Reports that the Moderna COVID-19 vaccine is causing heat problems in teens are being reviewed by the Food and Drug Administration, the company said on Sunday.
In June, the company requested authorization from the FDA to use its vaccine in children ages 12 to 17.
The application is still being processed by the FDA, leading to speculations about why it has been delayed.
Moderna said in a statement Sunday that the FDA “requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination.”
Several European countries have paused the use of the vaccine in people 30 and younger due to the concerns of myocarditis after it was approved in Europe for use in adolescents in July, the New York Times reported.
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Moderna cited current numbers, 1.5 million adolescents worldwide, saying that data from the vaccine does not suggest an increased risk of myocarditis.
On Friday, Moderna was notified by the FDA that it would need more time to look into the vaccine’s safety, and a decision may not come until January 2022, the company said.
In comparison, the Pfizer vaccine only took one month to be approved by the FDA for children ages 12-15.
The FDA asked Moderna in July to enroll more children in its clinical trials so that it could detect less-common side effects. As of now, the Pfizer vaccine is the only COVID-19 vaccine available for kids ages 5 to 18.
