The launch of a new version of the nasal-spray flu vaccine FluMist has run into another complication, raising questions about how quickly it might reach the market during the upcoming flu season.
Last week, a key advisory committee to the Centers for Disease Control and Prevention postponed a vote on FluMist. The panel's recommendations play an important role in government aid and private practice policies.
The Advisory Committee on Immunizations Practices said it wouldn't act until the MedImmune unit of
problems cited May 29 by the Food and Drug Administration at a FluMist manufacturing plant.
Until the FDA signs off on the plant, MedImmune, which was acquired by AstraZeneca last month, can't sell the vaccine.
If the CDC advisory panel doesn't endorse the vaccine, FluMist won't be available under the federal Vaccines for Children program, which provides free vaccines to children and teens under 19 who are uninsured, Medicaid-eligible, American Indian or Alaska natives.
In addition, suggestions by CDC advisers influence decisions by private insurers, physicians and states that provide free or low-cost vaccines to the uninsured.
Jamie Lacey, a spokeswoman for MedImmune, said Monday her company is working as quickly as possible to address the issues cited by the FDA. Lacey wouldn't speculate on how long it would take to resolve the matter. She said MedImmune traditionally ships FluMist in August and September.
Compounding the problem is the fact that the CDC advisory committee won't meet again until Oct. 24. However, assuming the FDA licenses FluMist before then, a CDC spokesman said it is "likely" the panel would hold a special telephone session to vote on the vaccine.
FluMist is approved for healthy people between the ages of 5 and 49. The age limit has contributed to the vaccine's poor showing since it was introduced during the 2003 to 2004 flu season.
MedImmune wants to expand FluMist's use to children between 12 months and 59 months. In May, an FDA advisory committee
endorsed FluMist for these children as long as they don't have a history of wheezing or asthma. In January, the FDA
approved a more convenient form of FluMist, making the vaccine easier to store in pharmacies and doctors' offices.
The company plans to produce 7 million doses for the upcoming U.S. flu season. Makers of injectable flu vaccines expect to provide up to 125 million doses.