박사. 마티 마카 리, 코로나 바이러스 백신 승인을위한 FDA 일정 발표: ‘3 주를 기다리는 이유?’

박사. 마티 마카 리, 코로나 바이러스 백신 승인을위한 FDA 일정 발표: 'Why are they waiting three weeks?'

The Food and Drug Administration (FDA) is unnecessarily dragging its feet on reviewing candidates for a 코로나 바이러스 백신, Fox News 의료 기고자 Dr. Marty Makary toldBill Hemmer 보고서” 월요일.

The country has taken tremendous sacrifices,” Makary told host Bill Hemmer. “We are waiting for this lifesaving vaccine, and the FDA got the [화이자] application on Nov. 22 and the Moderna one today. Why are they waiting three weeks? Why are they scheduling a review for Dec. 10?

The review committee is not interviewing subjects and volunteers, they’re not looking under a microscope at the cells or the virus, they are simply reading 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 apply to the FDA for an emergency use authorization after its vaccine candidate was demonstrated to be 94.1% effective against COVID-19 in human trials.

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The FDA has scheduled a Dec. 10 meeting of its Vaccines and Related Biological Products Advisory Committee to discuss Pfizer’s request for emergency use authorization (EUA) of its vaccine candidate. It was not immediately clear whether Moderna’s request would be considered at the same meeting or a separate meeting.

The FDA has been too bureaucratic, taking too much time,” Makary charged. “And I don’t know if they’re scheduling around vacation times and tee times of the reviewers, but they should turn the application around in 24 시간.”

Makary added that while the Trump administration has overseenOperation Warp Speedto develop a vaccine, the FDA has been engaged inOperation Turtle Speed.

The reason is, very simply, Bill, is that the FDA was designed to be slow,” he explained to Hemmer. “The military was designed to respond quickly. The FDA was designed to take their good old time and review things in the name of safety and independence.

“잘, if you talk to people there, they’ve clearly walled off any of the [주재관] appointeesIt’s the career staff there that have completely walled off anyone else and they’re taking their good old time.

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