Approval of vaccines in the EU

All vaccines must go through several stages of testing to ensure they are safe, and effective before being approved for use in the EU. 

It must undergo rigorous testing by its developer before a scientific evaluation by regulatory authorities, including the European Medicines Agency (EMA) and regulators in individual EU/EEA countries.

The vaccine's quality is evaluated by checking:

  • its purity
  • its ingredients, including inactive ingredients
  • how it is manufactured

The new vaccine’s effects are first tested both in the laboratory and through animal testing. Once these tests are completed, the clinical testing programme in humans begins

Clinical trials in humans work in three phases, with larger numbers of people in each phase. 

Phase 1 trials image

20 - 100 healthy volunteers

What is checked: 

  • Does the vaccine seem to work?
  • Are there serious side effects?
  • Is the vaccine safe?
Phase 2 trials image

Several hundred volunteers

What is checked: 

  • What are the most common short-term side effects?
  • What is the optimal dose?
  • How are the immune systems of the participants responding to the vaccine?
Phase 3 trials image

Thousands of volunteers

What is checked: 

  • Is the vaccine effective? 
  • What are the most common side effects? 
  • Is the vaccine safe? 

Regulatory requirements

The clinical testing programme must follow a strict set of criteria, procedures and protocols set by regulators. The entire process, from initial concept to authorisation, can take up to ten years. 

However, in public health emergencies, the process can be faster. This was the case with COVID-19 vaccines, developed at an accelerated pace due to significant efforts from the scientific community and investments in response to the pandemic. All these factors built on decades of research on new vaccine technologies. However, this process followed the same regulatory requirements for quality, safety and effectiveness as for other vaccines.

For more information on vaccine development and authorisation, see: 

Results and quality control

Once the testing programme is completed, the vaccine developer submits the results to the EMA as part of a marketing authorisation application. Regulators can only approve a vaccine if its scientific evaluation of the tests results show that the vaccine’s benefits are greater than its risks.

Medicines regulatory authorities can carry out inspections to make sure that the information the vaccine developer provides is trustworthy. They can also run tests to make sure that the batches of vaccines released onto the market are of the expected quality and have been manufactured correctly. 

Companies are required to conduct stringent testing on each batch of vaccine released onto the EU market. National authorities decide the related acceptance criteria.

For more information on vaccine benefits, see: 

Benefits of vaccination

How do vaccines protect us and stop the spread of disease? Find out their benefits for individuals and the community.

Reporting side effects

After a vaccine is approved for use in the EU/EEA, the European Medicines Agency (EMA) and national authorities continually monitor whether people who have received the vaccine experience any side effects. 

For more information about reporting side effects, see:

Reporting side effects

Find out how vaccine safety and any potential side effects are continuously monitored to protect patients across Europe.

Who decides on vaccine use?

Each EU/EEA country decides which vaccines to include in its national vaccination programme, and which may be funded by the national health system. This decision is based on local conditions, such as the prevalence of the disease, and economic factors.