Food and Drug Administration officials plan to present data they claim links the Covid vaccine to 25 deaths in children at what’s expected to be a closely watched vaccine advisory committee next week, a source confirmed to NBC News.
The Washington Post first reported the expected data.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, is scheduled to meet Thursday and Friday to review and make recommendations on several vaccines, including this fall’s updated Covid shots.
The FDA is basing its claim on an analysis of data from the Vaccine Adverse Event Reporting System, or VAERS, a publicly available database maintained by the FDA and the CDC, according to three sources familiar with the plan.
But, two of the sources said, the agency is misusing the database which allows anyone — including doctors, patients and caregivers — to submit reports to VAERS about adverse events they believe are linked to vaccines. The reports are unverified, but the health agencies use the database as a guide for topics to investigate further.
Dorit Reiss, a vaccine policy expert at the University of California Law, San Francisco, said the database reports can't prove a connection between vaccination and children's deaths.
“To identify causation to a vaccine you need to show that the cause of death was something the vaccine caused, and by itself, a VAERS report would not show that — you need larger studies comparing incidents of the harm with or without the vaccine,” she said in an email.
In a statement, Andrew Nixon, a spokesperson for the Department of Health and Human Services, said: “FDA and CDC staff routinely analyze VAERS and other safety monitoring data, and those reviews are being shared publicly through the established ACIP process.”
Last week, FDA Commissioner Marty Makary told CNN that the agency was looking into deaths of healthy children from the Covid shots.
“We’ve been looking into the VAERS database of self-reports that there have been children that have died from the Covid vaccine,” Makary said. “We’re going to release a report in the coming few weeks and we’re going to let people know. We’re doing an intense investigation.”
The VAERS website warns that reports can contain inaccurate, incomplete or biased information. "As a result, there are limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind."
The Washington Post reported that Makary’s special adviser Dr. Tracy Beth Høeg, a sports medicine physician who criticized Covid shots for children during the pandemic, is expected to present the new findings at next week’s vaccine committee meeting.
One former FDA official, who requested anonymity to speak freely, pushed back on the findings.
“I can tell you on a stack of Bibles that we looked through all of the autopsy reports and that we didn’t find anything,” the official said in a text message. “Unless someone was hiding them from us I don’t know what they’re referring to.”
Research into Covid vaccines and side effects
Numerous studies have shown that the Covid shots are safe in children, and also reduce their risk of hospitalization and death.
A 2023 analysis published in JAMA Pediatrics reviewed 17 studies, which included over 10 million children ages 5 to 11 who were vaccinated with the mRNA shots from Pfizer and Moderna. The shots were shown to reduce the risk of infection and hospitalization in vaccinated children, compared to kids who didn’t get vaccinated.
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Another study, published in Nature Communications in 2024, found no increased risk of adverse events in young kids who got Covid shots, including from Pfizer and Moderna. It found a small increased risk of myocarditis, a heart inflammation, in male teens following the first two doses.
At an FDA advisory committee meeting in May, Pfizer presented real-world data on its Covid vaccine, including in tens of thousands of kids ages 6 months and older, finding that the shot was safe and reduced the risk of hospitalization and death. The drugmaker also noted there are about a dozen post-approval studies evaluating the safety of the shots in more than 60 million people globally.
Pfizer and Moderna did not immediately respond to a request for comment.
Anti-vaccine activists have long pointed to VAERS data as evidence that vaccines are dangerous, but definitive conclusions cannot be drawn from VAERS reports alone.
Health and Human Services Secretary Robert F. Kennedy. Jr., a longtime anti-vaccine activist, referenced the database during a Senate Finance Committee hearing last week.
“There were more reports to VAERS, which is the only surveillance system we have of injuries and deaths from that vaccine, than all vaccines put together in history,” Kennedy said, referring to the Covid vaccine.
Over the summer, Kennedy fired all the members of ACIP and replaced them with his own handpicked members, some of whom are known anti-vaccine activists. The American Academy of Pediatrics called Kennedy’s new members a “radical departurer” from the committee’s mission of protecting children.
One of the new panel members, Retsef Levi, has been tapped to lead the panel’s Covid vaccine work group. Levi is a professor at the Massachusetts Institute of Technology and is not a doctor. He has claimed that Covid vaccines cause serious harm and death.
Any recommendations made during the ACIP meeting could influence who is able to get a Covid shot.
Kennedy has already taken steps to limit access to this year’s vaccine: Last month, he announced that the FDA had approved updated Covid shots for the fall for people 65 and up and those with underlying medical conditions. The limited approval has left some patients and pharmacies confused, and some patients report that they haven’t been able to get the shots.
In a Wall Street Journal op-ed published last week, Makary said the approval brings the U.S. in line with peer nations, including France, which recommends Covid shots for people over 80, and the U.K., which recommends the shots for people over 75.
“The FDA can approve products only if we believe there is substantial certainty that the benefits outweigh the risks,” Makary wrote, questioning whether the benefits of a “seventh Covid shot” currently outweigh the risks for a “healthy 12-year-old girl who recently recovered from Covid.”
