Moderna Advances Late-Stage Development of Its Vaccine (mRNA-1273) Against COVID-19; Phase 3 study of 30,000 subjects expected to begin in July 2020 at 100 μg Dose Level

On June 11, 2020, Moderna, Inc., (Nasdaq: MRNA) a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced progress on late-stage development of mRNA-1273, the Company’s mRNA vaccine candidate against COVID-19. Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants enrolled in the U.S., and is expected to be conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). 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. Moderna has completed manufacture of vaccine required to start the Phase 3 study. The Company 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 1 billion doses per year, beginning in 2021 from the company’s internal U.S. manufacturing site and strategic collaboration with Lonza.