The European Commission (EC) has granted marketing authorisation to AstraZeneca's Fluenz Tetra, a nasally administered four-strain live attenuated influenza vaccine for the prevention of influenza in children and adolescents from 24 months up to 18 years of age. This approval makes Fluenz Tetra the first and only intra-nasal four-strain influenza vaccine available in Europe.
Historically, seasonal flu vaccines have contained three strains of influenza: two influenza A viruses (H1N1 and H3N2) and one influenza B virus. Fluenz Tetra contains an additional influenza B strain. Over the past decade, influenza B strains accounted for approximately 25 per cent of the influenza strains circulating in Europe.
“Fluenz Tetra represents the next generation of influenza vaccine and we are pleased that it is now approved in Europe,” said Filip Dubovsky, vice president of Clinical Biologics Infectious Disease and Vaccines at MedImmune, AstraZeneca’s global biologics research and development arm. “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 of Fluenz Tetra is based on data from a pivotal paediatric study. Findings showed that Fluenz Tetra demonstrated a safety and immunogenicity profile that was comparable to Fluenz, a three-strain (trivalent) live attenuated influenza vaccine already approved in Europe.
The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use on 19 September 2013, and is applicable to all 28 member states and the three European Economic Area countries of the European Union.
Influenza is the most common vaccine-preventable disease in the developed world. In Europe and throughout the world, influenza creates a significant medical and economic burden. According to World Health Organization (WHO) estimates, seasonal influenza results in three to five million cases of severe illness and up to half a million deaths globally each year. Rates of infection are highest among children, and school-aged children are recognised as the main transmitters of the flu virus.
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.
Fluenz Tetra will replace the Fluenz three-strain (trivalent) live attenuated influenza vaccine from the 2014-2015 flu season onwards.
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.