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A leaked memo from the US Food and Drug Administration — the powerful regulator overseeing America’s medicines and vaccines — confirms ten child deaths linked to COVID shots and exposes major oversight failures.

At least ten American children died following COVID-19 injections, according to a newly disclosed memo from the US Food and Drug Administration (FDA), which also outlines plans to reform vaccine regulation in the United States.

The memo, written by Dr Vinay Prasad, director of the FDA’s Centre for Biologics Evaluation and Research (CBER), was circulated internally to agency staff and later obtained by The New York Times and other legacy news outlets.

In the memo, Prasad writes that the ten child deaths were “related to vaccination” in a “likely/probable/possible attribution made by staff” — and warns that the real number is likely higher due to conservative coding practices that often exculpate vaccines in ambiguous cases.

“Putting these facts together, it is horrifying to consider that US vaccine regulation… may have harmed more children than we saved,” he states.

In a striking admission not previously reported, the memo reveals that FDA Commissioner Robert Califf personally uncovered some of the child deaths while reviewing internal safety data — a task that would normally fall to pharmacovigilance staff.

Prasad notes that without Califf’s intervention, the problem might never have been formally investigated, highlighting major institutional blind spots within the agency.

NEWS: An internal FDA review found at least 10 children died following the COVID vaccine.

FDA Chief Medical Officer Vinay Prasad is calling for introspection, humility and reform at FDA in light of the finding.

"For the first time, the US FDA will acknowledge that COVID-19… pic.twitter.com/XvyYbpsWFb

— Emily Kopp (@emilyakopp) November 29, 2025

Mishandling of the Myocarditis Signal

An analysis of 96 reported child deaths between 2021 and 2024 confirmed at least ten fatalities linked to the injection.

The memo describes how post-market monitoring was insufficient, particularly for myocarditis and effects in pregnant women, stating, “the FDA has never requested the manufacturers demonstrate in randomised fashion that vaccinating children improves these outcomes.”

In the memo, Dr Prasad explains that “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”.

The internal review, conducted by Prasad and fellow CBER staff from the Office of Biostatistics and Pharmacovigilance (OBPV), highlights key systemic failures they say contributed to the deaths.

Myocarditis, an inflammation of the heart muscle, was identified internationally in young males long before the FDA acknowledged it. Delays in recognising and disclosing this risk by the nation’s leading vaccine regulator meant children were injected before the full safety profile was understood.

Specifically, the memo criticises early handling of the myocarditis signal by the Centres for Disease Control and Prevention (CDC), noting that then-Director Rochelle Walensky publicly downplayed or denied evidence of risk in May 2021 despite international data showing otherwise.

Prasad argues this inconsistency between agencies further delayed recognition of a real and emerging safety issue.

Delayed Action, Financial Incentives

Dr Prasad’s investigation began after Dr Tracy Beth Hoeg, a senior advisor, examined VAERS (Vaccine Adverse Event Reporting System) reports of child deaths and concluded by late summer 2025 that these deaths had indeed occurred — a fact the agency had not previously acknowledged publicly.

According to the memo, Hoeg had shared early findings internally through a slide presentation that was later leaked by staff attempting to portray her analysis as alarmist. Prasad wrote that these attempts to discredit her were “misguided,” noting that her conclusions were ultimately validated by subsequent internal review.

The memo goes on to critique career staff for underreporting and delaying action, explaining that “the FDA delayed acknowledgement of the safety signal until after it could extend marketing authorisation to younger boys 12-15”.

“Had the acknowledgement come early, these younger boys, who likely did not require COVID-19 vaccination, may have chosen to avoid the products,” the memo adds.

Prasad also highlights the financial stakes in vaccine production, noting that the COVID-19 injections generated approximately US$100 billion globally.

He further explains that vaccines face no genuine generic competition due to the absence of a biosimilar pathway for complex biologics. As a result, the current system creates long-term monopoly incentives that rely heavily on surrogate immune markers — markers he argues are insufficient for approving new vaccine products.

While acknowledging the general benefits of vaccines, he stresses that financial incentives should never override patient safety or scientific rigour.

A Call for Systemic Vaccine Reform

In response, CBER says it plans a fundamental shift in vaccine oversight in the United States, treating vaccines like all other medications with rigorous evidence-based standards.

Annual influenza vaccines will undergo stricter scrutiny, products for pregnant women or children will require robust clinical data before approval, and interactions between multiple simultaneous vaccines will be studied more thoroughly.

The memo states explicitly that prior commitments to rely on surrogate endpoints for approving vaccines in pregnant women or young children are now “null and void,” signalling the most significant rollback of expedited vaccine pathways in decades.

Specifically, future approvals will require pre-market randomised trials with clinical endpoints, rather than relying on surrogate immunogenicity markers, while post-market monitoring will be strengthened to detect and act upon safety signals promptly.

“Never again will the US FDA Commissioner have to himself find deaths in children for staff to identify it,” the memo notes.

Prasad concludes by noting that any staff opposed to the new evidence-based framework should “submit their resignations,” describing the reforms as non-negotiable and essential for restoring public trust.

Dr Prasad’s memo signals a historic pivot in US vaccine regulation, signalling a move toward greater transparency, evidence-based practice, and heightened responsibility in protecting children from preventable harm.

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