AstraZeneca says that the European Commission has granted marketing authorisation to Fluenz, its nasally-administered influenza vaccine for children.
The approval, which specifically covers, the prevention of seasonal influenza for children 24 months to less than 18 years of age, follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in October.
The green light for Fluenz, which was approved in the USA in 2003 and is marketed there under the trade name FluMist, is based on a review of data from 73 global clinical trials and US post-marketing studies of more than 141,000 subjects conducted in 38 countries. Alex Zukiwski, chief medical officer of MedImmune, the biologics unit of AstraZeneca, noted that flu "creates a significant medical and economic burden" and Fluenz, "with its novel mechanism of action," will help reduce its spread.
The Anglo-Swedish drugmaker noted that Fluenz will be initially available in select European markets for the 2012-13 influenza season.