The EU is responsible for ensuring that safe and effective COVID-19 vaccines reach the public in the EU/EEA. The European Commission authorised the first COVID-19 vaccine on 21 December 2020, after an evaluation by the European Medicines Agency (EMA) and consultation with the EU Member States.
How COVID-19 vaccines work
COVID-19 vaccines prevent COVID-19 by triggering an immune response.
Most COVID-19 vaccines trigger these immune responses to a tiny fragment of SARS-CoV-2. SARS-CoV-2 is the virus that causes COVID-19 disease.
If a person who has received a COVID-19 vaccine is infected by the virus later on, the immune system recognises the virus.
Because it is already prepared to attack the virus, that person’s immune system is able to protect them from COVID-19 disease.
See more information on How vaccines work.
Development and approval of COVID-19 vaccines
COVID-19 vaccines are developed following the same legal requirements for quality, safety and efficacy as for all other vaccines.
Like all vaccines, the effects of COVID-19 vaccines are tested first in the laboratory, including in animals, and then in human volunteers.
The European Medicines Agency (EMA) evaluates COVID-19 vaccines against the same high standards as for all other vaccines before they can be released for use. Read more on the Approval of vaccines in the European Union.
What is different for COVID-19 vaccines is that development and approval are happening much faster, in response to the public-health emergency caused by the virus.
EMA evaluates high-quality applications from companies developing COVID-19 vaccines in the shortest time possible, while ensuring its decisions remain robust. It does this by:
- providing guidance to help developers of COVID-19 vaccines prepare to apply for approval;
- using rapid review procedures;
- assessing key data on COVID-19 vaccines as soon as they become available.
Monitoring COVID-19 vaccine safety
The EU continually monitors the safety and effectiveness of COVID-19 vaccines.
EMA monitors side effects to these vaccines, as it does for all vaccines.
In parallel, the European Centre for Disease Prevention and Control (ECDC) intensively monitors the effectiveness of COVID-19 vaccines.
This enables the EU to identify and evaluate new information that arises on the benefits and safety of COVID-19 vaccines promptly. This will make sure that any possible risks are detected and managed as quickly as possible: see Monitoring vaccine safety and reporting side effects.
- European Commission: Coronavirus response
- European Commission: EU strategy for COVID-19 vaccines
- European Commission: Preparedness for COVID-19 vaccination strategies and vaccine deployment
- European Commission: How are vaccines developed, authorised and put on the market?
- ECDC: Vaccine Tracker
- EMA: Treatments and vaccines for COVID-19
- EMA: COVID-19 vaccines: key facts
- EMA: COVID-19 vaccines: development, evaluation, approval and monitoring
Vaccines authorised for use in the European Union
Infographic: How mRNA vaccines protect you against COVID-19
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Viral vector vaccines against COVID-19: how they work
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