AstraZeneca has received marketing authorisation from the European Commission (EC) for its new four-in-one influenza vaccine Fluenz Tetra for the prevention of influenza in children and adolescents from 24-months up to 18-years-old.
According to the company, the approval makes Fluenz Tetra the first and only intra-nasal four-strain influenza vaccine available in Europe.
Compared with 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 contains two strains each of influenza A and influenza B to provide broad protection against influenza B.
In the past ten years, influenza B strains on average accounted for about 25% of the influenza strains that circulate in Europe.
AstraZeneca’s global biologics research and development arm MedImmune is responsible for marketing ‘Fluenz Tetra’ in the US under the trade name FluMist Quadrivalent.
MedImmune Clinical Biologics Infectious Disease and Vaccines Filip Dubovsky vice-president Fluenz Tetra 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 marketing authorisation follows a review of data secured from a pivotal paediatric study, which showed that the safety and immunogenicity profile of Fluenz Tetra was comparable with the currently approved three-strain (trivalent) vaccine, Fluenz.
AstraZeneca intends to replace its existing three-strain Fluenz vaccine with the new Fluenz Tetra from the 2014/15 flu season.
The EC approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in September, and is applicable to all 28 member states and the three European Economic Area countries of the EU.
Image: Transmission electron microscopy (TEM) of negatively stained influenza virions, magnified approximately 100,000 times. Photo: courtesy of Cynthia Goldsmith.