Laid the groundwork for strict scientific regulatory standards used for the rapid development, testing and approval of lifesaving COVID-19 vaccines amid a deadly, once-in-a-century pandemic.
In the race to end the deadly COVID-19 pandemic, Dr. Peter Marks played a pivotal role in the development of safe and effective vaccines in record-breaking time by pushing pharmaceutical companies to accelerate their timelines, set strict standards for clinical trials and production, and ensure that a science-based approval process was followed.
“Without Dr. Marks, we’d still be counting many, many deaths that could have been prevented and many hospitalizations that could have been avoided,” said Arthur Caplan of the New York University School of Medicine.
Early in the pandemic, Marks, the director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, took the highly unusual step of engaging with multiple drug manufacturers—companies that are typically competitors—to discuss what would be needed for a successful vaccine to receive an emergency use authorization.
Marks recognized that the drug companies’ proposed timeframes were faster than any previous vaccine development, but “still completely inadequate to meet the exploding public health need,” said Dr. Cynthia Dunbar, a research scientist at the National Institutes of Health’s National Heart, Lung and Blood Institute.
“By the time we landed in April of 2020, it was clear we were going to need some heroic effort,” Marks said. “Every month we could shave off development could save a lot of lives.”
An avid “Star Trek” fan, Marks called this initiative Operation Warp Speed because the scale of the effort seemed so “improbable and difficult” as to be almost like science fiction, Dunbar said.
The project represented an unprecedented collaboration between government and the private sector to vaccinate the people of this country as quicky and safely as possible. The task became more urgent as millions were getting sick and tens of thousands were dying from the coronavirus across the nation. Now, more than a year later, thanks in large part to Marks’ efforts toward the onset of the pandemic, U.S. vaccination rates are faster than almost any other country in the world and confidence in the vaccines’ safety and efficacy remains high.
After standing up Operation Warp Speed, Marks returned to his full-time role overseeing the FDA’s approval process for vaccines and biologics. He believed this process would not only help the country produce and administer vaccines more quickly, but also inspire public confidence that any vaccines approved were safe and effective. He also wanted to make sure that the FDA based its decisions on science, not politics.
“He just kept making it clear that he could not be persuaded, influenced, shamed, guilted or threatened into acting in any way other than where the science led him,” Caplan said.
“Peter insisted that no FDA authorization would be given to a vaccine until at least half of the people in a trial had been monitored for at least two months after getting their second dose,” said NIH Director Dr. Francis Collins.
“That was extremely unpopular at the White House at the time, but it was the right thing to do,” Collins said. “And he withstood a great deal of criticism and pressure.”
“You have to stick to the science,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and a 2020 Samuel J. Heyman Service to America Medals award recipient. “Peter manifested a considerable degree of courage in sticking to his guns.”
In addition to the vaccines, Marks helped initiate studies of convalescent plasma for the treatment of patients with COVID-19 and led the development of a clinical program to provide access to this treatment while gathering critical safety and efficacy information.
Marks explained that getting drug companies comfortable with the idea of moving fast on vaccines required “lots of dollars” in the form of purchase guarantees and other commitments from the government. It also required the FDA to work in active partnership throughout the vaccine development process.
That commitment was only possible because of a decade-long effort—spearheaded in large part by Marks—to change the dynamic and build trust between researchers, pharmaceutical companies and the FDA, their chief regulator.
“He’s changed the way things work,” said Dr. Stephen Russell, a researcher at the Mayo Clinic who specializes in cell and gene therapies and has worked on vaccines for Ebola and COVID-19. “What he’s done is to streamline everything and apply an intelligence to the whole process.”
“We’ve made a lot of progress at FDA over the last decade in realizing that having an open dialogue with sponsors is really important,” Marks said. “At times, the dialogue really helped provide the quantum leap that we needed to make.”
“If the groundwork hadn’t been done to speed up the vaccine development process in advance, this could have taken a year longer,” Dunbar said.
Ultimately, the vaccines produced by drug companies Pfizer and Moderna proved to be about 95% effective. A third vaccine produced by Johnson & Johnson also was found to be highly effective, but its use was halted for10 days in April after reports of very rare but severe blood disorder among young women. Marks was involved in halting and then resuming the vaccine’s use with a new warning label after concluding the benefits of vaccine far outweigh the risks.
For Marks, this devotion to letting science be the guide throughout the review of all of the vaccines was p COVID-19 vaccines was paramount.
was paramount..
“The concept of doing anything other than following the science wasn’t an option,” Marks said.
