Dr. Francis Collins, Director of United States’ National Institutes of Health has opined that any potential COVID-19 vaccine backed by America’s “Operation Warp Speed” program is unlikely to receive a green light from regulators before November or December.
Dr. Collins thinks that testing a vaccine in at least 10,000 people could potentially give enough evidence of safety and efficacy to clear it for wider use. U.S’s current vaccine trials aim to recruit up to 30,000 people.
“I would not expect to see, on the basis of what we know scientifically, that we would be at the point where the FDA could make such a judgment until considerably later than October 1st,” Collins said, referring to the U.S. Food and Drug Administration. “Maybe November or December would be my best bet.”
Dr. Collins remained confident that at least one of the six vaccines funded by “Warp Speed” will come out as safe and effective solutions by the end of the year.
Earlier, American President Donald Trump was upbeat about having a coronavirus vaccine before the Nov. 3 election, a more optimistic forecast on timing than anything suggested by his own White House health experts.
Dr. Collins suggested that the first tens of millions of doses of vaccine produced in the United States will be allocated to those most in need, such as patients at higher risk of complications or front line healthcare workers.
The U.S. government has helped finance the development of several vaccines and therapies through the initiative called “Operation Warp Speed” aimed at accelerating access to medicines to fight COVID-19.
U.S. public health officials last month charged a group of independent scientists and ethicists with developing guidelines to determine who should get the first doses of a vaccine, once one becomes available.
