Moderna (MRNA) Announces FDA Requires Additional Time to Decide on Emergency Use Authorization of COVID-19 Vaccine for Adolescents

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Go back to Moderna (MRNA) Announces FDA Requires Additional Time to Decide on Emergency Use Authorization of COVID-19 Vaccine for Adolescents

Moderna Provides Update on Timing of U.S. Emergency Use Authorization of its COVID-19 Vaccine for Adolescents

October 31, 2021 10:00 AM EDT

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today provided an update that the U.S. Food and Drug Administration (FDA) has notified the Company that it will require additional time to complete its assessment of Modernas Emergency Use Authorization (EUA) request for the use of the Moderna COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of age.

On Friday evening, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses... More