The Food and Drug Administration (FDA) is needlessly dragging its feet on reviewing candidates for a coronavirus vaccine, Fox News medical contributor Dr. Marty Makary told Bill Hemmer Reports on Monday.
“The country has taken huge sacrifices,” Makary told host Bill Hemmer. “We are waiting for this vaccine that saves lives, and the FDA has obtained the [Pfizer] application on November 22 and that of Moderna today. Why are they waiting three weeks? Why are they planning a review for December 10?
“The review board doesn’t interview subjects and volunteers, they don’t look at cells or the virus under a microscope, they just read a piece of paper with the numbers,” Makary added. “We have an Internet now. They can get those numbers in real time. ”
Massachusetts-based Moderna announced earlier Monday that it would seek emergency use clearance from the FDA after its vaccine candidate was found to be 94.1% effective against COVID-19 in trials on the man.
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The FDA has scheduled a December 10 meeting of its Vaccines and Related Biologics Advisory Committee to discuss Pfizer’s application for Emergency Use Authorization (EUA) of its vaccine candidate. It was not immediately clear whether Moderna’s request would be considered in the same meeting or in a separate meeting.
“The FDA has been too bureaucratic, taking too much time,” Makary accused. “And I don’t know if they plan for vacation times and review tee times, but they should be running the app within 24 hours. ”
Makary added that while the Trump administration oversaw “Operation Warp Speed” to develop a vaccine, the FDA engaged in “Operation Turtle Speed”.
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“The reason is, quite simply, Bill, is that the FDA was designed to be slow,” he told Hemmer. “The army was designed to react quickly. The FDA was designed to take its good old days and review things in the name of safety and independence.
“Well if you talk to the people over there they clearly [political] the appointees … It’s the career staff over there that completely siled anyone else and are having their good old days. ”