The drug maker Moderna, working with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has started its Phase 3 trial of a potential vaccine for the novel coronavirus which causes COVID-19. The trial also includes the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.
The trial will include around 30,000 adult volunteers, half of whom will get two doses of the vaccine, and half of whom will get a placebo. The trial will help further determine whether the potential vaccine is safe and whether it actually works.
According to Moderna, it is using a new technology in developing this new vaccine, using Messenger RNA. According to Moderna, “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. Our approach is to use mRNA medicines to instruct a patient’s own cells to produce proteins that could prevent, treat, or cure disease.”
On July 14, the New England Journal of Medicine published results of Moderna’s Phase I trial, which tested different dosages of its potential vaccine in three groups of health volunteers ages 18 to 55. The participants received two doses of the vaccine, and the doses were determined in that small trial of three groups of 15, to be both safe and to produce an immune response. This trial is being done in conjunction with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Click here for a previous story about these results.
Moderna says it should be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021, if the vaccine proves to be successful. In the press release, the company gave no timetable for having final results.
The Moderna/NIH/BARDA effort is one of several vaccines showing promise. Click here for a previous story about COVID-19 vaccine development.