Vaccines and Related Biological Products Advisory Committee
December 17, 2002
FluMist™ Influenza Virus Vaccines, Trivalent, Types A & B, Live, Cold Adapted
FOOD AND DRUG ADMINISTRATION
FDA Statistical Review and Evaluation (pdf) (Word)
Corrections/Changes to FDA Clinical Briefing Document, December 10, 2002 (pdf) (Word)
Appendix 4.1: Genotypic and Phenotypic Analyses of Influenza Viruses Shed by Recipients of Cold Adapted, Live Attenuated Influenza Virus Vaccine (pdf) (Word)
MEDIMMUNE VACCINES, INC.
Disclaimer
The statements contained in this document 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.
Briefing Information - Part 1 (pdf)
Briefing Information - Appendix 1 - Part 2) (pdf)
Addendum to MedImmune Vaccines (pdf) (Word)
OPEN PUBLIC HEARING
Letter to Dr. Sachs Regarding FluMist, Dr. Harvey Bernstein, MD, FAAP, Stony Brook University (PDF)
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.