Vinay Prasad is the Director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). He also serves as the agency's Chief Medical and Scientific Officer, overseeing vaccine, gene therapy, and blood product regulation, while providing senior input on medical policy and regulatory decisions. Today he published a letter to his team at the FDA examining the risks & benefits of the COVID shots. This letter is worth a slow careful read because, among other things, it explains why and how we should to do (and not do) public health in the future. If we take Prasad's analysis to heart, maybe "at least 10 children" did not die in vain. Here's is Prasad's letter:

Dear Team CBER,

I am writing to report that OBPV (The Office of Biostatistics and Pharmacovigilance) career staff have found that at least 10 children have died after and because of receiving COVID-19 vaccination. These deaths are related to vaccination (likely/probable/possible attribution made by staff). That number is certainly an underestimate due to underreporting, and inherent bias in attribution. This safety signal has far reaching implications for Americans, the US pandemic response, and the agency itself, which I wish to discuss here. I also want to address some frequent objections.

Prior to joining the US FDA, the FDA Commissioner closely followed reports of vaccine-induced myocarditis. Unlike the COVID virus, which has a steep age gradient-- being at least 1000 times more likely to kill an 80 year old than an 8 year old-- myocarditis appeared to have the opposite pattern. Young, healthy boys and men-- those least likely to experience bad covid outcomes-- bore the greatest risk. The risk was as high as ~200-330 per million doses given in the highest risk demographic groups. Notably, the US FDA and CDC were not the first to recognize the safety signal-- instead the Israelis were-- and worse in May of 2021, then CDC director Rochelle Walensky stated, “We have not seen a signal and we’ve actually looked intentionally for the signal in the over 200 million doses we’ve given,” Many felt this statement was dishonest and manipulative.

The Commissioner, senior advisor Tracy Beth Hoeg MD PhD, myself and colleagues demonstrated that COVID-19 boosters, and the accompanying mandates by colleges, were on balance harmful to young men in a widely discussed, peer reviewed paper in 2022. Like many academic physicians, we felt the FDA and CDC abdicated their duty to the American people. These agencies did not quickly attempt mitigation strategies such as spacing doses apart, lowering doses, omitting doses among those with prior COVID-19.

Worse, the FDA delayed acknowledgement of the safety signal until after it could extend marketing authorization to younger boys 12-15. This is described by the Commissioner and I in JAMA. Had the acknowledgement come early, these younger boys, who likely did not require COVID-19 vaccination, may have chosen to avoid the products.

In the summer of 2025, Dr. Hoeg began investigating VAERS reports of children who had died after administration of the COVID-19 vaccine. By late summer, she had concluded that there were in fact deaths-- a fact this agency had never publicly admitted.

Dr. Hoeg organized a small meeting to discuss these deaths with (Office of Vaccines Research and Review) OVRR and OBPV stakeholders. The slides she presented, emails she sent, and distorted firsthand reports was shared with media outlets. The general narrative was that OVRR staff disagreed with Dr. Hoeg’s assessment that the deaths were due to vaccine receipt. Some staff present who leaked portrayed the incident as Dr. Hoeg attempting to create a false fear regarding vaccines.

I then asked OBPV to perform a detailed analysis of deaths voluntarily reported to the VAERS system-- in full interest of balance. Causality is easy to assess in a randomized trial, but with case reports, causality is typically assessed on a subjective scale. In this scale ranging from certain to unlikely-- certain, possible/likely, and probable are broadly considered as related to the product.

The team has performed an initial analysis of 96 deaths between 2021 and 2024, and concludes that no fewer than 10 are related. If anything, this represents conservative coding, where vaccines are exculpated rather than indicted in cases of ambiguity. The real number is higher.

This is a profound revelation. For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children. 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. In many cases, such mandates were harmful. It is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines.

Did COVID-19 vaccine programs kill more healthy kids than it saved? We do not have reliable data estimating the absolute benefit (absolute risk reduction) regarding severe disease and death in healthy children from vaccine receipt. OVRR and OBPV rely on observation cohort or case control data with notorious methodologic biases. FDA has never requested the manufacturers demonstrate in randomized fashion that vaccinating children improves these outcomes. The available randomized data in children is deeply limited, and broadly negative for symptomatic infection, as discussed in prior ad-coms. Furthermore, COVID-19 was never highly lethal for children, and now MIS-c has decreased drastically, and the harms, to kids, are comparable to many respiratory viruses for which we do not provide annual immunization.

Comparing the number of kids who died from COVID against these deaths would be a flawed comparison. We do not know how many fewer kids would have died had they been vaccinated, and we do not know how many more kids died from taking vaccines than has been voluntarily reported. Instead, the truth is we do not know if we saved lives on balance.

When it comes to vaccine deaths, VAERS is passively reported. It requires a motivated person, often a doctor, to submit the information. The submission process is tedious and most people who start the form give up along the way. Many more deaths may be unreported. Finally, the FDA has failed to properly enforce many required post market commitments for COVID-19 vaccines, including for pregnant women and to document subclinical myocarditis.

Putting these facts together, 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. [More . . . ]