U.S. government scientists have begun efforts to manufacture a strain of the novel coronavirus that could be used in human challenge trials of vaccines, a controversial type of study in which healthy volunteers would be vaccinated and then intentionally infected with the virus, Reuters has learned.
“Should there be a need for human challenge studies to fully assess candidate vaccines or therapeutics for SARS-CoV-2, NIAID has begun investigations of the technical and ethical considerations of conducting human challenge studies,” the agency statement said.
Such trials are typically done when a virus is not widely circulating, which is not the case with COVID-19. Many scientists consider human challenge trials of the novel coronavirus unethical because there are no “rescue therapies” for those who fall ill. Dr. Anna Durbin, a vaccine researcher at the Johns Hopkins Bloomberg School of Public Health, who has run a dozen challenge studies, estimates it could take nine to 12 months to set up a human challenge trial, and another six months to coordinate testing across multiple testing sites.
“In the setting of a pandemic that is raging, you don’t need it. You just do a trial and get a real result,” he said.
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