Dr. Noubar Afeyan, co-founder and chairman of Moderna Therapeutics, said the biotech firm hopes to have Covid-19 vaccine authorization by the FDA by the end of 2020 or early 2021.
Moderna is one of the top contenders in the global race to develop a vaccine to curtail the spread of the novel coronavirus.
“The plan is to start enrolling this morning, and this will continue over the next couple of months. We have a very strong demand of folks who volunteered to participate,” Afeyan told ABC News’ chief anchor George Stephanopoulos Monday on “Good Morning America.”
The blind trial is expected to include 30,000 volunteers. Half of the volunteers will receive Moderna’s vaccine and the other half will receive a placebo of sodium and water.
The authorization of Moderna’s vaccine by the Food and Drug Administration will depend on how quickly some 150 cases of the infection occur, according to Afeyan.
He said 150 cases of infection “need to occur … to statistically be able to compare the placebo … and declare whether the vaccine” provides adequate protection.
“The trial will essentially reach its goals once we hit 150 cases,” he noted.
If successful, the group receiving the vaccine should have a disproportionately lower portion of the cases than those who did not get the vaccine.
“We all want to have these answers. We have a certain number of cases that we need to see in the trial before we can demonstrate whether the vaccine arm [of the trial] gives us more protection than folks who are not in the vaccine part of the trial,” Afeyan said.
Afeyan added that Moderna hopes to have authorization by the FDA by the end of 2020 or early 2021. By 2021, Afeyan says the company expects to have between 500 million and 1 billion doses ready for distribution upon FDA authorization.
He added that he hopes Moderna will have additional clinical trial data available by the fall.
Moderna’s vaccine was among the first to begin testing in humans, with trials being conducted by the National Institutes of Health in collaboration with the National Institute of Allergy and Infectious Diseases. There are at least 25 vaccines that have advanced to human studies and another 141 that are being tested in a laboratory, according to the World Health Organization.