Pfizer, BioNTech get positive CHMP recommendation for COVID-19 vaccine

By The Science Advisory Board staff writers

December 21, 2020 -- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion to recommend the conditional marketing authorization for the Pfizer-BioNTech COVID-19 vaccine in Europe.

The recommendation was for the use of BNT162b2 for immunization to prevent COVID-19 in individuals 16 years of age and older. CHMP advisors based their recommendation on scientific evidence provided by Pfizer and BioNTech including data from a phase III clinical trial which was published in the New England Journal of Medicine on December 10.

Based on the CHMP opinion, the European Commission (EC) is expected to make a final decision on the CMA soon. If the EC grants the EMA, the decision will be immediate applicable to all 27 European Union member states.

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