Skip Navigation
  • Text Size: A A A
  • Print
  • Email
  • Facebook
  • Tweet
  • Share
  • Print
  • Email
  • Facebook
  • Tweet
  • Share

National Vaccine Advisory Committee (NVAC)

February 3–4, 2010, Meeting Minutes

 

Meeting Overview

The Committee approved the 2009 State of the Program Report describing accomplishments to date and priorities for the coming year. Howard Koh, M.D., M.P.H., the Assistant Secretary for Health (ASH), explained how the Department of Health and Human Services’ (HHS’) H1N1 response reflects NVAC’s priorities around communication, financing, and vaccine safety. Dr. Koh described other HHS initiatives in which NVAC’s advice would be welcome. The Committee discussed and expressed support for most of the recommendations made by the Institute of Medicine (IOM) on the National Vaccine Plan; NVAC will finalize a formal assessment of the IOM recommendations and prioritize the National Vaccine Plan objectives. The Centers for Disease Control and Prevention (CDC) Immunization Safety Office (ISO) summarized some of its responses to NVAC’s recommendations on the CDC ISO 5-Year Scientific Research Agenda.

RADM Nicole Lurie, M.D., M.S.P.H., Assistant Secretary for Preparedness and Response (ASPR), outlined how HHS will begin evaluating the H1N1 response and undertake a broad review of public health emergency response countermeasures. Representatives from CDC, the Health Resources and Services Administration’s (HRSA’s) Countermeasures Injury Compensation Program, and State and local partners gave updates on the H1N1 response. A recurring topic throughout the meeting was the need to maintain and build upon the public health infrastructure that was bolstered by the H1N1 response.

The National Vaccine Program Office (NVPO) described steps taken toward implementing NVAC’S adolescent vaccine financing recommendations, and the National Opinion Research Center (NORC) presented some preliminary data on the costs of providing first-dollar coverage of vaccines for adolescents. The Committee received updates from the Vaccine Safety Working Group (VSWG) and the Adult Immunization Working Group (AIWG). The H1N1 Vaccine Safety Risk Assessment Working Group (VSRAWG) summarized its findings supporting the safety of the H1N1 vaccine on the basis of data gathered so far. The Committee also heard presentations on proposed Congressional health care reform legislation, NVPO’s message mapping research project and communication goals for 2010, the new strategic plan for the Vaccines for Children (VFC) Stockpile, and NVAC liaison activities.

Committee Members in Attendance

Guthrie S. Birkhead, M.D., M.P.H., Chair

Jon R. Almquist, M.D.

Tawny Buck (by phone)

Cornelia L. Dekker, M.D.

Mark Feinberg, M.D.

Clement Lewin, Ph.D., M.B.A.

James O. Mason, M.D., Dr.P.H.

Marie McCormick, M.D., Sc.D. (by phone)

Julie Morita, M.D.

Christine Nevin-Woods, D.O., M.P.H. (by phone)

Trish Parnell

Andrew T. Pavia, M.D.

Laura E. Riley, M.D. (by phone)

L. J. Tan, M.S., Ph.D.

Executive Secretary

Bruce G. Gellin, M.D., M.P.H., Deputy Assistant Secretary for Health (DASH) and Director, NVPO

ASH

Howard Koh, M.D., M.P.H.

NVAC Ex Officio Members

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

COL Renata Engler, Department of Defense (DoD)

Geoffrey Evans, M.D., HRSA, Vaccine Injury Compensation Program (VICP)

Barbara Mulach, Ph.D., NIH (for George Curlin, M.D., on day one)

RADM Anne Schuchat, M.D., U.S. Public Health Service (USPHS), CDC

Michael Hodgson , Department of Veterans Affairs (VA, for Ronald Valdiserri, M.D., M.P.H.)

Melinda Wharton, M.D., M.P.H., CDC

Terry Watkins Bryant , HRSA (for Kyu Rhee, M.D., M.P.P.)

NVAC Liaison Representatives

Anne Bailowitz, M.D., M.P.H., National Association of County and City Health Officials (NACCHO)

Magdalena Castro-Lewis, Advisory Commission on Childhood Vaccines (ACCV, by phone)

Claire Hannan, M.P.H., Executive Director, Association of Immunization Managers (AIM)

XXX , U.S. Department of Agriculture (USDA, for Rick Hill, D.V.M., M.S.)

Paul Jarris, M.D., Association of State and Territorial Health Officials (ASTHO)

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

Jose Romero, M.D., Vaccines and Related Biological Products Advisory Committee (VRBPAC, for John Modlin, M.D.)

XXX , Public Health Agency of Canada (for Marhnaz FarhangMehr)

Invited Speakers

Vito Caserta, M.D., HRSA

Frank DeStefano, M.D., M.P.H., CDC

Caya Lewis, M.P.H., Director of Outreach and Public Health Policy, Office of Health Reform, HHS

RADM Nicole Lurie, M.D., M.S.P.H., ASPR

Stephanie Marshall, NVPO

Michael O’Grady, Ph.D., NORC at the University of Chicago

Lance Rodewald, M.D., CDC

Dan Salmon, Ph.D., M.P.H., NVPO

CDR Angela Shen, NVPO

CAPT Raymond A. Strikas, M.D., USPHS, NVPO

Day 1—February 3, 2010

Opening Remarks, Introduction, and Report of the Chair—Guthrie S. Birkhead, M.D., M.P.H.

Dr. Birkhead welcomed the participants and summarized the agenda for the meeting. He highlighted some of the main recommendations from the RAND Corporation’s evaluation of NVAC and some steps already taken by NVAC in response:

RANDRecommendation: NVAC should seek input on HHS priority issues via regular meetings with the ASH so that NVAC addresses those areas of concern to the agency.

Response: NVAC has been communicating more frequently with the ASH since Dr. Koh was named to that position.

RANDRecommendation: NVAC’s recommendations should be written with more specificity, identifying who should be responsible for implementing the recommendation and suggesting timelines for completion. In crafting recommendations, NVAC should think strategically about reaching the targeted audience with recommendations that are clearly written and feasible.

Response: NVAC has established a summary of action items and recommendations (a.k.a., the grid) that indicates the responsible party(s), due date, and status of each.

RANDRecommendation: NVAC should monitor the status of implementation of its recommendations.

Response: NVAC hopes to make review of past recommendations a regular occurrence, starting with the update during this meeting on the status of the 2008 adolescent vaccine financing recommendations.

Dr. Birkhead outlined recent NVAC accomplishments, which are noted in NVAC’s 2009 State of the Program report:

  • Monthly NVAC teleconferences since November, primarily focused on H1N1 influenza vaccination, which have facilitated stakeholder engagement and State input with Federal partners
  • Establishment of the VSRAWG to review evidence
  • Review of the draft National Vaccine Plan
  • Publication of a supplement to the journal Pediatrics on financing childhood and adolescent vaccines (December 2009), including recent scientific research and NVAC’s white paper and recommendations

Committee members suggested some additions to the 2009 report, which will be posted on the NVAC website once finalized.

Action Item

The State of the Program Report was approved with the following changes:

  • The NVAC progress grid will be added as an appendix. The grid will be edited down to include recent progress only.
  • In response to the RAND Corporation’s recommendation that NVAC raise its public profile, the report will include as a priority for 2010 that NVAC will explore ways to increase public awareness about and media coverage of NVAC activities. In addition, NVAC will consult with NVPO about whether and how to publicize key points of the 2009 State of the Program Report.

The minutes of the August, September, and November meetings were approved unanimously as written. Proposed 2010 meeting dates for NVAC are June 2–3 and September 14–15.

Welcome of the ASH—Howard Koh, M.D., M.P.H.

Dr. Koh thanked NVAC for its work, emphasizing that the group’s contributions are greatly appreciated and that it has helped spotlight the importance of vaccine availability, communication, and safety as the H1N1 pandemic spread. He applauded Bruce G. Gellin, M.D., M.P.H., and his staff as outstanding scientific leaders. Dr. Koh said the ASH oversees 13 offices in HHS, including the new Office of Adolescent Health, which will focus initially on pregnancy prevention but will broaden its scope to other issues, such as vaccines.

In September, NVAC identified for the ASH its three main areas of focus: communication, financing, and safety. Dr. Koh said HHS focused heavily on communication in June as it began developing a strategy for H1N1 vaccination. With the H1N1 vaccine, some insurance companies did provide first-dollar coverage, as recommended by NVAC, but much more remains to be done in that arena. NVAC asked for a clear Federal plan to monitor vaccine safety, and HHS implemented weekly teleconferences on vaccine safety communication across multiple departments, including DoD and VA, which resulted in a plan that is available online at Flu.gov. In addition, several Federal agencies enhanced active surveillance of vaccine safety, and NVPO launched the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) surveillance program, a public-private partnership that combines information from Vaccine Safety Datalink, several large health insurance plans’ databases, and State vaccine registries. Dr. Koh said HHS Secretary Sebelius was so impressed by the PRISM system that she cited it to demonstrate one way the Federal government effectively responded to the challenge of vaccine safety monitoring.

NVAC asked that more scientific evaluation of the background rates of disease (i.e., diseases that could be expected to occur regardless of the timing of vaccination) be communicated to the public, and a recent paper published in the Lancet helped in that regard. The VSRAWG has helped improve the transparency of H1N1 vaccine safety monitoring and received tremendous positive feedback. Dr. Koh said he appreciated NVAC’s emphasis on these issues, as it spurred the agency into action.

Dr. Koh noted his top three priorities, saying vaccines fit into all three:

  • Make the Healthy People goals come alive for those around the country.
  • Reduce disparities and improve equity in health and health care.
  • Implement a better system for preventive health care.

In terms of the Healthy People goals, Dr. Koh asked for NVAC’s input on how to evaluate and track the target vaccination rates. He also asked for advice on tackling health disparities. HHS has launched a department-wide committee to evaluate viral hepatitis, and Dr. Koh hoped NVAC would weigh in on the role of hepatitis B vaccination. He also welcomed communication with the new Office on Adolescent Health, such as NVAC input on human papillomavirus (HPV) vaccine and other vaccines. He added that NVAC’s input on the National Vaccine Plan will be vital to its success.

Dr. Koh concluded by noting that the budget proposed by Sec. Sebelius and President Obama includes more funding for medical countermeasures, including vaccine distribution, and more funding for NIH research and NVPO efforts.

Discussion

Andrew T. Pavia, M.D., asked Dr. Koh to outline the best process for identifying how NVAC can support the ASH’s goals. Dr. Koh reiterated the specific topics he cited in his presentation. He felt that NVAC is a model advisory committee. Dr. Koh suggested NVAC consider creating a working group to review the Healthy People 2010 goals and the proposed 2020 goals, evaluate the current data, identify gaps and disparities, and make recommendations.

National Vaccine Plan Status Update

Timeline for Strategic Plan—CAPT Raymond A. Strikas, M.D., USPHS, NVPO

CAPT Strikas said the current draft of the plan describes many objectives but lacks prioritization to help guide the Department’s efforts over the next 10 years. NVPO will incorporate the feedback it receives from NVAC after this meeting into the plan and post the resulting draft for public comments. The RAND Corp. will gather input from stakeholders. NVPO hopes to finalize the draft by June 2010 so that the first steps to implementation can be included in the 2012 budget. Once the plan is finalized, NVPO will begin working on an implementation strategy.

CAPT Strikas said NVPO agrees with most of the recommendations put forth by the IOM in its review of priorities in the plan. He gave NVPO’s responses to some recommendations with which NVPO does not fully agree or that merit more analysis, but he added that NVPO does not have the last word:

IOM Recommendation 1-4: Include therapeutic vaccines and vaccines against noninfectious diseases in future iterations of the plan.

NVPO response: Although the recommendation addresses an important area of the vaccine enterprise, NVPO was charged only with addressing vaccines against infectious diseases in the plan.

IOM Recommendation 2-3: Establish a permanent vaccine safety review committee.

NVPO response: NVPO seeks input on how to build on initiatives such as the VSRAWG for H1N1 vaccine.

IOM Recommendation 3-1: Develop a national communication strategy on vaccines for the public and health care providers.

NVPO response: More efforts may be needed to address this recommendation.

IOM Recommendation 4-2: Include strategies to eliminate financial barriers to vaccination.

NVPO response: Reducing financial barriers is a more achievable goal than eliminating them.

IOM Recommendation 6-1: HHS should support the plan by declaring it the primary strategic plan for the Federal government and allocating more resources to NVPO.

NVPO response: NVPO seeks input on how to implement such a recommendation.

Finally, IOM identified three criteria for prioritizing the objectives of the plan, and NVAC added a fourth:

  1. What is the feasibility, both financial and technical, of accomplishing the objective?
  2. What is the potential impact on morbidity and mortality?
  3. Does the objective represent a strategic opportunity that is likely to require or motivate involvement of multiple stakeholders?
  1. What is the public salience; i.e., how important is the objective to the public, in the context of the top five priority activities identified through the public engagement process?
  • Making vaccines affordable and available to all
  • Ensuring high rates of vaccination among children
  • Improving vaccine monitoring and disease monitoring
  • Improving vaccine safety
  • Ensuring there is enough vaccine

Discussion

Dr. Pavia argued in favor of setting a goal of eliminating financial barriers while recognizing that some factors will be beyond control. Bob Bednarczyk summarized the comments sent by six NVAC members in response to a request for input into the IOM priorities, which he distilled into 15 recommendations. Following some discussion, the Committee members agreed to further review the recommendations and continue the discussion in the time allotted on day two.

VSWG—Andrew Pavia, M.D.

Dr. Pavia said the VSWG has been gathering information to support its charge of reviewing current Federal vaccine safety systems. It has established five subgroups, three of which will address content concerns (structure/governance, epidemiology/surveillance of adverse events, and biologic mechanisms of adverse events), and two that deal with the process of making recommendations on safety systems (stakeholder engagement and implementation). The major topics of discussion so far have been:

  • evaluating the knowledge base;
  • understanding communication needs;
  • understanding the current response to known vaccine injuries;
  • improving public confidence; and
  • improving leadership, transparency, coordination, and the process of vaccine safety monitoring.

The VSWG is developing criteria that would help illuminate what an optimal safety monitoring system would look like by clarifying, for example, measures of effectiveness. Dr. Pavia emphasized that the VSWG is unlikely to identify a single set of recommendations but rather will summarize the pros and cons of several policy options. In addition, the VSWG will take into consideration the feasibility of its recommendations in terms of political will, administrative infrastructure, costs, and resources.

Dr. Pavia said the VSWG will develop several policy options and present them for consideration by stakeholders at a series of meetings. He anticipated that, initially, small gatherings of stakeholders would focus on the details of evaluation criteria, followed by larger meetings for broader input from stakeholders and the public. The VSWG proposes to provide its recommendations and white papers to NVAC at the September 2010 meeting. Dr. Pavia said the VSWG hopes its recommendations align with those of the National Vaccine Plan.

Discussion

Paul Jarris, M.D., raised concerns about the political will of stakeholders to support improved vaccine monitoring, given that Congress recently decreased funding for vaccine administration infrastructure in the Immunization Grant Program (a.k.a., Section 317) while increasing the amount for vaccine purchase. Dr. Pavia agreed on the need to look closely at the feasibility of the VSWG’s recommendations and said that, for this reason, separate subgroups were established for implementation and epidemiology/surveillance.

VSRAWG—Marie McCormick, M.D., Sc.D.

Dr. McCormick said the VSRAWG met bi-weekly starting in November to evaluate surveillance data and clinical trials findings from various Federal agencies as well as PRISM. Its conclusions were endorsed by NVAC and transmitted to the ASH:

  • The data are adequate to assess the presence or absence of a signal (i.e., an event that could be temporally related to administration of a vaccine and that occurs more often than would be anticipated by chance alone).
  • The data do not favor a signal between the outcomes examined and the H1N1 vaccines.

The Working Group plans to continue meeting and reporting monthly to NVAC.

Discussion

Dan Salmon, Ph.D., M.P.H., clarified that the VSRAWG was charged to meet for six months after the Federal H1N1 vaccination program ends. Dr. McCormick felt there would be data that should be reviewed but that will only be available several months from now. She also felt the VSRAWG could assist the VSWG with its proposed white papers. Dr. Birkhead suggested the VSRAWG consider summarizing its work in a final report.

Although the VSRAWG only evaluates domestic data, Dr. Gellin pointed out that information is shared with other countries through the World Health Organization and other mechanisms. He emphasized that the United States is using different vaccines from other countries, so data are not always comparable. Dr. Birkhead said the VSRAWG may be a model for other advisory groups. Mark Feinberg, M.D., hoped the VSRAWG’s findings would put to rest questions about the association of H1N1 vaccine with Guillain-Barré Syndrome (GBS).

James O. Mason, M.D., Dr.P.H., asked whether the Lancet’s retraction of a 1998 article that linked the measles-mumps-rubella (MMR) vaccine with autism should be mentioned in a VSWG white paper. Dr. Gellin said it is important to communicate that information to the public.

Action Items

VSRAWG will begin drafting a final report summarizing its work over the past several months in more detail.

VSRAWG will continue to report to NVAC periodically via teleconferences.

CDC ISO 5-Year Scientific Research Agenda—Frank DeStefano, M.D., M.P.H., CDC

Dr. DeStefano said the ISO plans to implement many of the recommendations made by NVAC on its five-year research agenda and will work with NVPO on those that fall outside the scope of the ISO. The ISO will harmonize its agenda with the National Vaccine Plan. Dr. DeStefano summarized the ISO’s responses to nine of NVAC’s 32 recommendations:

NVAC Recommendation 1: Develop research topic sections on vaccines and vaccination practices, special populations, and clinical outcomes with testable research questions that can be hypothesized.

ISO Response: ISO will generate a list of testable hypotheses; Dr. DeStefano presented a list of criteria for prioritization.

NVAC Recommendation 2: Obtain periodic external review of the research agenda.

ISO Response: ISO supports the recommendation. In addition to peer review, ISO will provide updates to NVAC. Stakeholders meetings may be one mechanism for review.

NVAC Recommendation 5: Research advanced approaches to safety monitoring, including in situations of potential mass vaccination, off-label use, or use in new populations.

ISO Response: This recommendation has been partially implemented as part of the H1N1 response.

NVAC Recommendation 6: Coordinate with other agencies to support basic research into the biologic mechanisms of adverse events following immunization.

ISO Response: ISO supports the recommendation. It may be helpful for NVPO to coordinate research on adverse events at the national level.

NVAC Recommendation 7: Seek an external expert committee to review the feasibility and other considerations of a study comparing vaccinated and unvaccinated children.

ISO Response: ISO is working with NVPO on implementing this recommendation.

NVAC Recommendation 9: Conduct risk communications research.

ISO Response: This recommendation reflects an agency-wide priority, and ISO has already begun some research as part of the H1N1 response.

NVAC Recommendation 10: Increase and improve the quality of the Vaccine Adverse Events Reporting System (VAERS) reporting.

ISO Response: This recommendation has been partially implemented as part of the H1N1 response. ISO plans to increase outreach to the public and providers via the media and medical societies. Quality could be improved with improvements in electronic reporting.

NVAC Recommendation 11: Evaluate approaches to follow up on VAERS reports of unusual or rare events, including methods to collect biological specimens when appropriate.

ISO Response: Activities regarding this recommendation are ongoing. NVPO is funding a conference in April 2010 on expanding biospecimen repositories.

NVAC Recommendation 17: Include vaccination of children with mitochondrial dysfunction/disease or other metabolic disorders as a priority area for research to develop clinical guidance.

ISO Response: Activities regarding this recommendation are ongoing.

ISO will present NVAC with a written response to its recommendations that indicates the changes made to the research agenda.

Discussion

Dr. DeStefano said the risk communications research undertaken as part of the H1N1 response revealed the need to develop messages and tools that providers can use in communicating with parents and patients. Risk communication messages must be balanced with vaccine management needs (e.g., limiting vaccine to priority populations). Melinda Wharton, M.D., M.P.H., added that CDC sees risk communication as a component of informed decision-making. She said providers may benefit from tools and messages that focus on balancing risks and benefits.

Dr. DeStefano said that as CDC evaluates its H1N1 response in relation to vaccine safety, it may look more closely at the effectiveness of PRISM and other safety monitoring efforts. The VSRAWG may be helpful in this regard. Dr. Feinberg suggested CDC publicize what it did to monitor H1N1vaccine safety so that future responses will not be constrained by misinformation or misplaced fears. Dr. Jarris and Dr. Pavia both emphasized the need for more and better communication with providers about vaccine safety and efficacy.

Update from the ASPR—RADM Nicole Lurie, M.D., M.S.P.H.

Dr. Lurie thanked NVAC for its advice to the agency on the H1N1 pandemic. She emphasized that as HHS evaluates the H1N1 response, it will focus on continuous quality improvement and rapid-cycle improvement. Compiling the lessons learned will include gathering input from a broad swath of stakeholders to identify major issues, then working with an external group to sort out the key themes and determining how they align with HHS activities. The process should identify successes, areas for short-term improvement, and systemic challenges. The HHS findings will be combined with those of the Department of Homeland Security and others and submitted to President Obama for consideration. HHS is also looking at the contract and procurement process.

Dr. Lurie said HHS hopes to build on the initiatives put in place to monitor and communicate about H1N1 vaccine safety. The H1N1 media tabletops were particularly helpful in ensuring that reporters understood the issues, she thought. Dr. Lurie asked for input from NVAC on the success of its efforts around vaccine safety. She emphasized the importance of instilling public confidence in vaccines and hoped HHS’ efforts would make an impact.

The H1N1 pandemic demonstrated gaps in the system, as five of the largest vaccine manufacturers were unable to produce enough H1N1 vaccine to meet demand at its peak. The United States needs a new model for getting needed countermeasures to market. Dr. Lurie has been charged with leading an end-to-end review of countermeasures, from discovery to development to distribution and delivery. The H1N1 pandemic did bring some pleasant surprises, said Dr. Lurie, such as demonstrating the extraordinary capability of public health providers. Initially, the countermeasures review will focus on market forces, incentives, and business and regulatory models that affect the development of countermeasures for public health threats, whether manmade or natural. Eventually, the review will address distribution and delivery. The review should dovetail with the National Vaccine Plan. The IOM and the National Biodefense Science Board will both meet in February to provide their input, and Dr. Lurie welcomed advice from NVAC as well.

Discussion

Dr. Birkhead said NVAC would like a formal opportunity to give input on the lessons learned. He noted that NVAC has convened representatives of various advisory committees and also State liaisons. NVAC already has scheduled monthly meetings and the VSRAWG, which could serve as platforms for gathering stakeholder input. Dr. Lurie asked for specific suggestions on a process that recognizes the many stakeholder perspectives and the overlapping interests of multiple communities.

Dr. Lurie offered more details about the countermeasure review process. By March 31, Dr. Lurie anticipates presenting Sec. Sebelius with a framework that describes how to improve the current system through collaboration across Federal agencies and departments. At present, HHS is considering how the countermeasures enterprise can be better integrated into the public health response in general. For example, some countermeasures may have more practical public health indications, and evaluation of such opportunities should not be constrained. Dr. Pavia recommended and Dr. Lurie agreed that HHS should seek to involve Congressional staff in its countermeasures deliberations early on so that it can build support for statutory changes and funding to support its recommendations.

Childhood and Adolescent Vaccine Financing Recommendations Update—CDR Angela Shen, NVPO

CDR Shen outlined the progress to date on the recommendations, noting that NVPO had provided cost estimates on nearly all of the recommendations, and the recommendations were published in the December 2009 supplement to Pediatrics. Many of the proposed actions are contingent on the passage of Federal health care reform legislation. For each of the 24 recommendations, CDR Shen indicated to whom it was directed (e.g., Congress, health care providers, insurers) and what stakeholders are doing (or could do) to support it. Some areas in which progress has been made are as follows:

  • The American Medical Association (AMA) approved two new vaccine administration codes for 2011 that enable discrete reporting of each vaccine antigen. The Centers for Medicare and Medicaid Services (CMS) is considering the AMA’s valuation for its 2011 reimbursement guidelines.
  • Some manufacturers implemented programs to reduce the financial burden on providers, such as flexible payment plans, volume discounts, return programs, and support for staff on getting reimbursement.
  • The American Academy of Pediatrics (AAP) updated its guideline “The Business Case for Pricing Vaccines and Immunization Administration” and allowed free online access to the Pediatrics supplement on vaccine financing.
  • Some AAP chapters are pursuing group purchasing options, and AAP is offering supporting materials online.
  • Provider organizations, manufacturers, employers, payers, and insurers are all developing or supporting education for employers about vaccination.
  • Model contract language to support flexible benefits (so that newly recommended vaccines are covered) has been developed but has led to questions about potential antitrust violations.
  • AAP has endorsed the principle of first-dollar coverage.
  • NVPO is studying provider payment and reimbursement practices.
  • The Office of the Assistant Secretary for Planning and Evaluation presented to NVAC preliminary data on the estimated increases to insurance premiums that would result from covering all recommended vaccines.
  • Consumer advocates helped secure $300 million under the American Recovery and Reinvestment Act (ARRA) for Section 317.
  • The H1N1 vaccine program provided an opportunity to educate providers about VFC and increased VFC provider participation.
  • ASTHO will publish guidance for State and local health departments on billing insured children served by the public health sector, and manufacturers offer software to assist with such billing.

Discussion

Dr. Pavia suggested another round of feedback and analysis because so many of the recommendations depend heavily on the ultimate outcome of health care reform. Dr. Birkhead asked those who worked on the recommendations representing various sectors to provide a brief update. Lance Rodewald, M.D., of CDC pointed out that CMS is considering updating the vaccine administration fee and also reviewing the mechanisms States use in charging administration fees. Lance Gordon, Ph.D., noted that manufacturers have been supportive of the recommendations, but none of the provider assistance programs described have yet been implemented. Dr. Jarris said State and local health departments are suffering from dramatic budget cuts, and funding from ARRA and Public Health Emergency Response (PHER) grants will end shortly. He emphasized the need to continue supporting the public health infrastructure and to look broadly at improving the entire vaccine system. Alan Rosenberg said most insurers did provide first-dollar coverage of vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) for children through employer-based plans, and all of the plans waived customer costs for the H1N1 vaccine. Jon Almquist, M.D., said the new AMA codes would help providers with billing, and providers are supporting cooperative efforts by AMA, AAP, and manufacturers to implement bar-coding that would improve tracking and efficiency.

Julie Morita, M.D., supported a follow-up conference to the 2007 AAP-AMA Immunization Congress [DT5] that addressed vaccine finance and access issues, and L. J. Tan, M.S., Ph.D., said AMA would be delighted to work with AAP on that. Clement Lewin, Ph.D., M.B.A., suggested NVAC should review progress on its recommendations annually.

Several participants indicated the costs and logistics of giving vaccines are prohibitive to many providers. The role of CMS in setting administrative fees was again raised.

Action Item

NVPO will alert NVAC when CMS publishes notices of proposed rulemaking about changes to the vaccine administration fees in the Medicare and Medicaid programs.

Draft First-Dollar Coverage Policy Brief—Michael O’Grady, Ph.D., NORC at the University of Chicago

Dr. O’Grady described the methods used by NORC to analyze the real costs of first-dollar coverage of vaccines and presented some preliminary findings. Through literature reviews, merger and analysis of databases, and interviews with experts in coverage decision-making, NORC seeks to determine what consumers actually pay now for vaccines and how coverage changes would affect them. Preliminary data appear to confirm the hypothesis that the cost of vaccines is a barrier to immunization. For example, 94 percent of those whose insurance benefits provide first-dollar coverage for MMR vaccination for children between 18 and 35 months do have their children vaccinated, compared with 75.7 percent of those whose plans require some cost-sharing.

Dr. O’Grady noted that providing first-dollar coverage to all beneficiaries would mean covering costs for a number of people (in the example above, over 75 percent) who were willing to pay for the vaccine when they had cost-sharing. The estimated return on investment of first-dollar coverage varies by the type of vaccine and population. Also, the rates of vaccination are much higher for those vaccinations that are required for school admission. Vaccination rates are lower among those who are covered by public health programs, suggesting socioeconomic factors other than the cost of the vaccine affect uptake.

Dr. O’Grady noted that further analysis will look at vaccination in older children, and attitudes about vaccination vary by age and vaccine. He suspected that first-dollar coverage might increase vaccine uptake but not lead people to comply fully with all vaccine recommendations (e.g., influenza vaccination).

Discussion

Dr. Feinberg hoped the analysis would reveal whether first-dollar coverage of newer, more expensive vaccines (e.g., HPV vaccine) would have a more pronounced effect on uptake. Dr. O’Grady stressed the importance of getting the right denominator to evaluate such issues. He reiterated that NORC’s analysis defines first-dollar coverage as coverage that requires no copay, no deductible, and no coinsurance for the vaccine. Trish Parnell and Claire Hannan, M.P.H., both pointed out that parents pay at least the cost of an office visit when vaccinating their children. Dr. O’Grady said NORC is looking at data for office visits, vaccine, and administration, and it is trying to determine what proportion of a plan’s well-child visit (which is free to the parent) covers vaccination.

Action Item

NVPO staff will seek clarification of the findings presented by NORC that suggest very few people who have employer-based insurance are required to pay any copay or other cost for their children’s vaccines.

NVAC recognized CDR Shen’s extraordinary efforts in support of NVAC’s adolescent vaccine financing recommendations by presenting her with a plaque thanking her for her work.

Health Care Reform and Vaccination—Caya Lewis, M.P.H., Director of Outreach and Public Health Policy, Office of Health Reform, HHS

Ms. Lewis described how vaccines are covered in the current Senate and House health care reform bills under consideration. Both bills would require insurers to cover vaccines recommended by ACIP or the U.S. Preventive Services Task Force (USPSTF) as part of their preventive services with no cost-sharing. The Senate bill would offer as an incentive a one-percent increase in the Federal medical assistance percentage (FMAP) to States that cover vaccines through Medicaid, effective in 2013, while the House would require Medicaid coverage, effective in 2011. Both bills would require Medicaid to offer certain vaccines with no cost-sharing. The Senate bill would allow States to purchase vaccine at Federally negotiated prices; the House bill would move vaccine provision from Part D of Medicare to Part B and provide demonstration grants for school-based partnerships to administer influenza vaccine. Both bills support use of school-based health centers to increase awareness and outreach. The Senate bill would cover an annual wellness visit that includes consultation about vaccines, effective in 2011. In summary, said Ms. Lewis, both bills focus on prevention and wellness, would require more vaccine coverage, and reference nationally accepted guidelines. Both would provide some coverage immediately or very soon.

Discussion

Dr. Birkhead noted that NVAC recommended that VFC cover the vaccine administration fee, which would be equivalent to a 90-percent increase in the FMAP, far more than the one percent proposed by the Senate. Dr. Jarris said self-insured employers are exempt from Federal mandates, and about 60 percent of workers are covered by a self-insured employer. The mandates could push the burden entirely onto smaller companies that purchase third-party insurance. Dr. Rawlins echoed Dr. Jarris’ point and said he believes Congress is discussing the issue of exemptions. Ms. Lewis responded that an important tenet of health care reform legislation is maintaining insurance coverage among smaller companies.

Ms. Lewis clarified that neither bill defines what is meant by an ACIP-recommended vaccine, though she presumed HHS would help with the definition. She noted that President Obama has urged Congress to continue working on health care reform legislation.

Agency, Department, Advisory Committee, and Liaison Reports

NVPO—Bruce Gellin, M.D., M.P.H.

Dr. Gellin said that in addition to the goals outlined by Dr. Koh, NVPO is monitoring the immunization component of the Healthy People goals. NVPO’s communication plans would be covered in a later presentation, he noted.

 CDC—Melinda Wharton, M.D., M.P.H.,, CDC

Dr. Wharton said ACIP would meet on February 24–25 and discuss the 13-valent pneumococcal vaccine and the timing of influenza vaccine recommendations, among other things.

Dr. Wharton stressed that the money allotted under ARRA for vaccines ($250 million) must be spent this year. Fourteen States are participating in projects to develop pass-through mechanisms for billing, and the President proposes to continue funding those projects in 2011. Dr. Wharton said CDC collaborated with the Association of Public Health Laboratories to launch a successful web-based training program for diagnosis of vaccine-preventable diseases. Recent published studies have confirmed the effectiveness of rotavirus vaccine in reducing mortality in Mexico and Africa.

The spread of H1N1 influenza has slowed down a little, said Dr. Wharton. Vaccine coverage varies; one community is debating a third vaccine dose for children.

Dr. Rodewald clarified that all ARRA vaccine purchasing funds must be spent by September 30, 2010, but pre-booking and pre-purchasing vaccine for fall 2010 qualifies as spending. Dr. Wharton confirmed that while there has been an overall increase in funding for vaccine purchasing, there has been a decrease in money for infrastructure. CDC’s estimates of funding requirements are reported to Congress in its annual Section 317 report.

HRSA—XXX[DT6] 

XXX[DT7]  emphasized the opportunities for collaboration, especially in communication with providers, available through HRSA’s many programs, such as the community health centers, HIV/AIDS Bureau, Maternal and Child Health Bureau, Bureau of Clinician Recruitment and Service, and the National Health Service Corps. She noted that HRSA’s Bureau of Primary Health Care can offer data to assist with developing metrics by which to measure progress toward NVAC goals. It already has data on immunization schedule completion for children under two years through 2008. XXX[DT8]  noted that 30 percent HRSA’s community health centers have exceeded Healthy People 2010 target immunization goals.

HRSA is collaborating with CDC on education and training programs around tuberculosis and hepatitis B vaccines. For example, South Carolina, Maryland, and New Jersey are conducting provider training on hepatitis B vaccine as part of the hepatitis education program.

VICP—Geoffrey Evans, M.D.

Dr. Evans pointed out some current trends in VICP claims: the overall number of claims is increasing (nearly doubling from 2008 to 2009), more claims relate to adult vaccination, and nearly half of the claims involve seasonal influenza vaccine. The number of autism claims appears to be decreasing, which may be related to the fact that three autism test cases were decided in favor of the government. Two of those three cases are being appealed. A decision is anticipated soon regarding the “thimerosal-only theory,” said Dr. Evans.

VICP’s project with the IOM to evaluate adverse events related to a number of vaccines will look at 12 vaccines. A report on the project is expected in 2011.

Dr. Evans clarified that most of the influenza claims involve demyelinating conditions such as GBS, most likely because of the recognition of an association between influenza vaccine and GBS in previous years. He noted that people who have received both seasonal and H1N1 influenza vaccines and suffer an injury are encouraged to file claims under both VICP and CICP if there is any question about which vaccine might be related to the injury.

ACCV—Magdalena Castro-Lewis

Ms. Castro-Lewis said the Commission established three work groups. The Outreach Work Group is working with an external public relations firm and VICP on a comprehensive marketing and outreach plan for families and health care providers to improve public awareness about the opportunity to file for injury compensation. The Petition of Payment Work Group sought to provide interim payment for a person who has exceptionally high medical expenses while awaiting the resolution of a VICP claim. However, ACCV has learned that it cannot make such a recommendation to HHS. The Concession Work Group discussed the fact that the increasing number of cases that are settled means specific information about causes never comes to light in an open forum. ACCV members did not come to consensus on a recommendation from the Concession Work Group.

VRBPAC—Jose Romero, M.D.

Dr. Romero said VRBPAC reviewed safety data on pneumococcal vaccine and recommended that the U.S. Food and Drug Administration consider approving it for prevention of invasive disease[DT9] . However, VRBPAC was not in favor of its use for otitis media. It reviewed safety data on purified recombinant influenza hemagglutinin vaccine for adults, which suggest that safety and efficacy vary by the subject’s age. In December, VRBPAC heard presentations from several divisions of the Office of Vaccines Research and Review and approved the data presented.

NIH—Barbara Mulach, Ph.D.

Dr. Mulach summarized the five themes for NIH identified by its new director, Francis Collins, M.D., Ph.D.: high throughput technology, such as genomics; translational research; health care reform; global health; and reinvigorating the biomedical community. NIH received ARRA funds that it is using to address these themes, and the agency hopes to receive additional funding. NIH is evaluating the lessons of H1N1 influenza, such as the results of clinical trials in special populations (e.g., pregnant women). Dr. Mulach said NIH hopes to better understand the framework for conducting clinical research on vaccines among pregnant women. She said NIH also hopes research findings can be extended beyond H1N1.

DoD—COL Renata Engler

COL Engler said DoD has distributed all of its seasonal and H1N1 influenza vaccine. About 85 percent of active and reserve personnel were immunized with seasonal influenza vaccine; about 60 percent of active military received H1N1 influenza vaccine. DoD now has 12 laboratory facilities with H1N1 testing capability and is helping with overall surveillance. It has also enhanced collaboration between the Defense Medical System and the DoD immunization registry. DoD continues to refine its anthrax and smallpox vaccine programs. COL Engler said that the newer anthrax and smallpox vaccine regimens have about the same rate of adverse reactions as older regimens but far fewer local reactions and better overall tolerability. COL Engler added that DoD has an aggressive—but not mandatory—policy to promote seasonal influenza vaccination among its health care workers, and she believes such workers have a higher rate of vaccination than their civilian counterparts as a result.

 

VA—XXX[DT10] 

XXX [DT11] said that the number of cases of H1N1 influenza seen by VA has been low (about five per week in December, and three per week in January). VA received about 1.4 million doses of H1N1 influenza vaccine, of which about 430,000 doses have been delivered so far. About 130,000 VA staff and volunteers were vaccinated, but doctors have been lagging behind. A few VA hospital experienced shortages of other preventive measures (e.g., N95 masks), which VA addressed by shuffling supplies among hospitals. XXX [DT12] said about 66 percent of VA health care workers received the seasonal influenza vaccine in 2008 and 2009. He said VA’s success is the result of year-round education and use of maps that show geographically where the disease is hitting. He believes VA can get to 80 percent voluntary vaccination coverage with continued focus on good health practices.

USDA—XXX[DT13] 

XXX[DT14]  explained that USDA is involved in extensive research on vaccine discovery to support biodefense efforts, especially the Strategic National Stockpile, as it tries to prevent foreign animal disease threats. USDA is also involved in initiatives to counter biological threats. He pointed out that many diseases are zoonotic in origin, so a good way to prevent them from affecting humans is to control them at the source. He noted that USDA recently issued a conditional license to Pfizer Animal Health for the first H1N1 vaccine for pigs.

Action Item

NVAC will consider whether to request for a future agenda that USDA present on the scope of animal vaccine development and countermeasures stockpiling.

Public Health Agency of Canada—Lisa XXX[DT15] 

XXX [DT16] described the structure of the agency’s governance regarding immunization. Canada has had a 45-percent uptake of H1N1 vaccine. The country is using primarily one type of vaccine (adjuvanted, from GlaxoSmithKline). She said only health care providers report information on adverse events to the vaccine safety database, so the data are of high quality but a lot of data are missing. It appears one lot of vaccine caused a number of allergic reactions; it was recalled and the agency is working with the manufacturer to understand the cause of the problem. The second wave of H1N1 influenza peaked later in Canada than in the United States. Preliminary data show a decrease in the severity of disease, which may be the result of the vaccination campaign or herd immunity.

XXX [DT17] reported that the National Advisory Committee on Immunization is now returning its attention to other issues, including a statement on seasonal influenza, herpes zoster vaccine, new recommendations for HPV vaccine for older women and some men, pneumococcal vaccine, and a two-dose varicella vaccine regimen. The Canadian Immunization Committee implements the National Advisory Committee on Immunization’s recommendations at the province level. The Canadian Immunization Committee also developed a National Immunization Strategy, similar to the United States National Vaccine Plan. It describes funding options, vaccine injury compensation, the security of the vaccine supply, and options for programming and research. The Canadian Immunization Committee also developed guidelines for pneumococcal and rotavirus vaccination.

Canada will host a national immunization conference in December 2010. XXX [DT18] noted that Canada now hopes to have a national immunization registry in place by 2011; current data capture about 30 percent of the children in the country.

AHIP—Wayne Rawlins, M.D., M.B.A.,

Dr. Rawlins said AHIP recently published the findings from its 2008 adult immunization survey, which looked at vaccine coverage among adults who belong to AHIP member plans (123 million enrollees). The results were compared with those from a similar survey from 2005. The new survey found that the vast majority of plans cover vaccines recommended by ACIP and provide first-dollar coverage. The interval between an ACIP recommendation and the inclusion of a recommended vaccine in the benefit plan has decreased as employers recognize the importance of vaccination as a central part of coverage. More plans now recognize an ACIP recommendation as the equivalent of the Good Housekeeping Seal of Approval for vaccines, Dr. Rawlins said.

Public Comment

Jim Moody of SafeMinds said he was heartened that CDC has agreed to evaluate the feasibility of a study comparing vaccinated and unvaccinated children; he believes such a study is the most important step HHS can take toward improving public confidence in vaccines. He said the National Vaccine Plan does not include a safety agenda that is aggressive enough. He proposed the creation of an independent body to evaluate vaccine safety to counter any possible conflicts of interest. Mr. Moody said he senses “too much glee” over the retraction of Andrew Wakefield’s 1998 paper in the Lancet associating MMR vaccine with autism. He pointed out that the paper was retracted because of ethical questions about doctors’ testimony but the scientific question remains open, as other researchers have also linked autism with vaccination. He hoped NVAC and others would continue to focus on getting the science right, not on politics.

Day 2—February 4, 2010

Unfinished Business from Day 1——Guthrie S. Birkhead, M.D., M.P.H.

Dr. Birkhead summarized the changes that would be made to the State of the Program Report following discussion on the first day of the meeting.

AIWG—Julie Morita, M.D.

Dr. Morita said the AIWG has been trying to identify specific priorities in relation to the nine recommendations it made in June 2009 on gaps in HHS and other Federal agencies’ efforts. However, prioritization has been difficult because so many pieces of adult immunization are lacking. Thus, the group’s new mission is to develop recommendations for a comprehensive, sustainable, national adult immunization program that will reduce vaccine-preventable disease and improve adult immunization coverage. Dr. Morita said Dr. Koh’s focus on Healthy People 2020 goals and reducing disparities both complement the AIWG mission.

The AIWG tentatively plans to meet via monthly teleconferences to develop a white paper that looks at existing recommendations for improving adult immunization coverage, among other things. It is also considering holding a stakeholder meeting to gather input.

Discussion

Dr. Feinberg said the major constraint is vaccine financing for adult immunization programs. He added that CMS should be more actively engaged with NVAC. Dr. Rawlins added that provider education, consumer education, and infrastructure are also important considerations. Ms. Parnell suggested addressing communication. Dr. Pavia noted that professional organizations can help identify the barriers that prevent more physicians from offering vaccinations. Dr. Mason suggested looking at the question of mandatory vaccinations for health care providers. Dr. Morita responded that the comments from NVAC members reflect those of the AIWG members, who found it difficult to narrow down the priorities. She hoped all of the issues raised would be addressed by the AIWG.

Dr. Tan added that Trust for America’s Health just released a report, Adult Immunization: Shots to Save Lives. He summarized some of the reports key findings and recommendations. Dr. Tan emphasized that the next step is to consider how to implement policy recommendations like these that have never gotten any traction. Dr. Pavia pointed out the importance of timing of recommendations.

Ms. Parnell said State and local health departments are being asked to do more with less funding; she felt funding for health departments should be a priority and questioned who should address it. Mr. Jarris said funding is an indicator of priorities: recommendations must be supported by resources.

Action Item

A representative from CMS will be strongly encouraged to attend future NVAC meetings.

National Vaccine Plan—CAPT Raymond A. Strikas, M.D., USPHS, NVPO

NVAC members further reviewed and discussed the compilation of comments sent by six NVAC members in advance of the meeting. Overall, NVAC supports the recommendations made by IOM. Following a lengthy discussion, NVAC members reached consensus on the following key points:

  • NVAC agrees with IOM on the need for clear assignment of authority, responsibilities, and resources to support the National Vaccine Plan and believes that coordination should be made Goal 1 of the National Vaccine Plan.
  • The plan should better define what is meant by the terms “independent” and “transparent.”
  • NVAC does not agree with IOM’s recommendations to include therapeutic vaccines in future iterations of the plan or to establish a permanent NVAC vaccine safety subcommittee. The VSWG is considering the best structure for oversight.
  • NVAC emphasizes the need to develop innovative strategies to improve the vaccine regulatory process. New vaccine development should attempt to address the complexity of the vaccine schedule.
  • Stable and consistent funding should be added to IOM’s recommendation to expand and strengthen vaccine safety research.
  • An ongoing public engagement process should be part of the objective to support informed decision-making, and education about vaccine safety issues should be part of improving knowledge of vaccines and vaccine-preventable diseases.
  • Immunization registries should be included along with other mentions of health information technology.
  • Performance measurement, vaccine management and distribution, disparities, and emerging infectious disease threats should all be addressed in the context of strengthening the public health infrastructure.
  • NVAC acknowledges the importance of global health, but does not believe that it has the expertise to properly address global health goals. NVAC membership should be expanded to include persons with such expertise.

Action Items

Changes discussed at the February 3–4 meeting will be implemented into the draft document and circulated among NVAC members for further consideration. The draft will be discussed at an upcoming teleconference (scheduled for February 26, subject to change).

Mr. Bednarczyk will circulate a document that summarizes the objectives described in the National Vaccine Plan, the Institute of Medicine’s recommendations, and the draft document created by NVAC. At the upcoming teleconference, NVAC members will prioritize the objectives.

NVPO staff will give NVAC some guidance on how to structure its priority list (e.g., label each objective as high, medium, or low priority; identify top 10 priorities).

2010 NVPO Communication Plan—Stephanie Marshall, NVPO

Ms. Marshall described NVPO’s message mapping research project, explaining that the project was developed in 2008 to test messages about vaccine safety. As the H1N1 pandemic peaked in fall 2009, NVPO conducted focus groups (all women, primarily mothers of young children) to evaluate its messages. Ms. Marshall said participants raised concerns about vaccine safety and wanted more information from trustworthy sources. Participants cited HHS and local and State health departments as trusted sources; this higher than usual confidence in government sources may have stemmed from the H1N1 response, Ms. Marshall said. Participants said they trust their health care providers, including obstetrician-gynecologists (which represents a new opportunity for partnering with providers). They want information in writing and in advance of vaccination appointments.

Ms. Marshall said the focus group participants had heard a lot about the risks of vaccines but not much recently about the benefits, and even those who fully vaccinated their children wanted more reassurance that benefits outweigh the risks. They were receptive to messages about the negative consequences of refusing vaccines, such as the effects of vaccine-preventable diseases. Participants responded to messages about the importance of vaccination against diseases no longer active in this country but still circulating elsewhere and the responsibility to vaccinate as a way to protect those who cannot tolerate vaccination.

Among the focus group participants, scientifically oriented messages that presented facts, especially data on reducing disease, were better received than those that used an emotional appeal or an anecdotal approach. Ms. Marshall summed up some key recommendations for vaccine safety communication:

  • Explain when, where, and how to find the best vaccine information.
  • Provide clear, current, relevant information in readily available formats.
  • Use medical appointments to discuss the benefits and risks of vaccination.
  • Ensure that messages are supportive, respectful, and informative—not prescriptive or judgmental.

Ms. Marshall outlined NVPO’s 2010 communications goals:

  • Launch Vaccines.gov, a portal that links together all of HHS’ vaccine information. Content drawn from various agencies will be presented in a more uniform manner; the site will aim to inform mothers but include information about vaccines across the lifespan.
  • Build on the experience of the H1N1 response. For example, the weekly interagency vaccine safety communication calls will be broadened to focus on a vaccine safety communication and outreach plan, beginning with a situation and market analysis.
  • Support the National Vaccine Plan’s goal of providing information to the public, providers, and policymakers for informed decision-making.

Discussion

Ms. Marshall clarified that efforts will target mothers because they tend to be the health care decision-makers for the whole family. Tawny Buck hoped communication efforts would let more consumers know about the safety nets in place, such as VICP, and what to do in case of an adverse event following immunization. Dr. Pavia said research shows that very few people are good at making sound decisions weighing risks against benefits. He also raised skepticism about the finding that the focus group participants were more responsive to facts than emotional messages, which seems to refute the findings of marketing experts, and Dr. Jarris shared that skepticism. Ms. Parnell was surprised that participants considered government a trusted source. Dr. Tan hoped the findings could be used by AMA to craft messages for providers to use in communicating about risks with their patients. XXX [DT19] of VA pointed out that providers’ knowledge about vaccines varies substantially by specialty. Ms. Marshall noted that Vaccines.gov would be just one communication avenue. NVPO will also work to improve outreach to racial and ethnic minorities.

VFC Vaccine Stockpile—Lance Rodewald, M.D., CDC

Dr. Rodewald explained the rationale for and development of a new strategic plan for the VFC Stockpile. The new plan is in the final phases of approval. It seeks to set smaller targets (i.e., less vaccine in the stockpile) when the benefit to public health is similar to that of larger targets. Dr. Rodewald noted some of the challenges to maintaining the stockpile:

  • Because both private and public health providers take part in the VFC program, the stockpile should mirror the market demand for a given vaccine.
  • When new vaccines become available, the stockpile should match the market demand. When new vaccines are unavailable because of high demand, stockpiling is impossible.
  • Shelf-life must be balanced against throughput.
  • Replacing outmoded vaccines is costly.
  • The VFC Stockpile may loan vaccine to private sector providers in times of shortage.
  • A vaccine may be made by multiple manufacturers and may be available in multiple forms.

Manufacturers play a key role in vaccine stockpiling, said Dr. Rodewald, so it is important to get their support for the strategic plan. As the next step, CDC will evaluate the VFC Stockpile of seasonal influenza vaccine to determine the ideal amount needed.

Discussion

Dr. Rodewald emphasized that CDC needs to develop more experience managing a full stockpile (albeit a modest one) to better understand how to address problems such as long disruptions and extended shortages. Phil Hossbach of Sanofi Pasteur noted that doctors’ offices and State warehouses store much less vaccine than they used to, and he cautioned against creating a stockpile that’s too lean. Dr. Rodewald said the flip-side of a smaller inventory is the need to “share the pain equally”— that is, to ensure that all States have some vaccine available.

Action Item

NVAC requests that VFC representatives report to NVAC on the success of the new stockpiling strategy.

2009–2010 H1N1 and Seasonal Influenza Update

Situation Report—RADM Anne Schuchat, M.D., USPHS, CDC

RADM Schuchat offered some observations about the H1N1 influenza response to date. CDC expanded its central distribution process to support the high demand for vaccine. It sent 300,000 shipments to 70,000 locations. CDC also strengthened its approach to safety and efficacy assessment. Because providers had to be enrolled in the VFC program to administer H1N1 vaccine, the number of enrollees tripled. RADM Schuchat noted that disparity in health care is not solely related to access; for example, in Chicago, she saw high demand and long lines for vaccine at clinics that served Latino, White, and Asian populations but low demand at clinics serving primarily African Americans.

RADM Schuchat provided some results from CDC’s influenza surveillance mechanisms. She estimated that more than 75 million people (mostly in ACIP target populations) have received the H1N1 vaccine. Children and pregnant women had the highest coverage rates, which is a great accomplishment, said RADM Schuchat, as these populations usually have the lowest rates of seasonal influenza vaccination.

RADM Schuchat said deaths from influenza and pneumonia are higher than in previous years. Since April 2009, 312 children have died as a result of influenza, and only two of those cases are clearly linked to seasonal influenza. Hospitalization among school-age children is much higher now than it has ever been for seasonal influenza. RADM Schuchat said 55 million people have become ill and 246,000 people have been hospitalized with H1N1influenza. Of those, 11,000 have died, and 90 percent of deaths have occurred in people under age 65.

Among the problems faced were the slow growth of H1N1 vaccine in the laboratory, delaying the production process. CDC was criticized for its messages about vaccine supply. Concerns were raised about the equity of allocation. Recalls related to potency declines added to the supply problems. On the positive side, coordination of the response at local levels was sound, bringing together leaders in preparedness and public health. Schools, physicians’ offices, and pharmacies are all playing important roles. CDC now plans an “enormous” evaluation effort to identify best practices.

RADM Schuchat pointed out that any increased funding for vaccines is likely to go toward development, not infrastructure. She said the existing public health system performed adequately, but she was not sure it would have been sufficient if more vaccine had been available early in the pandemic, when demand was very high.

Discussion

Dr. Birkhead asked that NVAC be involved in the evaluation of the H1N1 response.

RADM Schuchat said that uptake for seasonal influenza vaccine has been higher than ever, with 114 million doses distributed. The seasonal vaccine was available earlier than usual. The uptake for pneumococcal vaccine, which was also available earlier, has not increased.

RADM Schuchat noted that CDC worked aggressively over the summer to educate the media about the pandemic, which proved to be very useful in communicating about the disease and the vaccine. Also, RADM Schuchat said the summer’s public engagement efforts were helpful in understanding public concerns. She said CDC is thinking ahead to the 2010 influenza season. In a year of budget neutrality, RADM Schuchat said, it’s important to consider policy fixes that can improve public health response. Dr. Jarris said public health preparedness is an element of national security and thus should be exempt from budget cuts.

National Influenza Vaccine Summit—L. J. Tan, Ph.D.

Dr. Tan briefly described the themes for the next Summit, which takes place May 17–19 in Arizona: pandemic, perceptions, progress, prevention, and perspectives. The Summit will address pandemic H1N1 influenza data, vaccine communication, strategies for the 2010–2011 influenza season, and prevention efforts. Stakeholders are invited to attend to share perspectives, express concerns, and brainstorm about solutions.

CICP—Vito Caserta, M.D., HRSA

Dr. Caserta said the CICP is still awaiting finalization, but individuals are being encouraged to notify the program about their intent to file claims so that they meet the one-year filing deadline. The CICP differs from VICP in that it uses an administrative process, not a judicial one. Outreach has been underway via presentations to those involved in immunization at the State and local levels; inclusion in VAERS letters and the H1N1, anthrax, and smallpox vaccine information statements; and online links from CDC sites that address countermeasures, such as Tamiflu and antivirals.

Discussion

Dr. Caserta noted that the CICP is aware of 65 cases that would fall under its purview, all of which relate to H1N1 vaccine. People who received both H1N1 and seasonal influenza vaccine and who are seeking injury compensation are encouraged to file under both CICP and VICP, pending determination of the cause of injury. CAPT Strikas thought the number of cases seemed too low given the number of H1N1 vaccine doses delivered (when compared with the number of VICP claims filed for seasonal influenza vaccine). Dr. Caserta responded that more outreach is needed to ensure people know about the CICP.

Action Item

A representative from the CICP will be invited to give a more extensive briefing at a future NVAC meeting on the CICP.

State and Local Response Role

Anne Bailowitz, M.D., M.P.H., NACCHO

Dr. Bailowitz said local health departments used their H1N1 funding to hire more staff (both permanent and temporary), including data entry workers. She said local providers found that using the incident command structure made the H1N1 response feasible because it meshed the expertise of those responsible for preparedness and immunization. Communication efforts were largely successful and likely improved the credibility of the public health system at the local level. The vaccination effort would not have been possible without the flexibility granted to local health providers to tailor programs to their communities.

Among the challenges that counties and cities faced were the discrepancy between vaccine supply and demand (including the predictable drop in demand that begins at Thanksgiving), staff burnout, unforeseen problems with mass immunization efforts (such as paying contract workers “by the shot,” which led to indiscriminate vaccination), and finding the right media to reach target populations. Dr. Bailowitz said word of mouth was more useful than online social networking among those of low socioeconomic status, but cell phone communication can be very valuable in urban areas.

Dr. Bailowitz called for better vaccine technology, more information about using vaccines in very warm or very cool temperatures, and better management structures (e.g., the incident command structure). She hoped analysis of the H1N1 response would identify the successes and failures of school-based clinics, enhance the stability of the vaccine market, and serve as the cornerstone for an adult immunization program. She concluded that H1N1 influenza is unlikely to disappear in June, and it will be difficult for local health departments to continue fighting it without additional funding.

Paul Jarris, M.D., ASTHO

Dr. Jarris said the coordination among Federal, State, and local partners must continue through the fall to meet public expectations. He said the public health system was late in engaging the business community, and both employers and employees lost interest in H1N1 vaccination. ASTHO is meeting with retail pharmacies, AHIP, and major health insurers to discuss crosswalking benefits. It is also conducting an interim assessment of the Strategic National Stockpile and State stockpiles. ASTHO is considering bringing together State health officials and medical writers to discuss better mechanisms for communication and the need for more uniformity of State data.

Dr. Jarris said some entities may face administrative barriers to using all their ARRA funds by the September 30 deadline. In addition, the PHER grant program is ending in August. Dr. Jarris said the President’s proposed 2011 budget does not include money for pandemic influenza planning, which may force States to table their pandemic response efforts.

Claire Hannan, M.P.H., AIM 

Ms. Hannan said immunizers are challenged by questions such as whether to obtain and store H1N1 vaccine now or whether they should plan to do so later. They are asking whether a third wave of disease is anticipated and how much vaccine is currently being stored at doctors’ offices and clinics. Because demand is low, the minimum order of 100 doses is more than most programs need, so they are discussing how to split orders among several programs.

Ms. Hannan emphasized the importance of building on the lessons learned so far. School-based clinics were successful in part because some challenges were eliminated as a result of the emergency nature of the pandemic. It is important to look at data sharing and Family Educational Rights and Privacy Act (FERPA) restrictions to determine how to foster more collaboration. School-based clinics are labor-intensive but worth sustaining. The immunization community has made inroads into the infrastructure for adult immunization—such as retail pharmacies and health care providers who treat adults—but those inroads will be hard to sustain. Evaluation of the H1N1 response should consider how pharmacists were able to help when some barriers were lifted.

Discussion

RADM Schuchat said CDC is working with the Department of Education to let educators know that there should be no barriers between public health providers and schools that host vaccination clinics. She recognized that the education and public health systems must communicate with each other more. RADM Schuchat asked for specific suggestions and contacts to help CDC and the Department of Education address perceived barriers.

RADM Schuchat said CDC now has enough information to begin evaluating disparities in H1N1 vaccination rates and other issues more in depth. Several NVAC members and liaisons expressed the urgent need to maintain and expand funding for public health infrastructure to build on the successes of the H1N1 response.

Action Items

In the process of evaluating the government’s effort to address H1N1 influenza, NVAC will review data on how well the campaign reached specific populations (target demographics, racial/ethnic minorities, etc.)

Drs. Birkhead, Jarris, Mason, and Morita will develop a draft recommendation for consideration at the February 26 teleconference on maintaining the capacity developed in response to the H1N1 pandemic.

Public Comment

Nancy McGrory Richardson, education and outreach director for Hemispherx Biopharma, gave an overview of her company’s drug, Ampligen, a potential influenza vaccine adjuvant. (Written testimony is attached in the appendix.[DT20] ) She hoped her company could support the goals of all those committed to worldwide protection from pandemic influenza.

Closing Remarks and Adjournment

Dr. Birkhead said the February 26 NVAC teleconference would include a VSRAWG update, final approval of NVAC comments on the National Vaccine Plan, prioritization of objectives in the National Vaccine Plan, and review of a motion urging more funding to support the public health infrastructure. Dr. Birkhead thanked the members and all the participants for their contributions and adjourned the meeting at approximately 1:30 PM.

I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.

Bruce Gellin, M.D., M.P.H.                                           Guthrie S. Birkhead, M.D., M.P.H.

Executive Secretary                                                      Chair, National Vaccine Advisory Committee

National Vaccine Advisory Committee

These minutes will be formally considered by the Committee at its next meeting, and any corrections or notations will be incorporated in the minutes of that meeting.