Gaithersburg, Md.—The U.S. Food and Drug Administration‘s Vaccines and Related Biological Products Advisory Committee today (July 27) recommended that there are adequate data to support the effectiveness of FluMist for the prevention of influenza in healthy children and adults ages 1-64.

The committee also recommended that the data analysis completed to date is not sufficient to support the safety of the vaccine at this time. In closing the discussion, Dr. Robert S. Daum, chairman of VRBPAC, indicated that the committee would welcome the opportunity to evaluate the safety data when the analyses are complete. Aviron is continuing to work with the FDA as they complete the analysis of the safety data supporting the license application. FluMist is a cold-adapted, live-attenuated, trivalent influenza virus vaccine. Delivered as a nasal mist, FluMist could offer an important new approach to help protect people from influenza. FluMist is based on technology developed over a lifetime of work by Hunein “John” Maassab, professor of epidemiology, University of Michigan School of Public Health. Reached by phone at his Ann Arbor home, Maassab said, “I am pleased that the distinguished experts on the FDA committee have confirmed that FluMist is effective. I understand that the panel believed more data are needed to establish the safety of FluMist. I strongly believe FluMist is safe. Studies to confirm its safety should be completed as soon as possible.” Maassab began work on an influenza vaccine in the 1950s as a graduate student under the direction of Dr. Thomas Francis Jr., who had overseen the U.S. Army’s flu vaccine program during World War II. Maassab first isolated the influenza type A-Ann Arbor virus in 1960, and by 1967, he had developed a cold-adapted virus. For the next several decades, he worked to refine and evaluate his flu vaccine. The Biologics License Application for FluMist is currently under review by the FDA, which ultimately will decide whether to approve the license application. If licensed by the FDA, FluMist would be the first influenza vaccine delivered as a nasal mist to be commercially available in the United States. FluMist would be marketed by Aviron (Nasdaq: AVIR) and Wyeth Lederle Vaccines, a business unit of American Home Products (NYSE: AHP).”Delivering a flu vaccine via a nasal mist makes good clinical sense since influenza is an airborne virus that typically enters the body through the nose,” said Robert B. Belshe, professor of internal medicine, pediatrics, molecular microbiology and immunology at Saint Louis University.

Each year in the U.S., influenza infects 35-50 million people, resulting in 20,000 deaths (predominantly in the elderly) and as much as $12 billion in direct and indirect costs, including 70 million lost work days and 38 million lost school days. Influenza vaccination may be particularly significant for children, who are between two and three times more likely than adults to contract influenza and who remain infectious longer.

# # # # #

EDITORS: Dr. Maassab could not attend the meeting because he is too ill; he is unavailable for media comment.

For more information on U-M’s role in the development of FluMist, visit http://www.sph.umich.edu/flumist/. For details on the committee meeting: http://www.fda.gov/cber/advisory/vrbp/vrbp0701.htm. To learn about the U-M School of Public Health: http://www.sph.umich.edu/. An SPH tribute to Maassab is at: http://www.sph.umich.edu/symposium/john_maassab.html. For more on Aviron: http://www.aviron.com.

Contact people with the FDA are Nancy T. Cherry or Denise H. Royster, (301) 827-0314, or call the FDA Advisory Committee Information Line, (800) 741-8138 or (301) 443-0572 in the Washington, D.C. area), code 12391. Contact at Aviron is John Bluth, (650) 919-3716 or jbluth@aviron.com.

Food and Drug AdministrationRobert S. Daumhttp://www.sph.umich.edu/flumist/http://www.fda.gov/cber/advisory/vrbp/vrbp0701.htmhttp://www.sph.umich.edu/http://www.sph.umich.edu/symposium/john_maassab.htmlhttp://www.aviron.com