Moderna announced on Thursday that it had requested the FDA grant emergency use authorization for its COVID-19 vaccine in adolescents. Currently, the two-dose vaccine is authorized for use in the U.S. for those 18 years and older.
"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," Stéphane Bancel, Chief Executive Officer of Moderna, said in a statement. "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."
The request follows promising data from a Phase 2 /3 TeenCOVE study involving 3,732 teens ages 12 to 18 that found the vaccine produced immune responses similar to those observed in adults. Additionally, Moderna said that no cases of COVID-19 were observed in participants who had received two doses of the jab.
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If authorization is granted, it would mark the second COVID-19 vaccine made available to younger teens. Pfizer-BioNTech received expanded authorization for use in adolescents ages 12 and older in May.
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Earlier this month, Moderna had announced that it had begun the process of seeking full FDA approval for its vaccine in adults ages 18 and older.