The first Phase 3 clinical trial for the coronavirus vaccine started in the United States on July 27. Moderna, a pharmaceutical company, is working with the National Institute of Allergy and Infectious Diseases (NIAID) to develop the vaccine.
30,000 adult volunteers are expected in the trial, which is to be presented at 100 research sites across the United States. Volunteers receive either a vaccine or a placebo injected at two points 28 days apart. Phase 3 includes testing the vaccine for efficacy and safety, after Phase 2 that includes people with characteristics that need the drugs and Phase 1 studies a smaller cohort of people. Each Phase follows a successful previous phase.
Results from Phase 1 indicated an immune response in volunteers and was generally safe. There are currently 25 other clinical trials underway around the world.
“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate SARS-CoV-2 spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic,” said NIAID Director Anthony S. Fauci, M.D. “Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a Phase 3 clinical trial. This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last.”
“The launch of this Phase 3 trial in record time while maintaining the most stringent safety measures demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity toward a common goal,” said National Institutes of Health Director Francis S. Collins, M.D., Ph.D.
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