After no less than 10 children or teen deaths linked after having been administered a vaccine, a U.S. Food and Drug Administration (FDA) safety official advised adding a caution about fatal myocarditis to mRNA COVID-19 labels in December 2025.
This happened after an agency review detected various pediatric deaths as probably linked to vaccination. Still, according to a story by The Defender, more than 10 months later, the agency hasn’t added the warning.
The Defender reported that according to documents acquired by investigative journalist Paul D. Thacker, an FDA pharmacovigilance expert — Dr. Meghna Alimchandani — sent an email to the agency leadership on Dec. 5, 2025, officially recommending that a warning for fatal myocarditis be added to mRNA COVID-19 vaccine labels.
Drug safety advocate Kim Witczak, a prior member of the FDA Psychopharmacologic Drugs Advisory Committee, told The Defender that the warning label issue should not be political.
“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?”
Alimchandani’s recommendation followed an internal memo from Dr. Vinay Prasad, then-head of the FDA Center for Biologics Evaluation and Research (CBER). Later leaked to The New York Times, the memo showed that agency researchers had at first discovered “no fewer than 10” child or teen deaths tied to vaccine-induced myocarditis.
Still, documents released in June by Sen. Ron Johnson (R-Wis.) showed that a month after CBER identified the 10 child deaths, it lowered the number of deaths to seven and demoted the probability that the vaccines were directly responsible.
Various prior FDA officials told RealClearInvestigations that the disclosed 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 lower the number of child deaths that it connected to the COVID-19 shots.
The FDA directed in May 2025 the Pfizer and Moderna to fortify their COVID-19 vaccine label warnings by mounting the age group at risk for vaccine-related myocarditis and pericarditis and warning that myocardial injury can be lasting — but the warning about fatal after-effects has never been added.
