The Trump administration is reportedly considering a plan that would bypass normal regulatory procedures to fast-track an experimental coronavirus vaccine developed in the United Kingdom so that it can be used in the United States ahead of the November presidential election, according to the Financial Times. One option that is reportedly under consideration involves issuing an emergency use authorization, like the one that was announced Sunday for plasma treatment, to a vaccine being developed by AstraZeneca and Oxford University. That authorization would be on the back of a small U.K. study that, even if successful, would fall far short of the normal requirements for the approval of a vaccine.
Top administration officials told congressional leaders last month they were likely to award emergency approval for a vaccine before the end of Phase 3 clinical trials in the United States. The New York Times also reported on this July 30 meeting in which Treasury Secretary Steven Mnuchin and the White House chief of staff, Mark Meadows reportedly revealed the plan to congressional leaders, including House Speaker Nancy Pelosi and Sen. Chuck Schumer. During the meeting, the administration officials said that the AstraZeneca vaccine that is being developed with Oxford University was the most likely candidate, according to the Times. Pelosi reportedly warned there should be "no cutting corners" in getting a vaccine approved, reports the FT. Administration officials disputed the accounts of what was said at the meeting with spokesmen for Meadows and Mnuchin both claiming neither of them discussed the prospects for the AstraZeneca vaccine.
On Saturday, Trump made a baseless accusation against the Food and Drug Administration, claiming in a tweet that the "deep state" was slowing the development of treatments and vaccines against the coronavirus in order to hurt his prospects in the November election. The tweet illustrated how the president is pressuring the government's scientific agencies for quick results that could show progress in the fight against the coronavirus. Meadows defended the tweet, which was roundly criticized by Democrats, saying that Trump wants agency officials to " feel the heat." In the Sunday news conference celebrating the emergency use authorization for plasma treatment, Trump suggested there could be news on the vaccine front very soon. "We're years ahead of approvals then we would be if we went by the speed levels of past administrations. We would be two years, three years behind," he said. "That includes vaccines that you'll be hearing about very soon."
A fast-track approval of a vaccine for the coronavirus would likely lead to resignations at the FDA. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research said Thursday that he has not faced political pressure but vowed to resign if that ever changed. "In doing so, I would indicate to the American public that there's something wrong," he told Reuters.
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