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US FDA Tags Moderna COVID-19 Vaccine With Higher Myocarditis Risk Than Pfizer/BioNTech

 
• By Sue Sutter

In expanding authorization of booster doses for both mRNA vaccines, the agency updated Moderna’s fact sheet to state the vaccine appears to pose a higher risk of myocarditis/pericarditis in males under age 40 years after the second dose, although data are ‘not yet dispositive.’

Risk increase
The FDA updated Moderna's COVID-19 vaccine fact sheet to reflect an increased myocarditis risk relative to other mRNA vaccines. • Source: Alamy

Lost amid the fanfare of the US Food and Drug Administration’s recent decision to broadly authorize COVID-19 mRNA vaccine boosters for everyone 18 years and older was a quiet, but still notable, change in language on the myocarditis risk with Moderna, Inc.’s vaccine.

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