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AZ wins EU approval for four-strain flu vaccine

Fluenz Tetra offers competition to GSK’s Influsplit Tetra/Fluarix Tetra
AstraZeneca AZ headquarters London UK

AstraZeneca (AZ) has become the latest company to win approval for a four-strain influenza vaccine in the EU.

The European Commission backed an earlier recommendation made by the European Medicines Agency (EMA) to grant marketing authorisation to Fluenz Tetra for the prevention of influenza in children from 24 months to 18 years.

It follows the approval earlier this year of GlaxoSmithKline's (GSK) four-strain, or quadrivalent, influenza vaccine Influsplit Tetra/Fluarix Tetra as pharma companies look to shift towards vaccines that provide broader protection against the influenza virus.

Current standard vaccines only protect against two influenza A subtypes and a single influenza B subtype, whereas the new quadrivalent vaccines can protect against an extra B strain to reduce the risk of getting influenza during flu season.

Both AZ and GSK won approvals for their respective vaccines in the US in 2012, while Sanofi's Fluzone Quadrivalent was approved earlier this year.

Sanofi is still to have its four-strain vaccine recommended in the EU, however, although it was accepted for review by the EMA under the brand name Vaxigrip in April.

AZ is banking on the more convenient administration of Fluenz Tetra to set it apart from the competition, with the vaccine taken as a nasal spray rather than an injection.

The vaccine is also approved for the youngest patient population in Europe, as GSK's product is only approved in people over the age of three while Sanofi's Vaxigrip is under review in people aged nine and over.

“Fluenz Tetra represents the next generation of influenza vaccine and we are pleased that it is now approved in Europe,” said Filip Dubovsky, VP of clinical biologics infectious disease and vaccines at MedImmune, AstraZeneca's biologics R&D arm.

“The inclusion of a second influenza B strain will broaden the coverage of Fluenz Tetra and should have a valuable public health impact.”

Article by
Thomas Meek

9th December 2013

From: Sales



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