US National Institutes of Health (NIH) Director Francis Collins said regulatory approval for any potential COVID-19 vaccine included in the government’s Operation Warp Speed is unlikely to occur before November.
In an interview with reporters, Collins said even the most promising coronavirus vaccine candidates will not win approval any earlier than November or December, and added that testing a vaccine in at least 10,000 people could potentially provide enough data to support wide-scale distribution.
“I would not expect, on the basis of what we know scientifically, that we would be at the point where the US Food and Drug Administration could make such a judgment until considerably later than 1 October,” said Collins, adding: “Maybe November or December would be my best bet.”
The Trump administration-backed Operation Warp Speed initiative aims to deliver 300 million doses of a COVID-19 vaccine to the American public by January 2021.
A host of vaccine candidates have already been selected to receive funding, in a bid to advance development and bolster manufacturing capabilities for their respective COVID-19 candidates. This includes potential vaccines from Johnson & Johnson, AstraZeneca/Oxford University, Pfizer/BioNTech, GlaxoSmithKline/Sanofi, Moderna and Novavax.
In the same call with reporters, Collins said he is confident that at least one of the several candidates funded by Operation Warp Speed will be shown to be safe and effective by the end of the year.
Last week, President Donald Trump announced that it was possible a coronavirus vaccine would be available in the US before the start of the general election on 3 November. However, Collins dismissed concerns that Operation Warp Speed is advancing candidates too quickly without determining safety and efficacy first.
“I know there is some concern because of this warp speed label that maybe corners are being cut that shouldn’t be. I want to reassure you and everybody else that we will not allow that to happen,” he said.
Earlier this week, Russia announced that it had produced and approved the world’s first COVID-19 vaccine, Sputnik-V. However, health experts from across the globe have criticised the move, saying that the vaccine should not have been approved before large-scale phase 3 safety trials were completed.