On May 29, 2020, Moderna, Inc., (Nasdaq: MRNA), a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the first participants in each age cohort have been dosed in the company’s Phase 2 study (https://clinicaltrials.gov/ct2/show/NCT04405076?term=NCT04405076&draw=2&rank=1) of its mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2) that causes COVID-19. This Phase 2 study, being conducted by Moderna under its own Investigational New Drug (IND) application, will evaluate 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 18-55 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. Given the 25 μg and 100 μg dose levels in the Phase 1 study showed neutralizing antibody titers at or above convalescent sera and were generally well tolerated, the company has decided not to pursue the 250 μg dose level in the Phase 2 study. On May 6, 2020, the U.S. Food and Drug Administration (FDA) completed its review of the Moderna’s IND application for mRNA-1273 and on May 12, 2020, the FDA granted this vacccine Fast Track designation. On May 18, 2020, Moderna announced (https://bioquicknews.com/node/5369) initial data from the Phase 1 study of mRNA-1273 led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The NIH will be submitting the Phase 1 data to a peer-reviewed clinical publication.
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