European Commission approves nasal spray vaccine FLUENZ for the prevention of seasonal influenza in children

AstraZeneca announced today that the European Commission (EC) has granted marketing authorisation to FLUENZ Influenza Vaccine (Live Attenuated, Nasal), a nasally administered live attenuated influenza vaccine (LAIV), for prevention of seasonal influenza for children 24 months to less than 18 years of age. This decision follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 22nd October 2010 and is applicable to the 27 Member States and the 3 European Economic Area countries of the European Union.

“We are delighted that FLUENZ has received regulatory approval in Europe since influenza creates a significant medical and economic burden there and throughout the world. We hope that the availability of this nasal spray influenza vaccine with its novel mechanism of action will help reduce the spread of influenza,” said Alex Zukiwski, M.D., executive vice president and chief medical officer of MedImmune, the biologics unit of AstraZeneca.

It is expected that the FLUENZ vaccine will be initially available in select European markets for the 2012-13 influenza season.

The EC decision and CHMP positive opinion were reached after a review of data from 73 global clinical studies and US post-marketing studies of more than 141,000 subjects conducted in 38 countries. Study objectives included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.