27 / 2020
The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, issued in function as European Official Medicines Control Laboratory (OMCL) EU batch release certificates for three batches of BioNTech/Pfizer's Comirnaty vaccine on 22 December 2020. The three batches contain approximately 4.1 million vaccine doses. Also on 22 December 2020, the Paul-Ehrlich-Institut issued the national batch release of the vaccine for Germany.
The Paul-Ehrlich-Institut had already started the experimental testing of the batches at a time when the manufacturer was also still conducting batch tests.
Thereby, the official batch release for Germany as well as the issuing of European certificates by the Paul-Ehrlich-Institut immediately after the marketing authorisation of the COVID-19 vaccine Comirnaty by the European Commission on 21 December 2020, had become possible.
The Paul-Ehrlich-Institut’s national batch testing often takes place in parallel with the manufacturers' final testing, not only for COVID-19 vaccines, but also for vaccines against other infectious diseases, so that batch testing does not require additional or very little time after the vaccines are finished.
The Paul-Ehrlich-Institut is one of the European Official Medicines Control Laboratories (OMCL) that can perform experimental testing of vaccines in Europe.
For more information on batch testing in general and batch testing of novel mRNA vaccines, please see our FAQ on batch testing.
Updated: 23.12.2020
