Moderna Submitted an IND for Its mRNA Vaccine Candidate for Novel Coronavirus
Moderna (MRNA) announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its mRNA vaccine candidate, mRNA-1273, against the novel coronavirus, SARS-CoV-2. The filing is for the evaluation in Phase 2 and for late-stage studies if supported by safety data from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID) which is part of the National Institutes of Health (NIH).
The firm’s press release stated that Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study which is expected to begin in the second quarter of 2020. The Phase 2 trial will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
Details from Moderna acknowledged that each subject will be assigned to receive placebo, a 50 μg or a 250 μg dose, at both vaccinations; Moderna intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years and older adults ages 55 years and above; the participants will be followed through 12 months after the second vaccination.