FDAnews Drug Daily Bulletin

AstraZeneca Approved to Market New Influenza Vaccine in Europe

Dec. 9, 2013

The European Commission Dec. 5 granted AstraZeneca (AZ) European marketing permission for its Fluenz Tetra live attenuated intranasal influenza vaccine for patients age 2 to 18. The vaccine is sprayed into each nostril, where its weakened viral strains induce protective immunity.

Traditionally, seasonal influenza vaccines contain two strains of influenza A (H1N1 and H3N2) and one strain of influenza B. AZ’s quadrivalent vaccine contains an additional strain of influenza B, making it the first intranasal four-strain influenza vaccine approved in Europe, AZ says.

The commission’s decision comes almost three months after the Committee for Medicinal Products for Human Use granted the vaccine a positive opinion and was based on data from a pediatric study showing safety and immunogenicity equivalent to the three-strain vaccine.

The new quadrivalent vaccine will replace its trivalent older sibling in all 28 EU member states as well as Iceland, Liechtenstein and Norway for the 2014-2015 flu season.

Fluenz Tetra was approved in the U.S. under the name FluMist in Feb. 2012. — Lena Freund

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