Questions to the Committee May 21, 2002 Food

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Questions to the CommitteeMay 21, 2002 Food
Drug Administration Center for Biologics
Evaluation Research VACCINES RELATED
BIOLOGICAL PRODUCTS ADVISORY COMMITTEE  
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Questions to the Committee

• 1. Are the data adequate to support efficacy of
  Prevnar in infants and toddlers for prevention of
  otitis media caused by Streptococcus pneumoniae
  due to capsular serotypes included in the vaccine
  (4, 6B, 9V, 14, 18C, 19F, 23F)? If not, would
  additional analyses derived from the Finnish
  otitis media study, the Northern California
  Kaiser Permanente efficacy study, or additional
  clinical trials be useful in establishing
  efficacy?  2. Please discuss the strength of
  the data with respect to secondary otitis media
  outcomes  a) Acute otitis media episodes
  caused by S. pneumoniae, regardless of
  serotype b) Overall reduction in acute otitis
  media episodes c) Frequent otitis media d)
  Tympanostomy tube placement.