On 21 December 2020, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) pronounced the recommendation to grant a marketing authorisation for the COVID-19 vaccine from BioNTech/Pfizer for the EU. This vaccine is an mRNA vaccine. The final decision for the marketing authorisation will be made by the European Commission, which, as a rule, follows the recommendations from the CHMP. A decision by the European Commission will be made shortly.
On 21 December 2020, after a marketing authorisation procedure, which was accelerated by the rolling review, the Committee for Medicinal Products for Human Use (CHMP) at the EMA transmitted the recommendation to the European Commission to authorise the COVID-19 vaccine BNT162b2 in the form of a conditional marketing authorisation (CMA). This type of marketing authorisation is an accelerated authorisation with conditions. The Paul-Ehrlich-Institut is represented in the CHMP with one expert and is actively involved in the evaluations within the scope of European marketing authorisations.
Based on the evaluation by the CHMP, the European Commission either grants or rejects a marketing authorisation after consultations with the Standing Committee on medicinal products for human use. The regular deadline for such a decision is after 67 days. As a rule, the European Commission follows the recommendations of the CHMP. In view of the world-wide coronavirus pandemic, a decision from the European Commission regarding the COVID-19 vaccine is expected shortly.
Updated: 21.12.2020
