In another sign of growing scrutiny over Covid-19 vaccines, the Food and Drug Administration has asked the two makers of mRNA vaccines to widen the age range of boys and young men that their labels say are at risk for a rare side effect causing heart inflammation.
The letters, first reported by CBS News, asked Moderna and partners Pfizer and BioNTech to make updates to safety information based on new studies of myocarditis or pericarditis or both after vaccination. Both reactions are rare and known to occur most often in young men within a week after the second shot in the two-dose Covid-19 vaccine regimen, according to the Centers for Disease Control and Prevention. Most cases were mild, causing no more than brief chest pain.
Safety information was added in 2021, when a CDC advisory panel concluded the benefits of protection against Covid-19 outweighed the risks. Moderna’s label now warns of risk in young men ages 18-24, while Pfizer says the same for young men ages 12-17. The FDA letters asked the companies to expand that range to age 16-25 and to cite a 2024 paper funded by the agency in their product information.
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