CAMBRIDGE, MASS. (WHDH) - Cambridge-based Moderna announced Thursday that it has requested an emergency use authorization for its COVID-19 vaccine in adolescents with the United States Food and Drug Administration.
“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.”
The biotechnology company’s Phase 2/3 TeenCOVE study showed no cases of COVID-19 observed in participants, ages 12 to 17 years old, who received two doses of its vaccine, according to Moderna.
The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100 percent, Moderna added.
The Pfizer COVID-19 vaccine is currently available for people ages 12 and older.
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