Modern vaccine, with second dose risks for the heart: the Ema hypothesis

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The second dose of Covid’s vaccine Moderna could increase the risk of side effects of myocarditis or pericarditis. This was announced by the European Drug Authority, Ema, on the basis of “preliminary analyzes” of new data reported by some countries such as Sweden and Denmark, regarding possible adverse events following vaccination with mRna products. Adnkronos reports it.

Modern vaccine, with second dose risks for the heart: preliminary data

Although the institution specifies the need for further evaluations, the information collected in the study “indicates the possibility that the risk of myocarditis in younger men may be greater after a second dose of Spikevax”, Moderna’s vaccine, “compared to a second dose of Pfizer / BioNTech’s Comirnaty.

In light of the data in their possession, Sweden and Denmark announced the precautionary suspension of the administration of the Spikevax vaccine, respectively in the under 30 and under 18 populations.The risk of suffering from these side effects is very low“, The Swedish Public Health Agency has in fact recorded“ an increase in reports of side effects such as myocarditis and pericarditis ”.

Modern vaccine, with second dose risks for the heart: possible updates

“The PRAC will evaluate the new data to determine if it is necessary update current recommendations in product information“, The EMA said, which recalled how already in July 2021 the two inflammatory heart conditions were included in the package leaflet of the two vaccines against Covid-19” together with a warning to raise awareness among health professionals and people who receive these vaccines. Health workers have also received a communication ”.

Now the EMA points out the preliminary analyzes on the latest data received, in addition to confirming a risk for the male population in a lower age group, they also suggest “the possibility that the risk of myocarditis in younger men may be greater after a second dose of Spikevax compared to a second dose of Comirnaty, although further evaluation of the data is needed.

However, the agency goes back to specifying that “authorized Covid-19 vaccines are effective in reducing the risk of Covid-19“, As well as” hospital admissions and deaths due to Covid-19. As with all vaccines, EMA will continue to evaluate emerging data on these products to ensure that their benefits continue to outweigh their risks ”.



Virgil News | 06-10-2021 22:23



Photo source: ANSA

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