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**National Vaccine Advisory Committee (NVAC)**

**October 22--23, 2007, Meeting Minutes**

[Meeting Overview]{.underline}

The Committee heard presentations on a variety of issues and received
reports from Subcommittees and Working Groups on both days of the
meeting. Several presentations focused on aspects of adult immunization
(such as vaccination coverage among adults and attitudes about, and
barriers to, adult immunization). The first day of the meeting also
featured a report from the Adolescent Immunization Working Group and
presentations on the National Vaccine Plan, the Vaccines for Children's
(VFC) pediatric vaccine stockpile, and the draft Pandemic Influenza
Vaccine Prioritization. In addition to reports from agency, department,
and stakeholder liaisons, the second meeting day featured a report from
the Vaccine Financing Working Group as well as each of the three
Subcommittees.

[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.

Richard D. Clover, M.D.

Mark Feinberg, M.D.

Jaime Fergie, M.D., F.A.A.P.

Lance K. Gordon, Ph.D.

Sharon G. Humiston, M.D., M.P.H.

Charles Lovell, Jr., M.D., F.A.C.P.

Christine Nevin-Woods, D.O., M.P.H.

Trish Parnell

Andrew 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 Baylor, M.D., United States Food and Drug Administration (FDA)

Neal Brandes, United States Agency for International Development (USAID)

George Curlin, M.D., National Institutes of Health (NIH)

Geoffrey Evans, M.D., Health Resources and Services Administration
(HRSA)

Jeffrey A. Kelman, M.MSc., M.D., Centers for Medicare & Medicaid
Services (CMS)

Rear Admiral (USPHS) Anne Schuchat, M.D., Centers for Disease Control
and Prevention (CDC)

Ronald O. Valdiserri, M.D., M.P.H., Department of Veterans Affairs (VA)

[Liaison Representatives]{.underline}

Ruth Karron, M.D., Vaccines and Related Biologics Products Advisory
Committee

Wayne Rawlins, M.D., M.B.A., America's Health Insurance Plans (AHIP)

Alan Tom, Public Health Agency of Canada

[Committee Members Absent]{.underline}

Cornelia Dekker, M.D.

Calvin Johnson, M.D., M.P.H.

[Invited Speakers]{.underline}

Dr. Faruque Ahmed, CDC

Alina Baciu, Institute of Medicine (IOM)

Nancy Fasano, CDC

Dr. David R. Johnson, sanofi pasteur

Dr. Jeffrey A. Kelman, CMS

Dr. Gina T. Mootrey, CDC

Dr. Benjamin Schwartz, NVPO

James A. Singleton, CDC

Dr. Raymond A. Strikas, NVPO

Dr. Gregory S. Wallace, CDC

**Day 1---October 22**

**Opening Session---Dr. Gary L. Freed**

NVAC chairman Dr. Gary L. Freed welcomed Committee members and public
participants. Dr. Freed announced the resignation of the Assistant
Secretary for Health, Dr. John Agwunobi, and proposed that all NVAC
recommendations be funneled through Dr. Bruce G. Gellin (Executive
Secretary of NVAC). As the first order of business, Committee members
unanimously approved the May 11 and June 7--8, 2007, NVAC meeting
minutes.

**Presentation of Certificates of Appreciation to Outgoing Members and
Introduction of New Members---Dr. Gary L. Freed and Dr. Bruce G.
Gellin**

Dr. Freed welcomed two new members to NVAC, Dr. Christine Nevin-Woods
and Dr. Richard D. Clover.

Dr. Gellin presented outgoing members Dr. Alan R. Hinman and Ms. Mary
Beth Koslap-Petraco with a token of appreciation. The Committee is
continuing to look for new members to fill spaces that will become
vacant in March, and Committee members are encouraged to submit
nominations.

**Adult Immunization Session**

***Overview of Issues---Dr. Raymond A. Strikas***

Dr. Raymond A. Strikas began the session on adult immunization by
reviewing the Healthy People 2010 adult immunization objectives. A
midcourse review of the Healthy People 2010 objectives was conducted,
and changes were made. Several areas of chapter 14 of the Healthy People
2010 objectives focus on vaccination; specifically, sections 14-22
through 14-29, which contain the adult immunization objectives.

The first adult immunization objective of Healthy People 2010 (14-28) is
to increase hepatitis B vaccination coverage among three high-risk
groups---long-term hemodialysis patients, men who have sex with men
(MSM), and occupationally exposed workers. The objective requires that
occupationally exposed workers be offered hepatitis B vaccine at no
cost. This was mandated by the Occupational Safety and Health
Administration in 1990 and explains why coverage rates are higher with
occupationally exposed workers than with the other two high-risk groups.

The next adult immunization objective of Healthy People 2010 (14-29) is
to increase the proportion of adults vaccinated against influenza and
pneumococcal disease. During the midcourse review of the Healthy People
2010 objectives, part G of objective 14-29 was added to increase the
proportion of healthcare workers who receive the influenza vaccine.
However, statistics regarding influenza vaccination in healthcare
workers have not improved much since 2000.

Dr. Strikas reviewed NVAC's efforts to address issues of coverage in
reports from 1990 to 2005. He believes NVAC should review the status of
adult vaccination coverage and attitudes about---and barriers to---adult
immunization. He also suggested NVAC consider forming an Adult
Immunization Working Group and that the Committee review financial
barriers to vaccination and programmatic approaches for improving
vaccine update during their February meeting.

***Discussion***

In response to a question about how to address the issues identified in
the 1990 and 1994 reports, Dr. Strikas proposed that the Subcommittee on
Immunization Coverage examine current strategies that could be
incorporated into public and private healthcare settings, with no, or
limited, extra resources, to improve vaccination coverage. Dr. Andrew
Pavia suggested the Subcommittee create a report card of the original
recommendations to see which ones failed and which ones had not been
implemented and to identify the barriers to implementation in order to
come up with new recommendations.

Since the release of the 1990 and 1994 NVAC statements, there have been
several big changes related to adult immunizations. Therefore, Dr. Anne
Schuchat believed all strategies to improve vaccination coverage should
be reexamined. Since the initial reports were published, three new
vaccines became available for adults: The Tdap (tetanus, diphtheria, and
pertussis) vaccine, the herpes zoster (shingles) vaccine, and the human
papillomavirus (HPV) vaccine (for women). The annual supply of influenza
vaccine has increased substantially. And thirdly, the impact of indirect
protection of adults through childhood vaccination has been demonstrated
through the huge decrease in the number of cases of pneumococcal disease
in adults since administration of pneumococcal conjugate vaccine (PCV)
in children began in 2000.

Dr. Geoffrey Evans ended the discussion by clarifying that Zostavax, the
herpes zoster vaccine, is not covered under the National Vaccine Injury
Compensation Program (VICP) because it is not routinely used in
children. The same holds true for the pneumococcal polysaccharide
vaccine, the other vaccine given routinely to adults.

***Adult Immunization at CDC---Dr. Gina T. Mootrey***

Dr. Gina T. Mootrey began her presentation by explaining that the
Immunization Services Division (ISD), which is housed within the
National Center for Immunization and Respiratory Diseases (NCIRD) at
CDC, is the division within CDC that primarily coordinates adult
immunization activities. ISD works closely with the Advisory Committee
on Immunization Practices (ACIP).

NCIRD collaborates with each of its branches on various immunization
activities. The Assessment Branch uses various platforms to periodically
assess vaccination coverage, such as the National Immunization Survey
(NIS), the National Health Interview Survey (NHIS), and the Behavioral
Risk Factor Surveillance System (BRFSS). The Education, Information, and
Partnership Branch produces net conferences, satellite broadcasts,
podcasts, and educational materials on immunizations, and the Health
Services Research and Evaluation Branch plans to conduct a focus group
to evaluate the adult immunization schedule.

NCIRD also works with the Immunization Information Systems Support group
to discuss how immunization registries can be used to track adult
immunization coverage. NCIRD provides information, support,
collaboration, and coordination for National Influenza Vaccine Week.
They also conduct seasonal influenza activities and qualitative research
on factors influencing the immunization of healthcare workers and
barriers to vaccination. Within CDC, NCIRD works most closely with the
Division of Adult and Community Health, specifically with their Healthy
Aging Program.

The Center's funding comes from the section 317 program as there is no
VFC program for adults. The section 317 program provides funding for
vaccines that can be used for uninsured and underinsured adults.

[]{.mark}

***Discussion***

Dr. Charles Lovell, Jr., asked why there is such a difference in terms
of CDC's infrastructure for adult immunizations versus pediatric
immunizations. He wondered if CDC considered adult immunizations to be
less important than pediatric immunizations. Dr. Schuchat responded by
explaining that the provider is a very important part of the
infrastructure and that most healthcare providers for adults do not
provide immunizations. She went on to explain that CDC administers the
VFC program and that it is CDC's responsibility to purchase the VFC
vaccines and make sure they get to the providers in both the public and
private sector.

Dr. Pavia noted that the American College of Physicians (ACP) published
the "Green Book" approximately 18 years ago; it contained guidelines on
adult immunizations. He explained that a group of individuals is working
with ACP to try to get them more actively involved in adult
immunizations again. The goal is to work with ACP---and probably CDC and
the ACIP as well---to revise the "Green Book."

Dr. Gary Urquhart (NCIRD) noted that that 70 percent of CDC's grantees
have the capability of tracking adult immunizations.

Dr. Hinman followed up on Dr. Pavia's comments by explaining that it is
his understanding that the ACP is now formally endorsing the adult
immunization schedule, which it had not been doing in the past.

***Adult Immunization at CMS***---***Dr. Jeffrey A. Kelman***

Dr. Jeffrey A. Kelman began his presentation by explaining that CMS has
a two-sided interest in vaccines, Medicaid and Medicare. Medicaid is
usually discussed in terms of the VFC program and section 317 funding;
therefore, the focus of the presentation was on Medicare.

There have been many changes to Medicare this year. Part B, which covers
posttreatment exposure and specific preventive vaccines, will remain
essentially unchanged in 2008. There will be changes under the part D
vaccination program, which includes preventive vaccines.

The part D vaccination program is implemented by independent plans
operating in different regions with different formularies. In 2008, all
commercially available vaccines, other than those offered under the part
B vaccination program, will be required on all formularies. Another
change is that, in 2007, there was a bridge law, which separated the
ingredient payment under part D from the administration payment under
part B; however, next year both payments will be under part D.

Dr. Kelman spoke about three reimbursement approaches in use: The
in-network approach, the out-of-network approach, and the hybrid---or
combined---approach. All three approaches worked during 2007, and CMS
expects the same for 2008.

Dr. Kelman also discussed the Medicare Advantage Plan. Nine million of
the 43 million people who have Medicare are taken care of through the
Medicare Advantage Plan. The Medicare Advantage Plan has the same
requirement about vaccinations and basically offers the same benefits.

Dr. Kelman concluded his presentation by mentioning part D data
elements. With a new data regulation, CMS hopes to have data on the use
of part D vaccines by State.

***Discussion***

Dr. Freed began the discussion by asking who bills Medicare when a
specialty or retail pharmacy sends vaccine to a provider in bulk. Dr.
Kelman explained that the specialty or retail pharmacy bills Medicare
directly but that the dose is billed to the plan at the point of
administration.

Dr. Pavia mentioned that one of the barriers to adult immunization is
complexity in reimbursement. He asked if CMS had any data from providers
about the time involved, the barriers to, or the acceptance of part D
regulations. Dr. Kelman explained that part D is new and that CMS is
still trying to analyze data from 2006. According to one study,
beneficiary satisfaction with the program was at 80 percent as the
program is not as complex for the beneficiary as it may be for the
provider. Dr. Kelman agreed that there was more paperwork with this
program but that CMS is trying to reduce this burden. He also mentioned
that the program came in well under budget.

Dr. Feinberg asked if CMS conducted detailed analysis on how satisfied
providers and patients really are with the part D program as he found
the statistic of 80 percent hard to believe. He was curious as to how
many people were experiencing difficulties and not receiving vaccines
because of barriers. Dr. Kelman explained that CMS would be willing to
change its policies if it meant eliminating barriers. He went on to say
that the survey indicating an 80-percent satisfaction level was done by
an outside organization and that followup surveys are done each year to
look at satisfaction from the consumer point of view.

Dr. Guthrie S. Birkhead expressed concern about the program coming in
under budget as it suggests underutilization of the program. He wondered
if the recommendation should be made for NVAC to measure vaccine
coverage by insurance status and by plan type within the Medicare
program. He expressed concern that the vaccines were not getting to
those who needed them. Dr. Kelman stated that the program came in under
budget due to better pricing and not due to complexity issues or
underutilization of the program.

[]{.mark}

Dr. Jon R. Almquist asked what percentage of adults who qualify for
Medicare elected to have a pharmaceutical plan. Dr. Kelman explained
that in 2005, 40 percent of seniors had no drug coverage; however, this
year less than 7 percent were without drug coverage.

[]{.mark}

***Vaccination Coverage Among Adults***---***Mr. James A. Singleton***

Mr. Singleton described the data sources for population-based estimates
for vaccination coverage among adults. One of the main sources of
vaccination coverage information is the National Health Interview Survey
(NHIS), which is an annual in-home survey of the noninstitutionalized
population in the United States. Data from the NHIS provide national
vaccination coverage estimates on an annual basis. The NHIS is the
official monitoring system for the Healthy People 2010 objectives.

Another source of vaccination coverage information is the National
Immunization Survey-Adult (NIS-Adult). This is a periodic national
telephone survey that was conducted in 2003, 2004, and 2007. The
NIS-Adult provides more timely and detailed information about
vaccinations than the other systems. A third source of vaccination
coverage information was the BRFSS, which provides State-based estimates
on vaccination coverage by way of a random-digit telephone survey.

Mr. Singleton compared the three adult vaccination surveys. In terms of
schedule, the NHIS and the Behavioral Risk Factor Surveillance System
(BRFSS) are annual surveys while the NIS-Adult is a periodic survey done
on an as-needed basis when funds are available. In terms of method, the
NIS-Adult and the BRFSS are conducted over the phone while the NHIS is a
face-to-face survey. In terms of sample, the NHIS and the NIS-Adult are
conducted at the national level while the BRFSS is conducted at the
State level only.

The advantages of the NHIS are that it is a wealth of other health and
access data, it is conducted face to face (and therefore, response rates
are higher), and it includes non-landline households. The advantages of
the NIS-Adult are that more detailed information is obtained on
knowledge and attitudes about vaccination and it is a more flexible and
timely survey. The advantages of the BRFSS are that it provides
State-based information and that it is less expensive to conduct.

Other immunization surveys are being conducted in U.S. affiliated
jurisdictions. These are face-to-face household surveys; for children,
shot and medical records are reviewed to verify immunization status.
These surveys will be repeated in each of the eight areas every other
year.

For the institutionalized population, the National Nursing Home Survey
is used. It is a facility-based sampling frame, in which a knowledgeable
staff person records the immunization status of a sample of residents.
CMS also has the Minimum Data Set (MDS), which provides data on nursing
home residents.

Mr. Singleton also mentioned data sources for the Medicare population,
which include the Medicare Current Beneficiary Survey (MCBS), Medicare
Enrollment and Claims Data, and the Health and Retirement Study. Data
sources for pregnant women include the Pregnancy Risk Assessment
Monitoring System, which includes questions on the influenza vaccine.
One final data source is the National Health and Nutrition Examination
Survey (NHANES). For this survey, blood is drawn to determine serologic
evidence of immunity for various vaccine-preventable diseases.

Mr. Singleton presented estimates of vaccination coverage by vaccine
(tetanus, HPV, MMR, varicella, influenza, pneumococcal, hepatitis A and
B, meningococcal, and herpes zoster) among adults. He noted that even
though influenza and pneumococcal vaccination coverage levels are below
the 2010 Healthy People Objectives, they have been gradually increasing
over the years.

Mr. Singleton then discussed gaps in adult vaccination coverage
assessments. For example, there is a potential bias with telephone
surveys in that they miss wireless-only households. Also, telephone
surveys tend to have a higher number of nonresponders than in-person
surveys. There are also certain vaccines and target groups missed by the
NHIS.

Some priorities for adult vaccination coverage assessments include
keeping the NHIS and the BRFSS current with new vaccines for adults,
periodically assessing the validity of self-reporting vaccines other
than influenza, promoting State use of the BRFSS, and evaluating MDS
data for monitoring influenza and pneumococcal vaccines in long-term
care facilities.

[]{.mark}

***Discussion***

Dr. Lovell commented that one would expect the nursing home population
to have 100 percent influenza vaccination coverage. Mr. Singleton stated
that the main limitation with adult vaccination coverage surveys was
respondents' ability to recall what vaccines they had received. He went
on to note that the NHIS becomes expensive when additional questions are
added. Dr. Schuchat said that the BRFSS is not just an immunization
survey but is used by States for general health planning.

Ms. Trish Parnell expressed concern that there was not much information
on college-age individuals. Mr. Singleton stated that some organizations
such as the American College Health Association conduct surveys but that
that it is very expensive to conduct stand-alone surveys. College
students are missed or are not identified in NHIS and BRFSS.

***Attitudes About and Barriers to Adult Vaccination***---***Dr. Faruque
Ahmed***

Dr. Ahmed began by providing information on studies undertaken to
determine why patients do not seek vaccination. For example, the MCBS
asked patients why they did not get the pneumococcal vaccine. Some of
the most common responses were that patients did not know the vaccine
was needed, the patient's provider did not recommend the vaccine, and
they did not think about vaccinations at all. Another survey, conducted
in 2001, asked patients why they did not receive the influenza vaccine.
A common response was that patients were concerned about the vaccine's
side effects. Others were not offered the vaccine by their provider.
Some thought the vaccine was not effective, and others were not aware
that they needed the vaccine.

Dr. Ahmed reported on the differences among Whites, Blacks, and
Hispanics in terms of their awareness of specific vaccines and the
primary reasons for not being vaccinated. He observed that racial
disparities can be reduced by systematically offering vaccinations. The
most common reasons patients are not vaccinated is because of concerns
about the vaccine, misconceptions about the vaccine, a lack of awareness
that the vaccine is needed, mistrust, and specific cultural/ethnic
issues.

Physicians identified the following barriers to offering vaccines:
Urgent concerns that dominate the visit, not knowing the patient's
immunization history, the patient's concerns about the safety of the
vaccine, and inadequate reimbursement.

Dr. Ahmed went on to discuss some evidence-based interventions for
increasing adult immunization rates. These include provider and patient
reminders, standing orders for adult immunizations, and reducing
out-of-pocket costs for immunizations.

Dr. Ahmed also discussed a study that focused on whether an increase in
payment would encourage providers to adopt new adult immunization
strategies. Providers are more likely to discuss immunization needs if
they have time, if the information is available, and if they have the
operational support to do so.

Studies have shown that individuals with no regular personal healthcare
provider had lower influenza vaccination rates than those with a regular
personal healthcare provider. More Hispanics than non-Hispanics reported
not having a regular personal healthcare provider. Studies have also
shown that individuals with health insurance were more likely to get the
influenza vaccine than those without health insurance. Hispanics were
much more likely than Blacks and Whites to be without health insurance.

***Discussion***

Dr. Adele E. Young asked why people did not trust the influenza vaccine
and what specific side effects of the vaccine worried them. Dr. Ahmed
explained that members of the focus group stated---either from personal
experience or from hearing from others---that they still got the flu
after getting the vaccine. He also observed that compared with other
vaccines, the influenza vaccine seems to have the most problems.

Dr. Hinman explained that one reason people may not trust the influenza
vaccine is because there are many illnesses that are called
influenza---or the flu---that are really not the flu. He also mentioned
being surprised by the statistic that 44 percent of physicians said they
already immunized all eligible patients. He believes that this suggests
that physicians do not realize who their eligible patients are. He
believes that immunization registries can help identify eligible
patients but that physicians overestimate how well they are doing in
terms of vaccination coverage.

Discussion returned to the question of exactly what side effects
patients fear when getting the flu vaccine. Dr. Ahmed responded that
patients were more concerned about minor illnesses and not major
problems such as Guillain-Barré Syndrome (GBS).

Dr. Sharon G. Humiston asked for information on the costs, in 2007
dollars, of administering, purchasing, and storing the influenza
vaccine. One of Dr. Ahmed's colleagues responded that no data were
available in terms of 2007 dollars. However, when using old data with
much lower reimbursement rates, giving the flu vaccine was a losing
proposition, except in the largest practices. She concluded by saying
that for 2007, it is probably a break-even proposition.

Dr. Schuchat stated that in her opinion, the most telling statistic was
the survey of providers in which a very large proportion said that with
greater financing, they would still not offer the influenza vaccine. Dr.
Almquist noted that adult practices are not generally set up for a role
as immunization providers.

***Barriers to Adult Immunization: Findings From Recent Consumer and
Healthcare Provider Surveys---Dr. David R. Johnson***

Dr. David R. Johnson (sanofi pasteur) began the presentation by
explaining that sanofi pasteur commissioned Adelphi Research by Design
to conduct consumer and healthcare professional surveys to get more
information about barriers to adult immunization. The objectives of the
surveys were to provide a thorough assessment of the reasons U.S. adults
do not receive recommended vaccines and to provide recommendations to
increase vaccination rates. The surveys included questions about
vaccinations in general and, specifically, about three adult vaccines:
Influenza, pneumococcal, and Td. The surveys were conducted with just
over 2,000 consumers, over the telephone, during September and October
of 2006. An additional survey focused on 200 healthcare providers,
including 100 primary care physicians and a mix of 100 physician
assistants, nurse practitioners, and registered nurses in primary care
practices.

One key finding of the survey was that provider recommendations are a
critical factor in consumer vaccination decisions; however, most
consumers never talk to their providers about vaccines. Another key
finding was that healthcare providers' perceptions of why consumers
forgo vaccinations do not always accurately reflect reasons cited by the
consumers themselves for forgoing vaccination.

[]{.mark}

The study also found that healthcare professionals (HCP) have gaps in
their knowledge about vaccinations. For example, between 40 and 44
percent of HCPs do not use CDC's immunization schedule. Also, a small
number of providers believed that individuals with mild to moderate
illnesses should not be vaccinated even though this is not necessarily a
contraindication to vaccination.

The study also identified another barrier to vaccination***---***a lack
of regular well-care visits. According to the study, HCPs are more
likely to discuss vaccinations with patients during well-care visits
than during acute-care visits. Finally, the study also found that cost
was not cited very often as a major barrier to vaccination; however,
cost was more of an issue for uninsured individuals.

Dr. Johnson concluded his presentation by mentioning some strategies to
increase immunization rates, such as increasing awareness and knowledge
among consumers and HCPs, encouraging HCPs to make adult immunizations a
part of their routine, and expanding first-dollar insurance coverage.
Dr. Johnson believed these strategies should be the subject of
discussion for NVAC.

***Discussion***

[]{.mark}

Dr. Jaime Fergie began the discussion by focusing on the differences
between consumer perceptions and HCPs' perceptions of consumer
perceptions. For example, he mentioned the discrepancy in terms of side
effects of the influenza vaccine. Dr. Fergie wondered if HCPs might be
using this as an excuse not to worry about vaccinations. Dr. Johnson
agreed that the discrepancy between the perceptions was big. However, he
did mention that some of the more than 2,000 consumers that were
surveyed were going to doctors, thus influencing HCPs' perceptions of
consumer beliefs, while others were not going to the doctor. Therefore,
there are two different populations of consumers. Dr. Lowell followed up
by mentioning that physician distraction was not included in the study.
He explained that distraction is a factor that has to be contented with
as it is the reality of what physicians face when trying to treat
patients.

[]{.mark}

Dr. Gordon reflected on earlier comments on the broad definition of the
flu. He explained that physicians know that the influenza vaccine is not
completely effective; therefore, they may be reluctant to administer the
vaccine due to concerns about consumer satisfaction. He wondered what
the probability was that a physician would recommend a patient get the
flu vaccine and that that patient would get what they thought was the
flu. Dr. Schuchat responded that even during the middle of a typical flu
season, the majority of "influenza-like illness" is not influenza
viruses. The proportion of ILI clinical specimens tested that are
positive for influenza rarely exceeds 30% during the peak weeks of the
season, as many other respiratory pathogens cause similar syndromes.

***CDC Grantee Immunization Program Guidelines and Activities for Adult
Immunization---Nancy Fasano***

Ms. Nancy Fasano began her presentation by explaining that the Program
Operations Branch is the primary point of contact within CDC for the 64
immunization grantees, which are the 50 States, 6 select cities, and 8
island grantees. This branch develops the program announcement and
annual grant guidance and makes the funding recommendations for 317
operations, 317 vaccine purchase, and the VFC operations awards.

Ms. Fasano described the funding opportunity announcements, which are
the framework for each 5-year project period. Adult immunization is one
of 10 program components that applicants must address. The 2008--12
funding announcement included three requirements related to adult
immunization having to do with evidence-based approaches to increasing
vaccination, the influenza vaccination of healthcare workers, and
increasing access to vaccine for high-risk adults.

The Immunization Program Operations Manual is a companion document to
the program announcement. The manual describes in more detail the
specific expectations of the grantees. It describes 18 recommended
activities related to the three requirements for adult immunizations.
Activities related to adult immunization are simply recommended while
activities related to childhood immunization are required. This is a
function of funding as the CDC has not had additional funding to provide
for adult activities.

Ms. Fasano then provided information on the 2006 annual report that
grantees submitted and the activities included in the previous funding
announcement. Ms. Fasano said that outreach to the private sector by the
grantees is very important. Every State has identified adult
coordinators; however, specific funding for this position is not
included in the awards. Therefore, some States can afford a full-time
adult coordinator while others cannot.

***Discussion***

Dr. Young asked how much funding is given to grantees as part of 317.
Dr. Rodewald commented that the figure was around \$190 million and that
only 10 percent of that money was devoted to adult immunization
activities. Dr. Walter A. Orenstein mentioned that it was interesting
that some grantees are doing more than others in terms of adult
immunizations. He wondered if they were able to go beyond the
recommended strategies by using their own funds or if they were shifting
their 317 funds from childhood to adult immunization activities. He also
wondered if there was any correlation between those States that
developed and implemented patient reminder and recall systems and their
adult immunization coverage levels. Dr. Birkhead explained that New York
uses a combination of 317 funding and State funds. New York also
implemented a standing order statute for hospitalized patients so that
it is now a requirement to offer the influenza vaccine during flu
season. Dr. Hinman mentioned that the 317 Coalition is seeking to get
funding under 317 increased almost twofold.

***Summary of Adult Immunization Discussions and Proposed Next
Directions for NVAC---Dr. Raymond A. Strikas***

Dr. Strikas began his summary with the remark "Why can't we treat adults
like children?" He mentioned that there are higher rates of
vaccine-preventable diseases in adults than there are in children.

He said that the solution rests with the provider or the system and not
with the patient; it is much easier to influence a large number of
providers than an even larger number of patients. However, there are
limited Government resources for adult vaccinations. Dr. Strikas
discussed the idea of having a report card for the Government, which was
proposed by Dr. Pavia and Dr. Schwartz, to look at what CDC and CMS are
doing. He commented that CMS uses pay-for-performance plans and wondered
if that might work for immunization. He also suggested that the
Committee could arrange to have speakers discuss issues regarding
financing vaccination in adult practices. Dr. Strikas believed the
Committee should look at what HRSA and the Bureau of Primary Health Care
are doing about immunizations as well.

***Comments***

Dr. Freed noted that NVAC has not dealt substantively with adult
immunization issues in the past. He asked that the various Subcommittees
and Working Groups decide which issues they would take on and to report
back tomorrow.

Dr. Feinberg mentioned two issues that the Committee did not touch on.
The first is that there are an increasing number of elderly people in
the United States, making these issues more important than ever. He also
emphasized that it was important for the Committee to focus its
discussions on items that can be addressed so as to not produce another
report that does not make an impact. Dr. Humiston asked if the Committee
needed a motion to create an Adult Immunization Working Group. Dr. Freed
stated that rather than creating another Working Group and diluting the
Committee's resources, the Committee should determine where, within the
current structure, some of these issues can be addressed. Dr. Pavia
concluded the discussion by calling the Committee's attention to an
article published a few months ago in Clinical Infectious Diseases that
discussed lessons learned from pediatric immunization successes and how
they apply to adolescent and adult immunizations.

**Adolescent Immunization Working Group Progress Report---Dr. Gary L.
Freed**

Dr. Freed noted that the Working Group had been given a problem
statement that was approved by NVAC. The Working Group came up with, and
approved internally, recommendations for five of the six problem areas
that were identified: Financing, mandates, communications and public
engagement, consent, and venue and utilization.

The Working Group hopes to have recommendations for the last problem
area***---***surveillance***---***by the end of the calendar year. Once
the Working Group has the final set of recommendations, they will bring
back the package of full recommendations for NVAC to comment on and
ultimately approve.

The Adolescent Immunization Working Group made financing recommendations
that were sent to the Financing Working Group for their review and
comment. All of the recommendations of the Adolescent Immunization
Working Group focus on adolescent immunization issues in an attempt to
not overlap with the work of other Working Groups and Subcommittees.

[]{.mark}

***Comments***

Dr. Schuchat asked for clarification as to whether the problem area of
surveillance would focus on vaccine-preventable diseases in adolescents
or immunization coverage in adolescents. Dr. Pavia explained that the
Working Group is in the process of figuring this out; however, during
their meeting yesterday, they focused on surveillance of immunization
coverage. He also reiterated that it is NVAC's role to say what the role
of surveillance is and what kinds of things need to be looked at, not to
think about how to do it.

**Discussion and Vote on Draft Report and Recommendations Entitled
"Mandates for Adolescent Immunizations"---Dr. Lance K. Gordon**

Dr. Freed began the discussion by explaining that this particular
report, the "The Promise and Challenge of Adolescent Immunization" was
made available to the public for comment through the Federal Register. 
The initial report was prepared at the request of the Assistant
Secretary for Health by the NVAC's Adolescent Immunization Working
Group.  After reviewing public comments, the full committee voted to
endorse the document as an official NVAC report.

Dr. Gordon provided the Committee with background by explaining that
this was a yearlong effort that built upon previous policy
recommendations. He noted that the Working Group had to deal with
several difficult questions, such as balancing the benefits of mandates
with the ethical and logistical difficulties in creating mandates.

Dr. Feinberg wondered if it was within the purview of NVAC to make
recommendations to the Assistant Secretary, who would then make
recommendations to the State. Dr. Gordon explained that this had been
reviewed with Ms. Emily M. Levine (HHS) and that the Working Group had
adopted specific language recommendations from the NVAC Council.

Dr. Feinberg noted that States were assuming responsibilities that had
been traditionally viewed as those of the Federal Government. He gave
the examples of the FDA licensing vaccines based on safety and efficacy
and ACIP evaluating vaccines for their safety, cost-effectiveness,
efficacy, and the target population to select. Dr. Feinberg stated that
it was not clear whether there was going to be an additional level of
review that would happen at the State level. He was concerned that there
would be significant delays, complexity, and variations from State to
State.

Dr. Gordon said that the White Paper specifically addresses mandates or
State laws that require immunization as a prerequisite for school
admission. He went on to explain that it is in the purview of the
individual States to make the decisions regarding the passage of laws.
He explained that this is a separate matter from NVAC recommendations
and that the White Paper does make clear the importance of the ACIP
recommendations.

Dr. Feinberg continued to express concern about the States' ability to
evaluate vaccine safety issues, especially when the FDA, ACIP, and CDC
are all actively engaged in monitoring and evaluating vaccine safety.
Dr. Humiston asked if Dr. Feinberg was suggesting striking the words
"safety profile" from the last line on page 11 of the White Paper. Dr.
Feinberg agreed with the change suggested by Dr. Humiston. He also
brought the Committee's attention to table 2 on page 21, which also
contained language about safety and target population.

Dr. Gordon said that although experts from the FDA, the NIH, and
sometimes the CDC were involved in developing and licensing a vaccine,
the vaccine is tested only on a representative population. Therefore,
safety was a concern for the States. Dr. Birkhead asked that the
document be amended to make clear that the recommendation is not that
States undertake their own safety assessment. He explained that States
have to assume that if a vaccine is on the market and recommended for
use, safety issues have been addressed.

Dr. Birkhead noted that States do not immediately create mandates upon
ACIP approval; the barriers relate to vaccine supply, financing issues,
and getting the vaccine accepted into practice. Dr. Gordon said that
they tried to make the recommendations very general as they will vary by
product.

Dr. Pavia agreed with Dr. Birkhead's comments and said that safety would
become an added benefit of the need to wait to establish the supply,
financing, and logistical issues of the vaccine. He proposed adding a
sentence to the end of the document showing that an additional benefit
to establishing these criteria before mandates are considered would be
that more safety data would have accumulated.

Dr. Schuchat asked whom the recommendations are for. She also asked if
the Committee discussed the legality of the recommendations from NVAC
being aimed more broadly than to States---to advocacy groups or
pharmaceutical companies, for instance, that often drive State
activities. Ms. Levine stated that part of the advantage of the
Assistant Secretary of Health making the recommendations directly to the
State legislatures is that there are antilobbying restrictions on
grassroots lobbying.

Dr. Clover commented on the fact that issues around transmissibility of
vaccine-preventable diseases were discussed in the body of the text of
the White Paper but not in the recommendations. Dr. Gordon explained
that the Working Group considered whether mandates were intended to
address only diseases that are casually transmitted in a school setting
or whether they were a capture point used to encourage vaccination. He
explained that the initial focus was on school transmission but that the
report includes more examples on the capture aspect. Because there are
different circumstances for different diseases, the Working Group
decided to identify the issues but not make a recommendation either that
mandates be restricted to diseases casually transmitted in a school
environment or that mandates encourage the use of the school as a
capture point.

Dr. Birkhead asked whether there had been discussion about making an
affirmative recommendation from NVAC that school mandates are a
legitimate public health tool that are to be encouraged. He explained
that the U.S. Preventive Services Task Force has such a recommendation;
however, CDC and ACIP statements only reference the Task Force. He
further noted that neither CDC, nor ACIP, nor NVAC have made affirmative
recommendations. Dr. Gordon replied that through the process of
discussing mandates with State representatives and State
epidemiologists, the Working Group realized it was important to
acknowledge the value of mandates, which they did in the body of the
text but did not make blanket recommendations. Dr. Hinman observed that
the ACIP has recommended the use of mandates for the varicella vaccine.

Dr. Freed said that the Committee would be unable to vote without
specifically revised language. He then asked Dr. Gordon to make the
appropriate changes in wording that were recommended during today's
meeting. Dr. Freed focused on the wording around the issues of safety
and asked that Dr. Gordon bring specific wording back to the Committee
on the second day of the conference for a final vote.

**National Vaccine Plan*---*Dr. Raymond A. Strikas**

The purpose of Dr. Strikas's presentation was to report to the Committee
on the process of updating the National Vaccine Plan. NVPO had several
interagency meetings and one-on-one discussions with various Government
agencies that developed priorities for the plan, which NVPO is in the
process of refining. These priorities are still categorized by the 1994
plan's goals, which were to develop new and improved vaccines, ensure
optimal safety and effectiveness of vaccines, educate the public and
healthcare professionals on the benefits and risks of vaccines, and
achieve better use of existing vaccines.

NVPO developed the following 11 key priority areas for the plan:

-   Enhance vaccine research and development;

-   Improve adult immunization rates;

-   Achieve 90 percent coverage for ACIP-recommended vaccines in
    adolescents;

-   Reduce or eliminate financial barriers to vaccinations;

-   Maintain high vaccination coverage levels in children;

-   Develop new vaccines;

-   Enhance the security and stability of the vaccine supply;

-   Better monitor adverse events and determine risk factors for adverse
    events;

-   Continue vaccine injury compensation;

-   Advance global disease reduction and eradication; and

-   Ensure systems are in place to monitor vaccine-preventable diseases
    and immunization coverage through surveillance.

Many, but not all, agencies and offices provided NVPO with priorities;
however, at this point, the list of priorities has not been prioritized.
One of NVPO's tasks is to review the priorities they received to see if
they are appropriate and to determine if anything is missing. They also
need to propose actions or milestones to be completed by participating
agencies and offices as well as review who should be the participatory
agencies. In the short term, NVPO hopes to prioritize these areas and
have some milestones developed by 2012 to 2015. Once that has been
completed, NVPO will give a draft document to NVAC for their review.
NVPO also wants to involve stakeholders outside of the Government.
Therefore, NVPO will engage other expert stakeholders through the IOM
expert committee. NVPO would also like to involve the public and will do
so by engaging them in focus groups and town hall--style meetings. Dr.
Strikas also requested the presence of at least two NVAC members at the
focus groups next week.

***Discussion***

Dr. Gellin began the discussion by asking Dr. Strikas to provide more
information on how he plans to deal with the focus groups and what the
purpose of the focus groups is. Dr. Strikas explained that the focus
groups have been stratified into four different groups of people:
Mothers of young children, women who may be mothers in the future,
younger adults 35-54 years of age, and senior citizens 60 years of age
and older. NVPO will spend about an hour and a half with each of the
groups. They will introduce the topic of public health by introducing
CDC's top 10 list of public health achievements for the 20th century,
one of which is vaccinations. They will tell the groups that this is
what the Government thinks is important and will ask for their opinion
and for them to rank these achievements. They will then go through the
same exercise with the top 11 priorities on vaccination that were
previously mentioned. The town hall meetings would involve similar
activities as well as presentations of additional material and small
group discussion as they last 5 to 6 hours.

Dr. Feinberg continued the discussion by asking how the National Vaccine
Plan influences the activities of the Federal agencies and to what
extent the progress toward achieving those goals is tracked. Dr. Strikas
explained that the last plan did nothing to advance the future of the
agencies. This is why the revised plan is going to be prioritized, have
accountability, and set milestones. Dr. Strikas also explained that this
should not be just a Government activity, which is why IOM is going to
be involved to solicit non-government input, and make this a national
plan, not solely a Government plan.

[]{.mark}

**Review of Priorities in the National Vaccine Plan*---*Ms. Alina
Baciu**

[]{.mark}

Ms. Alina Baciu began her presentation by explaining that the IOM is in
the process of developing a new committee that will consist of 12
members with various areas of expertise. In addition to members with
expertise in the areas of medicine, epidemiology, public health, public
policy, vaccinology, and decision analysis, she also mentioned the
importance of having members with expertise in the areas of safety,
legal issues, and immunology. The committee's task is to review and make
recommendations regarding an update of the National Vaccine Plan. The
Committee will hold workshops with national expert stakeholders to
review a draft update of the plan and will prepare a report with
conclusions and recommendations about priority actions within the major
components of the draft plan. Ms. Baciu said that a Web site and
listserv will be established.

Ms. Baciu said that NVAC's input is needed in terms of the categories of
stakeholders that should be looked at and specific names of stakeholders
and possible Committee members that should be considered. She also said
that input was needed in terms of NVAC's role during the study. She
hopes that NVAC representatives will be able to attend and possibly
address the IOM committee during some of its meetings. The e-mail
address for the project is vaccineplan@nas.edu for further questions and
comments.

***Discussion***

[]{.mark}

Dr. Humiston began the discussion by stating that experts in
communication should be invited to participate in the Committee as they
were left out. She also mentioned that in terms of epidemiology, one
form of surveillance that was left out was surveillance on stakeholder
knowledge, attitudes, and beliefs. Dr. Hosbach also asked that a
representative from a vaccine manufacturer be considered as part of the
stakeholder group for the IOM panel.

Dr. Freed asked whether Ms. Baciu had a way in which she wanted NVAC to
be engaged in this project. She replied that NVAC's role is not clear at
this point but that once the IOM Committee convenes, that is something
they can discuss. One possible role for NVAC would be to assign someone
to serve as a liaison for the IOM Committee that could attend all public
meetings and speak about issues relevant to NVAC. Dr. Freed asked when
the IOM Committee would be convened. Ms. Baciu explained that the
process usually takes about 1 month and that they are hoping to have
their first meeting in early December. Dr. Gordon also mentioned that
the Vaccine Development and Supply Subcommittee would discuss the
possibility of their participation in the IOM process during their
Subcommittee meeting. Dr. Gellin ended the discussion by mentioning that
NVAC should consider how the input of the entire Committee could be
achieved, rather than just the input of one representative from NVAC.

[]{.mark}

As there was no further discussion, the full Committee adjourned, and
members broke into their assigned Subcommittee meetings, which
constituted the remainder of the meeting for the day.

**Day 2---October 23**

Dr. Birkhead opened the second day of the meeting in Dr. Freed's absence
as he had to return to Michigan.

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

[]{.mark}

***Advisory Committee on Immunization Practices (ACIP)/National Center
for Immunization and Respiratory Diseases (NCIRD)---Dr. Anne Schuchat***

Dr. Schuchat reported that more than 80 million doses of the influenza
vaccine have been distributed and that distribution of flu vaccine is
expected to be completed by the end of October.

In August, NCIRD launched a preteen vaccination campaign with new
communications materials targeting ethnic and minority media. They also
released the first teen module of the NIS for 13- to 17-year-olds.

Dr. Schuchat reminded the group that the ACIP meeting would be held on
Wednesday and Thursday and that ACIP was expected to vote on five main
issues:

-   Use of the live attenuated influenza vaccine (LAIV) in two- to
    four-year-old populations;

-   Clarification of the PCV schedule in children 24 to 59 months of
    age;

-   A change in the age indications for the meningococcal conjugate
    vaccine (MCV) in high-risk children between 2 and 10 years of age;

-   The childhood and adolescent immunization schedules; and

-   The immunization schedule for HIV-infected adults.

Dr. Schuchat addressed the cluster of measles cases associated with the
International Little League World Series. The index case was a Japanese
player, and to date, there have been seven confirmed cases. This case
highlights the variety of places where a person can be exposed to
vaccine-preventable diseases. The sibling of the index case was a
household exposure. There was a first-generation case of measles in
Texas in a corporate sponsor who attended the game. There were also two
second-generation cases of measles in Texas among college students that
were linked to the corporate sponsor. Finally, there were two cases of
measles in Michigan, one in an airline passenger who was seated near the
index case, and one in an airport worker who was exposed to the index
case. Dr. Schuchat explained that an MMWR report is currently being
developed on this cluster of measles cases. She also mentioned that
Japan has now passed India as the source of the most measles cases in
2007.

Dr. Schuchat concluded her update by mentioning that the second
international conference on congenital cytomegalovirus, "Public Health
Action toward Awareness, Prevention, and Treatment," will be held next
year from November 5 through 7 in Atlanta. She thought the conference
may be of interest to NVAC, especially due to the recent progress in
vaccine development.

***Discussion***

Dr. Riley asked if NCIRD had thought about looking at the Tdap
recommendations for pregnant women. She wanted to know why pregnant
women cannot be vaccinated during the third trimester so that the baby
would develop passive immunity. Dr. Schuchat explained that NCIRD is
trying to promote use of Tdap among adults but that they are not doing
well with adult immunizations. However, she went on to explain that ACIP
has a new Working Group that is focusing on vaccines in pregnancy. This
Working Group is reviewing all current ACIP recommendations that mention
pregnancy.

[]{.mark}

***Advisory Commission on Childhood Vaccines (ACCV)/National Vaccine
Injury Compensation Program (VICP)---Dr. Geoffrey Evans***

Dr. Evans began his update by explaining that the number of claims
received by the VICP has been fairly steady over time; however, this
year there was an increase as the 2-year deadline ended for the filing
of retroactive claims whenever a new vaccine is added to the VICP. To
date, the program has received 184 claims for the flu vaccine, which is
manageable.

Dr. Evans also reported that VICP received an increased number of autism
claims since the June autism hearing. Of the now 4,900 active claims,
most do not have medical records. Recently, the court decided that the
United States Department of Justice should being conducting legal
reviews of these claims to confirm they fall within the VICP's statute
of limitations. During the next fiscal year, Dr. Evans believes the
court may also begin requiring medical reviews; however, this remains
uncertain.

Dr. Evans then discussed the status of the Omnibus Autism Proceeding.
There are three test cases for each of the three autism theories. The
first two theories allege that either the MMR vaccine alone, or
thimerosal can cause autism. The third "combined" theory alleges that
both MMR and thimerosal, in combination, can cause autism. The decision
on the first of the hearings is expected sometime in the spring of 2008,
and the decision on the second set of hearings could be sometime in
mid-2009. However, appeals are expected to follow which could take
several years. It is believed the final outcome may not be known until
2010 or 2011.

***Discussion***

Dr. Gellin asked whether countries other than the United States were
reporting autism cases as well. Dr. Evans stated that the Legal Aid
Foundation Office in the United Kingdom tried to put together a case;
however, their funding was discontinued. He was unaware of any other
cases in the United Kingdom or Canada.

Dr. Almquist wondered if after the first three theories have been
tested, a fourth theory could be tested. He explained that Autism Speaks
has been expressing concern regarding the total number of antigens
introduced into children as a possible cause of autism. Dr. Evans stated
that the court has gone out of its way to allow people to bring theories
forward. Therefore, he would not rule it out. However, based on the
deadlines set by the court, he thought it might be difficult to bring a
fourth theory forward at this time.

***Vaccines and Related Biological Products Advisory Committee
(VRBPAC)/United States Food and Drug Administration (FDA)---Dr. Norman
Baylor***

Since the last NVAC meeting, the FDA has approved the Acambis 2000
Smallpox vaccine. This happened in August of this year. This is the
first vaccine that the FDA has approved that requires a RiskMAP (Risk
Minimization Action Plan). This requires the providers of the vaccine
and patients who will be receiving the vaccine to be educated about the
risks of the vaccine.

In September, the FDA approved the expansion of indications for FluMist
(the nasal spray influenza vaccine) to include children between 2 and 5
years of age. Also in September, the FDA approved another flu vaccine,
Afluria. Afluria is manufactured by CSL Biotherapies out of Australia.
Now there are six U.S. licensed manufacturers of flu vaccine in the
United States.

Dr. Baylor also mentioned a Federal Register notice on the development
of safety and effectiveness assessments for vaccines for pandemic
influenza. He explained that this document was for interested parties to
provide comments and information in order to help the FDA develop
programs to look at adverse effects following administration of pandemic
flu vaccines. The notice was part of the mandate for the FDA from the
President's National Strategy for Pandemic Influenza from November of
2005.

Dr. Baylor's last update concerned the FDA Amendment Act of 2007, which
was passed on September 27. One of the purposes of this act was to
reauthorize the Prescription Drug User Fee Act. It also reauthorizes the
Medical Device User Fee Act. There are 11 titles in this act in addition
to the user fees. Title 6 establishes the Reagan-Udall Foundation. This
Foundation's mission is to advance the mission of FDA to modernize
product development, accelerate innovation, and enhance product safety.
The foundation will be supported by private funding; however, some FDA
funding will go toward operations. Another highlight of this act is that
it includes a priority review, which is usually 6 months, for tropical
diseases such as tuberculosis, cholera, malaria, and dengue fever. This
serves as an incentive for manufacturers. If a manufacturer receives
approval for a vaccine or medical product for a tropical disease, the
act allows them to get a voucher for a priority review for something
else. This act provides FDA with the opportunity to look at issues and
license products for developing countries.

***Discussion***

In response to a question about the domestic and international capacity
of the flu vaccine, Dr. Baylor estimated that between 120 and 130
million doses of the flu vaccine were manufactured this year. However,
he explained that some manufacturers, especially the new manufacturers,
are still not at their full capacity. Dr. Gellin commented that the
World Health Organization (WHO) estimated that around 350 million doses
of trivalent influenza vaccine were manufactured; however, again,
existing manufacturers could create more. Dr. Hosbach explained that
while this year, close to 130 million doses of flu vaccine were
manufactured, next year, 170 million doses could be produced. However,
he reminded the Committee that every year manufacturers throw out
vaccine. Therefore, production for next year's flu vaccine will decrease
unless there is an increase in demand or unless the recommendations for
flu vaccine are expanded.

Regarding the tropical disease initiative, Dr. Feinberg asked if the FDA
would be serving as the regulatory authority for vaccines targeting
diseases primarily in other countries. He also asked if this might
resemble the article 58 mechanism that the European Regulatory
Authorities use. Dr. Baylor stated that this effort was not equivalent
to article 58 as FDA works with sponsors to develop products and looks
at protocols and clinical trials. He went on to explain that the FDA
does have a global vaccine initiative as there is the desire to license
products for diseases that are not in the United States.

***National Vaccine Program Office (NVPO)---Dr. Bruce G. Gellin***

Dr. Gellin explained that a lot of the work of NVPO is embodied in the
work of the National Vaccine Advisory Committee and its various
Subcommittees and Working Groups. The NVPO is also involved in the
development of the new National Vaccine Plan.

The NVPO has spent a lot of time on pandemic flu issues, such as
pandemic flu vaccine prioritization, which was an effort that was co-led
by HHS and the Department of Homeland Security (DHS).

Dr. Gellin concluded his update by recommending that everyone be
familiar with the Homeland Security Council's pandemic flu
implementation plan.

***National Institutes of Health (NIH)---Dr. George Curlin***

Dr. Curlin explained that NIH just awarded two contracts to look at the
management of uncomplicated skin and soft tissue infection (SSTI) in an
era of community-acquired MRSA. One goal of these contracts is to
identify ways to treat routine community-acquired, antibiotic-sensitive
staphylococcal infections with well-known antibiotics. Another goal of
these contracts is to separate the treatment of uncomplicated
staphylococcal infections from the treatment of methicillin-resistant
staphylococcal infections, for which the more powerful antibiotics
should be reserved.

Dr. Curlin explained that the issue of MRSA was embedded in the larger
problem of the development of antibiotic resistance. He explained that
inappropriate use of antibiotics was something that needed to be dealt
with and explained that vaccines are important but not the major factor
in combating MRSA.

There are currently two new *Staphylococcus* vaccines. The first vaccine
is very much in the development stage and uses a genomic approach. The
second vaccine uses a surface protein adhesion antigen approach and is
now ready for clinical studies.

Dr. Curlin mentioned the existing *Staphylococcus* vaccine from Nabi
Biopharmaceuticals that has gone through Phase III trials. The
manufacturers chose to evaluate this vaccine in populations with high
rates of *Staphylococcus* infections. The vaccine worked 10 weeks
earlier than the study had called for, and since then, the manufacturer
has added another antigen to the mix. However, Dr. Curlin mentioned that
it is very difficult to evaluate staphylococcal vaccines. Dr. Curlin
also mentioned the importance of immunotherapy in treating MRSA
infections and explained that one particular type of immunotherapy was
currently in the Phase III trials.

***Discussion***

Dr. Schuchat mentioned that CDC, NIH, FDA, and USAID were going to meet
in December to update the Public Health Action Plan on Antimicrobial
Resistance with 70 external consultants. She explained that vaccines
were only a very small part of this plan but that perhaps new action
would be provided.

***United States Agency for International Development (USAID)---Mr. Neal
Brandes***

Mr. Brandes began his update by discussing a journal article that was
published in the July issue of the Pediatric Infectious Disease Journal
on the effectiveness of the Hib conjugate vaccine in Bangladesh. He said
that this study was a good example of how a small amount of money can be
used quite well. This particular study reported that the vaccine was 90
percent effective in the population, 92 to 93 percent effective when
administered in a facility, and 89 percent effective when administered
in the community. The study was also shown to influence the government
of Bangladesh to seriously consider purchasing the vaccine. Mr. Brandes
explained that many countries are concerned about the cost of the
vaccine and do not recognize the disease burden, which is why studies of
this nature are needed. He continued by explaining that the Indian
press, which has been even more reluctant about vaccinations, picked up
this story, which is an important next step.

***Discussion***

Dr. Humiston began the discussion by requesting global usage data for
the Hib vaccine. Dr. Schuchat responded by stating that they have made
great progress in terms of Hib vaccine usage. One study found that at
the beginning of 2005, 19 of the 74 eligible countries were using the
Hib vaccine; however, by the end of 2007, 53 countries had applied to
use or started using the Hib vaccine. Dr. Feinberg reiterated Mr.
Brandes's point that many countries still do not have a full
appreciation of the disease. Dr. Gordon wondered if more focus should be
placed on surveillance rather than simple implementation of the vaccine.
Dr. Schuchat responded by saying that the WHO believes implementation of
the Hib vaccine should be global. She also commented that the WHO and
the Gates Foundation are interested in broader surveillance for
vaccine-preventable diseases to help sustain vaccination programs.

***United States Department of Veteran's Affairs (VA)---Dr. Ronald O.
Valdiserri***

Dr. Valdiserri began his update by explaining that the influenza vaccine
was selected as one of the measures that the VA plans to use to report
its performance to the public as part of the VA's effort to meet the
Presidential Executive Order on Quality and Transparency.

On October 19, the VA's Medical Advisory Panel voted to add Zostavax to
the VA National Formulary.

Dr. Valdiserri mentioned confusion surrounding the recommendations for
Zostavax in HIV-infected patients. He said the Morbidity and Mortality
Weekly Report (MMWR) stated that the vaccine is contraindicated for
HIV-infected patients with CD4 cell counts less than 200. However, the
document does not contraindicate or recommend the vaccine for
HIV-infected patients with CD4 cell counts greater than 200.

The VA also added vaccinations to its list of agents that are followed
as part of the pharmacovigilance program. He explained that this is a
Web-based program available in every VA facility. He also explained that
in 2008, the VA will pilot an active surveillance project that will
monitor adverse reactions to the flu and pneumococcal vaccines. If the
project is successful, it will be implemented nationwide.

Finally, the VA sent out a letter to all providers instructing them to
offer the HPV vaccine to women 18 to 26 years of age.

***Discussion***

Dr. Schuchat commented on Dr. Valdiserri's question regarding use of
Zostavax in HIV-infected patients. She explained that the Zostavax
statement had not yet been published by CDC and apologized for the
delay. Dr. Schuchat mentioned that this issue was going to be discussed
at the upcoming ACIP meeting.

***America's Health Insurance Plans (AHIP)---Dr. Wayne Rawlins***

Dr. Rawlins provided the following three updates:

-   America's Health Insurance Plans (AHIP) are engaged with the Vaccine
    Evaluation Project around economic modeling for vaccine
    reimbursement;

-   They are informing members about the upcoming National Influenza
    Week; and

-   They have put out a 2007 immunization recognition program, which
    looks at immunization strategies in various health plans.

**CDC's Vaccine Stockpile Plan---Dr. Gregory S. Wallace**

Dr. Gregory S. Wallace began his presentation with a brief history of
the vaccine stockpile. In 1983, 317 funding was used to purchase
stockpile vaccine for diphtheria, tetanus, pertussis, polio, and measles
containing vaccines. Currently, MMR and IPV vaccines are all that are
left as part of the 317 stockpile funding. In 1993, VFC legislation was
passed, which required a 6-month stockpile. There are currently more
than 20 million doses of vaccine in the CDC stockpile. However, no
funding has been obligated for the vaccine stockpile at this time.

Dr. Wallace then turned the focus of the presentation to the VFC
stockpile legislation. One of the principles of the legislation is that
there should be an adequate supply of pediatric vaccines to meet
unanticipated needs. He explained that it is difficult to anticipate
unanticipated needs. The legislation also states that CDC should
negotiate for a 6-month supply and should consider the potential for
outbreaks. With the exception of the remaining MMR and IPV vaccine, the
rest of the vaccine in the stockpile is VFC funded.

Dr. Wallace then looked at the vaccines for which CDC experienced supply
issues since 2000. Most of the supply issues ended up lasting more than
a year. MMR was the only vaccine for which there was actually stockpile
to use when the shortage occurred. The rest of the vaccine shortages
required that interim changes be made in the recommendations for
vaccination.

Dr. Wallace then discussed challenges with negotiating a 6-month
stockpile. Challenges lie in that the market changes, for example, with
the introduction of combination vaccines and that recommendations change
as well, for example, with the addition of the second dose of varicella
vaccine. In order to keep vaccine in the stockpile fresh, manufactures
store and rotate their vaccine supply.

It is also important to consider the potential for outbreaks and to
understand that the goal for outbreaks is different from the goal for
production interruptions. He explained that combination vaccines may
complicate outbreak response. For example, we would not want to use
Pediarix during a polio outbreak. He also mentioned the need to consider
whether to include vaccines that have low outbreak potential.

Dr. Wallace explained that because the stockpile is VFC funded, it may
limit the flexibility of the use of vaccine. He also mentioned the need
to minimize the risk of throwing away vaccine or of financial loss and
maximizing the stockpile's utility so that it meets public health needs.

There is now a CDC working group assigned to look at some of these
issues as the vaccination schedule and market get more complicated.

Dr. Wallace concluded his presentation by expressing his proposed role
for NVAC in this process, which includes the following:

-   Acting as a sounding board for difficult options;

-   Discussing options and approaches;

-   Presenting recommendations for external review (not as clearance but
    as an interested third party); and

-   Providing updates when major changes are considered.

***Discussion***

Dr. Strikas asked how often the vaccine stockpile is used for outbreak
control. He also asked if there are other countries that have vaccine
stockpiles from which the United States could learn. Dr. Wallace
commented that the stockpile was most recently used during the mumps
outbreak in the Midwest. He explained that some 317 vaccine was used,
some State-funded vaccine was used, and that Merck donated some vaccine
during the outbreak. The vaccine stockpile was also recently used in the
Marshall Islands. Dr. Wallace was not familiar with any other countries
with vaccine stockpiles.

Mr. Alan Tom commented that in Canada, there is no federal funding for
vaccine procurement; therefore, there is no national stockpile. However,
Canada has started building stockpile requirements into the contracting
process. As the contract comes to a conclusion, the stockpile is drawn
down and used within the contracting period.

Dr. Humiston asked if the costs for storage and handling of vaccines in
the stockpile are part of the contract or if they could be separated
out. Dr. Wallace explained that these are part of a separate contract
that gets negotiated periodically.

Dr. Hosbach explained that the vaccine stockpile serves as an insurance
policy for the Nation. However, he also stated that in the case of
nonemergency drawdowns, risk is not shared. Dr. Wallace mentioned that
the issue as to whether the vaccine stockpile is an insurance policy or
not is something the working group needs to take on.

Dr. Wallace responded to a question about possession of vaccines in the
stockpile by explaining that it is managed at the manufacturers so that
they can store and rotate it. He went on to explain that it is a
segregated inventory as CDC does go periodically to the manufacturer to
count doses to verify the stock.

Dr. Birkhead wondered what would happen when 317 vaccine is expired or
gone from the stockpile. Dr. Wallace explained that 317 vaccine does
continue to get rotated in.

As more complicated issues arise, Dr. Wallace said he would present them
to the Committee for their input. Dr. Birkhead was hesitant to appoint a
liaison member at this point; however, Dr. Wallace mentioned the
possibility of making NVPO a working member of the group.

**Draft Guidance on Prioritization of Pandemic Influenza Vaccine---Dr.
Benjamin Schwartz**

Dr. Benjamin Schwartz began his presentation by focusing on why pandemic
vaccine needs to be prioritized. He explained that it currently takes a
minimum of 20 weeks before the first pandemic vaccine will be available.
The United States currently does not have the production capacity to
rapidly produce the vaccine for the entire population. Therefore,
targeting groups for either earlier or later vaccination will best
support the pandemic response goals of reducing health, societal, and
economic impacts.

In order to improve our ability to rapidly vaccinate the entire U.S.
population, HHS has invested over \$1 billion to

-   Increase vaccine production capacity;

-   Develop and license new vaccine production technologies; and

-   Evaluate adjuvanted vaccine formulations.

[]{.mark}

Dr. Schwartz reminded the Committee that it is unclear whether or how
much pandemic vaccine would be available at the time of the first
pandemic wave. A mathematical model predicted that if an outbreak were
to occur in Southeast Asia, it would take 55 days for the first case to
appear in the United States and then 80 to 120 days from the first case
to the peak of the first wave. However, he cautioned that we do not know
where a pandemic will start. He also explained that once we have
vaccine, it is unclear what that supply will be as that depends on the
U.S. production capacity when the pandemic occurs as well as the antigen
concentration per dose.

The next part of the presentation focused on the first national effort
at pandemic vaccine prioritization, which occurred in 2005 as a joint
activity of ACIP and NVAC. The process included the consideration of
vaccine supply and efficacy, impacts of past pandemics by age and risk
group, potential impacts on critical infrastructures, and ethical
concerns. ACIP and NVAC's recommendations were included in the 2005 HHS
Pandemic Plan.

The priority groups for pandemic flu vaccination, identified by ACIP and
NVAC, were divided into tiers and subtiers. The first tier for
vaccination included healthcare workers, high-risk groups, and the
elderly. However, several factors suggested a value in reconsidering the
prioritization guidance. Planning assumptions evolved from a more
moderate pandemic, which ACIP and NVAC used to establish the initial
guidance, to a more severe pandemic. NVPO also heard from the public in
four public engagement meetings. The public indicated that it was more
important to protect essential services than high-risk individuals.
Also, an analysis of critical infrastructures was conducted by the
National Infrastructure Advisory Council (NIAC), a DHS Advisory
Committee, which identified vaccination priority groups.

Because of this, an Interagency Working Group was established to
reconsider pandemic vaccine prioritization guidance. The Working Group
process included the presentation and discussion of prior ACIP and NVAC
recommendations; scientific, public health, and ethical issues; analysis
and recommendations on critical infrastructure (CI) by the NIAC; as well
as national and homeland security issues. The Working Group held two
public engagement meetings and a stakeholders meeting and conducted
decision analysis. The Working Group also considered various ethical
issues and included the participation of an NIH ethicist and ethicists
from the Minnesota Center for Healthcare Ethics in examining process and
content issues.

The NIAC analysis of critical infrastructure for a U.S. pandemic
considered the following issues: The essential functions of critical
infrastructure and key resource sectors, their interdependencies, and
the workforces needed to maintain critical functions. The process
included a survey of critical infrastructure and key resource operators,
a review of existing data and plans, and interviews with subject matter
experts. Overall, of the 85 million workers in CI sectors, 12.4 million
were included in the top tier as most essential to preserving the
critical functions in these sectors. The healthcare sector represents
the majority of CI workers, with emergency responders coming in second.

The objective of the public engagement and stakeholder meetings was to
consider the goals of pandemic vaccination and assign values to each of
them. A total of 328 individuals participated in these meetings in Las
Cruces, NM, Nassau County, NY, or Washington, DC. The top four
objectives for vaccination were identical at each meeting. These
objectives included protecting people who are working to fight the
pandemic and provide care, protecting those who provide essential
community services, protecting those who are most vulnerable, and
protecting children.

The last part of the development process was decision analysis. In this
decision analysis, NVPO defined 57 different population groups by their
job, age, and health status. The Working Group then rated the extent to
which each group met occupationally related objectives. Then CDC and
external influenza experts rated the extent to which each group met
"science-based" objectives. Different weights were then applied based on
Interagency Working Group public and stakeholder values, and they came
up with an overall score for each of the different population groups.
The results showed that the groups that ranked the highest included
public health responders, healthcare workers, emergency medical service
providers, law enforcement, and children. These results were consistent
with the public and stakeholder values as well as with the ethical
principles.

The next part of the presentation focused on the actual draft guidance.
Similar to the ACIP and NVAC guidance, vaccine will be administered in
tiers, each of which includes several target groups. These target groups
are defined in categories: Healthcare and community support services,
critical infrastructure, homeland and national security, and the general
population. Within each of these categories, target groups are then
clustered in levels. Dr. Schwartz explained that NVPO defines vaccine
prioritization strategies differently based on pandemic severity, be it
severe, moderate, or less severe. However, the highest tier for
vaccination, tier 1, is the same across all pandemic severities.

Dr. Schwartz concluded the presentation by reiterating that this is
simply draft guidance. He also explained that there would be a 2-month
comment period, additional public and stakeholder meetings, and a
Web-based public engagement activity. During this time, NVPO will be
working with sectors to validate population estimates and to consider
options for implementation. Once the comment period has ended, changes
will be made, and the final interim guidance will be issued. However,
Dr. Schwartz emphasized the fact that pandemic planning has evolved and
will continue to evolve as science and technology change. ACIP and NVAC
have a special role in this process because of their expertise, their
credibility in making vaccination recommendations, and their role in
creating the 2005 guidance.

***Discussion***

Dr. Birkhead began the discussion by stating that NVAC members should
think about how they might organize their thinking in order to make a
single NVAC statement.

Dr. Lovell asked what the best case scenario is in terms of time course
between tiers 1 and 2. Dr. Schwartz replied that that depends on how
much vaccine we have and when the pandemic occurs. Ideally, we would be
able to vaccinate the entire population in a relatively short period of
time and ideally sometime in the future not need to prioritize at all.
However, until we reach that stage, strategy is important. Dr. Gellin
commented that the largest piece of funding for pandemic preparedness is
for vaccine development and that the goal is to vaccinate the entire
population within 6 months; however, we are still a few years away from
being at this final end point.

Dr. Birkhead wondered if there might be any overlap between the tiers or
if one group would be completely exhausted before moving onto another
group. Dr. Schwartz replied that there would likely be overlap in terms
of implementation. The concept, however, is that all the groups within a
tier would be vaccinated simultaneously. Dr. Schwartz continued by
explaining that he would not expect to see any regional differences
because the pandemic would spread so quickly. However, he did state that
it does take time to develop immunity and that two doses of the vaccine
may be required. A small supply of vaccine would be made available to
States to distribute per their particular needs. Dr. Birkhead followed
up by asking if this small supply of vaccine would be distributed
through the State government. Dr. Schwartz confirmed that the vaccine
would be distributed to States, which would then implement the program.

Dr. Gordon continued the discussion by asking how the two plans, the
2005 plan and the current draft plan, differ. He asked if a joint NVAC
and ACIP meeting might be necessary and expressed the desire to see
coordination, or at least a conference call, involving both Committees.
Dr. Schwartz responded that one major difference between the two plans
is that children are higher on the priority list with the current plan.
He explained that some modeling studies have shown that we may decrease
overall disease transmission by vaccinating children. Another difference
between the two plans is that the current plan identifies critical
infrastructure sectors higher on the priority list. The current plan
also identifies homeland and national security needs, which were not
considered by ACIP and NVAC during the earlier process.

Dr. Feinberg then asked when this plan would be implemented. He also
wondered if the plan might need to be revisited in the moment of a
pandemic and how that might actually occur. Dr. Schwartz explained that
each State has their own pandemic plan and that implementation of the
plan will be a challenge. Dr. Rawlins wondered if it had been taken into
consideration that the Reserves or the National Guard might need to be
called upon to keep public order or to transport vaccine to States. Dr.
Schwartz explained that currently the Reserves and the National Guard
are in the second tier; however, if they are used for other services,
they could be vaccinated earlier.

In response to a question about tracking the progress of a pandemic, Dr.
Schwartz explained that it is important to first quickly define the
severity of the event. He explained that CDC has a team that is trained
to define the severity of the event. Once the severity has been
categorized, that will help determine what vaccine priority strategy to
use.

Dr. Birkhead asked how States and local governments will be approached
to get stakeholder input on the plan. Dr. Schwartz explained that they
were included in the development of this guidance. He also explained
that a stakeholder meeting would be held in next year in Washington, DC.

Dr. Strikas commented that in the 2005 ACIP/NVAC prioritization, some
populations would not receive the vaccine because it would not be
successful; therefore, they were not included in the tier structure. Dr.
Schwartz explained that with the new prioritization, everyone has been
included. He explained that it was important that everyone have the
opportunity to be protected, but at the same time, he recognizes that
the vaccine may not be effective in everyone.

In response to a previous question about how information is provided to
the States, Dr. Jeanne Santoli (NCIRD/CDC) stated that CDC currently has
a procedure in place in which they communicate periodic guidance to
State grantees such as information about how to distribute and track
vaccine. Therefore, there is currently a system in place to get
information to the people who need it most.

Dr. Birkhead ended the discussion by saying that NVAC will look into
some of the suggestions from this discussion such as a joint call with
ACIP. He also stated that they will need to formulate official NVAC
input within the timeframe identified by Dr. Schwartz.

**Second Discussion and Vote on Draft Report and Recommendations
Entitled "Mandates for Adolescent Immunizations"---Dr. Lance K. Gordon**

Dr. Gordon began the discussion by revisiting the comments from Day 1 of
the NVAC meeting. He explained that the main comment concerned the use
of the phrase "safety profile." Therefore, the words

"safety profile" were removed from two places (the summary table on page
21 and in the text on page 12) and replaced with the words
"postlicensure experience."

On page 3, per Dr. Birkhead's recommendation, Dr. Gordon inserted a
reference to the evidence-based studies done by the task force on
community preventive services regarding a wide variety of potential
measures to increase vaccine coverage. The wording for this section was
taken directly from an MMWR report.

***Discussion***

Dr. Birkhead asked if there were any questions about what had been added
or changed. Dr. Almquist motioned to accept the document, and Dr. Lovell
seconded that motion. However, before the vote was finalized, Dr.
Feinberg had an additional concern about the very specific finance
wording in the document regarding the direct and indirect costs of
vaccines. Dr. Gordon explained that there are a wide range of costs
incurred when a mandate is put into place and that some of these costs
differ substantially from the cost associated with an ACIP
recommendation. Dr. Gordon asked if the Committee were to propose
changes, that they be regarding the identification and plan instead of
the types of things to be included. Dr. Feinberg reiterated his concern
about the specificity of the language used in the document.

Dr. Birkhead explained that the statement of page 12 of the document
does not imply that all of the issues will be dealt with and settled.
Dr. Gordon suggested the alternative of replacing the word "identify"
with the word "consider" and expressed wanting to not make broader
changes. Dr. Feinberg agreed to this change. The change was made on both
pages 12 and 21.

**Action:** The Committee voted unanimously to approve the document with
the amendment.

[]{.mark}

**Report: Subcommittee Update: Subcommittee on Vaccine Development and
Supply---Dr. Lance K. Gordon**

The Subcommittee's first agenda item was to review the draft manuscript
being prepared by the Subcommittee on vaccine development and supply.
This manuscript identifies why different technologies are needed to
enable new vaccines and to expand the amounts of existing vaccines that
might be needed in certain circumstances (such as in the event of a
pandemic). A listing of assignments was given to each of the agency
representatives (NIH, FDA, CDC, NVPO) to identify programs going on
within each of their groups that would relate to this manuscript to make
sure they are adequately inclusive.

The timeframe objective for the manuscript is as follows: The
Subcommittee hopes to move through the various steps so that by the
February NVAC meeting, the Committee can go through the same process
with this manuscript as it did with the Adolescent Immunization
document.

The second agenda item for the Subcommittee was regarding the
development of the National Vaccine Plan. Dr. Strikas provided the
Subcommittee with a more detailed process as to the development of the
Plan, and a representative from the IOM provided additional details on
the work they will be completing. Dr. Strikas distributed a draft of the
objectives, which includes input he has received from different
agencies. The Subcommittee has offered to help with the plan.

The last agenda item for the Subcommittee meeting was to evaluate what
is being done regarding the MRSA/staphylococcal issue. The Subcommittee
is going to evaluate what is being done in terms of developing a
staphylococcal vaccine and is going to take this issue on as a future
agenda item to be discussed.

***Discussion***

Dr. Young asked how NVPO's National Vaccine Plan interfaces with the
IOM. She wondered if the NVPO plan goes to the IOM for refinement. Dr.
Strikas explained that NVAC is going to review the document before it
goes to larger groups of stakeholders through the IOM. The piece the
Subcommittee is currently looking at deals with research objectives and
vaccine development. He explained that NVAC's process is to review the
document before the IOM gets it in order to make it the best product
possible. It is then taken to the IOM for a broader review. In response
to concerns about the timeline, Dr. Strikas stated that the timeline is
challenging and that the Subcommittee would see what it could get to IOM
by their December meeting.

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

The first agenda item of the Subcommittee on Immunization Coverage was
to discuss the adult immunization issues that were presented during the
morning presentations. The Subcommittee agreed that adult immunization
issues do need to be addressed by NVAC. They also agreed that the
Subcommittee on Immunization Coverage could potentially be the Committee
that addresses these issues. They envisioned the Committee working like
the Working Group on finance or adolescent immunizations. They proposed
having a brainstorming session where they would identify issues that
they could address in a reasonably short time period and then set up
smaller groups to develop recommendations. The Subcommittee hoped they
could have these recommendations ready for the new administration by the
end of 2008 or early 2009.

The Subcommittee then reported on the fact that one of the products from
the Subcommittee, the "Immunization Information Systems National Vaccine
Advisory Committee Progress Report," had been published in the Journal
of Public Health Management Practice.

Next, the Subcommittee recommended that there be a stakeholders'
conference on immunization information systems (IIS) immediately
following the next NVAC meeting. They reported that Dr. Gellin is going
to send out letters asking key stakeholders to attend.

The last part of the Subcommittee meeting consisted of a presentation by
Dr. Philip J. Smith on the new modules of the NIS. These new modules
have now incorporated adolescent information as well as updated
information about the insurance status of children and how that affects
their health.

Dr. Almquist then provided the Committee with a few of the study's
findings:

-   Results from the study showed that VFC-eligible children, who have a
    medical home and use it consistently to receive all vaccine doses,
    can have vaccination coverage rates that are comparable to non-VFC
    children living in more affluent households.

-   Results from that study confirmed that children who were insured
    with public insurance or who were uninsured were significantly less
    well vaccinated than children covered by private insurance.

-   Results also showed that children who were covered by health
    insurance at the time of the NIS interview and who had no breaks in
    health insurance coverage were significantly better vaccinated than
    children who were currently insured but who had breaks in coverage,
    than children who were currently uninsured but previously insured,
    and than children who were never insured.

***Discussion***

Dr. Humiston asked if the insurance module was going to be added to the
NIS for adolescents. Dr. Almquist explained that it already existed. Dr.
Riley asked if the data had been broken down by ethnicity. Dr. Almquist
explained that ethnicity data were not given as part of the presentation
but that that does not mean that they are not available. Dr. Santoli
explained that ethnicity data in children will be available in the
future on a national level.

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

Dr. Humiston explained that the Subcommittee on Public Communication,
Consultation, and Participation (PCCP) met with the Subcommittee on
Vaccine Safety. Dr. Karen Broder (NCIRD/CDC) provided the Subcommittee
with a review of CDC's Immunization Safety Office research agenda. Dr.
Humiston explained that the Committee's role is to continually ask how
the public is being engaged.

The Subcommittee also reviewed the Federal Inventory of Safety
Activities and was involved in the development and testing of versions
of this document so that when it is ready to go, it will be useful for
the general public.

In addition to the Subcommittee's meeting yesterday, they also meet by
phone and had previously gone over the transcripts from 11 key informant
interviews regarding Federal activities in vaccine communication. The
Subcommittee expects to use the key informant interviews, along with a
literature review, in a review paper.

The Committee also continues to work with the Immunization Services
Division within NCIRD on the NIS module for the parents of young
children on their knowledge, attitudes, and beliefs regarding childhood
vaccines.

***Discussion***

Dr. Gellin began the discussion by asking Dr. Humiston to elaborate on
the key informant interviews. Through a contract with the Oak Ridge
Institute for Science and Education (ORISE), the Subcommittee developed
a moderator's guide for questions regarding Federal activities in
communication, public consultation, and public participation related to
vaccines. They also developed a list of Federal employees as well as
former Federal employees; they asked them questions about what
activities have been good and bad and what direction things should go in
in terms of communication about vaccines. At this point, the 11
interviews have been completed. However, as a result of the interview
process, the Subcommittee was provided with the names of two more key
informants that need to be interviewed. ORISE is going to conduct these
two additional interviews. Once they have been completed, the
Subcommittee will decide whether they will do a formal qualitative
analysis of the information or if they will simply read the interviews
for content and review key literature on the subject.

Dr. Gellin asked what the Subcommittee's timeframe was in terms of
bringing something back to the entire NVAC Committee. Dr. Humiston
explained that they had no clear timetable as she is on sabbatical. Dr.
Gellin reiterated that the point of Subcommittees is to move things
forward. He stated that he would work with the other Subcommittee chairs
to determine how to move forward with the activities this Subcommittee
has identified.

**NVAC Vaccine Finance Working Group---Update---Dr. Guthrie S.
Birkhead**

Dr. Birkhead began his presentation by providing the Committee with a
brief summary of two studies that are underway by Dr. Freed. These
studies are funded by CDC, and the ideas for these studies were
suggested by this Working Group. He explained that the Working Group has
been waiting for this preliminary data in order to develop a White
Paper.

The first study was an assessment of private provider attitudes
regarding vaccine financing. The purpose of this study was to determine
the attitudes of private immunization providers regarding the purchase
of newly recommended vaccines and reimbursement for vaccine purchase and
administration. In this study, a survey was sent to a random sample of
pediatricians and family physicians across the Nation by mail.

Some of the draft findings of this study indicated that

-   A majority of physicians disagreed that reimbursement for vaccine
    and administration are adequate;

-   One-half of those surveyed indicated that they had delayed the
    purchase of vaccine in the last 3 years due only to financial
    issues; and

-   Approximately 11 percent of providers seriously considered stopping
    all vaccination services to privately insured patients in the past
    year.

The second study was an assessment of the charges and reimbursements for
vaccines and administration fees in private practices. The purpose of
this study was to determine the range of prices paid for
childhood/adolescent vaccines and administration fees charged and
reimbursement paid for each by their three largest insurers. This was a
telephone survey of practice managers, not the providers themselves.

Some of the draft findings of this study indicate that there is a wide
range in terms of the costs that practices are paying for vaccines and
the reimbursements they are receiving for vaccines. Data are being
collected on virtually all vaccines and all formulations. Dr. Birkhead
explained that the reason for the wide range in prices and reimbursement
is multifactorial. He also explained that a large-scale dropout of
providers is unlikely. The study also showed that it is clearly possible
to make money on vaccinations.

The timeline for the Vaccine Finance Working Group is as follows:

-   To complete the next draft of the White Paper by December 2007;

-   To hold a stakeholders' meeting to get input on the draft White
    Paper on January 8 and 9, 2008; and

-   To present the White Paper to the full NVAC for endorsement at the
    February NVAC meeting.

Dr. Birkhead concluded his presentation by explaining that perhaps the
future of the Working Group includes examining finance issues in adult
immunization.

***Discussion***

In order to not face the same issues experienced with the Adolescent
Immunization Working Group's White Paper, Dr. Humiston asked if the
Committee might be able to see a draft of the White Paper before the
February NVAC meeting. Dr. Birkhead explained that the draft document
will be shared prior to the public stakeholders' meeting.

In response to a question about the second set of data, Dr. Almquist
explained that these data are restricted as many practices have
contracts that state that they cannot give out this information.
Therefore, these data will be kept anonymous.

Mr. Brandes asked if the Working Group had communicated with the health
service research community as he recalled others collecting data of this
nature. Dr. Birkhead explained that he was not sure whether they were
contacted directly; however, the Working Group did conduct a literature
search before beginning these studies.

[]{.mark}

**Report: Subcommittee Update: Subcommittee on Vaccine Safety---Dr. Dan
Salmon**

Two main topics were discussed at the joint meeting of the Subcommittee
on Public Communication, Consultation, and Participation (PCCP) and the
Subcommittee on Vaccine Safety: The development of CDC's Immunization
Safety Office (ISO) research agenda and NVPO's activities in vaccine
safety and plans for future work of the Subcommittee.

In terms of the ISO research agenda, Dr. Broder provided the
Subcommittee with an update as to the group's activities. Based on a
recommendation from the IOM, the ISO is going through a process to
develop a research agenda to focus on the vaccine safety datalink.
During ISO's meeting with external consultants and the interagency
vaccine group meeting, the ISO discussed what their research agenda
would focus on. They are looking at research issues that should be
explored and not at the larger vaccine safety infrastructure. NVPO is
sponsoring a meeting with vaccine companies on November 16 where
representatives from the companies that manufacture vaccines that are
routinely recommended in the United States will review and comment on
what ISO has so far. CDC will then develop a draft research agenda,
which will be given to the NVAC Subcommittee on Vaccine Safety for their
comment.

In terms of NVPO's current vaccine safety activities, NVPO is in the
process of developing a comprehensive paper to review what is done by
the Federal Government to ensure the optimal safety of vaccines. The
document should be ready for wider distribution within the next few
months. Questions arose as to the intended audience of the document.
Therefore, the Subcommittee discussed the possibility of having
something more useful for the general public or for healthcare workers
to use to address patients' questions regarding vaccine safety.

The next step for the Subcommittee is to review this document as well as
the 1999 Vaccine Safety Action Plan and provide feedback. The
Subcommittee may develop a White Paper that would outline what the
safety system should look like according to the Subcommittee and NVAC.
To address these tasks, several consultants were invited to join the
Subcommittee.

**Strategic Issues in Vaccine Research Program---FY08 Review
Process---Dr. Benjamin Schwartz**

This year the NVPO had five priority categories for the program. A total
of 42 proposals were received this year, 20 of which address the
priority of standardizing immunological assays, 9 of which address
adolescent and adult immunizations, 5 of which address vaccine safety,
and 5 of which address vaccine financing. Most of the proposals come
from the various components at CDC and FDA, and one proposal came from
USAID.

The first phase of the review process includes a number of reviewers
from NVAC, the Federal agencies, and the NVPO reading and scoring these
proposals. The second phase will include an in-person meeting that will
take place in Washington, DC, tentatively on December 5. Last year, NVPO
was late getting money out to the agencies; therefore, this year they
are pushing for a quicker process.

***Discussion***

In response to a question about the abstracts, Dr. Schwartz explained
that he would need to e-mail the NVAC participants directly with their
specific assignments as to which proposals to review. He also hoped that
more NVAC participants would be willing to participate in the review
process. He emphasized that participants can be involved in either phase
1 or phase 2 or in both phases.

**Final Discussion and Public Comment---Dr. Guthrie S. Birkhead**

Dr. Gordon provided the Committee with information from another
conference he attended with Dr. Almquist on public trust in vaccines. He
explained that the dialogue between those who support vaccines and those
who do not, such as the autism groups, was constructive. He also
informed the Committee that transcripts from these conversations were
available. Dr. Birkhead asked if a specific report or recommendations
were going to come from this conference. Dr. Gordon responded that a
report would be available but that recommendations are not usually made.

[]{.mark}

With no further discussion or public comment, Dr. Birkhead thanked all
participants for their attendance and adjourned the meeting.

Appendix: Subcommittee Minutes

**Subcommittee on Vaccine Development and Supply---Chair: Dr. Cornelia
L. Dekker (Dr. Lance K. Gordon was acting chair for this session)**

Attendees: Alina Baciu, IOM; Dr. Norman W. Baylor, FDA; Dr. Karen Broder
(Lcdr., USPHS), CDC; Dr. George Curlin, NIH; Dr. Cornelia L. Dekker,
Subcommittee Chair (Telecon); Shannon Dzubin, Novartis; Dr. Scott K.
Fridkin, CDC (Telecon); Dr. Lance K. Gordon, NVAC Representative Member;
Dr. Phil Hosbach, sanofi pasteur; Eleanor Joseph, CRA International;
Megan Lindley, CDC; Alison C. Mawle, CDC (Telecon); Dr. Barbara Mulach,
NIAID/NIH; Jennifer Salesa, NVAC; Dr. Anne Schuchat, (Radm., USPHS),
CDC; Dr. Benjamin Schwartz (Capt., USPHS), NVPO; Dr. Ray Strikas,
(Capt., USPHS), NVPO; Dr. Richard Tardiff, ORISE; Elizabeth Thoburn,
Merck; Dr. Greg Wallace, CDC; Dr. Bruce G. Weniger, CDC (Telecon); Dr.
Laura York, Wyeth Vaccines Research; Keith Maynard, notetaker.

Dr. Gordon welcomed participants and turned the meeting over to Dr.
Dekker, who was participating by teleconference. She introduced the
agenda, which comprised (1) a discussion of the latest draft of the
report she is writing for the Subcommittee, addressing adjuvants and
dose sparing; (2) discussion of the Subcommittee's role in the
development effort for a new National Vaccine Plan; and (3) discussion
of a possible Subcommittee role with regard to *Staphylococcus*
vaccines.

**Draft Report: Dose Optimization Strategies for Vaccines: The Role of
Adjuvants and Other Technologies*---Dr. Cornelia L. Dekker, Subcommittee
Chair***

Dr. Dekker stated that the most current draft of Dose Optimization
Strategies for Vaccines: The Role of Adjuvants and Other Technologies,
dated October 17, 2007, reflected information received to date regarding
ongoing efforts of the Federal agencies. She asked for additional input,
with the goal of having the document completed for a telephone review by
the full NVAC committee and approval in early December. If that goal
cannot be met for administrative reasons, approval of the document would
be an agenda item for the February NVAC meeting.

Responding to the request for information on NIH-sponsored adjuvant
studies, Dr. Mulach stated that NIH grants for such studies were
available and research in the area was ongoing. Dr. Dekker will consult
with NIH colleagues and provide the information by e-mail.

Dr. Baylor, when asked, stated that research related to adjuvants was
ongoing at FDA but that he was not at liberty to discuss it. When asked
about any initiatives with regard to the development of FDA guidelines
similar to the WHO adjuvant guidelines, he stated that FDA recognizes
the need for such guidelines. He will provide a brief summary for the
report.

Dr. Schwartz stated that current NVPO adjuvant efforts were limited to
those related to pandemic influenza preparedness. He stated that there
is a need for research on the use of novel adjuvants with flu vaccines
where proprietary rights to the adjuvants and flu antigens are held by
different companies. The issues of access to proprietary technologies
and the supporting regulatory data packages necessary to enable such
research were discussed. Dr. Schwartz called for studies of H5N1
vaccines to be extended to subpopulations other than healthy adults,
such as elderly and immunocompromised individuals.

Dr. Schwartz said that NVPO, at one point, considered prioritizing the
Unmet Needs program funds to establishing new methods for FDA to
ascertain adjuvant safety. Although such exclusive funding did not
occur, research into such methods was still a priority.

Dr. Gordon pointed out that the report draft contains no reference to
the online version of the 1995/1999 compendium of adjuvants. He
indicated that these might provide additional current references. He
also stated that a new compendium was needed and asked those attending
if they could provide working lists currently in use in their agencies
for review and possible publication.

Dr. Baylor pointed out that a footnote was needed to table 4, stating
that only antigen/adjuvant vaccine formulations with publicly available
information are listed.

Next, Dr. Dekker asked for input regarding the research agenda outlined
in the current document. Dr. Schwartz stated that a possible expansion
of item 1, perhaps as item 1b, is stimulating research on adjuvant
employment issues and effector mechanisms. Dr. Baylor said the newer
adjuvants call for a new approach and that their possible pharmacologic
activities could have an impact on translational studies.

Dr. York stated that there was a need for information on immune
responses in various age groups. Dr. Hosbach added that information on
risks versus benefits was needed, and sourcing and scalability issues
should be considered. While some of these had been addressed,
proprietary concerns prevented resolution of others.

The discussion concluded with Dr. Dekker indicating that she would
provide the current draft document to any attendees, including
non-Subcommittee members, who requested it in an effort to ensure the
final report would represent a "best effort" by the Subcommittee. The
agency representatives were asked to provide their summaries of
currently sponsored research as soon as possible for inclusion into the
draft in order to inform the recommendations.

***The Development Effort for a New National Vaccine Plan---Dr. Ray
Strikas, NVPO***

Copies of the current draft of the National Vaccine Plan Update:
Priority Issues*,* dated October 18, 2007, were distributed along with
The Goals, Objectives, and Strategies of the National Vaccine Plan,
Chapter IV of the 1994 plan. As attendees reviewed the documents, Dr.
Strikas pointed out that the current draft included only input from
Federal Government agencies. He added that this draft had yet to address
any safety issues and addressed international issues only in the most
limited sense.

Dr. Gordon said that one objective for the current discussion was to
identify the role for the Subcommittee in the development process.
Clearly, he said, one issue is prioritization.

In response to a question of the timeline for the accomplishment of plan
goals, Dr. Strikas indicated it to be 2012 through 2015 based on
approval of the plan in 2009. Dr. Dekker observed that this timeline
would help in efforts of prioritization and determination of
specificity.

Dr. Wallace stressed that it was important to establish specific
criteria for prioritization. Dr. Gordon observed that the prioritization
methods employed in creation of the 1986 IOM report on priorities for
vaccine development were particularly effective and might be a good
place to start. He suggested that the plan now being drafted should call
for an annual addendum.

Dr. Hosbach reminded those attending that the National Vaccine Plan
would have a significant impact on industry. Dr. Strikas responded that
one specific intent of IOM involvement in the new plan's creation was to
ensure that manufacturers had some input to---and a degree of ownership
in---the final result. In response to Dr. Baylor's question of whether
the 1994 National Vaccine Plan significantly impacted the industry, Dr.
Gordon said yes although the 1985 IOM report's impact was even greater.

Dr. Baylor raised the question of whether the purpose of the plan had
yet been addressed. Dr. Gordon responded that he understood it was to
guide vaccine research and development (R and D) over the next 5 years.
Dr. Baylor responded that R and D was only part of the equation and that
the plan needed to address access---both to immunizations and to
healthcare---more broadly.

Dr. Schwartz said that NIH did not want to be so presumptuous as to tell
other agencies what research they should conduct. He said that R and D
represents less than 25 percent of preparedness overall and that
research by its nature does not lend itself to prioritization.

Dr. Schuchat stated that the plan's focus should be more on establishing
a strong research infrastructure than addressing a "laundry list" of
diseases. Dr. Gordon raised the point that the title of the Subcommittee
includes both "development" and "supply," which include much more than
research. With this in mind, suggestions regarding research might best
be general while those addressing development might well be specific.

Discussion of possible focus areas ensued.

**Action Item:** Those in attendance wishing to provide input to the
National Vaccine Plan should submit comments on the existing draft to
Dr. Strikas by November 2. There will be a conference call on November
8. Comments should address priorities and criteria for prioritization.
Comments can address specific diseases as well as broader methodologies
and enabling technologies.

Ms. Baciu, representing the IOM, reported that IOM efforts are currently
in their early stages but would include a broad spectrum of
stakeholders. Dr. Strikas will collect and process input from the
general public and provide resultant data to IOM for inclusion. IOM's
final report is targeted for March 2009 in support of the goal of
realizing a final plan by the latter part of 2009.

***Subcommittee Role With Regard to* Staphylococcus *Vaccines---Dr.
Cornelia L. Dekker, Subcommittee Chair***

Dr. Dekker opened the discussion by asking what the Subcommittee's role
should be, given the recent widespread national media coverage of
Methicillin-resistant *Staphylococcus aureus* (MRSA).

Dr. Schwartz said that MRSA had been a concern for a number of those
attending and that ACIP Chair Jon Abramson had, at one point, proposed
applying Unmet Needs funds to the problem.

Dr. Fridkin said the current focus to combat MRSA needs to be on the
hospital. This includes identifying the burden of disease across the
hospital population and characterizing trends to address appropriate
strategies for vaccination. Dr. Curlin said the NIH needs specific
information on community disease rates.

In the discussion that followed, Dr. Fridkin stated that CDC does have
samples of the strains in question. Dr. Gordon said that establishing
the burden of disease was key to any development efforts by industry.
Dr. York confirmed that identifying the subpopulations at highest risk
would be necessary for any proof-of-concept trials.

Dr. Curlin said that any efforts to combat MRSA had to be aimed at
management of infection and of clinical treatment at the provider level.
A number of efforts at developing vaccines are now being supported
through the NIH Clinical Trial Planning Grant Program (R34).

Dr. Schuchat suggested that *Staphylococcus* efforts would be a prime
example for informing the National Vaccine Plan. It might even suggest a
future path to financing such efforts.

Dr. Dekker proposed that this be an area of emphasis for the February
meeting and that she would invite an appropriate guest speaker to make a
presentation on efforts to fight *Staphylococcus* infection. Dr. Gordon
agreed but added that the National Vaccine Plan also should be addressed
at the Subcommittee's February meeting to ensure the Subcommittee
maintains an ongoing role in its creation. Also, he said he hoped that
additional NVAC members would join the Vaccine Development and Supply
Subcommittee.

Dr. Baylor observed that he was not sure that the Subcommittee has a
role with regard to *Staphylococcus* infection but that it "was in our
face" right now. His concern was that any efforts at this point would
simply be reactionary. Dr. Dekker again raised the point that these
efforts might provide a template for how to address emerging infectious
agents, and the meeting was adjourned.

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

Attendees: Dr. Faruque Ahmed, NCIRD/CDC; Dr. Guthrie S. Birkhead, New
York State Department of Health (NVAC); Dr. Jeffrey A. Kelman, CMS; Dr.
Charles Lovell, Jr., York Clinical Research (NVAC); Dr. Gina T. Mootrey,
NCIRD/CDC; Dr. Walter A. Orenstein, Emory University School of Medicine;
Dr. Wayne Rawlins, America's Health Insurance Plans; Dr. Lance Rodewald,
NCIRD/CDC; Dr. Jeanne Santoli, NCIRD/CDC; Dr. Phil Smith, NCIRD/CDC; Dr.
Raymond A. Strikas, HHS; Dr. Gary L. Urquhart, NCIRD/CDC; Dr. Adele E.
Young, George Mason University (NVAC); Melissa Athié, notetaker.

Dr. Jon R. Almquist began the Subcommittee meeting, per Dr. Gary L.
Freed's suggestion, by discussing what specific components of adult
immunization the Subcommittee on Immunization Coverage may want to take
on and/or address and by discussing what NVAC should be doing about
adult immunization coverage, even if it does not specifically fall
within the purview of this Subcommittee. Dr. Almquist opened up the
floor for discussion on this issue.

***Discussion on Subcommittee's Role in Terms of Adult Immunizations***

Dr. Charles Lovell, Jr., proposed looking at the public health sector as
a source of immunizations for adults rather than the private sector. He
wondered if patients should be directed to health departments for
immunizations and if health departments should be provided with more
education on adult immunizations. Because private offices are often
overwhelmed, Dr. Lovell asked for feedback from the Subcommittee
regarding what is the best site for administering adult immunizations.

Dr. Raymond A. Strikas responded by stating that no one site is best for
administering adult immunizations. He explained that about half of all
adults received their influenza (flu) vaccine at physicians' offices and
that a sizeable proportion received it in various other locations such
as clinics and senior centers. He explained that the workplace is the
second leading site for receiving the flu vaccine and that it is the
chief site, for people under 50 years of age, to receive the flu
vaccine. He did, however, recognize that this simply addresses the flu
vaccine and not other adult vaccinations. Dr. Strikas contemplated how
much more the public sector could do, in terms of adult immunizations,
in addition to what they are already doing. He asked various CDC members
to comment on what it would take to enhance the public sector and the
nonphysician office sector as a venue for delivering vaccines to adults.
He agreed that the workplace may be one of the most important options
but that workplaces have experienced frustrations in the past due to flu
vaccine supply shortages.

Dr. Almquist shared with the group that the Finance Working Group
received a report stating that the large insurers were considering not
involving the flu vaccine as it is cheaper for their members to go to
locations such as Walmart and Costco to receive the vaccine. He
explained that adults going to various locations to receive vaccines
would make it more difficult to record who has been immunized and to
then attach those data to an immunization registry. Dr. Almquist also
explained that not long ago, about 50 percent of childhood immunizations
were done in the public sector and that a minimum---15 percent or
so---are now done in the public sector while the majority of childhood
immunizations are given in the private sector. He explained that that
has made a difference in terms of coverage levels.

Dr. Adele E. Young pointed out the difference between adult immunization
as an entire topic and flu vaccination in terms of venue, delivery, and
uptake. She explained that we have to be careful not to confuse the
problems that are inherent with the yearly delivery of the flu vaccine
with the problems with adult immunizations. Dr. Lance Rodewald agreed
with Dr. Young's clarification between the flu vaccine and other adult
immunizations. He explained that there is a huge difference between a
vaccine series and a vaccine that is needed every year.

Dr. Lovell then commented on the complexity of the flu vaccine in terms
of the administration fees and managing the vaccine and vaccine
reimbursement. He explained that if the flu vaccine is going to be
administered in the private sector, an easier process needs to be
created.

Dr. Gina T. Mootrey then discussed one project that CDC will probably be
doing that was previously done in the 1990s for the pediatric
population. They initiated community action plans to see how grantees
could increase childhood immunization coverage. Currently, CDC is
thinking of a way to have a competitive process for similar plans for
adult immunizations for the grantees. Only some of the grantees would
come up with model plans for the other grantees. These plans would not
be implemented but would set the stage for the grantees to think about
what needs to be done to increase adult immunization coverage in their
jurisdictions.

Dr. Walter A. Orenstein mentioned the fact that in the United Kingdom,
physicians were given bonuses if certain vaccination coverage levels
were achieved. The result was that vaccination coverage levels
increased. He wondered if the United States was planning on doing
something similar or if that might even be feasible. Dr. Wayne Rawlins
responded by explaining that there are a variety of pay-for-performance
plans available for a variety of evidence-based activities. Most
insurers would value ways to encourage physicians to do the right thing
using incentives available, such as cash. However, the incentives need
to balance out, which may bring the need for negative incentives as
well. Dr. Rawlins did mention not wanting to reward people for doing the
wrong thing. In response to Dr. Orenstein's comments, Dr. Gary L.
Urquhart explained that there are health plans that pay up to \$250 per
patient for a completed pediatric series. The only catch to the plan is
that the vaccines have to be represented in the registry. He explained
that perhaps this plan would work with adults as well. Dr. Almquist
agreed that much like pediatric doctors offices, vaccination records are
going to go electronic for adults as well.

Dr. Lovell returned the focus of the discussion to the private sector
and stated that the challenges they face are different from those faced
by the workplace and public health facilities. He also explained that
the billing aspect in the private sector is too complex.

Dr. Jeffrey A. Kelman clarified that no Medicare part D plans provide
the influenza or pneumococcal vaccine and that this has always been a
part B benefit. He also mentioned that the Centers for Medicare &
Medicaid Services (CMS) recently completed a piloting project with CDC
that showed that flu vaccine uptake can be monitored to a very high
degree and that it can be linked to databases in real time.

Dr. Almquist reminded the group that when vaccination recommendations
become complex, uptake does not happen. He emphasized that the more
standard the recommendations, the more the uptake. If the
recommendations become too complex, it gives physicians an excuse not to
vaccinate. Dr. Young responded by emphasizing that while it is important
for recommendations to not be too complex, it is important not to simply
immunize anyone who wants to be immunized.

Dr. Almquist concluded the discussion by asking the Subcommittee if they
wanted to take the issue of adult immunization coverage on as a
challenge, and the Subcommittee agreed to this challenge.

***Update on Immunization Information System's (IIS) Stakeholder
Meeting---Dr. Gary L. Urquhart***

Dr. Gary L. Urquhart announced the fact that Dr. Alan R. Hinman's
article about Immunization Information Systems (IIS) was published in
the November edition of the Journal of Public Health Management and
Practice. There were four recommendations listed in Dr. Hinman's NVAC
report that addressed having meetings with stakeholders for various
purposes. The purpose of Dr. Bruce G. Gellin's letter, which accompanied
the article, was to invite people to attend a stakeholders' meeting to
debate the pros and cons of these recommendations and to develop action
plans as to how to proceed.

***Discussion on Immunization Information Systems (IIS)***

Dr. Almquist expressed hope that at least one member of the Subcommittee
would be able to attend the stakeholder meeting. Some discussion ensued
as to possibly changing the dates of the stakeholder meetings in order
to make it more feasible for members of the Subcommittee to attend.

Dr. Rawlins also mentioned the importance of including adult physician
groups in these stakeholder meetings even though the focus had been
primarily on pediatric populations. Dr. Almquist agreed as many of the
IISs already allow for the entry of adult data.

***Revisiting the Discussion on the Subcommittee's Role in Terms of
Adult Immunizations***

Dr. Rodewald revisited the issue of the Subcommittee on Immunization
Coverage's role in terms of adult immunizations. He wondered if there
should be a Working Group on adult immunizations or if this Subcommittee
should take on that role as it seemed to be the Subcommittee best
equipped to handle the issue.

Dr. Almquist expressed concerns about diluting the number of NVAC
members if a separate Working Group or Subcommittee was created to
handle the issue of adult immunizations. He offered the possibility of
creating Working Groups to address certain issues or areas of adult
immunizations. He also explained that the Financing Working Group was
doing a beautiful job of handling one of the Subcommittee's major issues
and that the Subcommittee had already addressed the issue of
immunization registries, so perhaps the possibility exists for this
Subcommittee to become an Adult/Adolescent Immunization Working Group.

Dr. Birkhead followed by explaining that the Financing Working Group was
currently focusing on childhood immunizations and that once that was
finished in the spring, they would move their focus to adult
immunizations. However, he also cautioned that the Financing Working
Group would not cover all issues related to adult immunization coverage.

Dr. Young mentioned her experience working with the Adolescent Working
Group and that the Working Groups seemed to move along quickly, meet
deadlines, and work well together while the Subcommittees never seemed
to get their teeth into anything.

Dr. Almquist responded by proposing that the Subcommittee tackle areas
that NVAC and other advisers felt needed to be dealt with immediately,
regarding adult immunizations, and then move into other areas. He
explained that the ultimate goal would be to have solutions ready for
when the new administration starts, approximately a year and a half from
now.

Dr. Jeanne Santoli reflected on Dr. Young's comments by explaining that
Working Groups work well because they are given a specific topic and
told to run with it. She explained that the same process could work for
Subcommittees as well. Dr. Birkhead agreed that Subcommittees needed to
be focused toward a specific goal, such as adult immunization coverage.

Dr. Lovell suggested the Subcommittee take on the task of framing or
outlining the scope of the problem, which is how to achieve higher
immunization rates for adults. He explained that once the Subcommittee
had created an outline, they could assign specific questions or
challenges to smaller groups to solve. He also explained that the
Subcommittee may be able to draw on the successes in pediatric
immunization.

Dr. Almquist concluded the discussion by suggesting that this group---be
it in the form of a Working Group or Subcommittee---take on the task of
modeling adult immunizations and working to identify strategies to solve
some of the problems experienced with adult immunizations. Dr. Birkhead
agreed and stated that the Subcommittee should identify the issues that
the group will address 2 to 3 years down the road. He also suggested if
there were no other immunization coverage issues that needed to be
addressed by this Subcommittee, that the Subcommittee possibly change
its name.

***Highlights of Recent Results from the New Health Insurance Modules of
the National Immunization Survey---Dr. Philip J. Smith, NCIRD/CDC***

Dr. Philip J. Smith provided the Subcommittee with a presentation
highlighting insurance results from the National Immunization Survey
(NIS). The purpose of his presentation was to share recent results from
the 2006 Health Insurance Module (HIM) of the NIS. During his
presentation, Dr. Smith also discussed the history of the 2001--02 HIM
and the history of the 2006 HIM and past and present uses of HIM data.

Dr. Smith began by talking about the history of collecting insurance
data for the NIS. Insurance data were collected on 24,514 children, and
their providers reported their vaccination history. Dr. Smith explained
that these data allowed CDC to learn about the use of "medical homes"
and whether children had public insurance or private insurance or they
were uninsured.

One research topic CDC investigated using the NIS data was the
association between having a medical home and vaccination coverage among
children eligible for the Vaccines for Children (VFC) program. Results
from that investigation showed that VFC-eligible children who have a
medical home and use it consistently to receive all vaccine doses can
have vaccination coverage rates that are comparable to non-VFC children
living in more affluent households.

Another research topic CDC investigated was the association between
childhood vaccination coverage, insurance types, and breaks in health
insurance coverage. Results from that study confirmed that children who
were insured with public insurance or who were uninsured were
significantly less well vaccinated than children covered by private
insurance. Results also showed that children who were covered by health
insurance at the time of the NIS interview and who had no breaks in
health insurance coverage were significantly better vaccinated than
children who were currently insured but who had breaks in coverage, than
children who were currently uninsured but previously insured, and than
children who were never insured.

Dr. Smith explained that the data from the 2001 to 2002 NIS HIM were
used to estimate the percentage of children who were VFC eligible by
State. The drawbacks to this survey revolved around confusion about
deductibles or copayments.

The data taken from the 2006 NIS HIM are being used to help allocate VFC
budgets to States, for estimating needs for 317 funding, and for
research on the underinsured. Improvements made in the 2006 NIS HIM
module included State-specific questions to determine whether children
were covered by Medicaid or the State Children's Health Insurance
Program (SCHIP) and an improved question about whether respondents'
insurance covered the entire cost of vaccines, excluding costs for
copays and office visits. The 2006 NIS HIM also contained national VFC
estimates for teenagers 13 to 17 years of age.

Dr. Smith first discussed 2006 NIS HIM data for 19- to 35-month-old
children. CDC plans to take these data and study the association between
vaccination coverage and being publicly insured, privately insured,
underinsured, and uninsured. So far, data have shown that since 2001,
the overall percentage of VFC-eligible children has not changed
significantly. However, there were significant increases in the
percentage of American Indian/Alaskan Native children between 2001 and
2006, and also among the uninsured. Research showed that most children
who have private insurance received vaccine doses at private facilities.

The 2006 teen survey included insurance data on approximately 5,468
teens between 13 and 17 years of age. As with the child survey, CDC will
continue to research the association between vacation coverage and type
of health insurance. The results from the teen survey showed that
approximately 34 percent of all 13- to 17-year-old teens were VFC
eligible, 23 percent were on Medicaid, 8.8 percent were uninsured, and
20.8 were underinsured at the time of the interview.

The Subcommittee meeting was adjourned.

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

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

Attendees: Robert Ball, FDA; Kenneth Bart, NVPO; Karen Broder (by
phone), ISO/CDC; Emma English, NVPO; Geoffrey Evans, HRSA/DVIC; Mark
Feinberg, NVAC; Meghan Ferris, FDA; Amy Geller, IOM; Bruce G. Gellin,
NVPO/NVAC; Sharon G. Humiston, NVAC; David Johnson, sanofi pasteur;
Erica Johnson, APCO; Nancy Lavine, CDC; Karen Midthun, CBER/FDA;
Christine Nevin-Woods, NVAC; Patrick O'Connor, FDA; Trish Parnell, NVAC;
Andrew Pavia, NVAC; Kristin Pope, ISO/CDC; Laura E. Riley, NVAC; Dan
Salmon, NVPO; Dixie Snider (by phone), ISO/CDC; John Stander (by phone),
ISO/CDC; Melinda Wharton, NCIRD/CDC; Andrea Savoye, notetaker.

Dr. Andrew Pavia began the joint Subcommittee meeting by welcoming
attendees and outlining the topics to be discussed during the meeting,
including updates on the CDC/ISO research agenda project and the
inventory of vaccine safety activities. Dr. Pavia also introduced Dr.
Dan Salmon of NVPO, whose responsibilities include coordinating Federal
vaccine safety issues and risk communications.

***Update on ISO/CDC Research Agenda---Dr. Karen Broder, ISO/CDC***

Dr. Karen Broder discussed key themes from the development of the ISO
research agenda focusing on phase 1 methods and findings. The overall
goal is to develop a comprehensive, scientifically robust research
agenda with extensive internal and external input. The research agenda
development is a three-phase process: (1) Develop draft agenda, (2)
allow NVAC to review agenda and provide feedback, and (3) respond to
feedback and update and finalize agenda. The process began in May 2007
and is expected to be completed in 18 months. Upon completion of the
research agenda, staff will consider how often it should be revised.

The phase 1 input has been organized into a framework divided into
research issues affecting a specific life stage and those issues that
cut across life stages. Some of the key research themes gathered so far
include

-   Specific vaccines; e.g., newly licensed vaccines; combination,
    annual, and pandemic influenza; bioterrorism and travel vaccines;

-   Vaccination practices; e.g., simultaneous vaccination, off-label
    use, clinical guidance for medical exemptions and causality
    assessment, reimmunization protocols;

-   Host factors,; e.g., gender, race, genetics, underlying conditions;

-   Clinical outcomes; e.g., demyelinating disorders, autoimmune
    disorders, allergic disorders, life-threatening disorders/death
    (including baseline rates);

-   Other areas; e.g., role in immune responses and vaccine adverse
    events, risk perception (e.g., autism).

To collect information for the agenda, ISO held an external scientific
consultancy meeting with representatives from various specialties,
including pediatric infectious diseases, adult infectious diseases,
obstetrics and gynecology, epidemiology, genomics, and immunology. An
Interagency Vaccine Group Meeting on the ISO Research Agenda included
participants from NVPO, FDA, HRSA, NIH, DoD, and CDC. A meeting with
vaccine manufacturer representatives is scheduled for November 16, 2007.

***Discussion***

In response to a question, Ms. Kristin Pope explained that research on
previously determined priorities was continuing while the new agenda was
being developed and that ISO was looking at the whole system to see if
current resources will meet emerging needs and to determine where gaps
(e.g., research, staffing, funding) exist and where resources need to be
shifted in order to make a more comprehensive agenda.

Dr. Broder noted that ISO has collected some non-research-related input
and that NVPO may play a role in coordinating this information across
agencies.

Ms. Trish Parnell asked if there were processes built into the
development of the agenda for public review. Dr. Broder noted that the
focus has been on scientific development and hoped that there would be a
mechanism for public review through the NVAC review process. Dr. Bruce
Gellin suggested that the NVAC wait until the agenda is completed to
determine the best way to solicit and incorporate public input.

Dr. Dixie Snider noted that ISO would like NVAC's assistance in
developing a process that is fair, open, and worthy of the public's
trust. Dr. Pavia suggested that NVAC review the finalized agenda and
produce a "next steps" White Paper.

***Next Steps in Developing ISO Research Agenda***

***NVPO Sponsored ISO/Industry Meeting---Dr. Karen Broder, ISO/CDC***

An NVPO-sponsored meeting with vaccine manufacturer representatives is
scheduled for November 16, 2007. ISO staff will collect additional
external input for the research agenda at this meeting. In general,
participants will be asked to provide input on their areas of concern,
clinical outcomes they would like considered, and their ideas on
research prioritization. A briefing book will be sent out to
participants prior to the meeting.

***Addition of Consultants for Safety Subcommittee---Dr. Dan Salmon,
NVPO***

Dr. Salmon discussed the expansion of the Safety Subcommittee to include
experts in immunology, epidemiology, biostatistics, genomics,
toxicology, pharmacology, neurology, internal child/health medicine, and
others to provide a broad panel for the NVAC review of the ISO research
agenda. Invitations have been sent to representatives from the various
fields, and many have accepted.

***Inventory of Federal Vaccine Safety Activities---Dr. Dan Salmon,
NVPO***

NVPO is coordinating an inventory of Federal vaccine safety activities
to compile the "story" of the Federal Government's role in immunization
safety. The inventory will detail the processes required for a vaccine
to be licensed, concentrating on the work of Federal agencies, but also
including FDA's guidance and oversight of the work completed by the
pharmaceutical industry. The inventory is intended for the public and
will be written at a level accessible to an educated public without a
science background. The document is in final draft form. Once the
inventory goes through clearance (approximately 6 to 8 weeks), Constella
staff will format it into a more user-friendly document.

The Subcommittee on Vaccine Safety will review the document, critique
the safety system as a whole, make recommendations related to
improvements (e.g., linking databases, addressing gaps and
redundancies), and include a vision for the near future. This review
will be presented in the form of a White Paper.

***Discussion***

Committee members discussed the need for sharing the inventory's safety
message with a broader audience and suggested secondary products that
may include versions written at appropriate reading levels and with an
appropriate amount of detail for target audiences; e.g., parents,
pregnant women, older adults.

On September 27, 2007, the FDA Amendments Act of 2007 was signed into
legislation. Dr. Pavia noted that it would be useful to have a summary
of this legislation presented at the February 2008 NVAC meeting.

***Next Steps in Federal Vaccine Safety Infrastructure and Role for the
NVAC---Dr. Andrew Pavia, NVAC***

Dr. Pavia discussed a new framework for working on the goals of
NVAC---instead of static Subcommittees, goal-specific work would be
conducted in Working Groups that would meet for finite periods of time;
i.e., until goal is achieved.

***Discussion***

Subcommittee members were positive about this potential transition and
suggested a consensus process for selecting priorities.