FDA says the benefits of the Moderna vaccine outweigh the risks after Nordic countries restrict use

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

The FDA responded after health officials in Finland said Thursday that men under the age of 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 had announced that it would stop using Moderna’s vaccine for those under 30, while Denmark suspended use for those under 18 and Norway recommended that people receive the Pfizer vaccine.

“The FDA is aware of this data. Currently, the FDA continues to determine 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The Nordic countries based their decision on an unpublished study that was due to be reviewed by the Committee on Side Effects of the European Medicines Agency. The Swedish health authority said the study found “an increased risk of side effects such as inflammation of the heart muscle or pericardium”, although the risk is “very small”.

The Moderna COVID-19 vaccine and other versions have been shown to be safe and highly effective against the risk of hospitalization or death due to the 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 dose of the Moderna COVID-19 vaccine into a man during a mass vaccination campaign at Maria Simmons Elementary School in Vieques, Puerto Rico. (AP Photo / Carlos Giusti, File)

“These are usually mild cases and people tend to recover within a short period of time after standard treatment and rest. The risk of myocarditis is significantly increased for those who contract COVID-19, and vaccination is the best way to protect yourself from it, “the company said in a statement.

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The FDA granted full approval for Pfizer’s COVID-19 vaccine in August. The application for full approval of Moderna is still pending.

The Associated Press contributed to this report.

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