- 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)
- Please discuss whether recipients of the pandemic (H1N1) 2009 influenza vaccine should be administered two doses of vaccine at the initiation of the program.
- Please discuss considerations for immunizing special populations such as children below the age of 6 months, and pregnant women.
- Please discuss considerations for use of adjuvanted vaccines.
- Please discuss the proposed post-licensure evaluations for safety. Please identify any gaps that may not have been included in our proposal.
- 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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