Food and Drug Administration
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.
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)