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**National Vaccine Advisory Committee (NVAC)**

**February 5--6, 2007, Meeting Minutes**

[Meeting Overview]{.underline}

The Committee heard presentations on a variety of issues during the
first day of the meeting and discussed specific Subcommittee topics
during the second day of the meeting. Presentation topics included
updating the National Vaccine Plan; discussing the Infectious Diseases
Society of America (IDSA) principles, distribution trends in the
2006--07 influenza season, and changes to the prioritization plan for
pandemic influenza; reviewing the National Influenza Vaccination Week
and an overview of the Pandemic and All-Hazards Preparedness Act. The
Committee also heard an update from the NVAC Adolescent Working Group
concerning an upcoming problem statement/white paper and a progress
report about immunization information systems. On the second day of the
meeting, four Subcommittees met---Subcommittee on Immunization Coverage,
Subcommittee on Vaccine Development and Supply, Subcommittee on
Communication and Public Engagement, and Subcommittee on Vaccine Safety.

[Committee Members in Attendance]{.underline}

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

[Executive Secretary]{.underline}

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

[NVAC Ex Officio Members]{.underline}

> Norman W. Baylor, Ph.D., Food and Drug Administration (FDA)
>
> Neal Brandes, United States Agency for International Development
> (USAID)
>
> George Curlin, M.D., National Institutes of Health (NIH)
>
> COL Renata J.M. Engler, M.D., Walter Reed Army Medical Center,
> Department of Defense (DoD)
>
> Geoffrey Evans, M.D., Health Resources and Services Administration
> (HRSA)
>
> Captain (USPHS) Anne Schuchat, M.D., Centers for Disease Control and
> Prevention (CDC)
>
> Ronald Valdiserri, M.D., M.P.H., Department of Veterans Affairs (VA)

[Liaison Representatives]{.underline}

> Jon S. Abramson, M.D., Advisory Committee on Immunization Practice
> (ACIP)
>
> Mahnaz FarhangMehr, Nova Scotia Department of Health
>
> Wayne Rawlins, America's Health Insurance Plans (AHIP)
>
> Phil LaRussa, Vaccine and Related Biological Products Advisory
> Committee (VRBPAC)

[Committee Members Absent]{.underline}

> Calvin Johnson, M.D., M.P.H.
>
> Jeffrey Kelman, M.M.Sc., M.D.

[Invited Speakers]{.underline}

> Dr. Neal A. Halsey, Infectious Diseases Society of America (IDSA)
>
> Mr. Brian Kamoie, Office of Assistant Secretary for Preparedness and
> Response (ASPR)
>
> Dr. Benjamin Schwartz, NVPO

Dr. Kristine Sheedy, National Center for Immunization and Respiratory
Diseases (NCIRD)

Dr, Raymond A. Strikas, NVPO

Dr. Gregory Wallace, CDC

**Welcome from Chairperson of NVAC---Dr. Gary L. Freed**

Dr. Gary L. Freed began the first day of the meeting at approximately 9
a.m. on February 5, 2007. He thanked the NVAC members for attending and
for their flexibility. After welcoming everyone in attendance, he
introduced the new liaison and ex officio members. Dr. Ronald Valdiserri
from the VA is the new ex officio member, and Ms. Mahnaz FarhangMehr of
the Nova Scotia Development of Heath and Dr. Wayne Rawlins of AHIP are
the new liaison representatives. Committee members and audience members
then introduced themselves. The audience included representatives from
the CDC, Oak Ridge National Laboratory, RTI International, the National
Association of County and City Health Officials, the FDA, sanofi
pasteur, and GlaxoSmithKline (GSK). Dr. Freed thanked everyone for
attending and being flexible with their schedules and introduced Dr.
Arthur Lawrence.

**Greeting from Dr. Arthur Lawrence**

Dr. Lawrence said that he always enjoys saying a few words at vaccine
meetings as he was Director of the NVPO for a brief time. He reiterated
the importance and necessity of the work done by the NVAC and said that
the amount of change that has occurred since the previous National
Vaccine Plan necessitates a new look at the National Vaccine Plan. There
is a need to develop priorities and tell members of Congress what the
priorities are and how resources should be directed. One of the key
items that Congress needs to see before providing funding is a coherent
plan.

Not only is the meeting important to send a message about the priorities
of NVPO, but it also sends an important signal to pharmaceutical
companies, those at NIH who award R01s, and researchers about what the
future may hold. There are significant problems that can occur with
underimmunization, and the economics of vaccines provides a high return
on investment for the public health field. In closing, he said that
there is a temptation to say that vaccines and immunizations have never
been so important, but they have always been important; this group is
charged with creating the future rather than just attempting to predict
it.

**Update on the National Vaccine Plan---Dr. Bruce G. Gellin and Dr.
Raymond A. Strikas**

Dr. Gellin began the discussion of the National Vaccine Plan by saying
that he talked about the need to update the plan when he interviewed for
his current position 4 years ago. After reading the quote from the 1994
National Vaccine Plan, he indicated that a new quote will likely be
needed since vaccines have a new prominence, and there is strong
potential to move forward in this area. He then introduced Dr. Raymond
A. Strikas to present information on the National Vaccine Plan.

Dr. Strikas began by presenting the statutory basis for the National
Vaccine Program and reviewed the goals and objectives of the 1994
National Vaccine Plan; he indicated that almost everything that is done
fits into the stated goals and objectives. Since 1994 there have been
decreases in the incidence of multiple vaccine-preventable diseases with
the exception of pertussis; he noted that a larger number would be seen
for mumps if the data presented included 2006 figures.

He then presented the recommended immunization schedules for children
and adults and reviewed several key points about the immunization
schedules for both children and adults:

-   Eleven vaccines in total are included on the immunization schedule
    for children up to 6 years of age.

-   Nine vaccines are recommended for use in the adult population
    depending on the particular characteristics and health concerns of
    the individual.

-   Striking improvements have been seen in the vaccine coverage for
    both older (MMR) as well as newer vaccines (Hep B, Hib, Varicella)
    in children with the majority reaching the 2010 target.

-   The situation is less positive for adults where influenza vaccine
    coverage peaked in the 1990s but has since declined, not achieving
    the *Healthy People 2010* goal.

-   In the adult population, racial and ethnic disparities in vaccine
    coverage remain, and this will need to be considered in any revision
    of the National Vaccine Plan.

Following the information on vaccine coverage in children and adults,
Dr. Strikas presented information on the progress of immunization
information systems. As of the end of 2005, 56 percent of children
participated in an immunization registry. Key "hot button" issues are
present in adolescent immunization programs, including school mandates,
informed consent, and school and nontraditional venue vaccination.

Dr. Strikas concluded with some of the priorities and top concerns of an
updated National Vaccine Plan, including (1) defining a roadmap and
addressing priorities for 2008 to 2010, (2) identifying need for
resources, (3) demonstrating the importance of the task, (4) linking to
*Healthy People 2010*, and (5) communicating the work to others.

***Discussion***

Dr. Gellin commented that the plan from 1994 is really a Federal rather
than a national vaccine plan and that the goal is to develop a plan that
represents a broader scope than only the Department of Health and Human
Services in the Federal government.

On a separate point, Dr. Jaime Fergie mentioned that he found it
interesting that the plan was originally intended for revision each
year. He questioned whether that would be feasible and said that review
every year might be excessive. Dr. Gellin responded that he was not sure
if there would be a pledge as to what would be accomplished during each
interval; limitations need to be considered.

Dr. Charles Lovell asked how the plan would incorporate the
fragmentation in reimbursement. He explained that adult coverage may be
lacking because providers lack confidence that they will be compensated
for conducting the vaccine program in their offices. Would the plan
incorporate the fragmentation and privatization of reimbursement? Dr.
Gellin responded that the process is just beginning and that this kind
of input is important. Clearer articulation of financing issues related
to access is necessary.

Considerable discussion surrounded the issue of framing the plan as a
national or Federal plan. Dr. Jon S. Abramson said that the question of
whether this is a national or Federal plan is critical. A national plan
would be very difficult to do and would require working on a
State-by-State basis; however, there may be room to consider a Federal
role in a national plan. Dr. Gellin said that a discussion can begin
about the plan, and then there can be a dialogue about what can be done
by the Federal government and what can be done outside of the Federal
government.

Dr. Freed agreed that this is a key issue but does not see it as an
either/or decision; some things may be done on a Federal level but
others would require State and local input. Dr. Alan R. Hinman said he
would encourage the plan to be a national plan that sets out initiatives
with specifications about what Federal agencies should be doing. Ms.
Trish Parnell also agreed that the States play such a key role in the
process that a Federal plan would be unsuccessful. Dr. Gellin pointed
out that involving the States brings in additional nodes, requiring more
resources devoted to coordination.

On a separate topic, Dr. Jerome O. Klein said that he hoped the plan
would incorporate creativity and innovation. An effort needs to be made
to break out of the usual and think of ways to market the message to get
people to realize the importance and benefit of the program.

Dr. Guthrie S. Birkhead suggested having an active liaison from NVAC who
would be a part of the planning committee thinking through the initial
steps, not just reviewing the final proposal. Dr. Gellin clarified that
the NVAC review mentioned did not mean just signing off on the final
document but providing input throughout the process. Dr. Lance K. Gordon
agreed that it would be useful to have a person who NVAC could provide
feedback to from the beginning; Dr. Gellin indicated that Dr. Strikas
would be this "point person." On a related topic, Dr. Freed said that it
would be important to ensure that NVPO is appropriately staffed and
structured for taking an active role in promoting and pursuing the
National Vaccine Plan.

Given the fact that the landscape of global immunization is one of the
areas where things have changed most since 1994, Dr. Anne Schuchat
suggested that the U.S. Government would need to determine its role in
this arena with billions of dollars directed toward global immunization.
Dr. Gellin agreed on the importance of the global setting and said that
the presence of a USAID representative on NVAC would facilitate this
dialogue.

Several committee members discussed the importance of evaluation as a
component of the National Vaccine Plan. Ms. Parnell said that she was
surprised to see the question of whether to evaluate presented. Dr.
Andrew T. Pavia said that evaluation is key and that an effort should be
made to determine where strategies did not perform optimally between
1994 and today. These could serve as lessons learned, and the revised
plan should have carefully considered measurables and deliverables that
would indicate whether the plan is on track, not just a simple
checklist. Dr. Gellin stated that there is a need to have a strategy for
determining whether the plan results in discernible outcomes and
accomplishes the stated goals.

Engaging the public about a National Vaccine Plan generated some
discussion. Ms. Mary Beth Koslap-Petraco said that it is critical to
listen to the public and to be out in front so that government officials
are not simply reacting constantly. Dr. Gellin felt that the
communications plan required getting the word out as well as getting the
word in. Publications need to be attractive for the public to read, and
there is a need to determine the current understanding and ideas of the
public. Multiple components should be on the radar screen in terms of
engaging the public.

COL Renata J.M. Engler would like to see issues such as vaccine safety,
surveillance, and adverse events considered. If a process for rare and
serious adverse events is not established, these occurrences are not
seen and consequently do not exist. As an example, there has been low
awareness among providers about thrombocytopenia following MMR vaccine
administration. In addition, there are new mixtures and formulations,
and safety surveillance is necessary to determine if work in this area
has been successful.

Discussion closed with Dr. Gellin directing each of the Subcommittee
leaders to attempt to go through some of the comments when the Working
Groups and Subcommittees met. At the early stages in the process, input
is critically important.

**Progress Report on the NVAC Adolescent Working Group---Dr. Gary L.
Freed**

Dr. Freed began with an acknowledgement of the Working Group members. He
explained that completion of a white paper/problem statement is the goal
of the Working Group. They have considered 22 versions of the white
paper at this point, and 2 consultants reviewed the document. The
Working Group approved final revisions in January 2007, and the plan
will be distributed for comment later in February. The Working Group
hopes to publish the document in a peer-reviewed journal and then
develop plans for distribution to the public.

After this initial discussion of the overall plan for the paper, Dr.
Freed outlined key issues addressed in the paper:

-   Current adolescent patterns of care utilization and their
    implications for immunization rates and acute and preventive care as
    well as additional data needs

-   Venue of vaccine administration in terms of limitations of
    traditional sites and complexities of developing novel venues

-   Consent as it varies among States and how existing laws are
    interpreted

-   Communication specific to adolescents and the potential to induce
    demand and use of age-appropriate messages

-   Financing

-   School mandates

Future work will consist of taking the fleshed out version of these
issues and developing specific recommendations to address each of the
above topics. The goal is to move forward to plausible recommendations
after careful study of the problems and potential solutions.

***Discussion***

Dr. Gellin commented that multiple issues arise with the implementation,
and he wondered about potential overlap with the ACIP. Dr. Freed
indicated that they do have people on specific Working Groups from ACIP
to make sure that perspective is presented.

An audience member asked about the involvement of professional societies
and their recommendations in the process and how the Working Group would
interact with the Adolescent Immunization Workshop. Dr. Freed responded
that the Subcommittee looked at available data on adolescent utilization
and that the Subcommittee will look at issues related to what
professional societies will be recommending; this will assist in
determining what solution or combination of solutions are most feasible.
Dr. Adele E. Young responded to the second part of the audience member's
question by indicating that the Subcommittee's work has focused on the
Adolescent Immunization Workshop.

Working Group members discussed how the work of the Adolescent Working
Group would coalesce with the work of other NVAC Working Groups. Dr.
Freed stated that many of the Adolescent Working Group issues are
related in some way to the other Working Groups. The different
constituents of each of the Working Groups help in bringing a clearer
idea of the range of needs. As such, it is important to demonstrate and
reiterate any alignment between constituencies when promoting
recommendations. Dr. Pavia stated that the next step in moving forward
with recommendations following writing reports and papers is what can be
challenging.

Dr. Freed briefly reviewed the next steps for the white paper/problem
statement of the Working Group following a request from Dr. Gellin. Dr.
Freed explained that the working group would meet in the evening and
that they would then like to distribute the paper to the NVAC. Following
distribution of the paper to the NVAC, the Working Group hopes to
receive feedback from NVAC members within a 21- to 30-day period. The
Working Group would work to consolidate the NVAC feedback, and the
consolidated version would be brought to the NVAC meeting for a vote.
NVAC members seemed to agree that this plan was feasible.

The NVAC members made several other comments regarding the Adolescent
Working Group:

-   Dr. Mark Feinberg asked if the group intended to make
    recommendations about how to ameliorate problems. Dr. Freed
    indicated that the next step would be developing specific
    recommendations and addressing new issues as they arise.

-   Dr. Klein asked if "variability" in obstetrician/gynecologist
    participation in vaccination referred to uptake or viewpoints. Dr.
    Freed indicated that both were an issue, not necessarily in the
    recommendations but in implementing in their own practices.

**The IDSA Principles on Adult and Adolescent Coverage---Dr. Neal
Halsey**

Dr. Neal A. Halsey began his presentation by stating that the IDSA
principles are working principles and will continue to evolve, requiring
ongoing feedback and fresh perspectives. IDSA advocates for a number of
activities in addition to immunization, but the idea of focusing on
adult immunization quickly became one of the top priorities given the
burden of disease that still exists. The CDC estimates more than 45,000
premature deaths and a cost of over \$10 billion annually for adult
vaccine preventable disease.

Demonstrating the challenges in adult and adolescent coverage, Dr.
Halsey presented several key trends:

-   Coverage rates decline with age as shown with tetanus toxoid
    coverage.

-   Lower coverage occurs in minority populations.

-   Pneumococcal coverage is actually higher in those older than 65 and
    has improved; however, ethnic differences are even more striking in
    these older individuals.

-   Coverage in this population seems mediocre when compared to the
    pediatric population.

Dr. Hinman indicated that it would be interesting to evaluate the total
burden of disease addressed by four new vaccines (meningococcal
conjugate, Tdap, human papilloma virus \[HPV\], zoster). He then
outlined the working principles of the IDSA and mechanisms for meeting
those principles. The principles are as follows:

-   Increase demand

-   Strengthen capacity to deliver

-   Expand provision for vaccines in insurance

-   Promote as a measure of healthcare quality

-   Monitor and improve performance of the vaccine delivery and safety
    monitoring system

-   Assure adequate support for research

The objective of strengthening the capacity to deliver vaccines requires
having specific targeted funds under the 317 program and having
automatic increases in 317 funding when ACIP approves a new vaccine;
each year it is a struggle to get these funds.

Dr. Hinman noted some comments received regarding components falling
under the principle of increasing demand:

-   Increase Demand---Point 1a: "All medical providers should be
    encouraged to offer immunization at all encounters whenever
    possible"; a number of members thought "whenever possible" should be
    removed since there are circumstances when it would not be
    practical, and there is a need to define encounters where vaccines
    should be administered.

-   Increase Demand---Point 1c: "Medical and nursing schools and
    post-graduate educational programs should support and expand
    curricula on VPD"; some actions are being taken by these
    institutions, but they are not adequate at this time.

***Discussion***

The topic of 317 funding generated significant discussion among Working
Group members. Dr. Abramson suggested that to clearly communicate the
goals of the group the discussion by IDSA about 317 funding should be
calling for a true mandatory program or Vaccines for Adults (VFA) rather
than an annual appropriation. Dr. Halsey questioned how much effort
should be put into a VFA program and indicated that the idea was to work
through existing 317 channels rather than deal with the potential
opposition to introducing a VFA program. The 317 program could be
modified to meet some of the concerns, and work of the group can be to
determine the best means to effect that change.

Dr. Philip LaRussa applauded the consideration of the topic by the group
and indicated that he liked several of the recommendations. Specific
examples would be helpful, and it may be useful to evaluate
interventions and why certain approaches have not worked; issues
surrounding uptake of new vaccines will likely be similar to issues
previously observed with older vaccines. Dr. Halsey agreed and said that
it is important to know why there is gross underutilization of vaccines
that have been available for some time.

On a separate topic, Dr. Klein indicated that he would like to hear
about (1) potential duplication of efforts and (2) what the
prioritization of the multiple items presented would be. IDSA is well
positioned because they have offices in the States, but there may be
additional challenges in Washington, DC, where additional lobbying
groups have a presence. Dr. Halsey responded that prioritization and
specific efforts are the next undertakings and that they will seek out
groups that want to work with them in cases of overlap.

Dr. Lovell discussed some of his observations about the lesser
attainments in adult and adolescent immunization. There is a need to
consider that adults often present with more morbidity so the preventive
side takes a backseat to the need to confront a potentially substantial
disease burden. He suggested that it may be important to include
immunization in the standards of care for certain adult conditions such
as diabetes and to make the immunization component of the preventive
health visit for Medicare more visible.

Dr. Geoffrey Evans noted that the National Vaccine Injury Compensation
Program covers 95 percent of vaccines distributed in the
U.S.---pneumococcal conjucate, herpes zoster, and travelers' vaccines
are not included. Dr. Halsey posed the question of whether it would be
feasible to change legislation to include these vaccines.

Dr. Hinman stated that the HPV vaccine has drawn a significant amount of
attention to adult and adolescent immunization. It is important to
insure that messages about adolescent and adult immunization are in sync
and that various initiatives and sources of information work together.
Dr. Halsey indicated that a meeting taking place on March 1 should help
with coordinating different groups that are working toward similar
legislative goals.

On the topic of information availability, Dr. Strikas suggested that it
may be challenging to include the relevant immunization information in
medical school and other curricula given the substantial amount of
material that is already covered. He questioned how the group would
influence medical boards and licensing tests so that people pay
attention. Dr. Halsey responded that IDSA is well positioned since many
members are teaching in medical schools.

In concluding the discussion, Dr. Halsey indicated that additional
comments should be sent to him or Julie Hantman
(<jhantman@idsociety.org>).

**Immunization Information Systems (IIS) Progress Report---Dr. Alan
Hinman**

Dr. Hinman began by presenting the background to the 1997 NVAC Registry
Initiative. The progress that has been made is striking in terms of the
participation in IIS between 2000 and 2005; participation of children
under 6 years old has increased from 21 to 56 percent. The mobility of
the population, 11,000 births per day, and overestimations of coverage
by providers and the public argue for having an immunization information
system. As an example, an immunization information system was useful in
finding over 56,000 immunization histories following Hurricane Katrina,
thereby avoiding the costs of unnecessary immunization.

In terms of the draft report that he presented to the NVAC in September
2006, Dr. Hinman received comments and suggestions as noted below:

-   Regarding the recommendation to have NVPO convene a meeting
    deliberating the pros and cons of mandating provider participation
    in an immunization information system, he received a comment that
    Federal funds should not support this activity.

-   Clarification of recommendation 3.1 is needed.

-   Concern was voiced about making patient contact information
    mandatory rather than optional (action step 3.3).

-   An action step should be included for HHS to propose legislation
    that would allow States and territories to share immunization and
    birth data without an individual Memorandum of Agreement (MOA).

-   An action step should be added to ensure that NCIRD has adequate
    funds and resources to undertake recommendations.

In concluding his presentation, Dr. Hinman indicated that he hopes to
receive approval of the report from the NVAC.

***Discussion***

Dr. Lovell began a discussion about the unique identifier employed in
the registry by asking about what would replace the social security
number. Dr. Hinman said that each State has its own unique identifier
and that technology people do not view the differences in unique
identifiers as a problem since they use other data to match cases.
States have not yet addressed this issue because it would require an
individual MOA between each State.

Dr. Sharon G. Humiston spoke to the comment about the use of Federal
funding to have a meeting to discuss mandating provider participation in
an immunization information system. She suggested that pediatricians are
already not content and that this is very premature for some States.
Instead of making it mandatory, it may be preferred to build a quality
system that providers want to join. Dr. Hinman clarified that the goal
would be to discuss the pros and cons at a meeting, not necessarily
leading to a mandate. Dr. Birkhead stated that 10 years of experience
has shown that a good product with no mandate does not result in
participation. Dr. Rawlins stated that those who are mandated need to
have a voice in the discussion so that they wholly participate in the
process. Dr. Gellin added that the simple use of the word "mandate" can
generate significant discussion and resistance. Reviewing the document
for this term may alleviate concern. Dr. Jon R. Almquist also said that
care should be used when discussing potential additional mandates as it
may discourage providers from administering vaccines.

**Action item:** The majority of the Committee voted that a meeting to
discuss mandating participation in the immunization information systems
should be held.

Dr. Young inquired about data concerning patients who know that they are
in the system in the "opt out" States. She also said that there may be
consent issues if the information systems are being turned into a
research tool, even if it is only for sampling.

Ms. Parnell asked about whether the systems would be designed so that
parents could access the information. Dr. Hinman responded that the
parents can access the information and that direct parental access is
being developed in some States. Related to this, Ms. Koslap-Petraco
noted that problems could arise if the patient cannot get information
from the provider because they have not paid the bill; alternative
access to the information should be available.

Some discussion surrounded the issue of mandatory provision of patient
contact information. Dr. Humiston raised the challenging issue of
situations where one parent would not want the other to have access to
contact information because of past abuse. For a percentage of the most
vulnerable populations, providing this information may produce barriers.
Dr. Hinman indicated that he would delete the mandatory requirement of
patient contact information.

Committee members discussed the connection between the freestanding
electronic record and the existing medical record. Dr. Pavia suggested
that it may be appropriate to add a bullet addressing linkage and
duplication issues between information systems.

The audience also made several comments:

-   It may be feasible to establish and link a measure of completeness
    of immunization records with NIS.

-   MOAs between States may be a matter of State policy and laws;
    approaches may consequently be necessary at the State rather than
    Federal level.

-   Incentives to providers for providing complete records to a registry
    may be appropriate.

Dr. Hinman summarized the suggestions that he heard during the
discussion:

-   Easy access for parents

-   Address completeness of information in records

-   Add a bullet to address technical issues dealing with linkage and
    duplication problems between medical information systems

-   Remove the requirement for mandatory information

-   Check for the use of the term "mandate" in the document

Taking these discussion points into account, the NVAC held a vote on
approval of the report.

**Action item:** The Committee approved the report pending a word search
for "mandate" in the document and discussion of any concerns/issues
because of this word with the NVAC.

**Addressing Administrative Issues**

Following lunch, the NVAC dealt with several administrative issues.
Slight changes were made to page 15 of the September 26--27 meeting
minutes with replacement of "the most likely" with "logical source."

**Action item:** The Committee voted unanimously to approve the minutes
from the September 26--27 meeting with the above change.

Dr. Freed announced that the next NVAC meeting has been changed from
June 5--6 to June 7--8. To have more continuity, it may be necessary to
discuss other potential venues.

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

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

Dr. Gellin reported that from the NVPO perspective, pandemic influenza
is the continuing undercurrent. The National Vaccine Plan is really the
prominent piece of work that NVPO wanted to bring to the attention of
NVAC. He then introduced Dr. Ken Markman to discuss the postmarketing
surveillance meeting organized for April 10--11, 2007.

Dr. Ken Markman described the meeting, which will look at postmarketing
surveillance and review methodologies currently used for assessing
vaccine safety. The principal intent is to look at what is being done
and what should be done differently. The meeting will be announced in
the *Federal Register*, and they are looking for participation from all
sectors to develop what an ideal safety system might look like.
Hopefully, the meeting will also impart knowledge about what is being
done internationally.

***Discussion***

Dr. Klein asked if the Clinical Immunization Safety Assessment Network
(CISA) and the Vaccine Safety Datalink (VSD) would also be involved in
the process. Dr. Markman responded that the agencies are the principals
for the meeting and that he attempted to group the many items needed for
discussion under the general heading of methodologies. He added that the
meeting would also address the reorganization of CDC and the separation
of risk management and risk analysis.

**ACIP/NCIRD---Dr. Anne Schuchat**

Dr. Schuchat reported briefly on six issues:

(1) OMB approval was received for Vaccines for Children (VFC) funds to
    support adolescent vaccine coordinators in the 61 VFC grantees for a
    2-year timeline to focus on enrolling additional VFC providers who
    care for adolescents.

(2) Rotavirus postlicensure activities are ongoing. Evaluation is
    continuing to look at tracking issues and intussusception; the
    preliminary information collected at this point is reassuring.

(3) Menactra meningococcal vaccine analysis is also ongoing. The
    possible increased risk of Guillain-Barré syndrome was put into the
    context of expected protection, resulting in no changes in
    recommendations for use; however, the supply has increased so there
    could be broader uptake than the initial prioritization scheme
    allowed.

(4) She reminded the audience that the ACIP meeting will be February
    21--22. She pointed out that there will be a session discussing
    thimerosal in vaccines and that there will not be a vote about
    Pentacel if it is not licensed by then.

(5) She also reminded the group that the National Immunization
    Conference will be March 5--8.

(6) The measles initiative achieved the goal of decreasing global
    measles deaths; it has been an extremely high-impact partnership.

***Discussion***

Ms. Koslap-Petraco asked about inclusion of family planning clinics in
the new funds available to VFC grantees. Dr. Schuchat responded that the
coordinators group would be charged with determining providers and that
family planning groups have been an important constituent in previous
meetings.

**NVICP---Dr. Geoffrey Evans**

Dr. Evans began by highlighting that the program is now covering a total
of 16 vaccines with the addition of the HPV and meningococcal vaccines.
He then clarified that the court will be entertaining a different
approach in the litigation involving thimerosal and autism. In response
to a request by petitioners, the first hearing will now be limited to
only one of the three theories---that a combination of
thimerosal-containing vaccines and MMR vaccines, which have never
contained thimerosal, can cause autism or autism spectrum disorder. The
chief consequence is that there now will be separate hearings for each
of the other two theories as causative factors. Much uncertainty remains
about the upcoming hearing, but it will most likely be smaller with
fewer witnesses. It begins June 11 and will last several weeks. More
will be known by the next NVAC meeting.

***Discussion***

Dr. Klein asked if anything has changed about the proof of causation
opinion. Dr. Evans responded that in the past year or two there have
been decisions by The federal Court of Appeals that have relaxed the
requirements for proving causation. The three prongs special masters
should use in judgments are generally (1) reasonable medical theory
tying the vaccine to the condition, (2) logical sequence of cause and
effect, and (3) temporal proximity. Interpretations of this language may
vary from case to case.

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

Dr. Baylor reported that the FDA has added a new manufacturer to the
list of influenza vaccine manufacturers. At their January meeting,
VRBPAC also discussed Pentacel and inconsistent trial results with this
combination vaccine; one trial saw a decrease in response to the Hib in
the combination vaccine as compared to the Hib antigen alone, while the
other trial reported the opposite results. In the second study, there
was also a decrease in the Hib response in control as well as the
combination vaccine groups so investigation is ongoing about a potential
decrease in response to the Hib vaccine overall in the country. The
combination vaccine is still under review and will be considered until
the March due date for a decision.

At an upcoming VRBPAC meeting on February 27--28, the potential strains
for the 2007--2008 influenza season and other topics related to
influenza will be discussed. VRBPAC is also in the process of getting
the final guidance documents out for the clinical pathway for developing
the seasonal and pandemic influenza vaccines.

Dr. LaRussa, also of VRBPAC, added several comments. There was a fairly
prolonged discussion about the significance of the antibody responses to
PRP and pertactin. Nine years of data from Canada assisted in reaching a
decision concerning this topic. He also added that there was a report on
the site review of the Office of Vaccine Research and Review; people
were very complimentary about regulatory and research work that was
done, and there was significant input about maintaining the office and
providing funds to hire new investigators.

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

Dr. Curlin reported on the development of vaccines for the top
priorities of NIH (HIV, pandemic and seasonal flu, malaria,
tuberculosis, vaccines for bioterrorism, and emerging threats).

**DoD---COL Renata Engler**

COL Engler stated that a summary of the status of the smallpox
vaccination program is included with the meeting information. The
summary also includes information on the number of individuals who have
received anthrax vaccine. She indicated that the mandatory anthrax
vaccine program would begin again for specific populations based upon
higher risk geographic locations and unique mission roles.

**VA---Dr. Ronald Valdiserri**

Dr. Valdiserri said that they are continuing to push for late influenza
vaccinations and do not anticipate problems meeting the goal of
75-percent coverage. Efforts are underway to determine how to respond to
the Tdap recommendation and the provisional recommendation for the
herpes zoster vaccine.

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

Mr. Brandes asked the group if he should get the group together to
present information about the Global Vaccine Fund. Dr. Hinman indicated
that he would find more information concerning the International Finance
Facility for Immunization very interesting. Dr. Schuchat added that
there would be a World Bank representative at the upcoming National
Immunization Conference meeting to discuss financing.

**AHIP---Dr. Wayne Rawlins**

Dr. Rawlins reported that insurers feel strongly that vaccines have a
significant role. Issues of costs, affordability, and timing are
important as it is critical to ensure vaccines are always available as
needed.

**National Influenza Vaccination Week---Dr. Kristine Sheedy**

Dr. Sheedy provided the NVAC with an overview of the National Influenza
Vaccination Week, which was held from November 27 to December 3, 2006.
The goal of the week was to raise awareness about the importance of
influenza vaccination. Plans for the event began in late October 2006,
and the Office of Health Communication selected the week after
Thanksgiving because the majority of the vaccine would be available by
that date and that date would assist in challenging the misconception
that it is too late to get vaccinated after Thanksgiving. The choice of
a whole week rather than 1 day resulted from a desire to give more time
for people to act.

Planning the event involved outreach to multiple partners in order to
have an impact at the local level (National Association of County and
City Health Officials, Association of Immunization Managers, Association
of State and Territorial Health Officials, National Influenza Vaccine
Summit). The group worked quickly to develop campaign materials,
including public service announcements, sound bites, posters, and a Web
site. During the week itself, there was a press conference and radio and
television ads played in 96 markets, covering 67.44 percent of the U.S.
population. Data suggest that a full-page advertisement in *USA Today*
reached an audience of 2.2 million readers.

In terms of the impact of this event, Dr. Sheedy said that as it is
primarily aimed at changing how people think and behave, it might take
several years to see the results. Evaluation measures used this year
should be focused on awareness, necessary before changes in behavior and
should serve as a baseline. The plan is to collect data about the impact
of the week on awareness using surveys of providers, other sponsors, and
the public. Surveys will also determine baseline estimates of annual
vaccination.

Dr. Sheedy concluded by saying that planning for 2007 was underway and
that sessions about National Influenza Vaccination Week will occur at
the National Immunization Conference and annual National Influenza
Vaccine Summit meeting.

***Discussion***

Dr. Klein asked what the Office of Health Communication would undertake
if money were not a concern. Dr. Sheedy responded that she would like to
pursue a campaign targeting a broad range of media. The office is
looking into new media, and advertising during prime television time
slots would also be useful.

**2006--2007 Influenza Season Distribution---Dr. Greg Wallace**

Dr. Wallace began by presenting historical perspectives on vaccine
distribution, indicating years when delays occurred and shortages
happened. This season's data show distribution of greater than 102
million does, 20 million more than ever distributed in previous years.
October appears to be the time when vaccination is solidly underway and
when delays in vaccine arrival can become problematic.

Evaluation of the doses by HHS region seems to indicate that claims that
some States are not getting their distribution may not be accurate.
Multiple providers distribute the vaccine, but private providers account
for over 40 percent of the influenza vaccine distribution. State and
local providers and pharmacies each account for approximately 10 percent
of the vaccine distribution. When looking at the distribution patterns,
there appears to be a relative delay in some of the sections (such as
State and local) compared to everyone else.

In conclusion, Dr. Wallace stated that there have been improvements in
distribution, but the system is complex and dynamic, and further
improvements are needed in the timing of public sector distribution.

***Discussion***

Dr. Cornelia Dekker asked if Dr. Wallace could speak specifically about
the pediatric population. Dr. Wallace responded that the data were
provided voluntarily in the aggregate, and he had not requested
permission to show data for the different formulations intended for
adults versus children.

Committee members discussed distribution issues. Dr. Young asked about
the process of distribution. Dr. Wallace explained that there is
variability in terms of distribution; some manufacturers do the
distribution themselves, but there are now more middlemen and
subdistributors. He indicated that some of the private providers would
not be captured in the distribution curve if they received vaccines from
small middlemen.

One comment questioned whether the States were slow to pick up in
distribution because they were providing the pediatric formulations. Dr.
Wallace responded that he did not think this was the case, but that the
Subcommittee on Vaccine Supply will have presentations to address these
questions.

Dr. Humiston said that the data seem to indicate that there should be
changes for clinics in terms of planning for vaccine distribution in
October; communication of this message may be important. Dr. Wallace
replied that some people are taking that viewpoint, but every year is
different, and from his perspective, it may be desirable to have early
as well as late clinics. Doing an early campaign and running out may be
the worst scenario.

Dr. Young stated that there were difficulties in the VFC program this
year in the pediatric population since people arrived but could not
receive the vaccination. Dr. LaRussa said that, at his institution, once
there are delays, they have a difficult time getting children in to get
vaccinated, resulting in a waste of vaccine. A representative from
sanofi pasteur said they were about 3 weeks behind schedule this year,
and as they fell behind, the pediatricians and public sector fell
behind. Both the pediatricians and public sector expressed frustration
with this. Dr. Wallace said that this was the first year with the new
unpreserved vaccine.

Related to this topic, Dr. Gordon asked if there was increased use of
preservative-free vaccine this year. Dr. Wallace answered that the
amount used has steadily increased each year, but the VFC program has
not yet reached the maximum agreed to in the contract with sanofi
pasteur. A representative in the audience from sanofi pasteur added that
they have seen additional demand for the unpreserved vaccine, but they
do have some left over; he indicated that they hope to have additional
capacity in the next year or two to be able to increase the number of
doses.

The Committee briefly discussed the issue of tracking vaccine
distribution. Dr. Pavia stated that tracking and real-time analysis have
been discussed in previous years. Although more details are available
this year, it seems there is a long way to go before distribution trends
in real time are known. Dr. Wallace said this is true for all vaccines
as they lose their identity once they leave the manufacturer. Research
is investigating use of radio frequency identification chips to better
track specific vaccines. He added that the system as it stands is
limited since it does not allow analysis of the number administered,
only the amount distributed; a registry could assist in this area.

Discussion concluded with a comment from Dr. Schuchat pertaining to
pediatric vaccine administration. She indicated that ACIP and the
American Academy of Pediatrics (AAP) are no longer harmonized in their
recommendations regarding the childhood immunization schedule. There
will be a vote at the February ACIP meeting to attempt to harmonize with
the AAP recommendations.

**Pandemic Influenza Coverage Prioritization---Dr. Ben Schwartz**

Dr. Schwartz said that the guidance about prioritization of coverage is
being developed in response to an action item in the national
implementation plan for pandemic influenza. There is a need to
prioritize because the U.S.-based production capacity is currently not
sufficient for the entire population. A number of initiatives are
underway to increase capacity; e.g., investments, development, and
licensing of new vaccine production technologies. Recent studies suggest
that an adjuvanted vaccine may provide a means to expand the number of
doses produced, but it is difficult to directly compare the results from
the studies. By building capacity and decreasing the amount of antigen
required per dose, it may be possible to approach the vaccination target
in several years.

After the initial recommendations for prioritization for pandemic flu
vaccination from ACIP and the NVAC, criticisms arose in some spheres
because of the similarities to seasonal flu vaccination prioritization.
The development of these initial recommendations assumed a 20- to
30-percent attack rate, up to 1-percent case fatality rate, and the
primary response goal of mitigating adverse health outcomes. The certain
benefit of vaccinating high-risk individuals versus the unclear benefit
of vaccinating critical infrastructure (CI) entered into the strategy
development. Since 2005, additional input led to reconsideration of
prioritization.

Dr. Schwartz summarized the input since 2005, which has included public
engagement, evolved planning assumptions, and evolving pandemic response
strategies. An interagency pandemic vaccine prioritization Working Group
that has met weekly since mid-November involved participants from
Federal agencies and evaluated ACIP/NVAC recommendations, written
comments, stakeholder input, National Infrastructure Advisory Council
(NIAC) recommendations on CI, and public engagement meetings.

NIAC developed a Tier 1 group that included 4.1 percent of the U.S.
population, approximately three-quarters of this group being healthcare
workers (report details are available at www.dhs.gov/niac). Public
engagement meetings revealed that individuals wanted to preserve
essential services as the primary goal. Participants weighted pandemic
vaccination goals with ties allowed between goals. The meetings occurred
in different geographic regions and consisted of presentations and group
discussions followed by electronic voting. Assumptions of all the
meetings were that it would be similar to the pandemic flu of 1918 but
no increased mortality among young, healthy persons.

Public engagement meetings revealed the four most valued goals were as
follows:

-   Protecting persons implementing pandemic response and providing
    pandemic healthcare

-   Protecting persons providing essential community services

-   Protecting persons at occupational risk

-   Protecting children

Moving forward in developing a strategy, it will be important to
determine how to use the information collected. The next steps for the
prioritization plan are to draft guidance on February 9 and obtain
comments and suggestions from March through April. Finalization of
guidance would occur from April to May.

***Discussion***

Dr. Abramson noted that, as he understood it, ethicists had indicated in
a prior pandemic influenza vaccine prioritization meeting that giving
healthy children a higher preference for vaccine than healthy adults
\<65 years of age saved could not be ethically justified even though it
would result in greater quality of life years saved. He questioned
weather ethicists have been involved in the public input session that
followed this prior meeting. Dr. Schwartz responded that ethicists had
been involved, and they said that the processes are transparent and
consistent with their understanding of ethical issues.

COL Engler asked about the classification for people in the DoD and what
will happen to DoD individuals that fall outside of those stockpiled for
active duty. Dr. Schwartz said that they realize the importance of
protecting military and homeland security personnel, and they will
consider and include DoD recommendations in the eventual prioritization
scheme.

Discussing the fact that children came up among the tour's most highly
rated priorities, Dr. Hinman said it seemed that people would rather
have their grandchildren receive the vaccine than themselves in the case
of limited supply. Dr. Schwartz said that the answer depended on the
wording of the question. Asking what is the *most* important goal
results in children being ranked lower; this wording of the question may
ignore the fact that vaccination of children is important to people even
if it is not *most* important.

Dr. Lovell asked about the differentiation from 1918 in terms of young,
healthy people. Dr. Schwartz responded that they chose not to consider a
peak in young adults because this assumption would have made the task of
prioritization development easier. Not making that assumption has
stressed the system.

Dr. Birkhead asked about the healthcare worker numbers included in the
presentation, which seemed smaller than those used in the past. Dr.
Schwartz answered that they would need to work to further define
healthcare workers.

At the end of the discussion, Dr. Freed proposed that Dr. Schwartz be
the coordinator of the NVAC input. Those who have special interest in
the area could notify Dr. Schwartz and would work to develop a
discussion group that would then present feedback through electronic
means.

**Pandemic and All-Hazards Preparedness Act---Mr. Brian Kamoie**

Mr. Kamoie summarized the main changes brought about by the Pandemic and
All-Hazards Preparedness Act. This includes the fact that HHS assumes
operational control of Federal public health and medical personnel and
assets (except DoD) during incidents and the creation of a new Assistant
Secretary for Preparedness and Response (ASPR). Among the duties
assigned by the act, the ASPR has authority over the National Disaster
Medical System, coordinates the Medical Reserve Corps, and leads
international preparedness and response initiatives. The act also
requires benchmarks to measure effectiveness. Importantly, the act also
established the Biomedical Advanced Research and Development Agency
(BARDA).

Additional items included in the legislation are as follows:

-   Publication of a strategic plan to integrate biodefense requirements
    with advanced research and development

-   Permission to use advanced and milestone payments in awarding
    grants, contracts, and cooperative agreements for medical
    countermeasures development

-   Provision of antitrust protection for industry meetings and
    activities pursuant to written agreements approved by the Attorney
    General and Federal Trade Commission Chairman

-   Establishment of a near real-time electronic nationwide public
    health surveillance system

In finishing his presentation, Mr. Kamoie stated that much work remains
to implement the statute, and the Office of Policy and Strategic
Planning will circulate a draft plan within HHS concerning
implementation of the statute. Following circulation of the draft plan,
HHS will convene an implementation team and workgroups. He concluded by
saying that the statute will generate increasing discussion as
development continues, and BARDA is a major development for medical
countermeasures.

***Discussion***

Dr. Dekker said that the resolution passed last year seems to go against
the wording of the current act, specifically the recommendation that
pandemic influenza be included under BioShield. Mr. Kamoie said he does
not know the reason that Congress chose that particular language, but
the statute allows flexibility to fund what is needed to acquire
countermeasures against influenza.

Dr. Pavia asked how Mr. Kamoie anticipated the strategy being developed.
Mr. Kamoie responded that they will have an advisory committee and will
use a transparent process. He expected to see frequent stakeholder
meetings and collaboration with industry and academia; he underlined the
importance of the antitrust exemption in permitting additional industry
collaboration under the act. Mr. Kamoie added that ahead of BARDA, the
Office of Policy and Strategic Planning developed a strategy that will
soon be released. During that process, stakeholders provided multiple
comments, and the office revised the document accordingly. One of the
possibilities for receiving feedback is use of the *Federal Register*
with a 30-day review.

An audience member asked about BARDA and the opportunities for funding.
Mr. Kamoie responded that there was nothing specifically in the
continuing resolution for BARDA, but there was money for continued
advanced development; it will be necessary to revisit the funding
required to support BARDA and its advancing of development.

**Closing Administrative Items**

Dr. Humiston brought forward a suggestion to change the name of the
Subcommittee on Communication and Public Engagement to the Subcommittee
on Public Communication, Consultation, and Participation since there are
three types of public engagement.

**Action item:** The Committee approved the recommendation for the
proposed name change with no discussion.

Before concluding the meeting, Dr. Freed announced that the
Subcommittees would convene the following day and operating procedures
would be discussed during lunch. Dr. Schwartz also announced that there
would be an unmet needs meeting.

With no further Committee or public comment, Dr. Freed adjourned the
meeting at 4 p.m.

Appendix: Subcommittee Minutes

**Subcommittee on Immunization Coverage---Chair: Dr. Alan R. Hinman**

**Attendees:** Jon R. Almquist, NVAC; Guthrie S. Birkhead, NVAC; Robin
Curtis, CDC; Stuart Feldman, sanofi pasteur; Kent Forde, NVPO; John
Hunsuker, AHIP; Sarah Landry, GSK; Charles Lovell, Jr., NVAC; Roland D.
McDevitt, Watson Wyatt Worldwide; Walter A. Orenstein, Emory University;
Wayne Rawlins, AHIP; Lauren Riley, *Infectious Diseases in Children*;
Lance Rodewald, CDC; Raymond A. Strikas, NVPO; Adele E. Young, NVAC;
Jennifer Zavolinsky, Every Child by Two; Bruce Campbell, notetaker.

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

Dr. Hinman reviewed recent emendations to the draft NVAC immunization
information systems progress report. All changes were approved. One
additional modification of the text was suggested and approved.

There was consensus that a condensed version of the report of
approximately 2,500 to 3,000 words should be submitted to *Health
Affairs* for publication.

***General Discussion and Introduction of Speakers---Dr. Raymond
Strikas, NVPO***

Dr. Strikas distributed copies of an article, "Immunization Practices
and Policies," from the January/February 2006 issue of *AHIP Coverage*,
which reported an assessment of HMO and PPO health insurance plans'
practices and policies regarding immunization. Although the majority of
health plans reported inclusion of all ACIP-recommended vaccines,
discussion ensued among Subcommittee members as to the degree of
coverage; e.g., patient co-pays and deductibles or reimbursement to
physicians for administrative costs.

Subjects touched on in the general discussion that followed included the
number of underinsured persons in the United States, compensation for
vaccine inventory maintenance, and the lag time between vaccine
recommendation and coverage.

Dr. Orenstein reported that the VFC contract for HPV vaccine had been
recently negotiated (October 31, 2006). He noted that, in general,
States prefer to focus HPV immunization efforts on 11 and 12 year olds
but that, at least upon physician recommendation, vaccine must be
provided to any child within the recommended age range. Dr. Rawlins
noted that most insurers have already accepted coverage for HPV vaccine.

Dr. Strikas introduced the speakers, Dr. Lance Rodewald and Dr. Roland
McDevitt. Their presentations were followed by a report from Dr.
Almquist on the upcoming immunization congress.

***Underinsurance With Respect to Childhood Vaccines---Dr. Lance
Rodewald, CDC***

Dr. Rodewald addressed the issues of the importance of underinsurance,
the difficulties of measuring it, previous estimates of the problem, and
current CDC measurement efforts.

Underinsured children are entitled to VFC vaccines but are limited to
providers in Federally Qualified Health Centers (FQHCs) and Rural Health
Clinics (RHCs). Of 45,000 VFC sites, underinsured children have access
to fewer than 10 percent of them.

For decades, State and local health departments maintained a vaccine
safety net. They purchased vaccines for the underinsured with
discretionary funding and maintained high vaccination coverage. Section
317 and State funding have been under increasing pressure to keep pace
with new children's vaccines. The gap between funding need and funding
amounts began to grow with the introduction of pneumococcal conjugate
vaccine in 2000; all new vaccines have added to that pressure.

VFC designated FQHCs and RHCs as safety-net providers for underinsured
children, but they have limited capacity and do not like to serve as
walk-in clinics. Public health clinics have been the traditional vaccine
safety net providers, and referral patterns are difficult to change. In
many areas that have inadequate access to FQHCs and RHCs, States are
making arrangements for these entities to delegate authority to public
health departments to vaccinate underinsured children with VFC vaccines.

VFC requires that efforts be maintained. If an insurance plan covered
recommended vaccines when the Program began in 1994, it is expected to
continue coverage of those vaccines, although this has not been
enforced.

Dr. Rodewald observed that benefits to insurance plans from vaccination
include a reduced number of hospital stays and emergency department
visits and a generally better health status among those covered. He
noted a Rhode Island study that found that covering all childhood
vaccines in that State required less than four-tenths of one percent of
overall insurance premiums.

Measuring the underinsured population is important in determining how
much State or Section 317 funding is needed and because two-tiered
policies can result from inadequate funding. It is important to be able
to judge the cost offset for Section 317 of adding health department
underinsured coverage to VFC. Knowledge of the extent of underinsurance
will affect the workability of solutions to vaccine financing problems.

Measurement of the number of underinsured children has had a low
priority among general assessments of insurance status; e.g., National
Health Interview Survey, Medical Expenditure Panel Survey, Current
Population Survey. Insurance verification is technically difficult and
very expensive. Parental knowledge of insurance coverage is often very
weak, and parents' answers to questions are probably setting and stakes
dependent. For example, a question about insurance coverage may elicit a
different response in a survey than it would in a treatment setting
where concrete financial issues arise.

Dr. Rodewald discussed the methods and findings of studies undertaken by
the University of North Carolina and the Institute of Medicine in 1999
and 2003, respectively. Levels of uninsured and underinsured children
were comparable at roughly 10 percent in both studies. He discussed the
National Immunization Survey (NIS) Insurance Module I for 2000 and 2001
and noted difficulties encountered in collecting and interpreting that
data. The NIS Insurance Module II for 2006 incorporates several
refinements. VFC operations funding covers the costs of implementing the
module. The data collected will be used as one factor in allocating VFC
vaccine budgets to States and will include a national estimate for
adolescents.

In conclusion, Dr. Rodewald noted that

-   Measurement of the rates of vaccine underinsurance is critically
    important to immunization programs.

-   Technical challenges force compromise. Insurance checks are too
    costly. Actual VFC implementation is based on parental reports.

-   VFC funding is paying for CDC measurement of immunization insurance
    coverage.

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-   The insurance module is now in the NIS core survey.

-   Adolescents are included.

-   The insurance module is planned to continue indefinitely.

***Discussion***

The discussion that followed Dr. Rodewald's presentation touched on the
following topics:

-   States may now use VFC Federal contract vaccines for children
    enrolled in State Children's Health Insurance Program.

-   First-dollar coverage for preventive care is becoming more
    prevalent.

-   The hard numbers are those for the uninsured (as opposed to the
    underinsured). States are using these to make plans.

-   There is variability in reimbursement rates, in some cases
    undercutting incentives to providers.

-   Administration and vaccine acquisition costs are not adequately
    funded.

-   Breaks in coverage have a damaging effect on vaccination rates. In
    the NIS Insurance Module I, 12.6 percent of children 19 to 24 months
    of age were uninsured at some time.

***Consumer-Directed Health Plan (CDHP) Designs: Implications for
Preventive Care---Dr. Roland McDevitt, Watson Wyatt Worldwide***

Watson Wyatt and the RAND Corporation are conducting a 4-year study of
the costs and use of high-deductible health insurance plans. They have
completed initial data collection from 40 large employers but have no
claims data at present.

In 2004, almost half of employer plans had no deductible. Of those that
did, the average was \$220. CDHPs may have a deductible of \$1,000 or
more, often with a tax-protected personal account. Of enrollments in
2005, 10 percent of privately insured people had a high deductible; 1
percent had a high deductible and a health reimbursement arrangement
(HRA) or health savings account (HSA).

Demand is growing. Many employers are considering CDHPs. Enrollment was
3 percent in 2006.

The high deductibles may lead to a rationing of healthcare, but it will
be rationing undertaken by the insured themselves. To this end, there is
an emphasis on decision support services and on wellness.

A report on the study by Melinda Buntin was published in the
November-December issue of *Health Affairs*.

When offered at all, CDHPs are generally offered as a plan option.
People choosing CDHPs tend to be slightly older, healthier than average
for their age, and relatively affluent. CDHPs may lower the overall cost
of insurance. Cost savings are estimated at 4 to 15 percent.

Dr. McDevitt compared HSAs and HRAs. HSAs are funded by employers and
employees jointly, HRAs by employers only. An HSA is portable (i.e.,
employees can take it with them, including employer contributions) while
an HRA is not. HSAs have a minimum deductible, and first-dollar drugs
are not allowed. In both plan types, preventive care can be, and usually
is, covered before the deductible is satisfied.

Dr. McDevitt presented a brief history of insurance coverage, showing an
increase in coverage for preventive services as traditional indemnity
plans were followed successively by HMOs, PPOs, and CDHPs. A 2006 survey
by Kaiser Family Foundation found that 82 percent of workers in HSA
plans and 74 percent in HRA plans have preventive services available
without a deductible. Ninety-two percent of employers in the RAND/Watson
Wyatt study paid preventive services at 100 percent.

CDHPs focus on the consumer as the decisionmaker, though physicians
still play a vital role in monitoring compliance with guidelines and
informing patients of the need for care.

***Discussion***

There was interest that the high deductibles were being set aside for
preventive services. Dr. McDevitt was asked how well the CDHP model
worked for those not so well off. He responded that, if one is hitting
the out-of-pocket maximum every year or much exceeding the yearly
deductible, CDHPs are probably not a good option. He noted, in response
to another question, that there is not good data yet on the persistence
of savings over time.

***Immunization Congress Update---Dr. Jon Almquist, NVAC***

Dr. Almquist reported the plans for the upcoming (February 27 through
March 1) Immunization Congress. The meeting will take place in Chicago
and is sponsored jointly by the American Medical Association and the
American Academy of Pediatrics.

Goals of the conference will be to find the best means to ensure access
to all ACIP-recommended vaccines for the entire U.S. population and to
identify and prioritize key problems in achieving that access.

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

Attendees: Jon S. Abramson, CDC; Norman W. Baylor, FDA; Chris Colwell,
BIO; Kevin Combs, MedImmune; Cornelia L. Dekker, NVAC; Shannon Dzubin,
Novartis; Lance K. Gordon, NVAC; David R. Johnson, sanofi pasteur;
Christine Layton, RTI International; Barbara Mulach, NIAID/NIH; Margaret
Rennels, GSK; David Ross, sanofi pasteur; Jennifer Salesa, NVAC; Laurie
Schowalter, GSK; Benjamin Schwartz, NVPO; Leah Sirkus, ASTHO; Greg
Wallace, CDC; Cole Werble, Windhover/RPM; Laura York, Wyeth Vaccines
Research; Keith Maynard, notetaker.

Subcommittee Cochair Dr. Dekker welcomed those attending and introduced
Dr. Gordon, who was representing the other Cochair Dr. Klein, who was
unable to attend.

Dr. Gordon, after expressing Dr. Klein's regrets, introduced two
speakers from the pharmaceutical industry who delivered presentations on
their companies' perspectives on the production and distribution of
influenza vaccine.

***sanofi pasteur Influenza Vaccine Production and Distribution,
2007---Dr. David Johnson, sanofi pasteur, Director, Scientific and
Medical Affairs***

Dr. Johnson introduced his remarks by saying that they were in response
to a recent *New York Times* article on influenza vaccine distribution.
However, he said, influenza vaccine distribution and production are
inextricably wedded. He also stressed that his remarks largely addressed
only his own firm and did not represent other manufacturers.

In the 2006--07 season, Dr. Johnson said, sanofi pasteur supplied some
53 million doses of vaccine in various presentations, exceeding their
goal of 50 million doses. Based on publicly available data, this
represents approximately 53 percent of the doses from all manufacturers.
Although vaccine was distributed to all market sectors, 90 percent of
the company's vaccine doses went directly to "end users," thereby
limiting their shelf time.

Currently, sanofi pasteur is investing \$150 million in a new production
facility that will double capacity when it comes on line in the 2008--09
season. When asked if the plant were based on cell-based production
technology, Dr. Johnson said that while it would be convertible to the
new technology, the present design was for the current egg-based
production.

Given that "fill and finish" is a limiting step in the rate of
production, this area is one of particular focus in the new facility.
Dr. Johnson stated that the fill and finish capacity of the new facility
is predicated on the limiting case---producing single-dose,
preservative-free units.

Next, Dr. Johnson reviewed the vaccine production process citing a
figure from an article by Dr. John Treanor in the *New England Journal
of Medicine*. Each year's vaccine is specific to the three dominant
circulating strains, determined by global surveillance. Seed viruses are
distributed by the FDA in the January/February timeframe.

The next step is incubation of the individual strains. This begins as
early as January, before actual announcement of vaccine strains for the
year, based on best estimates of the worldwide influenza pattern. It
generally runs at least through July.

In June through October, the individual strains are harvested, purified,
inactivated, and subjected to quality control procedures. At this point,
the inactive strains are combined, and individual batches are submitted
to the FDA for testing and release approval. Upon release of each batch,
fill and labeling of presentation units can begin and continues, in most
cases, through December. In reality, late production actually "bumps up
against" early production for the following season.

Typically, the first units are shipped in mid-August. Delivery this year
was delayed until August 23 due to two strain changes that occurred
during production and initially low yields of one of the strains
(A/H3N2) until better seed viruses were distributed. There is no
"warehousing" of vaccine---batches are distributed immediately upon
receiving approval.

Based on its years of experience, sanofi pasteur now employs a
"prebooking" system. This is done in January/February and comes after
early and frequent communication with customers. During the 2006--07
season, the company received more than 400,000 calls during the first
hour of prebooking, swamping the telephone ordering capacity, which had
been doubled in anticipation of increased demand. Online ordering
through the company Web site also was overwhelmed.

This year, sanofi pasteur has instituted an "early reservation" system
for return customers before, and in addition to, the prebooking period.
Not only will this ease the burden of taking order, but it also will
give early indication of the needed distribution of vaccine
presentations as customers respond to new State regulations in a number
of instances.

Customers confirm prebooking requests in June/July. Mr. Ross added that
sanofi pasteur now ships all orders in three installments (except for
orders of less than 230 total units). While a number of customers have
complained about this policy, the company finds that it works to ensure
all those who administer the vaccine have supplies in hand for early
vaccination of high-risk patients.

***Discussion***

There was a general discussion among attendees regarding the "bigger
picture" of vaccine distribution and availability. Dr. Greg Wallace of
CDC said that he viewed both production and distribution as limiting
factors in getting vaccine to customers. In response, Dr. Johnson said
that while that might well be true for CDC, sanofi pasteur does not see
distribution as a factor that limits their distribution of their
products.

Dr. Abramson stated that for most end customers who actually administer
the vaccinations, the supply process is complex. States and even other
levels play a role in distribution delays. An attendee observed that
these complexities make it almost standard customer practice to order
vaccine supplies from multiple sources.

Dr. Baylor stated that in his opinion, the production timeline was as
tight as it could be at present and that current efforts to resolve
vaccine availability issues are aimed at extending the vaccination
period.

Dr. Johnson observed that fickleness of demand is a factor in the
perceived vaccine shortages. He agreed that customer education on the
fact that the product changes each year, on the distribution process,
and on what is an appropriate administration schedule could help allay
customer concerns. He stated that the advertising and information
efforts for the 2007--08 season by his firm alone had been measured at
making more than 510 million customer impressions.

In response to a question, he said that sanofi pasteur sets their
product prices at the start of each year's cycle and does not change
them in response to demand variances over the course of that year. He
also raised the point that current practice is to inform customers of
their estimated window for a particular shipment a few weeks in advance
based on "worst case" estimation of the vaccine's release date and then
to confirm the actual shipment. Mr. Ross said that while many customers
try to demand an exact shipment date, to do so would only slow down the
process.

In summary, Dr. Johnson said that vaccine production into the fall would
continue to be the reality for the years ahead. He added that in spite
of excitement regarding cell culture production technology by some, it
would not markedly shorten the production cycle, although it might
result in some increase in surge capacity. In part, this is the result
of sanofi pasteur's already having assured their egg production
supplies.

***GSK Influenza Vaccine Production and Distribution, 2007---Ms. Laurie
Showalter***

After thanking the subcommittee for having extended her the invitation
to speak, Ms. Showalter presented a brief overview of GSK's production
and distribution processes. She stated that her firm has two production
facilities, one in Dresden, Germany, for Fluarix and a second in Laval,
Canada, for Flulaval. The latter is the result of GSK's acquisition of
another company and was recently approved by FDA. She stated that while
the two products are not identical, they do share a common profile.

***Discussion***

Distribution of Fluarix is directly from GSK and includes online
ordering. Flulaval, on the other hand, is entirely through physician
supply houses, employing distribution agreements inherited with the
purchase of the brand. When asked about the future of these agreements,
Ms. Showalter said that she was confident they were under review, but
could not specify whether future changes could be expected. She also
stated that use of the supply houses for distribution did not markedly
extend the distribution timeline.

At this point, the discussion returned to efforts underway to extend the
vaccination season and to overcome perceptions that administration even
into the next calendar year would be "too late." When asked about the
possible effects of a "no return" policy, Mr. Ross stated that sanofi
pasteur had such a policy and strongly enforced it, clearly sending the
message to those administering the vaccine that it was not too late to
use supplies on hand. He added that customers are allowed to cancel
orders upon notification of impending shipment, and this sometimes
occurs if the customer has intentionally ordered from multiple sources.

One attendee stated that "a message that needs to be hammered home" is
that the flu season usually peaks after January. This might help prevent
what is now a common occurrence---unvaccinated high-risk patients being
seen by healthcare providers who have unused vaccine in their
refrigerators.

The observation was made that campaigns to impose priorities on the
vaccination pattern, for example "Kids First," might well work contrary
to the existing goal of universal vaccination. With this in mind, the
current practice of early vaccination for self-identified candidates
should continue, and greater efforts should be made to reach additional
at-risk populations. The opinion was expressed that focusing solely on
the public sector would not have a great impact on the current overall
pattern of vaccination.

Summarizing the discussion so far, Dr. Gordon stated that the security
of supply of influenza vaccine is increasingly ensured by increased
aggregate production capacity of manufacturers---with the caveat that a
pandemic calls for an entirely separate discussion. Also, there is a
continuing trend toward recommending universal vaccination, and
manufacturers will always move to meet increased demand. Increases will
come in "fits and starts" and time lags however.

The question was raised as to whether the match between current
projected increases in demand and production was being studied. The
observation was made that international markets are also a significant
factor for manufacturers. The response to the question of extending the
use of a particular year's vaccine formulation into the next season
should the need arise was that this practice would be "very unlikely,"
although Dr. Baylor commented that there was historical precedence for
this if bulk remained, there was no strain change and stability data
that supported extension to the next season.

Dr. Gordon stated that the consensus seemed to be that inefficiencies in
the supply chain were the cause of perceived vaccine shortages and not
the manufacturers. One observation was that one practice that could
improve distribution in the public sector would be authorization to use
private sector vaccine supplies until such time as public sector
supplies became available.

Finally, the observation was made that the vaccination process was made
even more difficult by the fact that formulations from different
suppliers have different usage recommendations, which sometimes can be
overlooked by those administering vaccinations. Dr. Baylor stressed that
these differences were most critical in adhering to the guidance on
lowest age limits for vaccination.

Dr. Dekker thanked the presenters and attendees for their participation
in the discussion and then announced a short break, after which the
subcommittee would discuss the draft of a paper on vaccine dose
optimization strategies through use of adjuvants and other technologies.

***Vaccine Dose Optimization Strategies through the use of Adjuvants and
Other Technologies: Draft Document---Dr.*** ***Cornelia Dekker***

In opening the discussion of the draft document that had been
distributed to subcommittee members, Dr. Dekker pointed out that the
decision was made to focus on dose optimization because excellent
reviews on the adjuvants themselves had already been published. After
briefly reviewing the current draft's contents, she mentioned that if
the forthcoming report was not approved at the next meeting, a notice in
the *Federal Register* soliciting comment would be required.

One suggestion was that the last table describing adjuvants that have
already been evaluated in humans is most valuable, but that it should be
expanded to include columns on mechanism of action and safety
considerations. It was agreed that the expanded table could be generated
in "landscape" format, and that a smaller table on adjuvants yet to be
tested in humans would be included.

The question was raised as to how often any publication from NVAC would
need to be updated and the observation made that any recommendations
would need to be in an NVAC publication and not merely in academic
publication.

The recommendation was made that the section on the research agenda
should be broadened to specify what government agencies should be doing
to support the research. With that in mind, it is important to know what
agency support already exists. Liaison members from NIH, FDA, and CDC
agreed to supply that information for the next draft of the report. It
was stated that it is highly unlikely that industry would sponsor "mix
and match" studies of adjuvants and vaccines from different
manufacturers.

Dr. Baylor pointed out that regulatory issues have yet to be resolved
but that discussions of potential studies are already under way.
Reference was made to intradermal administration studies being conducted
by NIH and CDC and that NIH had supported studies of CpG and other
adjuvants in the pipeline.

The recommendation was made to include forward-looking data in the
report in addition to the table of human-tested adjuvants already
described. Information from the FDA on existing efforts could be
included in the report text. Dr. Baylor stressed that product approval
must include all aspects of that product, citing the example that
approval of administration of a specific adjuvant/vaccine via patch was
not approval of the adjuvant/vaccine combination in other application
modalities. He added that each antigen/adjuvant combination would have
to be treated as a new product; however, manufacturers can be given
credit for data on clinical studies conducted with different antigens.
Subsequently, he mentioned the "6-month" lower age barrier and
administration to pregnant women as specific issues requiring attention
in adjuvant research.

One member stated that Investigational New Drug and Emergency Use
Authorization regulations could be applied in event of a pandemic. This
led to the question of whether the paper under discussion should be
focused on pandemic flu, and it was agreed that it should not.

Dr. Baylor stated that the FDA is increasing efforts to assess
postmarketing effectiveness. With that in mind, what really is needed in
this research area is a better understanding of immunization mechanisms
and of *in vitro* methods to predict potential toxicities. This would
support both better prediction of safety profiles and rational product
development. Immunopathology of both product and subject should be
addressed.

The question arose as to whether "logistical preparedness" should be
emphasized in the paper. No conclusion was reached, as information from
CDC on current efforts would drive this decision. In any case, quality
control considerations could be an issue.

With regard to increased funding of pediatric studies, it was stated
that such studies by NIH would depend on the specific adjuvant and what
knowledge presently exists on it. It was mentioned that Vaccine and
Treatment Evaluation Units are subject to NIH priority and that while
they are available to companies, they are not used by some
manufacturers. Dr. Dekker said that she and Jenny Salesa would
incorporate comments into a next draft of the report and return this to
subcommittee and liaison members for another round of comment.

On a different topic, Dr. Schwartz appealed to the members to help
support a proposal to apply available NVPO unmet need funding to a
single "large focus" issue each year, thereby improving the program's
overall impact. He stated that the first such issue to be identified was
the need for a Methicillin-resistant Staphylococcus aureus *(*MRSA)
vaccine and encouraged the members to talk about how to stimulate this
effort upon returning to their agencies.

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

**Attendees:** Emma English, NVAC; Jaime Fergie, NVAC; Deborah Gust,
CDC/NIP; Mary Beth Koslap-Petraco, NVAC; Shelly Krycia, GSK; Deborah
McFalls, ORISE; Trish Parnell, NVAC; Kristine Sheedy, CDC/NCIRD; Jim
Singleton (by phone), NCIRD; Philip Smith, CDC/NIP; Dick Tardif, ORISE;
Lois Goodstein, notetaker.

Dr. Humiston began the Subcommittee meeting by welcoming attendees and
presenting the agenda. She reviewed the charge of the Subcommittee to
make recommendations to the general NVAC Committee regarding routine,
quantitative evaluation of parental knowledge, attitudes, and beliefs
toward childhood (and possibly adolescent) immunization.

Dr. Humiston cited five reasons why it is important to support the need
for the U.S. immunization program to take the pulse of its citizens:

-   Identifying the public's level of knowledge allows public health
    groups to provide them with appropriate immunization education.

-   Discovering what the public's primary concerns are at any given time
    assists public health groups in targeting and making more effective
    our public health messages.

-   Understanding public opinion could help shape effective public
    policy.

-   Listening to people's concerns demonstrates respect for those
    individuals.

-   Public consultation helps to ensure public cooperation in the
    resolution of a problem; e.g., raising vaccination rates.

####### The goals of starting such a program will be to 

-   Identify the public's level of knowledge, understanding, and
    concerns so that public health and other groups can better

    -   Provide the public with appropriate immunization education

    -   Target and make more effective public health messages

    -   Shape effective public policy

-   Listen to people's concerns to demonstrate respect for those
    individuals

-   Help to ensure public cooperation in the resolution of a problem,
    such as raising vaccination rates

-   Use results from this surveillance to

    -   Publish/communicate them broadly

    -   Encourage studies of implementation of lessons learned from this

    -   Implement best practices in communication at all levels of the
        healthcare system

These are the immunization topics for which it would be useful to
discern public opinion regularly:

-   Public's knowledge/awareness of

    -   New vaccines and the intended recipient age groups for those
        vaccines

    -   Vaccination schedules

-   Public's perception of

    -   The need for various vaccines for the individual or the
        individual's family members

    -   Risk/benefits for each vaccine

    -   Risk/severity of vaccine-preventable diseases

    -   Opinions/concerns about other vaccine delivery system
        satisfaction issues such as cost, availability, and immunization
        information systems and vaccine receipt within the medical home

The periodicity with which the public should be consulted on these
matters:

-   It would be preferable to survey at least twice each year.

-   It would be acceptable to survey at least once each year.

***The National Immunization Survey: An Overview of Data Pertaining to
Public Concern---Dr. Philip J. Smith, CDC/NIP***

Dr. Humiston introduced Dr. Philip Smith, whose presentation comprised
the background and scope of the NIS and how it can be instrumental in
fulfilling the Subcommittee's charge.

NIS is a surveillance service that collects annual data by telephone on
vaccination coverage among children 19 to 35 months of age. Results are
published by various criteria (e.g., geographic area; landmark ages;
child, maternal, and household characteristics) and show how vaccine
coverage varies according to parental attitudes and relationships with
their provider. Dr. Smith emphasized that there is a great deal of
variability from State to State and from county to county and that we
must make a nationwide policy relevant and useful to everyone. He also
pointed out that because this service collects data from parents only,
we do not have data on what providers' attitudes are on this subject.

Dr. Smith cited research on several determinants of vaccine coverage:
Safety, perceptions about safety and influence by healthcare workers,
information about next immunization and possible side effects, laws,
temporal events (e.g., concerns about mercury affecting hepatitis B
vaccination), and the history of a particular vaccine. He also gave
examples of the questions that would generate the longitudinal data
necessary for routine, quantitative evaluation. A key part of Dr.
Smith's presentation was the timeline of events leading to receiving
data in 2009 for publication in 2010. Because questionnaire development
is scheduled to take place in March and April 2007, he stressed the
importance of NVAC and CDC working together now to meet that goal.

***Discussion***

Discussion ensued about the overview of the proposed system, how the
information would be obtained, and how the results would be reported. Of
particular importance was how the Subcommittee could aid the process of
creating this important tool. Dr. Humiston pointed out that right now,
this type of longitudinal surveillance is not being conducted. There are
small, ad hoc, unrelated looks being done without a coordinated plan of
how they are to be carried out, implemented, and disseminated.
Identifying longitudinal trends is the most valuable tool, and an early
warning system and respect for the public are essential.

Dr. Smith talked about the importance of obtaining the data when the
children are vaccinated, not in hindsight. Dr. Dick Tardif suggested
that the Subcommittee might have to rely on tools other than NIS for
qualitative input. Ms. Koslap-Petraco added that library programs are
great support systems for parents in her community of Suffolk County,
NY. Dr. Jim Singleton added that perhaps an MMWR article would be a
quicker way to turn data around.

Dr. Smith addressed the issue of modules, what has been done in the
past, and whether modules can be revised during the year. Ms. Parnell
asked Dr. Singleton about the cost of adding a teen module for the next
5 years; he noted that the cost lies largely in getting people on the
phone. Additional questions can just be incorporated into the core
survey rather than creating an additional module.

Dr. Humiston stressed the importance of keeping the purpose/desired
outcomes in mind when crafting the modules. One of the goals of this
Subcommittee is to determine how to influence rapid looks at "hot"
topics.

There was some discussion about the feasibility of obtaining Dr. Deborah
Gust's research results to be used by the Subcommittee and whether the
NVAC Web site would benefit from posting those results. Ms.
Koslap-Petraco stressed the importance of building on Dr. Gust's
materials. The information garnered from this surveillance of parents'
attitudes has to be published in public forums so that other groups have
access to these data. It is essential to communicate the work that is
being done, and some discussion ensued about the best way to do that. A
future goal of the Subcommittee is to craft a second recommendation for
adolescents.

Action Items:

-   Dr. Smith will send an e-mail by February 15 with a thorough menu of
    topics and questions about knowledge, attitudes, and perception.
    Those topics will be circulated. A conference call was scheduled for
    February 26 at noon, e.s.t., to discuss those topics and decide
    which ones should be included in the surveillance.

-   Dr. Humiston will put together a recommendation to be presented at
    the June meeting suggesting that this become a long-term
    surveillance process rather than another ad hoc look.

-   Dr. Humiston will draft some ideas about the revision of the goals
    and objectives of the 1994 National Vaccine Plan (blue book). She
    will circulate them via e-mail by March 12 and include a due date
    for responses. Dr. Tardif noted that the Assistant Secretary
    indicated that the draft will be out by the end of the year, but
    there is no specific timeline as yet.

-   Ms. Parnell agreed to coordinate the publication of information on
    the Web site.

***White Paper Data Collection Process---Ms. Deborah McFalls, ORISE***

Ms. McFalls has developed a survey to collect data from key informants
for a white paper the Subcommittee is writing. It concerns providing
effective opportunities for ongoing dialogue with the public on vaccine
and immunization issues. The white paper will explore multiple
communication methods (communication, consultation, and participation)
for increasing the public's involvement in the decisionmaking process
for policy development.

Indepth questions will be asked of nine people---experts in vaccine
communication/public engagement issues---on the telephone. Ms. McFalls
indicated that the conversations would be taped and that the informants
would have the questions in front of them. She discussed the OMB
regulations about conducting surveys and indicated that she would like
to pilot test the survey on one or two people.

Ms. Parnell suggested inclusion of examples of the definitions of the
terms for the questionnaire; i.e., communication, consultation, and
participation.

Action Items:

-   Members will send their comments about the questionnaire to Ms. Emma
    English by February 12.

-   Ms. English will compile the comments and send them to Ms. McFalls
    along with a list of potential key informants to contact.

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

Attendees: John Iskander, Immunization Safety Office, ISO; Kenneth Bart,
NVPO; Karen Broder, ISO; Robert Davis, ISO; Renata Engler, DoD; Mark
Feinberg, NVAC; Geoffrey Evans, HHS; Gary Freed, NVAC; Andrew Pavia,
NVAC; Erica Johnson, APCO Worldwide; Kristin Pope, CDC; Stephanie A.
Russell, AAP; Ann Strauss, Wyeth; Lynne Sweeney, GSK; Melinda Wharton,
CDC; Anthony Dvarskas, notetaker.

Dr. Pavia began the Subcommittee meeting at approximately 9:05. He
outlined the key topics for consideration during the Subcommittee
meeting, including the review process at CDC and the role of NVAC.

***Role of the Immunization Safety Office---Dr. Robert Davis***

Dr. Davis started with a brief overview of the role of the Immunization
Safety Office (ISO) at the CDC. He indicated that a significant amount
of time was spent clarifying the vision of ISO during 2006. The goal of
the committee is to perform surveillance and high-quality research for
CDC vaccine activities and communicate findings in a clear and
transparent manner.

He said that new vaccines are coming through a very large pipeline, but
efforts are continuing to understand the safety of older vaccines. The
ISO is focusing increasingly on adolescents and adults and has increased
study of rare adverse events. Public safety is an ongoing challenge and
vaccines on cancer and chronic diseases will be of tremendous interest.

Dr. Davis explained that there are basically four large projects and
networks: VSD, Vaccine Adverse Event Reporting System (VAERS), CISA, and
the Brighton collaboration. He explained that in his work as Director he
has worked to build relationships between the units and demonstrate how
these work together to the outside world. VAERS generates the signal,
VSD allows hypothesis testing, CISA evaluates underlying biologic
characteristics, and Brighton provides case definitions.

Strategies for the future include creating a strategic panel for ISO and
establishing broad input into the ISO research agenda; an external
advisory board based in NVPO could serve this purpose. Scientifically,
ISO is looking at active surveillance of new vaccines with real-time
assessments, working on pandemic influenza preparedness, and continuing
to evaluate rare adverse events.

***Discussion***

COL Engler indicated that she would like to see the DoD incorporated as
a fifth piece of the structure since DoD is unique in some ways from
CISA. DoD has some very unique aspects for drug safety and has been
actively involved in development of new case definitions.

Dr. Pavia followed on this by asking about the integration of ISO with
other entities, such as DoD, industry-based safety initiatives, and the
National Institutes of Health. Dr. Davis said that it seems that ISO
needs to add the lines for connections that go outside the office.

Dr. Feinberg raised the question of whether there are employees within
ISO dedicated to communication and policy. In response, Dr. Davis
indicated that Ms. Kristin Pope heads work on policy and communications
and develops appropriate crafting of messages. One participant commented
that with vaccine messages it is necessary to be careful to balance any
advocacy slant for vaccines with input from science experts. Dr. Pavia
said that external review of what is happening may be useful; next time
there is a crisis, can conflict of interest stay out of the message and
communication still occur effectively?

Some discussion occurred about the differentiation of risk
analysis/assessment and risk management. Dr. Davis said that ISO has
dedicated significant efforts to clarify that ISO is a risk
analysis/assessment group. He pointed out that Dr. Melinda Wharton's
group deals with risk management aspects.

A guest in the audience asked about the value of the Web site in
communicating messages. Dr. Davis said that the risk assessment portion
has gone fairly well although there have been some challenges
communicating with the outside world. Ms. Pope indicated that one of the
challenges with the Web site has been that CDC is revamping its Web
site. As the Web site is developing, efforts are underway to keep risk
assessment separate from risk management and avoid duplication of
efforts between Web sites, and input into this from NVAC members would
be helpful.

***Development of ISO Research Agenda---Dr. Davis and Dr. Karen
Broder***

Dr. Davis began by introducing Dr. Broder who is the Acting Science
Advisor and has helped ISO develop a draft agenda. He explained that, in
February 2005, the Institute of Medicine (IOM) recommended that a
Subcommittee of NVAC be developed to include representatives of a wide
variety of stakeholders and provide advice on the VSD research plan. ISO
has expanded the research agenda beyond VSD since CISA works
hand-in-hand with VSD. He proposed the following four-stage development
process. Step 1 would entail developing briefing materials/studies and
background materials about the program that would be distributed to a
number of groups for input (CDC peers; an external scientific
consultancy composed of six peer-recommended scientists, 1
peer-recommended academic lead, and Dr. Pavia as the NVAC liaison; other
HHS agencies; CDC partners). The external scientific consultancy meeting
will take place in May 2007 in Atlanta, and the report from that meeting
will assist in guiding the research agenda. Output of step 1 would be a
draft that would be provided to NVAC for review by the public and
additional stakeholders in step 2. The input from this review would be
used in step 3 to finalize the document. The fourth step would be
lessons learned and evaluation of the process. The research agenda would
focus on a 3- to 5-year time horizon, although the horizon length is
open to discussion.

***Discussion***

Subcommittee and audience members began with a discussion of the role of
industry in the development of the research agenda. Dr. Feinberg said
that the points where industry expertise could enter do not seem
apparent. Dr. Davis clarified that ISO would be very interested in input
from industry during the scientific and public review process; NVAC
review would provide the venue for all external partners. Other
participants from ISO confirmed that they value and recognize the work
of safety monitoring conducted by pharmaceutical companies.

Dr. Pavia commented that partners are acknowledged in multiple places,
but it is not completely clear how the collaboration will work. Related
to this topic, Dr. Broder asked how important it would be to have every
stakeholder represented in the step 1 since there will be NVAC review at
step 2. Dr. Feinberg commented that industry input might be most useful
in the initial phases; otherwise industry is simply responding to the
review process, and this could lead to a more adversarial discussion. He
indicated that a venue for including industry may be the Pharmaceutical
Researchers and Manufacturers of America or the Biotechnology Industry
Organization.

The Subcommittee discussed the need to include other partners in the
consultation schema and diagram for the initial research agenda
development steps. Dr. Pavia suggested that a "CDC Partners" group may
need to be included in the schema in the early development step 1 phase.
Dr. Broder stated that if industry is included in step 1 of the schema
in the initial phases, it would be necessary to determine whether the
public should be engaged at that time is well. She also added that the
input would most likely be in the form of written comments, similar to
scientific journal review. COL Engler commented that she was concerned
that DoD seemed to be mentioned as an afterthought; service members
receiving novel vaccines and new formulations need to be an upfront part
of the process. Responding to these concerns, Dr. Davis reiterated that
this is a developmental process, and he recognizes the need to get input
from DoD and industry.

Dr. Pavia commented that the agenda and projects of other partners could
be important in providing a context as ISO works to develop its research
agenda. Ms. Pope indicated that ISO still needs assistance in sorting
out the critical parties to address in step 1. She mentioned that it may
be a mistake to combine DoD and industry with the public as there would
be a difference between those giving opinion versus those who are
collaborators. Dr. Bart agreed that significant scientific information
might not come from the public; instead it may be most appropriate for
them to react to what scientists collaborate to develop. Dr. Feinberg
pointed out that this process is an opportunity for figuring out how
many of the vaccine safety elements can fit together. Dr. Pavia stated
that it is critical to integrate opinions to develop an agenda and also
have some reference to potential additional issues in order to
demonstrate that ISO is not operating in a vacuum.

***Role of NVAC in Development of ISO Research Agenda*---*Dr. Andrew
Pavia***

Dr. Pavia began with an outline of several key questions concerning the
role NVAC should have in the ISO research agenda development:

-   Is this an appropriate role of NVAC?

-   What resources are available and how does this contribute to the
    overall answers?

-   Once we decide to do review, what is the public and scientific
    composition going to be?

-   What would the output be besides 2 days of commenting on the draft
    plan and sending it back to the public? Would there be something
    that the public could get into their hands that would be useful?

***Discussion***

Dr. Evans said that NVAC should clearly be involved with this process.
Dr. Davis said that it may be advisable for ISO to develop items where
they would specifically like feedback, and NVAC could specify concerns
that they have about the agenda. Dr. Bart commented that it is important
to remember that NVAC is made up of people of varying disciplines so
focused questions are useful to stimulate discussion and keep the
conversations relevant. He emphasized that it would be important to
remember that part of the IOM mandate involves public input, and
consequently, plans would be needed to determine how NVAC and the CDC
would approach the public input mandate.

The Subcommittee discussed the structure through which NVAC would gather
scientific input and have public engagement. Dr. Pavia raised the issue
by asking if ISO expected NVAC to play the role of an external
scientific advisory board or if it expected NVAC to meet all of the IOM
requests for public engagement. Dr. Davis said that the type of meeting
that will take place is important to consider; would it be public only
or the public and scientists, an NVAC meeting or an NVAC Vaccine Safety
Subcommittee meeting, or both. Dr. Broder said that she thought of
arranging the input process along the lines of a scientific meeting
rather than a typical public engagement meeting; the exact mechanisms by
which NVAC would conduct this could be determined by NVAC and NVPO, and
formation of a new Subcommittee could be possible. Given the limited
number of scientists on NVAC, several participants suggested formation
of a Working Group within NVAC that could provide scientific expertise
and feedback into the agenda; the Working Group meetings or larger NVAC
meetings could play the role of public involvement. Subcommittee members
appeared to agree on having a meeting process focusing on scientific
advice that would be open to the public.

Following this discussion of the format for the meeting, the
Subcommittee discussed the scope of the research agenda. Dr. Evans said
that prioritization would be one of the key steps to undertake. Dr. Bart
commented that there seem to be two possible paths: (1) Say what is
possible with what money is available and prioritize or (2) have a
visionary agenda with more items and then seek additional funding. Dr.
Broder suggested that ISO would like to be visionary in thinking about
the research agenda and then say what can be done keeping financial
constraints in mind. There seemed to be agreement that NVAC could bring
back a broad vision and then provide input into prioritization given its
inclusion of varied stakeholders for each potential subject area.

Dr. Pavia suggested that draft ideas for prioritization would be
important to have to avoid having a simple brainstorming session. It may
be beneficial to begin sharing an outline of what the chapters of the
draft research agenda would be. Dr. Broder said that the framing
questions that independent consultants use when providing input may be
useful in designing the interaction with NVAC moving forward. She
indicated that ISO is trying to learn from the CDC experience about what
to consider when assigning prioritization.

Completing the discussion about the scope of the agenda, the
Subcommittee discussed who and what would be needed in the process. Dr.
Broder suggested that some of the people considered for the external
scientific consultancy may be appropriate, and Dr. Pavia suggested
asking IDSA, agencies, and departments to propose people based on their
scientific knowledge. The Subcommittee developed the idea of a 10- to
15-person Working Group, with a meeting published in the *Federal
Register*, which would discuss the science and also allow time for
public input. There seemed to be agreement that a representative of the
public as well as a scientist proposed by advocacy groups should be
included in the Working Group. Dr. Bart felt that additional guidance is
needed about who should be on the Working Group and what the
expectations would be.

The Subcommittee returned to a discussion about the meeting logistics,
and there was some concern that one meeting would not be sufficient and
that unstructured feedback would not result in thoughtful comment. Dr.
Broder said that a potential meeting format might be to have breakout
groups about various topics that would mix the scientists and public.
Dr. Davis added to this, saying that the morning presentations at the
meeting could present the context for the agenda, followed by the areas
that ISO wants to focus on in the agenda, and conclude the day with a
series of breakout group sessions on specific topics. The second day
could consist of reports back to the assembly with
recommendations/prioritizations and time for public comment at the end
of the day. If the meeting only addresses the scientific review, it
seems to miss the IOM's public engagement recommendation. It may be
feasible to have some of the meetings closed and some of the meetings
open, and Dr. Pavia mentioned the idea of having Working Group members
meet in closed session to develop recommendations with technical
writers.

Ms. Pope said that it would be important to clearly articulate upfront
what the public expectations should be. Dr. Bart added that trust needed
to be assured, and the audience could not feel like they had been
cheated.

The Subcommittee concluded with some discussion concerning the timing
and interfacing with NVAC in its role in the ISO research agenda. Dr.
Broder suggested the possibility of discussing handover at the June 2007
NVAC meeting. Dr. Pavia said that ISO can present an update about how
the process has progressed to NVAC in June for discussion with the whole
Committee. He also proposed doing several Subcommittee conference calls
between now and June to discuss progress. ISO could prepare a PowerPoint
slide draft that indicates a list of key questions that ISO is asking
NVAC about the research agenda and that could be used to help formulate
the group and develop input for the research agenda. Dr. Davis said that
after presenting their agenda, ISO would like to know if it hit the mark
or what additions/subtractions NVAC suggests to the first attempt.

With no further comments, the Subcommittee meeting adjourned at 12:00
p.m.