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The National Vaccine Advisory Committee (NVAC)

National Vaccine Advisory Committee Teleconference Meeting
2009 H1N1 Influenza Outbreak and Response
Monday July 27, 2009 3- 5 pm EDT

Meeting Overview

The National Vaccine Advisory Committee (NVAC) met via conference call to discuss updates to the implementation of the Federal 2009 H1N1 vaccination program. Following welcoming remarks from the newly appointed Assistant Secretary for Health, the Committee heard from representatives of several agencies within the Department of Health and Human Services (HHS), State and local partners, and three of the other Federal advisory committees that are working on the H1N1 response. Following a period of public comment and final discussion, the Committee approved two sets of draft recommendations addressing vaccine safety monitoring and vaccine financing.

Committee Members in Attendance

Guthrie S. Birkhead, M.D., M.P.H., Chair
Jon R. Almquist, M.D.
Richard D. Clover, M.D.
Cornelia L. Dekker, M.D.
Mark Feinberg, M.D.
Lisa Jackson, M.D., M.P.H.
James O. Mason, M.D., Dr.P.H.
Marie McCormick, M.D., Sc.D.
Christine Nevin-Woods, D.O., M.P.H.
Trish Parnell
Andrew T. Pavia, M.D.
Laura E. Riley, M.D.

Committee Members Absent

Fergie, Jaime, M.D.

Assistant Secretary for Health

Howard Koh, M.D., M.P.H., Assistant Secretary for Health (ASH) and Director, National Vaccine Program (NVP)

Executive Secretary

Bruce G. Gellin, M.D., M.P.H., Deputy Assistant Secretary for Health (DASH); Director, National Vaccine Program Office (NVPO)

NVAC Ex Officio Members

COL Renata Engler, Department of Defense
Geoffrey Evans, M.D., Health Resources and Services Administration (HRSA), National Vaccine Injury Compensation Program
RADM Anne Schuchat, M.D., U.S. Public Health Service (USPHS), Centers for Disease Control and Prevention (CDC)

NVAC Liaison Representatives

Mahnaz FarhangMehr, Public Health Agency of Canada
John Modlin, M.D., Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Dale Morse, M.D., Advisory Committee on Immunization Practices (ACIP)
Wayne Rawlins, M.D., M.B.A., America's Health Insurance Plans

Invited Speakers

Anne Bailowitz, M.D., M.P.H., National Association of County and City Health Officials (NACCHO)
CAPT Jay Butler, M.D., USPHS, CDC
Claire Hannan, M.P.H., Executive Director, Association of Immunization Managers (AIM)
Paul Jarris, M.D., M.B.A., Executive Director, Association of State and Territorial Health Officials (ASTHO)
Megan Lindley, M.P.H., CDC
Patricia Quinlisk, M.D., M.P.H., National Biodefense Science Board (NBSB)
Robin Robinson, Ph.D., DASH; Director, Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR)

Introductory Remarks

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

Dr. Birkhead called the meeting to order. He reminded all on the call that this was a full public NVAC meeting, and briefly reviewed the agenda for the meeting.

Howard Koh, M.D., M.P.H., ASH and Director, NVP

Dr. Koh expressed his appreciation for the commitment of the NVAC in their role to help ensure the coordination of a possible H1N1 vaccination campaign in the fall as well as for all Federal vaccination efforts. He noted that the H1N1 vaccination program is evolving rapidly, and NVAC plays an essential role by helping the Department coordinate efforts at the Federal level, as well as with State and local partners. Dr. Koh emphasized that N1H1 is a case study and should be viewed through the lens of a draft national vaccine plan.

Dr. Koh commended Dr. Gellin for his commitment and scientific contributions. He noted that the NVPO was coordinating the work of the NVAC and was working closely with the ASPR in developing a possible H1N1 vaccine campaign. Dr. Koh urged the Committee to provide candid responses on all aspects of the plan, especially regarding safety and monitoring.

Federal H1N1 Vaccination Program Implementation Update

Introduction - RADM Anne Schuchat, M.D., USPHS, CDC

RADM Schuchat provided an update on the status of the H1N1 virus since the June NVAC meeting. The CDC has seen continued transmission of the virus, with disruptive clusters and outbreaks at summer camps. The frequency of illness in the U.S. is lower than it was in the spring, but much higher than usual for summer. The CDC has seen remarkable heterogeneity, with young people disproportionately affected. In the Southern hemisphere, the virus is circulating with, and in some cases dominating, seasonal strains.

RADM Schuchat noted that the government's vaccination planning efforts include numerous components of HHS as well as partnerships at the State, local, and Federal levels, including the Department of Education and the Department of Homeland Security. The government's response to the H1N1 virus has been organized into four pillars: surveillance; community measures, such as school dismissals and medical surge; vaccination; and communication. RADM Schuchat emphasized that vaccination programs must be integrated carefully with other interventions, such as mitigation and education efforts.

Vaccine Development - Robin Robinson, Ph.D., BARDA

Dr. Robinson noted that the virus reference strains from the CDC, Food and Drug Administration (FDA), and elsewhere were distributed to influenza vaccine manufacturers in early June to enable them to begin developing vaccines for clinical studies and commercial-scale manufacture. Two of the five vaccine manufacturers licensed by HHS started their clinical trials during the week of July 20; the National Institutes of Health (NIH) and the other three manufacturers will begin their studies during the first week in August.

Dr. Robinson stated that all five manufacturers would be producing the vaccine by the end of August. Four manufacturers (Novartis, Sanofi Pasteur, CSL, and GlaxoSmithKline) would produce inactivated subunit vaccines in the form of prefilled syringes and multidose vials. The fifth manufacturer, MedImmune, would produce a live attenuated vaccine in the form of a sprayer.

The first group of clinical studies would be conducted with adults. If these go well, the FDA would allow the studies to be expanded immediately to pediatric populations. The clinical studies would be conducted in two parallel phases. Each of the manufacturers and NIH would conduct a small set of clinical trials focused primarily on immunogenicity, to inform the manufacture of the vaccine. The second set of studies would focus on obtaining data related to product licensure and policy issues, such as the use of the vaccine for pregnant women and potential interference with the seasonal influenza vaccine.

Dr. Robinson noted that the growth and purification yields of the pandemic H1N1 virus strain for use in the subunit vaccine was only about 30 percent of that normally produced for the seasonally circulating H1N1 influenza strain. This is consistent with BARDA's projections, which took into account the difficulties of working with new virus strains. In contrast, the manufacturer of the live attenuated vaccine is able to produce much higher amounts than anticipated, and the supply may exceed the number of available sprayers. BARDA is in discussion with the FDA regarding the possibility of licensing droppers for this vaccine in order to increase the supply for the general population and for children. Dr. Robinson hoped to be able to provide an update regarding this issue at the next conference call.

Dr. Robinson noted that the VRBPAC met the week of June 20 and recommended to the FDA that the H1N1 vaccine be accepted as a strain change. The Committee also discussed suggested doses for the subunit and live attenuated vaccines, the potential use of adjuvants, and whether the vaccine would be administered in one or two doses.

Dr. Robinson stated that, to date, HHS has bought 195 million doses of bulk antigen and 120 million doses of adjuvant. BARDA will review its procurement efforts in early August to determine next steps.

Dr. Robinson noted that the ACIP would meet on July 29 to discuss the target populations for the H1N1 immunization program [NOTE: Presentations from the meeting are available on the ACIP website: http://www.cdc.gov/vaccines/recs/acip/slides-july09-flu.htm]. This information would help to determine how much of the product should be in pre-filled syringes and sprayers, and how much in multidose vials.

Vaccine Program Planning/Implementation - Jay Butler, M.D., CDC

Dr. Butler began by noting that the novel H1N1 situation differs from the planning scenarios in a number of ways. The illness is not as severe as the 1918 influenza; the epidemiology is different than for the seasonal flu, with the highest infection rate among the very young and a relatively low number of infections among the elderly; the disease began in North America; larger amounts of vaccine are available than planners had anticipated; and there will be a confluence of seasonal and pandemic vaccination. As a result, the novel H1N1 vaccine program will not be the same as programs for a severe pandemic, such as H5N1, or seasonal influenza.

Dr. Butler stated that implementation planning has already started, but plans could change based on Southern Hemisphere epidemiologic and virologic data; results of clinical trials; and ongoing analyses of novel H1N1 epidemiology and virology in the U.S.

Dr. Butler outlined four base assumptions for the planning scenarios: 1) the severity of the illness remains the same; 2) risk groups remain the same; 3) an unadjuvanted vaccine is immunogenic and safe; and 4) there are no major antigenic changes in the novel H1N1 virus. Based on these assumptions and the current epidemiology of the disease, the planners suggested the following implementation scenarios for the H1N1 vaccination program:

  • Children and staff in childcare centers and schools
  • Pregnant women, young children, household contact for children less than six months of age
  • Persons with underlying medical conditions
  • Health care workers
  • Everyone (when enough vaccine is available)

Dr. Butler stated that the CDC has created an H1N1 Vaccine Task Force that consists of teams working on implementation and distribution of the vaccine; uptake and coverage; safety monitoring; effectiveness; and communications. The CDC has also formed a Vaccine Implementation Steering Committee, which includes representatives of the ASTHO, the NACCHO, the Council of State and Territorial Epidemiologists (CSTE), the AIM, Preparedness Program Directors, NVPO, and BARDA. The Steering Committee's most recent meeting on July 27 addressed issues regarding safety, communications, and reimbursement.

Dr. Butler closed by outlining a number of uncertainties that will affect the implementation of the vaccine program. These include the amount of vaccine that is available, specific recommendations for vaccine use, the timing of the availability of H1N1 and seasonal vaccines, and the demand for the vaccine.

Discussion

Dr. Dekker asked if there were plans to track whether the vaccine formulation would be the same for both doses. Dr. Butler stated that this was contingent on decisions related to the distribution of the vaccine. At this point, the planning does not include a mechanism to ensure that both doses would be from the same manufacturer. Dr. Robinson stated that one of the clinical trials at NIH would study the effect of receiving doses from two different manufacturers. A separate study would look at the crossover effect of receiving one dose of live attenuated vaccine followed by a dose of inactivated vaccine, or vice versa.

Dr. Birkhead asked when the data from the clinical trials would be available. Dr. Robinson replied that preliminary data should be available in about two months, or the latter half of September. If HHS decides to move forward with the vaccine program, implementation would begin in October.

Responding to a question from Dr. Pavia, Dr. Robinson stated that the vaccine manufacturers and NIH were conducting studies to look at 7.5 and 15 microgram doses, with and without adjuvants. In response to a second question from Dr. Pavia, Dr. Butler stated that current data from the Southern Hemisphere support the base assumptions.

Dr. Almquist asked if the Steering Committee would be responsible for deciding whether to stop the implementation program due to safety risks. RADM Schuchat and Dr. Gellin stated that the final decision would rest with the HHS Secretary, with input from the NVAC and other advisory committees as well as members of a leadership group across HHS.

Noting that children are disproportionately affected by the virus, Ms. Parnell asked about the percentage of children in the clinical trials. Dr. Butler stated that about one-quarter to one-third of the population would be children, compared to 20 percent for most studies.

Vaccine Safety Workgroup/Subgroup on H1N1

Marie McCormick, M.D., NVAC

Dr. McCormick reminded the Committee that the H1N1 Subgroup of the NVAC Vaccine Safety Workgroup was charged with reviewing current Federal plans for safety monitoring for a 2009 H1N1 influenza vaccine and providing feedback on the adequacy, strengths, weaknesses, and considerations for enhancement. After listing the members of the subgroup and describing its process, Dr. McCormick presented the subgroup's three draft recommendations:

Recommendation #1

  • A clear Federal plan to monitor 2009H1N1 influenza vaccine safety is needed, both for proper planning purposes in the Federal government and to provide information to the public and stakeholders (including states) about important vaccine safety activities. A comprehensive and detailed plan should be developed and disseminated that outlines the HHS plan for monitoring vaccine safety.
  • This plan should include:
    1. Specific activities under development, with acknowledgement of gaps and limitations. Specific studies planned to be carried out should also be included.
    2. An organization chart outlining who is involved, what their responsibilities are, the flow of information, how coordination will be achieved between different Federal office and agencies, who makes which decisions, who is responsible, and other relevant roles.
    3. A clear timeline of planning processes, completion of preparations, and execution of activities.
    4. Involvement and role of other Federal agencies, such as Department of Defense and the Veterans Administration.

Recommendation #2

  • The need to actively monitor vaccine recipients for vaccine adverse events is critical given that the vaccine candidates will all contain a new antigen and may be combined with adjuvants that are not part of licensed vaccines in the US. Relevant parties of HHS should develop appropriate procedures for linking exposure and outcome data in as large a population base as feasible, including consideration of subpopulations targeted for vaccine use. In order to do this, accurate exposure to vaccine and adjuvant type for each dose administered (with lot numbers, if possible) must be linked to outcome data. The current vaccine safety infrastructure is unlikely to be sufficient to accomplish this.
  • Consideration should be given to the following strategies for active vaccine safety surveillance:
    1. Utilizing existing mechanisms that are used for vaccine adverse event surveillance but may need to be enhanced or refined.
    2. Exploring existing databases that have not yet been used for vaccine adverse event monitoring but could be.
    3. Developing novel strategies, although a process for collecting and vetting is needed given the short timeframe anticipated.
  • A clear timeline should be developed for finalizing necessary arrangements.

Recommendation #3

  • Consideration should be given to a transparent and independent review of vaccine safety data as it accumulates. This Vaccine Safety Assessment Committee (VSAC) would be an independent group of outside experts with a charge to advise the ASH and/or ASPR on the presence, investigation, interpretation, and implications of possible side effects of H1N1 vaccines. The committee should be reviewing pre- and post-licensure vaccine safety data accumulated in a timely way and not await activation when a specific signal is declared.
  • The VSAC should advise on distinguishing spurious from genuine side effects; anticipating and responding to coincident (non-causal) events; evaluating the occurrence, frequency, and seriousness of possible side effects associated with the vaccine; programmatic and policy steps to take in response to purported or demonstrated safety concerns; strategies and content of communication about vaccine safety; and such other matters related to vaccine safety that the ASH/ASPR would find useful.
  • Such an external review would involve an independent group of experts with no professional or commercial stake in the vaccines or conduct of an immunization program, to speed and improve response to possible vaccine side effects, to enhance public confidence, and to provide focused advice on what can become a scientifically and politically contentious issue. The VSAC may be made up of members of an existing Federal advisory committee, such as NVAC, and supplemented by other vaccine safety experts. The committee would only assess risks (not consider vaccine benefits), and the committee would be only advisory and not decision making. The ASH/ASPR would be responsible for assuring programmatic response to the assessment of risk.

Dr. McCormick emphasized that these recommendations were subject to change. The subgroup was planning to conduct weekly conference calls and would be preparing additional recommendations for the NVAC meeting on August 24, 2009.

Discussion

Dr. Birkhead stated that the Committee would vote on all recommendations after the public comment period.

Dr. Riley stressed that it would be critical to have a database or registry to address the concerns of pregnant women and their healthcare providers. Dr. Pavia stated that the subgroup had to address the concerns of special populations, such as pregnant women: 1) a registry, and 2) defining groups for active surveillance to determine short-term side effects. Dr. McCormick added that one of the reasons for developing detailed plans was to identify groups for which special attention may be needed.

Responding to a question from Dr. Dekker, Dr. McCormick stated that she did not know of any groups that were developing a pregnancy registry, but she hoped someone was trying. She noted that the natural rate of miscarriage presents challenges for researchers.

Dr. Birkhead stated that the recommendation for independent oversight was based on discussions regarding general vaccine safety. Dr. Riley felt that this recommendation would improve transparency and would help to address skepticism regarding the safety of vaccines.

Responding to a question from Dr. Birkhead, Dr. DeStefano and Dr. Mason stated that the CDC would apply the standard background rates for adverse events such as miscarriage or Guillain-Barr´┐Ż syndrome among the general, unvaccinated population. Rates of adverse events following receipt of vaccines from different manufacturers could be compared separately to known background rates, as well as to each other.

Dr. Birkhead suggested that the subgroup devote a future conference call to this issue and invite Dr. DeStefano or other experts in OB/GYN epidemiology to participate. Dr. Robinson offered to invite Alan Mitchell to discuss his study on vaccines and antivirals with pregnant women.

Vaccine Financing

Megan Lindley, M.P.H., CDC

Ms. Lindley presented the draft recommendations developed by the H1N1 Vaccine Financing Subcommittee of the CDC's Vaccine Implementation Steering Committee. The recommendations were based on the September 2008 NVAC recommendations for child and adolescent vaccination financing.

Ms. Lindley discussed general and specific challenges for financing the H1N1 vaccine program. General challenges include variable insurance coverage and underinsurance and highly variable reimbursement rates for vaccine administration, particularly under Medicaid. H1N1-specific challenges include the broader use of non-traditional vaccination settings, which would require contracts for reimbursement between private providers and private insurers and State waivers for Medicaid reimbursement. In addition, the program would place an unplanned strain on State budgets in the form of Medicaid matching for administration fees and program implementation costs.

Ms. Lindley noted that the CDC's H1N1 financing recommendations affirm the principles of the NVAC financing recommendations developed in 2008. These include voluntary first-dollar insurance coverage by public and private plans; increased Federal match for Medicaid vaccine administration reimbursement; vaccine administration reimbursed for all children who are eligible for the Vaccine for Children (VFC) program, including those on Medicaid; insurance reimbursements to cover all costs associated with vaccine administration; and Federal funding to support State vaccination infrastructure and vaccine implementation.

The CDC's recommendations for H1N1 financing were based on three assumptions:

  • The Federal government will purchase all doses of 2009-H1N1 influenza vaccine manufactured for distribution in the United States
  • The vaccine will be provided at no cost to State public health agencies who will distribute the vaccine to the public and private sectors
  • The Federal government will provide funding to States to help implement the vaccination program, including covering the costs of vaccine administration in clinics organized by the public sector.

Ms. Lindley presented six recommendations for financing the H1N1 vaccine, organized into four categories:

First-dollar Coverage for Administration of the 2009 H1N1 Influenza Vaccine

  1. Public and private health insurance plans should voluntarily provide first-dollar coverage for the administration of 2009 H1N1 influenza vaccine administered in any setting. All government-sponsored programs providing healthcare for uniquely defined populations should voluntarily provide first-dollar coverage for administration of 2009-H1N1 influenza vaccine to their beneficiaries in venues where those beneficiaries are traditionally served.

Reimbursement Rates for Administration of the 2009 H1N1 Influenza Vaccine

  1. Public and private health insurance plans should reimburse providers for administration of 2009 H1N1 influenza vaccine to, at a minimum, the nationally established Medicare payment rate, including geographic adjustment. Reimbursements should factor in all costs associated with administration of 2009 H1N1 influenza vaccine.
  2. Centers for Medicare and Medicaid Services (CMS) should establish a national policy where the Federal government provides 100% reimbursement, at the nationally established Medicare payment rate, for the administration of 2009-H1N1 influenza vaccine to Medicaid and State Children's Health Insurance Program beneficiaries and other non-Medicaid Vaccines for Children program (VFC)-eligible children served by VFC providers.

Community Vaccinators and Administration of the 2009 H1N1 Influenza Vaccine

  1. Community vaccinators and national, regional, and local insurance plans should work together to develop formalized relationships allowing community vaccinators to bill insurance plans for administration of 2009-H1N1 influenza vaccine to plan beneficiaries.
  2. CMS should establish a national policy whereby community vaccinators are permitted to bill Medicaid, including via roster billing, for administration of 2009-H1N1 influenza vaccine to Medicaid beneficiaries outside the provider office, without requiring each state to obtain a Section 1115 Medicaid State Waiver.

Funding to States for Administration of the 2009 H1N1 Influenza Vaccine

  1. Funding to support mass immunization campaigns for 2009-H1N1 influenza managed by State and local health departments should be allocated to states from the unobligated contingency funds authorized in the Supplemental Appropriations Act of 2009. ($335 million in funding for State and local immunization planning was announced on July 17, 2009; assessment of funding needs for states should be ongoing.)

Discussion

Dr. Dekker asked for a status update on the recommendations that NVAC submitted in 2008. Dr. Birkhead stated that legislation was being discussed in response to the recommendation to expand VFC to include under-insured children in public clinics. In addition, the CDC provided stimulus funds directly to states, in response to NVAC's recommendation on billing. He noted that the NVAC would revisit the 2008 recommendations at its September meeting, including an update from staff.

Responding to a question from Dr. Almquist, Ms. Lindley stated that "community vaccinators" would include pharmacists, commercial mass immunizers, retail-based clinics, and urgent care clinics. The definition would include school-based immunization programs, provided that they were conducted by a mass immunizer through a contract with a school system or public health department.

Responding to a question from Dr. Rawlins, Dr. Birkhead stated that it was safe to assume that community vaccinators must be licensed and credentialed to administer vaccines.

Dr. Rawlins expressed concern that some insurers or other payors might have pre-existing arrangements to reimburse community vaccinators at rates that would differ from the Medicare rates.

Dr. Mason asked whether CDC had considered liability issues that might arise from administration of the vaccine in various settings. Dr. Robinson added that the Family Educational Rights and Privacy Act (FERPA) for H5N1 was extended to include manufacturers and distributors of the H1N1 vaccine, as well as those who would administer the vaccine through clinical studies and a vaccination campaign.

State and Local Response Role

ASTHO - Paul Jarris, M.D., M.B.A.

Dr. Jarris stated that State health officials were working with the governors' offices to hold public forums and were also communicating the message that all members of the public need to prepare for the likely escalation of the virus in the fall. ASTHO understands that the CDC vaccine management system (VACMAN) would be used for the vaccination program. Given the scale of the program, Dr. Jarris stressed that the system must be as robust as possible and would include all necessary redundancies, such as increasing the capacity for call centers. He also emphasized the importance of developing mechanisms to ensure that all types of health care providers and community providers are involved in the VACMAN, the Countermeasure Response Application (CRA), and other systems.

Dr. Jarris noted that ASTHO was waiting to hear whether there would be a vendor contract for distribution and, if so, if there will be any restriction on the number of ship-to sites. As a result of the CDC's decision to phase-in centralized distribution for federally purchased vaccines, many states no longer have a centralized location to receive and distribute a large bolus of vaccine. The situation varies widely from state to state, and it would be important to understand how this level of complexity would be incorporated into any third-party contract.

Dr. Jarris stated that ASTHO was working with a number of states to determine the extent to which existing vaccine registries could be utilized and how the aggregate information could be incorporated into the CRA system. He noted that the registries would have to be expanded to include community settings and health care providers that do not normally administer vaccinations. He cited examples of community vaccinators that interact with the State vaccine registry, such as Walgreen's in Wisconsin.

Dr. Jarris stated that ASTHO was looking at various types of settings to reach specific risk groups. Schools are an excellent way to reach children, and states such as Maryland, Hawaii, and South Dakota have conducted successful school immunization campaigns that could be replicated across the country. ASTHO would be meeting with Rx Response and major retailers, such as Target and Walmart, in an effort to develop templates for agreements between State and local health agencies and retail pharmacies.

Citing ASTHO's concerns about surveillance, Dr. Jarris stated that the existing passive surveillance system was inadequate for a campaign of this scope and should be replaced by an active surveillance system.

NACCHO - Anne Bailowitz, M.D.

Dr. Bailowitz focused on three major issues from the point of view of local health agencies: staffing; vaccine availability and logistics; and communication points.

Dr. Bailowitz emphasized that staffing was a major concern. Local health departments have experienced major cuts in staffing and budgets, and they must carry out the day-to-day work of public health in addition to administering H1N1 vaccinations. Agencies could address this challenge by working with partners such as private practice health care providers, hospitals, pharmacists, fire departments, school and day care sites, the Immunization Action Coalition, and for-profit immunizers. Other strategies include cross-training of staff, using volunteers from schools of nursing and medicine, and outsourcing non-essential tasks. Dr. Bailowitz stressed that it would be critical to maintain staff morale.

Dr. Bailowitz noted that the H1N1 vaccine might not be available until late autumn, after the arrival of seasonal vaccine. There may be numerous shipments, and questions remain concerning allocation, distribution, priority groups, and the expected role of local health departments. NACCHO has successfully advocated for local health departments to be included in the planning effort.

At the local level, the emphasis would be to prepare for a variety of scenarios and to partner with local logistical experts, such as military supply officers, major retailers, or hospital logistical and supply managers. Dr. Bailowitz stated that administering concurrent mass vaccination programs and vaccine delivery dates would require complex plans for staffing, vaccine management, and clinic scheduling. An adverse events reporting system is imperative, but time consuming. Drop-shipping the vaccine would imperil the cold chain that is key to vaccine potency. Partnerships would be essential to effectively meet the logistical and administrative demands. They should be tailored to the target populations, such as OB/GYNs and nurse midwives for pregnant women, and schools and pediatricians for children. Volunteers could be drawn from diverse community groups, including scouts, high schools with health care tracks, elder service groups, faith-based organizations, and others. Dr. Bailowitz emphasized that local health departments should begin talking to potential partners immediately.

Dr. Bailowitz stated that communications programs must effectively deliver multiple messages, including the difference between the seasonal and H1N1 vaccines, which groups need to receive both vaccines, and how many doses are required. Messages must emphasize that the seasonal vaccine provides minimal protection against H1N1. Dr. Bailowitz noted that these messages would impact clinic screening and staffing and health department phone management systems, and local health departments must anticipate the need for surge capacity. She stressed that messages must be timely and credible, and agencies must admit what they do and do not know. Coordination between the local Press Information Officer (PIO), the State PIO, and the CDC PIO would be essential to ensure that all levels communicate the same message.

Dr. Birkhead suggested that the Committee focus on communication issues in the next conference call.

AIM - Claire Hannan, M.P.H.

Ms. Hannan updated the Committee on the issues that AIM raised in June.

  • Vaccine distribution model and capacity of states to receive and distribute vaccine: Ms. Hannan noted that the model had been adjusted to provide more flexibility. AIM is waiting for final decisions in this area.
  • "All hands on deck" approach: Ms. Hannan stated that more than 80% of the public immunization programs were planning to use the private sector to administer the vaccine.
  • Communication and collaboration: Ms Hannan stated that the newly formed Vaccine Implementation Steering Committee was meeting weekly to address key issues such as private sector involvement and financing models. Workgroups and teams had been created within the steering committee structure. Weekly calls had taken place among the partners and State and local agencies, as well as several webinars.
  • Tracking and monitoring H1N1 vaccine administration: In June, AIM expressed concerns that the CRA was based on the assumption of a limited supply of vaccine. Since that time, the CRA requirements had been modified. Most significantly, classification by age rather than priority group would allow many more states to use their immunization registries to report doses administered to CDC.

Ms. Hannan stated that AIM agreed with the vaccine financing recommendations that were presented by Ms. Lindley.

Ms. Hannan noted that identifying providers that are willing to participate in the H1N1 vaccination program would be a challenge. AIM has a large database and mechanisms for communicating with providers of childhood immunizations, but seasonal flu vaccinations for adults are primarily administered by the private sector. States have developed multiple approaches to address this challenge, such as websites where providers can pre-register. Ms. Hannan stated that AIM was exploring the possibility of collaborating with manufacturers and distributors to identify providers who have ordered and distributed flu vaccine in the past.

Ms. Hannan stated that AIM had been providing input to the CDC regarding the ordering and distribution system. She emphasized the need for sufficient capacity and staff to support a campaign of this scope, including additional call-in lines.

Ms. Hannan stated that AIM was continuing to track vaccine safety issues and changes to the CRA and would provide input as appropriate.

Federal Advisory Committees Updates

ACIP - Dale Morse, M.D.

Dr. Morse stated that ACIP would hold a special meeting related to Novel H1N1 on July 29, 2009 to review the epidemiology and virology related to Novel H1N1. The Committee would use the scientific evidence to provide guidance on which groups should be the focus of the vaccination efforts; to provide recommendations regarding priority groups for vaccination, if vaccine is produced and distributed in phases; and to provide recommendations to allow the overall influenza vaccination program, both seasonal and pandemic, to be most successful. Dr. Morse noted that the meeting agenda had been posted on the ACIP website. [NOTE: http://www.cdc.gov/vaccines/recs/acip/meetings.htm]

VRBPAC - John Modlin, M.D.

Dr. Modlin noted that VRBPAC met on July 23 to discuss regulatory issues related to H1N1. In a departure from its usual format, VRBPAC was not asked to take a vote or provide any direct advice based on the meeting.

Much of the meeting was devoted to discussing the evolving plan to license an H1N1 vaccine as a strain change supplement, which would be a change from the usual practice. In this scenario, the FDA would license the vaccine to existing manufacturers, with the vaccine being formulated in the same manner as seasonal vaccine, in advance of clinical data from the manufacturers. The Committee and many others at the meeting endorsed this approach as an appropriate and prudent way to proceed.

The Committee addressed the question of whether the vaccine should be administered in one or two doses. Dr. Modlin noted that one dose is typical for seasonal influenza, but some Committee members thought that a two-dose strategy would be safer, in the absence of clinical data regarding immunogenicity. The issue was unresolved, and further discussion was likely before the policy would be finalized.

The Committee discussed special populations, in particular pregnant women and infants under six months of age. Dr. Modlin stated that immunization of young infants under an Emergency Use Authorization (EUA) might be warranted if epidemiological data indicate that morbidity and mortality rates are sufficiently high. The Committee also discussed targeted use of adjuvenated vaccine under an EUA, safety monitoring, and the need for improvement in point-of-care diagnostic methods that would be regulated by the FDA.

NBSB - Patricia Quinlisk, M.D., M.P.H.

Dr. Quinlisk stated that the NBSB was asked to provide recommendations on H1N1 countermeasures. The Board's Pandemic Influenza Working Group (PIWG) met in June to discuss address a variety of issues related to H1N1 and subsequently developed a number of recommendations [NOTE: See NBSB website for details -
http://www.hhs.gov/aspr/conferences/nbsb/090717-nbsb-meeting.html]. Dr. Quinlisk highlighted the working group's recommendations related to the H1N1 vaccine:

  • NBSB recommends that HHS set a goal of having several tens of millions of doses of unadjuvanted monovalent A/H1N1 vaccine available for clinical use not later than September 15, 2009. To achieve that goal, HHS should pursue a simplified testing program.
  • Decades of experience with A/H1N1 influenza viruses provide a basis for selecting initial antigen quantities and dosing.
  • If the second wave is delayed or production is slower than expected, mix-and-match studies of vaccine plus separate adjuvant may yield information that may stretch the available vaccine supply.

Additional recommendations addressed antiviral and other therapeutic agents and diagnostics. The full report and recommendations are available on the NBSB website.

Dr. Quinlisk stated that the NBSB would have public teleconferences on August 14, October 14, and November 13, 2009 and would hold a public meeting in the Washington, DC area on September 25, 2009.

Public Comment

Dr. Deborah Robinson noted that several speakers had mentioned the involvement of community-based and faith-based organizations, yet these groups were not involved in advisory boards or planning meetings. She stated that these organizations could play a critical role in communications efforts related to the H1N1 vaccination campaign, could help to convince the public that the vaccine is safe, and could help to encourage participation of subgroups that traditionally have lower vaccination rates. She noted that the Voluntary Organizations Active in Disasters (VOADs) have effective models for involving various stakeholders and should be involved in planning the State meetings described by Dr. Jarris.

Ria Misra from Politics Daily asked if manufacturing vaccines for H1N1 and seasonal flu at the same time would cause delays and, if so, whether those delays had been accounted for in the planning process. Dr. Birkhead replied that the seasonal vaccine had already been produced, and switching to production of H1N1 vaccine was not likely to cause a problem.

Barbara Sachu expressed concerned about the safety of clinical trials with babies under two years of age and the safety of proceeding with the vaccination program without clinical data. She noted that the discussion of the vaccine manufacturers did not indicate where the vaccine would be produced, and she expressed concern about the safety of vaccines produced in other countries.

Discussion

Vaccine Safety Recommendations

Dr. Dekker moved to approve the vaccine safety recommendations. Dr. Mason seconded the motion. There was no further discussion, and the motion passed unanimously following a roll-call vote.

Vaccine Finance Recommendations

The Committee discussed revisions to Recommendations 2 and 4 to respond to issues raised by Dr. Rawlins.

Clarifying his concern related to Recommendation 2, Dr. Rawlins noted that some states are required by law to cover vaccinations through Medicaid, as opposed to Medicare, and some health insurance providers bundle vaccine reimbursements with other services that are not linked to Medicare. Linking the H1N1 vaccine reimbursement rate to Medicare would conflict with existing arrangements or regulations.

Dr. Birkhead stated that the intention of the recommendation was to ensure that providers were adequately reimbursed and to allow the maximum number of providers to participate. Ms. Lindley suggested modifying the recommendation to state that that public and private health insurance plans should "voluntarily" reimburse providers at the Medicare rate. Dr. Rawlins agreed, and he suggested adding language that would recognize other existing contracts.

Dr. Almquist argued in favor of retaining the original language. He was concerned that language about existing contracts would be detrimental to providers who have managed care contracts to serve Medicaid patients, because the Medicaid reimbursement rate for vaccinations is lower than the Medicare rate. Noting that the H1N1 vaccine did not exist when providers signed those contracts, Dr. Almquist emphasized that providers must be given an incentive to participate in the campaign.

Dr. Rawlins asked if HHS could override existing State arrangements regarding reimbursement for vaccinations. Dr. Birkhead thought that adding the word "voluntary" would address that issue. Dr. Almquist felt that States should be required to reimburse providers at the Medicare rate, if that is what they receive from the Federal government.

Dr. Birkhead proposed that Recommendation 4 be revised to specify that community vaccinators must be appropriately licensed and credentialed. Dr. Coleman stated that her research into this issue showed that most commercial vaccinators were highly cognizant of state laws, and those that function in multiple states tend to follow the maximum, rather than the minimum, requirements. Dr. Rawlins stated that the recommendations should be written in a way that would provide the most protection for citizens.

Dr. Birkhead reviewed the proposed changes to Recommendations 2, 4, and 5:

  1. Public and, on a voluntary basis, private health insurance plans should reimburse providers for administration of 2009-H1N1 influenza vaccine to, at a minimum, the nationally established Medicare payment rate, including geographic adjustment. (No change to the second sentence.).
  2. Appropriately licensed and credentialed community vaccinators and national, regional, and local insurance plans should work together to develop formalized relationships allowing community vaccinators to bill insurance plans for administration of 2009-H1N1 influenza vaccine to plan beneficiaries.
  3. CMS should establish a national policy whereby appropriately licensed and credentialed community vaccinators are permitted to bill Medicaid, including via roster billing, for administration of 2009-H1N1 influenza vaccine to Medicaid beneficiaries outside the provider office, without requiring each state to obtain a Section 1115 Medicaid State Waiver.

There were no proposed revisions for recommendations 1, 3, and 6.

Dr. Almquist moved to adopt the recommendations, as revised. Dr. Dekker seconded the motion. There was no further discussion, and the motion passed unanimously following a roll-call vote.

Summary/Wrap-up/Next Steps

Dr. Birkhead asked Committee members to suggest issues to be discussed during the conference call scheduled for August 24, 2009.

Dr. Mason suggested that it would be important to track the use of the vaccine in order to relate adverse events to manufacturers and lots. Dr. Birkhead noted that the Vaccine Safety Working Group had addressed that issue and would continue to follow up in that area.

Dr. Almquist asked if the FERPA would need to be modified if vaccinations were provided in schools. Dr. Butler stated that the CDC was addressing that with State attorneys, and he clarified that this was not a Federal issue.

Dr. Birkhead proposed that the Committee focus on communications issues in the next conference call. Committee members agreed that this would be of interest.

Dr. Gellin added that public engagement would be an important issue. Dr. Butler stated that the CDC would be holding public meetings in ten locations around the country in August to provide opportunities for public input.

In the area of implementation, Dr. Bailowitz reiterated the need to develop strategies to engage internists, OB/GYNs, and other practitioners who do not usually provide vaccinations.

Dr. Jarris noted that the Committee had been using the term "centralized distribution." which has a different meaning at the Federal level as opposed to the State level. Dr. Birkhead and Dr. Butler agreed to discuss this during the next weekly call.

Dr. Birkhead asked Committee members who were interested in participating in calls to discuss safety issues, communications and public engagement, distribution, and tracking and monitoring to contact him by email.

Dr. Birkhead noted that the approved recommendations would be submitted to the ASH. The Committee's next public meeting would be conducted via conference call on August 24, 2009. The public notice for that meeting was posted on the NVAC website.

Dr. Birkhead thanked all participants and adjourned the call at 5:04 pm

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

/Guthrie S. Birkhead/

Guthrie S. Birkhead, M.D., M.P.H.
Chair, National Vaccine Advisory Committee

September 4, 2009

Date

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.

OTHER ATTENDEES

HHS Staff

Vito Caserta, M.D., HRSA
Margaret Coleman, Ph.D., CDC
Frank DeStefano, M.D., CDC
Brandi Hight, M.P.H., NVPO
Andrea Krull, M.P.H., R.N., NVPO
Lance Rodewald, M.D., CDC
Elizabeth Saindon, J.D., Office of the General Counsel (OGC)
Jovonni Spinner, M.P.H., NVPO
LT Brooke Stone, Office of Medicine, Science and Public Health (OMSPH), ASPR
Kirsten Vannice, M.H.S., NVPO

Public Attendees

Laura Aird, American Academy of Pediatrics
Betsy Allbee, Carillion
Curtis Allen, GlaxoSmithKline
Chris Ambrose, Medimmune
Phyllis Arthur, BIO
Dee Bagwell, Los Angeles County Public Health
Pamela Ball, Carillion New River Valley Medical Center
Anita Barry, Boston Public Health Commission
Kristy Baumtart, Dallas County Health Services
Katie Brewer, American Nurses Association
Doug Brunk, International Medical News Group
Anna Buchanan, ASTHO
Cindy Burbach, Sedgewick County Health Dept
Amy Burkholder, CBS Evening News
Kim Bush, Baxter International
Ken Cadaret, Oklahoma Department of Health
Wendy Campron, Georgia Division of Public Health
Susan Carr, Que Solutions
Patrick Caubel, Sanofi Pasteur
David Chaplin, IFLSS
Judith Coates, Sanofi Pasteur
Kathleen Coelingh, Medimmune
Chris Colwell, B&D Co
Maura Comer, NY School Public Health
Christine Craig, 21st Century Science & Technology
Francesca Cunningham, Department of Veteran Affairs
Allie D'Accurzio, B&D Consulting
Dave Daigle, Center for Disease Control
Vicky Debold, NVAC
Daniel DeNoon, WebMD
Najala Dickson, Sanofi Pasteur
Cynthia Dold, Public Health Seattle
Anjelica Dortch, McKenna Long Aldridge
Jeff Duchin, Public Health King County
Sarah Duggan-Goldstein, American Medical Association
Shannon Dzubin, Novartis Vaccines
Paul Etkind, NACCHO
Joan Facelle, NACCHO
Kathy Fredrickson, Arizona Department of Health Services
Amanda Fuller, North Carolina Division of Public Health
Barry Gershon, Wyeth
Adrienne Goodrich-Doctor, Office of Global Health Affairs, HHS
David Greenberg, Sanofi Pasteur
Patricia Guadalupe, WTOP
Amanda Hauptfleisch, Sanofi Pasteur
Steven Helgerson, Montana State Health Department
Patricia Hon, Cyclone Pharmaceutical
Dan Hopfensperger, Wisconsin Immunization Program
Betsy Hubbard, Public Health Seattle and King County
Sharon Humiston, University of Rochester
Laura Iiyama, Freelance Deutschewelle
Zhoowan Jackson, HHS
Lisa Johns, NC Immunization Branch
Jennifer Joseph, NACCHO
Sandy Kaufman, Sanofi Pasteur
Molly Kelly
Laura Kilpatrick, McKenna Long & Aldridge
Ron Klein, Maricopa County Public Health
Sarah Landry, National Institutes of Health (NIH)
Clement Lewin, Novartis
Karen Lewis, Arizona Department of Health Services
Sarah Lister, Congressional Research Service
Michael Loehr, Seattle/King County Public Health
Jim Lutz, CDC
Ruth Lynfield, Minnesota Department of Health
Deirdre MacNeil, Federal Emergency Management Agency, Department of Homeland Security
Rob Margetta, Congressional Quarterly
Laurene Mascola, Los Angeles County Health Department
James Matthews, Sanofi Pasteur
Natalie Matthews, AHIP
Jennifer Mbuthia, Vaccine Health Center
Sean McGlynn, K&L Gates
Karin Miller, Michigan Department of Community Health
Ria Misra, Politics Daily
Jomana Musmar, NBSB
Mark Nacetoskie, AHIP
Amy Nevel, HHS
Jennifer Nuzzo, Center for Bio Security
Brit Oiulfstad, Los Angeles County Public Health
John Parker, National Bio Defense Science Board
Sarah Patrick, Missouri Department of Health and Senior Services
William Pinard, American Academy for the Advancement of Science (AAAS)
Aaron Rak, GlaxoSmithKline
Greg Reed, Maryland Department of Health
Bob Rehm, AHIP
Jennifer Ridge, Boston Public Health Commission
Israel Rios, Sciclone Pharmaceuticals
Corey Robertson, New Jersey Department of Health and Sr. Services
Mackenzie Robertson HHS
Deborah Robinson, Robinson Consulting
Juan Rodriguez, Dallas County Health and Human Services
Julie Rones, House Committee on Oversight & Gov't Reform
Bob Roos, CIDRAP News
Eric Rose, National Vaccine Advisory Committee
Nuphar Rozen-Adler, B&D Co
Barbara SachuMolly Sander, North Dakota Department of Health
Patrick Scannon, NVSB
Julie Schafer, HHS
Lisa Schnirring, CIDRAP News
Khristine Sheedy, CDC
Andela Shen, NVPO
Jack Sims, Texas Department of Health Services
Jean Smith, CDC
Jennifer Smith, FDA Week
Susan Smith, South Carolina Department of Health & Environmental Control
Teresa Smith, CDC
Elizabeth Sobczyk, American Academy of Pediatrics
Kenneth Soyemi, Iowa Department of Public Health
Heather Stafford, Pennsylvania Department of Health
Nicole Standberry, North Carolina Division of Public Health
Teresa Stowasser, Lewis Gale Medical Center
Raymond Strikas, National Vaccine Program Office
Chris Swain, Sanofi Pasteur
Maryann Sypert, OPHS
Ginger Taylor
Korinne Thompson
Kate Traynor, American Journal of Health-System Pharmacy (AJHP)
Lynn Trefren, Tri County Health Department
Peter Vigliarolo, Cooney Waters
Andrew Wade, House of Representatives
Margaret Wilson, Vermont Department of Health
Laurel Wood, Alaska Immunization Program
Matt Zahn, Louisville Metro Health Department