Drug makers have begun studies of the long-term impact of their mRNA COVID-19 vaccines to determine if there is a link between the vaccines and myocarditis.
The Food and Drug Administration had required Pfizer and BioNTech to conduct the studies when it approved the companies’ drug for use in August 2021.
The letter called for one study to be completed by 2024, and a longer five-year study to be completed by 2026.
A similar letter to Moderna in January called for one study to be completed by 2023 and the longer-term study by 2028.
Moderna has begun two trials, according to NBC News. Pfizer, the outlet reported, will be starting its trials soon. NBC said early results could be released early next year.
Myocarditis is an inflammation of the heart muscle. Pericarditis is an inflammation of the heart’s outer lining, according to the Centers for Disease Control and Prevention.
Claims of a link between the COVID vaccines and heart issues have been hotly debated, but some research suggests that it is not impossible.
CDC Admits Post-Vaccine Myocarditis Concerns That Were Labeled Covid Misinformation Are Legithttps://t.co/T3Yjm1tFy9
— The Federalist (@FDRLST) September 9, 2022
A study by Canadian researchers in the Journal of the American College of Cardiology found that there is an elevated risk of heart issues within three weeks of the second dose of the vaccine.
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“Some rare, but serious, side effects have been observed after both [the Moderna and Pfizer] vaccines, mainly myocarditis,” according to a news release from the American College of Cardiology.
Researchers found that the incidence of myocarditis within 21 days of the second dose was 35.6 cases per million. In 2018, the incidence of myocarditis in the general population was around two per million.
A study published by the Annals of Internal Medicine also noted a connection, although it said the risk is low.
“We found that myocarditis/pericarditis 0 to 7 days after mRNA vaccination in persons aged 5 to 39 years occurred in approximately 1 in 200 000 doses after the first dose and 1 in 30 000 doses after second dose of the primary series, and 1 in 50 000 doses after the first booster,” the study said.
Both studies noted that young men were at the highest risk of developing myocarditis after receiving the vaccine.
