FDA approves FluMist for 2- to 4-year-old children

Sep 20, 2007 (CIDRAP News) – The Food and Drug Administration's (FDA's) approval of FluMist for children aged 2 through 4 years makes a needle-free influenza vaccine available for small children in the United States for the first time.

The FDA announced its approval of the nasal-spray vaccine, which contains a weakened form of live virus, yesterday. The vaccine, made by MedImmune, Gaithersburg, Md., was previously approved only for healthy people between the ages of 5 and 49.

"The goal of preventing influenza is now more attainable with the availability of FluMist for younger children," said Jesse L. Goodman, MD, director of the FDA Center for Biologics Evaluation and Research, in a news release.

"This approval also offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot," he said.

MedImmune had asked the FDA to approve the vaccine for children aged 1 through 4 years with no history of wheezing, according to previous reports. But the FDA withheld approval of FluMist for children younger than 2 years because clinical trials showed an increased risk of hospitalization and wheezing for that group. The agency also said the vaccine should not be given to children under age 5 who have recurrent wheezing because it may trigger increased wheezing.

The FDA said its action means three flu vaccines are available in the United States for children younger than 5 years. Fluzone, made by Sanofi Pasteur Inc., Swiftwater, Pa., is approved for anyone older than 6 months, and Fluvirin, made by Novartis Vaccines and Diagnostics, Liverpool, England, is licensed for ages 4 and up.

MedImmune expects to produce about 4.5 million doses of FluMist for the 2007-08 flu season, compared with about 3 million doses last year, company spokeswoman Karen Lancaster told CIDRAP News.

Lancaster said the retail price of the vaccine this year is $17.95 per dose. "Last year there was a range of prices, from $17.95 to around $24, but it's a set price across the board this year," she said. Doses sold through the federal Vaccines for Children program will cost $16.90, she reported.

About 6,400 children aged 6 to 59 months received FluMist in three clinical trials of the vaccine's safety and effectiveness, according to the FDA. Two studies compared FluMist with a placebo vaccine and showed it was effective in preventing flu.

The third study compared FluMist with a conventional flu shot containing inactivated virus, the FDA reported. There were 53 flu cases among 3,900 children who received FluMist, versus 93 cases among an equal number of children who received the conventional vaccine, the agency said.

Common side effects of the spray vaccine were generally mild and typically included a runny nose and/or nasal congestion, plus a slight fever, the FDA said.

In a news release, MedImmune said it "anticipates shipping FluMist with the expanded label to healthcare providers in the coming days so that vaccinations may be offered to eligible individuals ahead of and throughout the upcoming influenza season."

FluMist has been on the market since 2003, but demand for it has been hampered by a higher cost than conventional vaccine and by the requirement to keep it frozen during storage. In January the FDA approved a new formulation that requires refrigeration but not freezing.

The vaccine has been tested in people up to 90 years old, according to Lancaster. "We're evaluating the paths forward for making the vaccine available" to people older than 49, she said.

See also:

Sep 19 FDA news release
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01705.html

Sep 19 MedImmune news release
http://phx.corporate-ir.net/phoenix.zhtml?c=83037&p=irol-investornewsArticle&ID=1053384&highlight

May 17 CIDRAP News story "FDA advisory panel recommends FluMist approval for young children"
http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/may1707flumist.html

Feb 16 CIDRAP News story "Large study supports FluMist use in toddlers"
http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/feb1507flumist-jw.html

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