It’s a critical stage without a set timeline, as companies look for 30,000 healthy volunteers to participate in each test and then need to reach specific markers to determine how and if it effectively fights the disease. Experts warned that it could take months to complete, with no guarantee that a vaccine will work. According to the Food and Drug Administration guidelines issued in June, a vaccine will have to be at least 50 percent effective to get approved.
But while the Trump administration has insisted it is not going to cut through security, a vote that vaccine developers also took, has left the door open to short-circuiting the process before those trials are completed. FDA guidelines indicate that the administration could issue emergency authorizations as soon as it is convinced that a vaccine is safe and effective, authorizing it to distribute it to the public.
In a statement, White House spokesman Judd Deere stressed that any vaccine “must be thoroughly tested to ensure it is safe and effective,” calling it Trump’s highest priority. But it also promoted the administration’s engineering of the “fastest test launch”, and did not address a question about whether the White House had any concerns about the distribution of a vaccine before it is officially approved.
The result could be a major milestone in the pandemic’s trajectory, days before an election that turned into a referendum on Trump’s management of the spiraling crisis. It could also launch the weapon in the scientific process, undermining public confidence in any eventual vaccines and increasing the risk that the initial round of shots won’t work, or worse, will lead to unpredictable side effects.
“That is the concern, not because Trump may raise his survey scores by a couple of percent, but that we could make a catastrophic mistake,” said John Moore, professor of microbiology and immunology at Weill Cornell Medical College. “Anything in October will be politicized. And the last thing this pandemic needs is more politicization. “
Maintaining a focus on science, not politics, could be especially critical to a coronavirus vaccine, amid a search effort that drew intense public interest and progressed at world record speed. The fastest scientists have developed a new vaccine to date is four years; If successful, a viable coronavirus injection can be found in less than one.
It is a tribute to the unprecedented number of companies and resources dedicated to the subject, vaccine experts said. But they were also concerned that the pace threatened to increase public skepticism of an eventual vaccine, a challenge the administration has already contributed to by spending months promising a breakthrough in winter.
“I think the government was right to do Warp Speed, it just wants to be called differently,” said Offit, warning that the emphasis on producing a vaccine quickly runs the risk of questioning its scientific rationale.
Offit, a member of the National Institutes of Health vaccine group who recently met with Warp Speed officer and Army Lt. Gen. Paul Ostrowski, also described the government as treating Warp Speed as a “weapon secret “and choosing to protect much of its activities from the public
