BRIEF—BioNTech and Pfizer submit formal COVID-19 vaccine application to EMA

BioNTech and Pfizer today said they 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 non-clinical data and partial Chemistry, Manufacturing, and Controls (CMC) data, followed by emerging clinical data submitted by Pfizer and BioNTech.

If the 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.

“As a company located in the heart of Europe, today’s milestone is important to us as we continue to seek to enable a worldwide supply upon potential approval of BNT162b2,” said BioNTech chief executive and co-founder Dr Ugur Sahin,

“We will continue to work with regulatory agencies around the world to enable the rapid distribution, should the vaccine receive the approval, contributing to the joint efforts to let the world heal and regain its normal pace of life,” he added.

Decision by December 29

Confirming receipt of the CMA application, the EMA issued a press release in which it said the agency and its scientific committees will continue working on the assessment over the Christmas period.

The EMA’s scientific committee for human medicines (CHMP) will conclude its assessment during an extraordinary meeting scheduled for December 29, at the latest.