Friday, May 18, 2007

Food and Drug Administration panel OKs FluMist for children under 5

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Officials at MedImmune Inc. are focusing this week on a more positive development than a class-action lawsuit: possible approval by the U.S. Food and Drug Administration of the company’s FluMist nasal vaccine for children younger than 5.

The FDA’s Vaccines and Related Biological Products Advisory Committee on Wednesday recommended that the agency approve FluMist for younger patients.

Spokeswoman Jamie Lacey said the Gaithersburg biotech expects FDA approval by May 28.

Dr. Carol Plotsky of Shady Grove Pediatric Associates in Rockville welcomed the development.

‘‘I do think it will be easier if the FluMist is available for kids under 5,” Plotsky said. ‘‘The price has come down and more insurance now covers it.”

Flu shots are now recommended for children 6 months to 5 years old, she said. While it’s usually easier just ‘‘to give the little kids a shot,” she would sometimes use the nasal spray with children older than 2 if the FDA approves it, she said.

However, some parents and children do not want something put up their noses, Plotsky said.

Susan Feidelman, a pediatrician with the University of Maryland, said she would appreciate the opportunity to use FluMist for children under 5.

‘‘It is very safe and easy and nice to have another option,” Feidelman said. Children already get many vaccine shots — perhaps three or four in one visit. ‘‘One less will help,” she said.

By Thursday, the FDA panel was still debating the risks and benefits of approving FluMist for children younger than 2 with a history of wheezing.

Unlike a flu shot, which is composed of dead influenza virus, FluMist contains live parts of three strains of flu virus.

MedImmune received FDA approval in June 2003 for administering FluMist in healthy people ages 5 to 49.

But after a disappointing inaugural season for FluMist in 2003-04, MedImmune officials announced that they did not expect FluMist to be a ‘‘meaningful contributor to revenue growth” before 2007, when the company expected to launch an improved version.

Sales of FluMist have been lower than MedImmune first expected in 2003. That year, it manufactured about 4 million doses of FluMist, but distributed much less. In November 2003, the company slashed its revenue guidance for FluMist in 2003 from $120 million-$140 million to $55 million-$85 million, but actually totaled $46.1 million for the year. Sales in 2004 increased to $53.5 million, but slowed to $ 21.3 in 2005 and $36.4 in 2006. MedImmune has not yet estimated a market for the possible expanded use of FluMist for children younger than 5.

In January, the company announced that the FDA had approved a more convenient, refrigerated version of FluMist for healthy children and adults 5 to 49 years old. MedImmune is replacing its current version — which must be kept frozen until administered — with the new version.

The approval came on the heels of a positive report in the New England Journal of Medicine in December on a study of 15,000 elementary school students. The study, funded by the company, showed that students vaccinated with FluMist were ‘‘significantly less likely to report fever or influenza-like illness” than unvaccinated schoolchildren.

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