Johns Hopkins professor Marty Makary slammed the Food and Drug Administration on Friday for prolonging the approval process for a Covid-19 vaccine, calling it “Operation Turtle Speed.”
“FDA regulators are wasting precious time in greenlighting a COVID vaccine as more than 2,000 Americans are dying each day and the pandemic continues to starve American society,” Makary wrote in a Friday op-ed for The Dispatch.
The FDA is scheduled to meet on Dec. 10 to review a vaccine developed by Pfizer, following the company’s Nov. 22 request for approval. That comes after the vaccine was approved in the United Kingdom on Wednesday through an emergency authorization. Dr. Anthony Fauci, the public face of the federal government’s efforts to counter the virus, appeared to criticize that approval in an interview with U.K.’s Sky News this week, telling the outlet the country had moved “very quickly” and in a way that was “less deep.”
However, he subsequently walked the comments back, saying, “There really has been a misunderstanding” and adding, “I do have great faith in both the scientific community and the regulatory community at the U.K.”
Makary said his team could successfully complete the FDA’s review procedures in a matter of hours.
“Contrary to popular belief, the FDA process is not hands-on — it does not interview vaccine trial patients or look under a microscope at the immune cells,” Makary wrote. “It’s doing a statistical analysis and looking at data. For the vaccine trial, the data set is small and straightforward. If my research team, normally tasked with analyzing data on millions of patients, was asked to review the smaller Pfizer vaccine study of 43,000 patients, it would take about one hour.”
“During a health emergency, the FDA should be convening a single, day-long meeting immediately when the data is submitted, in the same way American businesses have emergency board meetings when a crisis occurs,” 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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