The University Record, August 13, 2001

Data support effectiveness of vaccine for flu, FDA advisory committee says

By Colleen Newvine
News and Information Services

The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee on July 27 said that there is adequate data to support the effectiveness of FluMist for the prevention of influenza in healthy individuals ages 1–64.

The committee also said that data analysis so far is not sufficient to support the safety of the vaccine. In closing the discussion, Robert S. Daum, panel chairman, indicated that the committee is willing to evaluate the safety data when the analyses are complete.

FluMist is an influenza virus vaccine delivered as a nasal mist. It is based on technology developed by Hunein “John” Maassab, professor of epidemiology.

“I am pleased that the distinguished experts on the FDA committee have confirmed that FluMist is effective,” Maassab says. “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 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 refined his flu vaccine.

The FDA is reviewing the license application for FluMist. If approved, FluMist would be the first influenza vaccine delivered as a nasal mist to be commercially available in the United States. It would be marketed by Aviron and Wyeth Lederle Vaccines, a business unit of American Home Products.

Influenza infects 35–50 million people each year in the United States, resulting in 20,000 deaths, predominantly among the elderly. Children are between two and three times more likely than adults to contract influenza, and they remain infectious longer.

For more information on the U-M’s role in the development of FluMist, visit the Web at www.sph.umich.edu/flumist/. For details on the committee meeting, visit the Web at www.fda.gov/cber/advisory/vrbp/vrbp0701.htm.