How a Federal Vaccine Safety Database Became a Magnet for Misinformation
SOURCE:Time Magazine|BY:Jeffrey Kluger
The Vaccine Adverse Event Reporting System (VAERS) was established to protect public health. Now it's being used against it.
There’s no way of knowing if anyone believed Dr. James Laidler back in 2004 when he reported that a flu vaccine had turned him into the Incredible Hulk. The symptoms he described certainly fit—green skin and enormous muscles. And the news of his transformation appeared in a seemingly reputable place—the federal government’s Vaccine Adverse Event Reporting System (VAERS), jointly operated by the Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC).
Laidler was hardly alone in submitting his symptoms to VAERS. Each year, more than 38,000 Americans report possible side effects of vaccines to the site. Anyone can post anything at all—true or not, plausible or not. And so Laidler, an Oregon-based anesthesiologist concerned about unfiltered, unedited misinformation circulating about lifesaving vaccines, posted his made-up Hulk story to make a point.
“Because the reported adverse event was so…unusual, a representative of VAERS contacted me,” Laidler wrote in a blog post at the time. “After a discussion of the VAERS database and its limitations, they asked for my permission to delete the record, which I granted. If I had not agreed, the record would be there still.”
Uncounted other false reports linger on the site, and that’s a potential problem. With hostility to vaccines on the rise, the risk exists that VAERS will be increasingly hijacked for political or ideological purposes, experts say, turning what was designed as a way for epidemiologists to look for problems with vaccines into a tool for misinformation.
“VAERS can serve as an early warning system,” says Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a former long-serving member of the CDC’s Advisory Committee on Immunization Practices (ACIP). “It can’t prove there’s a problem, but it can show that there might be. It’s also misused horribly by anti-vaccine activists who say, ‘Look at all these reports.’”
“VAERS is a passive reporting system, and that’s both its strength and weakness,” says Dorit Reiss, a professor of law at the University of California, San Francisco, who studies legal and policy issues related to vaccines, including vaccine mandates and the anti-vaccine movement. “It’s fast and turns up signals of a problem quickly and easily. But it can also create scare memes and spread unfounded fears.”
VAERS was established with the best of intentions, authorized in 1986 as part of the National Vaccine Childhood Injury Act. The new law created what is popularly—and misleadingly—labeled the “vaccine injury court,” and correctly known as the Office of Special Masters. Mindful of the need to vaccinate millions of children a year against preventable diseases and keep the cost of vaccines low, Congress and then-President Ronald Reagan agreed to establish a no-fault court in which claims of adverse vaccine events could be litigated—or, more commonly, settled—with awards funded by a 75-cent surcharge on every vaccine dose manufactured in the U.S. The court would spare pharmaceutical companies from becoming tied up in endless lawsuits—many of them either frivolous or fraudulent or involving a true medical problem that was not actually caused by the vaccine—that would stop the needed flow of the shots.
Over the years, the government has made a yeoman’s effort at explaining the reason for the no-fault nature of the court—which has nothing to do with Washington cutting sweetheart deals with Big Pharma. But that hasn’t stopped Health and Human Services (HHS) Secretary and long-time vaccine skeptic Robert F. Kennedy Jr. from claiming, “If we want safe and effective vaccines we have to end the liability shield.”
VAERS was created as another provision of the law. Since 1990 when the VAERS program went wide, more than two million reports have been filed, most describing mild potential side effects. In that time, VAERS has notched some major public health wins. In 1998 the Rotashield vaccine, created to protect against the rotavirus, was introduced, and shortly after, scattered cases of intussusception—in which the intestine folds onto itself, causing blockage and cutting off blood flow—began appearing in babies who had received the shot. VAERS reports showed that the condition was occurring within the first week after the first shot, and in 1999, the manufacturer pulled the vaccine.
“The reports showed that intussusception was occurring in two-month-olds,” says Offit. “That was unusual because it usually occurs in five- to nine-month-olds. And that made us take a closer look to see whether [the vaccine] was a problem.”
More recently, VAERS was one source of early accounts of boys and young men developing myocarditis—or cardiac inflammation—after receiving the Pfizer-BioNTech and Moderna COVID vaccines. Once those first accounts were filed, Offit says, “You could do the kind of studies that would look at the link, to answer the question, ‘Were you more likely to get myocarditis if you’d gotten the vaccine?’”
A link was indeed established, but it was rare—about two additional cases in every 100,000 people who had received the shot. That was considered an acceptable risk, especially since the COVID virus itself was associated with a more than 16-fold increase in the risk of myocarditis, jumping from a baseline of nine cases per 100,000 individuals to 150 cases per 100,000 individuals.
But the credibility of the VAERS system could be endangered, worry some public health experts—not so much by pranks like Laidler’s or honest vaccine recipients posting reports about suspected side effects that turn out not to be unrelated to a shot, but by the current federal public-health leadership. The ACIP panel on which Offit once sat was composed of 17 physicians, public-health specialists, and other relevant experts, who advised the HHS and the government at large on vaccine deployment in the civilian population. On June 9, Kennedy fired all of the committee’s members, replacing them with a hand-selected group more in keeping with his longstanding anti-vaccine views. An HHS press release framed the move as “a bold step to restore public trust in vaccines by reconstituting ACIP.”
“A clean sweep is necessary to reestablish public confidence in vaccine science,” said Kennedy in a statement. “ACIP's new members will prioritize public health and evidence-based medicine. The Committee will no longer function as a rubber stamp for industry profit-taking agendas.”
Others were not as sanguine. “Of course, now the fear is that the ACIP will be filled up with people who know nothing about vaccines except suspicion,” posted Republican Sen. Bill Cassidy—a physician who voted in favor of Kennedy’s nomination—on X on June 9.
On Dec. 5, the newly configured ACIP panel took a first step in the direction of undoing vaccine guidelines, voting to reverse existing policy that recommends the hepatitis B vaccine for all newborns and instead calling for it only for children of mothers who test positive for the infection or whose status is unknown. HHS called the move “individual-based decision-making.” Offit counters that Kennedy is “going to make vaccines less available, less affordable, and more feared.”
On Nov. 28, HHS acted again when Dr. Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER), the FDA’s vaccine division, emailed an internal memo to the CBER staff, linking the deaths of 10 children to COVID vaccines—and citing VAERS reporting as part of the body of evidence. Prasad recommended a host of restrictions, including requiring vaccine manufacturers to provide significantly more data showing the safety of their products, revisiting recommendations for annual flu shots and questioning whether people should be receiving multiple vaccines at once. The memo was short on significant details about the VAERS reports—including the age of the children, a complete explanation of how CBER determined the vaccine was linked to their deaths, and information on whether they had any pre-existing health conditions.
“[Prasad] said he saw the data in VAERS, which proves nothing,” says Offit. “He didn’t in any way back it up.”
Though the FDA did not respond to a request for comment, the CDC provided an emailed statement.
“The CDC’s own research has shown that the post-licensure surveillance system, VAERS, captures fewer than 1% of vaccine injuries. It’s a system that was designed to fail,” read the statement in part. “HHS is now building surveillance systems that will accurately measure vaccine risks as well as benefits—because real science demands both transparency and accountability.”
Where U.S. vaccine policy—and tools like VAERS and the Court of Special Masters—go from here is not certain.
“You have an anti-vaccine President of the United States and an anti-vaccine Secretary of Health and Human Services. The world is upside down,” Offit says. “I think that if there was a case or two of polio in this country, that may change the dynamic.”
Reiss, the law professor, does not think that kind of development is at all outside of the realm of possibility. “I think we’re in trouble,” she says. “Things are going to get worse before they get better.”