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Letter from the Chair to the Assistant Secretary for Health, RE: NVAC – Dec 16, 2009 Meeting

Howard K. Koh, M.D., M.P.H
Assistant Secretary for Health
Department of Health and Human Services
200 Independent Avenue, SW, Rm. 701-H
Washington DC 20201

RE: NVAC – December 16, 2009 Meeting

Dear Dr. Koh:

This letter summarizes the National Vaccine Advisory Committee (NVAC) meeting held on December 16, 2009.  This meeting was an off-schedule meeting, held by teleconference, designed to brief the NVAC on both the status of the National Vaccine Plan update and the current state of the H1N1 influenza pandemic and vaccination campaign.  The agenda for this meeting is enclosed.

During the meeting, NVAC voted to accept the report from the Vaccine Safety Risk Assessment and to recommend continuation of the safety monitoring effort for H1N1 influenza vaccine.  This recommendation was transmitted to you by letter on December 17, 2009.  The remainder of the meeting was informational in nature.

National Vaccine Plan Update
CAPT Ray Strikas, National Vaccine Program Office (NVPO), presented an overview of the timeline for the revision of the National Vaccine Plan.  The current draft of the Plan is being revised by NVPO following receipt of recommendations from the Institute of Medicine (IOM) and the revised plan will be made available for an additional round of stakeholder engagement hosted by NVAC in the next few months.  It is anticipated that the National Vaccine Plan will be complete by mid-2010, with an implementation plan developed by the end of 2010.

Dr. Ed Marcuse and Dr. David Reuben, who were members of the IOM panel, presented an overview of the IOM report on the review of the draft National Vaccine Plan.  Discussions on the report were positive, particularly with the IOM suggestions for focus on coordination and vaccine safety. 

Federal H1N1 Vaccine Program Implementation Update
The first update was by Dr. Anne Schuchat and Dr. Jay Butler, Centers for Disease Control and Prevention (CDC), who informed the Committee that as of this meeting, over 96 million doses of H1N1 influenza vaccine have been made available for allocation and distribution by the contract distributor, a total that has exceeded the volume of vaccine handled over a full year through the Vaccines for Children program.  The increase in available vaccine has allowed for some changes to the vaccination program, notably the expansion out of the initial ACIP-recommended high priority groups and the increased utilization of retail pharmacies as vaccine distribution sites.  An update was given on the recall of 800,000 doses of pre-filled syringes that occurred on December 15, 2009, highlighting the routine stability and sterility testing that manufacturers perform to ensure the safety and efficacy of vaccines. 

Dr. Kris Sheedy, CDC, provided an overview of the H1N1 influenza communications strategy and recent activities, including a series of recently completed public service announcements from federal and state government officials.  Ms. Stephanie Marshall, National Vaccine Program Office (NVPO), discussed the efforts to disseminate H1N1 influenza vaccine safety information, which include press conferences, CDC webcasts, content placed on and releases of data summaries from the Vaccine Adverse Events Reporting System (VAERS).

Dr. Marie McCormick, Chair of the NVAC H1N1 Vaccine Safety Risk Assessment Working Group, presented background on the efforts of this working group, including an overview of the various data sources being utilized to examine the safety of the H1N1 influenza vaccine.  Dr. McCormick discussed the preliminary findings of the working group: first, that the data available to this point are adequate to assess the presence of a safety signal if present; second, the data available to this point do not favor a signal between the outcomes studied and receipt of the H1N1 influenza vaccine; and third, the H1N1 influenza vaccine safety monitoring systems should continue.  NVAC voted to accept the report from the Vaccine Safety Risk Assessment and to recommend continuation of the safety monitoring effort for H1N1 influenza vaccine.  This recommendation was transmitted to you by letter on December 17, 2009, and is also enclosed.  As additional data are collected and additional data sources come on-line, further examinations of the data will be performed to continue to monitor for the presence of a signal.

State and Local Response Role
Ms. Claire Hannan, Association of Immunization Managers, discussed the current state of the immunization program, focusing on the status of vaccine capacity and the ability of immunization programs to expand their vaccination target groups.  Ms. Hannan presented some needs, including better data to make decisions about vaccine allocation and the development and implementation of a better information technology/vaccine ordering infrastructure.  Suggestions for future discussion included examination of the roles of the private and public sector in vaccine ordering and distribution, preparation for next influenza season, the development of the adult immunization infrastructure, and the need to transition from the VACMAN system.

Dr. Paul Jarris, Association of State and Territorial Health Officials, focused his discussion points on two areas – the impact of opening up the vaccination program to everyone, especially through pharmacies; and the need to learn from this pandemic, particularly in light of funding needs that necessitated the supplemental funds for preparation and implementation of the vaccination program.

Dr. Anne Bailowitz, National Association of City and County Health Officials, discussed some potential issues, focused on the challenges of vaccine supply and demand especially around the holiday season, and the need to establish continuity of operations plans and.

Continued discussion between these liaisons and NVAC members focused on the role of NVAC in after-action follow-up that will occur, the need to learn from what was experienced, and the need to capitalize on the established momentum, especially for adult immunization.  Dr. Butler indicated that the capture of issues for future consideration has been an on-going process.

Public Comment
Ms. Theresa Wrangham, SafeMinds, asked whether there was evidence to support the possibility of a third wave of the pandemic and expressed concern both about the uncertain proportion of vaccine that would be thimerosal-free and the recent recall of pediatric dose pre-filled syringes.  Ms. Alison Fedarko, a concerned mother, indicated that since NVAC wants to increase reporting VAERS, vaccine manufacturer and lot information should be provided for all vaccinations given.  She indicated that no such information was given when her child was vaccinated.  Ms. Deb Huber presented a concern about the level of fear-mongering without the provision of any alternatives, including the role of vitamin D deficiency in influenza.  Ms. Eileen Danneman, National Coalition of Organized Women, expressed the need for appropriate oversight at the state-level, to ensure that appropriate information about thimerosal-containing vaccines was being distributed, and to ensure that physicians are adequately reporting adverse events.  Mr. James Moody, SafeMinds, expressed concern that the NVAC recommendation adopted in June regarding evaluation of the feasibility of a study of the health of unvaccinated children has not yet been acted on, and indicated that the call for transparency in vaccine safety evaluation recommended by the IOM is not sufficient, and that an independent safety oversight group is needed.  Dr. Paul King, Coalition for Mercury Free Drugs, expressed his concern that there have been no studies to prove the safety of thimerosal or the efficacy of influenza vaccines.  Mr. Timothy Walsh expressed his feelings that the discussion of a possible third wave of H1N1 influenza was alarmist.

Please feel free to contact me with any questions or concerns you may have in regard to any of the Committee’s activities.  I would also like to invite you to attend our next regularly scheduled NVAC meeting, which is scheduled for February 3-4, 2010, as well as any off-schedule meetings that will be held to address the H1N1 influenza situation or the revision of the National Vaccine Plan.  Of course, I am available at any time to speak to you by telephone or to meet in person.



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