Advisers to the Food and Drug Administration have recommended that
nasal-spray flu vaccine FluMist be cleared for children under 5 years old.
However, even if the FDA agrees with its panel of outside experts, MedImmune has said it won't produce any more than the 7 million doses already planned for the upcoming flu season. The FDA isn't bound to follow its advisers' recommendations, but it usually does.
FluMist is now available for healthy people between the ages of 5 and 49 years old, and MedImmune has been seeking to provide it to younger, more vulnerable people.
Although the panel said the vaccine was effective for children between the ages of 6 months and 59 months, members also expressed some concern about FluMist.
The key vote was 9-6 that the vaccine was safe in children between the ages of 12 months and 59 months who didn't have a history of wheezing. This was the guideline sought by MedImmune.
The panel voted 12-3 against allowing FluMist for children between 6 months and 23 months who had wheezing and other respiratory problems. The advisers also voted 15-0 that FluMist was acceptable for children ages 24 months to 59 months even if they had respiratory problems.
"We are very pleased with the committee's endorsement," said Dr. Edward Connor, executive vice president and chief medical officer at MedImmune. "We look forward to continuing discussions with the FDA in its review of our application." The agency is scheduled to decide by May 28.