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The FDA’s COVID “VACCINE” PUSH: A BETRAYAL OF SCIENCE AND PROFOUND BREACH OF PUBLIC TRUST
ACCORDING to the CDC, the FDA, the NATIONAL INSTITUTES of HEALTH, the NATIONAL INSTITUTE of ALLERGY and INFECTIOUS DISEASES, the NATIONAL CANCER INSTITUTE, the U.S. PATENT OFFICE, and the U. S. COURT of APPEALS for the NINTH CIRCUIT,
THE SCIENTIFIC AND LEGAL DEFINITION OF A VACCINE IS THAT IT MUST PREVENT THE DISEASE AND PREVENT ITS TRANSMISSION – the mRNA gene therapy “VACCINE” DOES NEITHER
https://tinyurl.com/3byezhau https://bit.ly/3ZQselr Written May 26, 2025
Because of the Restoring Gold Standard Science Executive Order (that is binding within 30 days [5 U.S.C. §7301]), I am now convinced that President Trump @realDonaldTrump will revert to the original and now current scientific and legal definition of a vaccine – as defined by the CDC, FDA, NIH, NIAID, NCI, U.S Patent Office, and the U.S. Court of Appeals for the Ninth Circuit – 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 thus defying President Trump’s Executive Order, the Ninth Circuit Court’s ruling, other agencies and Institutes, and thereby putting 100-200 million Americans at risk.
The FDA has skipped its usual process for creating guidelines, skipped open forum discussions, 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 making policy decisions (traditionally done only by CDC) with minimal expert input, limited consideration of current data, and little regard for the established vaccine evaluation system in the U.S.
In a dramatic flip-flop, they even call their policy “evidence-based approach to Covid-19 vaccination” rather than adhering to FDA’s mission of evaluating vaccines for efficacy and safety. (An evidence-based approach to Covid-19 vaccination. N Engl J Med 2025;392:2484-6). This defies President Trump’s “transparency and gold standard scientific excellence.”
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 – fully explained below. The same applies to self-amplifying RNA shots (saRNA), also a gene therapy.
There’s no scientific reason to continue the COVID “vaccine” program because it doesn’t prevent infection or transmission. “Vaccine” harm is real, and the shots can’t be justified given the low fatality rate of COVID. Young people who received four doses have more than a 300% greater mortality rate, and Pfizer’s trial showed an 87.5% fetal death rate. Authorizing it for infants is unjustifiable.
May 23, 2025 – President Trump @realDonaldTrump signed an Executive Order entitled Restoring Gold Standard Science (Watch at time marker 13:44 to 14:45
https://youtu.be/CEp7vV5rfMw?si=AGsBkYGM81BnTFco)
“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.”
Also, at the same time, in defiance of President Trump’s Restoring Gold Standard Science Executive Order, the Washington Post reports, “The plan to vaccinate all Americans, despite RFK Jr” (June 24, 2025).
“Professional medical societies, pharmacists, state health officials and vaccine manufacturers, as well as a new advocacy group, are mobilizing behind the scenes to preserve access for vaccines” to establish a grass roots movement for recommending, distributing and profiting from vaccines.
Promoting a movement based on misinformation, disinformation, fearmongering, or guilt—especially related to public health—can be dangerous and unethical. These tactics can undermine trust in medical science, and exploit vulnerable people.
This new coalition will use many tactics that may include television ads and partnering with telehealth companies that currently are not required to show risks. (https://tinyurl.com/2fv57x77).
This movement is an attempt to sidestep the scientific and legal definition of a vaccine.
https://www.washingtonpost.com/health/2025/06/24/vaccines-access-rfk-cdc/
BOSTON – July 7, 2025 – Today, the American Academy of Pediatrics (AAP), American College of Physicians (ACP), American Public Health Association (APHA), Infectious Diseases Society of America (IDSA), Massachusetts Public Health Alliance (MPHA), Society for Maternal-Fetal Medicine (SMFM), and a pregnant physician, filed suit in American Academy of Pediatrics v. Robert F. Kennedy, Jr. in the U.S. District Court for the District of Massachusetts to defend vaccine policy, and to put an end to the Secretary’s assault on science, public health and evidence-based medicine. Plaintiffs are suing HHS and Secretary Kennedy for acting arbitrarily and capriciously when he unilaterally changed Covid-19 vaccine recommendations for children and pregnant people.
The COVID-19 shots have been 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.
May 7, 2025 – After only a few weeks on the job, replacing Dr Marks who resigned before getting fired, Dr Prasad presented to FDA vaccine staff informing them and the public not to worry because he said:
“Randomized trials are not always needed” FLIP-FLOPPING from
Jan 11, 2022: “We must do randomization trials. It is scientifically and morally wrong to push policies year after year with no credible data they help. I look forward to the future society that fully embraces the power of randomization.”
“Based on prior immunologic endpoints, that means proof that the vaccine can create antibodies in people, companies can apply for approval for 65 and older and/or people at high risk of severe COVID-19….which effectively means 100 to 200 million Americans.”
https://www.youtube.com/watch?v=jbRGlEsbKQ4? Dr Prasad’s presentation.
FLIP-FLOPPING again, he carefully chooses the words ‘create antibodies’ knowing this is not a vaccine. A vaccine must prevent disease and prevent transmission
“CDC 2025 List of Underlying Medical Conditions That Increase Risk of Severe Covid-19.”
https://www.nejm.org/doi/pdf/10.1056/NEJMsb2506929 May 20, 2025
Dr Prasad Receives Consulting fees from United Healthcare and OptumRx according to disclosure to NEJM.
Both Drs Prasad and Makary know better. They know what a vaccine is supposed to do as defined scientifically and legally by the CDC, FDA, NIH, NIAID, NCI, U.S Patent Office, and the U.S. Court of Appeals for the Ninth Circuit, but now as FDA employees they FLIP and FLOP thus defying President Trump’s Executive Order and the Ninth Circuit Court’s ruling, and thereby putting 100-200 million Americans at risk.
June 12, 2022 – Dr Makary criticizing a CDC study said – video below (https://youtu.be/qRBF5luTfa0?feature=shared) :
“And that CDC study didn’t show any outcomes, it only showed a bump in antibodies” – acknowledging a ‘bump in antibodies’ is meaningless because
A VACCINE MUST PREVENT THE DISEASE AND PREVENT ITS TRANSMISSION –
The mRNA gene therapy “VACCINE” DOES NEITHER
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 my Report:
The CDC’s Vaccine Push for Children: A Betrayal of Science and Trust?
https://tinyurl.com/337h7n2b
On May 15, 2025 this Report compelled “HHS to Stop Recommending Routine COVID Shots to Children and Pregnant Women” – Wall Street Journal
Anthony Fauci, MD – a linchpin of the U.S. pandemic response, has inadvertently spotlighted this failure.
July 12, 2022 – he admitted that “[these] vaccines do not protect overly well against infection,” as seen in a Rumble clip.
January 11, 2023 – he co-authored a paper 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.
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.
Peter Marks, MD, PhD – was Director of FDA Vaccine Division – forced to resign on March 28, 2025 or get fired.
April 6, 2022 – he admits boosters are ineffective at preventing infection but continues to support this strategy as a temporary “stopgap measure” — “until a proper solution is found.”
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.”
Deborah Birx, MD – White House Coronavirus Task Force February 2020 to January 2021
December 15, 2020 – she told ABC “This is one of the most highly-effective vaccines we have in our infectious disease arsenal.”
July 16, 2022 – she said, “I knew these vaccines were not going to protect against infection.”
United States Court of Appeals for the Ninth Circuit
June 7, 2024 – in Health Freedom Defense Fund v. Carvalho the Court ruled 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.
A critique of the case:
“In Health Freedom Defense Fund, Inc. v. Carvalho, DC No. 2:21-cv-0688 DSF-PVC, the United States Court of Appeals of the DC Circuit overturned a district court decision dismissing plaintiffs’ cause of action, alleging that the COVID-19 vaccine was not a vaccine because it neither prevented individuals from contracting the disease nor prevented them from transmitting it to others. In ruling on a motion to dismiss, the Court accepts properly pled allegations of the plaintiff as true and rules on whether, if true, the plaintiff has stated a cause of action under the law, such that the case may proceed to a decision on the merits. Patently incredible factual allegations, or ones for which there is no nexus to fact presented in a complaint, may be insufficient to support denial of a motion to dismiss.
In this case, the Ninth Circuit accepted the argument that if the COVID-19 vaccine did not prevent contraction of COVID or transmission of it, it would not qualify under the law as a vaccine. Consequently, if not a vaccine, the seminal decision in Jacobson v. Massachusetts upholding the power of the state to compel vaccination would not apply. Rather, the Supreme Court’s decision in Cruzan v. Director, Missouri Department of Health would control, in which the Supreme Court held that an individual’s right to refuse a treatment was protected under the liberty component of the Fourteenth Amendment (and its correlative Fifth Amendment).
In reliance on this same rationale, it may be reasonably argued that the federal government lacks any rational basis to compel COVID-19 injections as conditions precedent to federal employment or service, and that the entire vaccine schedule to the extent that it mandates childhood COVID-19 vaccination in aid of school qualifications violates the right to refuse medical treatment recognized in Cruzan.”
Pfizer’s Admissions and the FDA’s Role
If the vaccines don’t prevent infection or transmission in adults like Fauci and others, 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 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 a federal 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.
CDC’s Advisory Committee on Immunization Practices (ACIP)
October 2024 – Conclusion of meeting: “the long-term efficacy of the COVID-19 vaccines was statistically negative for adults 18-64 years old.”
These people were fully vaccinated and got 2 boosters and all got infected with COVID-19: President Biden, Dr Fauci, CDC Director Walensky (10-22-22), Bill Gates (5-10-22), Xavier Becerra, Secretary of Health and Human Services (HHS), White House Domestic Policy Adviser Susan Rice, Secretary of State Antony Blinken, White House Communications Director Kate Bedingfield, Vice President Kamala Harris, U.S. Army Chief of Staff General James C. McConville, and Secretary of Agriculture Tom Vilsack
There is no scientific reason to continue the COVID “vaccine” program because it doesn’t prevent infection or transmission. “Vaccine” harm is real, and the shots can’t be justified given the low fatality rate of COVID. Young people who received four doses have a greater than 300% mortality rate, and Pfizer’s trial showed an 87.5% fetal death rate. Authorizing it for infants is unjustifiable.
https://youtu.be/3uIyRJhhjnU?si=g0FKtaTvL8UsBynw
November 4, 2021 the CDC exhibited conflict of interest and scientific misconduct by changing its definition of a vaccine to justify its needs for Big Pharma.
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 23, 2025 – The CDC’s updated website shows the current / revised definition of a vaccine – “to stimulate the immune system to provide protection against a disease.”
Safety Concerns Especially for Children and Adults
Beyond efficacy, the lack of safety of the shots is clear but remains contentious. The COUNTERMEASURE “VACCINE” Report cites peer-reviewed studies, U.S. Senate testimonies from expert witnesses, and adverse event data showing significant harm. 700+ days after injection of mRNA, there is persistent spike protein linked to post-vaccination syndrome and immune dysregulation. https://www.medrxiv.org/content/10.1101/2025.02.18.25322379v1
Eliminating cancer registries could be a tactic to hide rising excess 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.
However, on June 30, 2025 HHS announced it would continue funding cancer prevention, tracking work in states. But “efforts could still be affected by the agency’s reorganization.”
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.
https://tinyurl.com/5n7tajc5
May 21, 2025 – Opening Statement of Chairman Ron Johnson Permanent Subcommittee on Investigations https://www.hsgac.senate.gov/wp-content/uploads/2025-05-21-Chairman-Ron-Johnson-Opening-Statement-FINAL.pdf
“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.”
88% AMERICANS WANT CLINICAL PROOF OF COVID BOOSTER EFFICACY BEFORE THE FDA APPROVES
Fauci describes how a vaccine can cause great harm with time https://rumble.com/v1owpcx-fauci-describes-how-a-vaccine-can-cause-great-harm-with-time.html
During the COVID-19 pandemic U.S. government doctors, including Dr Fauci, would not recognize that a person who was infected by COVID-19 had natural immunity that was superior to the “vaccines” – this despite Dr Fauci’s C-SPAN interview in 2004 (October 11 Washington Journal):
“The best vaccination is to get infected yourself, the most potent vaccination is getting infected yourself.”
https://www.c-span.org/video/?c5008985/user-clip-dr-anthony-fauci-acknowledges-superiority-naturally-acquired-immunity-relative-vaccine
Dr Makary criticizing a CDC study said on June 12, 2022:
1) “And that CDC study didn’t show any outcomes, it only showed a bump in antibodies” – acknowledging a ‘bump in antibodies’ is meaningless because
A VACCINE MUST PREVENT THE DISEASE AND PREVENT ITS TRANSMISSION – THE mRNA GENE THERAPY “VACCINE” DOES NEITHER
A TOTAL FLIP-FLOP NOW AS FDA COMMISSIONER
2) “it didn’t seem to matter to the CDC that 75.2% of children under the age of 11 already have natural immunity”
3) “It is scientifically dishonest and intellectually disingenuous to ignore the power of natural immunity”
https://youtu.be/qRBF5luTfa0?feature=shared
June 30, 2022 – Dr Makary on Evening Fox Business. “Any additional dose to people who are already immune from natural immunity, have zero downsides.”
“There is an undercounting of vaccine complications in the VAERS database. There is 1 in 700 to 1 in 1000 who had a serious adverse event.”
Elizabeth MacDonald: “The risk of the vaccine side effects could be greater than the risk of being hospitalized from COVID infection.” Makary says, “That’s right.”
Study: “The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses”
https://truthsocial.com/@drsimone/108569338595815608
July 10, 2025 – Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax, in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease with no apparent data, and no notification on the FDA website https://www.fda.gov/news-events/fda-newsroom/press-announcements.
Nicolas Hulscher – “It shows, once again, that our regulatory agencies remain fully captured by the Bio-Pharmaceutical Complex”
The mRNA gene therapy shot has only one amount of mRNA needed to produce antibodies. A self-amplifying RNA shot (saRNA) also a gene therapy, is able to make more of itself once it enters cells.
Because of the Restoring Gold Standard Science Executive Order (that is binding within 30 days [5 U.S.C. §7301]), I am now convinced that President Trump @realDonaldTrump will revert to the original and now current scientific and legal definition of a vaccine – as defined by the CDC, FDA, NIH, NIAID, NCI, U.S Patent Office, and the U.S. Court of Appeals for the Ninth Circuit – 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 thus defying President Trump’s Executive Order the Ninth Circuit Court’s ruling, other agencies and Institutes, and thereby putting 100-200 million Americans at risk.
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. And the mRNA shot is a gene therapy and should have different guidance and thresholds for market approval.
Artificial Intelligence has generated the following about Drs Prasad and Makary
Dr Prasad’s Summary: From Critic to Collaborator — A Shift in Tone Toward the FDA
Before Joining FDA:
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, masking, distancing, but opposed broad mandates and highlighted the importance of natural immunity.
As FDA Commissioner, he supports vaccines for high-risk groups without acknowledging their possible natural immunity status – another flip-flop – while calling for stricter evaluation and targeted use, especially for those 65 and older. He emphasizes science and common sense in shaping “vaccine” policy.
FDA Definition of Vaccine
The FDA defines a vaccine as a biological product administered to stimulate the immune system to produce immunity to a specific disease. It’s a preparation designed to elicit an immune response that protects against a disease, potentially by using weakened or inactive forms of the pathogen. Vaccines are rigorously tested for safety and effectiveness before and after approval.
NIAID Definition of Vaccine
Vaccines stimulate the immune system to produce immune responses that protect against infection. Vaccines provide a safe, cost-effective and efficient means of preventing illness, disability and death from infectious diseases.
United States Patent and Trademark Office (USPTO) Definition of Vaccine
While the United States Patent and Trademark Office (USPTO) doesn’t provide a single, formal, and isolated definition of “vaccine” within their official documents and classification systems, its treatment within patent law and regulations allows us to understand how it’s defined in that context.
Based on the USPTO’s guidelines and classifications, vaccines are understood as biological or bio-affecting compositions used for medicinal purposes to:
- Prevent, alleviate, treat, or cure abnormal and pathological conditions of the living body.
- This can be achieved by:
- Destroying parasitic organisms.
- Limiting the effects of a disease by chemically altering the body’s physiology.
More specifically, within the USPTO’s classification system for “Drug, Bio-Affecting and Body Treating Compositions” (Class 424), vaccines fall under the category of immunospecific immunoeffectors, and methods of using them for vaccination purposes to produce protective immunity in vivo.
In essence, the USPTO considers vaccines as patentable subject matter that can be described as formulations or compositions designed to induce an immune response within the body to combat or prevent disease.
The U.S. Patent and Trademark Office (USPTO) itself doesn’t publish a standalone legal definition for “vaccine.” However, federal statutes that the USPTO enforces define it clearly. Under 26 U.S. Code §?4132(a)(2) (within the context of vaccine injury compensation), the term is defined as:
“Vaccine” means any substance designed to be administered to a human being for the prevention of one or more diseases. foley.com+2law.cornell.edu+2reddit.com+2
This definition is applied in federal law and is relevant for patent and injury-compensation matters.
Summary
| Context | Definition |
|---|---|
| Federal law | Vaccine = any substance intended to prevent one or more diseases finnegan.com+9uspto.gov+9reddit.com+9 |
| USPTO practice | Treated as a biological composition; eligibility depends on being more than a “product of nature” (e.g., altered strain, structural changes, formulated carriers) |
In short: Legally, the USPTO considers a vaccine to be “any substance designed to be administered to a human being for the prevention of one or more diseases,” and patent eligibility hinges on sufficiently distinguishing the invention from naturally occurring substances.
The mRNA shot is a GENE THERAPY and should have different guidance and thresholds for market approval:
The FDA’s approval process for gene therapies involves several key steps:
1. Preclinical Research – Before any clinical trials can begin, extensive preclinical research is conducted. This includes laboratory and animal studies to assess the safety and biological activity of the gene therapy. Researchers must demonstrate that the therapy has the potential to be effective and that it does not pose significant risks.
2. Investigational New Drug (IND) Application – Once preclinical data is collected, the sponsor submits an IND application to the FDA. This application must include:
– Results of preclinical studies
– The proposed clinical trial protocol
– Information about the manufacturing process
– Safety data
The FDA reviews the IND to ensure that the proposed trials are ethical and that participants will be adequately protected.
3. Clinical Trials are conducted in three phases:
– Phase 1: Focuses on safety, determining the therapy’s safety profile and the appropriate dosage.
– Phase 2: Evaluates the therapy’s effectiveness and further assesses safety in a larger group of participants.
– Phase 3: Involves a larger population to confirm effectiveness, monitor side effects, and compare the therapy to standard treatments.
4. Biologics License Application (BLA) – applies to any biologic product, not just gene therapy. If clinical trials demonstrate that the gene therapy is safe and effective, the sponsor submits a BLA to the FDA. This application includes:
-Detailed information on manufacturing, chemistry, clinical data, safety, and efficacy; and Proposed labeling for the therapy
Here’s a comparison chart between the Biologics License Application (BLA) and the New Drug Application (NDA):
| Feature | BLA (Biologics License Application) | NDA (New Drug Application) |
|---|---|---|
| Purpose | Approval to market a biologic product | Approval to market a small-molecule drug |
| Governing Law | Public Health Service Act (PHSA), 42 U.S.C. § 262 | Federal Food, Drug, and Cosmetic Act (FDCA) |
| FDA Center | CBER (Center for Biologics Evaluation and Research)or sometimes CDER (for some therapeutic proteins) | CDER (Center for Drug Evaluation and Research) |
| Product Types | – Monoclonal antibodies- Vaccines- Cell/gene therapies- Blood components- Proteins | – Small-molecule drugs- Some combination products |
| Approval Focus | Safety, purity, potency (effectiveness), manufacturing | Safety, effectiveness, manufacturing |
| Examples of Approved Products | – Humira (adalimumab)- Moderna COVID-19 vaccine- CAR-T therapies- Zolgensma (gene therapy) | – Lipitor (atorvastatin)- Ibuprofen- Paxlovid |
| Regulatory Pathways | BLA (351(a)) for original biologics Biosimilar BLA (351(k)) for biosimilars | NDA (505(b)(1)) for new drugs Abbreviated NDA (505(j)) for generics |
| Review Timeline (Standard) | ~10 months (can be faster under Priority Review) | ~10 months (or 6 months for Priority Review) |
| User Fees (FY 2025 est.) | ~$4.0 million (full BLA with clinical data) | ~$4.0 million (full NDA with clinical data) |
5. FDA Review – The FDA reviews the BLA, which can take several months. The review process includes:
– Evaluation of clinical trial data
– Assessment of the manufacturing process
– Consideration of the proposed labeling
The FDA may also convene an advisory committee of experts to provide recommendations.
6. Post-Marketing Surveillance – If the BLA is approved, the gene therapy can be marketed. However, the FDA continues to monitor its safety through post-marketing surveillance. This includes tracking adverse events and conducting additional studies if necessary.
Conclusion
The FDA’s approval process for gene therapies is designed to ensure that these innovative treatments are both safe and effective for patients. The process is thorough and can take several years, reflecting the complexity and potential risks associated with gene therapies.
Related Reports
COVID-19 BIOWEAPON² PART 1 Executive Summary https://bit.ly/3Fuiwdu
Written: March 2020
BIOWEAPON 1 – virus
BIOWEAPON 2 – shots
COVID-19 BIOWEAPON² PART 2 https://bit.ly/3eI11bK
COVID-19 BIOWEAPON² PREREQUISITE FOR U.S. INVASION – LONG TERM PLANNING
https://tinyurl.com/37fbrevd
COUNTERMEASURE “VACCINE” – NOT EFFECTIVE, NOT SAFE, NOT MADE AT “WARP SPEED”
https://tinyurl.com/5n7tajc5
CHILDREN SHOULD NOT GET THE “VACCINE”
“ABOVE ALL DO NO HARM”
Written November 21, 2021 https://bit.ly/3nB4CyK
PROTECT YOURSELF FROM THE SPIKE: COVID-19 INFECTION and/or VACCINE – OUR NEXT HEALTH CRISIS
Written August 23, 2021 https://bit.ly/3kkrejY