ANN ARBOR, Mich.---A nasal spray flu vaccine, deemed safe and effective for healthy people aged 5 to 49 by a Food and Drug Administration committee today, represents the life's work of a professor at the University of Michigan. The U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee reviewed FluMist, based on technology developed by Hunein "John" Maassab, professor of epidemiology at the U-M School of Public Health.

"The positive recommendations of the FDA committee reviewing FluMist are most welcome," Maassab said from his home in Ann Arbor. "I believe that more people will use the nasal spray vaccine than a vaccine that must be injected. This should reduce the overall risk of flu."

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. The Centers for Disease Control and Prevention estimates each year about 114,000 people in the U.S. are hospitalized and about 20,000 people die because of flu.

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.

FluMist uses a live but weakened virus, administered to help develop immunity. This weakened virus is adapted to grow at the lower temperatures of the nasal passages but not the warmer conditions of the lungs where disease develops. A trivalent vaccine, like the flu shot, it includes three different strains of vaccine.

The Biologics License Application for FluMist is currently under review by the FDA, which ultimately will decide whether to approve the license application. The original application for FluMist was submitted to the FDA in October 2000 by Aviron, a California-based vaccines company MedImmune acquired in January 2002.

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 MedImmune (Nasdaq: MEDI) in partnership with Wyeth (NYSE:WYE).

For further information contact Colleen Newvine, (734) 647-4411,
cnewvine@umich.edu.

For more information on U-M's role in the development of FluMist, visit
http://www.sph.umich.edu/news_events/flumist/index.html

A School of Public Health tribute to Maassab:
http://www.sph.umich.edu/symposium/2000/john_maassab.html

For details on the FDA vaccine committee meeting.

For more on MedImmune.

For more on Wyeth.

To contact University of Michigan News and Information Services:
By fax:  (734) 764-7084
By phone:  (734) 764-7260
By mail:  412 Maynard, Ann Arbor, MI 48109-1399
By Internet:  http://www.umich.edu/~newsinfo

Dr. Maassab could not attend the meeting because he is ill and unavailable for comment. Rosemary Rochford, assistant professor of epidemiology, is the U-M FluMist spokesperson and is available for interviews from Ann Arbor Dec. 18.

U-M has professional TV studios and uplink capabilities. Photos of Maassab in his lab are available, as are B-roll of campus and of the School of Public Health.

Lori Weiman, senior director of corporate communications at MedImmune, is the appropriate contact for questions about the timing of a launch for FluMist and about its FDA application. MedImmune's press room number at the FDA hearings is (301) 564-5210. Lori's office number is (301) 527-4321.
MedImmune's associate director of public relations, Jamie Lacey, can be reached at (240) 632-4035

For more on the FDA vaccine committee meeting, call Jody G. Sachs or Denise H. Royster, (301) 827-0314. The FDA Advisory Committee Information Line is (800) 741-8138, code 12391.

© 2003 The Regents of the University of Michigan
Updated February 04, 2003