FDA gives flu spray conditional approval
Although it won’t be available for this winter’s flu season, a novel flu vaccine that can be sprayed in the nose moved a step closer to approval last week when government scientists said it is safe and effective for healthy people ages 5 to 49.
A Food and Drug Administration advisory panel also said there was insufficient scientific evidence that the vaccine, called FluMist, is effective for people ages 50 to 64, a key group that health officials often urge to get vaccinated.
For the record:
12:00 a.m. Dec. 30, 2002 For The Record
Los Angeles Times Tuesday December 24, 2002 Home Edition Main News Part A Page 2 National Desk 19 inches; 707 words Type of Material: Correction
Flu vaccine -- A headline in Monday’s Health section, “FDA Gives Flu Spray Conditional Approval,” was incorrect. The independent advisory panel to the Food and Drug Administration gave conditional approval to the novel vaccine; it still must be approved by the FDA before it becomes available to the public.
For The Record
Los Angeles Times Monday December 30, 2002 Home Edition Health Part F Page 6 Features Desk 4 inches; 177 words Type of Material: Correction
Flu vaccine -- A headline in last Monday’s Health section, “FDA gives flu spray conditional approval,” was incorrect. The independent advisory panel to the U.S. Food and Drug Administration gave conditional approval to the novel flu vaccine; it still must be approved by the FDA before it will become available to the public.
Makers of the inhaled vaccine said they plan to collect more data on this age group if the drug is approved for the younger age group.
If approved, FluMist could be in doctors’ offices by the 2003 flu season, said Jamie Lacey, a spokeswoman for MedImmune Inc., the Gaithersburg, Md., company that makes the vaccine.
Federal health officials hope that FluMist could provide a painless alternative to the injected vaccines and encourage many Americans who dislike getting shots to get vaccinated, said Dr. Keiji Fukuda, an epidemiologist in the influenza branch of the Centers for Disease Control and Prevention in Atlanta.
More than 174 million Americans should get flu shots, but only about 70 million actually do.
Citing safety concerns, the FDA advisory panel last year declined to recommend its use by toddlers. It also recommended against anyone with asthma or a chronic illness using the mist, even though those with chronic illnesses are at high risk of serious flu complications.
Babies and toddlers are often urged to get vaccinated because they spread the infection through day care and to elderly grandparents.
However, in 20 clinical trials designed to evaluate the safety and efficacy of the vaccine to prevent influenza, up to 1.5% of children younger than 5 who received FluMist suffered asthma attacks or wheezing symptoms.
Still, if FluMist is approved and more data become available, said Fukuda, the FDA may broaden the number of people who could safely use the vaccine.
