Advisory: FDA advisors to look at nasal flu vaccine

July 13, 2001
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FluMist, an investigational intranasal influenza vaccine, is slated to go before the Food and Drug Administration‘s Vaccines and Related Biological Products Advisory Committee July 26-27. This meeting is open to the public and media are invited to attend.

FluMist was invented by Hunein “John” Maassab after more than four decades of work at the University of Michigan School of Public Health and is currently under develoment by Mountain View, Calif.-based Aviron. If approved, FluMist would represent a new approach to influenza vaccination—a nasal spray.

The FDA advisory committee meeting takes place July 26, 8:30 a.m. to 5:30 p.m., and July 27, 8:30 a.m. to 3:30 p.m., at the Holiday Inn, Grand Ballroom, 2 Montgomery Village Avenue, Gaithersburg, Md.

On July 26, the committee plans to hear presentations on the available safety and efficacy data for Aviron Inc.’s cold-adapted, live-attenuated, trivalent influenza virus vaccine (FluMist). From 8:30 to 10:15 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information.

On July 27, the committee will discuss the available data and the proposed indications for FluMist. Also on that day, between about 9-10:15 a.m., oral presentations from the public will be scheduled. The deadline has passed for people to inform the FDA if they plan to make formal presentations during that time.

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/

A 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, (301-443-0572 in the Washington, D.C., area), code 12391.

Contact at Aviron is John Bluth, (650) 919-3716 or [email protected].

Contact at University of Michigan is Colleen Newvine, (734) 647-4411 or [email protected].

Food and Drug AdministrationHunein “John” Maassabhttp://www.fda.gov/cber/advisory/vrbp/vrbp0701.htmhttp://www.sph.umich.edu/http://www.sph.umich.edu/symposium/john_maassab.htmlhttp://www.aviron.com/[email protected]