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FDA delays decision on EUA for Moderna shot in kids 12-17

FDA delays decision on EUA for Moderna shot in kids 12-17

According to Moderna, the FDA may not make its decision until January 2022.

WASHINGTON — It may be a few months yet until children will be eligible to receive Moderna’s COVID-19 vaccine. According to a press release from the company Sunday, the U.S. Food and Drug Administration will need more time before it rules on an Emergency Use Authorization for administering the shot to children ages 12 to 17. 

According to Moderna, the FDA says it’s using that extra time to further analyze results from studies on the risks of myocarditis after vaccination. Myocarditis is a type of heart inflammation. The FDA says its analysis may push its decision on whether to authorize an Emergency Use Authorization back to January 2022.

Concerns about this potential link arose in the spring and summer. According to the Centers for Disease Control and Prevention, hundreds of instances of heart inflammation have been reported after a person had received an mRNA vaccine (Moderna and Pfizer-BioNTech’s being the two FDA-approved mRNA vaccines). That risk was found to be higher in young men and adolescents. Despite this, both the CDC and the World Health Organization say that these cases are both rare and mild.

“The safety of vaccine recipients is of paramount importance to Moderna,” the company’s press release stated. “The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence.”

Because of this delay, Moderna says it will hold off submitting its request for an EUA for its vaccine in children 6-11. 

Currently, the Pfizer vaccine is the only option in the U.S. for people under the age of 18. The FDA issued an EUA for the shot for kids five and over on Oct. 29. A CDC advisory panel is meeting on Tuesday Nov. 2 to discuss whether to recommend the shot to that age group.

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