FDA’s Shocking Call for ‘Introspection’ After 10 Kids' Deaths Linked to COVID Vaccine – What’s Next?

A significant internal email from a senior official at the Food and Drug Administration (FDA) has raised alarms following a report suggesting that the deaths of at least ten American children may be linked to the COVID-19 vaccine. FDA Chief Medical Officer and Director of the Center for Biologics Evaluation and Research, Dr. Vinay Prasad, called for urgent introspection and transformation within the agency in a message addressed to his staff.

Dr. Prasad's email, obtained by the Daily Caller News Foundation (DCNF), stated, “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.” He emphasized the tragic notion that healthy young children, facing a low risk of death from COVID-19, were subjected to vaccination mandates imposed by the Biden administration. “In many cases, such mandates were harmful,” he noted, expressing distress over the implications of the reported fatalities among children aged 7 to 16.

Prasad's announcement follows a disturbing analysis performed by the FDA's Office of Biostatistics and Pharmacovigilance (OBPV), which he assigned earlier this year. The report indicated that the ten deaths attributed to the COVID vaccine had "likely, probable or possible" connections to the vaccine. Importantly, Prasad highlighted that the data likely underrepresents the actual figures, as only highly motivated physicians tend to undertake the cumbersome process of reporting adverse events through the Vaccine Adverse Event Reporting System (VAERS).

“Why did it take until 2025 to perform this analysis, and take necessary further actions?" Prasad asked, revealing his frustration that these deaths, reported between 2021 and 2024, had been overlooked for years. The urgency of this matter is underscored by the fact that FDA officials have yet to determine whether the benefits of the COVID-19 vaccine for children outweigh the risks they present.

“The truth is we do not know if we saved lives on balance,” Prasad wrote, acknowledging the gravity of the situation. He stated, “It is horrifying to consider that the US vaccine regulation, including our actions, may have harmed more children than we saved. This requires humility and introspection.”

This turning point in FDA's approach comes as the agency grapples with its role in vaccine approval and regulation amid intense scrutiny from both the public and internal factions. Prasad alluded to the cultural and systemic issues that may have contributed to the delayed response regarding vaccine safety, suggesting that a possible shift in priorities may be required to enhance public trust.

Prasad’s call for reform also serves as a critique of his predecessor, former CBER Director Peter Marks, who had pushed for the approval of annual COVID boosters even for young, healthy individuals. This push, according to a 2024 congressional investigation, contributed to the resignation of two top vaccine reviewers who felt pressured to compromise safety standards. The fallout from these decisions has left an indelible mark on the agency and its reputation.

Looking ahead, Prasad outlined forthcoming changes in vaccine policies and approvals, including more rigorous clinical trials for vaccines administered to pregnant women and a reevaluation of the annual flu vaccine rollout. The FDA faces pressure not only from internal stakeholders but also from the pharmaceutical industry, which has a vested interest in maintaining the lucrative $30 billion vaccine market.

In a striking ultimatum to his staff, Prasad stated, “Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it,” urging those who disagree with this new direction to resign. His commitment to a stricter framework of accountability may signal a pivotal shift in the agency's operational ethos, though it will likely encounter resistance from various quarters.

As this situation unfolds, the implications for public health and vaccine policy remain substantial. The FDA's ability to effectively monitor and evaluate vaccine safety will be crucial in restoring trust among American families, especially as the agency navigates the complex landscape of vaccine hesitancy and regulation in a post-pandemic world.