This article originally appeared on The Defender and was republished with permission.
Guest post by Michael Nevradakis, Ph.D.
In November 2025, the FDA’s Center for Biologics Evaluation and Research identified 10 child deaths related to the COVID-19 shots. In December 2025, the agency reduced the number to seven after revising at least two of the children’s autopsies, according to documents released last week by Sen. Ron Johnson.
Scientists at the U.S. Food and Drug Administration (FDA) revised the autopsy results of children who died after receiving the COVID-19 vaccine, reducing the number of children the agency classified as having likely died as a result of their vaccination, according to documents released last week by Sen. Ron Johnson (R-Wis.).
The documents show that in November 2025, the FDA’s Center for Biologics Evaluation and Research (CBER) identified 10 child deaths related to the COVID-19 shots. But in December 2025, it reduced the number to seven and downgraded the probability that those deaths were connected to the children’s vaccination.
The Daily Caller, which first reported, quoted two former FDA officials and a forensic pathologist who performed two of the children’s autopsies. One of the FDA officials told the outlet the emails reveal “a coverup” by the FDA and the Centers for Disease Control and Prevention (CDC).
Johnson included the documents in a letter sent last week to U.S. Health Secretary Robert F. Kennedy Jr., CDC Acting Director Jay Bhattacharya and FDA Acting Commissioner Kyle Diamantas.
Even the reduced number of deaths was enough to trigger concern among some FDA scientists about the safety of the COVID-19 shots, Johnson’s letter stated.
“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. These risks “should have raised serious concerns at HHS and CDC about the mRNA COVID-19 Injections.”
Even after the downgrade, the FDA’s Division of Pharmacovigilance recommended revising the label of the Pfizer and Moderna mRNA COVID-19 vaccines to include a warning about the risk of “myocarditis with fatal outcomes.”
The change was never made, for reasons that are not clear.
Myocarditis is widely associated with the mRNA COVID-19 vaccines and, with reports of deaths connected to the vaccines, particularly among teenage and young adult males.
Sen. Johnson: ‘The biggest government scandal’ of his lifetime
Johnson, who chairs the U.S. Senate Permanent Subcommittee on Investigations, is investigating a potential federal cover-up of COVID-19 vaccine risks.
In a post on X earlier this month, Johnson called the cover-up “way bigger than Watergate.” In a follow-up post, he called it “the biggest government scandal” of his lifetime.
According to the Daily Caller, the children’s deaths occurred in 2021 and 2022, but were not revealed until 2025.
One of the unnamed FDA officials who spoke to the outlet said, “One wonders if there was internal pressure at the FDA during that time not to report these pediatric deaths in a timely manner.”
Attorney Greg Glaser said the FDA’s “maneuvering to obscure the true devastation of these vaccines is the definition of a fraudulent act” to protect Big Pharma.
Johnson is asking the CDC to provide him with all records relating to its decision to award Pfizer new contracts for its COVID-19 shots, and all CDC and FDA records about child deaths related to COVID-19 vaccination and any deliberations that occurred over whether to change the labels of the Pfizer and Moderna vaccines.
Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), said the number of child deaths linked to the COVID-19 shots is likely much higher, citing reports from the federal Vaccine Adverse Event Reporting System (VAERS). He said:
“VAERS reports (for U.S. only) show 84 child deaths (17 and under) from the COVID shot. We know that because of the gross underreporting of VAERS and the consistent efforts by the medical profession to mask vaccine deaths, 84 child deaths are only the tip of the iceberg when it comes to mortality associated with the COVID shot.
“In light of this, it seems ridiculous to quibble over the HHS [U.S. Department of Health and Human Services] trying to reduce the number of deaths from 10 to 7. However, it belies the fact that when it comes to vaccines, the deep state within HHS, past and present, will lie through their teeth about a death or injury related to vaccines.”
Rutgers University molecular biologist Richard Ebright, Ph.D., said the deaths are the outcome of a government cover-up of the “reckless” gain-of-function research “that caused COVID” and “killed 20 million and cost $25 trillion.”
HHS did not respond to The Defender’s request for comment by press time.
FDA officials who studied child deaths linked to COVID shots later ousted
The Daily Caller published a Dec. 5, 2025, email by Dr. Meghna Alimchandani, deputy director of the FDA Division of Pharmacovigilance, to then-CBER Director Vinay Prasad, informing him of the downgrade from 10 to seven deaths.
Of the seven deaths, two were deemed “probable” and five were classified as “possible.” Five of the seven deaths involved myocarditis, with two of those considered “probable” and three “possible.” That email also contained the recommendation to change the Pfizer and Moderna vaccine labels.
A week earlier, on Nov. 28, 2025, Prasad sent a memo to CBER staff informing them that he had evidence that “at least 10 children have died after and because of receiving COVID-19 vaccination.” In that memo, Prasad linked those children’s deaths to the Biden administration’s COVID-19 vaccine mandates.
“For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children. Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death,” Prasad wrote.
According to the Daily Caller, the memo leaked to the press “within hours,” resulting in “a media firestorm.” In her email to Prasad, Alimchandani wrote that the FDA’s review of the children’s deaths was a “MONUMENTAL effort … while being bombarded with media articles on the subject.”
Tracy Beth Høeg, M.D., Ph.D., who at the time was acting director of the FDA’s Center for Drug Evaluation and Research and who was investigating VAERS reports of children who died after receiving a COVID-19 shot, noted that Prasad’s memo contained indications that a cover-up was underway. The memo stated:
“Dr. Hoeg organized a small meeting to discuss these deaths with OVRR [Office of Vaccines Research and Review] … stakeholders. The slides she presented, emails she sent, and distorted firsthand reports was shared with media outlets. The general narrative was that OVRR staff disagreed with Dr. Hoeg’s assessment that the deaths were due to vaccine receipt.
“Some staff present who leaked portrayed the incident as Dr. Hoeg attempting to create a false fear regarding vaccines.”
In April, Prasad resigned from the leadership of CBER — for the second time in less than a year. Last month, the FDA fired Høeg for unknown reasons. Her ouster came a week after Dr. Marty Makary resigned his FDA commissioner post following rumors that he would be fired.
Høeg had previously authored a report recommending that the number of diseases sccovered by the childhood vaccination schedule be reduced from 17 to 11.
Writing on Substack, Høeg questioned whether “any of these 10 cases have come to light if I had not given that presentation and Vinay had not asked for a ‘detailed analysis’ of the cases” or if Johnson “had not pursued getting the information.”
Claims children died due to parvovirus a ‘red herring’
The documents Johnson released show that two of the deaths were downgraded in part because of the presence of parvovirus B19 — a commonly occurring virus that causes mild symptoms in most people.
But in remarks shared with the Daily Caller, Dr. James Gill, a Yale School of Medicine pathologist who conducted the autopsies of two of the children who died postvaccination and published his findings in 2022, said the FDA and CDC’s parvovirus explanation is a “red herring.”
“Essentially, they could exclude about half of the potential complications because of this finding,” Gill said. He noted that parvovirus is found in the tissues of approximately half the population.
Gill said that while parvovirus infection can lead to heart problems, it would result in a different pattern of injury than what he observed in the two children. In his 2022 paper, Gill noted that the two children demonstrated symptoms of atypical myocarditis instead of “the alterations seen with typical myocarditis.”
Gill’s published study of the two cases “provoked an urgent rebuttal from the FDA and CDC,” the Daily Caller reported, citing documents the Epoch Times obtained through a Freedom of Information Act request.
The FDA documents Johnson released confirmed that the cases were downgraded in part due to the presence of parvovirus.
Karl Jablonowski, Ph.D., senior research scientist for CHD, said the CDC “muddied the waters” and “deliberately obscured” the evidence. Jablonowski referred to his analysis of the VAERS reports of two of the seven children listed in the documents Johnson released, noting that the FDA and CDC reached different conclusions.
One of the children, 16-year-old Micah Williamson, died a few days after receiving the second dose of the Pfizer COVID-19 shot. His death certificate attributed his death to “stress cardiomyopathy” related to his vaccination, and his VAERS report indicated myocarditis.
Yet, “The CDC claimed the presence of parvovirus B19 made the myocarditis of viral origins and not the vaccine,” Jablonowski said.
The FDA classified Williamson’s death as “possibly related to COVID-19 vaccination,” noting that “parvovirus B19 likely has long-term persistence in heart tissues and is frequently detected in heart tissues from autopsies of patients with no clinical or histopathologic evidence of myocarditis.”
Another of the children cited in Johnson’s documents, Jacob Clynick, died on June 16, 2021, three days after receiving his second Pfizer dose. His VAERS report referred to flu-like illness, but the report was later updated to include cardiac conditions including myocarditis, pericardial effusion and cardiomegaly.
This updated report was deleted in May 2025, Jablonowski said. Yet, “the CDC found a bacterial growth, and overstepping its purview, concluded that the death was attributable to C. septicum sepsis.”
The FDA overruled the CDC, finding that COVID-19 vaccination was the “probable” cause of Clynick’s death.
Jablonowski said Clynick received a vaccine from Pfizer lot number EW0217, “which consisted of 2,857,140 doses and resulted in 28 deaths reported to VAERS.”
“VAERS captures the smallest sliver of actual adverse events. Jacob and Micah represent the smallest sliver of actual adverse events from a time when every living generation jeopardized their heart health with an unsafe vaccine,” Jablonowski said.
Gill said he “tried to engage” the FDA in a dialogue, but “they shut it down.”
‘We must move immediately from investigation to indictment’
Experts said the cover-up warrants legal and regulatory action, especially in light of the FDA’s likely forthcoming approval of an mRNA flu vaccine and the liability shield COVID-19 vaccine makers continue to enjoy under the Public Readiness and Emergency Preparedness Act (PREP Act).
“With the approval of the mRNA flu jab, the carnage will continue, and federal officials will ‘smile and wave’ as they knowingly send precious children to their demise,” Hooker said.
“We most definitely should be talking about subpoenas, arrests and prosecutions,” Ebright said. “We also most definitely should be talking about debarment and clawbacks of federal pensions and benefits.”
Glaser agreed. “We must move immediately from investigation to indictment. The era of polite ‘oversight hearings’ is over. We need the full force of subpoena power followed by grand jury proceedings.”
“There is no need to debate seven versus 10,” said former pharmaceutical research and development executive Sasha Latypova. “The mRNA shots killed hundreds and possibly thousands of children. … However, even seven acknowledged children’s deaths are sufficient to remove the product from the market immediately.”
Related articles in The Defender
Leaked Memo: FDA Confirms ‘At Least’ 10 Child Deaths From COVID Vaccine, Promises Sweeping Reforms
CDC Awards Pfizer $1.24 Billion for COVID Vaccines for Kids and Adults
FDA Ousts Another Top Official: Who’s Behind the Shakeup — and Why?
Teens 5 Times More Likely to Develop Heart Conditions After mRNA COVID Vaccines
‘Stunning’ 620% Higher Risk of Myocarditis After mRNA COVID Vaccines
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