Sen. Ron Johnson released internal FDA emails that he says show agency officials revised assessments of pediatric deaths after COVID-19 vaccination, even as FDA pharmacovigilance staff recommended adding a warning about myocarditis with fatal outcomes to vaccine labels.
By yourNEWS Media Newsroom
Newly released internal Food and Drug Administration emails are raising questions about how federal officials reviewed pediatric deaths reported after COVID-19 vaccination, according to a report by the Daily Caller News Foundation.
The emails were released by Sen. Ron Johnson, R-Wis., in a June 16 letter seeking more information about a reported $1.24 billion Centers for Disease Control and Prevention purchase of Pfizer COVID-19 vaccines.
2026-06-16-RHJ-to-HHS-CDC-FDA1 by yourNEWS Media
Johnson said the records show FDA officials initially identified 10 pediatric deaths as probably or possibly connected to COVID-19 vaccines in late 2025, before revising several of those assessments within days.
Even after the revisions, the FDA’s Division of Pharmacovigilance recommended changing the labels for the Moderna and Pfizer vaccines to warn about the risk of “myocarditis with fatal outcomes,” according to the DCNF report. That label change did not occur, according to the report.
The FDA did not respond to the outlet’s request for comment. Pfizer and Moderna also did not respond to requests for comment.
Johnson’s Homeland Security and Government Affairs Select Subcommittee on Investigations has obtained millions of emails and other records from Health and Human Services Secretary Robert F. Kennedy Jr. and his investigative team. The subcommittee has released reports and held hearings based on those documents.
“The safety issues with the COVID-19 injections that the Subcommittee has uncovered so far should have raised serious concerns at HHS and CDC about the mRNA COVID-19 Injections,” Johnson wrote in the letter. “Instead, 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.”
According to the emails cited in the report, FDA officials last fall identified 10 pediatric deaths after COVID vaccination. Within days, that number was reduced to seven, and several cases were reclassified in a way that made them appear less likely to be vaccine-related.
“Although what drove the decision to change these three cases remains to be seen, what is clear is that these officials appear to have determined that the seven cases warranted warning about the risks,” Johnson wrote.
The report said two cases were downgraded in part because of positive parvovirus tests. Yale School of Medicine pathologist James Gill, a forensic pathologist who conducted autopsies on two teenage boys who died of myocardial injury days after receiving a second Pfizer dose, told the DCNF that citing parvovirus was a “red herring.”
Gill said parvovirus can be detected in the tissues of about half the population, and sensitive PCR tests can identify the virus years after infection.
“Essentially they could exclude about half of the potential complications because of this finding,” Gill said.
Gill said heart problems caused by parvovirus and the heart findings observed after vaccination show different microscopic patterns.
“It’s like saying everyone with blue eyes must be excluded. It’s kind of arbitrary I think,” he said. “It’s a red herring. Whether or not it was intentionally used as one, I don’t know, but certainly that would be a case of looking at the pathology.”
One former FDA official told the DCNF that the emails suggest federal agencies suppressed or minimized serious safety findings.
“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. During the heightened media scrutiny of this topic, scientists downcoded their initial impression of deaths,” the former official, who was granted anonymity to discuss sensitive matters, told the outlet. “There is little desire for an accurate appraisal of covid vaccine benefits and harms inside the agency.”
A second former FDA official told the DCNF that the emails raise questions about transparency and the agency’s internal review process.
The email “raises questions about the case adjudication process and FDA transparency, for example, why these 10 cases were not brought to public attention earlier than the end of 2025,” the second former official said.
The pediatric deaths occurred in 2021 and 2022, but according to Johnson’s letter and the DCNF report, they did not become public through the FDA review process until 2025 after the Trump administration returned to office.
“One wonders if there was internal pressure at the FDA during that time not to report these pediatric deaths in a timely manner,” the second former official said.
Johnson’s letter said that under Kennedy’s leadership, federal health officials appeared to begin addressing what he described as the Biden administration’s failure to seriously examine COVID-19 vaccine safety concerns.
On Nov. 22, 2025, the FDA office responsible for COVID vaccine safety identified 10 pediatric deaths as probably or possibly connected to the COVID-19 injections, according to the emails.
Vinay Prasad, director of the Center for Biologics Evaluation and Research, later referenced the figure in a Nov. 28 memo to staff. In that memo, Prasad called for higher vaccine standards and “humility” from the FDA in response to the findings. The memo, which became known as Prasad’s “Black Friday memo,” leaked to reporters within hours and triggered a media backlash.
By Dec. 5, 2025, CBER officials had changed findings on three pediatric deaths from “probably” or “possibly” caused by COVID-19 vaccines to “un-assessable” or “unlikely.” They also downgraded one death from “probably” vaccine-induced to “possibly” vaccine-induced.
“This was a MONUMENTAL effort from all of us, to do a diligent review while being bombarded with media articles on the subject,” Meghna Alimchandani, deputy director of the FDA Division of Pharmacovigilance, wrote in a Dec. 5 email.
The second former FDA official also pointed to how FDA and CDC staff handled a 2022 study coauthored by Gill involving two teenage boys who died with fatal heart issues after COVID vaccination.
That study prompted an urgent rebuttal from FDA and CDC officials, according to internal documents obtained through the Freedom of Information Act by The Epoch Times.
The CDC had stored tissue slides from the boys that Gill’s team sent in for review. The agency tested the samples and reported evidence of clostridium septicum, a bacterium associated with gas gangrene, as well as parvovirus. Federal officials argued in their own paper that the findings complicated Gill’s conclusions.
Gill’s team disagreed, saying parvovirus would produce a different pattern in heart muscle than what they observed. They also argued that bacteria can grow on cells after tissue has been stored for weeks.
Documents released through Johnson’s investigation show that in its 2025 assessment, FDA classified one of Gill’s cases as “probably” vaccine-related and the other as “possibly” vaccine-related, citing evidence of parvovirus.
Gill said FDA and CDC officials did not contact him to discuss the cases in either 2022 or during the 2025 review.
“Why would you even not want to discuss it with me professionally and sort it out?” Gill 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,” he added.
Johnson’s letter also referenced broader concerns about vaccine safety and cited bipartisan concerns over pharmaceutical companies and federal health decisions.
The newly released emails are likely to intensify congressional scrutiny of FDA and CDC decisions surrounding COVID-19 vaccine safety reviews, vaccine labeling and the handling of adverse event reports involving children.