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. They are examining more information on this cardiac risk 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 are often 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”.
“No sufficient evidence links vaccines-inflammatory syndrome”
The Safety Committee also concluded that at present “there is insufficient evidence on a possible link between Covid vaccines and very rare cases of multisystem inflammatory syndrome (MIS)”. This is one of the main data that emerged from the last meeting of the regulatory body’s pool of experts, which was held from 25 to 28 October.
Mis is a rare severe inflammatory condition that affects many parts of the body – Ema recalls – and symptoms can be fatigue, persistent severe fever, diarrhea, vomiting, stomach pain, headache, chest pain and difficulty breathing. This syndrome was previously reported as a condition that occurred in some cases as a result of Covid-19 disease. The Prac Committee has assessed whether there is a possible link also with the anti-Covid vaccination, based on the spontaneous reports available, and currently this evaluation does not justify an update of the product information.
The Prac, the agency informs, encourages all health professionals to report any cases of MIS that may have occurred after vaccination and other adverse events in people who receive these shield products.