A study funded by the US health regulator US FDA found that an increased risk of cardiovascular diseases was observed after COVID-19 mRNA vaccination and was highest among men aged 18-25 years after the second dose of the vaccine.
However, the occurrence was “rare”.
according to study Published in the peer-reviewed medical journal The Lancet, an increased risk of myocarditis or pericarditis was noted following mRNA vaccination.
Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer layer of the heart.
“These results do not indicate a statistically significant risk difference between mRNA-1273 (Modern Vaccine) and BNT162b2 (Pfizer BioNTech Vaccine), but should not be ruled out,” the study, published in Volume 11, said.
Several passive surveillance systems reported an increased risk of myocarditis or pericarditis, or both, following COVID-19 mRNA vaccination, particularly in young men.
The study used active surveillance from large health care databases to measure and enable a direct comparison of the risk of myocarditis or pericarditis, or both, following Moderna and Pfizer-BioNTech vaccination.
However, study results, along with a benefit-risk profile, continue to support vaccination using either mRNA vaccines,
A total of 411 myocarditis or pericarditis, or both, events were observed in 15 million people aged 18–64 years.
Among men aged 18–25 years, the combined incidence rate was highest after the second dose, 1 71 per million person-days for Pfizer and 2 17 per million person-days for Moderna.