Food and Drug Administration

Vaccines and Related Biological Products Advisory Committee

May 21, 2002

Briefing Information

Sponsor

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Letter to Dr Jody Sachs releasing briefing information without redaction, Jack D Love, Worldwide Regulatory Affairs  pdf

Prevnar , Pneumococcal Conjugate Vaccine 7-valent, for the Prevention of Acute Otitis Media  doc

Attachment C: FDA Statistical Review and Evaluation  pdf

Finnish AOM Study  pdf

Appendix 4: References  doc

Bibliography  doc