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Moderna Inc said on Thursday it had dosed the first participants in a mid-to-late stage study testing its COVID-19 vaccine candidate in adolescents aged 12 to less than 18, and aims for data ahead of the 2021 school year. The trial will enroll 3,000 healthy participants in the United States and will assess the safety and effectiveness of two doses of the company’s vaccine candidate, mRNA-1273, given 28 days apart. (12/10)

Moderna has dosed the first adolescents in a phase 2/3 clinical trial designed to position its COVID-19 vaccine for use in children as young as 12 years old before the start of the 2021-22 school year. Having shown mRNA vaccine mRNA-1273 is safe and effective in adults, Moderna is now running a 3,000-subject trial in adolescents. Moderna is aiming to deliver data in adolescents in the spring of 2021, setting it up to get an expanded label in time for a vaccination campaign ahead of the next school year. (Taylor, 12/11)

"Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year," Moderna CEO Stéphane Bancel said. Bancel said the primary results from phase three studies in adults are encouraging and will "help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population." (Lardieri, 12/10)