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European Commission Approves Fluenz Tetra for the Prevention of Seasonal Influenza in Children

Fri, 12/06/2013 - 8:26am

AstraZeneca today announced that the European Commission (EC) has granted Marketing Authorization to FluenzTM Tetra. Fluenz Tetra is a nasally administered four-strain live attenuated influenza vaccine for the prevention of influenza in children and adolescents from 24 months up to 18 years of age. The EC approval makes Fluenz Tetra the first and only intra-nasal four-strain influenza vaccine available in Europe.

Historically, seasonal flu vaccines have contained three strains of influenza: two influenza A viruses (H1N1 and H3N2) and one influenza B virus. Fluenz Tetra contains an additional influenza B strain. Over the past decade, influenza B strains accounted for approximately 25 percent of the influenza strains circulating in Europe.

“Fluenz Tetra represents the next generation of influenza vaccine and we are pleased that it is now approved in Europe,” said Filip Dubovsky, Vice President of Clinical Biologics Infectious Disease and Vaccines at MedImmune, AstraZeneca’s global biologics research and development arm. “The inclusion of a second influenza B strain will broaden the coverage of Fluenz Tetra and should have a valuable public health impact.”

The Marketing Authorisation of Fluenz Tetra is based on data from a pivotal paediatric study. Findings showed that Fluenz Tetra demonstrated a safety and immunogenicity profile that was comparable to Fluenz™, a three-strain (trivalent) live attenuated influenza vaccine already approved in Europe.

The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use on 19 September 2013, and is applicable to all 28 member states and the three European Economic Area countries of the European Union.

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