On July 27, the Massachusetts-based biotechnology company, Moderna Inc. announced the commencement of the Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19. Phase 3 clinical trial of investigational vaccine for COVID-19 begins, National Institutes of Health (Jul. 27, 2020), www.nih.gov/news-events/news-releases/phase-3-clinical-trial-investigational-vaccine-covid-19-begins. With Moderna as the regulatory sponsor and provider of the investigational vaccine for the trial, the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services’ (HHS) are providing funding for the trial. Id.

This trial is the first of the vaccine efficacy trials to be implemented under “Operation Warp Speed,” which is a collaboration of multiple agencies led by HHS with the goal of fast-tracking the development, manufacturing and distribution of biologics, drugs, and devices for COVID-19. Id. There are approximately 30,000 adult volunteers expected to be enrolled in the study at U.S. clinical research sites. Id. As of Sept. 8, 2020, the World Health Organization reports that there are 34 candidate vaccines in clinical evaluation and 145 candidate vaccines in preclinical evaluation. Draft landscape of COVID-19 candidate vaccines, World Health Organization (Sep. 8, 2020), www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines.