Prevnar Pneumococcal 7-valent (4, 6B, 9V, 14, 18C, 19F, 23F) Conjugate Vaccine (Diphtheria CRM197 Protein)

 

November 5, 1999

 

 

Questions to the Committee

 

1. Do the data provide sufficient evidence of efficacy against invasive disease for Prevnar, as it was studied in the efficacy trial (i.e., after administration at 2, 4, 6, and 12-15 months of age)?

If not, what additional information should be requested?

 

 

2. Do the data provide sufficient evidence of safety for Prevnar?

If not, what additional information should be requested?

 

 

3. Please discuss the data regarding concurrent use of Prevnar with other vaccines administered according to the recommended schedule of infant and childhood immunizations.

 

4. Please identify any issues that should be addressed by post-marketing studies.