More top vaccine regulators at the Food and Drug Administration have either left or been forced out following the resignation last week of Dr. Peter Marks, the agency’s top vaccine official, according to four former and current government officials familiar with the matter who spoke on the condition of anonymity for fear of retribution.
Experts say the exodus of top talent at the FDA’s Center for Biologics Evaluation and Research could hobble the agency’s ability to approve new vaccines and a wide range of other drugs — especially in the wake of the mass layoffs by the Department of Health and Human Services on Tuesday.
It also leaves a void of experienced staff at a time when distrust in vaccines and health institutions is growing.
“It represents a hollowing-out of the agency, and especially a tremendous loss of institutional memory,” Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Pennsylvania, said of the departures. “I’m not sure people realize how important that is, and we will suffer from this.”
Offit serves on an independent vaccine advisory committee for the FDA that convenes at CBER’s request.
CBER is responsible for assuring the safety and effectiveness of a number of medical products, including vaccines and gene therapies. It played a key role in authorizing the first Covid vaccines in late 2020 and approving the first RSV vaccine in 2023. CBER also approved a cure for sickle cell disease that uses the gene-editing technology CRISPR.
Julia Tierney, who was deputy director of CBER under Marks, and her staff were cut as part of the sweeping layoffs at HHS, three of the officials said. (As of early Thursday afternoon, an agency directory still listed Tierney as acting director of the division.)
Christopher Joneckis, the director of the office of regulatory operations at CBER, which ensures vaccines and drugs are safe, was also purged on Tuesday, along with his staff, the sources said.
Sheryl Lard-Whiteford, the associate director for product management at CBER, responsible for monitoring vaccines and drugs once they’ve been approved, was also let go, the officials said. Although, according to one person, HHS may rescind her termination and try to bring her back.
Michelle Limoli, who worked with international partners on regulatory issues as associate director for international affairs at CBER, plans to retire, the officials said.
Tierney, Joneckis, Lard-Whiteford and Limoli did not respond to requests for comment.
The departures come as HHS Secretary Robert F. Kennedy Jr. works to reshape the public health infrastructure.
Kennedy has previously been critical of CBER’s decisions, filing a citizens petition in 2021 requesting that the FDA revoke the authorization for the Covid vaccines. The same year, he falsely described the Covid vaccine as the “deadliest vaccine ever made.”
A former official described the bleak state of CBER during the mass layoffs.
“It’s been an absolute disaster,” the official said. “Websites weren’t covered. Mailboxes weren’t being read. We had no one in document control to receive our papers. It was just a complete s---show.”
Now, the official said, the administration “has left us decapitated.”
“Staff are very concerned that additional risk will be coming,” the official said.
Last week, Marks, who has led CBER since 2016, was forced out.
In a resignation letter obtained by NBC News, Marks wrote that undermining confidence in vaccines is “irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety, and security.”
The layoffs and resignations will have “real direct implications for every American,” said Arthur Caplan, the head of the division of medical ethics at the NYU Grossman School of Medicine in New York City.One affected area is cancer vaccines. In February, for example, researchers reported that an mRNA vaccine for pancreatic cancer had promising results in an early-stage trial. Research is also underway on mRNA vaccines for melanoma and colorectal cancer.
Approval of those vaccines would fall under the purview of CBER.
At the World Vaccine Congress in 2024, Marks said the FDA was “open for business” on novel vaccines, including mRNA cancer vaccines.
With Marks’ departure and Kennedy’s disdain for mRNA technology, much of that progress on those treatments is threatened, Caplan said.
“I think that’s really going to slow down and people are going to die,” Caplan said. “The vaccines that might have been useful are not going to be moving fast because regulators aren’t there to approve them.”
The departures also come as the U.S. is in the midst of a bird flu crisis.
As of Tuesday, the virus had infected 998 dairy herds across 17 states, according to the Agriculture Department. It has led to the culling of more than 160 million poultry. At least 70 people, most of whom had direct contact with sick animals, have been infected, according to the Centers for Disease Control and Prevention. One person has died.
In the event that the bird flu virus starts spreading from human to human, Offit said, CBER would be responsible for approving a vaccine.
A spokesperson for HHS declined to comment.
Top officials within the division haven’t entirely been eliminated. Dr. David Kaslow, the director of CBER’s Office of Vaccines Research and Review, is still said to be at the agency following the mass layoffs Tuesday, two officials said.
On Tuesday, Dr. Sara Brenner, the FDA’s principal deputy commissioner, announced that Scott Steele, who has been at the division for five years, most recently as senior adviser for translational science, would serve as acting director of CBER, according to a memo obtained by NBC News.
