Moderna Inc. (NASDAQ: MRNA) has reported its first adolescent participants have been dosed in the Phase 2/3 study of mRNA-1273, the company’s vaccine candidate to treat coronavirus in adolescents from ages 12 to under 18. The study is in collaboration with the Biomedical Advanced Research and Development Authority part of the Office of the Assistant Secretary for Preparedness and Response at the United States 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.”
The Phase 2/3 study will evaluate safety, immunogenicity and reactogenicity of two vaccinations of mRNA-1273 given 28 days apart. The company plans to enroll 3,000 participants in the United States, ages from 12 to under 18 years old. Each participant shall assign to receive a placebo at both vaccinations.