The European Commission (EC) has granted marketing authorisation for AstraZeneca's new four-in-one influenza vaccine Fluenz Tetra for the prevention of influenza in children and adolescents from 24 months up to 18 years of age.
The company said that the approval makes Fluenz Tetra the first and only intra-nasal four-strain influenza vaccine available in Europe.
Unlike traditional seasonal flu vaccines which had three strains of influenza: one influenza A (H1N1) virus, one influenza A (H3N2) virus and one influenza B virus, the new Fluenz Tetra includes two strains each of influenza A and influenza B to provide broad protection against influenza B.
MedImmune vice president of Clinical Biologics Infectious Disease and Vaccines Filip Dubovsky said, "The inclusion of a second influenza B strain will broaden the coverage of Fluenz Tetra and should have a valuable public health impact."
The approval follows a review of data secured from a pivotal pediatric study, which showed that the safety and immunogenicity profile of Fluenz Tetra the new vaccine was comparable to the currently approved three-strain (trivalent) vaccine, Fluenz.
The company plans to replace its existing three-strain Fluenz vaccine with the new Fluenz Tetra from the 2014/15 flu season.
AstraZeneca's global biologics research and development arm MedImmune is responsible for marketing 'Fluenz Tetra' in the US under the trade name FluMist Quadrivalent.
Image: AstraZeneca's new Fluenz Tetra includes two strains each of influenza A and influenza B to offer broad protection against influenza B. Photo: courtesy of Cynthia Goldsmith
