NIH announces start of phase 3 trial for COVID-19 vaccine
The NIH announced the start of a phase 3 clinical trial of the first investigational COVID-19 vaccine given to people in the United States.
The vaccine, mRNA-1273, will be studied at 89 clinical research sites in the U.S. in a trial that will involve around 30,000 adult COVID-19-negative volunteers.
The vaccine was developed by the NIH and Moderna, Inc. Researchers began studying it in March. Phase 1 results published this month showed that the vaccine induced anti-SARS-CoV-2 immune responses among participant.
“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” NIH Director Francis S. Collins, MD, PhD, said in a press release. “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.”
During the trial, study volunteers will receive two injections 28 days apart of either 100 µg of mRNA-1273 or a saline placebo. The researchers’ primary goals are to determine the safety of the vaccine and evaluate if it can prevent symptomatic COVID-19 after two doses, according to the release. Other objectives include determining if it can prevent severe COVID-19 or lab-confirmed SARS-CoV-2 infection with or without symptoms; and if it can prevent COVID-19-related death.
“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,” National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, said in the release. “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.”