Posted by Michael Wonder on 15 Dec 2020
Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
15 December 2020 - EMA’s CHMP and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation application for BNT162b2, a COVID‑19 mRNA vaccine.
The rate of progress is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation.
