By Carl O’Donnell and Mrinalika Roy
(Reuters) – Any potential COVID-19 vaccine backed by the Trump administration’s “Operation Warp Speed” program is likely to receive a green light from regulators before November or December, given the time required for a large-scale clinical trial trial, the Director National Institutes of Health said on Thursday.
In an interview with reporters, Francis Collins said he thinks testing a vaccine in at least 10,000 people could potentially provide enough evidence of safety and efficacy to clear it for wider use. U.S. vaccines with late-phase vaccines that have been launched so far aim to recruit up to 30,000 people.
“I would not expect to see, based on what we know scientifically, that we would be at the point where the FDA could make such a judgment until significantly later than October 1,” Collins said, referring to the US Food and Drug Administration. Drug Management. “Maybe November or December would be my best bet.”
He added that he was confident that at least one of the six faxes funded by the initiative would be shown safely and effectively by the end of the year.
President Donald Trump said last week that it was possible that the United States would have a vaccine for coronavirus ahead of the November 3 election, a more optimistic forecast about timing than all suggested by his own White House experts.
Collins expects 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 than frontline health workers.
The U.S. government has helped fund the development of various vaccines and therapies through a program aimed at accessing drugs to combat COVID-19.
U.S. public health officials last month accused a group of independent scientists and ethicists of developing guidelines to determine who should receive the first doses of a vaccine, once available.
(Report by Carl O’Donnell in New York and Mrinalika Roy in Bengaluru; Edited by Leslie Adler and Dan Grebler)
