The U.S. Food and Drug Administration (FDA) has indicated that the agency needs additional time to complete its assessment of Moderna’s emergency use authorization (EUA) request for the use of the company’s COVID-19 vaccine (mRNA-1273) at the 100-µg dose level in adolescents 12-17 years of age, Moderna said in a news release.
Specifically, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses on the risk of myocarditis after vaccination, and that this review may not be completed before 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.
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, the company said.
Moderna said it will delay filing a request for EUA of mRNA-1273 at the 50-µg dose level in the pediatric population (6-11 years of age) while the FDA completes its review of the adolescent EUA request.
