was
> approximately 53%. For FY 06-07, the agency followed the procedure
> recommended by its Office of Quality Improvement. Namely, facility
> health care worker vaccination rates were arrayed such that the 80th
> percentile (60%) was selected as meeting performance measures with 65%
> exceeding performance measures. VA has set a goal of 80% for employee
> vaccination by 2011, i.e., an increase of 5% per year.  This means
> that the performance target for the 2007-2008 flu season is 65%. This
> compares to a national average of approximately 40% of all health care
> workers who receive flu vaccine.

[^1]: Fifty-Eighth World Health Assembly. WHA58.3, Revision of the
    International Health Regulations. 2005. Available at
    http://www.who.int/gb/ebwha/pdf_files/WHA58/WHA58_3-en.pdf.