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U.S. Department of Health and Human Services

Advisory Committees

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July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Discussion Items

  1. Please discuss whether FDA’s approach to license non-adjuvanted pandemic (H1N1) 2009 influenza vaccines via a strain change supplement without new clinical data is appropriate with clinical data to be submitted post licensure.
    • The pandemic H1N1 2009 vaccine would be manufactured by U.S. licensed manufacturers using their currently licensed seasonal influenza vaccine process, and the current dose (15 μg HA/ 0.5ml dose for inactivated, and 106.5-7.5 FFU per 0.2mL dose for LAIV)
  2. Please discuss whether recipients of the pandemic (H1N1) 2009 influenza vaccine should be administered two doses of vaccine at the initiation of the program.
  3. Please discuss considerations for immunizing special populations such as children below the age of 6 months, and pregnant women.
  4. Please discuss considerations for use of adjuvanted vaccines.
  5. Please discuss the proposed post-licensure evaluations for safety. Please identify any gaps that may not have been included in our proposal.
  6. Please comment on approaches to assessing vaccine effectiveness. Consider the potential need for diagnostic methods to distinguish pandemic 2009 H1N1 strains from circulating seasonal strains and other influenza-like illnesses.
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