Make money doing the work you believe in
Vinay Prasad’s FDA Memo: More Fallout — Dr. Robert Malone provides a detailed analysis of Dr. Vinay Prasad’s FDA memo, Independent Medical Alliance expresses outrage over the carnage from mRNA shots forced upon the world’s population, CHD covers news and views. (posted 12/02/25, updated 12/03/25)
We offer three more views on a landmark November 2025 memo from FDA/ CBER* director Dr. Vinay Prasad. As usual, we encourage you to read the original articles for more details and context.
ED NOTE
The upcoming ACIP meeting on December 4-5. 2025 will reveal whether the committee is paying attention and will do the right thing for humanity, rather than kowtow to Big pharma and deep state agency testimony.* CBER stands for Center for Biologics Evaluation and Research, part of FDA
Prasad FDA Memo: Regulatory Implications. Yes, the investigation of VAERS childhood deaths is important. But Media is overlooking the big picture. By Dr. Robert W. Malone (12/01/25): malone.news/p/prasad-fd…
Independent Docs: “Yes, mRNA Shots Have Led to Unnecessary Childhood Deaths.” The Independent Medical Alliance (IMA) released a statement today regarding the FDA weekend memo that identified at least 10 children who died after receiving the COVID-19 mRNA shot. By Independent Medical Alliance (12/01/25): imahealth.substack.com/…
🆕 Leaked Memo: FDA Confirms ‘At Least’ 10 Child Deaths From COVID Vaccine, Promises Sweeping Reforms. In a leaked memo to staff, Dr. Vinay Prasad said the agency will make changes to how it approves all vaccines, after an internal analysis revealed that “at least” 10 children died from the COVID-19 vaccine, though that number is “certainly an underestimate due to underreporting,” Prasad said. Reaction to the memo was mixed, with some COVID-19 vaccine critics accusing the FDA of a cover-up. By Brenda Baletti, Ph.D. (12/01/25, includes links to related articles): childrenshealthdefense.…
(Images from articles.)
___________
1️⃣ Prasad FDA Memo: Regulatory Implications.
Dr. Malone responded to outrage and consternation on X concerning FDA/ CBER director Dr. Vinay Prasad’s official / unofficial / leaked memo regarding:
FDA admission of COVID mRNA-induced vaccine deaths of children.
Significant FDA regulatory policy changes planned for vaccines and gene therapies.
Summary (Grok ai, edited)
Dr. Malone acknowledged the grievous nature of child deaths from these (in our opinion, diabolical and worthless) shots then explained each major section of the Prasad memo and its implications.
Malone’s Personal Context and Initial Reaction
First encountered the child death data last summer during ACIP service but is embargoed by Federal Advisory Committee Act (FACA) federal law from disclosing details.
ED NOTE We found childhood COVID-shot death information easily using VAERS/OpenVAERS, so wonder why the data was such a secret. Many kids (and adults) died or were disabled while waiting for embargoes to lift and truth to be revealed officially.Memo's regulatory policy components are revolutionary.
Malone has alerted parents to risks for years and faced attacks.
Malone references his role in a mandates case against the largest school district in the USA where acknowledging death as a side effect led to settlement.
Myocarditis and Policy Critique
Prasad cites vaccine-induced myocarditis risk of 200-330 per million doses in young males is higher than COVID risks in children.
Myocarditis also is a documented risk of COVID shots.
Prasad criticizes former CDC Director Walensky for denying the signal in 2021.
Malone states Prasad’s criticism implies US Government (USG) policies may have harmed more children than saved. But this position overlooks the additional impact of active FDA and USG suppression of early treatment options pioneered by front-line physicians worldwide.
Criticism of Prior Leadership
Prasad criticizes prior CBER directors for approving ineffective gene therapies due to demand. Instead, Prasad favors approvals where benefits exceed risks.
Malone interprets this as acknowledging COVID vaccines are gene therapies, which require stricter guidance including addressing shedding.
Vaccine Market and Surrogates
Prasad highlights the profitable vaccine market with no biosimilar pathway. He states cell and humoral immunity surrogates are insufficient for approvals.
Malone notes this implies boosters authorized on immunity surrogates may lose validity, requiring clinical trials for efficacy.
New CBER Approach
CBER will direct regulation toward evidence-based medicine:
Swift action on pediatric death concern, likely adding warnings or rescinding authorizations.
No authorizations for pregnant women based on surrogates; prior promises void.
Require trials showing clinical endpoints, e.g., pneumonia vaccines must reduce pneumonia.
Revise flu vaccine framework, criticizing poor evidence, assays, and methods; re-appraise safety and labels.
Implications for Industry and ACIP
Policy shifts threaten Pfizer and Merck pneumonia vaccines, requiring ACIP reevaluation.
Changes impact influenza market, mandates, and CDC monitoring programs.
Malone sees this as the most comprehensive shift in 30 years, with global ripple effects.
Conclusion
Prasad's positions need translation into FDA guidance documents, facing potential industry opposition. This could take two or three more years.
ED NOTE Two or three more years may be too long. Permanent reform must be enacted quickly but carefully. This must be done without industry and political influences, only considering Americans' well-being. And it must occur before a new administration takes over or Congress can throw a monkeypox wrench into the good intentions.Geopolitical implications include challenges to UK secrecy on vaccine deaths and accountability for promoting products while suppressing objections.
___________
2️⃣ Independent Docs: “Yes, mRNA Shots Have Led to Unnecessary Childhood Deaths.”
This unproven, ineffective, and medically dangerous mRNA shot was mandated on the American people without proper oversight and safety testing. This was particularly egregious in mandating the shot for young children, the population least vulnerable to COVID. And yes, children lost their lives who otherwise would have been healthy had they not taken the shot.
As practicing physicians, our members even now are seeing a growing number of injuries from those who took one or multiple mRNA shots. So for those actually on the front lines of our healthcare system, this problem is very real.
It’s long past time to fully investigate and adjudicate this horrific era of mandated COVID shots. We must ensure this never happens again. History will remember the COVID shot mandates with the same contempt as other past atrocities that have been pushed by bureaucrats in the name of medicine. — IMA President and Chief Medical Officer Dr. Joseph Varon
___________
3️⃣Leaked Memo: FDA Confirms ‘At Least’ 10 Child Deaths From COVID Vaccine, Promises Sweeping Reforms.
This excellent article features quotes from many voices in the medical freedom movement.
Summary (Grok ai, edited)
Leaked Memo Content
Internal review of 96 VAERS-reported deaths in children ages 7-16 found at least 10 related to the COVID shot (likely underreported).
Linked deaths to myocarditis.
Described revelation as the first FDA acknowledgment of COVID-19 vaccine deaths in American children.
Mainstream Media and Public Health Expert Reactions
Mainstream: Downplayed memo.
Vaccine promoters Dr. Paul Offit, Dr. Peter Hotez, and Dr. Peter Marks doubted the findings and called for data release.
Public health experts warned: Erodes vaccine confidence.
Some media: Prasad downplaying COVID-19 risks to children or complicating vaccine approvals.
Responses from Vaccine Critics
Brian Hooker (Children's Health Defense): Step toward transparency but "tip of the iceberg."
Jeffrey Tucker (Brownstone Institute): Breakthrough in official acknowledgment.
Dr. Meryl Nass: Simply enforces already existing honest science policies.
Dr. Peter McCullough: FDA is covering up vaccine deaths.
Sasha Latypova: Younger children excluded, suggesting political motivations.
VAERS Data Insights
VAERS: 174 child deaths as of Oct. 31; reporting estimated at less than 1% of actual totals.
Analyst Albert Benavides: Child death data hidden in reports with unknown ages.
Jessica Rose: Found 230 deaths in children 0-16, including 30 under age 5.
Proposed FDA Reforms
Require studies including pregnant women for authorizations in that group.
Demand vaccines show direct efficacy, not just antibodies.
Revise flu vaccine updating process due to low-quality evidence.
Research benefits and harms of multiple simultaneous vaccines. These align vaccines with other medication standards.
Agency Statements and Upcoming Events
FDA Commissioner Marty Makary: Announced public release of child death data, no more routine boosters for healthy kids. Affirmed vaccines' role for older people.
HHS, Moderna, and Pfizer did not respond.
CDC's ACIP meets Dec. 4-5 to review vaccine schedules, safety, and hepatitis B birth dose recommendation.
___________
Related:
ACIP's Upcoming Meeting dates and agenda, and Comment link: tinyurl.com/3hunmbsn
A Revolution in Vaccine Regulation and Approval. The truth behind this letter [from Dr. Vinay Prasad, MD, CBER* Director] is stunning (11/29/25): tinyurl.com/v756abv9
The Federal Advisory Committee Act (FACA): Overview and Considerations for Congress: tinyurl.com/4r7fzsvk
Where’s VAERS? tinyurl.com/y7rfbh9z
