The recommendation followed an internal memo written by Dr. Vinay Prasad, then head of the FDA's Center for Biologics Evaluation and Research (CBER). According to the article, Prasad's memo stated that agency researchers had initially identified no fewer than 10 deaths of children or teens tied to vaccine-induced myocarditis, a finding that was later revised downward.
The disclosure adds to a growing record of internal debate over the cardiac risks of the mRNA shots. In May 2025, the FDA directed Pfizer and Moderna to strengthen label warnings by expanding the age group at risk for vaccine-related myocarditis and pericarditis and warning that myocardial injury can be lasting, according to a NaturalNews.com report.
Internal Review and Revised Death Count
The Prasad memo, later leaked to The New York Times, described the deaths as a "profound revelation," according to the RealClearInvestigations article. Documents released in June by Sen. Ron Johnson (R-Wis.) showed that one month after CBER identified the 10 child deaths, it reduced the number to seven and downgraded the probability that the vaccines were directly responsible, the article reported.
Several former FDA officials told RealClearInvestigations that the leaked memos and documents appeared to have unsettled the agency's safety office, leading the agency to reduce the number of child deaths it linked to the COVID-19 shots. The report did not name the former officials.
The sequence of internal findings and revisions occurred against a backdrop of mounting public pressure. A separate NaturalNews.com report on Dec. 17, 2025, said the FDA had decided against applying the black box warning despite internal recommendations [2].
Documents, Leaks and Public Accounts
According to emails provided to RealClearInvestigations, Alimchandani informed Prasad about the risks and the 10 child deaths before Prasad wrote his memo. The emails were among the documents obtained by Thacker.
Tracy Beth Høeg, M.D., Ph.D., later the FDA's top drug regulator, told Thacker in a podcast that she was surprised to learn FDA staff had already reviewed medical records, autopsy reports, and other evidence concerning deaths after vaccination, including deaths of teens and children, and that the investigations were not publicly disclosed. Høeg reviewed the investigations at a September 2025 FDA meeting; details were subsequently leaked to The Times, which described the review as a 'political exercise,' according to RealClearInvestigations.
The article reported that later Times stories cited remarks from former CBER head Peter Marks without disclosing that Marks had denied a 2023 Citizen Petition calling for improved safety labeling of mRNA COVID-19 shots and that in 2021 he helped push out FDA researchers who found risks linked to the shots. The report did not provide further detail on the researchers or the petition.
Labeling Standards and Regulatory Action Questioned
Kim Witczak, a former member of the FDA Psychopharmacologic Drugs Advisory Committee, told The Defender that the warning label issue should not be partisan. "This isn't about Republicans or Democrats, Trump, Biden or RFK Jr., it's about the American public's right to know," Witczak said. She also asked: "If FDA scientists identified credible evidence of fatal myocarditis and recommended updating the COVID vaccine labels, why hasn't that happened? Who made that decision?"
Karl Jablonowski, Ph.D., senior research scientist for Children's Health Defense, said the situation mirrors the FDA's tendency to change drug labels based on a small number of serious adverse events while not doing the same for vaccines. He cited a 2022 BMJ study that found the FDA has a "low evidentiary threshold to change drug labeling." Jablonowski asked: "Where is the regulatory action?"
The FDA's May 2025 directive to Pfizer and Moderna marked a tightening of label language but stopped short of a fatal-outcome warning. The December recommendation from Alimchandani would have gone further by explicitly citing fatal myocarditis.
Resignations, Lobbying and Political Context
Prasad resigned from CBER in April for the second time in less than a year; FDA Commissioner Marty Makary resigned in May amid reports he would be fired; and the FDA fired Høeg, the article reported. The departures came as the agency grappled with internal disputes over vaccine safety.
Thacker said the matter of vaccines was being handled in a "schizophrenic fashion."
"Trump greenlighted Kennedy to look into the childhood vaccine schedule, yet there has still been no action taken at FDA to update the COVID mRNA vaccines to note risk of cardiac death," he said. Thacker also said multiple people "very high up inside the Trump administration" told him that the CEOs of Pfizer and Eli Lilly have direct access to the White House, and he called the pharmaceutical lobby "the most powerful domestic lobby in America."
The article reported that the pharmaceutical and health industry spent $456.9 million on lobbying last year, the largest-ever single-year increase. An unnamed HHS official told the outlet that media organizations are "experiencing a professional hangover after getting drunk on the hundreds of millions of dollars that the Biden administration paid in advertising during the pandemic to promote COVID jabs."
Conclusion: Warning Status and Ongoing Investigation
As of the article's publication, the FDA had not added a warning for fatal myocarditis to mRNA COVID-19 vaccine labels, according to the documents and reporting cited. The agency did not announce a label change that included fatal outcomes in the period described.
Sen. Ron Johnson told RealClearInvestigations he intends to continue investigating COVID-19 vaccine harms and possible cover-ups by federal health agencies or the Trump administration. His staff has received over a million pages of documents on Peter Marks and recently interviewed him, the article reported.
The FDA's public posture has shifted incrementally. The May 2025 label directive and the December internal recommendation indicate that cardiac risks have been under active review, but the specific warning for fatal myocarditis remained absent from the labels as of the report. The documents and interviews cited by RealClearInvestigations leave open the question of who made the final decision not to add it.
Reference
- FDA Official Urged Fatal Myocarditis Warning on COVID Vaccine Labels 10 Months Ago. It Was Never Added. https://childrenshealthdefense.org/defender/fda-official-urged-fatal-myocarditis-warning-covid-vaccine-labels-10-months-ago-never-added/
- FDA rejects plans to add black box warning for COVID 19 vaccines despite safety concerns - NaturalNews.com, December 17, 2025.
Explainer Infographic
Please contact us for more information.
