Posted by Michael Wonder on 01 Dec 2020
EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
1 December 2020 - EMA has received an application for conditional marketing authorisation for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer.
The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.
