The biotech firm Moderna announced today that preliminary results of its potential vaccine for COVID-19 show a 94.5% effective rate.
In early results for its Phase 3 placebo-controlled human clinical trial, 30,000 volunteers were involved. Half received two doses of Moderna’s m-RNA (Messenger RNA) vaccine, and half received a placebo. An independent review board, appointed by the National Institutes of Health, reviewed the results and found that 95 of the volunteers had contracted COVID-19. Only 5 were in the group that received the actual vaccine, and 90 had received the placebo.
Further review found that 11 of the cases were severe, and all were in the placebo group.
The study also confirmed earlier findings that the vaccine appears safe.
The study includes more than 7,000 Americans over the age of 65. It also includes more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease. These medically high-risk groups represent 42% of the total participants in the Phase 3 study. The study also included communities that have historically been under-represented in clinical research and have been disproportionately impacted by COVID-19. The study includes more than 11,000 participants from communities of color, representing 37% of the study population, which is similar to the diversity of the U.S. at large. This includes more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African American.
Moderna says it plans to apply for Emergency Use Authorization (EUS) from the FDA as soon as 151 volunteers contract COVID-19. It also plans to apply for authorization to use the vaccine from other global health agencies.
Health experts caution that these results are preliminary and more study is needed.
This follows an announcement by Pfizer on Nov. 9 that its potential vaccine also showed positive results (90% effective) and was safe.
One difference between the Pfizer vaccine, which requires ultra-cold storage at minus 94 degree Fahrenheit, and the Moderna vaccine: the Moderna vaccine only requires refrigeration at normal refrigerator temperatures, not the ultra-cold storage.
For the Moderna press release, click here.
