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Tough Times for Nasal Flu Vaccines

Sales are off for one, some serious side effects may exist in another

WEDNESDAY, Feb. 25, 2004 (HealthDayNews) -- When the U.S. Food and Drug Administration gave approval last year to a new nasal spray flu vaccine called FluMist, some analysts predicted it could become a blockbuster.

Instead, sales sank like a stone.

Appearing before a federal health panel on Tuesday, officials from Maryland-based MedImmune Inc., the maker of FluMist, said sales have been dismal. Only one million of five million doses have been sold, despite a flu season marked by an usually early and harsh start, The New York Times reports.

"Our initial launch was very disappointing," Dr. Peter A. Patriarca, of MedImmune, told the panel, the Advisory Committee on Immunization Practices.

The 15-person panel is appointed by the U.S. Department of Health and Human Services to guide the Centers for Disease Control and Prevention on recommendations for influenza and a number of other immunizations, according to the Times.

Not even a shortage of traditional flu vaccines could boost sales of FluMist, approved for healthy people ages 5 to 49. The drug companies that make traditional vaccines produced 87 million flu doses for this season. But because the season began in October, leading to high demand for flu shots, the manufacturers said they had sold all their supplies to distributors by December.

Patriarca attributed FluMist's sagging sales to a series of factors, including price. Doctors charged their patients up to $150 for FluMist, he said. Not even a rebate program offered by MedImmune could jumpstart sales, the Times reports.

FluMist's woes aren't the only worrisome news about nasal flu vaccines.

A new study finds a possible link between a different nasal flu vaccine and Bell's palsy, a temporary paralysis of the facial muscles.

Researchers who were looking into the cause of an unusual number of cases of Bell's palsy in Switzerland began noticing a connection with people who had used a nasal vaccine called Nasalflu.

Bell's palsy is a neurological paralysis of one side of the face that can last from weeks to months, but doesn't normally have any permanent effects.

The study concludes that Nasalflu, which was used only in Switzerland but was pulled from the market several years ago, could be a possible cause of Bell's palsy.

"At this point these are hypothetical conclusions -- no cause has been determined as to the reason why these people contracted Bell's palsy," says Dr. Robert Steffen, of the University of Zurich's Collaborating Centre for Traveller's Health, and one of the study's authors. "What we were able to do is prove a strong association between the flu vaccine and Bell's palsy, but we cannot demonstrate why at this point."

The study appears in the Feb. 26 issue of the New England Journal of Medicine.

Health experts, however, don't see a link between the potential problems associated with Nasalflu, and FluMist.

"It would be hard to see an association," says Ira M. Longini Jr., of Emory University. "I just don't know where it would be. These are completely different vaccines: one [FluMist] is a live attenuated and cold-adapted virus and one [Nasalflu] is deactivated -- totally different."

Nasalflu was manufactured by the Swiss company Berna Biotech AG, and was used in Switzerland in the 2000-2001 flu season. It was pulled by the company when reports of possible Bell's palsy cases began surfacing.

More information

For more on nasal flu sprays, visit the Centers for Disease Control and Prevention and the Food and Drug Administration.

SOURCES: Ira M. Longini Jr., Ph. D., professor of Public Health, Rollins School of Public Health, Emory University, Atlanta; Robert Steffen, M.D., University of Zurich's Collaborating Centre for Traveller's Health, Bern; Feb. 26, 2004, New England Journal of Medicine; Feb. 25, 2004, The New York Times
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