But Sunday’s announcement came a day after he repeated his unfounded claim that the F.D.A. was deliberately holding up decision-making until after the election, this time citing a “deep state.” That accusation exacerbated concerns among some government scientists, outside experts and Democrats that the president’s political needs could undermine the integrity of the regulatory process, hurt public confidence in safety and introduce a different kind of public health risk.
No randomized trials of the sort researchers consider most robust have yet shown benefit from convalescent plasma. But the F.D.A. said the data it had so far, including more than a dozen published studies, showed that “it is reasonable to believe” that the treatment “may be effective in lessening the severity or shortening the length of Covid-19 illness in some hospitalized patients,” in particular those who receive it early.
White House officials have been urging speedy approval not just of Covid-19 treatments, but of vaccines. Their public statements that a safe and effective vaccine could be just around the corner have alarmed scientists who fear that White House pressure will result in premature approval timed to increase the president’s re-election chances.
In a July 30 meeting with Speaker Nancy Pelosi and Senator Chuck Schumer of New York, the Democratic minority leader, top administration officials suggested that emergency approval for a vaccine might be granted before Phase 3 trials in the United States are complete, perhaps as early as September, according to two people briefed on the discussion. Such a move would be highly unusual and most likely prompt more concern about whether the administration was pressuring the F.D.A. to approve drugs for political purposes.
Senior administration officials disputed the account of the meeting, saying Mark Meadows, the White House chief of staff, and Treasury Secretary Steven Mnuchin were either being misquoted or had been misunderstood on every major point.
In Russia, President Vladimir V. Putin announced this month that a billion doses of a vaccine for the new coronavirus would soon be rolled out, but Russian health officials have found themselves on the defensive because the vaccine has not been tested in late-stage, large, randomized control trials.
By skipping such trials, Russia is potentially endangering people to score propaganda points, health experts warn.
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