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November 13, 2023

Cristina Beato, M.D.

Acting Assistant Secretary for Health

Director, National Vaccine Program

Department of Health and Human Services

200 Independence Avenue, SW, Rm. 716G

Washington, DC 20201

**RE: NVAC -- October 5-6, 2004 meeting**

Dear Dr. Beato:

Let me first take this opportunity to express the Committee's
appreciation for your participation in the October 2004 National Vaccine
Advisory Committee (NVAC) meeting. The influenza vaccine supply crisis
that surprised us all on October 5^th^ has, I'm sure, turned your
calendar upside down. This turn of events only emphasizes the importance
of much of the work we, at your request, have been pursuing. We look
forward to continuing to serve as advisors to you and the Department as
these and other issues come to the forefront.

During October's two-day meeting, several working groups provided
reports and recommendations, three of which were accepted by vote of the
full Committee.

Per your request at the June 1-2, 2004 meeting, a Pandemic Influenza
Working Group was formed to prepare comments for NVAC on the
Department's Pandemic Influenza Preparedness and Response Plan, as
issued to the public in draft form on August 26, 2004. The full
committee approved the Working Group's comments and recommendations
(Attachment A). While the draft Plan provides an excellent overview of
the factors to be considered in national, state, local, and hospital
level plans, it remains incomplete; lacking specific recommendations for
action. It is the opinion of the Working Group and the Committee that
several key policy decisions need public discussion so that they may be
resolved in advance of a pandemic. Such key decisions include, but are
not limited to: the role of the Federal government in the purchase and
distribution of vaccine; identification of priority groups for
vaccination, the use of antivirals in prophylaxis and treatment; and the
purchase and stockpiling of syringes and needles. Additionally, it would
prove beneficial to the states if the Plan included a discussion of the
linkages to overall disaster preparedness activities in an effort to
string together related activities. To facilitate this discussion this
Working Group will remain active, consulting with stakeholders to carry
out the public discussions necessary to make policy recommendations by
June 30, 2005. It is anticipated that these recommendations will include
ongoing review of the Plan, providing for modifications as situations
change and new needs evolve.

In response to your challenging request during our February 2004
meeting, an Influenza Working Group was formed with three subgroups to
identify high priority issues and recommendations for improvement of the
national influenza immunization program. Those subgroups were defined
and chaired as follows: 1) Influenza Vaccine Research, Development and
Production (Dr. Ann Arvin, Chair), 2) Influenza Vaccine Recommendations
and Strategies (Dr. Jerome Klein, Chair), and; 3) Influenza Vaccine
Delivery, Financing and Demand (Dr. Fernando Guerra, Chair). Since the
June meeting, we have brought our findings together with the following
eight recommendations:

-   Improve vaccination coverage among recommended groups by
    facilitating delivery of influenza vaccines in a range of settings,
    especially in those "medical homes", other medical sites,
    workplaces, and community sites where people have not previously had
    access to vaccination

-   Make influenza vaccine purchase less of a burden and financial risk
    for providers.

-   Explore options for a comprehensive vaccination program for adults.

-   Increase influenza vaccination of healthcare workers.

-   Consider expanding influenza vaccination recommendations.

-   Implement systems to better understand the burden of influenza
    illness in the U.S. and to better assess the impact of vaccination
    programs and vaccine effectiveness.

-   Conduct a comprehensive review of the influenza research program to
    identify gaps and areas for additional support.

Our report can be found as Attachment B following this letter. We
appreciated your involvement in the discussion of the preliminary report
and your helpful comments.

The Working Group on Enhancing Public Participation in Vaccine Policy
Deliberations, chaired by Ruth Katz, MPH, JD, held a meeting on
September 13-14, 2004 to consider options for enhancing public
participation in vaccine policy deliberations and to evaluate the
proposal from the Wingspread Public Engagement Planning Group for the
Vaccine Policy Analysis Collaborative (VPACE) demonstration project.
Responding to the Working Group's charge, Ms. Katz presented several
recommendations developed by the Working Group following the meeting
(Attachment C). These recommendations, accepted by the full Committee,
include: the inclusion of a member of the public as a full NVAC member;
the active solicitation of attitudes, concerns, and suggestions from the
public, providers, and industry about their perspectives, experiences,
and perceptions of vaccines; and the development and promotion of
communications with the public through enhanced outreach activities. The
Committee encourages the consideration of the various models of public
involvement to facilitate the implementation of appropriate sections of
the Pandemic Influenza Preparedness and Response Plan, such as the
determination of priority groups.

In response to the IOM's request, as presented in their report
"Financing Vaccines in the 21^st^ Century," the Vaccine Financing
Working Group held a 2-day stakeholder forum on June 28-29, 2004 to
examine the administrative, technical, and legislative issues associated
with a possible shift from vaccine purchase to a vaccine mandate,
subsidy, and voucher financed strategy. Attendees represented
manufacturers, Federal agencies, public health agencies, and providers.
Insurers were invited to the table, but were unable to attend and have
not provided a payer's opinion. As a result of that forum, the Committee
has approved a number

of recommendations (Attachment D) we feel could contribute to the
stabilization of the current immunization financing system including:

-   improvement and expansion of Section 317 funding for program
    infrastructure and operations, and vaccine purchase for both current
    recipients as well as adolescent and adult immunization programs;

-   expansion of Vaccines for Children funding to include underinsured
    children in all public health clinics;

-   promotion of "first dollar" insurance coverage for immunization and
    prompt coverage and re-calculation of capitation rates when new
    vaccines are recommended;

-   regulatory harmonization to facilitate the introduction of vaccines
    holding foreign licenses into the US market; and

-   exploration of ways to remove barriers to vaccine research and
    development.

The Working Group on Public Health Options for Implementing Vaccine
Recommendations has continued its work on the development of a decision
making framework that could be utilized by state authorities in the
implementation of vaccine recommendations. This framework emphasizes the
public process, the thorough consideration of public health, public
policy, and operational environments, and a closer examination of
exemptions, particularly the effects of non-medical exemptions and the
process for obtaining such an exemption. The Committee anticipates it
will vote on a final document outlining the Working Groups
recommendations at the February 2005 meeting, at which point the
recommendations will be passed on to the Association of State and
Territorial Health Officers, who had originally requested that the
Committee examine the process.

The Vaccine Safety & Communication Subcommittee received a presentation
by Dr. Melinda Wharton, NIP, about the IOM review of the NIP Vaccine
Safety Datalink data sharing program. The IOM's final reports are
expected to be released in November 2004 (reviewing and presenting
recommendations on the program) and in February 2005 (reviewing and
presenting recommendations for the handling of preliminary data obtained
by Datalink).

The Immunization Coverage & Future Vaccines Subcommittees held a joint
meeting to begin the planning of a National Stakeholder Meeting on
Strategies to Increase the Uptake of New Vaccines for Adolescents,
currently proposed to be held in June 2005. The goals of such a meeting
would be to identify the strengths and weaknesses of key implementation
strategies and issues; identify approaches that will effectively and
efficiently increase the proportion of adolescents who receive vaccines;
develop plans to implement these approaches; and to identify research
initiatives in support of the successful introduction of these new
vaccines and to accelerate the development of vaccines in the
'pipeline.'

Other presentations of interest included the following: a review of the
2004-2005 Influenza Season (Drs. Steven Cochi, Eddie Wilder, and Alan
Janssen, NIP), National Children's Health Study (Dr. Peter Scheidt,
NIH), an update of the READII program (Tamara Kicera, NIP), and an
overview of project Bioshield (Monique Mansoura, OPHEP).

Last, but not least, valuable agency and committee updates were
presented by: NIP/ACIP (Dr. Steve Cochi - CDC), ACCV/DVIC (Dr. Geoff
Evans - HRSA), FDA/VRBPAC (Dr. Gary Overturf -- University of Mexico,
VRBPAC Chair and NVAC liaison), NIH (Dr. George Curlin -- NIAID).

Feel free to contact me with any questions or concerns you may have in
regard to our last NVAC meeting. The next NVAC meeting is scheduled for
February 8-9, 2005. We hope you will be able to join us.

> Sincerely yours,
>
> ![](media/image2.wmf)
>
> C[harles]{.smallcaps} M. H[elms]{.smallcaps}, M.D., Ph.D.
>
> *Chairman, National Vaccine Advisory Committee*
>
> *Professor of Medicine*
>
> *Roy J. and Lucille A. Carver College of Medicine*
>
> *University of Iowa*
>
> *Chief of Staff*
>
> *University of Iowa Hospital and Clinics*

CH/ee

Attachments

cc: Bruce Gellin, M.D., M.P.H.

NVAC members