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Johns Hopkins Doctor Rip FDA in Slow COVID Vaccine Review

Professor Johns Hopkins accused the Food and Drug Administration of lacking the urgency of green-lighting the coronavirus vaccine, suggesting that the bureaucratic process of the authorities is at the expense of life.

“There was Operation Warpspeed in the development of the vaccine, but Operation Turtlespeed in the review of the results,” wrote Dr. Martimakari of Johns Hopkins University School of Medicine and Johns Hopkins Bloomberg School of Public Health in conservative news. I am. Outlet dispatch.

He said Pfizer submitted data on vaccine safety and efficacy on November 20, but the FDA is planning an emergency approval application review meeting on December 10, almost three weeks later. It was. The FDA is awaiting approval, killing about 27,000 Americans. “

The second company, Moderna, filed an application for urgent approval of the vaccine on Monday.

The pace of the process has been faster as the White House has questioned the speed of the approval process on Tuesday.

Citing his own experience of conducting more than 100 clinical studies and reviewing thousands, Makary said the agency was able to review the data “without cutting corners” in 24-48 hours.

“They need to work harder,” he wrote, saying the agency isn’t checking patients or looking under a microscope. “About an hour when my research team, typically tasked with analyzing data from millions of patients, was asked to review a small Pfizer vaccine study of 43,000 patients. takes.”

McCulley said the FDA needs to use “rolling reviews” to evaluate data as it becomes available in real time, as the European Medicines Agency does, to speed up the process. I did. He added that the bureaucratic view of delaying approval was first seen at the beginning of the COVID-19 crisis and is the ice age pace of FDA test approval. In October, the decision to require more follow-up data for vaccine trials than other drugs was reflected.

“Pfizer’s vaccine is currently approved for use in the United Kingdom. Americans have the right to ask why the American vaccine was approved by the British but not by the Americans.” He wrote. “People who sympathize with the FDA’s career staff suggest that Britain was careless about promptly approving the vaccine, but the truth is how the US government bureaucracy took the time. Was it wasted? “

Johns Hopkins Doctor Rip FDA in Slow COVID Vaccine Review

Source link Johns Hopkins Doctor Rip FDA in Slow COVID Vaccine Review

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