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Patients participating in clinical trials are representative of the population that will use COVID-19 vaccines, if authorized.

The EU’s high standards of safety and efficacy require any new vaccine, such as COVID-19, to pass rigorous clinical trials. The manufacturer then has to submit the data from these clinical trials to the European Medicines Agency, which then reviews them and decides whether to recommend their use to the European Commission.

One of the factors examined by the European Medicines Agency is the group of patients tested in clinical trials. In order for clinical trials to verify whether a COVID-19 vaccine is safe and effective, trial participants must be representative of the population that will be given the vaccine if approved.

As a result, a very heterogeneous group of subjects (different in ethnicity, age and gender) participated in clinical trials. Participants in clinical trials also represented high-risk groups and the results showed that high levels of safety and efficacy were maintained in all groups.

Much of the misinformation also related to suspected undesirable effects of the vaccine on pregnant women. It is true that data on the use of COVID-19 vaccines during pregnancy are very limited, as pregnant women tend not to participate in studies, as pregnancy affects the immune system.

However, animal studies found that there were no harmful effects during pregnancy and experts do not predict any negative side effects. Nonetheless, the decision on whether to vaccinate a pregnant woman should be made in close consultation with a healthcare professional, after considering the benefits and risks. Vaccine manufacturers will continue to closely monitor recipients of vaccines to ensure long-term efficacy and safety.

Find out more about the EU Clinical Trials RegulationFor more information on patients participating in the clinical trial, see EMA’s Public Stakeholder Meeting on Safe and Effective COVID-19 Vaccines

Find out more about EMA’s guidelines for medicine developers and other stakeholders
See information on clinical trial participants for vaccines developed by BioNTech-Pfizer, Moderna, AstraZeneca and Janssen

Natural immunity to coronavirus after infection is temporary, and previously infected people should still be vaccinated after consulting their doctor.Available scientific data indicates that natural immunity does not last long: most estimates indicate that those who have been infected and recovered from the coronavirus enjoy natural immunity for about six to eight months.

Caution is needed when reading unverified claims about natural immunity after contagion, and you must continue to follow the necessary measures to protect yourself from any new infections: keep your distance, wear a mask and wash your hands frequently. Those who have recovered should consult their doctor or local health professionals to find out when to receive the vaccine.

Download the WHO scientific paper on natural immunity from COVID-19Watch microbiologist Peter Piot as he explains in 15 seconds why you should be vaccinated even if you’ve already been infectedSee the questions and answers contained in the Commission release on COVID-19 vaccination in the EU

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