Food and Drug Administration officials are preparing to present data at next week's CDC Advisory Committee on Immunization Practices meeting that they claim links COVID-19 vaccines to 25 deaths in children, according to sources familiar with the plan confirmed by NBC News.
The presentation is scheduled for the committee's Thursday and Friday meeting, where officials will review and make recommendations on several vaccines, including this fall's updated COVID shots. The FDA's analysis is based on data from the Vaccine Adverse Event Reporting System (VAERS), a publicly available database maintained by the FDA and CDC.
Controversy Over Data Interpretation
Health experts are raising significant concerns about the FDA's approach to the VAERS data. Dorit Reiss, a vaccine policy expert at the University of California Law, San Francisco, emphasized that the database reports cannot 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," Reiss said.
The VAERS system allows anyone — including doctors, patients and caregivers — to submit unverified reports about adverse events they believe are linked to vaccines. The database's own website warns that reports "can contain inaccurate, incomplete or biased information" and states there are "limitations on how the data can be used scientifically."
A former FDA official who requested anonymity pushed back strongly on the findings, stating: "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. Unless someone was hiding them from us I don't know what they're referring to."
Leadership Changes and Political Context
The presentation comes amid significant changes to the CDC's advisory structure. HHS Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, fired all members of the Advisory Committee on Immunization Practices over the summer and replaced them with his own appointees, some of whom are known anti-vaccine activists.
One of the new panel members, Retsef Levi, has been selected to lead the panel's COVID vaccine work group. Levi is a professor at MIT who is not a medical doctor and has claimed that COVID vaccines cause serious harm and death. The American Academy of Pediatrics called Kennedy's new appointments a "radical departure" from the committee's mission of protecting children.
FDA Commissioner Marty Makary told CNN last week that the agency was investigating reports of possible childhood deaths linked to the vaccine. "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."
Current Safety Evidence
Multiple large-scale studies continue to demonstrate the safety of COVID-19 vaccines in children. A 2023 analysis published in JAMA Pediatrics reviewed 17 studies involving over 10 million children ages 5 to 11 who received mRNA shots from Pfizer and Moderna. The research showed the vaccines reduced the risk of infection and hospitalization in vaccinated children compared to unvaccinated children.
Another study published in Nature Communications in 2024 found no increased risk of adverse events in young children who received COVID shots, though it identified a small increased risk of myocarditis in male teens following the first two doses.
At an FDA advisory committee meeting in May, Pfizer presented real-world safety data on its COVID vaccine in tens of thousands of children ages 6 months and older, finding the shot was safe and reduced the risk of hospitalization and death.
Known Side Effects and Risk Assessment
The CDC has acknowledged that myocarditis and pericarditis are known but rare COVID vaccine complications. A recent FDA analysis estimated these conditions occur in one in 125,000 doses of the 2023-2024 shots for children and adults under 65. However, for young men under 25, the risk was higher at 19 per 500,000 doses, equivalent to one in 250.
VAERS has received approximately 1,600 reports of myocarditis linked to the shots, but federal figures show the side effect remains extremely rare. The CDC emphasizes that while most cases are mild, severe myocarditis can in rare instances damage the heart and potentially lead to heart failure, heart attack, and stroke.
Current Vaccine Recommendations
Kennedy has already taken steps to limit access to this year's COVID vaccine, approving updated shots only for people 65 and older and those with underlying medical conditions. This limited approval has created confusion among patients and pharmacies, with some patients reporting difficulty obtaining the shots.
In a recent Wall Street Journal op-ed, Makary defended the restricted approval, stating it brings the U.S. in line with peer nations like France, which recommends COVID shots for people over 80, and the U.K., which recommends them for people over 75.
Andrew Nixon, a spokesperson for the Department of Health and Human Services, said in a statement: "FDA and CDC staff routinely analyze VAERS and other safety monitoring data, and those reviews are being shared publicly through the established ACIP process. Any recommendations on updated Covid-19 vaccines will be based on gold standard science and deliberated transparently at ACIP next week."
