If successful, the trial could produce a vaccine that would be available by early 2021.
There is some good news in the fight against the coronavirus. Drugmaker Moderna announced on July 14 that its stage one coronavirus vaccine, mRNA-1273, produced antibodies in all participants of the trial. In the study, 45 volunteers were given three doses in varying levels, 28 days apart, and blood samples were taken after each dose. A larger third phase trial of 30,000 people is expected to begin on July 27. The study is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in Bethesda, Maryland.
Study participants were healthy and ranged in age from 18 to 45. Each person was given three doses in 28-day intervals of 25, 100, and 250 micrograms. No major adverse reactions occurred in any of the volunteers, with more than 30 percent experiencing mild symptoms, including:
- Muscle pain or aches
- Injection site pain
The most severe side effects occurred after the 250 mcg dose. The vaccine produced antibodies in all the volunteers as well as an active T-cell response. Moderna will continue to take blood samples from the phase one volunteers for a year.
Photo by Retha Ferguson from Pexels
The third phase of the trial will add older adults over age 55. Volunteers will not be given doses larger than 100 mcg, and the study will be conducted over two years. Moderna is giving the vaccine a 60 percent efficacy target, and the U.S. Food and Drug Administration (FDA) won’t approve a vaccine for use unless it is 50 percent effective.
Moderna says it can produce 500 million to 1 billion doses per year starting in 2021. The study is currently recruiting volunteers for phase three in the United States. If you are interested in being a part of a coronavirus study, go to coronaviruspreventionnetwork.org.