I’ll outline what happened with FDA reviews of pediatric COVID vaccine deaths, show what the December 5, 2025 FDA memo said, explain how officials handled safety signals and monitoring systems, and detail the congressional actions seeking more records and accountability.
While officials publicly insisted pediatric COVID vaccines were safe, internal FDA reviewers compiled a file on 96 children who died after vaccination and concluded a subset of those deaths were possibly or probably related to the shots. The FDA team examined autopsy reports, death certificates, and medical records, then labeled several cases as new safety information under federal law. That designation, the reviewers said, was never added to the vaccine warning label even as government messaging pressed parents to vaccinate their kids.
The memorandum at the center of this reporting is dated December 5, 2025, and focuses on 96 pediatric deaths reported to VAERS, the federal Vaccine Adverse Event Reporting System. FDA medical officers found seven cases they judged “possibly” or “probably” linked to vaccination, with five of those involving myocarditis. These were not abstract numbers; the reviewers say they based those conclusions on actual medical documentation.
Most of the children in the reviewed cases were boys, with a median age of 13 and an age range from 7 to 16, and every death occurred between 2021 and 2022, the period of intense vaccination outreach for minors. All seven probable and possible cases involved the Pfizer-BioNTech vaccine, according to the memorandum. The reviewers classified the findings as new safety information, yet the public label and official guidance did not meaningfully change in response.
Sen. Ron Johnson released records referenced in a May 11, 2026 letter to HHS Secretary Robert F. Kennedy Jr., and investigative reporting first brought the documents into the open. The FDA memo does not try to extrapolate a full population toll, but it sits alongside other indicators that adverse events are vastly underreported, making the true scale hard to gauge.
An HHS-commissioned Harvard study has estimated that fewer than one percent of vaccine adverse events are reported to VAERS, a fact that raises the likelihood these 96 reviewed cases represent only a portion of pediatric harms. As of March 2026, VAERS showed 39,077 deaths worldwide following COVID-19 vaccination, a raw figure that the FDA memo did not expand upon. Systematic underreporting means that the full scope of potential pediatric harm remains deeply uncertain.
Beyond underreporting, congressional investigators say the system used to detect safety signals was actively flawed. An April 2026 report detailed that FDA officials were warned in March 2021 that their analytical system was obscuring red flags, and were later shown a superior algorithm that revealed dozens of buried signals, including sudden cardiac death and pulmonary infarction. Despite that, the agency allegedly continued to run the old system and set aside the better method.
Johnson’s report states that three weeks after the initial alert, staff handed officials results pointing to 49 cases where signals had been buried and 25 serious warnings the old system missed. According to the report, the new algorithm was shelved while the broken process stayed in use, a choice that critics argue kept safety signals out of public view. The memo and related documents describe internal conclusions that were not mirrored in public health guidance.
Accounts tied to the investigation also say NIH clinicians were treating patients injured after COVID vaccination as early as March 2021, yet those patients were reportedly told to remain quiet and promised a study that never appeared. Investigative records indicate Dr. Avindra Nath led a clinical team that treated dozens of patients who were allegedly asked not to speak publicly about their care, and no comprehensive study acknowledging their experience was published.
The congressional push has moved from exposure to demands for documents and accountability. Sen. Johnson’s May 11 letter asks for remaining records on pediatric vaccine deaths that have not been produced and presses for confirmation that the HHS Inspector General is probing allegations of deleted federal records. The inquiry references past referrals and recent indictments tied to conduct during the COVID response, seeking clarity about who will be held responsible.
Two direct quotations from the congressional record underline the urgency lawmakers feel about these findings. “They could be confident they would never find what they weren’t looking for,” Johnson wrote about the decision to keep a flawed monitoring system in place. He added a later demand: “Five years have already passed since Dr. Marks decided to ignore VAERS safety signals,” and called for an acceleration of the discovery process.
FDA reviewers concluded that certain pediatric deaths were potentially linked to vaccination and labeled the files as new safety information, yet public labeling and many official statements did not reflect those internal assessments. The documents and the congressional response aim to force disclosure of remaining records and to determine whether federal investigators will pursue alleged mishandling of sensitive safety data.
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