FluMist

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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 Clinical Briefing Document for MedImmune Vaccines Inc., Cold Adapted Influenza Vaccine, Trivalnet - FluMist™ (pdf) (Word

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)

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