The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on AstraZeneca's Fluenz Tetra, a nasally administered four-strain live attenuated influenza vaccine, for the prevention of seasonal influenza in eligible children and adolescents 24 months to 17 years of age.
Historically, seasonal flu vaccines have contained three strains of influenza: one influenza A (H1N1) virus, one influenza A (H3N2) virus, and one influenza B virus. However, Fluenz Tetra contains two strains of influenza A and two strains of influenza B to provide broad protection against influenza B. Influenza B strains on average account for approximately 25 per cent of the influenza strains that circulate in Europe.
The positive opinion was reached after a review of data from a pivotal paediatric study. These data indicated that the safety and immunogenicity profile of Fluenz Tetra was comparable to currently approved three-strain (trivalent) vaccine, Fluenz.
Filip Dubovsky, vice president of Clinical Biologics Infectious Disease and Vaccines, MedImmune, AstraZeneca’s global biologics research and development arm, said: “We are delighted that Fluenz Tetra has received a positive opinion from the CHMP. 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 CHMP’s positive opinion on Fluenz Tetra will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. Should the EC approve Fluenz Tetra, it will replace Fluenz from the 2014-2015 flu season onwards.
Fluenz Tetra is formulated to contain four live attenuated influenza virus strains that are weakened so as to not cause illness. The vaccine is administered by spraying into each
nostril where it induces protective immunity. The most common adverse reactions for Fluenz Tetra include runny nose or nasal congestion.
In the US, Fluenz Tetra is marketed by MedImmune Specialty Care Division of AstraZeneca, under the trade name FluMist Quadrivalent (Influenza Vaccine Live, Intranasal). FluMist Quadrivalent was approved by the US Food and Drug Administration on February 29, 2012.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases.