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Pfizer, BioNTech Apply For Conditional Marketing Authorization For COVID-19 Vaccine To EMA

Pfizer Inc. (PFE) and German biotech firm BioNTech SE (BNTX) Tuesday said they have submitted a formal Application for Conditional Marketing Authorization or CMA for their mRNA vaccine candidate, BNT162b2, against COVID-19 to the European Medicines Agency or EMA.

The submission completes the rolling review process initiated on October 6, 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 vaccine candidate outweigh its risks in protecting against COVID-19, it will recommend granting a CMA that could potentially enable use of BNT162b2 in Europe before the end of 2020.

The companies noted that the vaccine candidate will be assessed according to EMA's normal stringent standards for quality, safety and efficacy.

The BNT162b2 vaccine candidate is currently not approved for distribution anywhere in the world.

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