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In the study, which enrolled 3700 US participants ages 12 to less than 18 years, no cases of COVID-19 were found in participants who had received two doses of the Moderna COVID-19 vaccine.
Moderna announced on May 25, 2021 that its Phase II/III study of mRNA-1273, its COVID-19 vaccine, in adolescents has met its primary endpoints.
In the study, which enrolled 3700 US participants ages 12 to less than 18 years, no cases of COVID-19 were found in participants who had received two doses of the Moderna COVID-19 vaccine, Moderna said in a company press release. A vaccine efficacy of 93% in seronegative participants was observed 14 days after the first dose using the secondary Centers for Disease Control and Prevention case definition of COVID-19, which tested for milder disease.
Moderna plans to submit its findings to regulators globally in June 2021.
“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” said Stéphane Bancel, CEO of Moderna, in the press release. “We will submit these results to the US FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”