1. 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. 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 12-15 months of age, for the prevention of invasive pneumococcal disease caused by serotypes in the vaccine?

3. 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 12-15 months of age?

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

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