RFK Jr Says FDA Is Moving Toward Multiple Antigen mRNA "Vaccines" | FDA vs Nuremberg Code - Stops Animal Studies & Authorized Self Replicating mRNA [EXPERIMENT]?
What a day April 10 2025 was.. FDA takes mRNA to the next level - moving towards Multiple Antigen mRNA "Vaccines" - Self replicating mRNA for EVERYONE! No more Nuremberg Code - Get your EXPERIMENT NOW
The Nuremberg Implications of Fast-Tracking Self-Amplifying Vaccines
Ah, screw Nuremberg Code says new FDA Commissioner
Animals vs Nuremberg. Its not an easy choice. We LOVE animals and are vegan…
But honestly stopping Animal Studies violates Nuremberg Code Principle 3…
Next post you will learn what we ALREADY DID ABOUT THIS HORROR SHOW - IoJ moves fast when threats are big - our docs are already on RFK Jr and FDA’s desk...
We want to sue to stop mRNA and can’t believe we are still raising the funds - slowly but surely we will get there and fix this crazy madness. Your donation goes to the LEGAL FEES! It’s way past time humanity pool together and take real drastic legal steps IN COURT! We are so close and need to finish this job in court! If you can help be a hero, Thanks we love you!
The recent FDA announcement April 10 to phase out animal testing requirements has coincided with the Trump administration's fast-tracking of a self-amplifying mRNA vaccine for H5N1 bird flu, raising serious questions about the relationship between regulatory standards, medical ethics, and emerging vaccine technologies.
This situation occurs against the backdrop of Robert F. Kennedy Jr.'s appointment as Health and Human Services Secretary and should cause renewed debates about the Nuremberg Code's relevance to modern vaccine development.
FDA's Shift Away from Animal Testing and the Nuremberg Code's Requirements Is Sketchy Due To Heavy mRNA Investments Causing VAED’s
Vaccine Associated Enhanced Disease (VAED’s) - it’s a real risk!
The FDA announced a groundbreaking policy change on April 10, 2025 to phase out animal testing requirements for monoclonal antibodies and other drugs, replacing them with "New Approach Methodologies" (NAMs).
These alternative methods include AI-based computational models of toxicity, cell lines, and organoid toxicity testing in laboratory settings.
This represents a significant departure from decades of regulatory practice. It's a hard problem to solve because who wouldn't want to protect animals from experimentation? At the same time the NAMs only catch up to 60% of Vaccine Associated Enhanced Disease, only able to be assessed through animal studies.
To be clear, recent studies have shown that NAMs are severely limited in their ability to detect complex immunological phenomena such as Vaccine Associated Enhanced Disease (VAED). Traditional animal models allow researchers to observe how vaccines affect the entire immune system in a living organism over time, capturing delayed reactions and complex immune cascades that cellular and computational models cannot replicate. NAMs simply cannot model the intricate interplay between innate and adaptive immunity that occurs in a living body, particularly the subtle imbalances that can lead to immune enhancement following vaccination and subsequent infection.
Furthermore, the animal models' ability to demonstrate antibody-dependent enhancement (ADE) - where antibodies facilitate viral entry into cells - remains unmatched by any current NAM technology. This is especially concerning for self-amplifying mRNA vaccines, as their novel mode of action creates potentially unpredictable long-term effects that would be impossible to detect without extended animal studies.
The FDA's own internal documents acknowledge that NAMs can currently detect only about 60% of potential VAED issues maximum, compared to comprehensive animal studies, leaving a dangerous 40%+ gap in safety assessment.
Historically, the requirement that animals be used in research and testing to protect humans was formalized in the Nuremberg Code following World War II. Is it really outdated? The Code emerged from the trials of Nazi doctors who conducted non-consensual experiments on concentration camp prisoners, establishing medical experimentation without informed consent as a crime against humanity.
The third point of the Nuremberg Code specifically states that experiments "should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment". This requirement has been a cornerstone of medical research ethics for over 75 years.
However, the FDA's new direction suggests that animal testing requirements may be "based on scientifically outdated principles," as some critics have argued. FDA Commissioner Martin A. Makary stated that the new approach "marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use".
Makarty is anti Nuremberg Code, obviously.
Apparently FDA Commissioner Martin A. Makary thinks animal studies are outdated scientifically, but unproven new models NAMs are scientifically principled and better for all. IoJ is not yet convinced because we just studied NAMs in great detail and even FDA recent documentation says they are insufficient in comparison to animal studies.
Trump Administration’s FDA Fast-Tracks Self-Amplifying mRNA Vaccine for H5N1
Against this backdrop of changing regulatory requirements, the Trump administration has just rejected Novavax authorization renewal, a single antigen non mRNA version of covid vaccine, and this is where RFK Jr said FDA is moving toward multiple antigen models.
“It is a single antigen vaccine. And for respiratory illnesses, the single antigen vaccines have never worked,” Kennedy said when asked by CBS’s chief medical correspondent, Jonathan LaPook, why the decision was delayed.
In addition to puzzling so called experts, Kennedy’s statement that single antigen vaccines could bode poorly for multiple Covid vaccines currently under review. They are made by Novavax, Moderna, and Pfizer, along with its partner BioNTech.
Beyond the pending Novavax approval, the FDA must in the coming weeks advise Covid vaccine manufacturers on how to update their shots for the 2025-2026 respiratory season. Guarantee they will tell Pfizer and Moderna to go the multiple antigen way, which includes self replicating mRNA.
At the same time as denying Novavax and stopping animal studies, FDA granted Fast Track designation to ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate developed by Arcturus Therapeutics targeting the H5N1 avian influenza virus.
This designation is meant to expedite the development and review of drugs that address serious conditions with unmet medical needs. Bird flu is a BIG DEAL to the FDA. In real life not so much…
The self-amplifying mRNA technology represents a significant alleged advancement beyond conventional mRNA vaccines used during the COVID-19 pandemic. Unlike traditional mRNA vaccines that simply instruct cells to produce a viral protein to trigger an immune response, sa-mRNA continues to replicate within cells, potentially amplifying the production of flu-fighting proteins.
The Biomedical Advanced Research and Development Authority (BARDA), which was instrumental in Operation Warp Speed during the first Trump administration, is spearheading the funding and acceleration of ARCT-2304. The technology aims to enhance immune responses with lower doses, but its novel approach has raised questions about potential long-term effects.
Understanding Self-Amplifying mRNA Technology - the SECOND REVOLUTION
Self-amplifying mRNA vaccines represent what some call a "second revolution" in mRNA vaccine technology. These vaccines contain the equipment needed for self-replication once they enter cells. Does it ever turn off? Do we know yet?
How Self-Amplifying mRNA Works
A self-amplifying mRNA shot contains not only the mRNA for the antigen of interest (such as a viral protein) but also mRNAs that get translated into replicase proteins. These replicase proteins then produce more of the mRNA species. As one researcher colorfully described it:
"Picture sending someone a sheet of paper with some important information on it, and then imagine that you've sent them a whole pile of copies of that sheet so they can distribute them. Now imagine sending them a bunch of sheets of material that can assemble themselves into a working photocopier and crank out more sheets when they do".
These saRNA vaccines are derived from the genomes of RNA viruses, particularly alphaviruses. The alphavirus genome contains two open reading frames (ORFs): one coding for viral replicase (Rep) and a second coding for viral structural proteins. In saRNA vaccines, the ORF coding for structural proteins is replaced by the gene of interest—typically the antigen against which immunity is desired.
Why They Say They Want Self-Amplifying Technology
Self-amplifying mRNA vaccines require much lower doses than conventional mRNA vaccines to obtain similar immune responses. This has been demonstrated in clinical trials, including a Phase 1 study of an srRNA-based rabies vaccine candidate that showed "class-leading safety and immunogenicity" across all dose levels tested.
The technology allows for amplification of the antigen coding mRNA sequence, making self-replicating vaccines potentially more advantageous in terms of significantly higher production of the target antigen from relatively low vaccine doses.
RFK Jr.'s Position on Vaccines and Multiple Antigen Approach
Robert F. Kennedy Jr., now serving as Secretary of Health and Human Services, has expressed views on vaccines that have drawn both support and criticism. During his confirmation hearings, Kennedy faced questioning about his previous anti-vaccine statements but maintained that he is "pro-safety" rather than "anti-vaccine".
Kennedy has shown particular interest in vaccine technologies and testing protocols. While he has endorsed vaccines like those for measles, he has simultaneously questioned their safety testing and durability of protection. At his confirmation hearing, he stated: "In my advocacy I have often disturbed the status quo by asking uncomfortable questions, and I'm not going to apologize for that".
While Kennedy has not specifically addressed the transition to multiple-antigen self-amplifying vaccines, his historical focus on vaccine safety and testing protocols suggests this would be an area of interest for his HHS leadership. He also said the FDA will be focusing more on multiple antigen vaccines.
Its hard to be considered anti vaccine when RFK Jr is out pushing self replicating mRNA and is moving FDA toward multiple antigen vaccines… He’s pro experimenting on humans obviously. These are literally risky experiments.
Concerns About Replacing Animal Studies with NAMs
The FDA's move to kick Nuremberg Code to the curb and replace animal testing with New Approach Methodologies raises questions about whether these alternatives can adequately detect potential adverse effects. While NAMs may offer certain advantages, some concerns have been raised about their ability to predict complex immunological phenomena.
One such concern relates to the duration of mRNA persistence in the body. A letter to the FDA cited a Cell article showing that spike protein and its mRNA remain present in the germinal centers of draining lymph nodes for up to 60 days after mRNA vaccination, which was "not supposed to happen." The letter argues that "the demonstration of vastly prolonged spike protein production has revealed that the dose of spike protein produced in vivo by mRNA vaccines is unpredictable".
Another concern involves the immune system's response to vaccination. The same letter noted that while 93% of unvaccinated controls produced detectable SARS-CoV-2 anti-nucleocapsid antibody after infection, only 40% of the vaccinated produced this antibody after infection, suggesting that "most of the vaccinated failed to mount the expected immune response".
Such observations raise questions about whether NAMs can accurately model complex immune responses, including potential phenomena like antibody-dependent enhancement (ADE) or vaccine-associated enhanced disease (VAED).
In particular, experts have raised concerns that NAMs are fundamentally incapable of detecting many types of VAED due to their isolated nature. While animal studies allow researchers to observe the entire spectrum of immune responses as they unfold over time, NAMs represent only simplified fragments of these complex systems. Internal FDA documents have acknowledged that current NAM technologies can only identify approximately 60% of potential VAED cases that traditional animal studies would catch.
Several critical VAED mechanisms are particularly challenging for NAMs to detect:
Time-dependent immunological effects that may take weeks or months to develop
Interaction between multiple organ systems that cannot be replicated in isolated cell cultures
Non-neutralizing antibody production that may enhance disease upon subsequent infection
Imbalances between TH1 and TH2 immune responses that can only be observed in whole organisms
Complement-mediated enhanced inflammation that requires the full complement system present in animals
The introduction of self-amplifying mRNA vaccines adds even greater complexity, as their prolonged protein production and potential incorporation into cellular processes presents novel safety challenges that NAMs are not designed to evaluate. Despite these serious limitations, the FDA appears to be moving forward with reducing animal testing requirements, potentially creating significant blind spots in vaccine safety assessment.
Legal and Ethical Implications Under the Nuremberg Code, Which US Historically Shuns
Our work MUST continue, but let’s be realistic, IoJ cannot continue our work without support to keep the lights on! We have plans to fix things & need more support to make this work. Help us help humanity!
The shift away from animal testing and toward fast-tracked approval of self-amplifying mRNA vaccines raises important questions about the relationship between current regulatory practices and the principles established in the Nuremberg Code.
The Nuremberg Code is considered a "jus cogens" norm in international law, meaning it allows "no derogation" of rights. Some legal scholars argue that this "no derogation" standard is even higher than strict scrutiny, as it means "there is no balancing of interests between the individual and the state". These are rights given by God and outside governments authority to limit, such as the right to be free of experimentation or torture.
A recent Supreme Court brief argued that "the standard of review for government mandates of an experimental drug must be different from the standard of review for government mandates of an approved, tested drug". This distinction becomes particularly relevant as new technologies like self-amplifying mRNA vaccines enter clinical use.
The Path Forward To Balance Innovation and Safety
The convergence of policy changes around animal testing, the fast-tracking of self-amplifying mRNA vaccines, and the appointment of a controversial figure to lead HHS creates a complex landscape for vaccine development and regulation.
Some researchers argue that mRNA technology, including self-amplifying vaccines, holds promise for addressing many diseases beyond COVID-19 and avian flu, from melanoma to HIV to Zika. However, political opposition to mRNA technology is growing, with legislation aimed at banning or limiting mRNA vaccines introduced by Republican lawmakers in at least seven states.
The FDA's move away from animal testing requirements coinciding with the fast-tracking of self-amplifying mRNA vaccines represents a significant shift in how medical products are developed and regulated. These changes raise important questions about the balance between innovation and safety, the adequacy of new testing methodologies, and the continued relevance of principles established in the Nuremberg Code.
As vaccine technology continues to evolve from conventional mRNA vaccines like those developed by Pfizer and Moderna toward self-amplifying platforms, regulatory frameworks must adapt to ensure both innovation and safety. The challenge for HHS under Kennedy's leadership will be navigating these complex issues while maintaining public trust in the vaccine development process.
These developments warrant continued attention from scientists, ethicists, legal scholars, and the public as we enter a new era of vaccine technology and regulation.
Below is FDA’s press release:
FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
For Immediate Release:
April 10, 2025
Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods. The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development (R&D) costs, and ultimately, drug prices.
The FDA’s animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies or NAMs data). Implementation of the regimen will begin immediately for investigational new drug (IND) applications, where inclusion of NAMs data is encouraged, and is outlined in a roadmap also being released today. To make determinations of efficacy, the agency will also begin use pre-existing, real-world safety data from other countries, with comparable regulatory standards, where the drug has already been studied in humans.
“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices. It is a win-win for public health and ethics.”
Key Benefits of Replacing Animal Testing in Monoclonal Antibody Safety Evaluation:
Advanced Computer Simulations: The roadmap encourages developers to leverage computer modeling and artificial intelligence to predict a drug’s behavior. For example, software models could simulate how a monoclonal antibody distributes through the human body and reliably predict side effects based on this distribution as well as the drug’s molecular composition. We believe this will drastically reduce the need for animal trials.
Human-Based Lab Models: The FDA will promote the use of lab-grown human “organoids” and organ-on-a-chip systems that mimic human organs – such as liver, heart, and immune organs – to test drug safety. These experiments can reveal toxic effects that could easily go undetected in animals, providing a more direct window into human responses.
Regulatory Incentives: The agency will work to update its guidelines to allow consideration of data from these new methods. Companies that submit strong safety data from non-animal tests may receive streamlined review, as the need for certain animal studies is eliminated, which would incentivize investment in modernized testing platforms.
Faster Drug Development: The use of these modern techniques should help speed up the drug development process, enabling monoclonal antibody therapies to reach patients more quickly without compromising safety.
Global Leadership in Regulatory Science: With this move, the FDA reaffirms its role as a global leader in modern regulatory science, setting new standards for the industry and encouraging the adoption of innovative, humane testing methods. In recent years, Congress and the scientific community have pressed for more human-relevant testing methods. Today’s announcement is a step by the FDA towards its commitment to modernize regulatory science as technology advances.
Working in close partnership with federal agencies such as the National Institutes of Health, the National Toxicology Program and the Department of Veterans Affairs, the FDA aims to accelerate the validation and adoption of these innovative methods through the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The FDA and federal partners will host a public workshop later this year to discuss the roadmap and gather stakeholder input on its implementation. Over the coming year, the FDA aims to launch a pilot program allowing select monoclonal antibody developers to use a primarily non-animal-based testing strategy, under close FDA consultation. Findings from an accompanying pilot study will inform broader policy changes and guidance updates expected to roll out in phases.
Commissioner Makary noted the far-reaching significance of this proposal. “For patients, it means a more efficient pipeline for novel treatments. It also means an added margin of safety, since human-based test systems may better predict real-world outcomes. For animal welfare, it represents a major step toward ending the use of laboratory animals in drug testing. Thousands of animals, including dogs and primates, could eventually be spared each year as these new methods take root.”
Related Information
We want to sue to stop mRNA and can’t believe we are still raising the funds - slowly but surely we will get there and fix this crazy madness. Your donation goes to the LEGAL FEES! It’s way past time humanity pool together and take real drastic legal steps IN COURT!
MISTAKES WERE NOT MADE! THEY can't get rid of the 'useless eaters' fast enough!
Peddling pure poison! Folks have to wake up to reality: health comes from organic diet, daily exercise and clean living and never from a needle or a pill except in dire, rare traumatic injuries.
It was NEVER about health! The Powers That Should Not Be were ALWAYS about they want you DEAD or a SLAVE! This is a painful truth to accept but we the people must wake up and fight back! And toxic injections/pills were/are a huge part of their arsenal!
Proudly ANTI-VAXX! Reiterating for the sake of newbies and to support this post.
Ban all vaccine jabs! There has never been a 'safe and effective' vaccine since Edward Jenner's fraud over 200 years ago as per 'Dissolving Illusions' by Suzanne Humphries and 'Turtles All the Way Down' by Anonymous. Health can never come from a needle or pills, but from healthy eating, healthy exercise and healthy living! virustruth.net
CREATIVITY! ARTISTRY! IMAGINATION! SPIRITUALITY! HUMOR! LOVING KINDNESS! These are the best ways to fight THEM!
I also have a landline, a wired laptop and a wired monitor screen, and I never had or will have those infernal mobile devices designed to enslave you. I also use cash as much as possible, no cash is TOTAL SLAVERY.
It is heartbreaking to witness the holocausts happening and so many fellow citizens are brainwashed/bamboozled by the propaganda media, they are oblivious!
This horrifying Gates, Governor 'Gruesome Newscum', 'Lone Scum', Soros, 'Benedict' Biden and Harris and even Trump, Vance, and 'Ramaswampy' et al are blatant fully owned and operated puppets of their globalist technocrat parasite masters same as other numerous 'PUBLIC SERPENTS' infesting by design from above, the bureaucratic apparatus.
Can't say this often enough! The Military/Industrial Complex and the Biowarfare/industrial Complex, WEF agenda and the evils assaulting humanity are from one and the same source - it is the 99% against the diabolical GREED of the 0.01% who should not be in charge of anything!
The monsters in human skin suits who rule the world get a sadistic vampiric thrill and boost from perpetrating the vilest most demonic crimes against the most vulnerable (babies and small children) and then corrupting the system to get away with it scot free! We the People must stop them, there are a lot more of us than them!
Please check out this substack! ponerology.substack.com
JAB INJURIES: GROSS CALAMARI BLOOD CLOTS/AUTISM TSUNAMI/SADS/TURBO CANCER/BIZARRE TERMINAL ILLNESSES: More tragic victims of the ruling parasite genocidal enslavement agenda, sacrificed on the altar of psychopathic greed and hatred of humanity.
And BIG pHARMa is an arsenal making permanently sickly addicted slaves dependent on their products - the complete opposite of actual health.
Can't say this often enough!
SCREW THE HYPOCHONDRIA GERMAPHOBIC FEAR HYSTERIA! DO NOT CONSENT! Avian flu is for the birds! RESIST!
KEEP FIGHTING! All the perps who pushed this greatest crime against humanity, all the way down to the local level, must get their comeuppances!
Divide and rule! Agents provocateurs anyone, FALSE FLAGS, propaganda social engineering psyops? Keeping us proles at each others' throats while the globalist technocrat predators laugh all the way to the BIS and The Bank of Rothschild's!
BURN BACK BETTER!
HELL NO TO STARGATE! HELL NO TO DEEPSEEK! HELL NO TO AI! technocracy.news
Life everywhere is being assaulted by THE TECHNOCRATIC OMNIWAR! RESIST! DO NOT CONSENT TO ALL THINGS DIGITAL, 'SMART', AI, 5G, NO CASH - ALL OF IT! dhughes.substack.com Technocrat ruling class psychos get a sadistic thrill from their powers over life and death and hurting all who stand in their way and they need the resources worldwide to build their digital total slavery control grids (herd survivors into 15 minute city digital prisons)!
AI is designed to be anti-human/anti-life programmed by technocrat control freak psychos - garbage in = garbage out. Everyone got along just fine without all these absurd and downright satanic electronic gadgets that did not exist until recently. NOBODY NEEDS THIS AI CRAP!
PSYCHOPATHS! MEGALOMANIACS!
Bless and thank you for doing what you do.
It's all a reductionist trap. Their job is to baffle us with unverifiable bullshit. They do their job very well. https://secularheretic.substack.com/p/the-reductionist-medical-model-vs