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The FDA’s COVID “VACCINE” PUSH: A BETRAYAL OF SCIENCE AND PROFOUND BREACH OF PUBLICTRUST
ACCORDING TO THE CDC and U.S. PATENT OFFICE A VACCINE MUST PREVENT THE DISEASE AND PREVENT ITS TRANSMISSION – THE mRNA GENE THERAPY “VACCINE” DOES NEITHER
“One of the issues we’ve had in recent decades is that government policy has been made on the back of junk science, scientific studies and findings that included conflicts of interest or scientific misconduct. The purpose of this Executive Order is to re-center policy making around Gold Standard Science, scientific efforts that have followed appropriate scientific methods that don’t include those sorts of conflicts of interest and to ensure that when departments and agencies that are relying on scientific studies to promulgate rules, to promulgate regulations that the science they’re relying on is highly reliable and available to the public.”
Because of the Restoring Gold Standard Science Executive Order, I am now convinced that President Trump will revert to the original and now current definition of a vaccine – as per the CDC and U.S Patent Office – A VACCINE MUST PREVENT THE DISEASE AND PREVENT ITS TRANSMISSION – THE mRNA GENE THERAPY “VACCINE” DOES NEITHER – a salient fact arbitrarily and capriciously ignored by FDA’s Drs Prasad and Makary.
The FDA has skipped its usual process for creating guidelines and overlooked existing data. Instead, two individuals with no specific experience in vaccinology—Drs. Vinay Prasad (oncologist) and Marty Makary (surgeon) —are now leading the agency’s vaccine review. They are setting policy with little expert input, minimum attention to current data, and minimum respect for the long-standing vaccine evaluation system in the U.S. The public deserves an FDA that puts safety and science ahead of market speed and Big Pharma profit.The mRNA shot is a gene therapy and should have different guidance and thresholds for market approval. The COVID-19 shots are still on the market because of their Emergency Use Authorization (EUA) status — through which they continue to enjoy a federal liability shield.
An EUA should only be granted if there was a “novel” or new feature to the virus that presents as a new threat that can be isolated, identified, evidenced and supported by clear data.
1) the virus was not novel because there were 73 patents on parts of this virus and scores of medical papers,
2) there were effective treatments, and
3) Obama removed SARS from the Biological Select Agents and Toxins List (BSAT) because SARS – Coronavirus – no longer posed a threat to humans.
After only a few weeks on the job, replacing Dr Marks who resigned before getting fired, Dr Prasad presented to FDA virology staff on May 7, 2025 and informed them and the public not to worry because:
(1) randomized trials are not always needed, and
(2) if Big Pharma companies show that their shot can simply elicit an antibody response without showing it can prevent disease or prevent transmission, then the FDA will approve those shots for 100-200 million people in the U.S. who have at least one risk factor. https://www.youtube.com/watch?v=jbRGlEsbKQ4?YouTube presentation.
Dr Prasad Receives Consulting fees from UnitedHealthcare and OptumRx according to disclosure to NEJM.
However, these COVID shots are not vaccines because they do not prevent disease nor do they prevent transmission of the disease – a salient fact ignored by Drs Prasad and Makary.
THEREFORE, REGARDLESS OF AGE, THE COVID SHOTS WILL NOT HELP ANYONE WITH OTHER RISK FACTORS BECAUSE IT WON’T PREVENT THEM FROM GETTING COVID NOR WILL IT PREVENT THEM FROM TRANSMITTING COVID. This was thoroughly reviewed in
The CDC’s Vaccine Push for Children: A Betrayal of Science and Trust?
On May 15, 2025 this Report compelled “HHS to Stop Recommending Routine COVID Shots to Children and Pregnant Women” – Wall Street Journal
Dr. Anthony Fauci, a linchpin of the U.S. pandemic response, has inadvertently spotlighted this failure. On August 13, 2024, he disclosed contracting COVID-19 for the third time, despite being vaccinated and boosted six times, as captured in a Twitter video. This wasn’t a fluke but a symptom of a wider trend: vaccinated individuals, even those with multiple doses, continue to contract and spread the virus. Fauci reinforced this in a July 12, 2022, interview, admitting that “vaccines do not protect overly well against infection,” as seen in a Rumble clip. And on April 6, 2022, Peter Marks, MD, PhD, Director of FDA Vaccine Division, admits boosters are ineffective at preventing infection but continues to support this strategy as a temporary “stopgap measure” — “until a proper solution is found.” Then on testified to Congress: Youngest kids vaccine won’t need to hit 50% efficacy mark. Two doses of pediatric vaccine failed to trigger an immune response in 2-, 3- and 4-year-olds.” (Marks was forced to resign on March 28, 2025 or get fired).
If the vaccines falter in adults like Fauci, and in children as per Marks’ own admissions, what rationale justifies exposing children—who face negligible risk from COVID-19—to the same intervention?
The judiciary has echoed this sentiment. On June 7, 2024, the United States Court of Appeals for the Ninth Circuit ruled in Health Freedom Defense Fund v. Carvalho that, unlike traditional vaccines, the COVID-19 shots do not prevent infection or transmission, as documented in the court’s decision. This ruling highlights a key distinction: while vaccines for smallpox or polio offer sterilizing immunity, stopping both disease and spread, the mRNA-based COVID-19 vaccines do not.
This legal finding aligns with a January 11, 2023, paper co-authored by Fauci in Cell Host & Microbe, which conceded that SARS-CoV-2 and other respiratory viruses “have not to date been effectively controlled by licensed or experimental vaccines,” available in PDF format.
Pfizer’s Admissions and the FDA’s Role
If the vaccines don’t halt the virus, why are they being injected into children? The answer grows murkier with revelations from Pfizer itself. On January 19, 2024, Pfizer admitted in federal court that its COVID-19 gene therapies—commonly marketed as vaccines—were never approved by the U.S. Food and Drug Administration (FDA), operating instead under Emergency Use Authorization (EUA), a lesser standard lacking long-term safety data, as noted in afederal court filing. This admission casts doubt on the CDC’s decision to target children, a group already at minimal risk from severe COVID-19 outcomes.
Also a presentation delivered during the October 2024 meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP), which stated that the long-term efficacy of the COVID-19 vaccines was statistically negative for adults 18-64 years old.
There’s no scientific reason to continue the COVID “vaccine” program because it doesn’t prevent infection or transmission. Vaccine injuries are real, and the shots can’t be justified given the low fatality rate of COVID. Young people who received four doses have a 318% higher mortality rate, and Pfizer’s trial showed an 87.5% fetal death rate. Authorizing it for infants is unjustifiable.
On November 4, 2021 the CDC had to change its definition of a vaccine to justify its needs.
Original definition: “A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.”
Nov 4, 2021: “A preparation that is used to stimulate the body’s immune response against diseases.”
May 26, 2025 – The CDC has now updated their website regarding the definition of a vaccine
Safety Concerns Especially for Children and Adults
Beyond efficacy, the safety of the shots remains contentious. The COUNTERMEASURE“VACCINE” report cites peer-reviewed studies and adverse event data suggesting significant risks.
Eliminating cancer registries could be a tactic to hide rising cancer cases linked to the COVID-19 vaccine, allowing continued vaccine distribution without scrutiny.
As of May 2025, the National Program of Cancer Registries (NPCR) and the Surveillance, Epidemiology, and End Results (SEER) Program are still functioning but are challenged by funding cuts and restructuring as is cancer data reporting from Veterans Affairs facilities. Their ability to collect comprehensive cancer cases and cancer data are at risk due to financial and operational hurdles.
And as of May 2025, the National Cancer Institute (NCI) is struggling with a stagnant budget and proposed NIH cuts, impacting cancer research. While at the same time, China has surpassed the United States in cancer research output for the first time.
“The Corruption of Science and Federal Health Agencies: How Health Officials Downplayed and Hid Myocarditis and Other Adverse Events Associated with the COVID-19 Vaccines.”
Remove COVID-19 mRNA gene therapy “vaccine” from the market until and unless randomized controlled trials show safety and efficacy after a period of at least 12 years.
Dr Prasad’s Summary: From Critic to Collaborator — A Shift in Tone Toward the FDA
Then (April–June 2024): Dr. Vinay Prasad strongly criticized the FDA, accusing it of being too close to the pharmaceutical industry, approving drugs based on weak surrogate endpoints, suppressing dissent, and failing to generate credible evidence to guide optimal care. He claimed the agency was harming public trust, especially through rushed and opaque vaccine policies, and even questioned its overall value, saying we might be “better off” without it.
Now (May 2025, remarks to FDA CBER staff): Prasad struck a sharply different tone—praising FDA scientists, calling their work a “public service,” and expressing admiration and humility. While still referencing controversial decisions (e.g., approving dubious products or acting without strong data), he framed his concerns as part of a broader effort to protect public trust. He also notably softened his stance on randomized controlled trials, recognizing that in the context of rare diseases, alternative evidence standards may be appropriate.
Commentary: This evolution—from calling the FDA incompetent and corrupt to praising its staff and asking to learn from them—suggests a strategic shift. Some subtle criticisms remained, but were veiled in diplomacy. Whether this marks a genuine change in perspective or a tactical adaptation remains to be seen.
Dr. Marty Makary
Before joining the FDA, Dr. Makary supported early COVID-19 vaccination but opposed broad mandates and highlighted the importance of natural immunity.
As FDA Commissioner, he supports vaccines for high-risk groups while calling for stricter evaluation and targeted use, especially for those 65 and older. He emphasizes science and common sense in shaping vaccine policy.
Because of the Restoring Gold Standard Science Executive Order, I am now convinced that President Trump will revert to the original and now current definition of a vaccine – as per the CDC and U.S Patent Office – A VACCINE MUST PREVENT THE DISEASE AND PREVENT ITS TRANSMISSION – THE mRNA GENE THERAPY “VACCINE” DOES NEITHER – a salient fact arbitrarily and capriciously ignored by FDA’s Drs Prasad and Makary.
