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