EC Clears AstraZeneca's Fluenz Tetra

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AstraZeneca’s (AZN) intranasal influenza vaccine, Fluenz Tetra has received approval from the European Commission (EC). The vaccine is approved for the prevention of influenza in children and adolescents aged between 24 months and 18 years. The approval marks the first nasally administered four-strain influenza vaccine approval in Europe.

Fluenz Tetra contains two strains of influenza A and two strains of influenza B, which will provide an edge over currently marketed trivalent vaccine, Fluenz.  Fluenz Tetra will be available from the 2014-2015 flu season in place of Fluenz.

The EC approved Fluenz Tetra based on encouraging data from a pivotal pediatric study. The safety and immunogenicity profile of Fluenz Tetra was found to be comparable to that of Fluenz in the study.

The Fluenz Tetra EU approval was not surprising considering that, in Sep 2013, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had a rendered a positive opinion on the approval of Fluenz Tetra.

We note that Fluenz Tetra is already marketed in the U.S. under the trade name FluMist Quadrivalent (influenza vaccine live, intra nasal). The U.S. Food and Drug Administration (:FDA) had approved FluMist Quadrivalent in Feb 2012.

Currently approved quadrivalent influenza vaccines include GlaxoSmithKline’s (GSK) Flulaval Quadrivalent and Sanofi’s (SNY) quadrivalent formulation of Fluzone. While Flulaval Quadrivalent is an intramuscular vaccine, Fluzone has an intradermal administration.

AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Allergan Inc. (AGN). The stock carries a Zacks Rank #2 (Buy).

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