FDA Requires More Time To Assess Moderna's COVID-19 Vaccine For Adolescents

(RTTNews) - Moderna Inc. (MRNA) said Sunday it was notified that the U.S. Food and Drug Administration will require additional time to complete its assessment of the company's emergency use authorization request for the use of its COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of age.

According to Moderna, the FDA informed the company on Friday evening that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination. The review may not be completed before January 2022.

The company said it is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence.

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.

Moderna noted that 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.

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.