Peter Marks—director of FDA's Center for Biologics Evaluation and Research (CBER), and likely the most important person at the agency when it comes to approving a coronavirus vaccine—last week said he'll resign if FDA approves a vaccine that's not supported by research.

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Who is Peter Marks?

According to the Washington Post, Marks started his career intending to become a research biochemist, but, while working part-time as a phlebotomist, he found that he enjoyed working with patients. Marks ended up going to medical school and also getting a PhD in cell and molecular biology.

Eventually, Marks landed at Brigham and Women's Hospital alongside Ned Sharpless, director of the National Cancer Institute and a former acting FDA commissioner. After leaving Brigham and Women's, Marks worked for Genzyme and Novartis before "return[ing] to academic medicine at" Yale University and becoming the CCO at the university's cancer hospital, the Post reports.

From there, Marks was hired by FDA in 2012 and, in 2016, he became director of CBER. During Marks' tenure at CBER, the center has approved several new treatments, including the first CAR T-cell therapy for advanced cancer and the first Ebola vaccine.

'The single most critical figure in the vaccine decision'

According to the Post, Marks in his current role is the highest-ranking career official involved in the approval of any potential vaccine candidate—and if historical precedent holds true, that means Marks, rather than a political appointee, ultimately will be tasked with recommending for or against FDA approval of any potential coronavirus vaccine. (That said, Stephen Hahn, as FDA's current commissioner, typically holds the authority to issue an emergency use authorization for a vaccine, Reuters reports, and the HHS secretary technically could overrule any decision issued by FDA.)

According to Jason Schwartz, an expert on vaccine decision-making at the Yale School of Public Health, Marks' position essentially makes him "the single most critical figure in the [coronavirus] vaccine decision."

In April, Marks proposed what ultimately became known as Operation Warp Speed, which is the Trump administration's initiative to fast-track a vaccine against the new coronavirus. According to the Post, Marks initially was part of the effort, participating as a vaccine expert. However, he ultimately returned to his FDA job. The Post reports that Marks decided to leave his post with Operation Warp Speed after several other experts were recruited to the effort, and he determined that he would be most useful in his regulatory role at CBER.

In June, Marks laid out guidance for coronavirus vaccine developers that stated FDA would approve a coronavirus vaccine candidate only if a clinical study had proven that the candidate is safe and at least 50% more effective than a placebo at preventing coronavirus infection; Covid-19, the disease caused by the virus; or decreasing the severity of the disease. Under Marks' guidance, those requirements apply to full approval by FDA, as well as an emergency use authorization. In addition, FDA has added that officials will publicly consult the agency's expert advisory panel before approving a coronavirus vaccine.

And even after a vaccine is approved, Marks noted that FDA will require the vaccine's manufacturer to monitor for any related safety issues that arise. Further, Marks has cautioned that some questions regarding the vaccine's effectiveness won't be answered right away, such as whether people will need to receive the vaccine on an annual basis or whether the vaccine will remain effective if the novel coronavirus changes genetically.

Some stakeholders voice concerns about political pressure

Amid the ongoing process to develop and approve a coronavirus vaccine, some health experts have expressed concerns that FDA may be placed under political pressure to approve a vaccine as fast as possible—particularly given the upcoming presidential election.

And Arthur Caplan, director of the medical ethics division at the NYU Grossman School of Medicine, pointed out that even if Marks decides not to back a vaccine candidate, his superiors could overrule his decision. "This is not a hypothetical," Caplan said.

However, Hahn in a statement said that Marks and his team will "call the balls and strikes" on a coronavirus vaccine. "There are no circumstances under which the FDA would allow a vaccine to be released for use by the public if it is not shown to be safe," Hahn added.

Similarly, Michael Caputo, assistant secretary for public affairs at HHS, said although the government aims to identify a vaccine that's safe and effective by January 2021, speculation about whether FDA is being pressured to approve a vaccine "only undermines confidence in the public health system." He added, "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."

And former FDA Commissioner Scott Gottlieb said he has confidence that Marks won't buckle to political pressure. "He'd do what he needed to do to secure our public health prerogatives," Gottlieb said.

For his part, Marks during a conference call last week with government officials, pharmaceutical executives, and academics who are part of a vaccine working group formed by NIH said he will resign if FDA approves a vaccine that hasn't been proven to be safe and effective.

Marks later confirmed those statements with Reuters, adding that he hasn't felt any political pressure yet. However, he noted that if that changed, he "could not stand by and see something that was unsafe or ineffective that was being put through."

"You have to decide where your red line is, and that's my red line," Marks said. "I would feel obligated [to resign] because in doing so, I would indicate to the American public that there's something wrong" (McGinley, Washington Post, 8/11; Levine/Taylor, Reuters, 8/20).