>>BETHESDA, Md., Dec 17 (Reuters) - A U.S. advisory panel on Tuesday backed MedImmune Inc.'s (NasdaqNM:MEDI - News) nasal spray influenza vaccine FluMist.
The Food and Drug Administration advisory panel voted that FluMist was safe and effective for healthy people aged 5 to 49.
For people aged 50 to 64, the panel voted that FluMist was safe, but the majority of panel members said there was not enough data to prove the vaccine was effective for people in that age group.
The endorsement means the FDA likely will approve FluMist for sale because the agency usually follows its panels' advice. FluMist would be co-marketed by Wyeth (NYSE:WYE - News).
Millions of Americans get influenza each year. About 20,000 of them die from it, and about 114,000 have to be hospitalized, according to the Centers for Disease Control and Prevention.
MedImmune said FluMist could offer a pain-free alternative to annual flu shots for healthy people, most of whom do not get the yearly immunizations.
"It is in this healthy population where we believe FluMist can fill an important public health need," James Young, MedImmune's president for research and development, told the panel.
In July 2001, FDA advisers said they were not convinced FluMist was safe enough to win marketing approval. The company submitted additional data in the hopes of easing any concerns.
The application to market FluMist was first submitted in October 2000 by Aviron, a California-based vaccine company acquired by MedImmune in January. <<
Cheers, Tuck |
