The Food and Drug Administration (FDA) announced a more stringent approach to vaccine approvals, attributing the deaths of at least 10 children to coronavirus vaccines. This information came from an internal email obtained by The Washington Post, which revealed that FDA officials had concluded, without providing detailed evidence, that these vaccines contributed to the fatalities.
In an email to FDA personnel, Vinay Prasad, an FDA official with a focus on vaccine policy, outlined plans for a comprehensive reassessment of the agency’s vaccine approval framework. These changes include revising the criteria for annual flu shots, evaluating the safety of administering multiple vaccines simultaneously, and demanding more extensive data from manufacturers to validate the safety and efficacy of their products. For example, Prasad indicated that makers of pneumonia vaccines would need to demonstrate actual reductions in pneumonia cases, rather than simply showing antibody responses.
Prasad’s email suggested that the FDA would implement rigorous new requirements for authorizing vaccines for pregnant women, emphasizing the need for thorough scrutiny. He expressed a willingness to engage in open discussions regarding these new principles, while urging staff who oppose them to consider resigning.
The proposed changes represent a significant shift from the FDA’s long-standing practices, potentially delaying the approval process for new vaccines. Current and former FDA officials, along with public health experts, have raised concerns that these stricter requirements may hinder the development of innovative vaccines. They noted that the implications of the changes remain unclear, as the email did not provide a detailed plan for implementation.
Prasad’s remarks about the administration of multiple vaccines at once could reverse decades of federal guidelines that encourage simultaneous vaccinations for various illnesses. The Centers for Disease Control and Prevention (CDC) has traditionally recommended multiple vaccines during key developmental milestones, including childhood vaccinations.
Former FDA Center for Biologics Evaluation and Research Director Jesse Goodman characterized the existing vaccine guidelines as already stringent. He emphasized that vaccines undergo rigorous evaluation and are approved based on robust scientific evidence. “They’re being approved with strong scientific evidence,” Goodman stated, challenging the notion that the approval process lacks rigor.
During a recent interview on “Fox & Friends Weekend,” FDA Commissioner Marty Makary indicated that the agency would provide further information regarding the deaths linked to the coronavirus vaccine. He criticized the Biden administration for what he described as a “rubber-stamped” approval process, particularly concerning the updated coronavirus vaccine for children.
The Department of Health and Human Services, which oversees the FDA, did not respond to inquiries about Prasad’s email. The contents of the email were initially reported by a correspondent for PBS NewsHour.
Vaccination experts, such as Paul Offit, highlighted the necessity of providing diverse evidence when adding new vaccines to the childhood immunization schedule. He described Prasad’s proposed changes as “vague” and emphasized the need for clarity to facilitate meaningful discussion.
Prasad’s approach aligns with the views of Robert F. Kennedy Jr., a prominent figure in the anti-vaccine movement, who has advocated for increased scrutiny of vaccine safety. In his email, Prasad noted his team’s findings linking coronavirus vaccines to child deaths, stating, “This is a profound revelation.” He emphasized that this marks the first acknowledgment by the FDA of a connection between COVID-19 vaccines and fatalities among American children.
Contradicting Prasad’s assertions, past leaders of the FDA and numerous public health experts maintain that the safety of the coronavirus vaccines has been thoroughly assessed. Peter Marks, a former FDA vaccine chief, pointed out that extensive evaluations had been conducted to ensure vaccine safety, asserting that no deaths had been definitively linked to the vaccine.
Meanwhile, Peter Hotez, director of the Center for Vaccine Development at Texas Children’s Hospital, expressed the need for more substantial data supporting Prasad’s claims about vaccine-related deaths. He cautioned against making sweeping statements without comprehensive evidence, particularly given the vast number of COVID-19 vaccinations administered in the United States.
The FDA’s recent deliberations have reignited discussions about vaccine safety, particularly among children. Earlier this year, reports surfaced regarding a number of children who died following COVID-19 vaccinations. Prasad indicated that these cases were filed in the federal Vaccine Adverse Event Reporting System, which compiles unverified reports of vaccine side effects.
While the CDC maintains that the reporting system is not designed to establish causation, Prasad’s analysis of 96 deaths between 2021 and 2024 concluded that at least 10 deaths could be associated with the vaccines. He stated that the agency intends to take “swift action” in response to this new safety concern.
The FDA had previously planned to present findings suggesting a link between COVID-19 vaccines and the deaths of 25 children to federal vaccine advisors, a move that alarmed public health officials who argued that the risks of the virus itself were being minimized. Although this presentation did not occur, CDC staff reported that at least 25 children who had been hospitalized due to COVID-19 since July 2023 subsequently died, with many not up-to-date on their vaccinations.
As vaccine policy continues to evolve amid ongoing public scrutiny, the implications of the FDA’s proposed changes may shape the future landscape of vaccination for years to come.
