“The EMA concluded that there is a small risk of myocarditis and pericarditis after vaccination with Comirnaty (BioNTech-Pfizer) and Spikevax (Moderna). Product information will be updated to include myocarditis and pericarditis as very rare side effects of these vaccines “.
This was reported by the head of vaccine strategy of the European Medicines Agency (Ema).
The analysis conducted by the EMA Safety Committee also revealed that cases of myocarditis and pericarditis occurred within 14 days of vaccination, more frequently after the second dose and in young men. Of all the cases examined, there were five deaths, but they still involved people of advanced age or suffering from other diseases.
The available data also suggest that the course of myocarditis and pericarditis after vaccination is similar to the typical course of these conditions and that it generally improves with rest or therapy.
At the moment, according to the EMA, there is no causal relationship between myocarditis and pericarditis relating to the Janssen and Vaxzevria vaccines and the Committee has asked the two manufacturers for further data.
In general, the EMA confirms that “the benefits of all authorized anti-Covid-19 vaccines continue to outweigh the risks” and that “scientific data indicate that they reduce deaths and hospitalizations for Covid-19”.
(Unioneonline / vl)
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