Coronavirus and COVID-19
Safety of COVID-19 Vaccines
In Germany, the Paul-Ehrlich-Institut is the authority responsible for monitoring the safety of vaccines and biomedicines. For this purpose, the institute’s Division Pharmacovigilance collects and reviews reports on adverse drug effects and takes the necessary steps if required.
Reporting suspected cases of adverse effects is a central pillar for being able to judge the safety of medicines. Thus, new signals can be detected in a timely manner, and the risk/benefit profile of vaccines can be continuously monitored. In this context, it must be noted that even reactions with a timely relation to a vaccine do not necessarily have a causal relation.
Open communication of risks, including potential ones, is a prerequisite for a high acceptance rate for vaccines among the population. The benefit of the COVID-19 vaccination for the health of individuals and the population as well as their effect in combating the pandemic essentially depends on the confidence in the vaccination. To meet this requirement, the Paul-Ehrlich-Institut publishes continuously all suspected cases reported in Germany on adverse effects or vaccination complications in a temporal relationship with the COVID-19 vaccination.
Safety Report 27 December 2020 to 30 June 2021
The Paul-Ehrlich-Institut (PEI) reports on 106,835 suspected cases of side effects or vaccination complications reported from Germany in the temporal connection with the vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH), Spikevax (formerly COVID-19-Vaccine Moderna, MODERNA BIOTECH SPAIN, S.L), the vector vaccines Vaxzevria (AstraZeneca AB) and COVID-19 vaccine Janssen to protect against COVID-19 from the start of the vaccination campaign on 27 December 2020 to 30 June 2021. According to the Robert Koch Institute, 74,871,502 vaccinations were carried out by June 30, 2021, of which 54,898,640 vaccinations with Comirnaty, 6,471,052 vaccinations with Spikevax, 11, 570,155 vaccinations with Vaxzevria and 1,931,655 vaccinations with the COVID-19 vaccine Janssen. 49,735 suspected cases of vaccination with Comirnaty were reported, 14,153 suspected cases of Spikevax, 39,398 suspected cases of Vaxzevria and 3,061 reports of the COVID-19 vaccine Janssen.
In 488 reported suspected cases, the COVID-19 vaccine was unspecified. The reporting rate for all vaccines together was 1.4 per 1,000 vaccine doses, for reports of serious reactions 0.1 per 1,000 vaccine doses in total.
Archive Safety Reports
In addition to the observation of adverse effects on the basis of incoming reports of suspected cases – the so-called spontaneous recording process of adverse effects – the Paul-Ehrlich-Institut is committed to active pharmacovigilance studies for a high safety standard for vaccinations.
The Paul-Ehrlich-Institut has developed a smartphone app called SafeVac 2.0 to gain further insights into the tolerability of COVID-19 vaccines. All persons vaccinated are invited to use the app to contribute actively to this observational study.
Reporting Portal for Suspected Cases of Adverse Effects
The Paul-Ehrlich-Institut accepts reports of suspected cases of adverse effects after vaccinations from healthcare providers, the marketing authorisation holder, and persons vaccinated as well as their relatives.