1st Apr 2016 16:36
LONDON (Alliance News) - AstraZeneca PLC on Friday said the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending the conditional approval of pandemic live attenuated influenza vaccine.
P/LAIV is indicated for the prevention of influenza in children and adolescents from 12 months to 18 years of age.
The positive recommendation allows a vaccine containing a strain of pandemic potential to be developed and authorised in advance of a pandemic being declared, AstraZeneca said.
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 then provides an additional public health tool to protect European children when the next pandemic emerges, AstraZeneca added.
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, AstraZeneca said.
Shares in AstraZeneca closed up 0.8% at 3,932.11 pence on Friday.
By Karolina Kaminska; [email protected] @KarolinaAllNews
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