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 31 August 2021
The Paul-Ehrlich-Institut (PEI) reports on 156,360 suspected cases of side effects or vaccination complications reported from Germany in connection with vaccination with the mRNA vaccines Comirnaty (BioNTech Manufacturing GmbH), Spikevax (MODERNA BIOTECH SPAIN, SL) and 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 31 August 2021. According to the Robert Koch Institute, 101,877,124 vaccinations were carried out by 31 August 2021, of which 76,982,568 vaccinations with Comirnaty, 9,396,381 vaccinations with Spikevax, 12,645,915 vaccinations with Vaxzevria and 2,852,260 vaccinations with COVID-19 Vaccine Janssen. 84,763 suspected cases of vaccination with Comirnaty were reported, 24,457 suspected cases of Spikevax, 41,534 suspected cases of Vaxzevria and 4,895 reports of COVID-19 Vaccine Janssen. In 711 reported suspected cases, the COVID-19 vaccine was unspecified. The reporting rate for all vaccines together was 1.5 reports per 1,000 vaccine doses, for serious reactions 0.15 reports per 1,000 vaccine doses.Reports on suspected cases of adverse effects and vaccination complications following a vaccination for the protection against COVID-19 (reporting period 27 December 2020 to 31 August 2021) (German only)
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.