An increased risk of heart diseases was observed after Covid-19 mRNA vaccination and was highest in men aged 18–25 years after a second dose of the vaccine, a study funded by American health regulator US FDA found.
However, the incidence was “rare”.
According to the study published in peer-reviewed medical journal The Lancet, an increased risk of myocarditis or pericarditis was noted after mRNA vaccination.
Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart.
“These results do not indicate a statistically significant risk difference between mRNA-1273 (Moderna vaccine) and BNT162b2 (Pfizer BioNTech vaccine), but it should not be ruled out that a difference might exist,” said the study published in Volume June 11.
Several passive surveillance systems reported increased risks of myocarditis or pericarditis, or both, after Covid-19 mRNA vaccination, especially in young men.
The study used active surveillance from large healthcare databases to quantify and enable the direct comparison of the risk of myocarditis or pericarditis, or both, after Moderna and Pfizer–BioNTech vaccinations.
However, the study results, along with the benefit-risk profile, continue to support inoculation using either of the two mRNA vaccines.
A total of 411 myocarditis or pericarditis, or both, events were observed among 15 million people aged 18–64 years.
Among men aged 18–25 years, the pooled incidence rate was highest after the second dose, at 1·71 per lakh person-days for Pfizer and 2·17 per lakh person-days for Moderna.
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