[COLOR="#000000"]AstraZeneca says the European Commission has granted marketing authorisation to Fluenz Tetra, its nasally administered four-strain influenza vaccine for children aged up to 18.
The approved is based on data from a paediatric study which showed that the product demonstrated a safety and immunogenicity profile comparable to the company’s already-marketed three-strain vaccine Fluenz. The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use in September.[/color]
[COLOR="#000000"]Historically, seasonal flu vaccines have contained two influenza A viruses (H1N1 and H3N2) and one influenza B virus. Fluenz Tetra contains an additional influenza B strain and over the past decade, thew latter have accounted for 25% of the strains circulating in Europe.
The approval makes Fluenz Tetra the first intra-nasal quadrivalent vaccine available in Europe. Filip Dubovsky, head of clinical biologics infectious disease and vaccines at AstraZeneca’s MedImmune unit, said it “represents the next generation of influenza vaccine [and] should have a valuable public health impact”.[/color]