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This picture taken on November 23, 2020 shows a bottle reading "Vaccine Covid-19" next to US pharmaceutical company Pfizer and German biotechnology company Biontech logos on November 23, 2020. (Photo by JOEL SAGET / AFP)
The Hague
The European Medicines Agency (EMA) confirmed Friday a “possible link” between the Pfizer/BioNTech and Moderna mRNA-based covid-19 vaccines and several sporadic cases of myocarditis and pericarditis that developed after vaccination and will list them as side effects in its package insert.
The EMA’s safety committee (PRAC) concluded, during its meeting this week to analyze the available information shared by European physicians, that the detected cases of myocarditis and pericarditis developed by some people vaccinated with Pfizer or Moderna could be a side effect of this preparation.
These two symptoms will now be included in the product information, together with a warning to raise awareness among healthcare professionals and patients receiving these vaccines and to monitor this unusual adverse effect.
Myocarditis is an inflammation of the heart muscle and pericarditis inflammation of the membrane around the heart, and symptoms of these inflammatory conditions can vary. However, they often include difficulty breathing, a pounding heartbeat that can be irregular (palpitations), and chest pain.
To reach its conclusions, the PRAC analyzed 145 cases of myocarditis and 138 cases of pericarditis in people receiving Pfizer, as well as 19 cases of myocarditis and 19 cases of pericarditis with Moderna (or Spikevax, as the trade name), reported through the Eudravigilance database by countries in the European Economic Area (EEA), which includes all 27 EU countries, plus Iceland, Liechtenstein, and Norway.
From an overall perspective, these cases were among a total of 177 million Pfizer doses and 20 million Moderna doses administered in the EEA as of May 31. However, the PRAC also considered and reviewed cases received from countries around the world.
Unlike clinical trials, which involve a limited number of volunteers, the ongoing mass vaccination campaigns allow for the detection of unrecognized adverse events during vaccine use in trials due to the injection of doses into patients with different patient profiles and medical histories.
