AstraZeneca's FluMist Quadrivalent influenza vaccine garners US approval

AstraZeneca's MedImmune unit received FDA clearance for FluMist Quadrivalent, making the product the first influenza vaccine containing four virus strains to be cleared by the agency, the company reported. FluMist Quadrivalent contains two influenza type A strains and two influenza type B lineages and is authorised for use in children and adults aged 2 to 49 years.

The approval was based on clinical studies comparing FluMist Quadrivalent with two trivalent formulations of MedImmune's licensed seasonal influenza vaccine FluMist. Results showed that the quadrivalent vaccine had a similar safety profile to the trivalent FluMist formulations, and immunogenicity to individual vaccine strains was comparable in trivalent and quadrivalent formulations. Further, the company noted that the addition of the second B strain did not result in immune interference to other strains included in the vaccine.

Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, commented that "a vaccine containing the four virus strains most likely to spread and cause illness during the influenza season offers an additional option to aid in influenza prevention efforts."

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