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

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Sweden’s Public Health Agency notes ‘an increased risk of side effects such as inflammation of the heart muscle’

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

Health officials in Finland said Thursday that the FDA responded that men under the age of 30 should not receive the Moderna vaccine because of a slightly higher risk of developing myocarditis, an inflammation of the heart. A day earlier, Sweden said it would halt the use of Moderna’s vaccine for people under the age of 30, while Denmark halted use for those under 18 and Norway allowed people to receive the Pfizer vaccine. recommended to do.

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

The Nordic countries based their decision on an unpublished study to be reviewed by the Adverse Reactions Committee of the European Medicines Agency.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 the pericardium”, though noted that the risk was “very small”.

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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 the administration of mRNA vaccines against COVID-19.”

“These are usually mild cases and individuals 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 prevents it. the best way,” 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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