FDA advisory panel recommends FluMist approval for young children

May 17, 2007 (CIDRAP News) – A US Food and Drug Administration (FDA) advisory panel unanimously agreed Wednesday that FluMist, a nasal spray vaccine against seasonal flu, is safe and effective in children 2 years of age and older.

The live-virus vaccine, which is manufactured by Gaithersburg, Maryland–based MedImmune, is already FDA-approved for 5- to 49-year-olds. The company has filed a supplemental biologics licensing application (sBLA) to expand its use to children younger than 5.

In a 15-0 decision, the panel of outside experts supported the vaccine's use for children 2 and older who do not have a history of wheezing. The FDA, which is expected to make a decision by the end of May, is not required to follow the panel's recommendations.

"The question remaining is how the FDA ultimately will rule on children under 2," said MedImmune's Chief Medical Officer Dr. Edward Connor, according to an Associated Press report.

The panel voted 9-6 for the vaccine's safety and benefits for children between 12 to 59 months without wheezing history and 12-3 against using the nasal spray in children between 6 to 23 months, according to a MedImmune press release.

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

A recent international study published in the New England Journal of Medicine showed children between 6 and 11 months who received FluMist had more hospitalizations and slightly more wheezing than those who got the standard vaccine, CIDRAP News reported in February. However, the same study, which was conducted in the 2004-2005 flu season, revealed 55% fewer cases of flu in the children who received the FluMist.

CIDRAP Medical Director Kristine Moore, MD, MPH, said the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommends vaccination for children between 6 and 59 months because they have an increased risk for influenza-related hospitalizations and emergency room visits. Having a vaccine that is not a shot could enhance vaccination rates, Moore said.

"It's more tolerable to younger children," she noted. "If FluMist is approved for this age-group, it would probably improve compliance to the CDC recommendation."

Currently only injectable inactivated vaccines are available for this group.

FluMist vaccine has been on the market since 2003. It is effective against influenza A and B viruses; side-effects of the vaccine based on results from placebo-controlled clinical trials have included runny nose, sore throat, cough, headache, and chills.

In January, the FDA also approved a refrigerated formulation of FluMist (previous formulations had to be frozen), which will be available for the 2007-2008 flu season, according to MedImmune.

British company AstraZeneca is scheduled to acquire MedImmune in June in a $15.6 billion sale.

See also:

MedImmune Press Release

Feb 16, 2007, CIDRAP News story "Large study supports FluMist use in toddlers"

2007 New England Journal of Medicine article [Abstract]

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