The FDA has approved Sanofi Pasteur's Fluzone Intradermal Quadrivalent vaccine for use in adults who are 18 to 64 years old. The vaccine offers protection against influenza A subtype viruses and type B viruses.
In a clinical trial involving 5,168 3- to 8-year-olds, researchers found that an inactivated quadrivalent flu vaccine yielded an overall effectiveness rate of 55% in preventing influenza A or B of any severity. The vaccine had an efficacy of about 70% in protecting children against moderate to severe flu and was linked to an 80% decline in lower respiratory tract infections, according to the study published in the New England Journal of Medicine.
The European Commission has approved AstraZeneca's intranasal influenza vaccine Fluenz Tetra for use in children and adolescents 24 months to 18 years. The approval makes Fluenz Tetra the first nasally administered four-strain flu vaccine approved in the region. The vaccine, which was approved in the U.S. last year under the name FluMist Quadrivalent, will be available in the 2014-2015 flu season.
The European Medicines Agency endorsed AstraZeneca's nasal spray quadrivalent influenza vaccine for European Commission approval. The vaccine could be released in the European market for the 2014-2015 flu season if it wins approval.
GlaxoSmithKline secured approval from the FDA to supply its influenza vaccine, Fluarix Quadrivalent, to CDC distribution centers and health care providers in the U.S. Fluarix was approved by the FDA last year to protect adults and children 3 and older against four strains of flu. The CDC ordered more than 4 million doses of the vaccine.