AstraZeneca files in Europe intranasal flu vaccine

Published: 6-Jan-2009

Medimmune, the biologics division of AstraZeneca, has filed in Europe its nasal spray live attenuated influenza vaccine (LAIV). The proposed indication is for prevention of seasonal influenza.


Medimmune, the biologics division of AstraZeneca, has filed in Europe its nasal spray live attenuated influenza vaccine (LAIV). The proposed indication is for prevention of seasonal influenza.

LAIV was approved in the US in 2003 and is marketed as FluMist (Influenza Virus Vaccine Live, Intranasal). It is a relatively small product for AstraZeneca, generating US$71m (Euro 53m) sales in the third quarter of 2008.

The application for LAIV is based on data from 73 global clinical and US post-marketing studies of more than 141,000 volunteers ranging in age from seven weeks to 97 years and carried out in 38 countries. Study objectives have included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.

Each dose of LAIV is formulated to contain three live attenuated influenza virus strains: two type A influenza strains (A/H1N1 and A/H3N2) and one type B strain. The vaccine strains are selected annually by the World Health Organisation (WHO) based on anticipated circulating influenza strains for the forthcoming season.

"Influenza creates a heavy medical and economic burden on Europe and throughout the world, and we are hopeful that the future availability and product characteristics of this novel nasal spray influenza vaccine will contribute to an increase in vaccination rates and reduce the spread of influenza around the world," said MedImmune's senior vice president, clinical affairs and chief medical officer Dr Alex Zukiwski.

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