Leaked FDA Memo Indicates Major Changes Coming in How Vaccines are Tested & Approved
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Leaked FDA Memo Indicates Major Changes Coming in How Vaccines are Tested & Approved
Published: 12/6/2025 – 6:00 PM
On November 28, 2025, the Washington Post published a “Leaked Memo”, first obtained by NPR, from Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER) titled -- “Deaths in children due to COVID-19 vaccines and CBER’s path forward” that was forwarded to his staff.
Director Vinay Prasad said: 1 & 2
“at least 10 children have died because of the COVID-19 shots”
“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.”
“These 10 deaths are related to vaccination and are certainly an underestimate of the safety concerns surrounding COVID-19 vaccines, without offering further evidence or data.”
The director attributed these mortalities to “vaccine-induced myocarditis,” or the inflammation of heart muscles.
The Internal Memo from Vinay Prasad also said: 3
"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."
“When these products later result in post market deaths, it is difficult to take corrective action. I favor approving products with benefits that exceed risks.”
the agency would change its annual flu vaccine framework, update vaccine labels to be "honest," and make other changes to how it reviews vaccines, according to contents of an internal email reviewed by NPR and reported on first by a PBS News Hour correspondent and later by The Washington Post.
Prasad wrote that the FDA would also no longer authorize vaccines for pregnant women without stricter requirements.
And for pneumonia vaccines, manufacturers will have to PROVE they REDUCE disease rather than show they Generate Antibodies.
He also raised questions about giving multiple vaccines at the same time, which is standard practice.
Vinay Prasad concedes that the mRNA Covid Vaccine was responsible for killing 10 children. 4
According to the FDA email from Prasad, he told the agency's biostatistics and pharmacovigilance team to analyze 96 reported deaths from 2021 to 2024.
They determined 10 children died "after and because of" the COVID vaccine.
Vinay Prasad said the true number was likely higher.
Healthy young children who faced tremendously Low Risk of Death were Coerced via school and work mandates, to receive a vaccine that could result in death.
Other Interesting Comments in this Leaked Memo by Vinay Prasad: 5
Covid-19 vaccines earned 100 billion dollars globally.
The annual US vaccine market is estimated to be over 30 billion dollars, projected to pass 50 billion in a decade, and a single new vaccine for pregnant women has industry analysts estimating 1 billion a year in annual returns.
Vaccines do not go "generic."
There is no biosimilar pathway.
You can't show your biosimilar vaccine has the same antibody titer and get approval.
This means two things: companies can expect long tails of earnings, and FDA acknowledges that cell and humoral immunity surrogates are insufficient for generic approvals.
The fact that we don't offer generic or biosimilar vaccines because no amount of cell or humoral mediated immune surrogates would mean that a product retains efficacy has a deeper logical conclusion: how can we accept such endpoints to approve entirely novel products?
CBER Director Vinay Prasad then Outlined the “Path Forward.” 6
Our general approach in CBER will be to direct vaccine regulation towards evidence based medicine.
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 (any prior promises will be null and void).
We will demand pre market randomized trials assessing clinical endpoints for most new products.
Pneumonia vaccine makers will have to show their products reduce pneumonia (at least in the post-market setting), and not merely generate antibody titers.
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.
We will re appraise safety and be honest in vaccine labels
Is this for real?
Someone in the FDA actually talking about being HONEST about how they “label” vaccines?
THEN --
On November 29, 2025, FDA Commissioner, Martin “Marty” Makary said: 7
"Were' just getting back to science, back to Gold Standard Science."
"Were not just going to Rubber Stamp new products that don't work, that fail in a clinical trial."
"It makes a Mockery of Science if we're just going to Rubber Stamp things with No Data and that was the MO in the Biden Administration, with the eternal COVID Booster Approvals for Young Healthy Kids."
"Now recommending that a 6 year old girl get another 70 mRNA COVID Shots, one each year for the rest of her life is NOT based on Science."
"So, we're not just going to Rubber Stamp Approvals without seeing some scientific evidence."
DR. Peter McCullough called for transparency, notification of the parents of the vaccine victims, and complete market removal of COVID-19 vaccines.
Dr. Peter McCullough says: 8
“These 10 deaths are the Tip of the Iceberg.”
“VAERS – Vaccine Adverse Effects Reporting System has 19,480 deaths for U.S. residents, about 2,000 of these occurred within 48 hours of the shot and then 19,279 Americans reported to be permanently disabled.”
“If the Vaccines were not the cause of Deaths, we wouldn’t do the report to VAERS.”
“VAERS does indicate Causation by Proxy of Reporting.”
“The VAERS system indicated the vaccine IS the cause of the problem because the doctor / provider at the scene has examined the patient, examined the autopsy and the medical record information, examined the clinical record and has determined the vaccine is the cause, otherwise a VAERS report would not be made.”
“Both Makary and Prasad should immediately call for the COVD Vaccines to be removed from the market.”
“Every day they delay on this, the more Americans will be hurt.”
“An Independent Panel should review all this data, the CDC has these families names, emails and addresses. There needs to be interviews of family members of the deceased to get their side of the story. This should all be done independently by NON CDC and FDA employees.”
“Makary and Prasad need to show up in Washington D.C. as there have been multiple Hearings on Vaccine Safety. I was the main witness on the one on May 21, 2025.”
“We published a Report indicating there was a Government Cover-up of COVID-19 Vaccine Induced Myocarditis & Pericarditis, including Fatal cases.”
“This was held in the Russell Building in the U.S. Senate in Washington D.C. and Makary and Prasad did not show up to get the important information.”
“They have not indicated in any of their statements that they have read the Final Report of the Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations conclusion that there WAS a government coverup going back to early 2021 to CONCEAL COVID-19 Vaccine Induced Myocarditis & Pericarditis, predominantly on young people, including Fatal Cases.”
“I think the fact that this had to be LEAKED and it didn’t come out with a Press Release and were not forthright with the American people, there is only a SLIVER of intellectual honesty, there is just a MORSEL of Medical Prudence from the FDA and it’s FAR from what Americans deserve
2025 Rasmussen Survey: 1 in 10 Adults Seriously Injured by COVID-19 Vaccine 9
A recent Rasmussen survey revealed that 10% of U.S adults who received the mRNA COVID-19 Vaccine experienced "MAJOR" Side Effects, and 36% suffered "minor" side effects.
The survey, which included 1,292, also revealed that 46% of both vaccinated and unvaccinated adults think it’s likely that COVID-19 vaccines have caused a significant number of unexplained deaths.
How can our Government Agencies who are supposed to be protecting us still, as of December 2025 say that the Benefits of the COVID mRNA Vaccines Outweigh the Risks?
I believe it is Encouraging News that FDA CBER Division Director, Vinay Prasad indicated that antibody tests will no longer be acceptable for Pneumonia vaccines.
Dr. Peter McCullough says: 10
“Antibodies are NOT an adequate surrogate for Immune Protection. They are good surrogate for antigenic exposure, but not immune protection.”
This is important because almost all vaccines were approved because of certain antibodies being found in the blood after the jabs.
That is how Big Pharma vaccine makers convinced the FDA to approve their products, all based on Antibody response and “presuming” that these antibodies produced would lead to immunity.
True efficacy studies were never accomplished. Efficacy is most often based on antibodies.
Antibodies have been used as the main “Predictor” of vaccine efficacy.
Browse through the FDA Vaccine Package Inserts and take a look for yourself. They never compare a vaccinated person to an unvaccinated person with a true inert placebo and follow them for six months, a year, or five years.
Antibody Tests have been the standard surrogate marker in vaccine clinical trials that are used as a “predictive” model.
Vaccines are approved on this premise.
Vinay Prasad, Chief Medical and Scientific Officer and the Director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration is at least indicating that he wants vaccine makers to PROVE a True REDUCTION in disease and not just prove they generate antibodies.
Vinay mentioned this for Pneumonia vaccines, but it should be for ALL vaccines.
There has been instant resistance from Former FDA Commissioners on no longer relying on antibodies.
Former FDA Commissioners pushing back on Vinay Prasad's desire on wanting cease the practice of using antibody levels generated by a new version of an existing vaccine to determine whether the vaccine is effective.
Former Commissioners state: 11
“This change would impede the ability to update vaccines to keep up with the natural evolution of respiratory viruses or changes in the prevalence of bacterial serotypes.”
In other words, speaking in plain English: This would “impede” the easy money that Big Pharma makes by dishing out untested and unproven vaccines and selling them like hotcakes.
Hopefully this just isn’t political speech by the new leadership within the FDA.
This is the first time in all of my research that such change has been “internally” proposed.
Going against a Trillion Dollar industry will come with a little pushback, more like ferocious pushback.
God Forbid they have to actually Prove their Vaccines Reduce Disease.
Source: PeterMcCulloughMD -- https://rumble.com/v72i1pq-mccullough-foundation-response-to-fda-concession-of-ten-pediatric-mrna-covi.html
12/6/2025 – 6:00 PM
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1. Prasad, Vinay. "Deaths in children due to COVID-19 vaccines and CBER’s path forward." November 28, 2025. Washington Post PDF. https://www.washingtonpost.com/documents/3042d15c-676b-48ac-8148-1a2204ef420e.pdf.
2. Stein, Rob. “FDA to Raise Hurdles for Vaccines, Faulting COVID Shots for 10 Kids’ Deaths.” NPR, 29 Nov. 2025, www.npr.org/sections/shots-health-news/2025/11/29/nx-s1-5624998/fda-vaccines-covid-children-safety.
3 -- 6. Prasad, Vinay. "Deaths in children due to COVID-19 vaccines and CBER’s path forward." November 28, 2025. Washington Post PDF. https://www.washingtonpost.com/documents/3042d15c-676b-48ac-8148-1a2204ef420e.pdf.
7. Waking the World up. “FDA Commissioner – Martin Makary – “We’re Getting Back to Gold Standard Science”.” Rumble, 06 Dec 2025, rumble.com/v72l5p4-fda-commissioner-martin-makary-were-getting-back-to-gold-standard-science.html.
8. Waking the World up. “Dr. Peter McCullough -- “FDA Concedes COVID-19 mRNA Vaccines Killed 10 Children & Vows Changes”.” Rumble, 06 Dec 2025,rumble.com/v72l8wy-dr.-peter-mccullough-fda-concedes-covid-19-mrna-vaccines-killed-10-children.html.
9. “Rasmussen Survey: 1 in 10 Adults Seriously Injured by COVID-19 Vaccine – NaturalNews.com.” NaturalNews.com, 26 Nov. 2025, www.naturalnews.com/2025-11-26-1-in-10-adults-injured-by-covid-vaccine.html. Accessed 4 Dec. 2025.
10. Waking the World up. “Dr. Peter McCullough -- “FDA Concedes COVID-19 mRNA Vaccines Killed 10 Children & Vows Changes”.” Rumble, 06 Dec 2025,rumble.com/v72l8wy-dr.-peter-mccullough-fda-concedes-covid-19-mrna-vaccines-killed-10-children.html.
11. Herper, Matthew. “A Dozen Former FDA Commissioners Decry Prasad Memo on Vaccine Regulation.” STAT, 3 Dec. 2025, www.statnews.com/2025/12/03/fda-former-commissioners-vaccine-policy.
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