NVAC Vaccine Safety Risk Assessment Working Group (VSRAWG) Update NVAC Meeting February 3, 2010 Marie McCormick, M.D., Sc.D. Sumner and Esther Feldberg.

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NVAC Vaccine Safety Risk Assessment Working Group (VSRAWG) Update NVAC Meeting February 3, 2010 Marie McCormick, M.D., Sc.D. Sumner and Esther Feldberg Professor of Maternal and Child Health Department of Society, Human Development, and Health Harvard School of Public Health

Charge To conduct independent, rapid reviews of available federal immunization safety monitoring data for the 2009 H1N1 influenza vaccines

Working Group Members Stephen Cantrill Vicky Debold Kathryn Edwards Chris Carlson Theodore Eickhoff 1 NVAC Member 2 NVAC VSRAWG Chair Susan Ellenberg Marie McCormick 1,2 Laura Riley 1 Mark Sawyer

–Meets bi-weekly to review H1N1 safety data Initial meeting Nov. 2, meetings to-date –Reports for NVAC monthly 2 reports reviewed to date –December 16, 2009 –January 20, 2010 Transmitted to the ASH ASPR, CDC, FDA, NIH, HIS, CMS, DoD and VA Available on NVPO website at: Progress

“Working Group concluded that the data are adequate to assess the presence or absence of a signal. Additionally, the Working Group concluded that the data do not favor a signal between the outcomes examined and the H1N1 vaccines. A signal is defined as an event that could be temporally occurring more often after vaccine receipt than anticipated by chance alone.” Report Conclusions

Moving Forward Working Group will continue to review the safety data of H1N1 vaccines Reports from the VSRAWG will be presented on NVAC conference calls on the following dates: –February 26 –March 23 –April 21 –May 19