Letter from the Chair to the Assistant Secretary for Health, RE: NVAC – January 20, 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 – January 20, 2010 Meeting
Dear Dr. Koh:
This letter summarizes the National Vaccine Advisory Committee (NVAC) meeting held on January 20, 2010. 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 endorse the use of the three criteria put forth by the Institute of Medicine committee charged with reviewing the priorities of the National Vaccine Plan while adding a third criteria, as well as 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 January 21, 2010. The remainder of the meeting was informational in nature.
National Vaccine Plan Update
CAPT Ray Strikas, National Vaccine Program Office (NVPO), reviewed the process of the National Vaccine Plan revision to this point and presented the three criteria used by the Institute of Medicine to evaluate priorities in the draft Plan – 1) technical and financial feasibility, 2) potential impact on morbidity and mortality, and 3) strategic opportunities. Following discussion by the NVAC, the use of a fourth criterion, public salience as defined by the five priority areas selected in the public engagement meetings, was proposed and unanimously approved by the NVAC. Further NVAC comments on both the current draft of the National Vaccine Plan and the IOM recommendations are being collected and a formal NVAC response to the draft Plan is expected following the February in-person NVAC meeting.
H1N1 Vaccine Program Update – State and Local Response Role
Dr. Paul Jarris, Association of State and Territorial Health Officials, discussed the upcoming Public Health Emergency Response (PHER) Phase 4 funding, indicating that this funding would be available for continuing vaccination campaigns through August, but not through the upcoming fall. Previous PHER funding for areas such as laboratories, epidemiology and surveillance could be extended, however. Dr. Jarris expressed concern that, given current estimates of 50 million Americans having been infected with H1N1 influenza and another 100 million vaccinated, approximately half of the nation’s population still has no immunity to this virus, and with the prospect of returning to a fully private sector vaccine distribution system, the ability to target groups for focused vaccination may be lost.
Dr. Anne Bailowitz, National Association of City and County Health Officials, discussed three areas of concern to local health officials – 1) staff burnout, 2) the ability to keep up with standard childhood vaccines during the H1N1 vaccination campaign, and 3) the ability ensure that children under 10 years get their second dose of H1N1 vaccine.
The NVAC did not receive an update from the Association of Immunization Managers at this meeting.
H1N1 Vaccine Program Update – Federal Response
The first update was by Dr. Anne Schuchat, Centers for Disease Control and Prevention (CDC), who informed the Committee that as of this meeting, over 144 million doses of H1N1 influenza vaccine have been made available for allocation and distribution by the contract distributor, with 121 million doses shipped to states. Dr. Schuchat also pointed out the report in the January 15 Morbidity and Mortality Weekly Report, where it was estimated that approximately 61 million people have received the H1N1 vaccine in the US. Provider outreach efforts also proved successful, with 120,000 providers signing the CDC provider agreement and vaccine distribution to 70,000 individual sites. Discussion focused on ways to continue with the momentum generated through this provider outreach, which will be one of the topics covered in the after-action reviews currently planned.
Dr. Glen Nowak, CDC, provided an overview of the recent activities around H1N1 influenza vaccination communications, and Ms. Stephanie Marshall, National Vaccine Program Office (NVPO), discussed communications around H1N1 vaccine safety, highlighting the weekly communications coordination calls and the fact that there has not been a need to respond to any safety signals throughout the campaign.
Dr. Marie McCormick, Chair of the VSRAWG, presented a report summarizing the findings of the group through their five meetings held prior to this NVAC 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 Vaccine Safety Risk Assessment and to transmit it to the ASH. This recommendation was transmitted to you by letter on January 21, 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.
Mr. James Moody, SafeMinds, discussed the idea of “injection rejection” due to safety concerns, and expressed concerns that if another pandemic were to occur, there would be limited time to examine the safety of the vaccine, highlighting the need for baseline data on adverse events in unvaccinated populations as well as special populations such as pregnant women. Ms. Theresa Wrangham, SafeMinds, echoed a previous concern about provision of information on the percent of vaccine available without thimerosal preservative and also sought clarification on the pre-specified outcomes examined by the VSRAWG and the methods used for the analyses they reviewed. Ms. Wrangham also expressed thanks for the inclusion of the additional criterion on public salience for use during review of the National Vaccine Plan.
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