FDA Says Benefits of Moderna Vaccine Outweigh Risks After Nordic Countries Limit Use

The United States Food and Drug Administration on Friday reiterated its position that the benefits of Moderna’s COVID-19 vaccine outweigh its risks after several Nordic countries began restricting its use for certain age groups in 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 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 suspend the use of Moderna’s vaccine for people under 30, while Denmark suspended use for people under 18 and Norway has 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 to the Moderna COVID-19 vaccine, ”an FDA official said in a statement.

The Nordic countries based their decision on an unpublished study which is due for review by the Adverse Reactions Committee of the European Medicines Agency. The Swedish 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 the risk was “very low” .

The Moderna COVID-19 vaccine and other versions have been shown to be safe and very 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 administration of COVID-19 mRNA vaccines.”

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

“These are usually mild cases and individuals tend to recover within a short 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 avoid it. ‘protect it,’ the company said. said in a statement.

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

The Associated Press contributed to this report.


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Richard V. Johnson

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