FDA Delays Moderna Vax For Adolescents–Cites Side Effect
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The FDA announced it is delaying its decision on the Moderna vaccine being used on adolescents.
The reason they cited is myocarditis, a heart condition that has become a side effect in some from this vaccine.
The U.S. Food and Drug Administration announced Friday it would delay its decision on administration of the Moderna vaccine to adolescents, citing concerns the shot may lead to a heightened risk of a rare heart condition.
The FDA has not yet determined if the risk is higher for adolescents, but the agency is planning to review the data further before extending the vaccine’s eligibility, according to the Wall Street Journal.
“I think people can be reassured that the risk of myocarditis with an mRNA vaccine is low, it appears to be balanced between the different products,” Paul Burton, Moderna’s chief medical officer, told the outlet.
Myocarditis is the inflammation of the heart muscle, with symptoms including chest pain, shortness of breath, and feelings of having an abnormal heartbeat. The inflammation typically occurs a few days after the second COVID-19 vaccine injection, according to the Centers for Disease Control and Prevention .
Finland, Sweden, and Denmark have all done the same.
Finland on Thursday paused the use of Moderna’s (MRNA.O) COVID-19 vaccine for younger males due to reports of a rare cardiovascular side effect, joining Sweden and Denmark in limiting its use.
Mika Salminen, director of the Finnish health institute, said Finland would instead give Pfizer’s vaccine to men born in 1991 and later. Finland offers shots to people aged 12 and over.
“A Nordic study involving Finland, Sweden, Norway and Denmark found that men under the age of 30 who received Moderna Spikevax had a slightly higher risk than others of developing myocarditis,” he said.
Swedish and Danish health officials had announced on Wednesday they would pause the use of the Moderna vaccine for all young adults and children, citing the same unpublished study.