-(4)-1731951738-q80.webp){kind=small}
In a stunning revelation that further underscores the growing tensions within the Biden administration, a former top official at the Food and Drug Administration (FDA) claims he deliberately restricted access to a vital vaccine safety database from aides of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., citing serious concerns over data manipulation.
Dr. Peter Marks, who served as the long-time director of the FDA’s Center for Biologics Evaluation and Research (CBER) before his abrupt departure in March, spoke candidly in an interview with the Associated Press published Monday.
He alleged that Kennedy’s team could not be trusted with direct access to the Vaccine Adverse Event Reporting System (VAERS), fearing they might “write over it or erase the whole database.”
“Why wouldn’t we [restrict access]?” Marks told the AP, reportedly using profanity during the exchange. “Because frankly we don’t trust [them].”
Marks stated that while he was willing to provide Kennedy’s associates with read-only access to the database—allowing them to review reported incidents—he drew a hard line against granting them editing capabilities.
The decision, he said, was based on what he described as Kennedy’s deeply flawed views on vaccine safety and his perceived agenda to distort scientific data.
The confrontation reflects a broader clash of ideologies within the Department of Health and Human Services, where Kennedy’s controversial history as a vaccine skeptic has long stirred concern among health experts. Since his appointment as Secretary of HHS, Kennedy—a figure historically aligned with anti-vaccine activism—has faced scrutiny over his ability to lead the nation’s public health infrastructure.
Marks claimed that efforts to establish a collaborative relationship with Kennedy’s team failed early on. “We tried to work with him, to address concerns about transparency,” Marks said. “But he wasn’t interested in scientific inquiry. He wanted confirmation of his misinformation and lies.”
Kennedy has previously criticized federal health agencies for what he calls a lack of openness around vaccine safety, often citing cherry-picked data and anecdotal reports from VAERS.
Health experts have repeatedly warned that VAERS is not designed to establish causality between vaccines and adverse effects, and that its self-reported nature can lead to misleading interpretations if used without context.
VAERS, the Vaccine Adverse Event Reporting System, is a nationwide program co-managed by the FDA and the Centers for Disease Control and Prevention (CDC). It was established in 1990 as an early warning system to detect possible safety problems with U.S.-licensed vaccines.
Healthcare professionals, vaccine manufacturers, and the public can submit reports to VAERS, which logs everything from mild side effects to severe medical events.
However, because the system is open-access and self-reported, anyone can submit a report—whether or not the vaccine actually caused the event. Experts emphasize that VAERS is not a verified database and should not be interpreted as a definitive source of evidence.
Nonetheless, anti-vaccine groups often cite VAERS data out of context to suggest that vaccines are more dangerous than scientific consensus supports.
During the COVID-19 pandemic, VAERS came under increased scrutiny as the rollout of mRNA vaccines prompted thousands of new entries. Although public health officials repeatedly stressed that the vast majority of side effects were mild and expected, conspiracy theories flourished online, fueled in part by selective readings of VAERS reports.
In response to Marks’ allegations, a spokesperson for the HHS defended Kennedy’s request for deeper access to VAERS, telling the Associated Press that it was “perfectly reasonable” for Kennedy’s team to conduct their own analysis of the database.
An HHS official speaking to The Hill went further, calling Marks’ claims “false” and suggesting the former FDA executive was misrepresenting events for political reasons.
Since leaving the FDA after nearly a decade of service, Marks has embarked on what many are calling a media campaign to discredit Kennedy’s leadership. In an interview with The Wall Street Journal, Marks described his departure as a matter of principle, saying he could not continue working under a cabinet secretary who refuses to “follow the science.”
Marks also alleged that Kennedy’s team had made formal requests for data on brain swelling and deaths linked to the MMR (measles, mumps, and rubella) vaccine—data he said did not exist.
“They were asking for information that simply isn’t there,” he told the Journal. “There are no credible cases of brain swelling or death from MMR vaccines that would justify their inquiries.”
The dispute between Marks and Kennedy represents a broader battle between science-based governance and populist mistrust of federal institutions. Kennedy’s appointment to the HHS post was widely seen as a political compromise, bringing a well-known name into the administration but risking backlash from the scientific community.
While Kennedy’s supporters argue that his presence at HHS promotes accountability and transparency, critics warn that his views threaten the credibility of U.S. health policy at a time when trust in institutions is already fragile.
“This isn’t just an internal spat,” said Dr. Lisa Brenner, a public health expert at Johns Hopkins University. “When leadership doesn’t speak with one voice on vaccine safety, it confuses the public and can cost lives.”
Brenner warned that undermining confidence in regulatory systems like VAERS could lead to reduced vaccination rates, particularly among vulnerable populations. “The very people VAERS was designed to protect are now being put at greater risk,” she said.
It remains unclear how the standoff will be resolved. Congressional oversight committees may soon get involved, especially if Marks is called to testify about his experiences at the FDA. Some lawmakers have already signaled interest in investigating the internal conflict, especially given the potential implications for vaccine rollout and public health data integrity.
For now, the clash between Peter Marks and Robert F. Kennedy Jr. underscores the high stakes of scientific leadership in a polarized political environment. As misinformation continues to spread and public trust remains fragile, the integrity of health data—and who gets to access and interpret it—has become a frontline issue in the battle for truth and transparency in government.
