Moderna doses first participants in Phase II/III COVID-19 vaccine in adolescents

Moderna has announced that the first adolescent participants have been dosed in the Phase II/ III study of mRNA-1273, its vaccine candidate against COVID-19, in adolescents ages 12 to less than 18. The study is being conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

“We are pleased to begin this Phase II/III study of mRNA-1273 in healthy adolescents in the US. 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,” said Stéphane Bancel, Chief Executive Officer of Moderna.

“We are encouraged by the interim and primary analyses of the Phase III COVE study in adults ages 18 and above and this adolescent study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population. We hope we will be able to provide a safe vaccine to provide protection to adolescents so they can return to school in a normal setting.”

This randomised, controlled Phase II/III study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The company intends to enroll 3,000 adolescent participants in the US aged from age 12 and less than 18 years. Each participant will be assigned to receive a placebo or a 100 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.

Image credit: Ethan Johnson

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