Dr. Peter Marks, the esteemed head of the U.S. Food and Drug Administration’s (FDA) vaccine division, has resigned in protest, citing a fundamental disagreement with Health Secretary Robert F. Kennedy Jr.’s stance on vaccines.
His departure signals growing turmoil within the health agency, as Kennedy moves forward with policies that critics argue threaten public confidence in immunisation.
Dr. Marks, a veteran of the FDA and a key figure in the rollout of COVID-19 vaccines, submitted his resignation on Friday after a tense meeting with the Department of Health and Human Services (HHS). According to insiders, he was presented with an ultimatum: resign or be dismissed. In his resignation letter, Dr. Marks did not mince words, accusing Kennedy of propagating “misinformation and lies” and warning of the dire consequences of undermining public faith in vaccines.
A Respected Figure in Turmoil
Dr. Marks has long been regarded as a steady hand in the often-fraught world of vaccine regulation. Having steered the FDA’s Center for Biologics Evaluation and Research through the COVID-19 pandemic, he was instrumental in authorising vaccines under Operation Warp Speed. His scientific integrity and commitment to public health were widely acknowledged, even by some of his critics. However, his tenure had not been without controversy—some had accused him of being overly lenient with pharmaceutical companies in approving certain therapies.
His resignation highlights the escalating tensions between the scientific community and the Kennedy-led health department. Since taking office in February, Kennedy has issued a series of sweeping directives that signal a radical shift in vaccine policy. He has long been a controversial figure in this space, questioning vaccine safety despite overwhelming scientific evidence supporting their efficacy. His appointment was met with trepidation from experts who feared his influence would reverse decades of progress in immunisation efforts.
Clash Over Vaccine Policy
Kennedy’s approach to vaccine policy has been met with concern from many within the medical establishment. He has promoted vitamin A as an alternative treatment during a severe measles outbreak in Texas while downplaying the necessity of vaccination. Additionally, he has appointed an analyst with deep ties to the anti-vaccine movement to investigate the long-discredited claim that vaccines cause autism.
On Thursday, Kennedy announced plans to establish a vaccine injury agency within the Centers for Disease Control and Prevention (CDC), describing it as a means to bring “gold-standard science” to the federal government. His supporters argue that the move will provide greater transparency, but critics view it as an attempt to legitimise unproven theories and fuel public distrust in vaccines.
Dr. Marks, in his resignation letter, was unequivocal in his condemnation of these policies. “Undermining confidence in well-established vaccines that have met the highest standards for safety and efficacy is irresponsible, detrimental to public health, and a clear danger to our nation’s safety and security,” he wrote. He also pointed to the resurgence of measles—once thought eradicated in the U.S.—as a direct consequence of vaccine hesitancy, exacerbated by political rhetoric and misinformation.
A Fractured Health Agency
The FDA has already been grappling with internal divisions over vaccine policy. Dr. Marks’ departure follows the resignations of two senior vaccine regulators in 2021, who left in protest over the Biden administration’s handling of COVID-19 booster shots. The rift within the agency is deepening, with many expressing concerns over the future direction of vaccine oversight.
Dr. Ellen Sigal, founder of Friends of Cancer Research, described Dr. Marks as a pivotal figure in medical innovation. “His leadership has ensured that lifesaving treatments reach those who need them most. His departure leaves a significant void,” she said.
Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, echoed these sentiments. He warned that Kennedy’s focus on vaccine injuries—an area that has already been extensively studied—risks distorting the true risks of vaccination. “This is a way to emphasise vaccine injuries in a manner completely disproportionate to reality,” he said.
The Future of Vaccine Policy Under Kennedy
With Dr. Marks’ exit, the direction of U.S. vaccine policy remains uncertain. While Kennedy’s supporters champion his push for increased scrutiny and transparency, public health experts fear his rhetoric will erode confidence in vaccines and lead to declining immunisation rates.
Dr. Marks remains steadfast in his belief that science must guide public health policy. “I did everything possible to work with this administration to restore confidence in vaccines,” he said in an interview following his resignation. “It became clear that’s not what they wanted.”
His departure may be a turning point for vaccine policy in the U.S., but whether it leads to renewed scientific leadership or a further entrenchment of vaccine scepticism remains to be seen.
