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Flu vaccine seeks sales approval

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A nasal spray flu vaccine containing three strains of the virus, which is being reviewed by the European Medicines Agency (EMEA), may soon be on the market.

Makers MedImmune, the global biologics unit of AstraZeneca, has submitted a marketing authorisation application based on 73 global clinical and US post-marketing studies.

The trials covered clinical safety and tolerability, efficacy, effectiveness and immunogenicity, and involved 141,000 subjects ranging in age from 7 weeks to 97 years in 38 countries.

Each dose contains three live attenuated flu strains, weakened so as to not cause illness: two type A strains (A/H1N1 and A/H3N2) and one type B.

MedImmune spokesman Alex Zukiwski said: “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.”

The vaccine is the result of selections made every year by the World Health Organisation (WHO) based on what it anticipates will be the prevalent strain.

Copyright Press Association 2009

MedImmune






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