TUESDAY, SEPTEMBER 27, 2016

EC approves Fluenz Tetra for flu prevention in children

AstraZeneca, a biopharmaceutical company, announced on Friday that the European Commission granted marketing authorization to Fluenz Tetra for the prevention of seasonal influenza in children.

Fluenz Tetra is a four-strain live-attenuated influenza vaccine that is administered nasally for the prevention of influenza in children and adolescents between 24 months and 18 years of age. The approval makes Fluenz Tetra the only available, intranasal, four-strain flu vaccine in Europe.

"Fluenz Tetra represents the next generation of influenza vaccine and we are pleased that it is now approved in Europe," Filip Dubovsky, the vice president of clinical biologics infectious disease and vaccines at MedImmune, AstraZeneca's global biologics research and development arm, said. "The inclusion of a second influenza B strain will broaden the coverage of Fluenz Tetra and should have a valuable public health impact."

While seasonal flu vaccines historically contained three influenza strains, two influenza A viruses and one influenza B virus, Fluenz Tetra contains a fourth strain, an additional influenza B strain. In the last decade, influenza B strains accounted for approximately 25 percent of circulating influenza strains in Europe.

The marketing authorization by the EC was based on data from a study demonstrating that Fluenz Tetra had a safety and immunogenicity profile comparable to Fluenz, a three-strain vaccine already approved in Europe. The EC decision is applicable to all 28 member states and three European Economic Area countries of the European Union.