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.
- Almost 912 million doses of vaccines have been given to people in the EU and European Economic Area (EEA), as of September 2022.
- 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.
- The vast majority of known side effects of COVID-19 vaccines are mild and short-lived.
- Serious safety problems are extremely rare.
Latest safety information
The latest information on the safety of each vaccine is in the vaccine’s monthly safety update, available via the links below.
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 (BioNTech and Pfizer): 665,000,000 Doses given to people in the EU/EEA, 919,242* Reports of suspected side effects in the EU/EEA (see www.adrreports.eu)
- Vaxzevria (AstraZeneca): 69,000,000 Doses given to people in the EU/EEA, 315,312* Reports of suspected side effects in the EU/EEA (see www.adrreports.eu)
- Spikevax (Moderna): 158,000,000 Doses given to people in the EU/EEA, 252,725* Reports of suspected side effects in the EU/EEA (see www.adrreports.eu)
- Jcovden (Janssen): 19,400,000 Doses given to people in the EU/EEA, 57,567* Reports of suspected side effects in the EU/EEA (see www.adrreports.eu)
- Nuvaxovid (Novavax): 271,000 Doses given to people in the EU/EEA, 1,319* Reports of suspected side effects in the EU/EEA (see www.adrreports.eu)
* 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.
EMA will publish safety data for COVID-19 Vaccine Valneva, authorised in June 2022, as soon as these become available.
As of May 2022, EMA is using a different method to calculate the figures for COVID-19 doses administered in the European Union / European Economic Area.
How EMA monitors vaccine safety
The EU safety monitoring plan for COVID-19 vaccines requires EMA to monitor suspected side effects reported by individuals and healthcare professionals in the EU.
An EU database called EudraVigilance holds these reports. The European suspected adverse drug reactions database provides public access to these data in a number of ways, while taking account of EU data protection law.
EMA’s PRAC and the national competent authorities continuously monitor EudraVigilance to identify any new safety issues that require investigation. These are known as safety signals.
When assessing a safety signal, the PRAC looks for any unusual or unexpected patterns, such as a medical event occurring in vaccinated people at a higher rate than in the general population.
They review other sources of evidence, such as clinical studies, epidemiology and pharmacoepidemiology studies, the medical literature and information from regulators outside the EU.
The PRAC then conducts a robust assessment of all combined safety data before concluding on how the signal affects the vaccine’s safety and its benefit-risk balance.
If needed, EMA may decide to update the vaccine’s product information to provide the right advice to healthcare professionals and patients, require the manufacturer to conduct additional studies, or restrict the use of the vaccine.
Patients and healthcare professionals should report any suspected side effects after receiving a COVID-19 vaccine to their national competent authority.