An FDA advisory panel has decided that a newer version of MedImmune’s influenza vaccine is beneficial for use in some children between 1 and 5 years old.

In a 9 to 6 vote, the panel determined that company studies showed the benefits of the nasal spray outweighed its risks in children without known respiratory problem. The newer spray, which unlike the older version can be refrigerated rather than frozen, is already approved for healthy 5- to 49-year-olds.

At the meeting, panel members unanimously said data proved MedImmune’s vaccine was effective but expressed concern about the risk of wheezing, especially in very young children. It wasn’t clear whether evidence of respiratory problems seen in the company’s studies signaled a safety problem with FluMist or was due to something else, some panelists said.

“It’s there, but we don’t understand it,” said panelist Melinda Wharton, deputy director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention. According to the CDC, younger kids are at a greater risk to be hospitalized with the flu than are older children, and U.S. health officials recommend influenza vaccines for those as young as 6 months old.

MedImmune’s studies indicated a “residual increase” in wheezing in the first 42 days after children ages 12 months to 23 months received FluMist. While six members of the advisory panel voted against approval in this age group because of these side effects, the majority said the risks weren’t significant.

Company data showed an increase in hospitalizations for children 6 months to 11 months old, and children ages 12 months to 5 years old with a history of wheezing and asthma need further evaluation, according to Ed Connor, MedImmune’s chief medical officer and exec vp. But one of his colleagues was more dismissive of the wheezing concerns.

“Given that it’s a better vaccine against the flu, are we willing to compromise on a little bit of wheezing?” asked Jim Young, who heads MedImmune’s R&D. Doctors and parents should be allowed to consider the risks on a case-by-case basis, he said, and estimated that 20 percent to 25 percent of children have a history of wheezing.

Further reading…
Reuters;
[tags]FluMist, MedImmune[/tags]