It’s a critical stage with no fixed timeline, as the companies are seeking 30,000 healthy volunteers to participate in each trial and then need to hit specific markers for determining how and whether it effectively fights the disease. That could take months to complete, experts cautioned, without any guarantee a vaccine will pan out. Under Food and Drug Administration guidelines issued in June, a vaccine will need to be at least 50 percent effective to win approval.
But while the Trump administration has insisted that it won’t cut corners on safety — a vow the vaccine developers have taken as well — it’s left the door open to short-circuiting the process before those trials are complete. The FDA guidelines indicate the administration could issue emergency authorizations as soon as it’s convinced a vaccine is safe and effective, clearing it for distribution to the public.
In a statement, White House spokesperson Judd Deere stressed that any vaccine “must be thoroughly tested to ensure it is safe and effective,” calling it Trump’s highest priority. But he also touted the administration’s engineering of the “fastest-ever launch of a trial,” and did not address a question on whether the White House harbored any concerns about distributing a vaccine before it’s officially approved.
The result could be a major milestone in the pandemic’s trajectory, days before an election that’s evolved into a referendum on Trump’s management of the spiraling crisis. It could also jump the gun on the scientific process, undermining public confidence in any eventual vaccine and raising the risk that the initial round of shots won’t work — or worse, will lead to unpredictable side effects.
“That’s the concern, not that Trump might boost his poll ratings by a couple percent but that we could make a catastrophic mistake,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. “Anything in October is going to be politicized. And the last thing this pandemic needs is more politicization.”
Keeping a focus on science, not politics, could be especially critical for a coronavirus vaccine, amid a search effort that’s drawn intense public interest and progressed at world-record speed. The fastest that scientists have developed a new vaccine to date is four years; if successful, a viable coronavirus shot could be found in less than one.
It’s a tribute to the unprecedented amount of companies and resources dedicated to the issue, vaccine experts said. But they also worried that the pace threatens to raise public skepticism of an eventual vaccine — a challenge that the administration has already contributed to by spending months promising a breakthrough by winter.
“I think the government was right to do Warp Speed — I just wish they called it something else,” Offit said, warning that the emphasis on producing a vaccine quickly risks casting doubt on its scientific underpinnings.
Offit — a member of a National Institutes of https://bt-hypnotise.com/ vaccine group that met recently with Warp Speed official and Army Lt. Gen. Paul Ostrowski — also described the government as treating Warp Speed like a “secret weapon,” and opting to shield much of its activities from the public.