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.
Since the beginning of 2022, the safety reports on suspected cases of adverse drug effects with the authorised COVID-19 vaccines have been published on a quarterly basis. The next report with data up to and including 30 June 2022 is currently being prepared.
Safety Report 27 December 2020 to 31 March 2022
In the current safety report, the Paul-Ehrlich-Institut summarises reports on suspected cases of adverse events and vaccination complications. These reports were received between 27 December 2020 (start of the vaccination campaign in Germany) and 31 March 2022.
- A total of 172,062,925 COVID-19 vaccinations were carried out in Germany between 27 December 2020 and 31 March 2022. 73.3% of vaccine doses were Comirnaty (BioNTech Manufacturing GmbH), 17.1% were Spikevax (MODERNA BIOTECH SPAIN, S.L.), 7.4% were Vaxzevria (AstraZeneca AB), 2.1% were COVID-19 Vaccine Janssen (now called Jcovden) and 0.1% were Nuvaxovid (Novavax CZ, a.s.).
- In the same time period, the Paul-Ehrlich-Institut received 296,233 reports of suspected adverse events.
- The overall reporting rate for all vaccines was 1.7 reports per 1,000 doses of vaccine. The reporting rate for serious adverse events was 0.2 reports per 1,000 doses of vaccine.
- The reporting rate after booster vaccinations with Comirnaty or Spikevax was lower than after primary immunisation.
- No new risk signal has been identified since the last safety report, which contained data through 31 December 2021.
- The Paul-Ehrlich-Institut will closely monitor and continue to investigate cases of myocarditis/pericarditis, thrombosis and immunologically mediated adverse events such as immune thrombocytopenia occurring after administration of the approved vaccines.
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.