Fluenz Tetra, four-strain nasal spray vaccine, receives positive opinion in EU from CHMP

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on Fluenz Tetra, a nasally administered four-strain live attenuated influenza vaccine, for the prevention of seasonal influenza in eligible children and adolescents 24 months to 17 years of age.

Historically, seasonal flu vaccines have contained three strains of influenza: one influenza A (H1N1) virus, one influenza A (H3N2) virus, and one influenza B virus. However, Fluenz Tetra contains two strains of influenza A and two strains of influenza B to provide broad protection against influenza B. Influenza B strains on average account for approximately 25 percent of the influenza strains that circulate in Europe.

The positive opinion was reached after a review of data from a pivotal paediatric study. These data indicated that the safety and immunogenicity profile of Fluenz Tetra was comparable to currently approved three-strain (trivalent) vaccine, Fluenz.

Filip Dubovsky, Vice President of Clinical Biologics Infectious Disease and Vaccines, MedImmune, AstraZeneca’s global biologics research and development arm, said: “We are delighted that Fluenz Tetra has received a positive opinion from the CHMP. The inclusion of two influenza B strains in the vaccine will provide broad protection and should help to reduce the overall incidence of influenza.”

The CHMP’s positive opinion on Fluenz Tetra will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. Should the EC approve Fluenz Tetra, it will replace Fluenz from the 2014-2015 flu season onwards.