Staff Reports
Senator Ron Johnson this week released internal FDA files that raise big questions about how federal health agencies handled reports of children who died after getting mRNA COVID vaccines. The documents show career reviewers at the FDA initially flagged 10 pediatric deaths as probably or possibly linked to the shots, then changed three of those decisions so the total fell to seven. The papers also show a Division of Pharmacovigilance recommendation to add “myocarditis with fatal outcomes” to vaccine labeling — a warning that never made it into the official label.
What the newly released documents actually say
The core of this story is a June 16 letter from Senator Ron Johnson, Chairman of the Senate Permanent Subcommittee on Investigations, to HHS Secretary Robert F. Kennedy Jr., Acting CDC Director Jay Bhattacharya, and Acting FDA Commissioner Kyle Diamantas. He attached draft FDA/CBER memoranda and emails showing a December review of 96 pediatric VAERS reports. The review used standard causality categories and found zero deaths that were “certainly” caused by vaccination, but it did classify a handful as “probable” or “possible” and recommended stronger myocarditis warnings. That recommendation reportedly was discussed in a December meeting — but the label change was not implemented.
Autopsies, parvovirus and why the science is messy
The documents show some deaths were downgraded after reviewers pointed to other findings, like parvovirus detection or bacterial growth on tissue slides. One forensic pathologist called the parvovirus finding a “red herring,” noting the heart damage seen in these autopsies looks different from classic parvovirus heart disease. The FDA used accepted causality categories — possible, probable, unlikely — which do not equal proof. Still, the presence of competing explanations does not erase the timing and pattern of cardiac injury reported in those pediatric cases. Parents deserve clear answers, not bureaucratic obfuscation.
Follow the money: the CDC Pfizer purchase and agency accountability
Johnson tied the document release to another eyebrow‑raiser: a roughly $1.24 billion CDC procurement for Pfizer vaccines. He asked for all records explaining that purchase and set a deadline for agency responses. That’s the right move. If FDA reviewers recommended a labeling change over myocarditis with possible fatal outcomes, the public needs to know why the label stayed the same and why large federal buys moved forward. Trust in vaccine safety depends on transparent decision‑making, not on closed‑door edits to assessments about dead children.
Conclusion — transparency, not spin
At a minimum, HHS, CDC and FDA should answer Senator Johnson’s questions and release the underlying records. If the Division of Pharmacovigilance asked to add “myocarditis with fatal outcomes” to labels, explain why it didn’t happen. If competing autopsy findings convinced career reviewers to change some case adjudications, publish the reasoning and the evidence. The American people deserve plain talk about vaccine safety, clear labeling, and a government that does not look like it’s playing hide‑and‑seek with parents. Bureaucrats can’t have it both ways: they cannot ask for public trust while keeping the files under lock and key.
