Vaccines, Ema evaluates further data on the risk of myocarditis and pericarditis

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29 October 2021 mRna vaccines and myocarditis risk, 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

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 serious inflammatory condition that affects many parts of the body - recalls the Ema - and the symptoms may be tiredness, 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 information on the product. The Prac, informs the agency, encourages all health professionals to report any cases of MIS that may have occurred after vaccination and other adverse events in people receiving these shield products.encourages all healthcare professionals to report any cases of Mis that may have occurred after vaccination and other adverse events in people receiving these shield products.encourages all healthcare professionals to report any cases of Mis that may have occurred after vaccination and other adverse events in people receiving these shield products.

"Ema will continue monitoring the safety and efficacy of vaccines", reads a statement.

The EMA committee has also begun evaluating reports of capillary leak syndrome in people who have been vaccinated with Spikevax.

There are six cases reported in the Eudravigilance database.