Letter from the Chair to the Assistant Secretary for Health, RE: NVAC – Feb 26, 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 – February 26, 2010
Dear Dr. Koh:
This letter summarizes the National Vaccine Advisory Committee (NVAC) meeting held on February 26, 2010. This meeting was an off-schedule meeting, held by teleconference, to facilitate discussion on the update of the National Vaccine Plan and the vaccine safety monitoring programs for the H1N1 influenza 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 from the H1N1 Vaccine Safety Risk Assessment Working Group (VSRAWG) was transmitted to you by letter on February 26, 2010. Additionally, the NVAC voted on a recommendation regarding sustainability of the public health infrastructure developed in response to the H1N1 influenza pandemic as well as a suite of recommendations on the update of the National Vaccine Plan.
H1N1 Vaccines Safety Risk Assessment Working Group Report
Dr. Daniel Salmon, National Vaccine Program Office, presented a report summarizing the findings of the VSRAWG through their seven 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 February 26, 2010, 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. The VSRAWG will continue to meet to review the H1N1 vaccine safety efforts of the federal agencies.
Public Health Sustainability Recommendation
Following discussion at the NVAC in-person meeting of February 3-4, 2010, a formal recommendation was drafted regarding the need to maintain the gains made in public health infrastructure at the state and local levels through the H1N1 pandemic that were funded through emergency appropriations, such as the Public Health Emergency Response (PHER) grants. Briefly, given that PHER funding is slated to expire by the middle of this year, the NVAC is recommending that you work with the Secretary, Department of Health and Human Services (HHS) and other Assistant Secretaries, HHS, to identify ways to preserve and maintain these improvements in public health infrastructure. The full recommendation is enclosed.
National Vaccine Plan Recommendations
Acting on your request for the NVAC to review the draft National Vaccine Plan, a review process was begun prior to the February 2010 NVAC meeting. A final set of 15 recommendations, addressing both the draft National Vaccine Plan itself and the Institute of Medicine recommendations was developed. These recommendations were approved by the NVAC during this meeting, and are enclosed. NVAC is still working on prioritizing the different goals and recommendations in the Plan. These results will be forwarded to you shortly.
Mr. James Moody, SafeMinds, expressed his concern that the draft National Vaccine Plan fails to achieve a “safety first” agenda, which would require independent, accountable, well-resourced oversight, and stated his desire for more independent research into vaccine adverse events.
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