FDA Vaccine Chief Vinay Prasad Circulates Unsubstantiated Memo Claiming COVID Vaccines Killed At Least Ten Children

Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), circulates an internal memo to FDA staff asserting that COVID-19 vaccines caused “at least 10 deaths in children” and calling for sweeping changes to vaccine regulation—despite providing no supporting data and before FDA scientists completed their assigned analysis of the question. According to STAT News, experts are skeptical of the “extraordinary” claim because it was not presented with detailed data, and subsequent investigation revealed that FDA’s own scientific analysis found the actual number of deaths linked to COVID-19 vaccines is somewhere between zero and seven, contradicting Prasad’s higher figure.

The November 28, 2025 memo sent by Prasad to FDA staff represents an extraordinary intervention by the agency’s top vaccine regulator making definitive claims about vaccine-caused deaths without providing the underlying analysis, patient data, or scientific evidence that would typically accompany such serious allegations. STAT News reported that “outside experts said it was surprising that more data were not included in the memo,” noting that standard scientific and regulatory practice requires detailed documentation when claiming causal connections between medical interventions and serious adverse events including death.

According to Inside Medicine’s investigation, Prasad’s memo cited 10 pediatric COVID-19 vaccine deaths, but the FDA’s own analysis found between 0 and 7 deaths potentially linked to the vaccines. The discrepancy between Prasad’s “at least 10” claim and FDA scientists’ “0-7” finding indicates Prasad made his assertion before scientific staff completed their work and potentially used different, less rigorous methods for attributing deaths to vaccines than the agency’s career scientists employed.

A December 5, 2025 post-marketing safety memo prepared by FDA scientists—the agency’s formal scientific analysis of the question—concluded the actual number of deaths linked to COVID-19 vaccines is somewhere between zero and seven. The wide range (0-7 rather than a specific number) reflects scientific uncertainty about causation in cases where children died after vaccination but where establishing that the vaccine caused death requires careful analysis of medical histories, autopsy findings, and temporal relationships that may not definitively establish causation.

Prasad apparently sent the November 28 memo before FDA scientists had completed their assigned work analyzing vaccine-associated deaths. This timing suggests Prasad bypassed normal scientific review processes to make public claims about vaccine dangers based on preliminary or incomplete analysis, prioritizing speed and political messaging over scientific rigor and accuracy. The decision to announce a higher death count than FDA scientists subsequently documented reveals Prasad’s agenda of maximizing perceived vaccine risks regardless of what careful scientific analysis concludes.

NBC News reported that Prasad said the deaths appeared to be tied to myocarditis, a rare type of heart inflammation that has been seen in some people after COVID vaccination, though he did not share any data used in the review, including the children’s ages, whether they had existing health conditions, or how the FDA determined there was a link. The absence of basic epidemiological details—age, comorbidities, temporal relationships, autopsy findings, alternative explanations—prevents independent evaluation of Prasad’s claims and violates standard scientific practice for reporting adverse events.

CBS News emphasized that the FDA official made claims linking COVID-19 vaccines to pediatric deaths “without providing data,” highlighting the extraordinary nature of a senior government scientist making definitive public health claims without the transparency and documentation that scientific integrity requires. The refusal to provide supporting data prevents peer review, independent verification, or informed public debate about the claims—exactly the opacity that undermines public trust in vaccine safety surveillance systems.

STAT News reported that the memo uses “highly ideological language, repeatedly characterizing Covid vaccine requirements as ‘coercive,’ calling past agency decisions ‘dishonest,’ and arguing that vaccine regulation ‘may have harmed more children than we saved.’” This inflammatory, politically charged language in an official FDA memo represents a dramatic departure from the neutral, evidence-based tone expected in government scientific communications. The characterization of vaccine policies as “coercive” and “dishonest” reflects anti-vaccine movement rhetoric rather than objective regulatory analysis.

The claim that vaccine regulation “may have harmed more children than we saved” contradicts overwhelming scientific evidence documenting COVID-19 vaccines’ effectiveness in reducing pediatric hospitalizations, long COVID, MIS-C (multisystem inflammatory syndrome in children), and deaths from COVID-19. Even accepting Prasad’s higher unsupported death count of “at least 10,” this would need to be weighed against hundreds of pediatric deaths from COVID-19 that vaccines prevented, making the cost-benefit calculation dramatically favorable for vaccination—opposite of Prasad’s suggestion.

U.S. News & World Report noted that the memo claims COVID vaccines are “tied to 10 child deaths,” using language suggesting causation while actually documenting temporal association (death after vaccination) that may or may not represent causal relationship. The distinction between temporal association and causation is fundamental to epidemiology and vaccine safety surveillance. Deaths that occur after vaccination are not necessarily caused by vaccination—a distinction that Prasad, as a physician and epidemiologist, understands but appears to deliberately obscure.

Prasad announced in the memo that he plans sweeping regulatory changes to vaccine oversight, including bypassing scientific advisory committees for many major decisions. According to STAT News reporting on related developments, “Previous FDA officials frequently turned to expert committees of outside advisers in the past, particularly in cases seen as controversial, but the agency has more recently suggested it will break with that practice, with Commissioner Martin Makary’s leadership team saying they intend to forgo advisory committee meetings for many major decisions.”

The decision to bypass scientific advisory committees eliminates the primary mechanism for external expert review of controversial FDA decisions. Advisory committees provide independent scientific expertise, transparency through public meetings, and credibility for agency decisions by demonstrating that outside experts support regulatory conclusions. Eliminating advisory committee review for vaccine decisions removes accountability and allows Prasad and other FDA political appointees to implement vaccine skeptic agendas without challenge from the broader scientific community.

STAT News reported that twelve former FDA commissioners decried Prasad’s memo on vaccine regulation in an article published in the New England Journal of Medicine. The fact that “almost every FDA commissioner who has served in the role since 1990, during the administration of George H.W. Bush,” felt compelled to publicly oppose Prasad’s planned changes represents an extraordinary rebuke from former agency leaders spanning both Democratic and Republican administrations.

The former commissioners’ opposition indicates career FDA leaders recognize that Prasad’s approach threatens fundamental principles of vaccine regulation including reliance on scientific evidence, transparency in decision-making, and prioritization of public health over political ideology. Former commissioners rarely intervene publicly in current FDA controversies, making their coordinated opposition particularly significant as a warning about threats to the agency’s scientific integrity and regulatory mission.

STAT News’s earlier investigation revealed how Prasad and Dr. Tracy Beth Hoeg “seized vaccine oversight” at FDA, documenting how these two officials—both known for contrarian positions on COVID-19 vaccines and pandemic policies—have concentrated vaccine regulatory authority and sidelined career FDA scientists and traditional scientific advisory processes. The seizure of vaccine policy by ideologically driven appointees represents capture of FDA’s vaccine regulatory mission by individuals whose pre-appointment records indicate skepticism of vaccines and opposition to public health measures.

Prasad serves as both the FDA’s Chief Medical and Scientific Officer and as Director of the Center for Biologics Evaluation and Research (CBER), which oversees vaccines, blood products, and gene therapies. This concentration of authority in a single individual with documented vaccine skeptic views, combined with elimination of advisory committee review, removes institutional checks on ideologically motivated decision-making and creates conditions for regulatory capture where vaccine policy serves political agendas rather than public health.

The timing of Prasad’s memo—late November 2025, approximately ten months into the Trump administration—suggests coordination with broader administration efforts to undermine public confidence in vaccines and implement HHS Secretary Robert F. Kennedy Jr.’s vaccine skeptic agenda. Kennedy, a prominent vaccine critic who has promoted debunked theories linking vaccines to autism, installed Prasad and other vaccine skeptics in key FDA positions specifically to implement regulatory changes that traditional public health authorities would reject as scientifically unsupported and dangerous.

NBC News noted that Prasad’s announcement of “new vaccine rules” based on unsupported death claims indicates the memo serves as pretext for predetermined regulatory changes rather than careful reconsideration of vaccine policy based on new evidence. The predetermined nature of planned changes—announced simultaneously with alleged evidence supporting them—suggests Prasad sought justification for policies he intended to implement regardless of what scientific evidence actually showed.

The memo’s characterization of past FDA vaccine decisions as “dishonest” attacks the integrity of career FDA scientists and previous commissioners who developed vaccine policies based on extensive evidence of benefits substantially outweighing risks. This attack on predecessor credibility serves to justify radical policy changes by claiming previous policies were not merely wrong but deliberately deceptive—rhetoric that delegitimizes institutional expertise and replaces scientific decision-making with ideological assertions.

CBS News reported that experts expressed skepticism about the claims because of the lack of supporting documentation, with public health professionals noting that proper reporting of vaccine-associated deaths requires extensive medical detail, transparent methodology, and peer-reviewed analysis—none of which Prasad provided. The expert skepticism reflects recognition that Prasad’s memo violates basic scientific standards for claiming causal relationships between medical interventions and adverse outcomes.

The FDA scientists’ December 5 analysis finding 0-7 deaths potentially linked to COVID vaccines employed standard pharmacovigilance methods including review of VAERS (Vaccine Adverse Event Reporting System) reports, medical records, autopsy data when available, and assessment of biological plausibility and temporal relationships. The range of 0-7 rather than Prasad’s “at least 10” reflects appropriate scientific caution about attributing causation in complex medical cases where multiple factors may contribute to adverse outcomes.

STAT News emphasized that the “extraordinary” nature of Prasad’s claims without supporting data violates scientific norms because claims of vaccine-caused deaths carry enormous public health implications. Unsupported assertions about vaccine dangers risk undermining vaccination rates, leading to preventable disease outbreaks and deaths that far exceed any actual vaccine risks. Scientists making such claims bear responsibility for ensuring accuracy and providing evidence sufficient for evaluation—responsibilities Prasad failed to meet.

The ideological language in Prasad’s memo—calling vaccine requirements “coercive”—reflects libertarian opposition to public health mandates rather than scientific analysis of vaccine safety and efficacy. The characterization of policies as “coercive” is a political judgment about the appropriate scope of government public health authority, not a scientific determination about vaccine characteristics. The injection of this political ideology into what should be scientific regulatory analysis reveals how Prasad’s agenda extends beyond technical vaccine regulation to advancing broader anti-mandate political positions.

U.S. News reported that Prasad’s position as director of CBER gives him authority over vaccine approvals, safety monitoring, and regulatory standards—making his unsupported claims about vaccine deaths particularly dangerous because they come from the official responsible for ensuring vaccine safety and maintaining public confidence in vaccination programs. When the government’s top vaccine regulator promotes unsubstantiated claims about vaccine dangers, it predictably undermines public trust and vaccination rates regardless of whether the claims are accurate.

The memo’s claim that vaccine regulation “may have harmed more children than we saved” suggests Prasad intends to implement restrictive policies that would reduce pediatric vaccination rates, potentially leading to outbreaks of measles, whooping cough, and other vaccine-preventable diseases. The hint at future regulatory restrictions reveals the memo’s purpose as laying groundwork for limiting vaccine access and recommendations, using inflated and unsupported death counts as justification.

STAT News’s reporting on former commissioners’ opposition noted their concern that eliminating advisory committee review threatens to make FDA vaccine decisions less transparent, less scientifically rigorous, and more vulnerable to political pressure and ideological bias. Advisory committees provide sunlight on controversial decisions through public meetings where evidence is presented and debated, creating accountability that internal agency deliberations lack—exactly the transparency that Prasad apparently seeks to avoid.

The fact that FDA scientists’ formal analysis contradicted Prasad’s higher death count suggests career scientists attempted to correct the record with accurate information even after their director made unsupported claims. However, the December 5 scientific memo received far less public attention than Prasad’s November 28 claims, demonstrating how sensational unsupported allegations about vaccine dangers spread widely while careful scientific corrections receive limited notice—an asymmetry that anti-vaccine advocates exploit.

NBC News noted that Prasad “did not share any data used in the review,” preventing verification of his claims and enabling him to avoid accountability for errors or exaggerations. The refusal to share data contradicts scientific norms of transparency and replicability, where researchers are expected to provide sufficient detail for others to evaluate methods and conclusions. Prasad’s opacity suggests awareness that detailed scrutiny would undermine his claims.

The myocarditis link Prasad cited is well-documented as a rare adverse event following COVID vaccination, particularly in young males after the second dose. However, published research establishes that myocarditis cases following vaccination are generally mild, resolve with conservative treatment, and occur at far lower rates and with better outcomes than myocarditis cases caused by COVID-19 infection itself. Prasad’s focus on vaccine-associated myocarditis without mentioning the greater and more severe myocarditis risk from COVID infection itself represents selective presentation designed to exaggerate vaccine risks while minimizing disease risks.

CBS News’s emphasis on the lack of provided data highlights that Prasad’s position as FDA vaccine chief should impose higher standards for transparency and documentation when making public claims about vaccine safety, not lower standards that allow unsupported assertions. Senior government scientists making claims about public health interventions causing deaths must provide detailed evidence supporting causation claims—evidence Prasad conspicuously failed to provide.

The memo’s appearance just months into Prasad’s tenure suggests he views his role as implementing predetermined anti-vaccine policies rather than objectively evaluating evidence to reach scientifically supported conclusions. The speed with which Prasad moved from appointment to making controversial unsupported claims and announcing major policy changes indicates he came to FDA with an ideological agenda rather than openness to following evidence wherever it leads.

STAT News’s reporting documented that between April and September 2025, ACIP’s (Advisory Committee on Immunization Practices) policymaking maturity rating fell from an overall score of 100% to 58% following RFK Jr.’s reconstitution of the committee with vaccine skeptics. The parallel degradation of both CDC’s ACIP and FDA’s vaccine oversight under Kennedy appointees reveals coordinated capture of the nation’s vaccine policy apparatus by anti-vaccine ideology, with Prasad playing the key role at FDA while Kennedy’s ACIP appointees transformed CDC vaccine guidance.

The former FDA commissioners’ decision to publish their opposition in the New England Journal of Medicine—one of the world’s most prestigious medical journals—ensures their critique reaches the broader medical and public health community and creates a permanent scientific record of expert opposition to Prasad’s approach. This documentation may prove important for future accountability and for courts reviewing vaccine policy decisions when determining whether FDA followed appropriate scientific standards.

The contradiction between Prasad’s “at least 10” deaths claim and FDA scientists’ “0-7” finding demonstrates the consequences of political appointees making public health pronouncements without waiting for or deferring to career scientists’ evidence-based analysis. The institutional conflict between ideologically driven leadership and scientific staff attempting to maintain evidence-based practices creates dysfunction that threatens FDA’s core mission of protecting public health through rigorous science-based regulation.

Inside Medicine’s reporting on the discrepancy between Prasad’s memo and FDA scientists’ analysis suggests internal agency concerns about their director’s approach but also reveals limitations in career scientists’ ability to constrain political appointees who control the agency. Even when scientists document that leadership claims are unsupported or contradicted by evidence, political appointees retain authority to implement policies based on ideology rather than science unless courts or Congress intervene.

The memo exemplifies the broader pattern of Trump administration political appointees making sensational claims about public health threats or vaccine dangers without providing supporting evidence, then using those unsupported claims as justification for policy changes that serve ideological agendas. The technique of allegation followed by policy change, without intervening rigorous evaluation, has become characteristic of how Trump administration health agencies operate under captured leadership prioritizing political objectives over evidence-based public health.