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EU CHMP recommends approval of BNT 162b2 for COVID-19.- Pfizer + BioNTech

Read time: 1 mins
Published:22nd Dec 2020
Pfizer Inc. and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the conditional marketing authorization (CMA) of BNT 162b2, the Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.The CHMP advisors based their positive opinion on the scientific evidence supporting the Pfizer-BioNTech COVID-19 Vaccine, including data from a Phase III clinical study announced last month and published in The New England Journal of Medicine on December 10, 2020. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on the conditional marketing authorization in the near future. If the EC grants the CMA, the decision will be immediately applicable to all 27 EU member states.
Condition: Coronavirus/COVID-19 Infection
Type: drug

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