By Renae Merle
Washington Post Staff Writer
Friday, June 29, 2007
A federal panel delayed a vote yesterday on whether to recommend MedImmune's nasal influenza vaccine, FluMist, for children under 5 years old, a key market for the Gaithersburg biotechnology firm.
The delay endangers MedImmune's hopes to market the vaccine for needle-averse youngsters this coming winter. The delay was prompted by a Food and Drug Administration warning that its inspectors found contamination problems with the company's manufacturing process for FluMist. The warning does not stop the firm from making the vaccine, but puts the company's effort to gain wider approval for the drug on hold.
"It looks as if they have missed the window for getting their product strongly endorsed" by the Centers for Disease Control and Prevention for the under-5 market for the upcoming flu season, said Geoffrey Porges, an industry analyst for Sanford C. Bernstein & Co.
The under-5 market has been critical to MedImmune's strategy for FluMist, which has not caught on in the overall marketplace. The company has spent hundreds of millions of dollars trying to revive the troubled vaccine. It is now approved only for people ages 5 to 49, but relatively few in that age group have seen much advantage in a nasal spray over a shot.
Last month, an FDA advisory panel agreed that FluMist worked in children under age 5, but had a mixed opinion on whether the product was safe enough for children younger than 2.
The FDA will not approve the proposal to lower the age range until manufacturing problems are resolved, said Karen Riley, an FDA spokeswoman. In the interim the company can continue to make the vaccine, she said. The FDA has not indicated when the issue could be resolved.
"We're very much continuing to work with the FDA; we're moving forward," said Jamie Lacey, a MedImmune spokeswoman.
The CDC's Advisory Committee on Immunization Practices, which makes recommendations on vaccines to doctors and hospitals, is not scheduled to meet again until October, after the beginning of the season for flu shots. But if the FDA approves the expanded license before then, the committee could hold a special meeting, said Curtis Allen, a CDC spokesman.
"The committee would likely meet before October to review the recommendations for FluMist," he said. "We can't do anything until the FDA makes a licensing decision."
MedImmune is a wholly owned subsidiary of London drug company AstraZeneca, which bought the company for $15.6 billion in a deal that closed this month. AstraZeneca pursued the firm, in part, to jump-start its presence in the vaccine business, from which it has been absent.
"I don't think AstraZeneca bought them for what they could sell this year or next year," Porges said. "While it's a disappointment, I don't think it's going to cause AstraZeneca to reconsider its acquisition."