“Revolution In Vaccine Regulation” Following FDA Acknowledgement Of COVID-19 Vaccine Child Deaths

Dr. Robert Malone, ACIP vaccine advisory member, declared that there is a “revolution in vaccine regulation and approval” following the release of an internal FDA letter stating  “at least 10 children have died after and because of receiving COVID-19 vaccination.” The letter was written by Dr. Vinay Prasad, the FDA Director of the Center for Biologics Evaluation and Research (CBER). In the letter, Dr. Prasad calls out FDA officials under the Biden administration for failing to disclose safety signals or evaluate the concerns in real time.

“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,” Dr. Prasad wrote.

The Office of Biostatistics and Pharmacovigilance (OPBV) evaluated 96 reports of death that may have been connected to COVID-19 vaccination. The team utilized “conservative coding, where vaccines are exculpated rather than indicted in cases of ambiguity,” Dr. Prasad wrote in his letter. “The real number is higher,” he added.

Dr. Prasad further called out Biden-era vaccine mandates that were “harmful” in many cases. “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.”

Dr. Prasad explained that the pre-market studies were not rigorous enough to establish causation. Thus, the reliance upon VAERS reports means it is difficult, if not impossible, to establish causality between the vaccine and any reported adverse event, including death. Dr. Prasad said that the COVID-19 vaccines caused the death of “at least” 10 out of the 96 VAERS reports examined and these cases are classified as “likely” or “probable” causation.

“The Washington Post called me a liar for stating what is now official FDA policy and truth,” Dr. Malone said. “These products do not work. They do not prevent disease and death. And as Secretary Kennedy testified in the Senate, objective analysis cannot even demonstrate that, on balance, they saved lives.”

The leaked memo has received significant pushback for lacking transparency and not providing the data or the evidence that were used to determine likely causality. Dr. Malone has responded to some of these critiques on X and said he has seen the initial draft of the study, adding that Dr. Prasad’s memo was “not intended as a data disclosure, but a policy statement.” In another response on X, Dr. Malone said the data and evidence discovered during the investigation are “even more shocking” and “politically explosive,” while also stating legal action will need to be taken.

Dr. Malone said he can’t disclose any of the specific details that he knows about the investigation as he is embargoed from doing so as an ACIP member.

In addition to the acknowledgement of deaths, including children, as a result of the COVID-19 vaccines approved via “Operation Warp Speed,” Dr. Prasad indicated there will be some significant changes in the ways vaccines are approved moving forward. He stated that previous CBER directors chose to override reviewers to “approve gene therapies that do not work because of patient demand,” while directly referencing the resignations of Dr. Gruber and Dr. Krause who refused to comply with pressures from CBER Director Peter Marks. “I favor approving products with benefits that exceed risks.”

Dr. Prasad said that moving forward, they will demand “pre-market randomized trials assessing clinical endpoints for most new products” rather than relying upon “unproven surrogate endpoints” for authorizations of vaccines for pregnant women. Dr. Prasad also said there will be stricter assessments of pneumonia and flu vaccines without relying on antibody titers, “low quality evidence,” and “uncertain vaccine effectiveness.”

The Guardian reported, “Current and former FDA staff, as well as outside public health specialists, said the new plan could dramatically slow the vaccine pipeline, according to the Washington Post. Requiring far larger studies before granting approvals, they said, could delay product launches and make companies more cautious about developing or expanding vaccines and may discourage innovation in vaccine research.”

Attorney Aaron Siri, Author of Vaccines, Amen, has frequently described the lack of placebo-controlled trials for any of the vaccines on the CDC childhood schedule. In a letter to Representative Thomas Massie ahead of a Congressional hearing, Siri explained that the COVID-19 vaccines were “robust when compared with other vaccine trials,” but “anemic when compared to drug trials.” The COVID-19 vaccine trials included a placebo group for two months.

Siri explains that the Department of Health and Human Services (HHS) is responsible for promoting vaccines, determining causality between vaccines and adverse events, and paying out liability damages for any injuries caused by the products. This is a result of the PREP Act for COVID-19 vaccines and the 1986 National Childhood Vaccine Injury Act, which provides the manufacturers with immunity from charges for any alleged harm caused by the product. Siri argues that these pieces of legislation remove economic incentive for companies to identify safety concerns or to make a safer product.

Sayer Ji, founder of GreenMedInfo, wrote that the 10 deaths out of 96 evaluated are likely just the “tip of the iceberg.” He referenced the Harvard Pilgrim Study that concluded that, likely, less than 1% of adverse events from vaccines are reported to VAERS. The VAERS system includes 15,430 reported deaths in the United States connected with the COVID-19 vaccine. For children 17 and under, there are 60 reported VAERS deaths, over 170,000 adverse events, and 27,466 serious adverse events. The CDC Wonder database classifies 1,391 cases of child death attributed to COVID-19 from 2020 to 2025.

ACIP member Retsef Levi posted on X, “Those asking for ‘evidence of vaccine harm’ on a child’s death just a few days after COVID vaccination, and with autopsy confirmed myocarditis, will willingly determine that a death 30 days after a positive PCR test is a COVID death. The definition of DOUBLE STANDARD!”

The VAERS system has been criticized on both sides of the discussion for not having reliable data to prove causality and for underreporting adverse events. Siri has pointed out that without long-term clinical trials with an inert placebo, causality is difficult, if not impossible, to prove.

In response to Prasad’s memo and call for more rigorous standards to uphold vaccine safety and efficacy, Dr. Malone wrote, “The ACIP now has to be the first ones to publicly walk through this widened Overton window. What a privilege. See you next week!” ACIP will meet later this week on December 4 and 5.