COVID-19

Safety of COVID-19 vaccines

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.

  • Around 950 million doses of vaccines have been given to people in the EU and European Economic Area (EEA), as of mid November 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.
  • The vast majority of known side effects of COVID-19 vaccines are mild and short-lived.
  • Serious safety problems are extremely rare.

Safety information (updated)

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Update: EMA will stop publishing monthly safety updates of COVID-19 vaccines after the December 2022 issue.

EMA has provided these updates since December 2020. 

By December 2022, the majority of the EU population had received at least one COVID-19 vaccine. Data from related clinical trials, studies and spontaneous reporting on side effects have helped establish the safety profile of these vaccines.

From January 2023, relevant changes to the product information of COVID-19 vaccines will be communicated via the PRAC highlights.

As for all medicines authorised in the EU, emerging safety data will continue to be monitored and assessed. 

High-level information on suspected adverse reaction reports will also continue to be updated monthly in the vaccine cards below.

The related figures provide overall numbers of suspected side effects that individuals and healthcare professionals reported after using a COVID-19 vaccine in the EU and EEA.

For more information on these reports, see:

 

Comirnaty
(BioNTech and Pfizer)
Status as of 13/11/2022

701,000,000
Doses given to people in the EU/EEA, including over 16,000,000 doses of adapted vaccines

971,021*
Reports of suspected side effects in the EU/EEA, including 3,670 cases for adapted vaccines (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.

PDF icon Read latest safety update

All Comirnaty safety updates 
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Vaxzevria
(AstraZeneca)
Status as of 13/11/2022

69,000,000
Doses given to people in the EU/EEA

328,643*
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.

PDF icon Read latest safety update

All Vaxzevria safety updates 
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Spikevax
(Moderna)
Status as of 13/11/2022

161,000,000
Doses given to people in the EU/EEA, including over 317,000 doses of adapted vaccines

273,947*
Reports of suspected side effects in the EU/EEA, including 3,120 cases for adapted vaccines (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.

PDF icon Read latest safety update

All Spikevax safety updates 
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Jcovden
(Janssen)
Status as of 13/11/2022

18,600,000
Doses given to people in the EU/EEA

58,223*
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.

PDF icon Read latest safety update

All Jcovden safety updates 
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Nuvaxovid
(Novavax)
Status as of 13/11/2022

361,000
Doses given to people in the EU/EEA

1,423*
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.

PDF icon Read latest safety update

All Nuvaxovid safety updates 
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COVID-19 Vaccine Valneva
Status as of 13/11/2022

2,900
Doses given to people in the EU/EEA

24*
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.

PDF icon Read latest safety update

All COVID-19 Vaccine Valneva safety updates 
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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. For information on how to do this see:

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