Approval of vaccines in the European Union

Before a vaccine can be approved in the EU, it has to undergo rigorous testing by its developer and then scientific evaluation by regulatory authorities. These include the European Medicines Agency (EMA) and other regulators in the EU/EEA countries.

Testing includes checking the vaccine’s quality:

  • its purity;
  • its ingredients, including its inactive ingredients or ‘excipients’;
  • how it is manufactured.

Then the vaccine developer tests the vaccine’s effects. This involves tests in the laboratory and in animals.

This is followed by a clinical testing programme in humans. The vaccine developer tests the vaccine in three phases of clinical trials, with larger numbers of people in each phase. This programme has to follow strict standards and the procedures and protocols set by the regulators.

This can take around ten years from initial concept to authorisation, but it can also happen faster during public health emergencies. For example, COVID-19 vaccines were developed following the same  regulatory requirements for quality, safety and effectiveness as other vaccines. However, development was much faster due to significant joint efforts and investments in response to the pandemic. It was also based on decades of research on new vaccine technologies, like the mRNA vaccines.

approval first phase illustration 2

20 - 100 healthy volunteers

What is checked: 

  • Does the vaccine seem to work?
  • Are there serious side effects?
  • Is the vaccine safe?
approval second phase illustration 2

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?
approval third phase illustration 2

Thousands of volunteers

What is checked: 

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

At the end of the testing programme, the vaccine developer submits the results to the medicines regulatory authorities in Europe as part of a ‘marketing authorisation’ application.

The regulators can only approve the 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. The companies are required to conduct stringent testing, for which the acceptance criteria are pre-defined by the authorities, on each batch of vaccine released onto the EU market.

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Benefits of vaccinating

Vaccines prevent diseases that could cause health problems, disabilities, or death. Many diseases are now rare due to vaccination.

Vaccine effectiveness

Approved vaccines are effective at preventing disease, serious symptoms, and decreasing transmission.

Page last updated 11 Sep 2020