Dr. Marty Makary blasts FDA timetable to approve coronavirus vaccine: 'Why are they waiting three weeks?'
FDA staff have 'completely walled off' political appointees and are 'taking their good old time,' Fox News medical contributor says
{{#rendered}} {{/rendered}}The Food and Drug Administration (FDA) is unnecessarily dragging its feet on reviewing candidates for a coronavirus vaccine, Fox News medical contributor Dr. Marty Makary told "Bill Hemmer Reports" Monday.
"The country has taken tremendous sacrifices," Makary told host Bill Hemmer. "We are waiting for this lifesaving vaccine, and the FDA got the [Pfizer] 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."
{{#rendered}} {{/rendered}}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.
WHEN WILL MODERNA'S CORONAVIRUS VACCINE BE READY TO SHIP?
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.
{{#rendered}} {{/rendered}}"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 hours."
Makary added that while the Trump administration has overseen "Operation Warp Speed" to develop a vaccine, the FDA has been engaged in "Operation Turtle Speed."
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{{#rendered}} {{/rendered}}"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.
"Well, if you talk to people there, they've clearly walled off any of the [political] appointees ... It's the career staff there that have completely walled off anyone else and they're taking their good old time."