A senior health official in the US, who was seen as a guardrail against any future politicisation of the Food and Drug Administration’s approval of life-saving vaccines, has resigned abruptly, citing the health secretary Robert F Kennedy Jr’s “misinformation and lies”.
Dr Peter Marks served as the FDA’s top vaccine official. He had been lauded by Donald Trump during the US president’s first term for his role in Operation Warp Speed, the initiative that developed, manufactured and helped distribute the Covid-19 vaccines.
Multiple media outlets, including the Wall Street Journal and New York Times, citing people familiar with the matter, reported late on Friday that Marks had been given the choice to resign or be fired by a Health and Human Services (HHS) department official. He chose to resign. The FDA is a key federal agency within HHS.
In a resignation letter, referring to Kennedy, Marks wrote: “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 also issued a stark warning, according to media outlets who obtained the letter, saying: “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.”
The departure follows reports that Kennedy has turned to a noted vaccine sceptic, David Geier, to lead the HHS in a study of potential links between vaccines and autism. Any links between autism and vaccines have long been debunked.
Kennedy has claimed he is not anti-vaccine, but for years he has led a movement to sow doubts about their safety and effectiveness. In 2021, a group then led by Kennedy called for the emergency approval of Covid-19 vaccines to be revoked, saying: “The current risks of serious adverse events or deaths outweigh the benefits.”
Studies later showed that claim was inaccurate. A study by the Commonwealth Fund found that Covid-19 vaccines saved 3.2 million American lives and prevented more than 18m hospitalisations through November 2022.
During his confirmation process, Kennedy ultimately secured the votes of almost all Republican senators, including Dr Bill Cassidy of Louisiana, by promising that he would not change the FDA’s system for approving vaccines.
But that system was overseen by Marks, who has been with the FDA since 2012 and oversaw the division’s approval process for vaccines, biotech and blood products.
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The Wall Street Journal reported a statement on the resignation by an HHS official: “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’s departure comes a day after the Trump administration said it was laying off 10,000 employees at HHS. In comments about the move posted on YouTube, Kennedy suggested his office was facing opposition inside the department from “defiant bureaucrats” who had stopped his office from gaining access to “closely guarded databases that might reveal the dangers of certain drugs and medical interventions”.
The Guardian has sought more information about Kennedy’s remarks but has not yet received a comment from HHS. Some experts have warned that Kennedy and other senior Trump-appointed health officials may seek to challenge the authorisation behind the Covid-19 vaccines. Kennedy also said in his confirmation hearings that he had been asked by Trump to study the safety of mifepristone, which is used for medication abortion and has already been extensively investigated for safety.
It is not clear what precise databases Kennedy was referring to in his YouTube statement. When pharmaceutical companies seek FDA approval for drugs they have developed, they disclose proprietary information, which the FDA keeps confidential. That includes information about manufacturing methods and clinical study reports.
