The Cambridge, Mass.-based biotech company said in a news release that it finalized the Phase 3 study protocol for the mRNA-1273 COVID-19 vaccine candidate based on feedback from the FDA. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 enrolled U.S. participants in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Moderna’s trial will have a primary endpoint of the prevention of the symptomatic COVID-19 disease, with key secondary endpoints including prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2, the virus causing COVID-19.
Primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19, with 100 μg chosen as the optimal dose level, based on results from the Phase 1 study.
Moderna said it completed the manufacturing of the vaccine in preparation for Phase 3 and is on track to deliver approximately 500 million doses per year and possibly up to 1 billion per year, beginning in 2021 through its internal U.S. manufacturing site and strategic collaboration with Lonza.
“We look forward to beginning our Phase 3 study of mRNA-1273 with some 30,000 participants in July,” Moderna chief medical officer Dr. Tal Zaks said in the news release. “Moderna is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease.”
Moderna has already fully enrolled the first cohort of healthy adults between ages 18-53 in the Phase 2 study, 13 days after the first participant was dosed. Sentinel participants in the 55-and-over cohort are fully enrolled as well. The Phase 2 study is evaluating the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
The Phase 1 study, which included eight patients receiving two doses at the beginning of March, is still ongoing with the original cohorts in long-term follow-up but reported positive results last month.
Funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Dept. of Health and Human Services (HHS), helped to support planning for the Phase 2 and Phase 3 studies, as well as the manufacturing process to scale up production of the vaccine candidate.
Having priced a $1.3 billion public offering on the back of the positive results from Phase 1, Moderna’s stock continues to rise with today’s news, trading up 6.9% at $64.24 per share in the early morning.