In a move that has reignited fierce debate across the country, officials from the United States Food and Drug Administration (FDA) are preparing to present data next week that they claim links COVID-19 vaccinations to at least 25 deaths among children. The presentation, set for the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) on September 18 and 19, 2025, is already drawing intense scrutiny from medical experts, public health officials, and political figures, according to reports from The Washington Post, NBC News, and The New York Times.
The FDA’s forthcoming report is based on an analysis of entries in the Vaccine Adverse Event Reporting System (VAERS), a publicly accessible database managed jointly by the FDA and CDC. VAERS allows doctors, patients, and caregivers to submit reports of adverse events they believe may be linked to vaccines. Importantly, these reports are unverified and can include anything from suspected side effects to unrelated incidents. The CDC itself cautions that “a report alone doesn’t prove a vaccine caused an adverse reaction,” and that all reports, especially those involving deaths, trigger follow-up investigations before any formal determination is made.
Dr. Tracy Beth Høeg, a senior adviser for clinical sciences at the FDA and a sports medicine physician who previously voiced skepticism about COVID-19 shots for children, is expected to present the findings at the ACIP meeting. According to CNN and NBC News, Dr. Høeg’s review focuses on case reports involving children who died soon after receiving COVID-19 vaccines, including at least one death potentially linked to myocarditis, an inflammation of the heart muscle. The FDA’s presentation comes as ACIP prepares to make crucial recommendations about which groups of Americans should be inoculated with updated COVID-19 vaccines this fall, and who should receive them with government subsidies.
FDA Commissioner Dr. Marty Makary addressed the issue in a recent interview with CNN, stating, “We’ve been looking into the VAERS database of self-reports that there have been children that have died from the COVID vaccine. 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.” He further emphasized the need for transparency, saying, “We think the public deserves to have that information. It was not released in the last administration, and it should have been.”
The timing of the FDA’s review is notable. It follows sustained pressure from Health and Human Services Secretary Robert F. Kennedy Jr. and his allies, who have called for greater public disclosure of vaccine safety data. Kennedy, a longtime critic of vaccines, recently replaced all 17 members of the ACIP with his own appointees, some of whom are known for their skepticism toward COVID-19 vaccines. The American Academy of Pediatrics described the new committee as “a radical departure” from the mission of protecting children. One of the new ACIP members, MIT professor Retsef Levi, has been tapped to lead the panel’s COVID-19 vaccine work group despite not being a medical doctor and having publicly claimed that COVID-19 vaccines cause serious harm and death.
The FDA’s reliance on VAERS data has drawn sharp criticism from many in the medical community. Angela Lynn Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, voiced her concerns on X (formerly Twitter): “Manipulating VAERS is one of the oldest tricks in the anti-vax book. There was no meaningful analysis here. This decision was already made and VAERS is being used to manufacture justification.” Dorit Reiss, a vaccine policy expert at the University of California Law, San Francisco, echoed this skepticism, telling NBC News, “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.”
Indeed, numerous peer-reviewed studies have consistently found COVID-19 vaccines to be safe and effective in children. A 2023 analysis published in JAMA Pediatrics reviewed data from over 10 million vaccinated children aged 5 to 11, showing reduced risk of infection and hospitalization compared to unvaccinated peers. Similarly, a 2024 study in Nature Communications found no increased risk of adverse events in young children who received COVID-19 vaccines from Pfizer and Moderna, though it did note a small increased risk of myocarditis in male teenagers after the first two doses. At an FDA advisory committee meeting in May, Pfizer presented real-world data from tens of thousands of children, finding that the vaccine was safe and reduced the risk of hospitalization and death. Pfizer also highlighted ongoing post-approval safety studies involving more than 60 million people worldwide.
Despite the scientific consensus, public opinion remains deeply divided. A recent Rasmussen Reports survey conducted from September 7 to 9, 2025, found that 56% of likely U.S. voters consider it likely that side effects from COVID-19 vaccines have caused “a significant number of unexplained deaths.” More than one-third of respondents said it was not likely that significant deaths had resulted from the vaccines.
The political undertones of the FDA’s investigation are hard to ignore. Many public health experts and former FDA officials see the review as a response to mounting claims from Kennedy and his allies that vaccine safety data has been withheld from the public. “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,” one former FDA official told NBC News anonymously. “Unless someone was hiding them from us I don’t know what they’re referring to.” Dr. Peter Marks, the former top FDA vaccine regulator, told The New York Times, “To the best we could see, these vaccines were not associated with the deaths of children. Is it possible that a death could have occurred that was related to the vaccines? Yes, I guess, possible. But in terms of the millions of doses given of these mRNA vaccines, they really had — aside from the known side effect of myocarditis, pericarditis — they had a very good safety profile.”
The upcoming ACIP meeting could have significant consequences for vaccine policy nationwide. Recommendations from the committee may influence who is eligible for COVID-19 shots, insurance coverage, and even availability in some states. Already, the FDA has limited use of COVID-19 vaccines to people 65 and older or those with underlying health conditions. This has led to confusion at pharmacies and prompted some state governors to override federal guidelines, allowing broader access to the shots.
As the debate rages on, the FDA’s decision to bring VAERS data to the forefront—despite its limitations—underscores the ongoing struggle between scientific evidence, public perception, and political influence in America’s pandemic response. With millions of children vaccinated and the vast majority experiencing no serious side effects, the nation awaits the ACIP’s recommendations and the FDA’s full report, hoping for clarity in a landscape crowded by uncertainty and distrust.
