Health-U.S. health says approval of COVID vaccines unlikely before November

Any potential COVID-19 vaccine backed by the Trump administration’s “Operation Warp Speed” program is unlikely to receive a green light from regulators any earlier than November or December, given the time needed for a large-scale clinical trial, the National Institutes of Health director said on Thursday.

In a call with reporters, Francis Collins said he thinks 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. late-stage vaccine trials launched so far 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.”

He added that he is confident that at least one of the six vaccines funded by the initiative will be shown to be safe and effective by the end of the year.

The U.S. government has helped finance the development of several vaccines and therapies through the program aimed at accelerating access to medicines to fight COVID-19.