A Johns Hopkins professor lambasted the Food and Drug Administration for lacking urgency in greenlighting a coronavirus vaccine, suggesting that the agency’s bureaucratic process is costing lives.

“We’ve had Operation Warp Speed in developing vaccines but Operation Turtle Speed in reviewing the results,” Dr. Marty Makary, a professor at the Johns Hopkins University School of Medicine and Johns Hopkins Bloomberg School of Public Health, wrote in the conservative news outlet The Dispatch.

He noted that Pfizer submitted its data on the safety and effectiveness of its vaccine on Nov. 20 but the FDA scheduled its review meeting for its emergency approval application almost three weeks later, Dec. 10. “As Pfizer’s application sits on the shelf at the FDA awaiting authorization, about 27,000 Americans will have died.”

A second company, Moderna, submitted its application for emergency approval for its vaccine on Monday.

The pace of the process has come up before, with the White House questioning the speed of the approval process on Tuesday.

Makary, who cited his own experience conducting more than 100 clinical studies and reviewing thousands more, said the agency could have reviewed the data in 24 to 48 hours “without cutting any corners.”

“They just need to work harder,” he wrote, noting that the agency isn’t checking patients or looking under microscopes. “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.”

Makary said the FDA should use “rolling reviews” that evaluate data as it becomes available in real time, as the European Medications Agency does, to speed up the process. The bureaucratic mentality that is slowing down the approval was first seen at the beginning of the COVID-19 crisis, he added, with the FDA’s glacial pace for approving tests. It was echoed with a decision in October to require more follow-up data for the vaccine trials than they do for other drugs.

“Pfizer’s vaccine is now approved for use in the UK. Americans have a right to ask why an American vaccine has been approved by the British but not by Americans,” he wrote. “Some sympathetic to the FDA career staff have suggested that the UK was careless in approving the vaccine quickly, but the real story is how the American government bureaucracy wasted time.”



Source link