On Mar. 16, 2020, Moderna announced that the first participant had been dosed in the Phase 1 study of the Company’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2). This Phase 1 study was conducted by the National Institutes of Health (NIH) under its own Investigational New Drug (IND) application.

mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH. Manufacture of the first clinical batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

The Phase 1 study evaluated the safety and immunogenicity of three dose levels of mRNA-1273 (25, 100, 250 μg) administered on a two-dose vaccination schedule, given 28 days apart. A total of 45 healthy adults were enrolled in the study. Participants were followed through 12 months after the second vaccination. The primary objective was to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective was to evaluate the immunogenicity to the SARS-CoV-2 S protein.