FDA Panel Supports Expanded FluMist Use
Safety for Children Under 2 Still Debated

By Michael S. Rosenwald
Washington Post Staff Writer
Thursday, May 17, 2007

A Food and Drug Administration advisory panel unanimously agreed yesterday that MedImmune's nasal flu vaccine FluMist worked in children under age 5, but it had a decidedly mixed opinion on whether the product was safe enough for children younger than 2.

The Gaithersburg firm, which has spent hundreds of millions of dollars trying to revive the troubled vaccine's fortunes, wants to win approval for kids under 5 and as young as 1, a key market of about 16 million needle-averse customers. If MedImmune gets approval only for those 2 and older but younger than 5, it will lose access to several million children a year. FluMist is currently approved for ages 5 to 49.

During a lengthy and spirited meeting yesterday, the panel focused intensely on safety, particularly for those under 2, who suffered more episodes of wheezing and hospitalization after receiving FluMist than children who received the standard flu shot. MedImmune has requested approval for children without a history of wheezing.

The panel agreed by a 9 to 6 vote that the vaccine's benefits outweigh its risks in children ages 1 to 5 without a history of wheezing. But the number of dissenters gave pause to FDA officials, who will decide later this month who may receive the vaccine.

"The vote did demonstrate that there is a safety concern among a significant minority of the advisory committee," said Florence Houn, deputy director of the FDA office handling MedImmune's application. She added, "We do have to be careful about this respiratory adverse event profile and make sure we understand it."

Henry Bernstein, a New Hampshire physician and member of the Committee on Infectious Diseases of the American Academy of Pediatrics, said that "there are important concerns around the safety data" for children under 2. Bernstein, who attended the meeting, said he sensed that the consensus would be that "down to 24 months it sounds like FluMist can be a useful addition to influenza vaccine administration."

The committee was unanimous in agreeing that the benefits outweighed the risks for ages 2 to 5. Winning approval for that age group would still represent a major victory for MedImmune, which has stumbled badly in the marketplace with FluMist.

The company spent $1.5 billion in 2002 to buy Aviron, the company that had been developing FluMist. But despite a flashy ad campaign, FluMist didn't catch on in the marketplace -- in part because it needed to be stored in a freezer and also because its use was limited to people ages 5 to 49. The company sold $36.4 million of FluMist last year.

MedImmune recently won approval for a version that could be stored in a refrigerator, like standard flu shots, and it spent $100 million on a recent study to prove that the vaccine was safe and that it worked better than the flu shot for children under age 5. That market is important not only because of the needle factor, but also because federal health officials recommend that children under 5 get yearly vaccinations.

James Young, MedImmune's president of research and development, told reporters that the company was pleased with the outcome of the meeting. "It further for us endorses the efficacy and safety of this product and hopefully provides now the opportunity for the FDA to act in expanding the indication to include children below 5 years of age."

Asked about prospects for approval for children under 2, he said, "It certainly gives me confidence that it was a positive vote; there was a lot of positive discussion, and we'll just have to see where it leads the FDA."

MedImmune recently agreed to be bought by British drug giant AstraZeneca for $15.6 billion. One of the key reasons for the purchase was AstraZeneca's desire to enter the flu vaccine market.

Earlier this week, MedImmune disclosed in a filing with federal regulators that "an alleged shareholder of MedImmune commenced a purported class action against MedImmune and its directors in state court in Maryland" trying to block the sale by arguing, among other things, that it was for the personal benefit of the company's executives. MedImmune said that the claims are without merit and that it will defend itself.