The European Medicines Agency (EMA) monitors the safety of COVID-19 vaccines authorised in the European Union (EU) extremely carefully. This enables the detection of any rare side effects that may emerge once many millions of people are vaccinated.
- Nearly 563 million doses of vaccines have been given to people in the EU and European Economic Area (EEA), as of the end of September 2021.
- The authorised COVID-19 vaccines are safe and effective. They were evaluated in tens of thousands of participants in clinical trials and have met EMA’s scientific standards for safety, efficacy and quality.
- The safety of COVID-19 vaccines is continuously monitored and evaluated.
- Monthly safety updates give an overview of the PRAC’s regular safety evaluation (Pharmacovigilance Risk Assessment Committee: the committee that is responsible for assessing all aspects of the risk management of medicines for human use).
- The vast majority of known side effects of COVID-19 vaccines are mild and short-lived.
- Serious safety problems are extremely rare.
The latest information on the safety of each vaccine is in the vaccine’s monthly safety update.
The figures below provide overall numbers of suspected side effects that individuals and healthcare professionals have reported after using a COVID-19 vaccine in the EU and EEA.
Reported cases concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine. The problem may have happened anyway, for example, because of an unrelated health issue.
The nature of spontaneous reporting also means that some people may have not reported their side effects, particularly if they were mild.
- Comirnaty (Pfizer): 420,000,000 Doses given to people in the EU/EEA and 361,767* Reports of suspected side effects in the EU/EEA
- Vaxzevria (AstraZeneca): 68,700,000 Doses given to people in the EU/EEA and 199,999* Reports of suspected side effects in the EU/EEA
- Spikevax (Moderna): 59,800,000 Doses given to people in the EU/EEA and 80,486* Reports of suspected side effects in the EU/EEA
- Janssen: 14,300,000 Doses given to people in the EU/EEA and 23,455* Reports of suspected side effects in the EU/EEA
* Reported cases concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine.