Moderna, 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 the 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 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. It 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 the manufacture of the 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, the company remains on track 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 US 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, 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 reduce the risk of Covid-19 disease significantly.”
The first cohort of healthy adults ages 18-54 years (n=300) in the Phase 2 study of mRNA-1273 is fully enrolled, 13 days after the first participant was dosed. The sentinel participants in the cohort of older adults ages 55 years and older (n=50) are fully enrolled. This Phase 2 study, conducted by Moderna, evaluates the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The company intends to enroll 600 healthy participants across two cohorts of adults ages 18-54 years (n=300) and older adults ages 55 years and above (n=300). Each participant will be assigned to receive a placebo, a 50 μg or a 100 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.
On May 6, the US Food and Drug Administration (FDA) completed its review of the Company’s Investigational New Drug (IND) application for mRNA-1273. On May 11, the FDA granted it Fast Track designation. On May 18, Moderna announced initial data from the Phase 1 study of mRNA-1273 led by NIAID. The Phase 1 study is ongoing with the original cohorts in long-term follow-up and enrollment in 9 of 12 cohorts complete. The NIH will be submitting the Phase 1 data to a peer-reviewed clinical publication.
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 US Department of Health and Human Services (HHS), partially supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273 and is supporting the execution of these studies, as well as the manufacturing process scale-up of mRNA-1273. Moderna will also fund costs required to complete the development of mRNA-1273, including portions of the Phase 3 study and the scale-up of manufacturing capacity at the final established dosage to obtain licensure for mRNA-1273.