VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

July 26-27, 2001

Slides

Aviron Live Attenuated Influenza Virus Vaccine, FluMist™

FDA Slides

Aviron Cold-Adapted Live Attenuated Influenza Virus Vaccines, Trivalent FluMist™, FDA Clinical Summary, ChrisAnna M Mink, MD, FDA   ppt   htm

Overview of Development of Cold Adapted, Live Attenuated influenza Vaccines; basis for Attenuation; and Potential for Reassortment with Wild-Type Viruses in Nature, Dr. Brian Murphy, NIH   pdf

Session 2: Introduction, Peter A Patriarca, MD, FDA   ppt   htm

Sponsor Slides

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.

Introduction, Harry Greenberg, MD, Aviron   pdf

Large Scale Safety in Healthy Children, The Kaiser Study - AV019, Steven Black, MD & Henry Shinefield, MD, Northern California Kaiser Permanente Vaccine Study Center   pdf

Safety in Children, Paul M Mendelman, MD, Aviron   pdf

Safety in Adults, Paul M Mendelman, MD, Aviron   pdf

Efficacy and Effectiveness in Healthy Adults, Kristin L Nichol, MD, MPH, MBA, University of Minnesota and the Minneapolis VA Medical Center   pdf

Efficacy in Children, Robert B Belshe, MD, Saint Louis University   pdf

Conclusions & Contributors, Harry Greenberg, MD, Aviron    pdf