Moderna introduced on Thursday that it had requested the FDA grant emergency use authorization for its COVID-19 vaccine in adolescents. At present, the two-dose vaccine is permitted to be used within the U.S. for these 18 years and older.
“We’re happy to announce that we’ve got submitted for an emergency use authorization for our COVID-19 vaccine with the FDA to be used in adolescents in the USA,” Stéphane Bancel, Chief Government Officer of Moderna, stated in a press release. “We’re inspired that the Moderna COVID-19 vaccine was extremely efficient at stopping COVID-19 and SARS-CoV-2 an infection in adolescents. We’ve already filed for authorization with Well being Canada and the European Medicines Company and we’ll file with regulatory businesses around the globe for this necessary youthful age inhabitants. We stay dedicated to serving to to finish the COVID-19 pandemic.”
The request follows promising knowledge from a Part 2 /3 TeenCOVE examine involving 3,732 teenagers ages 12 to 18 that discovered the vaccine produced immune responses much like these noticed in adults. Moreover, Moderna stated that no circumstances of COVID-19 have been noticed in contributors who had obtained two doses of the jab.
If authorization is granted, it could mark the second COVID-19 vaccine made accessible to youthful teenagers. Pfizer-BioNTech obtained expanded authorization to be used in adolescents ages 12 and older in Might.
Earlier this month, Moderna had introduced that it had begun the method of in search of full FDA approval for its vaccine in adults ages 18 and older.