**NVAC APPROVED, OCTOBER 6, 2004**

**Institute of Medicine Report on Financing Vaccines in the 21^st^
Century:**

# National Vaccine Advisory Committee/National Vaccine Program Office Follow-up

Alan R. Hinman,[^1] Bruce G. Gellin,[^2]

and the National Vaccine Advisory Committee

In 2000, an Institute of Medicine (IOM) report "Calling the Shots"
examined the infrastructure and financing of the immunization system in
the United States and recommended a substantial increase in the federal
immunization grant program as well as increases in state support to
strengthen the infrastructure.[^3] There have been some increases in the
federal grant program but there has been little increase in state
support.

The pneumococcal conjugate vaccine, introduced in 2000, had a
considerably higher price than previous vaccines and local, state, and
federal governments had difficulties identifying funds to purchase the
vaccine. In addition, temporary shortages of several vaccines occurred
beginning in late 2000. Consequently, in 2002, the National Immunization
Program of the Centers for Disease Control and Prevention (CDC/NIP)
asked the Institute of Medicine (IOM) to carry out a study to:

"identify financial strategies designed to achieve an appropriate
balance of roles and responsibilities in the public and private health
sectors, integrate federal and state roles in supporting the purchase
and administration of recommended vaccines for vulnerable populations,
and develop a framework for identifying pricing strategies that can
contribute to achieving current and future national immunization goals
for children and adults."[^4]

In response, IOM formed an 11-member committee including economists as
well as medical, nursing, and public health experts. Over a 12-month
period, the committee met four times and heard testimony from a variety
of perspectives, including CDC, the vaccine industry, public and private
health plans, clinicians, and employee benefit managers. The committee
also commissioned a national survey and eight background papers. The
committee released its report in August 2003; the report was officially
published in 2004.

**Conclusions of the IOM Committee**

1.  "Current public and private financing strategies for immunization
    have had substantial success, especially in improving immunization
    rates for young children. However, significant disparities remain in
    assuring access to recommended vaccines across geographic and
    demographic populations.

2.  "Substantial increases can be expected to occur in public and
    private health expenditures as new vaccine products become
    available. While these cost increases will be offset by the health
    and other social benefits associated with theses advances in vaccine
    development, the growing costs of vaccines will be increasingly
    burdensome to all health sectors. Alternatives to current vaccine
    pricing and purchasing programs are required to sustain stable
    investment in the development of new vaccine products and attain
    their social benefits for all.

3.  "Many young children, adolescents, and high-risk adults have no or
    limited insurance for recommended vaccines. Gaps and fragmentation
    in insurance benefits create barriers for both vulnerable
    populations and clinicians that can contribute to lower immunization
    rates.

4.  "Current government strategies for purchasing and assuring access to
    recommended vaccines have not addressed the relationships between
    the financing of vaccine purchases and the stability of the U.S.
    vaccine supply. Financial incentives are necessary to protect the
    existing supply of vaccine products, as well as to encourage the
    development of new vaccine products.

5.  "The vaccine recommendation process does not adequately incorporate
    consideration of a vaccine's price and societal benefits."

The Committee identified two overall goals of financing strategies --
assuring access to recommended vaccines and sustaining the availability
of vaccines in the future. Specific goals for the funding strategy were
to:

-   Eliminate individual financial barriers to immunization

-   Increase incentives to the industry to invest in research and
    development and production capacity

-   Reduce provider burden and improve provider compensation

-   Minimize fragmentation of financing and delivery

-   Maintain existing community and provider relationships

-   Control escalation of costs and increasing fiscal burden on state
    budgets.

**Alternatives considered by the IOM Committee**

1.  "Maintain the current system.

2.  "Expand the VFC \[Vaccines for Children\] program to include
    additional eligibility categories.

3.  "Provide universal coverage through federal purchase and supply of
    all recommended vaccines.

4.  "Provide a federal block grant to the states for vaccine purchase.

5.  "Use public vouchers to purchase recommended vaccines for
    disadvantaged populations.

6.  "Create an insurance mandate that would require public and private
    health plans to cover all recommended vaccines.

7.  "Combine features of the insurance mandate and voucher alternatives
    into a new funded mandate system."

**Recommendations of the IOM Committee**

1.  "The committee recommends the implementation of a new insurance
    mandate \[requiring all health insurance policies to cover
    immunizations\], combined with a government subsidy and voucher
    plan, for vaccines recommended by the Advisory Committee on
    Immunization Practices (ACIP). \[The subsidy/price of a vaccine
    would be set in advance of its development based on its estimated
    societal value.\]

2.  "The Secretary of the Department of Health and Human Services should
    propose changes in the procedures and membership of ACIP so that its
    recommendations can associate vaccine coverage decisions with
    societal benefits and costs, including consideration of the impact
    of the price of a vaccine on recommendations for its use."

3.  "As part of the implementation of recommendations 1 and 2, the
    National Vaccine Program Office should convene a series of
    stakeholder deliberations on the administrative, technical, and
    legislative issues associated with a shift from vaccine purchase to
    a vaccine mandate, subsidy, and voucher finance strategy. In
    addition, the Centers for Disease Control and Prevention (CDC)
    should sponsor a postimplementation evaluation study (in 5 years,
    for example). CDC should also initiate a research program aimed at
    improving the measurement of the societal value of vaccines,
    addressing methodological challenges, and providing a basis for
    comparing the impact of different measurement approaches in
    achieving national immunization goals."

**Response to the IOM Committee Report**

The response to the IOM Report has been varied. Editorials in the Wall
Street Journal[^5] and the New York Times[^6] helped raise awareness of
the complexities of the vaccine industry. In addition, several
organizations have held discussions to further examine the options
raised in the report. A briefing was held at the American Enterprise
Institute at which reservations were expressed by many stakeholders
about the Committee's recommendations.[^7] The Winter Immunization Forum
of the National Partnership for Immunization discussed the report at
some length and also raised questions about the recommendations.[^8] The
past president of the American Academy of Pediatrics (AAP) wrote an
editorial comment in Pediatrics discussing the issues.[^9] The American
College of Preventive Medicine has issued a policy statement endorsing
the recommendations of the IOM Committee.[^10]

The National Vaccine Program Office (NVPO) and the National Vaccine
Advisory Committee (NVAC) formed a Workgroup to develop a response to
the IOM Report. The authors co-chaired the Workgroup. Other Workgroup
members are listed below. [^11] Prior to hosting a stakeholders meeting,
NVPO and NVAC conducted a series of stakeholder interviews in late
September-early October, 2003, after the release of the Executive
Summary of the report but before the final printed version was released.
Bruce Gellin (NVPO), Alan Hinman (NVAC), and Nicole Smith (CDC/NIP)
conducted informal telephonic interviews that were not for attribution.
Stakeholders interviewed included representatives of vaccine companies
(Aventis, Baxter, Chiron, GlaxoSmithKline, Merck, Wyeth), federal
government agencies (Centers for Medicare and Medicaid Services, Health
Resources and Services Administration), public health agency
organizations (Association of Immunization Managers, Association of
State and Territorial Health Officials, National Association of County
and City Health Officials), provider organizations (American Academy of
Family Physicians, American Academy of Pediatrics, American College of
Physicians), and payers/insurers (American Association of Health Plans).

Given that the full report had not yet been published, the results of
the interviews represented initial reactions, rather than formal
positions. The stakeholders' initial overall reactions were presented to
NVAC at its meeting October 7-8, 2003. In summary, there was universal
commendation to IOM for highlighting the value of vaccines; highlighting
the need to vaccinate adults as well as children; attempting to ensure
access to vaccines by all children; and identifying factors contributing
to instability in vaccine research, development, production, and supply.
However, stakeholders were concerned about some of the sweeping changes
recommended by IOM. There was skepticism that the recommended approaches
would provide incentives to manufacturers or improve immunization levels
in children and adults. There was also concern about undertaking a
dramatic shift from the present system to an unproven new system;
concern about the lack of detail about how the proposed new system would
operate; and concern about the cost of the new system. Stakeholders
questioned whether the system was sufficiently broken to require this
level of "fix." They also felt that improvements in the current system
might go a long way to achieving the goals. These incremental changes
might include expanding VFC to all underinsured children; removing price
caps; giving providers a choice of vaccines; harmonizing the regulatory
process with other countries; and encouraging the expansion of health
plan benefits.

**June 28-29, 2004, NVPO/NVAC meeting**

On June 28-29, NVPO and the NVAC Working Group hosted a meeting of
stakeholders in Washington, DC. The purpose of the meeting was to obtain
a fuller understanding of the perspectives of stakeholders now that
there had been sufficient time to consider the implications of the IOM
recommendations. The Agenda for the meeting is Attachment 1 and the list
of participants is Attachment 2. Unfortunately the representative from
America's Health Insurance Plans and the representative from the
American College of Preventive Medicine were unable to attend, as
scheduled.

At the beginning of the meeting, Dr. Mark Pauley, a member of the IOM
committee, presented the major findings and some of the philosophical
issues that the committee considered in developing their conclusions and
recommendations.

On behalf of the Pharmaceutical Research and Manufacturers of America
(PhRMA), representatives of two major vaccine manufacturers summarized
PhRMA's views on the IOM Report. There was agreement with IOM on the
value of vaccines and their public health benefit, the need to improve
immunization coverage in adolescents and adults, and the desirability of
extending insurance coverage for vaccines. However, the PhRMA
representatives were not convinced that the recommendations address the
real reasons why some individuals are not immunized appropriately. In
addition, they were concerned that the recommendations for a subsidized
insurance mandate and voucher system would make the vaccine business an
even less attractive market to manufacturers than it is now. They noted
that achieving the necessary legislative and regulatory changes to
implement the recommendations would be extremely difficult, as it would
require legislative changes in all 50 states as well as national
legislation amending the Employee Retirement Income Security Act
(ERISA).

They questioned the IOM premise that financial barriers are the major
reason people are not immunized. They recommended encouragement of
"first dollar" insurance coverage and including coverage of immunization
as a quality measure, tax incentives to employers to cover
immunizations, coverage for poor children through expanded VFC
entitlement; more aggressive public and professional education
approaches; adequate reimbursement of providers for administering
vaccines; regulatory harmonization; and improved liability protection
through changes in the Vaccine Injury Compensation Program (VICP).
Manufacturers do not support universal purchase of vaccine by the
federal government.

With respect to the feasibility of establishing a subsidy in advance of
vaccine development and production, representatives of individual
vaccine manufacturers, representing both established firms and those
seeking to enter the market, commented on the increasing challenges in
assessing candidate vaccines -- for example, phase III trials for
hepatitis B vaccine involved approximately 1,500 subjects whereas Phase
III trials for pneumococcal conjugate vaccine involved 36,000 subjects
and the new rotavirus vaccine trials may involve 75,000 subjects. It was
also pointed out that private coverage for new vaccines generally occurs
before government funding (particularly through Section 317 or state
appropriations) whereas IOM recommends going to a fully government
funded program. Anticipatory pricing of vaccines by establishing the
level of federal subsidies, as called for by IOM, would, in effect, set
price caps on vaccines and these have proven detrimental in the past.
The manufacturer representatives also highlighted the continuing need
for support of the public health infrastructure through Section 317
grant funds.

Representatives of CDC/NIP, the Association of Immunization Managers
(state/territorial health departments), and the National Association of
County and City Health Officials presented their perspectives. Although
coverage for new vaccines through VFC is rapid and keeps pace with the
introduction of new vaccines, support through Section 317[^12] and state
appropriations has lagged significantly in recent years. This gap in
funding has led to a "two-tier" system in 19 states in which public
health clinics provide pneumococcal conjugate vaccine to VFC-eligible
children but not to non-VFC-eligible children coming to the same
facilities; a similar situation may occur with implementation of the new
ACIP recommendations for routine influenza vaccination of children 6-23
months of age. The introduction of new vaccines such as meningococcal
conjugate and tetanus-diphtheria-acellular pertussis vaccines for
adolescents will further challenge the ability of state and local health
departments to provide all recommended vaccines.

In 1999, funding through Section 317 was adequate to purchase vaccines
to fully immunize 747,000 children; however, in 2004, Section 317
funding is only sufficient to purchase vaccines for 467,000 children.
The importance of immunization registries and infrastructure to assure
delivery and improve immunization coverage in both public and private
sectors was also stressed. State and local health department
representatives agreed that radical financing changes are infeasible in
the near term and recommended that existing policies and delivery
systems be employed to address these current pressing problems.

A representative of CDC/NIP described CDC's involvement in vaccine
purchase and distribution, as exemplified by the very successful VFC
program. There are more than 40,000 VFC provider sites and VFC has
helped to privatize the delivery of childhood vaccines -- 70-80% of
children now receive immunizations in their medical home. There are
several key elements of VFC. For example, it is a vaccine replacement
program rather than a reimbursement program, so health care providers
have no vaccine purchasing costs. VFC has fostered strong public-private
relationships, in part through annual visits to private providers to
assure that quality control standards for refrigeration and handling of
vaccines are met. The current inability of Section 317 to handle
pneumococcal conjugate vaccine indicates that, without some changes, it
will not be able to accommodate other new vaccines in the future.
Discussion brought out the problem that the current proposed expansion
of VFC would be accompanied by concomitant reductions in Section 317.
The point was also made that expansion of VFC to cover underinsured
children only in public health clinics would undermine the concept of
the medical home.

Presentations were made by representatives of the American Academy of
Family Physicians (AAFP), the American Academy of Pediatrics (AAP), the
American College of Physicians (ACP), and the Infectious Diseases
Society of America (IDSA), as well as individual practitioners. None of
the associations had official positions on the IOM report overall but
each had specific points to make. The AAFP endorses the concept that all
children and adults, regardless of economic and insurance status, should
be able to receive AAFP recommended or approved vaccines without cost at
their own clinician's office. The vaccines could be provided through
government purchase or paid for by other payers. Administration of
vaccines involves personnel time, overhead costs, and systems to promote
vaccination. Clinicians should be reimbursed a reasonable fee for these
administration costs. Requiring clinicians to stock separate supplies of
vaccines for VFC-eligible persons and for persons covered by other
payers can be burdensome. Therefore, AAFP recommends that states allow
intermingling of VFC and other vaccine supplies, with appropriate cost
accounting. AAFP's representative would like to see the VICP expanded to
cover vaccination of adults, especially pregnant women, as well as
prospective therapeutic vaccines. ACP is concerned about the limitation
of proposed coverage for influenza and hepatitis B vaccines to adults
with defined high-risk disorders -- high-risk behaviors should also be
included, although ACP recognizes that risk-based strategies have not
been as successful as desired.

The AAP has three basic principles regarding childhood immunization: 1)
all children should have access to immunizations in their medical home,
2) all pediatricians should provide the highest quality care possible,
and 3) every child health care professional should receive fair and
equitable reimbursement for providing health care, including
immunizations. The AAP supports federal subsidies for vaccine production
and delivery to assure a system that does not have shortages or
disparities and does not leave children at risk. AAP supports an
insurance mandate for all recommended vaccines but has concerns about
the cost and complexity of the proposed voucher system for the uninsured
and the process of determining the societal benefits of a vaccine. The
AAP is concerned that implementation of the IOM recommendations could
lead to loss of the gains achieved by VFC, both in terms of provision of
vaccines and quality assurance. The tenuous public health infrastructure
will not be helped by the IOM recommendations and might be further
damaged. AAP is also concerned about adequacy of reimbursement for
administering vaccines -- although the IOM report calls for fair and
equitable reimbursement from third party payers, this is not the current
practice. In many circumstances, physicians lose money on each dose of
vaccine administered.

The IDSA has no formal position on the IOM recommendations themselves
but feels that the solutions proposed are not achievable in the near
term. IDSA recommends expanded access to VFC vaccines (but not at the
expense of Section 317 funding); improving adult and adolescent access
to vaccines and funding for immunization; provider and consumer
education; adequate physician reimbursement; regulatory harmonization;
and consideration of financial incentives for development of new
vaccines and introduction of foreign vaccines.

A family physician/local health officer described the difficulties of
maintaining dual vaccine systems (for VFC and non-VFC vaccines) and the
difficulties in determining whether insured individuals have coverage
for vaccines. He stated that practitioners currently lose money
administering vaccines and described how helpful immunization registries
would be in dealing with children affected by current shortages of the
pneumococcal conjugate vaccine. Three pediatricians described individual
perspectives, including the need to expand VFC and increase support for
Section 317 to accommodate new vaccines on the horizon (e.g.,
meningococcal conjugate vaccine). Tax credits for insurance companies
and employers who cover immunizations were also recommended along with
adequate reimbursement for administration of vaccines. Information was
presented indicating that, in some instances, providers lose money on
vaccine purchase as well as administration. The prospect was raised of a
system in which the government would pay for all "mandated" vaccines
(i.e., those required by state law for school entry), an insurance
mandate would cover the other recommended vaccines, and individuals or
their insurance would pay for elective vaccines.

Representatives of the Children's Defense Fund (CDF), Every Child By Two
(ECBT), the Immunization Action Coalition (IAC), the Partnership for
Prevention (PFP), and the Albert B. Sabin Vaccine Institute (SVI)
presented some consumer perspectives. They noted that vaccines have
provided great health and economic benefits for society and reinforced
the need to maintain and improve on those benefits. Concerns were voiced
about whether the IOM recommendations would solve current problems as
well as the feasibility of getting the necessary legislation passed to
implement the recommendations. Given the success of VFC, the proposal to
legislatively disband it for an untested and more expensive program was
questioned. Another concern was the potential for fraud and abuse should
government issue vouchers for reimbursement of vaccination services. It
was also pointed out that having the government influence, if not
determine, vaccine prices through subsidies is not really a
market-oriented approach and that it might be difficult to reach
consensus about the societal benefits of a vaccine. The prospect of a
Vaccines For Adults (VFA) program was supported by several speakers as a
means of providing adult vaccines to those who cannot afford them.
Several examples were cited of pending legislation that would remedy
some of the issues raised by IOM without calling for sweeping changes to
the healthcare system. Other cost saving methods, including full
implementation of immunization registries and economizing the current
vaccine distribution system, were suggested as partial remedies to the
funding shortfalls experienced in recent years.

**Summary of the June 28-29, 2004, Meeting**

Among stakeholders who attended the meeting, there was widespread
agreement on:

-   The importance of vaccines and immunization.

-   The exciting prospects for new vaccines.

-   The fact that vaccines are undervalued in our society. We make a
    mistake when we talk about how expensive vaccines are. The marvel is
    that vaccines were so inexpensive in the past. Vaccines continue to
    represent a tremendous value for the cost. The cost-effectiveness of
    immunizations is very well documented and is higher than that of
    virtually any other preventive or therapeutic health activity.

-   The need to assure access by everyone to recommended immunizations
    without financial barriers.

-   The need to assure providers are adequately reimbursed for giving
    vaccines.

-   The need to markedly improve efforts to vaccinate adolescents and
    adults. There is currently little or no existing framework to
    accomplish this effort. Both public and provider education are
    needed.

-   The need for regulatory harmonization to remove artificial barriers
    to entry to the US market. This issue has been discussed for many
    years but it is time to take specific action to identify and promote
    needed legislative and regulatory changes.

-   The need to strengthen liability protection for manufacturers.

-   The need to have a better understanding of insurance and health plan
    coverage for vaccines and immunization.

-   The need to have a better understanding of factors responsible for
    low immunization coverage in adolescents and adults.

No one who spoke at the meeting felt that the IOM proposal for mandate,
subsidy, and voucher is currently practicable. Many who spoke did not
feel that, even if implemented, it would solve current problems. For
example, many participants did not feel setting vaccine prices in
advance would stimulate research and development; in fact it might even
be counterproductive. There was also concern about how, and by whom,
societal benefits would be calculated.

Most of those who spoke at the meeting favored improvements in the
current system, specifically:

-   Expanding VFC coverage for underinsured children.

-   Removing VFC price caps.

-   Many speakers favored a Vaccine for Adults entitlement similar to
    VFC but some participants currently would oppose such an entitlement
    unless the factors responsible for adult under-immunization were
    identified and the benefit was clearly limited to a population that
    is not currently being served.

-   Increased support for childhood immunization through Section 317.

-   Specific support for adolescent and adult immunization through
    Section 317.

**Recommendations**

The Institute of Medicine Committee on Financing Vaccines in the 21^st^
Century made a number of important observations about the situation in
the United States and made recommendations for major changes in the
approach to financing immunizations in this country. The National
Vaccine Advisory Committee agrees with many of the observations made,
particularly about the fact that society undervalues vaccines, that
actions are necessary to assure easy access to vaccines in a variety of
settings by all for whom they are recommended (particularly adolescents
and adults), and that actions are necessary to stabilize the vaccine
market and make it attractive for manufacturers to remain in, or enter,
the field. However, NVAC does not feel it is advisable to adopt the IOM
recommendation to replace the current system with an insurance mandate
and system of subsidies and vouchers. The approach recommended by the
IOM does not take into account the peculiarities of research,
development, and manufacture of biological agents. Furthermore, the IOM
recommendations do not sufficiently acknowledge the progress made under
the current system, the potential feasibility and impact of incremental
changes, and the growth in the vaccine market that has occurred since
the inception of VFC. NVAC is not convinced that the recommended
approaches would have the desired effects of increasing vaccine
research, development and production capacity; reducing provider burden;
and maintaining existing community and provider relationships. In
addition, bringing about the legislative changes needed would be
extremely complicated and difficult to achieve. NVAC also does not
support the recommended changes in composition or charter of the ACIP,
as they would not be necessary in the absence of the proposed
mandate/subsidy/voucher approach and the ACIP currently incorporates
economic considerations of new vaccines in its deliberations.

NVAC believes that changes in the current system would go a long way
towards stabilizing the financing of immunizations in the United States.
Therefore, NVAC recommends:

-   Expanded and stable funding through Section 317 for immunization
    program infrastructure and operations, as well as for vaccine
    purchase, within existing guidelines.

-   Expanded funding through Section 317 to support adolescent and adult
    immunization programs including vaccine purchase.

-   Rapid appropriation of new funds through Section 317 when new
    vaccines are recommended for universal use.

-   Expansion of VFC to include underinsured children (as currently
    defined) in all public health clinics; removing price caps; and
    giving all providers and clinics a choice of vaccines.

-   Regulatory harmonization to facilitate introduction into the US of
    vaccines licensed in other countries that are in compliance with
    FDA-approved harmonized standards.

-   Further exploration of regulatory and other factors impeding vaccine
    research and development to alleviate barriers.

-   Increased communication between industry and FDA throughout the
    process of vaccine research and development.

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

-   Assuring adequate reimbursement for administration of vaccines.

-   Expanded discussion about the need, desirability and feasibility of
    a variety of approaches (e.g., Vaccines for Adults or Vaccines for
    All program) to ensure that adults have access to vaccines,
    regardless of whether they have insurance.

**References**

[^1]: Task Force for Child Survival and Development, Decatur GA; Member,
    National Vaccine Advisory Committee.

[^2]: Director, National Vaccine Program Office, Department of Health
    and Human Services.

[^3]: Institute of Medicine. Calling the Shots. National Academy Press;
    Washington DC. 2000

[^4]: Institute of Medicine. Financing vaccines in the 21^st^ century:
    Assuring access and availability. National Academy Press; Washington
    DC. 2004

[^5]: \_\_\_\_\_. Hillary's vaccine shortage. Review & Outlook in the
    Wall Street Journal, August 15, 2003.

[^6]: \_\_\_\_. Preventive Medicine. Editorial in the New York Times,
    August 18, 2003.

[^7]: American Enterprise Institute. A new approach to vaccine
    development. Available at
    <http://www.aei.org/news/newsID.19641,filter./news_detail.asp> .
    Accessed July 8, 2004.

[^8]: National Partnership for Immunization. IOM Vaccine Finance Report.
    Summary of a stakeholder discussion. Available at
    <http://www.partnersforimmunization.org/winterforumsummary.html> .
    Accessed July 8, 2004.

[^9]: Berman S. Do we need a structural engineer to redesign our vaccine
    infrastructure. Pediatrics. 2003; 112:671-2.

[^10]: Kurian S, Blog DS, Sherin KM. Optimizing vaccine availability and
    utilization. Position statement of the American College of
    Preventive Medicine. Am J Prev Med 2004: 26:372-4.

    **Attachment 1**

    **[VACCINE FINANCING STAKEHOLDERS' FORUM\
    NVPO responds to the IOM Report]{.underline}**

    **[AGENDA]{.underline}**

    **Four Points Sheraton -- 1201 K Street, NW -- Washington, DC**

    [Monday, June 28, 2004]{.underline}

    9:00 am Welcome & Opening Remarks Bruce Gellin & Alan Hinman

    9:15 am Review of IOM Findings and Recommendations Mark Pauly

    9:45 am Response to IOM Report Alan Hinman

    9:30 am Manufacturers' Perspectives

    > PhRMA (Ronan Gannon and Bronwen Kaye)
    >
    > Chiron (Clem Lewin)

    11:00 am Break

    11:15 am Manufacturers' Panel Discussion

    > Baxter (Kim Bush), MedImmune (Jeff Stoddard),\
    > Merck (Richard Haupt), Aventis Pasteur (Chris Grant),\
    > Mass. Public Health Labs (Donna Ambrosino)

    11:45 am Q&A and Discussion of Manufacturers' Perspectives

    12:30 pm Lunch

    1:30 pm Federal, State, and Local Health Departments' Perspectives

    > AIM (Claire Hannan), NAACHO (Donna Brown),\
    > CDC (Steve Cochi)

    2:15 pm Q&A and Discussion of Federal, State, and Local\
    Health Departments' Perspectives

    3:00 pm Break

    3:15 pm Distributors/Purchasers' Perspectives

    > CDC (Lance Rodewald), Henry Schein (Brian Cox)

    4:00 pm Q&A and Discussion of Distributors/Purchasers' Perspectives

    5:00 PM Adjourn

    [Tuesday, June 29, 2004]{.underline}

    8:30 am Health Care Providers' Discussion Panel

    > AAFP (Richard Clover), IDSA (Andrew Pavia),\
    > Iron Mountain Medical (Andrew Eisenberg)

    ACP (Cara Egan), AAP (Alan Kohrt),

    > Children's Hospital of Philadelphia (Paul Offit)
    >
    > Ed Marcuse, Christopher Rizzo

    9:30 am Q&A of Health Care Providers' Perspectives

    10:15 am Break

    10:30 am Consumers' Perspectives Panel Discussion

    Immunization Action Coalition (Deborah Wexler)

    Sabin Vaccine Institute (Dean Mason)

    Children's Defense Fund (Emil Parker)

    Every Child By Two (Amy Pisani)

    11:30 am Q&A of Consumers' Perspectives

    12:15 pm Concluding Remarks

    12:30 PM ADJOURN

    **Attachment 2**

    **[National Vaccine Program Office - Vaccine Finance
    Meeting]{.underline}**

    Four Points by Sheraton -- Washington, DC

    June 28-29, 2004

    **[Participants]{.underline}:**

    Donna Ambrosino -- Massachusetts Biological Laboratory

    Donna Brown -- NACCHO

    Kim C. Bush -- Baxter

    Rick Clover -- AAFP

    John Clymer -- Partnership for Prevention

    Steve Cochi -- CDC/NIP

    Margaret Coleman -- CDC

    Brian Cox -- Henry Shein Inc.

    Dack Dalrymple -- Dalrymple Associates

    Anna DeBlois -- ASTHO

    Kenneth Demao -- Northeastern University

    DeeAnn Divis -- UPI

    Cara Egan -- American College of Physicians

    Ronan Gannon -- GlaxoSmithKlein

    Bruce Gellin - NVPO

    Chris Grant -- Aventis Pasteur

    Amy Greene -- ASTHO

    Sarah Gregg -- Baxter

    Rick Haupt -- Merck, Vaccine Division

    Karen Hendricks -- American Academy of Pediatrics

    Alan Hinman -- The Task Force for Child Survival and Development

    Bronwyn Kaye -- Wyeth Vaccines

    Maggie Keane -- Merck Vaccines

    Peter Khoury -- Baxter Vaccines

    Jerome Klein -- Boston University Med. Ctr.

    Alan Kohrt -- AAP

    Sarah Landry - NVPO

    Marie-Michele Leger -- AAPA

    Clem Lewin -- Chiron

    Edgar K. Marcuse -- University of Washington

    David Neumann -- NPI

    Paul Nielsen -- MedImmune

    Jackie Noyes -- American Academy of Pediatrics

    Paul A. Offit Children's Hospital of Philadelphia

    Tanisha Parker -- IDSA

    Andrew Pavia -- IDSA

    Vicki Petrone -- PA Dept. of Health

    Amy Pisani -- Every Child By Two

    Sarah Radcliffe -- BIO

    Christopher Rizzo -- Ohio AAP

    Lance Rodewald -- CDC/NIP

    Brian Rosen -- MedImmune

    Candace Rosen -- HJF/DAIDS

    Judy Rusk -- Infectious Diseases in Children

    Robert Salcido -- Nevada State 12 Program

    Sourav Sengupto -- Duke University

    Susan Silver -- CDC/NIP

    Nicole Smith -- CDC/NIP

    Marie Soldo -- Sierra Health Services

    Jeffrey Stoddard -- MedImmune

    Wanda Sullivan -- Association of Health Insurance Plans

    Kathy Talleyton -- Association of Immunization Managers

    Christy Taylor -- PIDS

    Edward Wake -- NYC Dept. of Health/CDC

    Cole Werble -- National Health Policy Forum

    Deborah Wexler -- Immunization Action Coalition

    Andrea Wilkinson -- Aventis Pasteur

    Andrew Wisenberg -- Iron Mountain Medical

    Bitzie York -- GlaxoSmithKlein

    Jen Zavolinsky -- Every Child By Two

    Tom Zink -- GlaxoSmithKlein

[^11]: Other members of the workgroup: Anne Arvin, Steven Black, Ronan
    Gannon, Bronwen Kaye, Jerome Klein, David Neumann, Lance Rodewald,
    Una Ryan, Patricia Whitley-Williams, Don Williamson.

[^12]: Section 317 of the Public Health Service Act provides support
    (through CDC) for health department immunization programs and
    vaccine purchases.