For years, anyone who questioned the safety of COVID-19 shots for children was derided as an “anti-vaxxer.” Parents who hesitated were pressured to comply, and pediatricians who voiced doubts risked professional backlash.
Now an internal FDA memo has put that certainty under a harsh spotlight.
Between 2021 and 2024, the agency’s own safety reviewers identified at least ten deaths in children and adolescents ages 7 to 16 that they classified as “likely, probable, or possible” vaccine-related, following an in‑depth review of pediatric reports in the federal adverse event reporting system.
Lead and scene
When an internal memo from the Food and Drug Administration quietly circulated through agency inboxes this fall, it landed like a bomb among staff who had spent years reassuring the public that COVID-19 vaccines were “safe and effective” for nearly everyone. In blunt language, the memo asserted that an FDA review of federal safety reports had identified at least 10 deaths in U.S. children that were “likely, probable, or possible” consequences of COVID-19 vaccination—a first-of-its-kind admission inside the agency.
The meme stated, “Dear Team CBER, I am writing to report that OBPV career staff have found that at least 10 children have died after and because of receiving COVID-19 vaccination. These deaths are related to vaccination (likely/probable/possible attribution made by staff). That number is certainly an underestimate due to underreporting, and inherent bias in attribution. This safety signal has far reaching implications for Americans, the US pandemic response, and the agency itself, which I wish to
discuss here. I also want to address some frequent objections.”
To read the entire memo, click here.
Publicly, however, the story that parents heard from most major news outlets during the pandemic was far simpler: vaccinate your kids, full stop. Skeptical clinicians were cast as fringe, worried parents as misinformed, and vaccine risk was often framed as a talking point of “anti-vaxxers” rather than a legitimate subject for open debate.
What the FDA memo actually says
According to reporting based on the leaked document, the internal analysis by FDA safety staff examined dozens of pediatric deaths reported to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024. The memo’s author, the agency’s chief medical and scientific officer, wrote that “no fewer than 10” of those deaths were judged to be “because of” COVID vaccination, with myocarditis, or heart inflammation, flagged as a likely mechanism in several cases.
“The evidence before us constitutes a profound revelation,” the official wrote, calling the findings the first time the FDA had explicitly acknowledged that COVID vaccines “have killed children.” The memo did not disclose the children’s ages, underlying health conditions, or which manufacturers’ vaccines were involved, and it has not been published in a peer-reviewed journal or released in full for independent scrutiny.
In a subsequent television interview, FDA Commissioner Marty Makary confirmed that agency data pointed to 10 pediatric deaths attributable to COVID vaccination and pledged an “intense investigation” and tighter standards for future vaccine approvals. “When we say rare, we have to remember those rare cases have names, parents, birthdays,” Makary said. “Our job now is to understand what happened and to make sure our processes reflect that reality.”
Parents who felt dismissed
For many parents, the memo landed as a bitter vindication. Over the past four years, surveys have consistently found that safety concerns and the perception that COVID is less dangerous for children were the dominant reasons families hesitated to vaccinate their kids. Yet parents who voiced those worries in school meetings or pediatric waiting rooms often found themselves ridiculed as ignorant or selfish.
“I wasn’t against vaccines,” said Maria Hernandez, a mother of two in Texas who delayed COVID shots for her 9-year-old son after hearing about myocarditis in teenage boys. “I just wanted someone to look me in the eye and say, ‘Here’s the risk, here’s the benefit, here’s what we still don’t know.’ Instead I got, ‘Do you want to kill your grandmother?’”
What changes the FDA is proposing
In response to the memo and months of internal debate, FDA leaders have begun outlining a tougher framework for evaluating future vaccines, particularly for low‑risk groups like healthy children. Proposals include requiring larger and longer trials before products are authorized for pediatric use, mandating randomized evidence for each age band, and tightening post‑marketing surveillance thresholds that trigger public communication and regulatory review.
“The bar for exposing healthy kids to a new biomedical product should be higher than the bar for adults at high risk from a disease,” Commissioner Makary said in one recent interview. “We didn’t always get that balance right in the urgency of the pandemic. We have to learn from that.”
The agency has also signaled that data from the memo’s review will be presented to an upcoming advisory committee at the Centers for Disease Control and Prevention, where outside experts will be able to press FDA staff on methods and assumptions in a public forum.
In June, Kennedy dismissed all 17 sitting members of the committee and installed a new slate, a move he said in a memo was intended to “restore public trust” in vaccines.
