A Covid-19 vaccine will go into production while researchers are still studying if it works, under an ambitious plan by NIH’s Anthony S. Fauci to get a vaccine across the finish line in record time.
The proposal to start ramping up production while the candidate is still in a clinical trial is a risky step for a manufacturer, which would have to start assembling raw materials to make a vaccine without knowing whether it would work.
But the plan would make sure a vaccine is ready for patients if Covid-19, the disease caused by the new coronavirus, comes back next year, Fauci, the director of the National Institute of Allergy and Infectious Disease in the National Institutes of Health, said Thursday at a White House press conference.
The vaccine candidate, which is being developed by scientists at Fauci’s institute, entered into a phase I clinical trial earlier this month, which means it’s being introduced into the human body for the first time to a small group of patients. It’s the larger phase II trials that demonstrate whether the potential vaccine is safe and works well enough to warrant Food and Drug Administration approval.
“When I go into phase II, I want to find somebody that’s going to make it,” Fauci said. “Because once you know it works, you can’t say, ‘Great it works. Now give me another six months to produce it.’ So we’re working with a variety of companies to take that risk.”
Both the federal government and those companies would assume the risk of producing a vaccine that might not go anywhere, Fauci said. “A lot of companies are not shy now about doing that,” he said,
When asking companies to take on that risk, “You’ve got to give some back up to them,” he added. “And we’ve done that. We’ve put hundreds of millions of dollars into companies that try and make vaccines. I wouldn’t hesitate to do that for a moment now.”
Manufacturing a vaccine still in a clinical trial could also help push it onto the market where other vaccine candidates never made it, such as those for the Zika and SARS viruses.
“That has been a stumbling block for previous development of vaccines,” Fauci said. “We have a nice Zika vaccine, but we don’t have enough to do it because there’s no Zika around—same with SARS. So that’s one of the things we’re really going to push on is to be able to have it ready if in fact it works.”