On Dec. 1, 2020, Pfizer and BioNTech announced they had submitted on Nov. 30, 2020, 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 completed the rolling review process initiated on Oct. 6, 2020, with nonclinical data and partial Chemistry, Manufacturing, and Controls data, followed by emerging clinical data submitted by Pfizer and BioNTech.