Moderna Inc, a biotech company currently developing a COVID-19 vaccine, announced today they have finalized their Phase III study protocol expecting to begin human trials by this July.
The company announced only a couple weeks ago, their mRNA-1273 vaccine for COVID-19 had entered Phase II testing. This announcement means the company has finalized their protocol in conjuction with the FDA. Back in mid May, the company received the "Fast Track" designation from the FDA according to a press release.
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)
Moderna describes the goal of their vaccine as "prevention of symptomatic COVID-19 disease" while more severe cases requiring hospitalization and the prevention of initial infection will be a secondary endpoint. The company expects to deliver 500M to 1B doses per year beginning in 2021.
Moderna's plan is 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 placebo, a 50 μg or a 100 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination."
Yesterday, Johnson & Johnson announced they too would pull in their Phase III human trials timeline into this July.