Director of Center for Biologics Evaluation and Research at FDA
Peter Marks isn't famous like NIH's Anthony Fauci. He hasn't stood up at daily press conferences with President Donald Trump, much less thrown out the first pitch at a Major League Baseball game or starred in social media memes. But Peter Marks may be the most important person in the closely watched COVID-19 vaccine review process.
Trump has routinely pushed for fast vaccines—including by directly pressuring drug company CEOs, according to CNN—but it's up to Marks and his team to make sure any shot that reaches the arms of Americans is safe and effective.
As head of the FDA’s Center for Biologics Evaluation and Research, Marks understands the importance of his role. In recent weeks and months, he's spoken routinely about the agency's unwavering commitment to following the data. In August, Marks said he’d resign if the Trump administration approved a vaccine before it was proven safe and effective.
But Marks isn't just a critical figure for vaccine reviews. Early in the pandemic, he was "very much involved in the initial push to help jumpstart some of the vaccine research that needed to happen," he said in an interview, including animal experiments, early development and the "idea of collapsed development plans."
His ideas eventually became the multibillion-dollar federal program Operation Warp Speed that's supported many of the leading vaccine candidates. Warp Speed has deals with Pfizer, AstraZeneca, Moderna, Johnson & Johnson, Novavax, Sanofi/GSK and Merck.
After a short time, though, Marks realized he couldn't participate in Operation Warp Speed and remain an independent regulator. He decided to step away from the vaccine development process to focus on his regulatory role.
Ultimately, it'll be FDA's career scientists, not politicians, who dig into the trial data and decide whether to sign off on a vaccine for widespread use, just as they do for any vaccine that's up for FDA review. Marks said that it's his job to allow "the process to take place ... free of distractions from factors that aren’t related to quality, safety or efficacy of the vaccine."
In an in-depth profile in August, the Washington Post called Marks the “most important federal official you probably don’t know” and said he “holds the fate” of COVID-19 vaccines in his hands. While the stakes around COVID-19 vaccine reviews are huge, a close associate of Marks’ told the newspaper he “won’t play the political game one way or another. If he gets pushed, he’ll go public or maybe resign. He won’t be quiet.”
The FDA seemingly scored a victory over outside pressure in early October, when it released vaccine guidelines that all but nixed the possibility of a pre-election shot. Through the summer and early fall, Trump had repeatedly said a vaccine could be available in short order, but the White House eventually came to accept the FDA's tighter rules.
The guidelines call for two months of data to review after trial participants receive their final vaccine doses—plus detailed information on manufacturing and more—for each emergency use authorization application. When the FDA managed to release them publicly, SVB Leerink analyst Geoffrey Porges said the agency was “protecting their integrity and reputation by putting all this regulation into the court of public opinion.”
Despite intense attention to the regulatory work around COVID-19 vaccines, Marks has kept a relatively low profile personally, focusing attention on the agency's process instead. At a Friends of Cancer Research event in late September, he said there’s no reason “to get all excited” because the agency will “have a transparent advisory committee meeting for each and every emergency use authorization that comes through,” as quoted by the New York Times.
The first advisory committee, to review COVID-19 vaccine progress in general rather than any specific program, was on October 22. The agency has said another transparent meeting will follow for each vaccine application.
Outside of vaccine development and reviews, Marks has his concerns about distribution and whether Americans will want to take the shots. He said it's "one of the most challenging times for vaccine development,” both because people don't see the diseases that vaccines are already preventing, and because social media allows disinformation to prosper.
“If we can be as transparent as possible," he said, "then hopefully people will start to feel more comfortable about rolling up their sleeves and having a vaccine put into their arm."