AstraZeneca receives CHMP recommendation for new flu vaccine

AstraZeneca has received a recommendation for European approval of its new pandemic influenza vaccine.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the conditional approval of its pandemic live attenuated influenza vaccine, also known as P/LAIV.

Indicated for the prevention of influenza in an officially declared pandemic in children and adolescents from 12 months to less than 18 years of age, the vaccine is based on the same biologically-active components used in AstraZeneca's approved product Fluenz Tetra.

This positive CHMP recommendation allows a vaccine containing a strain of pandemic potential to be developed and authorised in advance of a pandemic being declared. Once this occurs, a variation dossier specific for the pandemic strain can be submitted to the EMA for an accelerated assessment and approval.

The committee's positive ruling was based on a review of safety and immunogenicity studies of the vaccine conducted in collaboration with the US National Institutes of Health, as well as data demonstrating the safety and efficacy for Fluenz Tetra in children.