December 1, 2025
Will the Vaccine Industry Finally Follow the Science?
A scathing internal memo from Dr. Vinay Prasad, MD, MPH, director of the Center for Biologics Evaluation and Research, (CBER) was leaked to the media in late November by staff in the FDA’s Office of Biostatistics and Pharmacovigilance.
The memo stated in plain language:
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. [Emphasis added.] 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. [Emphasis added.]
Worse, the FDA delayed acknowledgement of the safety signal until after it could extend marketing authorization to younger boys 12-15. [Emphasis added.] This is 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 childrenwho 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. [Emphasis added.]
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. [Emphasis added.]
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. . . [Emphasis added.] 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.
Dr. Prasad laid out his vision for this department going forward:
Our general approach in CBER will be to direct vaccine regulation towards evidence based medicine.This means: we will take swift action regarding this new safety concern, we will not be granting marketing authorization to vaccines in pregnant women based on unproven surrogate endpoints. [Emphasis added.](any prior promises will be null and void), and we will demand pre-market randomized trials assessing clinical endpoints for most new products.
We will revise the annual flu vaccine framework, which is an evidence-based catastrophe of low quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods. . . [Emphasis added.] We will re-appraise safety and be honest in vaccine labels. I look forward to hearing your thoughts on how to do this better.
Additionally, at FDA, we have not been focused on understanding the benefits and harms of giving multiple vaccines at the same time. This is a concern shared by many Americans. [Emphasis added.] The FDA’s standard has been to require randomized studies too small to draw any conclusions from– creating a false sense of efficacy and safety. OVRR and OBPV staff will be tasked with writing guidelines to reflect these changes, and the mission of CBER will change to reflect this worldview. Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it. [Emphasis added.]
This memo indicates a long-awaited goal of the MAHA (Make America Healthy Again) movement: a demand to follow the true science…the data… to where it leads and let the results speak for themselves. The truth should not be filtered through consultants or news media with clear conflicts of interest because they are funded by Big Pharma. We urge you to read Prasad’s incredible 6 page memo.
Dr. Robert Malone, an mRNA pioneer and new member of the FDA’s vaccine advisory committee, said it best: “I am stunned, gobsmacked by his letter. 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.”
This is a revolution we welcome!
This leak came right on the heels of another stunning action by the CDC a few weeks ago.
Under the direction of the Secretary of Department of Health and Human Services, Robert F. Kennedy Jr., the CDC quietly placed an * by the statement “Vaccines do not cause Autism” on their website.
If you recall during Kennedy’s confirmation hearing, Senator Bill Cassiday (R-La.) said he would only vote for his confirmation if the CDC did not “remove statements on their website that vaccines do not cause autism.” The CDC acknowledged his demand on their website as well:
* The header ‘Vaccines do not cause autism’ has not been removed, due to an agreement with the chair of the U.S. Senate Health, Education, Labor, and Pensions Committee that it would remain on the CDC website.
But by adding the asterisk, the CDC has managed to keep that promise and open the door to scientific inquiry and public disclosure. The HHS has officially announced it will launch a “comprehensive assessment of the causes of autism” which will include reviewing possible causal links to vaccines.
This is another revolutionary step. For decades parents whose children were demonstrably negatively impacted by childhood vaccines faced a governmental infrastructure which placed insurmountable obstacles before them while shielding Big Pharma from accountability.
- In 1986, Congress passed the National Childhood Vaccine Injury Act (NCVIA), which created essentially a no-fault shield for Big Pharma. It limited their legal liability in vaccine injury cases. It also created the Vaccine Adverse Events Reporting System (VAERS) and a special vaccine court for injured patients to receive compensation.
- In 1986, there were 11 vaccines on the recommended childhood vaccination schedule. Today it exceeds 50. If flu and Covid shots are included, that number approaches 100 injections before a child is 18.
- In 1985, the rate of childhood autism was 2-5 per 10,000 children.
- In 2025, the estimated rate of childhood autism is an astonishing 1 out of every 31 children!
This is the kind of data the HHS will be looking at. Correlation does not prove causation, but it is a clear signal. Autism rates exploded when recommended childhood vaccines exploded.
We also now know that the entire childhood vaccination schedule was built without rigorous scientific inquiry and testing in two essential areas:
- The “cumulative effect” of all the recommended vaccines has never been studied.
- No childhood vaccine has a known safety profile. None were ever tested against a real placebo such as an inert ingredient like saline. They were tested against older versions of the same vaccine or another shot with a similar “safety profile.” But since all existing “safety profiles” were created using this flawed process, true safety profiles are literally unknown. This shocking revelation was revealed in the groundbreaking book “Turtles All the Way Down”.
We celebrate the promised deep dive into the Covid 19 shots for children and what’s really fueling the explosive rates of childhood autism. We support Dr. Prasad’s and Secretary Kennedy’s efforts to follow the science and provide the real data to the American people.
Contrast these announcements with the CDC and FDA under the Biden Administration. When the FDA voted to make the Covid-19 shot part of the Childhood Vaccination Schedule, one of the members of the advisory board literally admitted our children were being used as guinea pigs…live test subjects.
“We’re never going to learn about how safe this vaccine is [for children] unless we start giving it.” Eric Rubin
He made that statement while MILLIONS of vaccine injury and death reports were piling up in their own reporting system- VAERS! Today, there are over two MILLION formal reports. These are almost always submitted by a medical professional due to their complexity and it’s one reason VAERS is woefully underreporting the real totals. Colleges and universities around the country made the experimental Covid-19 shots mandatory for enrollment and children were coerced and enticed with money to take the shots as well. Both demographics had virtually no risk of death from the Covid virus, but Biden’s CDC and FDA were pushing the shots on them anyway.
We are grateful that President Trump appointed Robert F. Kennedy to lead the HHS and that the entire vaccine industry is finally facing the scrutiny it deserves after decades of protection and obfuscation. We are hopeful the HHS will return to its 1979 mission of “protecting the health of Americans” not Big Pharma. Let us finally, truly follow the science.
Let the results fall where they may. But first, let’s get those results.
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