Earlier this week, we focused in on technologies around messenger RNA, or mRNA, as key players in the search for a coronavirus vaccine. More news on that front.
In Massachusetts, Moderna disclosed that the first participant has 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 is being conducted by the National Institutes of Health under its own Investigational New Drug application.
The Phase 1 study is evaluating 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 will be enrolled in the study. Participants will be followed through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein.
Messenger RNA, or mRNA, plays a fundamental role in human biology, transferring the instructions stored in DNA to make the proteins required in every living cell. Moderna’s approach is to use mRNA medicines to instruct a patient’s own cells to produce proteins that could prevent, treat, or cure disease.
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.
The Bottom Line
The fine print in this story speaks about months, even years of testing. No miracle vaccine for next week. Moderna’s timeline is here.