Internal FDA emails released by Wisconsin Senator Ron Johnson show that career staff revised their assessments of children suspected of dying from COVID-19 vaccines, reducing the number of probable or possible vaccine-related pediatric deaths within days of an initial finding — even as the agency’s own pharmacovigilance division recommended adding a fatal heart-inflammation warning to vaccine labels. That warning was never added.
Johnson released the emails in a June 16 letter demanding answers about a recent $1.24 billion CDC contract awarded to Pfizer for COVID vaccines, citing bipartisan concerns about safety. The FDA, Pfizer, and Moderna did not respond to requests for comment.
The timeline begins November 22, 2025, when the FDA’s Center for Biologics Evaluation and Research identified 10 pediatric deaths as probably or possibly connected to COVID-19 injections. Center director Vinay Prasad announced the figure in a memo calling for higher standards and “humility” from the agency. The memo leaked within hours, triggering widespread media coverage.
By December 5, officials had revised three cases downward — from “probably” or “possibly” vaccine-related to “un-assessable” or “unlikely” — and downgraded a fourth from “probably” to “possibly” vaccine-induced, all during intense public scrutiny. “This was a MONUMENTAL effort from all of us, to do a diligent review while being bombarded with media articles on the subject,” wrote Meghna Alimchandani, deputy director of the FDA Division of Pharmacovigilance.
Two of the downgraded cases were revised partly because of positive parvovirus tests. Yale pathologist James Gill, who autopsied two teenage boys who died of myocardial injury days after their second Pfizer dose, called that reasoning a “red herring.” Parvovirus is detectable in roughly half the population years after infection, and the heart damage it causes produces a different microscopic pattern than what his team observed. “It’s like saying everyone with blue eyes must be excluded,” Gill said. “It’s kind of arbitrary.”
Gill said neither the FDA nor CDC ever contacted him to discuss the cases. “Why would you not even want to discuss it with me professionally and sort it out?” he said. “I tried to engage them in that dialogue and they shut it down because they had already made up their mind that this was not a death due to the vaccine.”
The deaths occurred in 2021 and 2022 but did not surface publicly until 2025. One former FDA official told the Daily Caller News Foundation the emails amount to a coverup. “The career FDA scientists identified new safety information not on the label — that COVID-19 shots have caused deaths — that information should be added to the label, but has not been,” the official said. “There is little desire for an accurate appraisal of COVID vaccine benefits and harms inside the agency.”
Johnson said the CDC’s new Pfizer contract signals the agency has not absorbed the findings. “CDC’s reported awarding of approximately $1.24 billion in new contracts to Pfizer for a vaccine linked to serious adverse events — including potentially the deaths of children — suggests CDC continues to fail to take its vaccine safety responsibilities seriously,” he wrote.
Additional document releases from Johnson’s subcommittee are expected as the investigation continues.
