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Nasal Flu Vaccine Sniffing for Approval

FDA panel to weigh recommending spray mist that could appeal to the shot-wary

WEDNESDAY, July 25, 2001 (HealthDayNews) -- A government panel is expected to consider tomorrow whether to approve the first flu vaccine that can be administered through the nose.

Under review is FluMist, a nasal spray designed expressly to prevent recipients from catching the infection. Other oral and inhaled drugs that treat -- and even prevent -- the illness have already been approved, but they are not intended to be used as vaccines.

FluMist, which contains a live but weakened strain of virus, is made by Aviron, a biotech firm based in Mountain View, Calif. In support of its product, the company is submitting data on almost 25,000 adults and children who have used the vaccine in clinical trials. Although the FDA is not bound by its panels' advice, it seldom goes against the recommendations.

Proponents argue that a nasal vaccine may attract people who regularly avoid flu shots because they are needle-wary.

The committee meeting comes shortly after health officials announced that flu vaccine will be delayed for the second straight year. Officials project that only 15 million doses of the shots will be produced by the end of October, two months after many people traditionally start lining up to receive the injections.

As a result, officials are recommending that healthy people delay getting vaccinated in order to free up shots needed for the sick and the elderly. This year, flu vaccine makers expect to produce 77 million doses of the shots, up about 10 percent from 2000.

Even if the FDA approves FluMist in the coming months, the drug is unlikely to have a major impact on the vaccine market this flu season, which typically runs strong between December and April. The company has begun making a "limited" number of doses just in case it gets the nod, but full production will be possible only for the 2002-2003 season, said John Bluth, an Aviron spokesman.

Bluth said that although both FluMist and conventional flu shots are made from chicken eggs, the new product would not strap other vaccine producers. "I don't think that's an issue at all. It would provide additional, not replacement, vaccine," he said. Aviron is developing FluMist with the help of American Home Products, whose Wyeth Lederle division also makes an injected flu vaccine.

A spokesman for Aventis Pasteur, the nation's largest flu vaccine maker, also said Aviron's production would not inhibit its own ability to produce inoculations.

Dr. Carolyn Buxton Bridges, a flu expert at the Centers for Disease Control and Prevention, wouldn't discuss this week's FluMist hearing. However, Bridges did say that the agency welcomed "any new tool" to fight influenza, and that in principle mists might be a particularly useful alternative to injections.

"Intuitively, one would guess that people would prefer not to get a shot if they could avoid one," she added.

What To Do

Health officials recommend that people at high risk of the flu should get vaccinated as early as possible. These include nursing home residents, people over 65, pregnant women and anyone with lung or heart problems or a condition that weakens the immune system.

If you're not in any of these categories, be patient.

For more on the flu vaccine situation, check out the Centers for Disease Control and Prevention or the CDC's National Immunization Program.

SOURCES: Interviews with John Bluth, spokesman, Aviron, Mountain View, Calif.; Carolyn Buxton Bridges, M.D., influenza researcher, Centers for Disease Control and Prevention, Atlanta; Food and Drug Administration background material
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