This marks the first American company to advance to Phase 3 of clinical testing.
The investigational vaccine in question (mRNA-1273) is developed by Modern Inc., a biotechnological company based in Cambridge, Massachusetts, along with the National Institute of Allergy and Infectious Diseases (NIAID).
The clinical testing for phase three of this vaccine is going to take place in clinical research sites in the United States, and approximately 30,000 individuals who do not have COVID-19 have signed up as adult volunteers for the trial.
According to the news release, these trial volunteers will be separated into two groups, and be issued either the vaccine or the controlled placebo. Two separate shots of either 100 micrograms of the vaccine or the placebo solution will be given to the volunteers, but they will be issued 28 days apart from each other. Moreover, this trial will be a blind one, where both the volunteers and the researchers will not know which one is given to whom.
Anthony S. Fauci, the NIAID director, indicated in the NIH news release that mRNA-1273 had gone through the previous stage, and through those earlier-stage tests, the vaccine was deemed safe and immunogenic, allowing the vaccine to move on to phase three testing.
“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,” Fauci said, the news release indicated.
According to Francis S. Collins, the NIH Director, being able to develop a working vaccine against COVID and be able to distribute it to the public by the end of 2020 might be a far-away goal, but it’s something that the American people need to strive towards.
“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,” Collins said.
“Thanks to President Trump’s leadership and the hard work of American scientists, the investigational vaccine developed by NIH and Moderna has reached this Phase 3 trial at record pace,” Alex Azar, the United States Department of Health and Human Services secretary said.