Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccin

Moderna Inc. , a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the first adolescent participants have been dosed in the Phase 2/3 study of mRNA-1273, the Company’s 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 U.S. Department of Health and Human Services.
"We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy adolescents in the U.S. 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 3 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 randomized, controlled Phase 2/3 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 U.S. ages 12 to 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. Vaccine effectiveness will either be inferred through achieving a correlate of protection (if established) or through immunobridging to the adult population. Evaluation of vaccine safety and reactogenicity is also a primary endpoint of the study. The ClinicalTrials.gov identifier is NCT04649151.