FDA panel: Nasal flu vaccine not safe

WASHINGTON (CNN) -- An advisory committee to the U.S. Food and Drug Administration voted Friday that a new nasal flu vaccine spray was effective, but not safe for most people. The committee's findings were based on data from more than 24,000 people from ages one to 64 years.

The panel voted 10-4 against the overall safety of FluMist, made by Aviron Pharmaceuticals of Mountain View, California. The company intended the product as an alternative to the standard flu vaccine shot. Unlike the injection, it is made from weakened live flu virus, rather than killed virus.

Earlier on Friday, the panel voted 13-2 in favor of the effectiveness of the spray for the adult population, ages 18 to 64 years. However, the panel only narrowly found the nasal vaccination to be effective for the pediatric and adolescent population by a vote of 8-7.

The panel did not vote on whether it would or would not recommend the vaccine to the FDA, citing the need for more research data. It is not clear when the FDA will decide whether or not it will approve the drug.

FDA officials told CNN the voters who recommended against the vaccine for teenagers and infants did not believe the data had enough information on children under the age of two years.

In research presented to the FDA's Vaccines and Related Biological Products Advisory Committee, FluMist was 93 percent effective in preventing influenza in children. Thursday, the committee learned that a study involving adults failed to show that FluMist can significantly reduce fever during a flu outbreak. The flu shot, which is currently recommended for adults and children with asthma, is only 70 percent effective.

Supporters of the nasal spray say the flu vaccine will give those who are afraid of needles another alternative by having the drug administered through the nose.

"You're giving people a choice and there clearly are a group of people that find needles rather distressing and if indeed they had choice of another way to deliver a vaccine, it could indeed allow the public health system to expand its vaccine coverage." said Carole Heilman of the National Institute of Allergy and Infectious Diseases.

According to Aviron, over 70-million people received a flu shot last year. Heilman says she hopes FluMist will encourage more people to get a flu vaccine.

Ninety percent of infections occur in the mucus lining of the nose. Research has shown FluMist provides protection in both the bloodstream and in the upper respiratory tract.

The flu and related flu symptoms cause 20,000 deaths annually in the United States, primarily in the elderly.

It is unlikely the FDA will make a decision on FluMist before the next flu season, which begins in October and lasts until March. If the vaccination spray is approved by the FDA, Aviron says it will be ready for the 2002-2003 flu season. Only a limited amount of the vaccine could be available for this year's flu season.