Pfizer, BioNTech Submit CMA for Covid-19 Vax to EMA

Approval could potentially enable the use of BNT162b2 in Europe before the end of 2020.

By: Contract Pharma

Contract Pharma Staff

Pfizer Inc. and BioNTech SE have submitted a formal Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their mRNA vaccine candidate, BNT162b2, against Covid-19.   This submission completes the rolling review process initiated on October 6, 2020, with nonclinical data and partial Chemistry, Manufacturing, and Controls (CMC) data, followed by emerging clinical data submitted by Pfizer and BioNTech. If EMA concludes that the benefits of the vaccin...

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