The Paul-Ehrlich-Institut monitors the safety of COVID-19 vaccines. Since the beginning of the vaccination campaign, the Institute has provided information in a transparent manner regarding new findings on the safety and side effect profile of the new vaccine products.
Vaccination against COVID-19 significantly reduces the risk of serious disease after SARS-CoV-2 infection. Vaccines only receive authorisation if they have a favourable benefit-risk ratio when the authorisation is issued. However, unexpected vaccine side effects or complications may occur during post-authorisation use that were not yet detected in pre-authorisation clinical trials due to their rarity. It is therefore important to record and evaluate suspected cases of vaccination side effects or complications in order to be able to recognise even very rare side effects. This task is handled in Germany by the Paul-Ehrlich-Institut and its experts in the “Safety of Biomedicines and Diagnostics” Division. The safety of the COVID-19 vaccine products authorised for use in Europe is monitored and evaluated in cooperation with experts from the other European national medicines authorities.
It is important to set the reporting threshold low in order to identify previously unknown risks as quickly as possible. Therefore, reports of any symptoms occurring after vaccination are welcomed, even if there is only a suspicion of a causal connection with the vaccination.
The authorised COVID-19 vaccines, which include the mRNA vaccine products Comirnaty (BioNTech) and Spikevax (Moderna) and the vector vaccine products Vaxzevria (AstraZeneca) and Jcovden (Janssen-Cilag), were novel vaccine types, and never before have so many people been vaccinated in such a short time. This is one of the main reasons why the experts at the Paul-Ehrlich-Institut reported on new findings on the safety and side effect profiles of the new vaccine products in such a transparent and timely manner. The vaccination campaign against COVID-19 began on 27 December 2020. The first of the Paul-Ehrlich-Institut's periodic safety reports on “Suspected cases of adverse events and vaccination complications after vaccination against COVID-19”, appeared shortly afterwards on 4 January 2021. A total of 20 safety reports were published by the end of 2022.
Thanks to the willingness of doctors and vaccinated persons to submit reports, the spontaneous reporting system was able to identify very rare side effects at a very early stage.
Dr Dirk Mentzer (Head of the Pharmacovigilance Section in the Safety of Biomedicines and Diagnostics Division)