Top FDA vaccine official resigns, citing Kennedy’s ‘misinformation and lies’

The Food and Drug Administration’s top vaccine official, Dr. Peter Marks, resigned under pressure Friday and said that Health Secretary Robert F. Kennedy Jr.’s aggressive stance on vaccines was irresponsible and posed a danger to the public.

“It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote to Sara Brenner, the agency’s acting commissioner. He reiterated the sentiments in an interview, saying: “This man doesn’t care about the truth. He cares about what is making him followers.”

Marks resigned after he was summoned to the Department of Health and Human Services on Friday afternoon and told that he could either quit or be fired, according to a person familiar with the matter.

Marks led the agency’s Center for Biologics Evaluation and Research, which authorized and monitored the safety of vaccines and a wide array of other treatments, including cell and gene therapies. He was viewed as a steady hand by many during the COVID pandemic but had come under criticism for being overly generous to companies that sought approvals for therapies with mixed evidence of a benefit.

His continued oversight of the FDA’s vaccine program clearly put him at odds with the new health secretary. Since Kennedy was sworn in Feb. 13, he has issued a series of directives on vaccine policy that have signaled his willingness to unravel decades of vaccine safety policies. He has rattled people who fear he will use his powerful government authority to further his decades-long campaign of claiming that vaccines are singularly harmful, despite vast evidence of their role in saving millions of lives worldwide.

“Undermining confidence in well-established vaccines that have met the high standards for quality, safety and effectiveness that have been in place for decades at FDA is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety and security,” Marks wrote.

Kennedy has, for example, promoted the value of vitamin A as a treatment during the major measles outbreak in Texas while downplaying the value of vaccines. He has installed an analyst with deep ties to the anti-vaccine movement to work on a study examining the long-debunked theory that vaccines are linked to autism.

And Thursday, Kennedy said on NewsNation that he planned to create a vaccine injury agency within the Centers for Disease Control and Prevention. He said the effort was a priority for him and would help bring “gold-standard science” to the federal government.

An HHS spokesperson said in a statement Friday night that Marks had no place at the FDA if he was not committed to transparency.

In his letter, Marks mentioned the deadly toll of measles in light of Kennedy’s tepid advice on the need for immunization during the outbreak among many unvaccinated people in Texas and other states.

Marks wrote that measles, “which killed more than 100,000 unvaccinated children last year in Africa and Asia” because of complications, “had been eliminated from our shores” through the widespread availability of vaccines.

Marks added that he had been willing to address Kennedy’s concerns about vaccine safety and transparency with public meetings and by working with the National Academies of Sciences, Engineering and Medicine, but was rebuffed.

“I did everything I possibly could for this administration to work with them in an effort to restore confidence in vaccines,” Marks said in the interview. “It became clear that’s not what they wanted.”

Leaving the FDA, Marks added, was a “weight lifted from me, because I was in an environment where it was spiraling deeper and deeper into danger.”

Ellen V. Sigal, founder of the advocacy group Friends of Cancer Research and a close ally of Marks’, said his “leadership has been instrumental in driving medical innovation and ensuring that lifesaving treatments reach patients who need them most.” His departure, she said, “will create a significant void.”

Marks steered the FDA’s vaccine program during the tumultuous pandemic years, guiding the agency and its outside advisers through a number of decisions about the kind of evidence needed to grant emergency authorization for the vaccines produced under the Trump administration’s Operation Warp Speed initiative, which Marks helped start up.

In June 2022, he pleaded with a committee of outside experts to consider the danger the virus posed to children younger than 5; the panel voted later that day to recommend vaccines for that age group.

“We have to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here,” Marks said at the time.

Dr. Peter Hotez, a vaccine expert from Baylor College of Medicine, said he had spoken with Marks regularly during the pandemic. “He was extraordinarily committed to using science to help the American people,” he said. “He was one of the heroes of the pandemic, so I’m sorry to see him go.”

Marks was viewed skeptically by some at the FDA, including former members of his own vaccine team. The two most senior regulators in the agency’s vaccine office resigned in 2021 in part because of a Biden administration effort to expedite the licensing of Pfizer’s coronavirus shot and the authorization of COVID booster shots.

While Kennedy has been pressing for more study of vaccine injuries, Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said such research had already been a priority for decades.

“I fear this is a way to emphasize vaccine injuries in a way that’s completely disproportionate to what the real risk is,” he said.

Marks clearly shared those concerns. In his letter, he expressed a desire that damage caused by the current administration be limited.

“My hope,” he wrote, “is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science.”