![]() Serious side effects may occur, but they are very rare. Fatal outcomes have been reported in very few of these rare cases.įor a visual summary of how EMA monitors vaccine safety, watch the video below: The vast majority of known side effects are mild and short-lived. The safety profiles of the COVID-19 vaccines authorised in the EU are very reassuring. This ensures that healthcare professionals and patients have up-to-date information to hand. If there is at least a reasonable possibility that a vaccine could have caused a suspected side effect, it is included in the vaccine’s product information. Reports of suspected side effects from patients, parents and healthcare professionalsĮMA carefully assesses suspected side effects to determine if they were caused by a vaccine or by something else, such as an illness.COVID-19 vaccines: development, evaluation, approval and monitoringĮMA and EU Member States continuously monitor the safety of COVID-19 vaccines to ensure any possible risks are detected and managed as early as possible.ĮMA continuously checks new information on the safety of all vaccines available in Europe from many data sources.Regulators have an unprecedented amount of data to confirm the safety and efficacy of COVID-19 vaccines.īefore their authorisation, the vaccines were tested in tens of thousands of clinical trial participants to confirm they met EMA’s scientific standards for safety, efficacy and quality.Īs always, the benefits of these vaccines were weighed against the risks of side effects. Since December 2020, people in the EU and EEA received almost 1 billion doses of COVID-19 vaccines, making it the largest vaccination programme in history. It remains particularly dangerous for older or sick people with low immunity and those with faulty immune systems.Įstimates indicate that millions of lives have been saved by COVID-19 vaccination. ![]() Infection can cause severe disease and long-term damage, including in healthy adults and children. Vaccination is the best tool to prevent the consequences of infection. COVID-19 vaccines continue to protect people from severe disease and death caused by infection with SARS-CoV-2, the virus that causes COVID-19. ![]()
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