The Food and Drug Administration has approved the nasal influenza vaccine FluMist for children aged 2–5 years, which could help push up childhood vaccination rates.

FluMist manufacturer MedImmune Inc. said that it anticipated shipping the vaccine to physicians and health care providers almost immediately.

The Centers for Disease Control and Prevention (CDC) currently recommends that all children aged 6 months to 5 years be vaccinated against influenza. The trivalent FluMist vaccine had previously been approved only for healthy children over age 5 years and for adults aged 18–49 years.

Dr. Sarah Long, chief of infectious diseases at St.Christopher's Hospital for Children in Philadelphia, said that the new FluMist approval is likely to spur higher vaccination rates. But, she added, physicians probably will not widely use the vaccine in young children until the CDC's Advisory Committee on Immunization Practices recommends it for the approved populations. Without an ACIP endorsement, insurers are reluctant to reimburse for a vaccine, Dr. Long, a member of the American Academy of Pediatrics committee on infectious diseases, said in an interview.

That recommendation is likely to come at ACIP's next meeting in late October, as FluMist's likely approval for use in young children had been discussed at its last meeting, Dr. Long said.

The AAP and the CDC agree that children of all ages are vastly undervaccinated. The CDC just issued vaccination statistics on children aged 6–23 months, and only 21% of children that age received full vaccination coverage—that is, two doses—in the 2005–2006 flu season, said Dr. Jeanne M. Santoli, deputy director of the Immunization Services Division in the CDC's National Immunization Program. (See related story, page 12.)

Dr. Santoli spoke at a national news conference on the upcoming flu season that was held in Washington by the National Foundation for Infectious Diseases.

“This is a very troubling statistic, and we must do our part in getting children vaccinated,” Dr. Jay E. Berkelhamer, president of the AAP, said at the news conference.

FluMist joins two other vaccines currently approved for use in young children. Sanofi Pasteur's Fluzone is indicated for anyone over 6 months of age, and Novartis's Fluvirin for anyone aged 4 years or older. But only FluMist offers the ease of nasal administration. “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,” said Dr. Jesse L. Goodman, director of the Food and Drug Administration's Center for Biologics Evaluation and Research in a statement.

The approval was based on a pivotal study of 4,000 children aged 2–5 years who received the live attenuated vaccine during the 2004–2005 flu season. According to MedImmune, there was a 54% reduction in influenza in children given FluMist, compared with those who received a traditional injection.

The FluMist vaccine is contraindicated in those with asthma, children under age 2 years, and children under age 5 years who have recurrent wheezing because of potential exacerbation of that symptom. It also should not be given to children receiving concomitant aspirin, or therapy containing aspirin, according to MedImmune. The company will charge $17.95 per dose this flu season.

At the flu news conference, CDC Director Julie Gerberding said that the FluMist approval was good news because of its ease of use and because it offered “yet another sign of the growing stabilization of the vaccine supply.”

Courtesy of American Academy of Pediatrics