AstraZeneca's Nasal Flu Vaccine Approved In Europe
LONDON -(Dow Jones)- AstraZeneca PLC (AZN) Tuesday said its nasal flu vaccine has been approved in Europe for children and adolescents, but is unlikely to go on sale until 2012.
The vaccine, which is sprayed into the nose rather than given as an injection, was developed by the drug maker's U.S. unit MedImmune and is already on sale for both adults and children in the U.S. where it is known as FluMist.
Marketing approval in Europe, where it will be called Fluenz, is for the prevention of seasonal influenza in children aged from two to less than 18 years and follows a recommendation by the London-based European Medicines Agency in October.
"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.
The product's approval is based on a review of data from 73 global clinical studies and U.S. post-marketing studies of more than 141,000 people conducted in 38 countries. Study objectives included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.
Feb 03, 2011