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Letter from the Chair to the Assistant Secretary for Health, RE: NVAC – March 23, 2010 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 – March 23, 2010 Meeting

Dear Dr. Koh:

This letter summarizes the National Vaccine Advisory Committee (NVAC) meeting held on March 23, 2010. This meeting was an off-schedule meeting, held by teleconference, to receive an update on the vaccine safety monitoring programs for the H1N1 influenza vaccination campaign and to vote on the report presented by the H1N1 Vaccine Safety Risk Assessment Working Group (VSRAWG). The agenda for this meeting is enclosed.

H1N1 Vaccine Safety Risk Assessment Working Group Report

Dr. Vicky Debold, National Vaccine Information Center, presented a report summarizing the findings of the VSRAWG through their nine meetings held prior to this NVAC meeting, on behalf of Dr. Marie McCormick, VSRAWG Chair, who was unable to attend the meeting.  This draft report stated the conclusions that the data available to this point are adequate to assess the presence of a safety signal if present, and that the available data do not favor a signal, that is any link between the outcomes studied and receipt of the H1N1 influenza vaccine, and that the H1N1 influenza vaccine safety monitoring systems should continue.  NVAC voted to accept the report from the VSRAWG and to transmit it to the ASH.  This recommendation was transmitted to you by letter on March 23, 2010.  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.  The VSRAWG will continue to meet to review the H1N1 vaccine safety efforts of the federal agencies.  In response to the slowing distribution of H1N1 influenza vaccine, the VSRAWG is beginning to work towards an end-of-season analysis of H1N1 influenza vaccine safety.

Public Comment

A commenter expressed concerns about the potential for bias in determining rates of adverse events following H1N1 based on vaccine doses distributed versus doses administered, and whether individuals could still experience adverse events due to vaccine in the absence of a population-level signal.  The commenter also asked for a review of the safety of rotavirus vaccine in light of the suspension of one of the rotavirus vaccines on March 22, 2010. 

I anticipate further updates for the NVAC on the rotavirus suspension situation, especially in light of the recent work of NVAC on vaccine safety issues. 

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 June 2-3, 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