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**National Vaccine Advisory Committee (NVAC)**

**February 5­--6, 2008, Meeting Minutes**

[Meeting Overview]{.underline}

The Committee heard presentations on a variety of issues during this
2-day meeting. These included information on vaccine supply, adult
immunization, seasonal and pandemic influenza, health information
technology (HIT), public engagement with the National Vaccine Plan, and
the Health and Human Services (HHS) proposed 2009 budget for vaccines
and immunization activities. Attendees received an introduction to the
objectives and structure of the National Biodefense Science Board. The
Vaccine Financing Working Group and the Vaccine Safety Working Group
updated the Committee on their activities. Votes were taken on
recommendations presented by the Adolescent Immunization Working Group
and on a paper drafted by the Vaccine Development and Supply
Subcommittee.

[Committee Members in Attendance]{.underline}

> Gary L. Freed, M.D., M.P.H.---*Chair*
>
> Jon R. Almquist, M.D.
>
> Guthrie S. Birkhead, M.D., M.P.H.
>
> Richard D. Clover, M.D.
>
> Cornelia L. Dekker, M.D.
>
> Mark Feinberg, M.D.
>
> Jaime Fergie, M.D., F.A.A.P.
>
> Lance K. Gordon, Ph.D.
>
> Calvin Johnson, M.D., M.P.H.
>
> Christine Nevin-Woods, D.O., M.P.H.
>
> Trish Parnell
>
> Andrew T. Pavia, M.D.
>
> Adele E. Young, Ph.D.

[Executive Secretary]{.underline}

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

[Acting Assistant Secretary for Health]{.underline}

> Don Wright, M.D., M.P.H.

[NVAC Ex Officio Members]{.underline}

> Norman Baylor, M.D., Food and Drug Administration (FDA)
>
> George Curlin, M.D., National Institutes of Health (NIH)
>
> Geoffrey Evans, M.D., Health Resources and Services Administration
> (HRSA)
>
> Jeffrey A. Kelman, M.D., Centers for Medicare & Medicaid Services
> (CMS)
>
> Anne Schuchat, M.D. (Rear Admiral, U.S. Public Health Service
> \[USPHS\]), Centers for Disease
>
> Control and Prevention (CDC)

[Liaison Representatives]{.underline}

> Mahnaz FarhangMehr, M.D., Public Health Agency of Canada
>
> John Hunsaker, M.P.H., America's Health Insurance Plans (AHIP)
>
> Dale Morse, M.D., Advisory Committee on Immunization Practice (ACIP)
>
> Wayne Rawlins, M.D., M.B.A., AHIP
>
> David Salisbury, C.B., F.R.C.P., F.R.C.P.C.H., F.F.P.H.M., United
> Kingdom Department of Health
>
> Tamara Tempfer, M.S.N., P.N.P., Advisory Commission on Childhood
> Vaccines (ACCV)

[Committee Members Absent]{.underline}

> Sharon G. Humiston, M.D., M.P.H.
>
> Charles Lovell, Jr., M.D., F.A.C.P.
>
> Laura E. Riley, M.D.

[Invited Speakers]{.underline}

> Dr. Margaret S. Coleman, CDC
>
> Ms. Liz DeVoss, HHS Office of Budget
>
> Dr. Katherine M. Harris, Rand Corporation
>
> Ms. Donna Lazorik, Massachusetts Department of Public Health
>
> Dr. John W. Loonsk, HHS Office of the National Coordinator for Health
> Information Technology
>
> (ONC)
>
> Ms. Shelley Ludwick, Visiting Nurse Associations of America
>
> Dr. Nicole Lurie, Rand Corporation
>
> Dr. John Mascola, National Institute of Allergy and Infectious
> Diseases (NIAID)
>
> Dr. Gina T. Mootrey (CAPT, USPHS), CDC
>
> Dr. Julie Morita, Chicago Department of Public Health
>
> Dr. Walter A. Orenstein, Emory University
>
> Dr. Gerald W. Parker, Office of the Assistant Secretary for
> Preparedness and Response (ASPR), HHS
>
> Mr. Steve Pellito, Maxim Health Systems
>
> Dr. Michael N. Robertson, Merck
>
> Dr. Jeanne M. Santoli, CDC
>
> Dr. Benjamin Schwartz (CAPT, USPHS), NVPO
>
> Dr. Kristine Sheedy, CDC
>
> Ms. Angela K. Shen (CDR, USPHS), NVPO
>
> Ms. Shannon Stokley, CDC
>
> Dr. Raymond A. Strikas (CAPT, USPHS), NVPO
>
> Dr. Jane R. Zucker (CAPT, USPHS), New York City Department of Health
> and Mental Hygiene

**Day 1---February 5, 2008**

**Opening Remarks---Dr. Gary Freed**

Dr. Gary Freed welcomed the participants. This will be his last meeting
as Chair of the Committee. He reported that he has had discussions with
the Executive Secretary about the aspects of Committee organization that
have worked well and those that might be improved.

Historically, the Committee has had a number of standing Subcommittees
organized around general topic areas, with the task of defining for
themselves those specific issues within their respective areas that most
deserved their attention. A certain amount of time at NVAC meetings was
reserved for Subcommittee meetings.

Dr. Freed announced a new organizational plan that will replace the
permanent Subcommittees with Working Groups, each of which will receive
a specific charge and whose existence will end when its assignments are
completed. This will allow flexibility in the focus of the Committee,
provide a product relevant to the country, and free up time at the
general meeting as Working Group members will meet regularly by
conference call.

The two Working Groups already in existence---the Vaccine Financing
Working Group and the Adolescent Immunization Working Group---have been
the models for the new organization. They are expected to come to an end
approximately 1 year from now. The Subcommittee on Vaccine Safety will
become a new Working Group with a specific charge. There may also be a
Working Group on adult immunization.

Dr. Bruce Gellin observed that the new structure will allow greater
participation by NVAC members in these key areas of study.

Dr. Freed expressed the hope that creating a better defined and targeted
process will increase NVAC's value to the Nation.

**Proposed 2009 HHS Budget for Vaccine and Immunization Activities---Ms.
Liz DeVoss**

Ms. Liz DeVoss noted that the 2008 budget had been presented to Congress
in October. The proposed budget for fiscal year 2009 is a deficit
reduction budget.

The budget requests \$5.4 billion for immunization activities across
HHS, an increase of \$36 million over fiscal year 2008. It includes
increases for CDC's Vaccines for Children (VFC) program and FDA
immunization activities. It maintains the funding for section 317 at the
2008 level.

Ms. DeVoss focused her remarks on immunization and vaccine funding for
CDC, the NIH, and the FDA. For CDC, an overall increase of \$49 million
is proposed. VFC allocation is \$64 million higher because of increased
vaccine costs. Funding for influenza has dropped by \$15 million; this
reflects shifts within the total pandemic influenza funding to other
activities; e.g., surveillance.

The NIH estimates that spending for immunization-related research will
be \$1.3 billion, approximately the same as in fiscal year 2008. The
slight decrease in funding between 2008 and 2009 (\$1 million) is
consistent with the NIH's estimates in many disease areas in the context
of an overall straight-lined budget.

Five million dollars more is requested for the FDA in 2009 than in 2008
and reflects increased FDA vaccine-related activities.

***Discussion***

Dr. Freed asked how much of the NIH immunization budget would support
research for immunization for communicable diseases. While Ms. DeVoss
did not have that information readily at hand, she promised to furnish
it to Dr. Freed at a later time.

Several participants expressed disappointment with the proposed budget.
Dr. Andrew T. Pavia asked whether finer detail was available online. He
also asked whether it would be possible to learn what agency requests
were relative to the final funding levels. Ms. DeVoss said that more
detailed information was available but would depend on the agency; the
budget for immunization activities would be clearer, for instance, for
CDC than for the NIH, where immunization funding would be dispersed
across many institutes. She added that the Office of Budget would be
happy to try to find the answers to specific questions. Ms. DeVoss was
not able to share information about agencies' initial funding requests.

Dr. Mark Feinberg asked to what extent allocation for the 317 program
matches CDC's estimate of need. Ms. DeVoss said that the funding level
for 317 is essentially the same as for 2008. It does not correspond to a
specific need for childhood vaccination. It allows States to prioritize
their immunization needs and to use VFC funds to serve uninsured
children.

Dr. Feinberg asked whether there has been an assessment of how the
proposed 2009 funding levels serve to meet the need the FDA has to
function as effectively as possible. Ms. DeVoss said that the FDA's most
increased need for resources is probably in the area of pandemic
influenza.

Dr. Christine Nevin-Woods noted the significant decrease in CDC's budget
for influenza and asked for particulars. Ms. DeVoss said that within
CDC, funding for pandemic influenza was increased by approximately \$3
million, but there has been a shift among the activities that the CDC
funds. For instance, last year, funding was included for a diagnostic
reagent stockpile. The requested 2009 budget proposes continued funding
for such activities but at a lower level while shifting funds to
domestic surveillance and other preparedness activities. She observed
that she had presented only the portion of funding that related to
immunization. The budget maintains funding to States for influenza
demand. She said that the 2009 budget also includes \$507 million for
pandemic influenza funding and remains committed to getting an
additional \$870 million that was requested but not appropriated for
2008.

Dr. Guthrie Birkhead noted that funding to States for pandemic influenza
preparedness is coming to an end and creating problems for States trying
to maintain the infrastructure that was created. He wished to highlight
this as a gap in the budget.

**Introduction of the Acting Assistant Secretary for Health**

Dr. Gellin introduced Dr. Don Wright, Acting Assistant Secretary for
Health.

Dr. Wright said that he was impressed with the work of the Committee and
extended his thanks to its members.

Dr. Wright briefly outlined his career in private practice and public
service. He completed his residency in family practice at Baylor College
of Medicine and established an extensive clinical and consulting
practice in central Texas, where he also became involved in occupational
health and preventive medicine. He observed that he found the knowledge
rewarding that a single effective workplace intervention affects the
well-being of many individuals.

Dr. Wright noted that concerns have been raised about turnover in the
Office of Public Health and Science. To provide consistency in
leadership, Dr. John O. Agwunobi made Dr. Wright's position as Principal
Deputy Assistant Secretary for Health a career---not a
political---appointment.

He said that having spent a significant amount of time in the developing
world as a volunteer, he has great respect for the value of vaccination.
For the last several years, Dr. Wright has been heavily involved in
pandemic influenza preparedness. He spoke of the abysmally low
immunization rates of healthcare workers and of strategies to increase
their immunization.

Dr. Wright noted the increasing cost to fully immunize children and said
that he was pleased that there is a Working Group to study the issue; he
looks forward to the paper they are preparing. He is also pleased that
Dr. Agwunobi recognized the need for attention to the vaccination of
adults and adolescents. He said that vaccine production is a big issue;
he looks to the Committee to provide guidance and to warn of roadblocks.

Other issues Dr. Wright touched on in his address included the promotion
of electronic health records and the importance of communication skills
in maintaining the public trust. He expressed appreciation for Dr.
Freed's 4 years of service (2 of them as Chair). He extended a welcome
to Dr. Birkhead, who will succeed Dr. Freed, and expressed confidence in
Dr. Birkhead's leadership.

Dr. Pavia observed that advice goes up from the Committee but that the
Committee members are not provided with an understanding of how
decisions are arrived at. He asked how feedback from above can be
improved. Dr. Wright said that he could not speak for others but that he
will make every effort to communicate that information. He committed
himself to report what he has conveyed to those above him and what the
response has seemed to be.

**Current Vaccine Supply Disruptions---CDR Angela Shen**

Ms. Angela Shen stated that her purpose was to lay out a framework for
discussion of vaccine supply issues. She offered an update on current
supply disruptions and then spoke about the system in place for
Government response to vaccine supply issues.

In November, Merck reported a supply issue with regard to *Haemophilus
influenzae* type b (Hib) vaccine and, in December, initiated a recall.
Supply is expected to resume in the fourth quarter of 2008. Sanofi
pasteur is able to supply the U.S. market for only the primary series
early in the year. Their supply forecast for late 2008 is currently
under review.

In August 2007, Merck reported a supply issue with hepatitis A vaccine,
with anticipated resumption of supply in the first quarter of 2008.
GlaxoSmithKline (GSK) is able to cover the U.S. demand as needed.

In January 2008, sanofi pasteur reported a supply issue with single-dose
vials of yellow fever vaccine. Five-dose vials are available until
resumption of the single-dose supply, anticipated in March.

An ad hoc interagency group was formed in 2003 by CDC and FDA to handle
shortages of VFC vaccines and to provide guidance to providers during
supply disruptions. The FDA ensures resolution of regulatory problems.

NVAC hosted discussions with stakeholders on vaccine supply in 2002 and
2005. The results were published in 2006 (Clin. Infect. Dis. 42 Suppl.
3: S97­--103). The meetings resulted in five stakeholder recommendations:

-   Provide incentives to manufacturers.

-   Streamline regulatory authority to ensure reliable production of
    safe and efficacious vaccines.

-   Strengthen liability protections.

-   Implement more comprehensive stockpiles. (A Securities and Exchange
    Commission ruling resolved this issue \[17 CFR Parts 231, 241, and
    271; release nos. 33-8642; 34-52885; IC-27178\].)

-   Develop a program to educate consumers as to the value of vaccines.

**Review of Investigational New Drug (IND) and Emergency Use
Authorization (EUA) Process---Dr. Norman Baylor**

Dr. Norman Baylor discussed the role of INDs and EUAs in mitigating and
minimizing supply shortages. He began by outlining the types of IND
application:

-   Commercial---submitted by companies with the goal of obtaining
    marketing approval;

-   Investigator Initiated---submitted by a physician to study an
    unapproved drug or an approved drug for a new indication or in a new
    population;

-   Treatment---for experimental drugs showing promise in a clinical
    setting for serious or immediately life-threatening conditions; and

-   Emergency Use---for use in an emergency situation that does not
    allow time for submission of an IND submission. A request may be
    submitted by telephone or other rapid communication. The sponsor
    must make an appropriate IND submission as soon as possible after
    receiving authorization.

Dr. Baylor then spoke of EUAs in Project Bioshield. In a national
emergency, the Secretary of HHS can authorize the use of a drug for up
to 1 year if

-   The agent can cause a serious or life-threatening disease or
    condition.

-   There exists no adequate or sufficiently available approved
    alternative.

-   The products known or potential benefits outweigh its known or
    potential risks.

For a drug to be used under an EUA, conditions must allow for monitoring
and reporting adverse events. If feasible, healthcare workers and
recipients should be

-   Informed that the product is authorized for emergency use;

-   Told of any risks and benefits; and

-   Given the opportunity to refuse the product.

Dr. Baylor ended with a discussion of priority reviews. Such a review
sets a target date for completing all aspects of a review and for the
FDA's taking action on the application at 6 months from submission.
Priority reviews are intended for those products that would mark a
significant improvement in the safety or effectiveness of treatment,
diagnosis, or prevention of a serious or life-threatening disease.

***Discussion of CDR Shen's and Dr. Baylor's Presentations***

Ms. Shen offered a number of suggestions for discussion, one of which
was a report card on supply issues for the June NVAC meeting. Another
was whether stockpiles of nonpediatric vaccines are appropriate or
feasible.

Dr. Freed said that the report card would be quite helpful to the
Committee and asked that NVPO staff prepare a report on the current
status of recommendations made by NVAC and other bodies on the subject
of vaccine supply and to have this ready for the June NVAC meeting. He
asked for similar information regarding the status of any
recommendations having to do with stockpiles of non-VFC
vaccines---whether such recommendations had been implemented and if they
had not, why not---in order for the Committee to have a complete
understanding of the subject as it moves forward.

Dr. Gellin said that the request was a substantial one and that the
results would vary by vaccine. He gave the example of disruptions in
influenza vaccine supply with the threat of a pandemic to illustrate the
extraordinary efforts the Government has made to minimize the chance of
that happening again. He added that a look at Project Bioshield would
offer another lesson about the development of vaccines that were not
available (not having a needed product being, in some sense, a supply
issue). Dr. Gellin noted that each of these would inform the broader
picture in different ways. The larger question remains---"What do you do
with this kind of machinery?" He noted that Dr. Freed had raised a
legitimate question but one whose answer requires a broader context than
is provided by a focus on vaccines.

Dr. Birkhead observed that it is a timely topic and one that NVAC should
be involved with; there is no single entity managing vaccine supply.

Dr. Lance Gordon said that the identification and consolidation of
vaccine-related recommendations for disparate bodies should be taken on
as a separate project.

Dr. Lance Rodewald of CDC said that after discussions with sanofi
pasteur, it appears that the United States can weather a 1-year shortage
of Hib vaccine but that if the shortage should last longer than 1 year,
there will be a cohort of children who will miss their 2-year-old dose.

Dr. Baylor was asked about EUAs to cover shortages. He replied that
there had been some discussion of the matter but that it might require
Congressional action.

Ms. Trish Parnell recalled that in 2004, following a media campaign to
encourage the public to be vaccinated, there was a shortage and messages
that only at-risk persons should seek vaccination. She believed that the
message finally conveyed by this sequence of events was that vaccination
was not terribly important for most people.

Dr. Jon Almquist asked why a stockpile of Hib vaccine did not exist. Dr.
Anne Schuchat replied that there had been a stockpile---not large---but
that some was recalled because of a manufacturing issue. Dr. Baylor said
that another manufacturer might be brought on but questioned whether
there would be a market when the shortage had passed.

**Proposed Recommendations for Adolescent Vaccination---Dr. Gary Freed,
Ms. Shannon Stokley,**

**Dr. Lance Gordon, Ms. Trish Parnell, and Dr. Andrew Pavia**

Dr. Freed said that the recommendations were the product of more than a
year of effort. He wished to publicly recognize the members of the
Working Group for the amount of time they had devoted to the
undertaking. The recommendations covered the following areas and were
presented in the order shown:

-   Venue/Healthcare Utilization

-   Consent

-   Communication/Public Engagement

-   Financing

-   Surveillance

-   School mandates

The recommendations for financing engendered the most heated and
detailed discussion and are appended below:

> 1\. All public and private health insurance plans should offer
> first-dollar coverage of all costs associated with the acquisition,
> handling, storage, and administration of all vaccines recommended for
> routine and "catch-up" use among adolescents by ACIP. Vaccine
> administration costs should be calculated to include the value of time
> and materials needed for patient/parent education and for record
> keeping.
>
> 2\. Provision of Federal and State tax incentives for insurance
> carriers and other entities (such as employers who purchase health
> insurance for their employees) should be explored as an effort to
> stimulate compliance with the foregoing recommendations on insurance
> coverage of immunizations.
>
> 3\. National legislation to mandate first-dollar insurance coverage of
> ACIP-recommended adolescent vaccines (and associated vaccination
> costs) in all health plans covered by the Employee Retirement Income
> Security Act (ERISA) and in all health plans serving Federal
> employees.
>
> 4\. Substantially decreased time from creation to official publication
> of ACIP recommendations.
>
> 5\. Significant expansion of Public Health Services Act 317 funding to
> support the additional national, State, and local public health
> infrastructure needed for adolescent immunizations.
>
> 6\. Refining of the VFC program so that all VFC-enrolled providers are
> allowed to use VFC vaccine to vaccinate adolescents who are
> underinsured for one or more of the recommended vaccines and who
> cannot otherwise afford to be vaccinated.
>
> 7\. Funding to ensure that all costs (including those incurred by the
> schools) associated with adolescent immunization mandates for school
> attendance are covered.
>
> 8\. Shared public and private sector approaches to funding
> school-based and other alternative-venue adolescent immunization
> efforts.
>
> 9\. Ongoing Federal funding for cost-benefit studies of vaccinations
> targeted for adolescents.
>
> 10\. Careful implementation of the foregoing recommendations so that
> the private market for vaccines is not destroyed or substantially
> decreased.

***Discussion of Financing Recommendations***

Dr. Gordon was asked why this Working Group had addressed financing when
there is another Working Group devoted to that topic. He replied that
the Adolescent Immunization Working Group felt that there were a number
of unique aspects of financing for adolescent vaccines. They are, as a
rule, more expensive; there are fewer adolescents with health insurance
that covers immunization; and fewer adolescents are eligible for VFC
programs. He added that comments have been sought from---and provided
by---members of the Financing Working Group and that the collaboration
will continue. A concern was raised that incompatible recommendations
might be forthcoming from the two Working Groups. Dr. Freed pointed out
that it is the full Committee that will make the final recommendations.
Dr. Birkhead, Chair of the Financing Working Group, said that there
should be an effort to synchronize the presentation of the
recommendations.

Dr. Wayne Rawlins expressed displeasure that feedback from AHIP did not
appear to be reflected in the recommendations. He said that AHIP could
not support two elements of the proposed recommendations concerning
vaccine financing. These were (1) those concerning public and private
financing of first-dollar coverage and (2) those having to do with
ERISA. The latter were objectionable for two reasons: (1) Mandates tend
to have unintended consequences. By mandating coverage---especially in
markets for individual and small groups, which are typically very cost
sensitive---prices will be driven higher, leading to dropout and
consequent uninsurance. (2) If States with mandates are compared to
States without mandates, those without have a higher vaccination rate.

Dr. Gordon replied that he was aware of the experience with mandates. In
general, he thought there was some benefit but agreed that it was small.
Most of that experience, he said, however, has been with pediatric
vaccines, and circumstances differ substantially when adolescents are
considered. Dr. Freed stated that the recommendations were modified in
the light of AHIP comments. For insurance plans that are not covered by
ERISA, there is no call for a mandate but, rather, for tax incentives
intended to create an environment for the insurance market to be able to
respond to a call for first-dollar coverage. The mandate is for
self-insured plans, essentially calling on employers who are regulated
by Federal law because they are not subject to State mandates. These
groups were distinguished on the basis of the AHIP comments. Dr. Freed
pointed out that these recommendations were an opportunity for new
feedback and proposed solutions.

Dr. Deborah Wexler of the Immunization Action Coalition noted that
currently, practices can ask for a donation from patients to cover
administration of VFC vaccines. She expressed the hope---if there is a
recommendation to eliminate copayments for insured patients---that this
practice be disallowed, also, as it puts the practitioner in the awkward
position of asking for money from patients who were expecting free
vaccine and may lead to cross-cultural misunderstandings. Dr. Gordon
replied that the recommended first-dollar coverage includes the fully
absorbed costs. The recommendations also recognize that clinics and
individual practitioners who incur significant costs over and above the
cost of the vaccine itself deserve to be reimbursed.

Dr. Almquist said that the American Academy of Pediatrics would oppose
opening VFC legislation to accomplish what can be done by delegation of
authority from Federally Qualified Health Centers.

Dr. Feinberg said that the recommendations make sense, but if only some
of them are implemented, they may worsen the situation. Mr. John
Hunsaker from AHIP suggested that employer groups be considered in the
mandate to plans.

***Discussion of Other Recommendations***

Ms. Shannon Stokley was asked for examples of complementary venues. She
suggested schools and retail-based clinics as possibilities. Dr. Richard
Clover said that the Working Group believes in the medical home model
but that there is a need to reach more adolescents.

In discussion of consent, Dr. Gordon observed that adolescence is a time
of separation from parental control and seeking independence. Therefore,
parental consent may be difficult to obtain. He also noted that there is
a complex body of law, and interpretations of those laws will need to be
made; for instance, whether a vaccine for a sexually transmitted disease
should be considered under the laws pertaining to the treatment of
sexually transmitted diseases. Finally, he noted that there are strong
regional beliefs about adolescent consent.

During discussion of the recommendations concerning communication, a
representative from GSK suggested contacting advocacy groups who make a
practice of reaching out to teens. Dr. Freed observed that there would
be a need to know how effective communication efforts have been and that
private sector involvement would be needed.

In the discussion of school mandates, Dr. Alan Hinman noted that
community support must be built before the introduction of mandates if
they are to be successful.

**Conclusion**

The recommendations will be refined on the basis of comments made at the
meeting or sent to the Working Group, following which they will be
forwarded to a group of interested parties for further evaluation. The
Working Group will present its revised recommendations for a vote at the
NVAC meeting in June.

**Adult Vaccination: Economics, Study Example, and Future Research---Dr.
Margaret Coleman**

Dr. Margaret Coleman began with a discussion of a literature review on
the cost-effectiveness of vaccines and remarked on the philosophical
differences between epidemiology and economic theory and how these
differences in outlook and methodology affect research.

Dr. Coleman presented results from a study of the difference, between
2001 and 2007, in the expense-payment gap for the delivery of influenza
vaccine in adult medical practices of varying sizes. The costs included
the cost of the vaccine and other supplies (e.g., syringes), clinical
and nonclinical labor, and overhead. Costs were compared to the Medicare
payment rate for the 2 years studied. Profit differences between
scheduled and walk-in visits were also compared.

In 2001, practices of all sizes lost money on influenza vaccinations. In
2007, larger practices may make a profit---an average of over \$9
(scheduled) and \$16 (walk-in) per shot for the very largest practices.
Smaller practices lost less than they did in 2001---an average loss of
over \$22 (scheduled) and approximately \$15 (walk-in) for a physician
in solo practice in 2007 compared with over \$34 and \$28, respectively,
in 2001.

Dr. Coleman stressed that more data are needed so that fewer assumptions
will need to be made in future studies. For instance, it will be
necessary to be able to amortize a physician's original advice when
patients continue to get annual vaccinations because of that advice. It
will be necessary to collect data on office staff composition and on
salaries and benefits. She offered some examples of the kinds of studies
that are needed.

In conclusion, Dr. Coleman noted that

-   Economic studies of adult vaccination need to be tailored to adults.

-   Broader economic analysis needs to be applied to system studies.

-   Complex questions require complex studies, but the results are worth
    it.

-   Such studies may inform policy decisions and encourage stakeholder
    communication.

**Vaccination Status Versus Health Insurance Status Among Adults---Dr.
Gina Mootrey**

Dr. Gina Mootrey gave preliminary results from the 2007 National
Immunization Survey (NIS)---Adult. This is a periodic national telephone
survey, conducted previously in 2003 and 2004.

The survey found that U.S. adults between 18 and 64 years of age who
have health insurance are 1.5 times more likely to be vaccinated than
those who do not have health insurance. This relationship is fairly
consistent across all levels of household income but is most prominent
among those living 200 percent below the poverty line and 400 percent
above it.

When deciding whether or not to get an annual flu shot, the
out-of-pocket costs of vaccination are unimportant to about 75 percent
of those with---and 54 percent of those without---health insurance.
Below the poverty line, costs are considered to a greater extent, and
the difference between the insured and uninsured largely disappears.

Vaccination cost was given with relative infrequency as the main reason
for nonvaccination. Other reasons were as follows:

-   The patient did not think the vaccination was needed.

-   The patient knew little or nothing of the vaccine or that it was
    recommended.

-   The physician did not recommend the vaccination.

-   There was concern about side effects.

***Discussion of Dr. Coleman's and Dr. Mootrey's Presentations***

A participant noted that it is important to differentiate annual
vaccinations from others in that recall should be expected to be better
for annual vaccinations. Dr. Almquist asked whether studies had been
done of the accuracy of recall for vaccinations. Dr. Raymond Strikas
said that studies of pneumococcal polysaccharide and tetanus
vaccinations correlate well with self-reports.

Dr. Feinberg observed that it was not clear how the Government will
decide the course of future research. Dr. Mootrey said that a
prioritization process is underway at CDC and that they are also
discussing validation of self-reports.

A question was raised about the relationship of provider
nonrecommendation to reimbursement issues. Dr. Coleman said that her
experience as an economist led her to suspect that a relationship exists
and cited the results of a Florida study.

Dr. Hinman said that he was struck by Dr. Coleman's data that indicated
it might not be a money-losing proposition to provide immunization.

**Community Vaccinators' Perspective: Maxim Health Systems---Mr. Steve
Pellito**

Mr. Steve Pellito reported on efforts in community vaccination by Maxim
Health Systems. Maxim has 400 branch offices nationwide and employs more
than 60,000 healthcare providers. In 2007, they conducted more than
47,000 flu clinics. Other immunizations Maxim provides include tetanus,
hepatitis A and B, meningitis, papillomavirus (HPV), and travel
vaccines. The sites at which Maxim has offered vaccination include
retail outlets such as drug and grocery stores, corporate offices,
senior centers, colleges, and YMCAs.

Mr. Pellito discussed changes in the retail flu market, such as the
increasing number of pharmacists administering vaccine. He noted that
the 2007 demand was drastically lower than that in 2006.

Mr. Pellito cited a CDC survey showing that depending on the age group,
between 39 and 46 percent of adults receive their influenza vaccine in a
doctor's office. The workplace is also a popular vaccination site. He
noted that for adults under 50, none gave vaccination in a store as a
preferred site, yet 10 percent received their vaccination there.

In discussing current challenges, Mr. Pellito mentioned legislation that
varies from State to State. This affects consent, thimerosal content,
immunization registries, and State-issued vaccine, among other things.
He closed with a discussion of ways to improve uptake. These include

-   Education;

-   Universal recommendation;

-   Support from healthcare workers;

-   Increased insurance coverage;

-   Increased number of access points; and

-   Expansion of vaccination season.

**The Visiting Nurse Associations of America---Ms. Shelley Ludwick**

Ms. Shelley Ludwick said that though not often thought of as community
immunizers, visiting nurses do perform that function. Visiting nurses
have been around for over 120 years. They see about 4 million patients
in their homes each year. Seventy percent of these patients are over 65,
70 percent are on Medicare, and 12 percent are on Medicaid.

Visiting nurses provide over 2 million flu shots each year to homebound
patients and in such community venues as schools, nursing homes,
community centers, local businesses, airports, and fire and police
stations. Promotion efforts have included Web sites, flyers and posters,
mailings, and public service announcements (PSAs).

A new venue is the drive-through clinic. Ms. Ludwick reported that in 3
to 4 hours, 800 flu shots can be given and that whole families are
vaccinated at the same time. Other new venues include libraries and
churches. Collaboration with community partners allows the offering of
movie passes or zoo tickets as an incentive to vaccination.

***Discussion of Mr. Pellito's and Ms. Ludwick's Presentations***

Dr. Mahnaz FarhangMehr asked whether first-time immunizations proved a
problem at the drive-through clinics. Ms. Ludwick said that a section of
the parking lot is set aside for first timers in order to allow time to
see whether there will be a reaction.

Another participant asked how long a visit to a drive-through clinic
took. Ms. Ludwick said that if it was not the first immunization, a
person could be in and out in 15 to 20 minutes.

Dr. Nevin-Woods raised a concern about physicians' ordering a supply of
vaccine but finding that the patients that they expected to vaccinate
get their vaccinations at the grocery store instead. The physician loses
money and next year may not order. Mr. Pellito said that barring
shortages, there need be no reason for the physician to order a large
shipment up front.

**Massachusetts Adult Immunization Program---Ms. Donna Lazorik**

Ms. Donna Lazorik began her presentation with a background of the
State's efforts in the area of adult immunization. She discussed
influenza and pneumococcal immunization rates among the adult population
generally and in long-term care facilities. Though the rate for patients
is high, that for healthcare workers remains low. In 2007, the
Massachusetts Department of Public Health promulgated new regulations
designed to increase vaccination among employees of long-term care
facilities.

Projected State-supplied vaccines for adults in fiscal year 2008 include
universal distribution of tetanus/diphtheria (370,000 doses) and PPV23
(95,000 doses) and select distribution of flu, hepatitis A and B,
measles/mumps/rubella (MMR), and varicella vaccines.

Ms. Lazorik outlined Medicare and health plan reimbursement programs.

The State is working with pharmacists, community vaccinators, and
correctional facilities to expand access and conduct outreach projects
to non-English-speaking communities.

Masspro is the State's most important partner in adult immunization
efforts. It sponsors the Adult Immunization Coalition of 53 member
organizations, an annual conference on adult immunization, a flu clinic
Web site listing 2,800 clinics, and other special projects.

Unlike childhood vaccine efforts, those for adults have no Federal---and
limited State---investment. The Massachusetts childhood vaccine budget
is \$40 million (\$109 million with Federal funds included); the adult
vaccine budget is \$7 million.

Ms. Lazorik said that the recent rise in Medicare reimbursement rates
has been very helpful as has engagement with national partners such as
CMS, the Joint Commission, the American Medical Association, and the
American College of Obstetricians and Gynecologists. There is a need,
she said, for greater insurance coverage for adult vaccination and
expanded State-specific data.

**Piecing Together an Adult Immunization Program---Dr. Julie Morita**

Dr. Julie Morita was snowbound in Chicago and gave her presentation by
speaker phone. Dr. Strikas operated the slides.

Dr. Morita spoke of efforts in Chicago to enhance access to adult
vaccines and to increase community demand. She also addressed
provider-based interventions.

There is a limited infrastructure that includes an adult coordinator and
the VFC program infrastructure. Influenza, pneumococcal, and hepatitis
vaccines are consistently available; others are only intermittently so.
City and Federal funding for adult influenza and pneumococcal vaccines
has remained stable since 2001. While the number of clinics has dropped,
the number of vaccinees has risen somewhat, indicating greater
efficiency. There has been a broadening of ethnic coverage. The number
of agencies receiving hepatitis vaccine from the Chicago Department of
Public Health has increased. 317 funds were used in 2007 to provide
20,000 doses of Tdap post partum regardless of insurance status and age.
In 2008, a foundation grant will allow HPV vaccine to be provided for
underinsured and uninsured adults.

Community outreach, education, and media campaigns are dependent on
sporadic funding. Dr. Morita mentioned programs sponsored by GSK and
CDC.

In 2004, 31 clinics participated in an intervention using VFC's
Assessment, Feedback, Incentives, and Exchange strategy to raise
immunization coverage and improve standards of practice at the provider
level. Influenza and pneumococcal coverage improved dramatically.
Provision of free vaccine was necessary for clinics to participate in
the program.

Dr. Morita said that the essential pieces of an adult vaccination
program include a public health infrastructure and regular,
comprehensive State and local assessments of adult vaccination coverage.

**New York City Adult Immunization Program---Dr. Jane Zucker**

Dr. Jane Zucker noted that the annual number of vaccine-preventable
deaths of children in the United States is between 200 and 300; of
adults, more than 46,000. She outlined the components of New York's
influenza vaccination strategic plan for the current season. Resources
for providers include a newsletter, presentations at grand rounds, a
broadcast fax, outreach to medical societies, a resource guide and
vaccine toolkit, provision of forms and templates, and a provider access
phone line.

Service delivery has been enhanced through walk-in clinics established
in collaboration with community organizations.

Advertising efforts include press releases and conferences, PSAs, health
bulletins in five languages, subway ads, community boards, and health
fairs. Efforts are being made to brand the disease as "influenza" so
that it will not be confused with less serious diseases colloquially
known as "flu."

A clinic locator is available either through a Web site or through a
three-digit telephone number.

Regulatory and legislative action is being pursued at the State and
Federal levels, and State laws regarding vaccination in hospitals and
long-term care facilities are being enforced. The city health code now
requires vaccination for staff in daycare centers.

Despite the investment, rates are not increasing. Dr. Zucker noted,
however, that this is the first year since these efforts began that
vaccine has been plentiful and available early in the season. Other
challenges include a need for better understanding of cultural barriers,
a limited capacity to work at the provider level, and the need to build
a robust infrastructure.

**Strategies and Models for Promoting Adult Immunization---Dr. Nicole
Lurie and Dr. Katherine Harris**

Dr. Nicole Lurie and Dr. Katherine Harris presented results of a study
of the current policy and practice climate surrounding adult
immunization and of promising strategies and models that may improve
that picture.

They conclude that existing practices and high-level reform strategies
are insufficient. Expansion or replication of innovative grass roots
programs are hindered by reliance on creative and charismatic
individuals and frequently lack stable funding. High-level strategies
devised by commissions, consultants, and expert panels tend to be
expensive and divorced from broader trends and to lack a focus on
implementation.

Dr. Harris and Dr. Lurie identified four strategic areas for promoting
adult immunization and examined nine existing models of implementation
of these areas:

-   Strategic Area 1: Integrate adult vaccines into quality and
    performance measurement.

    -   Model 1: Establish a workgroup to promote vaccine-related
        quality and performance measures.

    -   Model 2: Create an "ACIP User's Guide" to help clinical and
        coverage decisionmakers understand the evidence base.

    -   Model 3: Develop an administrative data infrastructure in
        partnership with regional health systems.

-   Strategic Area 2: Institutionalize synergies between seasonal
    influenza immunization and pandemic preparedness.

    -   Model 4: Establish an annual "Look Back" to improve seasonal
        response and pandemic preparedness.

    -   Model 5: Use rapid Web-based surveys to fill gaps in existing
        data and inform immunization performance.

-   Strategic Area 3: Promote vaccine counseling and referral in
    office-based practice.

    -   Model 6: Develop a "Clinician's Guide" to vaccine counseling and
        referral.

    -   Model 7: Request a category III vaccine-specific counseling CPT
        code.

    -   Model 8: Develop an interactive tool to inform physicians'
        decisions to administer vaccines.

-   Strategic Area 4: Make consumer information relevant and actionable.

    -   Model 9: Use international standards to develop consumer support
        tools.

***Discussion***

Dr. Pavia asked how well validated the tools were that had been referred
to and was told that they had not been well validated in the context of
vaccines but had established validity in other areas. He also made
reference to the subway ads that had been presented earlier and
expressed a concern that some of the consumer information advocated by
Dr. Lurie and Dr. Harris might be over the heads of some consumers. The
speakers replied that there is an appetite for quantitative information
from physicians; they were thinking of information passed from doctor to
patient.

Dr. Almquist referred to model 6 when he noted that "counsel and refer"
means lower rates than "counsel and give"; telling patients to go
somewhere else means that some will forget. The speakers said that
practices were changing in an effort to make them more lucrative; they
would not wish people to get no information from a knowledgeable source.
Dr. Gordon pointed out that this is, in fact, more the case in adult
practices than in pediatrics. The question arose as to whether
establishment of a CPT code might be a disincentive to vaccinate. Dr.
Schuchat observed that adults tend not to come for regular visits and
that when they do, there is a long problem list for physicians to get
through.

Dr. Hinman said that it is difficult for practitioners---let alone
consumers---to know the schedule. He wondered whether CDC could develop
a decision aid module for inclusion in immunization registries.

**National Biodefense Science Board---Dr. Gerald Parker**

Dr. Gerald Parker is the HHS Principal Deputy Assistant Secretary for
Preparedness and Response. He spoke about the responsibilities and
makeup of the new National Biodefense Science Board (NBSB), which was
mandated by the Pandemic and All-Hazards Preparedness Act. Its purpose
is to advise the Secretary on scientific and technical matters.

As part of the HHS Public Health Emergency Medical Countermeasures
Enterprise, the NBSB will facilitate the coordination of planning and
execution of preparedness activities across all HHS divisions. Every
cabinet department has a member on the board.

The first meeting was held on December 17--18, 2007, in Washington, DC.
Meetings will be held twice a year; some of the Working Groups will meet
more often than that. Initially, there will be four Working Groups:

-   Pandemic Influenza;

-   Medical Countermeasures and Public Health Surveillance Research and
    Development;

-   Disaster Medicine; and

-   Medical Countermeasures Markets and Sustainability.

The mission of the Pandemic Influenza Working Group is to "consider
scientific progress and policy options regarding the research and
development portfolio of medical countermeasures, supplies, and product
utilization to prevent, treat, and mitigate the effects" of a pandemic
influenza.

Dr. Parker said that he will encourage the chairs of advisory bodies to
get together periodically so that information does not get stovepiped.

***Discussion***

Dr. Parker was asked whether the meetings will be open. He said that
they will be when at all possible. The first meeting was open. There may
be a need for closed meetings on occasion, such as when non-open source
information is being discussed with other Government bodies.

**Day 2---February 6, 2008**

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

***Vaccine Injury Compensation Program (VICP)---Dr. Geoffrey Evans***

VICP funding went from \$3.9 million in fiscal year 2007 to \$5.4
million in 2008 because of the autism hearings scheduled for this fiscal
year. The proposed 2009 budget brings the level down to \$4.5 million,
but no autism hearings are scheduled. The program has done well in terms
of support, due, in part, to help from their stakeholders in making
known that the unique situation in fiscal year 2008 called for
additional funding.

Referring to the printed report circulated before the meeting, Dr. Evans
said that

-   The three test cases of the first theory will probably not be heard
    before the second theory in May. They will probably take a year,
    from June to June.

-   Under Adjudications in 2008, the claim noted as compensated for
    autism is an error. Compensation was given for a claim that was part
    of the autism proceedings, but it was for a non-autism-related
    condition.

-   Under Awards Paid, the largest total outlay to date was in 2007
    though it appears that 2008 will be as large. This is in response to
    decisions by the Federal Circuit Court of Appeals that relaxed the
    standard of causation. As a result, claims that would have been
    defended are being settled.

-   The total outlay of \$849 million since 1990 is only part of the
    story. When compensation before the start of the program is
    included, total outlay has been \$1.7 billion.

Dr. Evans reported that the trust fund stands at \$2.7 billion. With
influenza vaccine now part of the program, revenues exceed \$300 million
per year, so the trust fund continues to be in good shape.

***ACCV---Ms. Tamara Tempfer***

The ACCV approached Medscape, with the objective of increasing awareness
among healthcare workers of the VICP. Medscape posted an accurate and
informative article in January 2008. More than 5,000 people have already
used that article for continuing education credit.

As part of an effort to get feedback from VICP petitioners, the ACCV has
developed a survey, which is currently being tested.

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

Dr. Gellin reported that a cross-Government review of the vaccine safety
system is in the final stages of clearance. The document will be
delivered to the Vaccine Safety Working Group for its opinion before
being presented to the full Committee.

The NVPO has also been involved with issues concerning vaccine supply,
pandemic influenza, and vaccine finance.

Dr. Gellin said that Dr. Wright had been briefed the day before by CDC
on healthcare worker vaccination, the result being Dr. Wright's resolve
to develop a multifaceted initiative that will engage NVPO and other HHS
programs in improving the current 42 percent.

Dr. Gellin also reported that the NVPO is involved in a number of
activities that try to engage the public in order to learn what their
expectations are with regard to vaccines and vaccination.

***National Center for Immunization and Respiratory Diseases---Dr. Anne
Schuchat***

The National Immunization Conference will be in Atlanta from March 17 to
20. The keynote speaker will be the American Academy of Pediatrics
president, Renee Jenkins. The International Conference on Emerging
Infectious Diseases will be held in Atlanta at the same time. There will
be some joint activities.

In March, Clinical Infectious Diseases will publish a supplement
containing 16 articles on smallpox vaccination. It will probably be
released online in February.

CDC plans a number of activities around National Infant Immunization
Week (April 19--28). Some activities will be held in conjunction with
the Pan American Health Organization (PAHO).

CDC participated in a National Foundation for Infectious Diseases press
conference on adult immunization on January 23. CDC released high-level
results from the Adult NIS.

The next ACIP meeting will be February 27 and 28. The major vote to be
taken concerns whether the recommendation for routine influenza
immunization should be expanded to cover all children between the ages
of 5 and 18 and, if so, on what timeline.

The ACIP recommendation for zoster vaccine should appear in MMWR in
March. Dr. Schuchat said that CDC is looking at ways to prevent similar
delays in the future.

***ACIP---Dr. Dale Morse***

Also at the next ACIP meeting will be briefings on a number of vaccines
that have been awaiting FDA action. There will be discussion of revision
of the anthrax vaccine recommendation from subcutaneous to intramuscular
administration, with potential dose reduction (leading, possibly, to
fewer side effects).

***FDA/Vaccines and Related Biological Products Advisory Committee
(VRBPAC)---Dr. Norman Baylor***

As a result of December's workshop on identifying correlates for
influenza, the FDA---in partnership with the World Health Organization
and other agencies and national regulatory authorities---has initiated a
global research agenda to improve the efficacy of influenza vaccines.

The next VRBPAC meeting will be held on February 20 and 21. Topics on
the agenda include discussions of

-   A new rotavirus vaccine manufactured by GSK;

-   Influenza strains for the 2008--09 season; and

-   Regulatory pathways for the evaluation of pandemic and prepandemic
    influenza vaccines.

***NIH---Dr. George Curlin***

Dr. George Curlin said that it would not be wise to make a specific
report of promising vaccine candidates. He offered as an example that he
could not have predicted what was found with the adenovirus 5 (Ad5)
prime boost and the impact that it has had not only on HIV vaccine but
also on malaria and others. Nonetheless, he said, the vaccine
development enterprise is still strong at NIH.

He will have a breakdown of the NIH vaccine budget (curative versus
preventive vaccines), at Dr. Freed's request, for the next NVAC meeting.

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

There have been no major new payment initiatives since the last meeting.
Administration is now counted as part of the drug costs for preventive
vaccines in Medicare part D; administration had been uncovered until
this year. As far as Dr. Jeffrey Kelman is aware, there has been no
major change in State Medicaid coverage of vaccination.

***AHIP---Mr. John Hunsaker***

In support of preventive services and immunization, AHIP is conducting a
survey of its members similar to the one that was done in 2005. They are
recognizing members with the greatest increase in immunization rates,
according to their Healthcare Effectiveness Data and Information Set
(HEDIS) scores. AHIP is also promoting best practices in provider
communication and is working with a pharmaceutical company to develop an
online tutorial on coding practices. AHIP is continuing its activities
in support of immunization registries and vaccine safety.

***United Kingdom Department of Health---Dr. David Salisbury***

Dr. David Salisbury reported the publication the previous day in
Archives of Disease in Childhood of an exemplary scientific study of 100
children with autism; the study found no evidence of retention of
measles virus in autistic individuals. He said that they are seeing a
restitution of confidence in the safety of MMR.

Dr. Salisbury also said, with regard to British immunization priorities,
that they map very well to U.S. priorities.

***Public Health Agency of Canada---Dr. Mahnaz FarhangMehr***

Four provinces have begun Canada's publicly funded HPV program. So far,
the coverage rate for the first dose ranges between 75 and 85 percent.

**Dose Optimization Strategies for Vaccines: The Role of Adjuvants and
New Technologies---Dr. Cornelia Dekker**

Dr. Cornelia Dekker presented a paper that had been drafted by the
Subcommittee for Vaccine Development and Supply. The paper included
recommendations for a research agenda for further development of options
for dose optimization.

Dr. Dekker began with background on the types and sources of information
the Subcommittee had considered, provided an overview of the
organization of the manuscript, and moved to a discussion of the role of
adjuvants in vaccine development, with pertinent information about
particular adjuvants and vaccines, regulations, and business issues.

The presentation was interrupted when a fire alarm required evacuation
of the building. When the meeting resumed, approximately a half hour
later, Dr. Dekker presented the Subcommittee's suggested NVAC
recommendations. These were to

-   Ensure funding at NIH for basic research on adjuvants to better
    understand the immunology of how adjuvants function with different
    types of antigens;

-   Ensure that FDA guidance on approaches to licensure path for novel
    adjuvant systems from regulatory agencies receives high priority in
    the Critical Path Initiative;

-   Ensure funding availability for translational medicine studies with
    adjuvants in the following areas:

    -   Identify benchmarking candidate adjuvants;

    -   Create novel clinical trial designs to more efficiently answer
        questions of safety, immunogenicity, and effectiveness;

        -   Designs for safety evaluation of repeated and concurrent
            exposure to adjuvanted vaccines and longer term safety data;
            and

        -   Studies on duration of immunogenicity and cross-protection,
            including clinical effectiveness studies to confirm these
            properties.

    -   Search for early biomarkers of adjuvant activity/toxicity to aid
        in clinical study evaluation and postmarketing surveillance
        studies; and

    -   Continue to identify correlates of protection for vaccine
        targets to aid in optimal design and testing of adjuvanted
        vaccine candidates.

-   Support dose optimization studies for antigens in short supply,
    including alternative immunization routes and addition of adjuvants
    by other than intramuscular route; and

-   Fund studies of mass delivery devices and logistical preparedness
    for mass vaccination campaigns as part of pandemic planning efforts.

***Discussion***

Following a thorough discussion, Dr. Hinman summarized the changes that
had been suggested:

-   Remove the pairing of specific adjuvants with hypothetical risks
    from a table in the paper;

-   Highlight the safety issues more (perhaps by making one of the
    subbulleted recommendations a bullet);

-   Add a recommendation for research on intervals of doses; and

-   Make some specific mention of the need to ensure that the FDA has
    adequate resources.

Dr. Freed noted that none of the suggested changes were controversial or
unacceptable to the Subcommittee members present and so put the document
before the Committee for a vote, with the provision that the suggested
amendments would be made and circulated by e-mail.

**Action Item:** The document "Dose Optimization Strategies for
Vaccines: The Role of Adjuvants and New Technologies" was approved, with
Dr. Dekker abstaining. Otherwise, approval was unanimous.

**Results From the Step Study (Merck V520 Protocol 023/HVTN 502)---Dr.
Michael Robertson**

Dr. Michael Robertson reported Merck's efforts to design an AIDS
vaccine. An early success with monkeys immunized with an Ad5--simian
immunodeficiency virus gag vaccine was encouraging. The vaccine did not
prevent infection; it controlled replication. Within 1 month of
challenge, the viral load dropped significantly. Another study of
HIV-infected individuals showed that those with the lowest viral loads
were the least likely to transmit.

The vaccine developed by Merck for testing was a mixture of three
vectors expressing different proteins. A Phase II test-of-concept study
was undertaken, in collaboration with NIAID's Division of Acquired
Immunodeficiency Syndrome, to test whether a cell-mediated immune
response elicited by the vaccine would prevent infection or control
viral replication if infection did occur.

Three thousand people at study sites in North and South America and in
Australia took part in the trial. The vaccine failed on both of the
primary end points of the study. Merck is in the process of
investigating the reasons for the failure.

There were more infections in vaccinees than in placebo recipients.
(This trend was more pronounced in participants with high baseline Ad5
titers.) Circumcision status seems to be important; there were more
infections in men who had not been circumcised. The mechanism is not yet
understood.

**Plans for NIAID Vaccine Research Center DNA/rAd5 HIV-1 Candidate
Vaccine in the Post-Step Results Era---Dr. John Mascola**

Dr. John Mascola described the Vaccine Research Center's (VRC) Ad5 HIV
vaccine product. It provides gene delivery using a DNA prime with rAd5
boost. In early tests, it proved to be safe and highly immunogenic. A
Phase IIb efficacy trial conducted in collaboration with the Partnership
for AIDS Vaccine Evaluation was scheduled to open in North America in
September 2007. Implementation was halted when Merck announced the
results of its Step study.

In December, NIAID's AIDS Vaccine Research Subcommittee (AVRS) reached
the conclusion that the VRC regimen is sufficiently different from the
Merck product to warrant further testing.

The proposed study was modified to include only Ad5 seronegative
subjects, to enroll a smaller number of subjects who will be followed
longer and evaluated more frequently, and to limit the study to two
large geographic regions (Africa and the Americas) to reduce the number
of subgroups. There will be a followup meeting of the AVRS on March 3,
2008; final protocol design will follow soon thereafter.

An Ad5 seronegative population will have the strongest vaccine responses
(no antivector immunity) and offers the best chance of witnessing a
vaccine effect. A measurable effect of reduced HIV-1 acquisition or
decreased viral load would be the first demonstration of HIV protection
in humans.

***Discussion of Dr. Robertson's and Dr. Mascola's Presentations***

Dr. Gordon asked for a summary comparison of the two vaccines. Dr.
Mascola said that the genes are generally similar, but the envelopes
differ.

Dr. Schuchat asked about circumcision and how the risk compares with the
baseline Ad5 titer. Dr. Robertson said that the data suggest that both
are factors. Dr. Schuchat also asked about outcomes in women. Dr.
Robertson said that there were insufficient data; 38 percent of
participants were women, but no seroconversion was seen.

**National HIT Update---Dr. John Loonsk**

Dr. John Loonsk outlined the main points of the national HIT agenda:

-   Widespread adoption of interoperable electronic health records
    within 10 years;

-   Medical information that follows the consumer;

-   Complete computerized patient information for clinicians;

-   Quality initiatives to measure performance and drive quality-based
    competition; and

-   Public health and bioterrorism surveillance seamlessly integrated
    into care.

If HIT is to support clinical activities, adoption of HIT must be a
major objective; currently, adoption is below 20 percent. Getting health
records to work together is also a major goal. To notify a registry, it
is necessary to have reliable and interoperable software and secure data
transfer. The Certification Commission for Healthcare Information
Technology helps to ensure this. Other public-private partnerships
involved in HIT processes include the American Health Information
Community (AHIC) and the Health Information Technology Standards Panel
of the American National Standards Institute.

Dr. Loonsk outlined the "use case roadmap." The most basic things come
first, he said, followed later by such things as surveillance
capability, disaster emergency response, quality and medication
management, remote monitoring, and remote consultation.

Dr. Loonsk said that immunization management and public health reporting
remain high among ONC's priorities.

***Discussion***

There was discussion of specific AHIC use cases. Dr. Hinman encouraged
the participants to examine the detailed list.

**Vaccine Financing Working Group Update---Dr. Walter Orenstein**

Dr. Walter Orenstein offered an update on the previous evening's meeting
of the Financing Working Group. The Working Group is in the process of
preparing a white paper on vaccine finance that will include conclusions
and recommendations to put before the Committee.

Dr. Orenstein summarized preliminary results of a study of private
practice costs and reimbursement in five States that had been presented
to the Working Group by Dr. Freed:

-   There is a wide range in prices.

-   There is a wide range of reimbursement (even among the most common
    payer).

-   The variation is multifactorial by vaccine and by payer.

-   A large-scale dropout of private providers is unlikely at this time.

The white paper should be ready for release on April 1, 2008. There will
be a stakeholders' meeting on April 29 and 30 to gather feedback on the
conclusions and recommendations. There will be a notice in the Federal
Register in late February, with a Web address given for registration.
(The NVPO will have blocked rooms.) Stakeholders include Federal, State,
and local health departments; employers and health insurers; vaccine
manufacturers; and healthcare providers, distributors, and consumers.

Dr. Orenstein reported that there has been great difficulty achieving
consensus. If consensus is not possible, the NVAC members on the Working
Group will vote on the conclusions and recommendations to present to the
full Committee and will provide a list of pros and cons for each.

There will be a preliminary discussion of the recommendations at the
June NVAC meeting and a final vote in September.

***Discussion***

There was some discussion about providers' concerns about advancing
capital for a stock of vaccines---particularly the newer, more expensive
vaccines---and about manufacturers' responses to these concerns.

**Vaccine Safety Working Group Update---Dr. Andrew Pavia**

Dr. Pavia, Chair of the new Vaccine Safety Working Group, presented its
charge and a list of its members with their affiliations.

***Discussion***

Dr. Salisbury said that it would be valuable for the Working Group to
examine the work of the World Health Organization's Global Advisory
Committee on Vaccine Safety. Dr. Pavia said that it might be possible
for a representative of that body to be a consultant to the Working
Group.

Dr. Wexler and Ms. Parnell suggested individuals who might be valuable
additions to the Working Group. It was also suggested that the Working
Group should have a member with a legal and ethical background. It was
pointed out that the kind of legal advice one would get from an ethicist
would be likely to differ from that one would get from someone with
product and liability experience.

**Update on the 2007--08 Influenza Season---Dr. Jeanne Santoli**

Dr. Jeanne Santoli reported that there is widespread activity in 11
States (Alabama, Alaska, Colorado, Hawaii, Kansas, Massachusetts, New
Mexico, New York, Pennsylvania, Texas, and Virginia) and regional
activity in 26 others.

Distribution at the end of January was over 115 million doses. More
vaccine has been distributed this season than in any prior one. Most
vaccine has gone to private providers' offices, followed next by State
and local health departments.

The February ACIP meeting will include a vote on expansion of the
pediatric vaccination recommendations, a surveillance update, and an
update on oseltamivir resistance. On this latter, resistance of
influenza A strains has been reported in Europe. In the United States,
3.8 percent of viruses tested by CDC have shown resistance. All
resistant strains are H1N1. There is no change in the CDC guidance for
antiviral use in the 2007--08 season.

Dr. Santoli also reported a donation of influenza vaccine from the CDC
stockpile. The stockpile had contained 500,000 doses of various
products. Through collaboration with the General Services
Administration, the United States Agency for International Development
(USAID), and PAHO, approximately 200,000 doses were donated to the
Ministry of Health in El Salvador.

***Discussion***

Dr. Calvin Johnson asked whether CDC was tracking vaccine that did not
get used. Dr. Santoli replied that they would have better data in a
month, when distribution could be compared with manufacture.

Discussion also touched on trends in vaccination venues, vaccine use by
community vaccinators, equitable distribution, the central distribution
system, real-time data collection, antiviral resistance, and vaccination
of healthcare workers.

**Influenza Vaccination Communication---Dr. Kristine Sheedy**

Dr. Kristine Sheedy reported on CDC's 2007--08 influenza communication
campaign.

A diverse array of channels and strategies were used to reach the target
audiences. These included education and outreach to healthcare workers,
partnership development, local events, Web and e-health communication,
and media outreach such as radio and television PSAs, interviews, and
newspaper articles. Preparation for the season began in the spring and
summer and included the conducting of formative research and message
testing, development and vetting of the campaign plan, and a
collaboration with States to plan for local events.

Dr. Sheedy discussed CDC efforts built around National Influenza
Vaccination Week (NIVW)---November 26 through December 2, 2007---to
encourage vaccination and to raise awareness generally. Promotion for
the week's activities included ethnic media roundtables held in Chicago
and Miami, an MMWR Notice to Readers, and nationwide radio media tours
in English and Spanish. In partnership with Families Fighting Flu (FFF),
CDC set aside November 27 as National Children's Flu Vaccination Day,
during which the importance of vaccination for high-risk children was
emphasized.

Other NIVW activities included the nationwide release of audio bite
packages to radio stations, news conferences, and participation in grand
rounds in New York City, Chicago, Washington, DC, and Atlanta. Ads were
placed in airline magazines to reach travelers. A "Dear Provider" letter
from CDC Director Dr. Julie L. Gerberding was distributed. Dr.
Gerberding also appeared on CNN American Morning. Outreach to national
media resulted in messages on "Martha Stewart Living" (4.3 million
viewers) and "Live with Regis and Kelly" (2.8 million) and in Redbook,
Family Circle, and Ebony.

Private industry helped to distribute CDC messages. CVS sent direct mail
pieces to a half-million households in 35 markets. Henry Schein, Inc.,
arranged for PSAs to run on two jumbo screens in Times Square through
January and in patient waiting rooms. Eckerd's, Food Lion, A&P, and
Wegmans stores aired PSAs on in-store radios.

PSAs have run on "Oprah," "Dr. Phil," "The Rachael Ray Show," and "Judge
Judy" and on Web sites such as Parents.com. The number of estimated
exposures is approximately 200 million.

Ebony.com distributed an e-mail to 82,000 subscribers, reminding them to
get a flu shot. Blackdoctor.org posted articles and banner ads on its
Web site.

Dr. Sheedy said that next season's NIVW will run from December 8 to 14,
2008.

***Discussion***

Dr. Freed, referring to the point made by Dr. Zucker about "branding,"
asked whether any of CDC's promotional materials attempt to educate
people as to what "flu" is. Dr. Sheedy said that it is a longstanding
debate in CDC whether to use "flu" or "influenza." She said the
materials use both terms. "Flu" is a commonly used term among the
audience CDC wants to reach, but, she said, efforts are made to be clear
that it is not a "stomach bug" that is being talked about, but rather
something much more serious. She mentioned, in this connection, the CDC
partnership with FFF that resulted in a piece for television showing
what flu has done in particular families. She also said that CDC
representatives can say "influenza" until they are blue, but news
reporters will still say "flu."

**Update on the National Vaccine Plan---Dr. Raymond Strikas**

Dr. Strikas presented the goals of the 1994 plan and discussed the
process to date. Interagency meetings and one-on-one discussions with
representatives of CDC, FDA, NIH, HRSA, ASPR, USAID, the Agency for
Healthcare Research and Quality, and the Department of Defense resulted
in the development of priorities. An HHS steering committee---consisting
of members from the NVPO, CDC, FDA, and NIH---is in the process of
drafting objectives and strategies and has added to new priorities.
These are enhancing preparedness for pandemic influenza, biological
threats, and emerging diseases and enhancing communication and
education.

The Institute of Medicine (IOM) has been retasked to evaluate the 1194
plan to engage expert stakeholders. The IOM plans to hold five
stakeholders meetings to begin in mid-2008 and conclude in 2009.

In October 2007, four pilot focus groups---mothers, women expecting to
have children, adults 35 to 54 years of age, and adults over 60---were
asked to rate the original 11 vaccine priorities. There was significant
variation across the groups. Proof of concept was achieved. The
importance of infectious disease control was widely recognized. Other
findings were the following:

-   Across the groups, the highest-ranked vaccine priorities were

    -   Making vaccine available and affordable to everyone;

    -   Maintaining a high rate of vaccination in children;

    -   Developing new vaccines;

    -   Ensuring vaccine supply; and

    -   Improving vaccine safety.

-   Vaccine injury compensation and adult immunization were the lowest
    ranked priorities.

-   Underlying values focused on vaccine safety, education, social
    equity, global issues, and children.

-   Comments and questions from respondents focused most frequently on
    education and safety. The new priorities for preparedness and
    communication were added, in part, because of this.

***Discussion***

There was some discussion of whether adolescents should be included in
focus groups. Dr. Strikas said that he would raise the issue with his
colleagues. Dr. Strikas was asked whether public perception of vaccines
is affected for long or short terms by media attention to product
safety. He said that while these were only pilot programs to see whether
more focus groups would be warranted, an ad hoc question at the end of
the meeting did try to elicit that information.

**Pandemic Influenza Update---Dr. Benjamin Schwartz**

Dr. Benjamin Schwartz updated the Committee on draft guidance for
pandemic vaccination. The plan prioritizes persons for vaccination
according to the criticality of their occupations, their disease risk,
and the severity of the emergency. The plan was presented in public
engagement meetings in Wisconsin and North Carolina and to stakeholders
in Washington, DC. A request for comments appeared in the Federal
Register and on the HHS pandemic flu Web site.

The most frequent focus of comment was the need for a higher priority
for the commenter's group. Other frequently occurring areas of comment
were higher priority for other groups, implementation of the plan, and
general agreement with the plan. Most commenters strongly agreed with
targeting children before older adults. There appeared to be general
agreement with the draft guidance, overall. Most favored prioritizing
healthy adults before the ill and elderly and prioritizing pharmacists,
food and transportation workers, the National Guard, and the family
members of emergency responders. Most wished to move Government
officials without close contact with the disease to their general
population group. Most commenters opposed prioritizing financial
services personnel and persons living in communal settings.

The Interagency Working Group (IAWG), co-led by CDC and the Department
of Homeland Security, will consider revisions to the draft guidance,
based on the comments, and will develop guidance on implementation.

Dr. Schwartz also offered an update on antiviral drug use guidance. The
IAWG considered current and proposed antiviral drug use strategies. The
proposed guidance was vetted in meetings and discussions with
stakeholders and with the public and through surveys and focus groups
and was subjected to analysis by the CDC Ethics Subcommittee. There was
general agreement that the guidance is evidence based and appropriate.
More discussion will be needed on the value of household postexposure
prophylaxis, given limited overall pandemic resources. A concern of
commenters was that family members of emergency responders should
receive prophylaxis.

Thirty-four percent of hospital decisionmakers believed that their
institutions would purchase and stockpile antiviral drugs in accordance
with the proposed guidance. Another 36 percent thought that their
institutions might do so. Barriers to compliance included

-   Cost (most important);

-   Shelf life;

-   Potential liability;

-   Logistical difficulties (e.g., regulatory issues, prescribing,
    dispensing);

-   Potential seizure by State or local government; and

-   Ethical and equity concerns.

Dr. Schwartz said that if recommended under current conditions, purchase
and stockpiling by healthcare and emergency services is likely to be
limited and nonuniform. Without addressing cost and stimulating
increased interest, household stockpiling will be minimal. He noted,
also, that many States question whether additional antiviral drug
purchase is the best use of public health resources.

***Discussion***

Dr. Evans mentioned the creation of the new HRSA Preparedness
Countermeasures Injury Compensation Program.

In regard to antiviral stockpiles, Dr. Abramson observed that it is
uncertain when or how much vaccine will be available.

**Closing Remarks**

Dr. Freed opened the floor for any additional comment. Dr. Hinman
announced a change of name for the group formerly known as "People for
Immunization," which will now be called "Voices for Vaccines."

Dr. Gellin took the opportunity to acknowledge Dr. Freed for his work as
Chair.

The meeting was adjourned.