EMA's Drug Risks Supervisory Committee (Prac) has come to the conclusion, based on a small number of reported cases, that myocarditis and pericarditis can occur after taking the Covid vaccine Nuvaxovid manufactured by Novavax.
It can be read on the Ema website based on an update just published.
The Committee therefore recommended that these risks be included in the information accompanying the vaccine.
The Committee also asked the competent authorities to provide further data on these possible side effects.
On July 5, Novavax announced that the European Commission had approved the Conditional Marketing Authorization (CMA) extended for Nuvaxovid, the vaccine against COVID-19, in adolescents in Europe between the ages of 12 and 17. years.
The approval followed the positive opinion issued on 23 June by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).