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 side effect related to the heart.
The FDA responded after health officials in Finland said Thursday that men under the age of 30 should not get the Moderna vaccine because of a slightly increased risk of developing myocarditis, an inflammation of the heart. A day earlier, Sweden said it would discontinue use of the Moderna vaccine for people under 30, while Denmark paused use for people under 18 and Norway recommended that people receive the Pfizer vaccine.
“The FDA is aware of this data. At this time, the FDA continues to find that the known and potential benefits of vaccination outweigh the known and potential risks of Modern COVID-19 vaccine,” an FDA official said in a release.
The Nordic countries based their decision on an unpublished study that will be reviewed by the adverse reactions committee of the European Medicines Agency. Sweden’s public health agency said the study found “an increased risk of side effects such as inflammation of the heart muscle or pericardium,” although it noted that the risk was “very small.”
The Modern COVID-19 vaccine and other versions have been found to be safe and highly effective against the risk of hospitalization or death from coronavirus. Moderna said she was “aware of the very rare occurrence of myocarditis and / or pericarditis following the administration of mRNA vaccines against COVID-19.”
“These are typically mild cases and people tend to recover in a short time after standard treatment and rest. The risk of myocarditis increases substantially for those who contract COVID-19, and vaccination is the best way to protect against this,” he said the company. it said in a statement.
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The FDA granted full approval for Pfizer’s COVID-19 vaccine in August. Moderna’s request for full approval is still pending.
Associated Press contributed to this report.