Tags: Coronavirus | Trump Administration | fda | covid | vaccine | operation warp speed

Top FDA Official: Pressure to Approve Coronavirus Vaccine Is 'My Red Line'

a vaccination needle is set against covid cells
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By    |   Friday, 21 August 2020 04:13 PM

An official at the Food and Drug Administration (FDA) has vowed to resign if the agency approves an unsafe and ineffective coronavirus vaccine, according to Reuters.

Peter Marks, who runs the FDA’s Center for Biologics Evaluation and Research, said the Trump administration hasn't pushed him to rush a vaccine across the finish line to approval. He said, however, any pressure to hastily approve a vaccine would be his “red line,” to push him to quit.

“I could not stand by and see something that was unsafe or ineffective that was being put through,” Marks said.

“You have to decide where your red line is, and that’s my red line,” he said. “I would feel obligated [to resign] because in doing so, I would indicate to the American public that there’s something wrong.”

Michael Caputo, assistant secretary for public affairs at the Department of Health and Human Services, didn't buy the framing of Mark's response, saying speculation about political meddling in the FDA approval system “only undermines confidence in the public health system.”

“I’ve never met one FDA regulator who wouldn’t resign over improper pressure, and that’s how America knows their seal of approval is the gold standard,” Caputo said. He said the FDA is targeting January as a soft deadline to come up with a viable vaccine candidate.

Various large-scale trials for coronavirus vaccines have begun recently, with the United States pouring billions of dollars into an effort called Operation Warp Speed.

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US
An official at the Food and Drug Administration has vowed to resign if the agency approves an unsafe and ineffective coronavirus vaccine, according to Reuters.
fda, covid, vaccine, operation warp speed
243
2020-13-21
Friday, 21 August 2020 04:13 PM
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