By Brownstone Institute at Brownstone dot org.

Over the last November weekend of 2025, a memo circulated throughout the Federal Food and Drug Administration that might well trigger the entire unraveling of the US vaccine program with a focus on the mandated Covid shot in particular. The author is Dr. Vinay Prasad, who was a moderate critic during the Covid but has become ferocious since his appointment as the head of the Center for Biologics Evaluation and Research of the FDA.

Of this memo, ACIP member and scientist Robert Malone has written: "I am stunned, gobsmacked by his letter below. The significance and importance of this letter in the context of US and global vaccine policy cannot be overestimated. This is a revolution, the likes of which I never expected to see in my lifetime."

It is reprinted in full below.

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 eas...