According to The New York Times, two people briefed on a meeting between Trump administration officials and congressional leaders said the officials indicated “they would probably give emergency approval to a coronavirus vaccine before the end of Phase 3 clinical trials in the United States, perhaps as early as late September.”
- The Times noted that such a “move would be highly unusual and would most likely prompt concerns about whether the administration is cutting corners on approvals for political purposes.”
- Those who attended the two-hour meeting on July 30 include Treasury Secretary Steven Mnuchin; the White House chief of staff, Mark Meadows; House Speaker Nancy Pelosi; and Senate Minority Leader Chuck Schumer.
- The newspaper’s two sources said “Mr. Meadows indicated that a vaccine being developed by AstraZeneca and Oxford University was the most likely candidate.”
The AstraZeneca-Oxford team is now conducting Phase 2 and Phase 3 trials in Britain, Brazil and South Africa. Researchers have said they expect results by September, at the earliest. Along with a number of other pharmaceutical companies, AstraZeneca has also begun large-scale trials in the United States, although it began enrolling volunteers only a few days ago.
- According to The Times, the Food and Drug Administration generally requires clinical trials involving American patients prior to greenlighting a vaccine for use in the U.S.
- A willingness to grant approval prior to that indicates “that the White House is significantly more sanguine than its own scientific experts about the prospects for a speedy vaccine against a virus that has killed 176,000 Americans,” The Times reported.
In an Aug. 13 briefing with reporters, Francis Collins, the director of the National Institutes of Health, said it “would be astounding” if vaccine development progressed fast enough for the Food and Drug Administration to approve one by the end of next month. “Maybe November, December would be my best bet,” he said.
Dr. Anthony S. Fauci, the infectious disease expert who serves on the coronavirus task force, has said early next year is the most likely timing.
- The Times reported that senior administration officials disputed the two people’s characterization of Meadow and Mnuchin’s statements, saying they “were either being misrepresented or had been misunderstood on every major point.”