* Fluenz recommended by European Medicines Agency
* AstraZeneca working towards launch in 2012
* Vaccine already sold in U.S. under trade name FluMist
(Adds details on vaccine, background)
By Ben Hirschler
LONDON, Oct 22 (Reuters) - AstraZeneca’s (AZN.L) nasal flu vaccine has been recommended for approval in Europe, initially for children, although it is unlikely to go on sale until 2012.
The European Medicines Agency said on Friday it had issued a positive opinion for Fluenz for the prevention of seasonal influenza in children aged from two to less than 18 years.
The vaccine, which is squirted into the nose rather than given as an injection, was developed by the drugmaker’s U.S. unit MedImmune and is already on sale for both adults and children in the United States, where it is known as FluMist.
FluMist was approved by the U.S. Food and Drug Administration in 2003 and its roll-out in Europe will boost AstraZeneca’s limited presence in the vaccines market.
However, a spokeswoman said that the complexity of the approval process and the need to wait for strains selected annually by the World Health Organization means the company is working towards a European launch in autumn 2012.
In the next stage of the approval process the European Commission must endorse the recommendation from the European Medicines Agency’s expert committee. This normally happens within a few months.
AstraZeneca’s vaccine contains live attenuated flu virus strains, which are weakened so as to not cause illness.
In several clinical studies it has proved more effective in children compared with traditional injectable vaccines containing inactivated strains, made by companies such as GlaxoSmithKline (GSK.L), Sanofi-Aventis (SASY.PA) and Novartis NOVN.VX. (Editing by Greg Mahlich)