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Up to Him

The fate of any US approval of a SARS-CoV-2 vaccine is in the hands of Peter Marks, a career official at the Food and Drug Administration, the Washington Post reports.

Marks, a hematologist and medical oncologist, heads up the Center for Biologics Evaluation and Research at FDA. The Post notes that, traditionally, career officials at the agency, rather than political appointees, make the final call on medical products. That means, it says, he "is sitting on the hottest of hot seats."

Scientists have been concerned about potential political influence on the vaccine approval process as there has been a push to have a vaccine by year's end, and the Post adds that President Trump has gone after officials whose advice he finds unhelpful. 

However, FDA Commission Stephen Hahn has said the agency will not allow a vaccine to be released unless it is safe, it says. 

Additionally, Marks tells the Post that it is his responsibility to ensure the process isn't hurried. "Let's be realistic," he adds. "There are so many eyes on this vaccine that if somebody decided to go around the process, I think there would be red flags that would be put up by a variety of sources. So I think it's going to be critical that we work through the process."