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.
There is now extensive data on the safety of COVID-19 vaccines. The safety report will therefore adapt in nature and scope to the current needs: the focus will be on the booster vaccinations recommended by the Standing Committee on Vaccination (STIKO); new vaccines, including new variant vaccines; and new possible safety signals.
The next safety report will be published in the Bulletin on Drug Safety, Issue 4/2022 (www.pei.de/bulletin-sicherheit.de), at the end of December 2022.
Safety Report 27 December 2020 to 30 June 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 30 June 2022.
- From 27 December 2020 to 30 June 2022, a total of 182,717,880 vaccinations were administered to protect against COVID-19. 73.7% of the vaccine doses were related to Comirnaty (BioNTech Manufacturing GmbH), 17.1% to Spikevax (MODERNA BIOTECH SPAIN, S.L.), 7.0% to Vaxzevria (AstraZeneca AB), 2.1% to Jcovden (Janssen-Cilag International NV) and 0.1% to Nuvaxovid (Novavax CZ, a.s.).
- In the same period, 323,684 suspected cases of adverse reactions and vaccine complications were reported to the Paul-Ehrlich-Institut.
- The reporting rate of suspected cases for all vaccines together was 1.8 reports per 1,000 vaccine doses, for suspected cases of serious adverse reactions and vaccine complications 0.3 reports per 1,000 vaccine doses.
- The reporting rate after booster vaccinations was lower for the two mRNA vaccines Comirnaty and Spikevax than after basic immunisation.
- Individual cases of myocarditis and/or pericarditis were reported after Nuvaxovid, including a few cases from Germany.
- An evaluation of reports of chronic fatigue syndrome and long COVID-like complaints to the Paul-Ehrlich-Institut and a comparison with international reports in the adverse reaction database at the European Medicines Agency (EMA) did not reveal any risk signal up to the date of this evaluation.
- The latter also applies to an evaluation of suspected case reports from Germany on a wide variety of cycle disorders in women of childbearing age and seizures after COVID-19 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.