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Vaccines and Related Biological Products Advisory Committee (VRBPAC)May 21, 2002Prevnar?, Pneumococcal Conjugate Vaccine 7-valent, for the Prevention of Acute Otitis Media? R. Douglas Pratt, M.D., M.P.H. Review Team Jingyee Kou, Ph.D. Marion Gruber, Ph.D. Carl Frasch, Ph.D. Proposed Indication For active immunization of infants and toddlers against invasive disease and otitis media caused by Streptococcus pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, 23F) Regulatory Background November 1999 February 2000 June 2000 May 2001 October 2001 March 2002 May 2002 VRBPAC for invasive disease Prevnar licensed for prevention of invasive disease AOM license amendment submitted FDA Letter to sponsor Response to FDA letter received Second FDA letter to sponsor; major amendment- Finnish follow-up data VRBPAC for otitis media Global Issues Efficacy estimates for AOM outcomes are comparatively low for preventive vaccines Possible increased risk of AOM (negative efficacy) for pneumococcal serotypes not included in Prevnar Potential for unrealistic public expectations regarding benefit in preventing AOM Comments from Medical Community:Correspondence to New England Journal of Medicine Clinical significance of overall treatment effect questioned (Lavin A; Damoiseaux R; Cantekin E; Sauder K) Concern that limited benefit may be misunderstood by the public (Sauder K) Concern that credibility of existing recommendations may be compromised (Sauder K) Misunderstanding of FDA action taken regarding AOM (Cantekin E) Clinical Studies Reviewed Outline of FDA Presentation Introduction Efficacy data from Finnish OM study Supplementary analyses Finnish follow-up study Efficacy data from the NCKP study Safety data from Finnish OM study Considerations Questions to the Committee Finnish OM Study—Primary Objective Determine the protective efficacy of the pneumococcal conjugate vaccine against culture-confirmed pneumococcal acute ot