Flu Vaccine in a Spray Wins Vote From Panel

http://www.nytimes.com/2002/12/18/health/18FLU.html?tntemail0

Flu Vaccine in a Spray Wins Vote From Panel

By REUTERS

ETHESDA, Md., Dec. 17 (Reuters) — A Food and Drug Administration advisory panel voted today to support the use of a nasal spray influenza vaccine.

The panel decided that the vaccine, FluMist, produced by MedImmune of Gaithersburg, Md., was safe and effective for healthy people ages 5 to 49.

For people 50 to 64, the panel voted that FluMist was safe. But a majority of panel members said there was not enough information to prove that the vaccine was effective for people in that age group.

The endorsement means that the agency will probably approve the drug for sale. The agency usually follows the advice of its panels. FluMist would be sold by Wyeth under a co-marketing agreement.

Millions of Americans suffer from influenza each year, and 20,000 die from it. About 114,000 are hospitalized, according to the Centers for Disease Control and Prevention.

MedImmune said FluMist could offer an alternative to annual injections for healthy people. Most healthy people do not receive the yearly immunizations.

"It is in this healthy population where we believe FluMist can fill an important public health need," James Young, president for research and development at the company, told the panel.

In July 2001, advisers said they were not convinced that FluMist was safe enough to obtain approval. The company submitted additional information.

The application to market FluMist was first submitted in October 2000 by Aviron, a company that MedImmune acquired in January.

In addition to the FluMist decision, the panel said an experimental cancer drug, Bexxar, developed by the Corixa Corporation of Seattle and GlaxoSmithKline, had benefits in treating non-Hodgkin's lymphoma.

The committee did not formally vote on Bexxar, which aims to help patients whose lymphoma has relapsed or become resistant to other treatment.

Panel members said they were impressed by the reports on Bexxar.

"It's at least as good, if not better, than what's out there," said a member, Dr. James E. Krook, a cancer specialist from Duluth, Minn.

The agency approved a similar therapy by IDEC Pharmaceuticals of San Diego in February.

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