AstraZeneca’s four-strain flu vaccine receives EU positive opinion

AstraZeneca’s FluenzTetra has received a positive opininon from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). FluenzTetra is a nasally administered four-strain live attenuated influenza vaccine for the prevention of seasonal influenza in eligible children and adolescents 24 months to 17 years of age.

The Committee came to its positive decision after a review of data from a pivotal pediatric clinical study.

“We are delighted that Fluenz Tetra has received a positive opinion from the CHMP. The inclusion of two influenza B strains in the vaccine will provide broad protection and should help to reduce the overall incidence of influenza.”

Filip Dubovsky, Vice President of Clinical Biologics Infectious Disease and Vaccines, MedImmune, AstraZeneca’s global biologics research and development arm.

The European Commission will now review the CHMP’s positive opinion on Fluenz Tetra and will decide whether or not to approve it for use in the European Union.

 

Related news:

Four-strain AstraZeneca flu vaccine wins EU green light (Reuters)

Reference links:

AstraZeneca press release

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