Is the COVID-19 vaccine safe?
In the development and approval of vaccines against COVID-19, as for any other drug, their efficacy, safety and quality was guaranteed through clinical trials and rigorous evaluation by the European Medicines Agency. Clinical trials of COVID-19 vaccines were conducted in accordance with the standard procedures for testing any vaccine.
Tens of thousands of volunteers were vaccinated and compared with the same number of unvaccinated volunteers for the occurrence of adverse effects. The time during which the vaccinated individuals were followed up after taking the 2nd dose exceeded eight weeks. This is the period during which common adverse effects appear after taking vaccines, and there has not been a frequency or severity of these effects that jeopardizes the safety of the vaccines.
As with any other drug, trials cannot, however, exclude the occurrence of very rare adverse effects, which are only detectable when a vaccine is administered to millions of people. These effects are detected by surveillance implemented by the drug regulatory authorities of each country, which in our case is INFARMED (in the context of the National Pharmacovigilance System). If you detect any adverse effects, it can and should be analyzed together with your reference physician and therefore be reported through the Adverse Reactions Notification Portal (ADR) of INFARMED, I.P.