Safety of COVID-19 vaccines
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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.
- Since the start of the pandemic, close to 1 billion doses of vaccines have been given to people in the EU and European Economic Area (EEA).
- 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.
- The vast majority of known side effects of COVID-19 vaccines are mild and short-lived.
- Serious safety problems are extremely rare.
EMA monitors and assesses safety data on COVID-19 vaccines, as it does for all medicines authorised in the EU.
EMA provides the latest safety information and an overview of known side effects in all EU languages in the product information for each authorised COVID-19 vaccine.
EMA published the final issue of its monthly safety update on COVID-19 vaccines in December 2022. EMA’s monthly safety updates provided information from the Pharmacovigilance Risk Assessment Committee (PRAC)'s assessment of COVID-19 vaccines, along with data on the number of doses administered in the EU/EEA. In total, EMA published more than 50 monthly COVID-19 vaccine safety updates, beginning in December 2020. By December 2022, the majority of the EU population had received at least one COVID-19 vaccine. The wide uptake of COVID-19 vaccines during the COVID-19 pandemic led to the rapid accumulation of extensive safety data from clinical trials, studies and spontaneous reporting on side effects. These data have established the safety profiles of these vaccines. Therefore, regular monthly safety updates are no longer necessary. If the PRAC recommends important safety-related changes to the product information of COVID-19 vaccines, EMA will include these in the PRAC highlights. For more information, see: |
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. For information on how to do this see: