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

The U.S. Food and Drug Administration reiterated its stance that the benefits of Moderna’s COVID-19 vaccine outweigh its risks on Friday after several Nordic countries began restricting its use for certain age groups due to concerns about a rare heart-related side effect.

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The Nordic countries based their decision on an unpublished study set to be reviewed by the European Medicines Agency’s adverse reaction committee.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.”

“These are typically mild cases and individuals tend to recover within a short time following standard treatment and rest. The risk of myocarditis is substantially increased for those who contract COVID-19, and vaccination is the best way to protect against this,” the company said in a statement.The FDA granted full approval for Pfizer’s COVID-19 vaccine in August. Moderna’s application for full approval is still pending.

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