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A U.S. Food and Drug Administration (FDA) safety official recommended adding a warning about fatal myocarditis to mRNA COVID-19 vaccine labels in December 2025, after an agency review identified several pediatric deaths as possibly or probably related to vaccination.
More than 10 months later, the agency hasn’t added the warning.
According to documents obtained by investigative journalist Paul D. Thacker, an FDA pharmacovigilance expert — Dr. Meghna Alimchandani — emailed agency leadership on Dec. 5, 2025, formally recommending that a warning for fatal myocarditis be added to mRNA COVID-19 vaccine labels.
Her recommendation followed an internal memo from Dr. Vinay Prasad, then-head of the FDA Center for Biologics Evaluation and Research (CBER). The memo, later leaked to The New York Times, revealed that agency researchers had initially identified “no fewer than 10” child or teen deaths tied to vaccine-induced myocarditis.
However, documents released in June by Sen. Ron Johnson (R-Wis.) showed that a month after CBER identified the 10 child deaths, it reduced the number of deaths to seven and downgraded the probability that the vaccines were directly responsible.
Several former FDA officials told RealClearInvestigations that the leaked memos and documents — along with reporting by The New York Times and other news outlets — “appears to have unsettled the FDA’s safety office,” leading the agency to reduce the number of child deaths that it linked to the COVID-19 shots.
In May 2025, the FDA directed Pfizer and Moderna to strengthen their COVID-19 vaccine label warnings by expanding the age group at risk for vaccine-related myocarditis and pericarditis and warning that myocardial injury can be lasting — but the warning about fatal outcomes has never been added.
Thacker suggested that overlapping political, pharmaceutical and media interests may have led to the FDA decision not to add the warning.
He attributed the lack of action partly to the Trump administration’s investment in Operation Warp Speed, which accelerated vaccine development in 2020, and to what he describes as the Biden administration’s reluctance to publicize findings that could undermine its vaccination policies.
Drug safety advocate 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. “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?”
‘Significant level of evidence’ for fatal myocarditis after mRNA shots
Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense, said this mirrors the FDA’s tendency to change drug and pharmaceutical product labels based on a small number of serious adverse events, while not doing the same for vaccines.
Jablonowski cited a 2022 study published in The BMJ which found that the FDA has a “low evidentiary threshold to change drug labeling.”
There is “a significant level of evidence” for “fatal myocarditis associated with mRNA COVID-19 vaccines. Where is the regulatory action?” Jablonowski asked.
Johnson told RealClearInvestigation he intends to continue investigating COVID-19 vaccine harms and possible cover-ups by federal health agencies like the FDA — or by the Trump administration. He said his staff has received over a million pages of documents on Peter Marks, M.D., Ph.D., and recently interviewed him as part of his investigation.
Vaccine safety investigations leaked to the media — which attacks them
According to RealClearInvestigations, federal health agencies’ probes into the safety of the COVID-19 shots resumed with the Trump administration’s second term.
In some cases, FDA researchers found the Biden administration had already identified risks connected to the COVID-19 shots — but didn’t disclose them.
Tracy Beth Høeg, M.D., Ph.D., who later served as the FDA’s top drug regulator, told Thacker in a podcast last month 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.
She said those investigations, which had identified a causal link between the vaccines and the deaths, 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.
In later stories, the Times cited remarks from vaccine advocate and former CBER head Marks — without disclosing that Marks had denied a 2023 Citizen Petition calling for improved safety labeling of the mRNA COVID-19 shots and that in 2021, he helped push out FDA researchers who found risks linked to the shots.
Witczak, who helped lead the Citizen Petition, said the petition didn’t ask for vaccines to be pulled from the market. “We were asking for updated safety labeling so people and their doctors could make informed decisions based on the available evidence.”
According to emails provided to RealClearInvestigations, Alimchandani informed Prasad, who was Marks’ successor at CBER, about the risks — and about the 10 child deaths. The warning prompted Prasad’s subsequent memo, which described the deaths as a “profound revelation.”
Prasad’s memo was also leaked to the Times. The Times report — which again quoted Marks without disclosing his ties to COVID-19 vaccines — suggested that politics were behind an “escalation of broadsides on vaccines.”
Later Times reports cited several federal FDA leaders, without disclosing that two of them helped oversee the FDA during the time that the child deaths were identified and ignored, while another of the former officials sat on the board of mRNA COVID-19 vaccine manufacturer Pfizer.
“In Alimchandani’s final email to Prasad, she wrote that her office had bit back the number of suspected child deaths from 10 to 7,” RealClearInvestigations reported.
By April, heads rolled at the FDA. That month, Prasad resigned from CBER for the second time in less than a year. The following month, FDA Commissioner Marty Makary resigned amid reports he would be fired. The FDA also fired Høeg.
Pressures from inside these agencies may have contributed to the resignations — or to efforts to stymie U.S. Health Secretary Robert F. Kennedy Jr.’s vaccine safety agenda. “Kennedy has plenty of people in the White House who hate him,” Thacker said.
However, the administration’s seemingly contradictory stance on vaccines may also be contributing to inaction on vaccine safety initiatives.
“The entire matter of vaccines is being handled in a schizophrenic fashion,” Thacker said. “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. These pieces don’t fit together into a coherent policy.”
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Key pharma CEOs ‘have direct access to the White House’
Thacker said multiple people “very high up inside the Trump administration” have told him that “the CEOs of Pfizer and Eli Lilly have direct access to the White House,” likely contributing to pressure to downplay or conceal vaccine risks. He called the pharma lobby “the most powerful domestic lobby in America.”
Last year, the pharmaceutical and health industry spent $456.9 million on lobbying — the largest-ever single-year increase in lobbying spending.
This spending has shown no sign of slowing down so far this year, with Big Pharma already reporting hundreds of millions of dollars in lobbying expenditures.
Pharma pressure reportedly led to Prasad’s first resignation from CBER last year.
In 2024, pharmaceutical companies spent over $10 billion on drug ads. The U.S. and New Zealand are the only countries that permit direct-to-consumer drug ads. Last year, the U.S. Department of Health and Human Services (HHS) and the FDA announced that drugmakers will have to provide full safety disclosures in such ads.
An unnamed official at HHS told RealClearInvestigations that media outlets 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.”
Related articles in The Defender
- FDA Reviewed Autopsies of Children Who Died After COVID Vaccines, Reduced Number From 10 to 7
- Leaked Memo: FDA Confirms ‘At Least’ 10 Child Deaths From COVID Vaccine, Promises Sweeping Reforms
- Pfizer, Moderna Must Add Stronger Warnings About Possible Heart Damage From COVID Vaccines, FDA Says
- Pharma PR Executive Leaked Insider Criticism of NIH Vaccine Injury Center to New York Times — Paper Neglected to Mention His Industry Ties
- Pharma Spent Record $456.9 Million Last Year on Lobbying — With No Signs of Slowing Down
- Who’s the ‘Real’ Peter Marks? New Website Exposes Failure of Former FDA Vaccine Czar to Protect Americans From COVID Vaccine Dangers
