Covid mRna and myocarditis vaccines, Ema evaluates new data

MRNA and myocarditis covid vaccines, the Prac, Safety Committee of the European Medicines Agency EMA, is evaluating further data on the risk of myocarditis and pericarditis after vaccination. This is what the EU regulatory body announces, reporting the main conclusions that emerged from the last meeting of the pool of experts, from 25 to 28 October. More information on this cardiac risk is being investigated following vaccination with Pfizer / BioNTech’s Comirnaty * and Moderna’s Spikevax *. And the Committee has now “asked the companies that market the vaccines in question to perform a thorough review of all published data on the association between myocarditis and pericarditis, including clinical trial data, literature data and data available in the public domain. “. Myocarditis and pericarditis are inflammatory conditions of the heart, recalls the Ema. Symptoms can vary, but often they are shortness of breath, rapid heartbeat which can be irregular (palpitations), and chest pain. The Prac had previously examined cases reported spontaneously in the European Economic Area (SEE). The review concluded in July 2021 with a recommendation to list both conditions as side effects in the product information for these vaccines, along with a warning to raise awareness among healthcare professionals and people receiving these shield products. The EMA, a note reads, “will continue to monitor the safety and efficacy of vaccines and will further communicate when new information becomes available”.