1 Vaccines and Related Biological Products Advisory Committee Meeting November 18, 2009 Questions for the Committee Prevnar 13 Pneumococcal 13-valent Conjugate.

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Presentation transcript:

1 Vaccines and Related Biological Products Advisory Committee Meeting November 18, 2009 Questions for the Committee Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein] Applicant: Wyeth Pharmaceuticals Inc.

2 Questions for the Committee 1.Are the available data adequate to support the effectiveness of Prevnar 13, when administered to infants and toddlers at 2, 4, 6, and months of age, for the prevention of invasive pneumococcal disease caused by serotypes in the vaccine?

3 Questions for the Committee 2.Are the available data adequate to support the safety of Prevnar 13 when administered to infants and toddlers at 2, 4, 6, and months of age?

4 Questions for the Committee 3.Please comment on the proposed phase 4 observational safety study.

5 Questions for the Committee 4.Please discuss whether the available data support the effectiveness of Prevnar 13 for the prevention of otitis media.

6 Questions for the Committee 5.Please comment on the proposed postmarketing IPD effectiveness studies.