A top FDA official threatened to resign if the agency green-lights an unproven coronavirus vaccine

By Yelena Dzhanova

A high-level official within the Food and Drug Administration threatened to resign if the agency green-lights an unproven coronavirus vaccine.

In a statement to Reuters, Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, said he "would feel obligated" to step down from his role if the agency approves a dubious vaccine.

"In doing so," Marks said, "I would indicate to the American public that there's something wrong."

In his role, Marks oversees a team of experts who are responsible for identifying potential coronavirus treatments, the Washington Post reported. Historically, FDA officials like Marks have the final say on medical items issued out to the public. If this trend holds, Marks will be the determining figure on when a vaccine will be released, according to the Post. 

The FDA did not immediately respond to Business Insider's request for comment.

There is mounting pressure to secure a vaccine for the coronavirus, as the number of confirmed cases continues to climb worldwide. More than 5.5 million people have contracted the virus in the United States, according to the latest data compiled by Johns Hopkins University. Of that sum, more than 174,000 Americans have died from it.

Moderna vaccine
Scientist Xinhua Yan works in the lab at Moderna in Cambridge, MA on Feb. 28, 2020.
David L. Ryan/The Boston Globe/Getty Images

President Donald Trump has been urging health officials to work faster to approve a vaccine and said it was possible that one would be available before the November 3 election. Most health experts say it's unlikely that a vaccine could be proven safe that soon.

Trump's eagerness to put out a vaccine comes as lawmakers remain critical of him for his response to the coronavirus pandemic.

Perhaps more importantly, voters who will take to the polls in November to determine whether he gets re-elected have also indicated they're not satisfied with the way he's handled the pandemic. Only 35% of voters said they approved of his response in a July Quinnipiac University poll. That figure is compared with the overwhelming 62% who said they didn't. 

Adding on to the pressure, Russia in July announced the release of what President Vladimir Putin has called the first coronavirus vaccine in the world. 

But the pressure isn't enough to drive officials to put out a vaccine just yet. 

"You have to decide where your red line is, and that's my red line," Marks said in the statement, adding that he "could not stand by and see something that was unsafe or ineffective that was being put through."

Still, scientists and health officials have concerns that the quickly approaching November election will only encourage Trump to double down on the pressure, Reuters reported. The federal government is testing possible treatments, but a vaccine is not likely to be approved before the election, health officials have said. 

The government hopes to release a proven vaccine by January 2021, Reuters reported, citing Michael Caputo, assistant secretary for public affairs at the Department of Health and Human Services.