FDA panel says FluMist OK for children under 5 years old

Thursday, May 24, 2007

FDA panel says FluMist OK for children under 5 years old

by Steve Berberich | Staff Writer

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Bill Ryan⁄The Gazette

Edie Ann Feigles of Dillon Development Partners in Frederick putts at the Frederick County Chamber of Commerce’s golf tournament Friday at Glade Valley Golf Club in Walkersville. Looking on are (from left) Marc Mezzanotte of Dewberry in Frederick, Jim Caffes of Caffes-Steele Inc. of Beltsville and Michael Snyder, also of Dewberry.

MedImmune Inc. won a key ruling last week when a U.S. Food and Drug Administration panel recommended the FDA approve the company’s FluMist nasal vaccine for children younger than 5.

The FDA’s Vaccines and Related Biological Products Advisory Committee, meeting in Gaithersburg, endorsed the move. Currently, FluMist is approved for healthy people from 5 to 49 years old.

Spokeswoman Jamie Lacey said the Gaithersburg biotech, which is spending $250 million to expand its Frederick facility, expects FDA approval by next week.

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. 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.

This report originally appeared in the Business Gazette.