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Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 in the U.S.
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has requested an emergency use authorization (EUA) for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration (FDA).
“We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents. We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic.”
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