CITIZENS NEWS

CARDIAC DEATH of a preschool-aged child was COVERED UP in clinical trials for Moderna's omicron booster

By ljdevon // 2025-01-07

• A preschool-aged child participating in Moderna's KidCOVE clinical trial for a COVID-19 booster died of cardio-respiratory arrest, prompting debates about transparency and accountability.
• The FDA has not disclosed the death to the American public, raising concerns about the safety of mRNA vaccines for children and the integrity of the regulatory process.
• Moderna reported the death to European regulatory authorities but has not published the trial results on ClinicalTrials.gov as required by law.
• Journalist Alex Berenson is pressing the FDA for answers, questioning whether the agency knew about the death and why it has not been disclosed.
• The incident has intensified concerns about potential side effects of mRNA vaccines, particularly myocarditis, and the importance of transparency in clinical trials.

In late 2022 or early 2023, a preschool-aged child enrolled in Moderna’s KidCOVE clinical trial for a COVID-19 booster died of cardio-respiratory arrest. The death, which Moderna reported to European regulatory authorities but not to the U.S. public, has sparked a heated debate about transparency, accountability, and the ethical responsibilities of pharmaceutical companies and federal health agencies. Journalist Alex Berenson, a former New York Times reporter, has raised critical questions about whether the U.S. Food and Drug Administration (FDA) knew about the death and why it has not been disclosed to the American public. As the FDA remains silent, concerns grow about the safety of mRNA vaccines for children and the integrity of the regulatory process.

The death of child in a vaccine clinical trial and its aftermath

The child, whose exact age was not disclosed, was part of Moderna’s KidCOVE trial, which tested the company’s mRNA-1273.214 booster, designed to target an early Omicron variant of COVID-19. According to Moderna’s report to the European Union’s Clinical Trials Register, the death was recorded as unrelated to the vaccine. However, the company has yet to publish the trial results on ClinicalTrials.gov, a U.S. government website where drug makers are legally required to report such data. Berenson, who now writes for his Substack publication Unreported Truths, has been pressing the FDA for answers. “Did Moderna inform the FDA of the death, as it was legally required to do?” Berenson asked in a recent interview with The Defender. “Neither the agency nor the company has said, but considering Moderna published the death in its report to European regulators, it seems very likely it did also tell the FDA.” The FDA has declined to provide a clear response. In a two-paragraph statement to Berenson, the agency did not acknowledge the death or deny that it occurred. This lack of transparency has fueled speculation about what the FDA knew and when.

The broader context: mRNA vaccines are destroying children’s health

The death of a child in a clinical trial is rare, but it raises significant concerns about the risks and benefits of mRNA vaccines for children. By the time COVID-19 vaccines were authorized for children, it was widely understood that the risk of severe illness or death from the virus in this age group was extremely low. According to Berenson, “The shots had significant side effects, so the only rationale for giving them shots — even theoretically — was to reduce transmission.” One of the most serious potential side effects of mRNA vaccines is myocarditis, an inflammation of the heart muscle that can, in rare cases, lead to cardiac arrest. While the risk of myocarditis is higher in adolescents and young adults, the possibility of similar complications in younger children has been a point of contention among medical professionals and parents. The FDA’s silence on the matter has only deepened these concerns. “If the death of a child in the most closely scrutinized vaccine trial in history could go unreported,” Berenson said, “people will rightly wonder what else is being missed — or covered up.” Berenson has called on both Moderna and the FDA to disclose all relevant information about the child’s death. “For the FDA, which answers to the public, transparency is even more vital,” he said. His efforts have gained traction among lawmakers, including Sen. Ron Johnson (R-Wis.), who plans to subpoena the FDA for answers once Republicans take control of the Senate later this month. “The FDA will not be able to stonewall much longer,” Berenson predicted. Moderna, for its part, has not responded to requests for comment. The company’s decision to report the death to European regulators but not to the U.S. public has raised questions about its commitment to transparency. Doctors and parents, Berenson argues, have a right to know about such incidents, even if the company claims the death was unrelated to the vaccine. Sources include: ChildrensHealthDefense.org AlexBerenson.substack.com Trials.Modernatx.com

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