• Tue. Oct 26th, 2021

Myocarditis after mRna vaccines, Ema evaluation

Byeditorial

May 7, 2021

“Case reports of myocarditis” after mRna anti-Covid vaccines under evaluation by the Prac, the Pharmacovigilance Committee of the European Medicines Agency Ema. This is what emerges from the report on the latest meeting of the EU body’s pool of experts. “Ema is aware of cases of myocarditis”, ie inflammation of the heart muscle, “and pericarditis”, inflammation of the membrane around the heart, “mainly reported following vaccination with Comirnaty *”, Pfizer’s vaccine, it reads in the report. “At the moment – the agency points out – there are no indications that these cases are due to the vaccine”. However, the Prac asked the company to “provide further detailed data, including an analysis of events based on age and gender, in the context of the next safety report. And it will consider whether any other regulatory action is necessary”. Additionally, EMA’s panel of experts asked Moderna for its mRna vaccine to “monitor similar cases with their” product. And “to also provide a detailed analysis of the events in the context of the next security report”. Ema assured that it will communicate further on this front when new information becomes available. The Pharmacovigilance Committee of the European Medicines Agency Ema, “after reviewing all available evidence, including cases reported to the European database of suspected side effects ( EudraVigilance) and scientific literature data “, also believes that there is” at least a reasonable possibility of causal association between the Comirnaty * vaccine, Pfizer’s anti-Covid, “and reported cases of facial swelling in people with a history of dermal filler injections “. The panel of experts then concluded that” facial swelling in people with a history of dermal filler injections should be included as a side effect in section 4.8 of the Summary of Product Characteristics (SmPC) and section 4 of the patient information leaflet (GDP). The risk-benefit ratio of the vaccine remains unchanged “, the EU regulatory body is keen to specify.