With former director of the FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., out of the picture, HHS secretary Robert F. Kennedy Jr. (RFK Jr.) appears to be setting his sights on the vaccine safety database that was reportedly a key factor in Marks’ departure.
At a Tuesday event in Indiana, Kennedy pledged to unleash changes to HHS’ Vaccine Adverse Event Reporting System (VAERS), Stat News reports. Along with implementing an automated data collection system and adding new datasets on the effects of vaccinations, the health secretary said he's looking to create global data-sharing programs on vaccine use and health, according to the report.
“It’s outrageous that we don’t have a surveillance system that functions," he said at the event, as quoted by Stat. “We’re going to find out what contribution vaccines and everything else—mold, [electromagnetic fields], food, all of these other exposures [that] began in the late 1980s — which one of those are the culprits?”
Kennedy didn't what explain what outcomes he believes the vaccines and other “culprits” may be causing, Stat noted. He's previously vowed to get to the bottom of a nationwide "chronic disease epidemic" and an "autism epidemic."
VAERS was established in 1990 and is meant to be used as an early warning system to detect possible vaccine safety issues. The program allows anyone to submit a report to the system, but a disclaimer warns that the reports alone “cannot be used to determine if a vaccine caused or contributed to an adverse event or illness." Information in the database may be “incomplete, inaccurate, coincidental or unverifiable," according to the disclaimer.
The reports can be biased, so VAERS has “limitations” on how it can be used scientifically, the disclaimer stresses. A guide to interpreting the data further emphasizes these limitations. Still, anyone can access raw data from the system and adverse event reports are encouraged as “valuable information.”
Kennedy and anti-vaccine activists alike have used the system to back misleading vaccine safety claims. During his Senate confirmation hearings, Kennedy cited VAERS reports as evidence supporting a prior statement that the COVID-19 vaccine was “the deadliest vaccine ever made." While the COVID-19 shots reached billions of people, it's estimated the products saved millions of lives.
Marks, for his part, previously stood in the way of Kennedy’s control over the VAERS system, he told Associated Press in an interview. Before resigning, the former CBER chief said he'd refused RFK Jr.'s team full access to the sensitive data based on a belief that “they’d write over it or erase the whole database,” he told AP.
The long-time FDA leader later hit the exit with a scathing resignation letter calling out Kennedy for wanting “subservient confirmation of his misinformation and lies,” as opposed to truth and transparency surrounding vaccines. The departure came after it was made clear that “either I was going to resign or they were going to fire me,” Marks told AP.
Still, Marks did propose a revamp of the VAERS system to make it "more transparent," he explained to AP. The unverified nature of the data means that officials must thoroughly adjudicate the reports, often finding that deaths attributed to vaccines were actually caused by unrelated incidents, he said.
Elsewhere at the Indiana event on Tuesday, multiple news outlets reported that Kennedy spouted factually incorrect statements—including inaccurate claims about U.S. obesity rates, COVID fatalities and measles vaccines—which he described as “a leaky vaccine.”
“People get measles because they don’t vaccinate,” Kennedy told reporters at the event, according to USA Today. “They get measles because the vaccine wanes. The vaccines wane about 4.8% per year.”
The CDC lists two doses of a measles, mumps, and rubella (MMR) vaccine as 97% effective against measles. Some studies have shown that the level of protection the vaccination offers can decrease slightly over time, but only by about 0.04% each year post-vaccination, according to one study published in The Lancet Public Health.
Kennedy endorsed MMR vaccines last week amid a measles outbreak in Texas, but he later also promoted unproven treatment regimens. There is currently no FDA-approved treatment for measles.