Marty Makary, a professor at the Johns Hopkins University School of Medicine and Johns Hopkins Bloomberg School of Public Health, observes that Britain approved a Covid-19 vaccine faster than the U.S. did: "FDA insiders say the agency and its approximately 17,000 employees were dark for the four-day Thanksgiving holiday, including those working on the vaccine approval. It's time the FDA adopts a sense of urgency. We've had Operation Warp Speed in developing vaccines but Operation Turtle Speed in reviewing the results."
He also notes how the timing related to the election: "The FDA career staff also delayed the vaccine by adding an unprecedented requirement to slow down Phase III trials. Four weeks before the Nov. 3 presidential election, the FDA increased the median follow-up period requirement for vaccine patients, ensuring that it would be impossible for the vaccine to be approved before the election. The move was a departure from a decades-old standard operating procedure at the agency and the process used to authorize convalescent plasma just months ago."
