FDA panel says FluMist not proven safe

The Vaccines and Related Biological Products Advisory Committee voted 10-4 Friday that the data presented by Aviron are not adequate to support the safety of FluMist. The majority of panel members, however, said data already collected by the company but not fully analyzed by FDA or AVIR might resolve their concerns. In addition, 6 of the 10 panel members who voted that the company has not demonstrated safety characterized their votes as "provisional" and said they would like to revisit AVIR's application when FDA has completed its analyses, particularly of data suggesting that FluMist might be associated with an increased incidence of pneumonia or exacerbation of asthma.

Panel members also said it is important to gather data about the safety of FluMist in children when it is given along with other vaccines, and to study the long-term safety of repeated administration. Prior to voting on safety, the advisory committee voted 13-2 that AVIR's trials demonstrated efficacy in individuals from 15 months up to age 64. ...