VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

July 26-27, 2001

Aviron
Cold Adapted Influenza Vaccine, Trivalent - FluMist

Briefing Information

FDA Briefing Document   pdf   doc

Sponsors Briefing Information

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.

Table of Contents   pdf

List of Abbreviations   pdf

List of Tables   pdf

List of Figures   pdf

1.  Introduction   pdf

2.  Epidemiology and Prevention of Influenza   pdf

3.  Rational for FluMist Development   pdf

4.  FluMist Clinical Program   pdf

5.  Summary of Efficacy  pdf

6.  Summary of Immunogenicity   pdf

7.  Summary of Safety   pdf

8.  Overall Conclusions   pdf

Appendices   pdf

Appendix 1: Pre-Specified Medically Attended Events in Study AV019   pdf

Appendix 2:  MAE Categories (N-147) Recorded in Hospital, ED, or Outpatient Clinic Databases for Study Participants during the Safety Evaluation Period in Study AV019   pdf