AstraZeneca and its global biologics research and development arm, MedImmune, announced that 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 Pandemic Live Attenuated Influenza Vaccine (P/LAIV). P/LAIV is 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.
This positive recommendation allows a vaccine containing a strain of pandemic potential to be developed and authorised in advance of a pandemic being declared. Once the World Health Organisation has declared an actual pandemic, a variation dossier specific for the pandemic strain can be submitted to the EMA for an accelerated assessment and approval. This provides an additional public health tool to protect European children when the next pandemic emerges.
P/LAIV is an intranasally administered vaccine that contains a live attenuated H5N1 strain of influenza virus. The vaccine is based on the same biologically-active components currently used to make AstraZeneca/MedImmune’s approved seasonal influenza vaccine, Fluenz™ Tetra. P/LAIV differs from Fluenz Tetra, because it protects against a single influenza A pandemic strain as opposed to four seasonal strains in Fluenz Tetra.
The positive CHMP opinion was based on a review of safety and immunogenicity studies of the H5N1 vaccine conducted in collaboration with the US National Institutes of Health as well as by the comprehensive clinical data that demonstrate the safety and efficacy for Fluenz Tetra in children.
The CHMP’s opinion will now be advanced to the European Commission for adoption of a decision on EU-wide marketing authorisation of the vaccine as a pandemic preparedness vaccine. The final decision will be applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein.
