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Professor Johns Hopkins Marty makary criticized the Food and Drug Administration on Friday for extending the approval process for a Covid-19 vaccine, calling it “Operation Turtle Speed.”
“FDA regulators are wasting precious time giving the green light to a COVID vaccine as more than 2,000 Americans die every day and the pandemic continues to starve American society,” Makary wrote in a Friday editorial for The dispatch.
The FDA is due to meet on December 10 to review a vaccine developed by Pfizer, following the company’s request for approval on November 22. It comes after the vaccine was approved in the UK on Wednesday through emergency clearance. Dr. Anthony Fauci, The public face of the federal government’s efforts to counter the virus appeared to criticize this approval in an interview with UK Sky News this week, telling the outlet the country had moved “very quickly” and in a “shallower way” “.
However, he later went back to the comments saying: ‘There really was a misunderstanding’ and adding: ‘I have great confidence in both the scientific community and the regulatory community in the UK. “.
Makary said his team could complete FDA review procedures in a matter of hours.
“Contrary to popular belief, the FDA process is impractical – it doesn’t interview patients in vaccine trials or look under a microscope at immune cells,” Makary wrote. “He does a statistical analysis and looks at the data. For the vaccine trial, the data set is small and simple. If my research team, normally tasked with analyzing data from millions of patients, were to review the smallest Pfizer vaccine study involving 43,000 patients, it would take about an hour. “
“During a health emergency, the FDA should convene a single one-day meeting immediately when data is submitted, in the same way that American companies hold emergency board meetings in a crisis.” , he added. “The FDA has a moral and civil obligation to review the data with a sense of urgency. It’s not too late – the FDA could call an emergency meeting today. “
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