British drugmaker AstraZeneca has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its new four-in-one flu vaccine Fluenz Tetra.
Fluenz Tetra, a nasally administered four-strain live attenuated influenza vaccine, is intended for the prevention of seasonal influenza in eligible children and adolescents 24 months to 17 years of age.
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.
According to the company, Influenza B strains on average account for about 25% of the influenza strains that circulate in Europe.
The positive opinion follows a review of data secured from a pivotal pediatric study, which showed that the safety and immunogenicity profile of the new vaccine was comparable to the currently approved three-strain (trivalent) vaccine, Fluenz.
MedImmune vice president of Clinical Biologics Infectious Disease and Vaccines Filip Dubovsky said, "The inclusion of two influenza B strains in the vaccine will provide broad protection and should help to reduce the overall incidence of influenza."
The company intends to replace its existing three-strain Fluenz vaccine with the new Fluenz Tetra from the 2014/15 flu season if the CHMP's recommendation is confirmed by the European Commission.
AstraZeneca's MedImmune Specialty Care Division markets 'Fluenz Tetra' in the US under the trade name FluMist Quadrivalent.
