The U.S. Food and Drug Administration will need more time before it rules on an Emergency Use Authorization for administering the Moderna’s vaccine shot to children ages 12 to 17, Moderna said in a press release Sunday.
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.
An increased risk of myocarditis has been described for COVID-19 vaccines, including the Moderna COVID-19 vaccine, particularly in young men and following the second dose. The U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have stated that myocarditis following vaccination with mRNA vaccines has been rare and generally mild.
Over 1.5 million adolescents have received the Moderna COVID-19 vaccine. To date, the observed rate of myocarditis reports in those less than 18 years of age in Moderna’s global safety database does not suggest an increased risk of myocarditis in this population, the statement said.
“Moderna is committed to conducting its own careful review of new external analyses as they become available,” the statement said.
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