Moderna seeks FDA authorization for use of its vaccine in adolescents


(WPRI) — Moderna announced Thursday they have requested emergency use authorization for its COVID-19 vaccine in adolescents ages 12 to 17 with the U.S. Food and Drug Administration.

Moderna’s vaccine is currently only authorized for those ages 18 years and older.

Last month, Moderna released results of a trial with nearly 2,500 kids, showing it was 100% effective, making it the second shot to demonstrate high efficacy in younger age groups.

No significant safety concerns showed up. Like some adults who have taken Moderna, some adolescents experienced headaches, fatigue and chills.

The company has already filed for authorization with Health Canada and the European Medicines Agency, according to Chief Executive Officer Stéphane Bancel, and plans to file with regulatory agencies around the world for this important younger age population.

Pfizer already received authorization for people as young as age 12 to use its vaccine on May 10.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.


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