FluMist Quadrivalent regulatory update

The U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) recommended against the use of FluMist Quadrivalent from AstraZeneca to prevent seasonal influenza during the 2016-17 flu season. The intranasal live attenuated influenza vaccine (LAIV) is the only non-injection-based flu vaccine available in the U.S.

CDC said ACIP based its vote on weak efficacy data in children ages 2-17 in the last 3 flu seasons. The agency said FluMist showed no measurable protective benefit in the 2015-16 season, based on an estimated 3% vaccine effectiveness rate in that age group. AZ said CDC’s 2015-16 effectiveness data contrast with AZ’s own studies and cited “preliminary independent findings” from studies in the U.K. and Finland showing that FluMist was 46-58% effective overall against circulating influenza strains in 2015-16. The pharma said it is analyzing the effectiveness results and that FluMist contains the same strains in the U.S. and Europe. ...