1 Like all medicines, vaccines are first tested in the laboratory.
2 They are then tested on human volunteers in several rounds of studies called clinical trials. These trials help confirm how the vaccines work and ensure that their benefits outweigh any potential side effects or risks.
3 Once there is sufficient data from research and clinical trials, companies can apply to the European Medicines Agency for authorisation to put the vaccine on the market.
4 The European Medicines Agency evaluates all the data and conducts an independent and thorough scientific assessment of the vaccine.
5 Based on the Agency’s scientific assessment, the European Commission grants a marketing authorisationin the EU. The vaccine can then be used
SAFETY AND EFFECTIVENESS
The safety and effectiveness of vaccines which have received conditional marketing authorisations are rigorously monitored, as for all medicines, through the EU’s established medicines monitoring system.
In addition, special measures are in place to quickly collect and evaluate new information. For example, manufacturers must usually send a safety report to the European Medicines Agency every six months. For COVID-19 vaccines, safety reports must be sent every month.
The European Medicines Agency will set up additional large-scale safety monitoring given the exceptionally high numbers of people expected to receive the vaccines.
