FDA says Moderna vaccine's benefits outweigh risks after Nordic countries limit use

The FDA responded after health officials in Finland said Thursday that males under age 30 should not receive the Moderna vaccine due to a slightly higher risk of developing myocarditis, an inflammation of the heart. A day earlier, Sweden said it would pause use of Moderna’s vaccine for people under 30, while Denmark paused use for people under 18 and Norway recommended people receive the Pfizer vaccine.

“The FDA is aware of these data. At this time, FDA continues to find that the known and potential benefits of vaccination outweigh the known and potential risks for the Moderna COVID-19 Vaccine,” an FDA official said in a statement.

The Nordic countries based their decision on an unpublished study set to be reviewed by the European Medicines Agency’s adverse reaction committee. Sweden’s public health agency said the study found “an increased risk of side effects such as inflammation of the heart muscle or the pericardium,” though it noted the risk was “very small.”

The Moderna COVID-19 vaccine and other versions have been found to be safe and highly effective against the risk of hospitalization or death due to coronavirus. Moderna said it was “aware of the very rare occurrence of myocarditis and/or pericarditis following administration of mRNA vaccines against COVID-19.”

FILE - In this March 10, 2021 file photo, a healthcare worker injects a man with a dose of the Moderna COVID-19 vaccine during a mass vaccination campaign, at the Maria Simmons elementary school in Vieques, Puerto Rico. (AP Photo/Carlos Giusti, File)

FILE – In this March 10, 2021 file photo, a healthcare worker injects a man with a dose of the Moderna COVID-19 vaccine during a mass vaccination campaign, at the Maria Simmons elementary school in Vieques, Puerto Rico. (AP Photo/Carlos Giusti, File)

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