Moderna says FDA needs more time to assess its COVID-19 vaccine for kids 12 and up
(Gray News) – Moderna said Sunday that the U.S. Food and Drug Administration needs more time to assess whether kids ages 12 to 17 can take its COVID-19 vaccine.
Moderna has asked the FDA to grant emergency use authorization (EUA) for its vaccine for the 12-17 age group, but the agency may not finish its review of that request until January 2022, according to a news release from the company.
The FDA needs more time to evaluate “recent international analyses of the risk of myocarditis after vaccination.”
Myocarditis is described by the CDC as an inflammation of the heart muscle.
Moderna said in the release:
“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.
It is estimated that 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. Moderna is committed to conducting its own careful review of new external analyses as they become available. The Company does not yet have access to data from some recent international analyses.”
The Moderna vaccine is currently cleared for use in the U.S. for those who are 18 and older.
The company said it will delay filing an EUA request for kids ages 6-11 while the FDA completes its review of the EUA request for the 12-17 age group.
The FDA has already approved the emergency use of Pfizer’s COVID-19 vaccine for children as young as 5.
Copyright 2021 Gray Media Group, Inc. All rights reserved.