FluMist endorsed as influenza vaccine alternative.(Healthy People Aged 5-49 Years)

ATLANTA -- The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention has endorsed the use of FluMist as "an important new option" for vaccinating healthy individuals aged 5-49 years.

The new intranasal trivalent, cold-adapted, live attenuated influenza vaccine (LAIV) is manufactured by Medimmune Inc. and comarketed by Wyeth Vaccines. The Food and Drug Administration licensed the vaccine the day before an ACIP meeting, where the committee drafted recommendations for its use. Its label will call for a two-dose regimen (60 days apart) for first use in healthy children aged 5-8 years and one dose for individuals aged 9-49 years, FDA reviewer ChrisAnna Mink told ACIP.

According to Dean Mason of the CDC's National Immunization Program, the production target of FluMist for the 2003-2004 influenza season is expected to be about 46 million doses. The vaccine, which must be kept frozen at less than 5[degrees]F or below, will be shipped directly from Wyeth Vaccines to U.S. physicians. The price range will be $45-$50 per dose, which few health insurance companies are expected to cover the first year out.

"Most purchases in year one will be out-of-pocket to the consumer," Mr. Mason said.

Among 4,303 healthy working adults aged 18-64 years who were studied during influenza outbreaks, the vaccine reduced the number of severe febrile illnesses by 17% and febrile upper respiratory illnesses by 22%.

Adverse reactions included runny nose, nasal congestion, and headache. Most reactions were self-limited; there were no serious adverse events.

Medimmune now plans to gather more data in order to seek expanded indications for use in adults aged 50-64 years, children less than 5 years, and high-risk populations, said Dr. Edward M. ...