(Armradio)- A vaccine against COVID-19 developed by US biotech firm Moderna will enter the third and final stage of its clinical trial in July with 30,000 participants, the manufacturer has announced.
Moderna, co-founded and chaired by Noubar Afeyan said it already has made enough doses for the pivotal late-stage testing.
The trial’s primary endpoint will be the prevention of symptomatic COVID-19 disease; key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2, the virus that causes COVID-19.
The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. Based on the results of the Phase 1 study, the 100 μg dose level was chosen as the optimal dose level to maximize the immune response while minimizing adverse reactions.
With the Phase 3 dose being finalized at 100 μg, the Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company’s 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,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “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.”