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

Hours earlier in West Virginia, Kennedy asserted that Covid did not kill healthy people, contrary to research showing that 30% of those who died early in the pandemic did not have underlying conditions.

The Food and Drug Administration's top vaccine official, Dr. Peter Marks, abruptly resigned Friday, saying in a searing letter 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.

Marks resigned under pressure, according to a person familiar with the matter who said an official with the Department of Health and Human Services told Marks on Friday that he could either resign or be fired.

Hours earlier in West Virginia, Kennedy asserted that Covid did not kill healthy people, contrary to research showing that 30 per cent of those who died early in the pandemic did not have underlying conditions. Kennedy has also extolled the value of vitamin A as a treatment during a major measles outbreak in Texas, while downplaying the value of vaccines. On Thursday, he announced that he was creating a new office to study vaccine injuries.

Marks noted in his letter 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."

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

"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.

He went on to express his desire for the current administration's damage to be limited.

"My hope 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," Marks wrote.

Marks did not respond to a request for comment. Andrew Nixon, the HHS spokesperson, issued a statement Friday night saying, "If Peter Marks does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy."

Marks steered the FDA's vaccine program during the tumultuous years of the coronavirus pandemic, guiding the agency and its outside advisers through multiple decisions about the kind of evidence that was necessary to grant emergency authorization for the vaccines produced under the Trump administration's Operation Warp Speed initiative.

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 University, said he spoke 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."

Dr. Peter Lurie, a former FDA associate commissioner, called it "a real tragedy" when someone like Marks runs afoul of "these alleged distortions."

"He's quite concerned about the integrity of the scientific enterprise," Lurie said, "and I share his concern that the secretary is making truth subservient to his own personal beliefs, which appear not to be grounded in science."

Kennedy was confirmed by the Senate after a tense two days of hearings that included his repeated pledges to uphold the importance of vaccinations. But he has already begun to show signs that he is continuing the type of activities he engaged in for 20 years to deeply undermine vaccine confidence.

During the measles outbreak in Texas, he has promoted the value of alternative medicines and issued tepid advice for people to get vaccinations. Despite a federal hiring freeze, his agency recently hired a prominent researcher in the anti-vaccine movement to study the long-discredited link between vaccines and 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.

Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said the study of vaccine injuries has 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.