Top FDA official says would resign if agency rubber-stamps an unproven COVID-19 vaccine--Reuters

(Reuters) - A top U.S. health regulator who will help decide the fate of a coronavirus vaccine has vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective, Reuters has learned.

Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, made the statement in response to concerns raised on a conference call late last week of government officials, pharmaceutical executives and academics who serve on a vaccine working group organized by the National Institutes of Health, according to three sources familiar with the matter.

When contacted by Reuters, Marks confirmed the account.

Scientists, public health officials and lawmakers are worried that the Trump administration will pressure the FDA to authorize a COVID-19 vaccine in advance of the November presidential election, even if data from clinical trials do not support its widespread use.

Marks told Reuters he has not faced any political pressure and that the FDA would be guided by science alone. Should that change, “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.”

He added that he would equally object if someone sought political gain by holding up approval of a vaccine that was shown to work, and that was safe. ...