Moderna Announces Progress on Late-Stage Development of mRNA COVID-19 Vaccine Candidate

Moderna, Inc. (Cambridge, MA, USA) has announced progress on late-stage development of mRNA-1273, the company’s mRNA vaccine candidate against COVID-19.

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH). Following the completion of enrolment for the Phase 2 study for evaluating the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart, Moderna has now finalized the Phase 3 study protocol based on feedback from the US Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants enrolled in the US and conducted in collaboration with the NIAID. 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 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. Moderna has completed manufacture of vaccine required to start the Phase 3 study and expects dosing in the Phase 3 study to begin in July. With the Phase 3 dose being finalized at 100 μg, Moderna remains on track to be able to deliver approximately 500 million doses per year, and possibly up to one billion doses per year, beginning in 2021.

“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.”

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