Archive for the ‘Activism’ Category

Lost Signals: Study Shows VAERS Buries Vaccine Harm & CDC, FDA Admit to Using ‘Mostly Useless’ Tool

https://imahealth.substack.com/p/lost-signals-new-study-shows-how?

Lost Signals: New Study Shows How VAERS Buries Vaccine Harm

VAERS already catches only a fraction of vaccine harm. New research by Jessica Rose reveals the system is losing even more data to fixable flaws.

America’s vaccine safety system already catches only a fraction of the harm that occurs. That much has been known for years. VAERS is a passive reporting system, and most adverse events are never reported at all.

But what happens to the data that does make it in?

A new study by Jessica Rose, a computational biologist, immunologist, and IMA Senior Fellow, shows that VAERS is losing critical safety data from the inside. The system’s own infrastructure is so outdated and poorly maintained that real signals of harm are being buried by fixable data problems. When Rose cleaned the data and reassembled what had been scattered, she found safety signals for fetal loss and cardiac arrest that had been there all along, invisible to anyone using the system as designed.

“The main claim to fame here is that I pointed out some of the problems inherent in VAERS that most people, unless they’re using it as part of data analysis, wouldn’t really know about.” — Jessica Rose

📖 Read and Download the Full Paper

Minimizing Signal Loss and Optimizing Pharmacovigilance in VAERS (JIM Vol. 2, No. 2, 2026) — Author: Jessica Rose

👉 Visit the Journal of Independent Medicine to create a free account and download the full article.

What’s Broken in VAERS?

VAERS was built in the 1980s and has operated with the same basic infrastructure ever since. Reports are submitted through an online form that takes about 30 minutes to fill out. There are no pull-down menus. No standardized formats for vaccine lot numbers or dates. The form has session timeouts that can erase a report before it’s finished. And the system creates multiple IDs for the same patient rather than linking a serious reaction to a follow-up death report.

The people filing reports experience these problems every time they sit down to submit one. But the people relying on the data to detect harm may never realize what’s being lost.

Rose showed just how small the fixes can be. Two simple corrections to vaccine lot numbers (capitalizing letters and removing stray spaces)  recovered 8,871 reports that had been invisible to analysis. Not because the data was missing. Because the system couldn’t recognize its own records.

(See link for article and video)

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https://childrenshealthdefense.org/defender/cdc-fda-admitted-mostly-useless-tool-detect-covid-vaccine-safety-signals/

CDC, FDA Admitted to Using ‘Mostly Useless’ Tool to Detect COVID Vaccine Safety Signals

Federal health officials knew the statistical tool they relied on to look for COVID-19 vaccination safety signals in VAERS was “mostly useless,” according to internal documents obtained by Sen. Ron Johnson and analyzed by scientists at Children’s Health Defense. CDC and FDA researchers used the tool anyway to create analyses they tried to publish that supported the vaccines’ safety.

files and covid vaccine

Federal health officials knew that the statistical tool they relied on to look for COVID-19 vaccination safety signals in the Vaccine Adverse Event Reporting System (VAERS) was “mostly useless,” according to internal documents obtained by Sen. Ron Johnson (R-Wis.) and analyzed by scientists at Children’s Health Defense (CHD).

The documents show that officials at the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) internally acknowledged that the tool — empirical Bayesian (EB) data mining — had “blind spots” that rendered it “mostly useless” for picking up on safety signals of COVID-19 vaccines.

Yet, the agencies used the method in analyses and attempted to publish findings from those analyses — including studies that supported the safety of COVID-19 vaccines.

Karl Jablonowski, Ph.D., CHD senior research scientist who analyzed the documents, told The Defender:

“Imagine a night watchman has to find something on the ground. But instead of holding a flashlight, he is wearing sunglasses. In the morning, he says he didn’t find anything. That’s true, but it’s because he was using a tool that impeded his ability to see.”

The records obtained by Johnson’s office include emails between CDC and FDA researchers from 2021 to 2023, along with draft manuscripts and peer reviewer comments.

In one case, researchers sought to publish an analysis in The Lancet Infectious Diseases using EB data mining on early COVID-19 vaccine data. They dropped the plan only after a reviewer wrote that the likelihood of detecting a safety signal using the method was “likely close to zero.”

FDA official Dr. David Menschik, who initially was a co-author on the paper, wrote to the study’s lead author in December 2021 saying he knew the method was essentially useless.

“We acknowledged this in the limitations and understand that there is a considerable bias toward the null when using our data mining methods in this current, unprecedented situation,” he wrote.  (See link for article)

For more:

Study Identifies 86 Serious Neuropsychiatric Safety Signals Linked to COVID-19 Shots

https://www.thefocalpoints.com/p/breaking-study-identifies-86-serious

BREAKING: Study Identifies 86 Serious Neuropsychiatric Safety Signals Linked to COVID-19 Vaccination

CDC/FDA safety thresholds breached for 86 adverse events including dementia, schizophrenia, suicidal and homicidal thoughts, stroke, psychosis, depression, cognitive impairment, delusions, and more.

By Nicolas Hulscher, MPH

The study by Thorp et al titled, Association between COVID-19 Vaccination and Neuropsychiatric Conditions, was just uploaded to the Preprints.org preprint server. They analyzed VAERS data from January 1990 through December 2024 and identified alarming increases in 86 adverse events related to brain function, behavior, and cognition following COVID-19 mRNA injection:

Introduction: COVID-19 mRNA vaccines are known to penetrate the blood-brain barrier and could potentially cause a myriad of unintended adverse effects. The purpose of this study is to explore potential associations between vaccination and neuropsychiatric conditions.

Methods: Data were collected from the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). The CDC/FDA Vaccine Adverse Event Reporting System (VAERS) was queried from January 1, 1990, to December 27, 2024, for adverse events (AEs) involving neuropsychiatric complications following COVID-19 vaccination. The timeframe included 420 months for all vaccines except COVID-19 vaccines which have been available to the public for only 48 of the 420 months (from January 1, 2021, to December 27, 2024). Proportional reporting ratios (PRRs) were calculated by time comparing AEs after COVID-19 vaccination to those after influenza vaccination and to those after all other vaccines. The CDC/FDA stipulates a safety concern if a PRR is ≥ 2.

Results: Comparing COVID-19 vaccination to influenza vaccinations, the CDC/FDA’s safety signals (PRR, 95% confidence interval, p-value, Z-score) were breached for the following combinations: 47 AEs associated with cognitive impairment (PRR: 118, 95% CI: 87.2-160, p < 0.0001, Z-score: 30.9); 28 AEs associated with general psychiatric illness (PRR: 115, 95% CI: 85.1-156, p < 0.0001, Z-score: 30.8); and 11 AEs associated with suicide/homicide (PRR: 80.1, 95% CI: 57.3-112, p < 0.0001, Z-score: 25.7). Likewise, when comparing COVID-19 vaccination to all other vaccines except COVID-19, the safety signals were also breached for the following: 47 AEs associated with cognitive impairment (PRR: 26.8, 95% CI: 19.8-36.1, p < 0.0001, Z-score: 21.5); 28 AEs associated with general psychiatric illness (PRR: 28.6, 95% CI: 21.2-38.6, p < 0.0001, Z-score: 21.9); and 11 AEs associated with suicide/homicide (PRR: 14.0, 95% CI: 10.3-19.0, p < 0.0001, Z-score: 16.8).

Conclusions: There are alarming safety signals regarding neuropsychiatric conditions following COVID-19 vaccination, compared to the influenza vaccinations alone and to all other vaccinations combined. These data raise concerns about long-term consequences, including continued cognitive decline, dementia, and neuropsychiatric morbidity and mortality. An immediate global moratorium on COVID-19 vaccination is warranted.  (See link for article)

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**Comment**

Psychosis, schizophrenia, delusion, delirium, and brain injury, along with Alzheimer’s depression, sleep disorders, and hemorrhagic stroke all listed…..

Why these kill shots are still on the market defies ALL logic and sanity.

For more:

 

WHO Teams With Singapore Firm Tied to Pfizer, Bill Gates to Roll Out Global Vaccine Passports

https://childrenshealthdefense.org/defender/global-vaccine-passports-who-partner-singapore-firm-pfizer-bill-gates-temasek

Vaccine Passport

WHO Teams With Singapore Firm Tied to Pfizer, Bill Gates to Roll Out Global Vaccine Passports

The WHO is partnering with Temasek, a firm owned by the Singapore government that participated in a $250 million investment in BioNTech in June 2020 — a few months before BioNTech released a COVID-19 vaccine in conjunction with Pfizer. Temasek will help the WHO develop “interoperable digital health wallets.”

WHO logo and vaccine passport on cellphone

Five years after digital vaccine passports were introduced during the COVID-19 pandemic, the World Health Organization (WHO) is partnering with an investment firm linked to COVID-19 vaccine maker BioNTech and the Gates Foundation to roll out “interoperable digital health wallets.”

The WHO announced earlier this week that it is partnering with Temasek, a firm owned by the Singapore government that participated in a $250 million investment in BioNTech in June 2020 — a few months before BioNTech released a COVID-19 vaccine in conjunction with Pfizer.

The initiative “builds on lessons from the COVID-19 pandemic, which demonstrated the urgency of reliable, verifiable digital health documentation,” the WHO said.

The initiative will begin with digital international certificates of vaccination or prophylaxis and will later expand to “broader personal health summaries.” It will be piloted in the 11 member states of the Association of Southeast Asian Nations to develop a “replicable model” for potential export to other countries.

The initiative is a result of last year’s amendments to the WHO’s  International Health Regulations (IHR), which called for “globally recognized digital health certificates.”

Kee Kirk Chuen, Temasek’s head of Health & Well-being, said the COVID-19 pandemic “showed how important it is for health records to be trusted, verifiable and able to travel with people across borders.”

But Natalie Winters, co-host of “Bannon’s War Room,” countered that the WHO is attempting to formalize what was once touted as a temporary response to the pandemic.

“During COVID, digital health verification systems determined whether people could travel, work, or enter public spaces based off vaccination status,” Winters wrote on Substack. “Those systems were justified as temporary. Now they are being formalized into something much broader and far more durable.”

Dr. David Bell, a public health physician, biotech consultant and senior scholar at the Brownstone Institute, said private interests are driving the WHO’s initiative.

“The WHO is required to concentrate on vaccine passports as they are important from an investment viewpoint to its major funders, who fund the WHO through voluntary specified funding — meaning the WHO is required to follow the directions of the funder.”

Bell said major WHO funders, including the Gates Foundation, “have direct financial interests in increasing the use of both vaccines and digital platforms.”

COVID Justice Resolution: Sign the Resolution

‘A clear conflict of interest’

Winters argued that Temasek’s involvement in the WHO’s initiative “adds a clear conflict of interest.

In June 2020, Temasek and other investors poured $250 million into BioNTech, a German biotechnology company. According to a BioNTech press release, the investment would boost the company’s efforts to develop “patient-specific immunotherapies for the treatment of cancer and infectious diseases.”

Reuters noted at the time that BioNTech was developing an “experimental vaccine against the coronavirus with pharmaceutical giant Pfizer.’’

According to a 2021 Asia Business Council report, Temasek’s investment in BioNTech “is just one example of how the government-owned but private-sector-oriented company went full out as an investor and a steward to fight the coronavirus.”

On its website, Temasek states that “sustainability is at the core of everything we do.”

But the company’s current and former investment portfolio reveals an extensive history of investing in pharmaceutical companies and digital health providers.

In 2021, Temasek, through its digital identity subsidiary Affinidi, developed and piloted Unifier, a universal verification system for authenticating COVID-19 vaccination and test results across different QR code standards.

That same year, Temasek helped lead a $700 million investment round for Chinese pharmaceutical company Abogen Biosciences, with the funds used to advance the company’s mRNA COVID-19 vaccine candidate to late-phase trials.

In 2010, Temasek formed a joint venture with U.S. pharma company Emergent BioSolutions to develop a “broad spectrum pandemic flu vaccine and therapeutic.”

Temasek has investments in Clover Biopharmaceuticals, a Chinese company that developed candidate COVID-19 vaccines, Celltrion Inc., a South Korean biopharmaceutical firm that developed therapies for COVID-19, and Novotech, a clinical research organization that specializes in clinical trials for drugs and vaccines.

Temasek is also an investor in major tech and financial firms that are involved in health-related technologies.

This includes Amazon — which, through Amazon Web Services, is involved with the Vaccination Credential Initiative, a backer of the SMART Health Card, which several states and countries used as a vaccine passport during the COVID-19 pandemic.

Docket, a digital vaccine record app, also uses SMART Health Card technology in some states. Nathan Scott, Docket’s chief technical officer, was previously affiliated with Amazon and Amazon Web Services.

During the COVID-19 pandemic, BlackRock— one of the world’s “Big Three” asset managers and a shareholder in COVID-19 vaccine makers Pfizer, Moderna and Johnson & Johnson — was among the top 10 shareholders in dozens of corporations mandating vaccines for their employees.

One of those companies is Mastercard. During the pandemic, Mastercard supported the Good Health Pass vaccine passport initiative, with backing by the Gates Foundation-linked ID2020 Alliance. Temasek is an investor in Mastercard.

In 2021, Mastercard promoted technology to track people’s “personal carbon allowance.”

Bell said that while it is reasonable for an investment firm like Temasek to invest in pharmaceutical companies, “it obviously should exclude them from participating with WHO in activities that directly improve their subsequent return on investment.”

“This is a really basic conflict of interest that would be a no-go for any ethical public health program, as their duty as an investment house is to maximize return on investment from the companies they have invested in. This is obviously likely to be contrary to what populations need to improve health,” Bell said.

The Singaporean government was a “pioneer” in the development of COVID-19 tracking and tracing apps, according to a 2020 article in Media International Australia. The government later exported the technology to other countries.

Temasek’s ties to Gates Foundation, Gates-linked Gavi, the Vaccine Alliance

Temasek also maintains direct collaborative ties with the Gates Foundation — and the Gates-linked Gavi, the Vaccine Alliance.

For instance, the Philanthropy Asia Alliance — Temasek’s charitable arm — lists the Gates Foundation as one of its early core members, according to Bloomberg.

In 2022, Temasek invested in Select, a fund launched under Breakthrough Energy Ventures, a climate-focused investor founded by GatesYahoo! Finance reported at the time that Temasek was “already an existing co-investor to several other Gates-backed ventures.”

In 2024, Breakthrough led investment in “climate vaccines” to reduce carbon emissions from cows.

Last year, the Gates Foundation opened a Singapore office — which Gates announced at the Philanthropy Asia Summit organized by Temasek Trust’s Philanthropy Asia Alliance.

Temasek has also partnered with Gavi on vaccination programs in Southeast Asia. According to a 2025 Gavi press release, Temasek partnered with the Clinton Health Access Initiative and the UBS Optimus Foundation on a $4.5 million initiative “to reach zero-dose and under-immunized children” in Indonesia.

The Gates Foundation funded Gavi’s launch in 1999 and holds a permanent seat on its board. Gavi is listed by the WHO as an official “stakeholder.”

Last year, Temasek’s Philanthropy Asia Alliance helped launch the Climate and Health Funders Coalition — along with the Gates Foundation,  Rockefeller Foundation and Bloomberg Philanthropies. In 2024, Temasek, the Rockefeller Foundation and BlackRock joined a new infrastructure investment initiative in Southeast Asia.

“Increasing sales of vaccines directly improves return on investment where such investments exist in vaccine manufacturers, such as is the case of the Gates Foundation and its owners,” Bell said. “And it improves profits for private pharmaceutical corporations that contribute to the public-private partnerships.”

Digital ID ‘the end of privacy, anonymity and liberty’

Before the U.S. exited the WHO, which was announced last year and  formalized in January, the U.S. was its largest individual funder. The next two? The Gates Foundation and Gavi.

During the COVID-19 pandemic, the WHO repeatedly pushed for a pandemic agreement or treaty — which it achieved last year — and amendments to the IHR. The WHO passed a set of IHR amendments in 2024. They took effect in September 2025.

Those amendments included a recommendation for the development of digital health certificates. The WHO cited the amendments when announcing its collaboration with Temasek.

In 2023, the WHO and the European Commission — the executive branch of the European Union — launched a “landmark digital health partnership” marking the beginning of the WHO Global Digital Health Certification Network (GDHCN).

The digital passes that the WHO will develop in partnership with Temasek will use the GDHCN standard.

Independent journalist James Roguski said he warned two years ago that the WHO’s efforts to pass the IHR amendments would lead to a push for global health passes.

“Nations may be somewhat constrained in their abuse of their own citizens by their constitutions, charters of rights, or laws,” Roguski said. “But numerous articles within the IHR clearly state that sovereign nations are absolutely free to disregard and abuse the rights, freedoms and health of travelers who may be visiting from other countries.”

Tim Hinchliffe, editor of The Sociable, said that for Gates and other unelected globalists, globally interoperable vaccine passports serve a couple of purposes.

“First off, there’s a lot of money in getting everyone in the world to get injected with their products. It’s a great return on investment. Secondly, vaccine passports further the agenda to get everybody in the world pegged to a digital identity scheme,” Hinchliffe said.

He cited a 2022 World Economic Forum report acknowledging that vaccine passports are a type of digital identity.

“With that type of power and influence, the powerful interest groups then set up their digital control grid, because mandating proof of vaccination means mandating digital ID. When digital ID is mandated, it is the end of privacy, anonymity and liberty,” Hinchliffe said.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

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Many articles have come out on Gates’ involvement and how he’s financed so many things controlling messaging. He’s no philanthropist!

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Weedkillers: Unexpected Breeding Ground for ‘Superbugs’

https://phys.org/news/2026-03-agricultural-soils-exposed-controversial-weedkiller.

Agricultural soils exposed to controversial weedkiller may be unexpected breeding ground for hospital ‘superbugs’

Each year, antimicrobial resistance (AMR) is responsible for an estimated 1.1 to 1.4 million deaths worldwide. Now, scientists have found evidence that the spread of AMR isn’t always driven by bacteria evolving to resist the antibiotics themselves: rather, certain weedkillers can have the same effect.

“Here we show that the most common species of multidrug-resistant bacteria from hospitals are not only resistant to multiple antibiotic classes, but also to high concentrations of the weedkiller glyphosate,” said Dr. Daniela Centrón, a researcher at the Institute of Medical Microbiology and Parasitology in Buenos Aires and the senior author of the study in Frontiers in Microbiology.

“These results suggest that weedkillers—which, unlike antibiotics, are widely applied in agricultural environments—may have the unintended side effect of selecting for AMR among bacterial communities within the soil.”  (See link for article)

https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2026.1740431/full

Glyphosate resistance as a potential driver for the dissemination of multidrug-resistant clinical strains

Camila A. Knecht 1,2 Barbara Prack McCormick 1,2,3 Verónica E. Álvarez 1,2 Adrián Gonzales Machuca 1,2 Fernanda Buzzola 3,4 Julio Fuchs 5 Pablo Salgado 6 Josefina Campos 7,8 Daniela Centrón 1,2*

  • 1. Departamento de Microbiología, Parasitología e Inmunología, Facultad de Medicina. Universidad de Buenos Aires, Buenos Aires, Argentina

  • 2. Laboratorio de Investigaciones en Mecanismos de Resistencia a Antibióticos (LIMRA), Instituto de Investigaciones en Microbiología y Parasitología Médica (IMPaM), CONICET – Universidad de Buenos Aires, Buenos Aires, Argentina

Abstract

The rise of antimicrobial resistance (AMR) constitutes a serious threat to global health. Environmental bacterial communities are a key reservoir of AMR genes (ARGs) that can spread to clinical pathogens. Biocides, which include broad-spectrum herbicides, can co-select for ARGs, posing a potential driver for AMR spread. Glyphosate, the world’s most widely used herbicide with known bactericidal properties, targets the shikimate pathway and may thus exert selective pressure favoring resistant bacteria, potentially elevating clinical AMR risk from a One Health perspective. We assessed glyphosate resistance in multidrug-resistant (MDR) species isolated from nosocomial infections. Furthermore, we investigated the relationship between glyphosate-resistant environmental species and clinically relevant MDR pathogens using whole-genome sequencing of environmental and clinical strains. Multidrug-resistant species from hospital-acquired infections exhibited high levels of glyphosate resistance. We established a link between glyphosate-resistant environmental species and typically MDR species common in nosocomial settings. Genomic analysis revealed that glyphosate resistance is partially independent of mutations in the target enzyme (5-enolpyruvylshikimate-3-phosphate synthase), suggesting the contribution of alternative mechanisms, such as efflux pumps. Our findings indicate that glyphosate exposure could favor the prevalence of bacteria associated with nosocomial infections and the rise of MDR clinical strains. This suggests that intensive glyphosate use may accelerate the dissemination of AMR. Consequently, the AMR dimension should be incorporated into the environmental risk assessment of biocidal products that are not used as antimicrobial agents.

GMO Risk – Who’s Watching?

https://regenerationinternational.org/2026/03/16/genetically-modified-microorganisms-what-are-the-risks-and-whos-watching/

Genetically Modified Microorganisms: What Are the Risks, and Who’s Watching?

A summary of: Lerner et al., “Genetically Modified Microorganisms: Risks and Regulatory Considerations for Human and Environmental Health,” Microorganisms, 2026. https://doi.org/10.3390/microorganisms14020467

This summary is based on a peer-reviewed paper co-authored by Andre Leu, International Director of Regeneration International, a global nonprofit network dedicated to promoting regenerative agriculture and land management practices. Leu is a longtime advocate for organic farming and soil health, and has written extensively on the risks of pesticides and industrial agriculture. His involvement in this paper reflects Regeneration International’s broader mission to protect the biological integrity of soils and ecosystems, concerns that are central to the study’s findings on GMMs and the soil microbiome.

The Big Picture

When most people hear “GMO,” they think of crops – corn or soybeans engineered to resist pests. But scientists have been quietly engineering something far smaller and potentially far more consequential: microorganisms. Bacteria, yeasts, and fungi have been genetically modified and, in some cases, released into the environment on a massive scale, sometimes without the public even knowing.

A new review article published in the journal Microorganisms by a team of eight scientists and physicians argues that we are moving too fast. The technology to create genetically modified microorganisms (GMMs) has outpaced the regulations designed to keep them in check, and the potential consequences, for human health, for soil, and for the climate, deserve urgent attention.

What Is a Genetically Modified Microorganism?

A microorganism (or “microbe”) is any living thing too small to see with the naked eye: bacteria, viruses, fungi, and more. A genetically modified microorganism is one whose DNA has been intentionally altered in a lab, often using tools like CRISPR-Cas9, a kind of molecular “cut and paste” that can add, remove, or rewrite genetic instructions.

GMMs are not new. Since the 1980s, engineered bacteria have been used to produce human insulin, which transformed diabetes treatment. But the technology has become dramatically cheaper and more accessible. Today, CRISPR kits are available online, and high school students are creating novel microbes in classroom experiments.

The global market for GMMs used in agriculture alone was valued at over $10 billion in 2021 and is expected to nearly triple by 2029.

Why Microbes Are Different, and Potentially More Risky

The authors point out five features of microbes that make them uniquely challenging to regulate compared to genetically modified plants or animals:

  1. They reproduce extremely fast. Under ideal conditions, a single bacterium can double its numbers every 20 minutes. An engineered trait can spread through billions of organisms in hours.
  2. They’re nearly impossible to contain. Microbes travel on wind, water, animals, and people, reaching distant ecosystems and hosts.
  3. They share genes with each other. Through a process called horizontal gene transfer, microbes can pass genetic material to other, completely unrelated, microbes. An engineered gene could end up in microbes that were never modified in the first place.
  4. Microbiomes are essential to life. The communities of microbes living in and around humans, animals, plants, and soils are not just passengers, they are vital to health, immunity, and ecological balance.
  5. We know very little about them. Scientists estimate there are roughly one trillion different microbial species on Earth. We’ve only identified and characterized about 1% of them.

What Could Go Wrong? Key Risk Scenarios

The paper walks through several concrete scenarios where GMMs could cause harm.

Your Baby’s First Microbiome

The first three years of a child’s life are a critical window for establishing the gut microbiome, the community of microbes that shapes immune development, brain development, and lifelong health. A baby’s microbiome is seeded from the mother: through vaginal birth, breastfeeding, and skin contact.

The authors raise concern that GMMs could interfere with this delicate transfer. A genetically modified microbe could colonize a mother’s gut, mouth, vagina, or breast tissue, and then pass to her infant. The authors note that babies born by C-section, who miss out on vaginal microbiome transfer,  already face higher rates of asthma, allergies, celiac disease, and diabetes. Anything that further disrupts microbial inheritance could have lasting consequences. Yet there is currently no research on how GMMs might affect breast milk, pregnancy outcomes, or infant microbiome development.

Your Mouth: A Highway for Gene Transfer

The oral microbiome, the 770-plus species of microbes living in your mouth, plays a surprising role in whole-body health. Friendly oral bacteria contribute up to 25% of your daily production of nitric oxide, a molecule essential for healthy blood pressure. An imbalanced oral microbiome has been linked to increased risk of heart attack, brain inflammation, diabetes, lung infections, and even preterm birth.

The mouth is also a prime location for horizontal gene transfer, meaning it’s a place where engineered genes could easily spread to other microbes. If a GMM displaced beneficial bacteria or shared genes with harmful ones, the downstream effects could be significant and very difficult to reverse.

An Industrial Yeast That Could Trigger Gut Infections

One of the more detailed examples in the paper involves a yeast called Yarrowia lipolytica, which has been widely engineered in industrial settings to produce various compounds. In one application, it was modified to consume a common sugar (xylose, found in fruits, bread, and many processed foods) and produce large amounts of succinate, a chemical normally present only in small quantities in the gut.

The problem: high succinate levels are known to trigger overgrowth of Clostridium difficile (C. diff), a bacterium responsible for severe, potentially life-threatening diarrhea. If engineered Y. lipolytica were to accidentally escape containment and colonize the human gut, particularly in vulnerable people like newborns, premature infants, or immunocompromised patients — it could set the stage for dangerous infections.

A Food Additive Enzyme That May Trigger Autoimmune Disease

An enzyme called microbial transglutaminase (mTg) is widely used in the food industry to improve the texture of processed meats, dairy, and baked goods, essentially acting as a “protein glue.” It’s produced using genetically modified bacteria and is present in countless processed foods worldwide. The global market for mTg was valued at $136 million in 2024, growing rapidly.

The authors argue the safety status of this enzyme deserves serious reconsideration. Unlike the human body’s own transglutaminase enzyme, mTg lacks the usual biological “off switches.” It can operate across a wider range of conditions, penetrate tissue more readily, and form chemical bonds that are highly resistant to the body’s normal breakdown processes.

Research has linked mTg to increased intestinal permeability (sometimes called “leaky gut”), celiac disease, autoimmune conditions, and potentially neurodegenerative diseases. Regulatory bodies in Switzerland, Germany, and Canada have already issued warnings, yet mTg continues to be used in processed foods globally with limited oversight.

Soil Microbes: The Foundation of All Life, and Climate Stability

Perhaps the most sweeping concern in the paper is about soil. One teaspoon of healthy soil contains billions of microbes. These microbes break down organic matter, cycle nutrients, and, critically, sequester carbon dioxide from the atmosphere. Soils hold more carbon than all plants and the atmosphere combined.

GMMs are already being released into agricultural soils at enormous scale. One company has spread its genetically engineered bacteria across nearly 5 million acres of farmland, releasing as many as 5 trillion microbes per acre. Another product covers 10 million acres and counting.

The authors warn that introducing engineered microbes into soil ecosystems, which are already stressed by climate change and industrial agriculture, could have cascading effects. Genetically engineered microbes could transfer their genes to native soil bacteria, creating new organisms with unpredictable traits. They could disrupt the delicate microbial processes that stabilize carbon in the soil. They could pave the way for “super bugs”,  highly adapted, resistant microbes — just as herbicide-resistant “super weeds” emerged after widespread use of GM crops.

The Regulatory Gap

In the United States, GMMs used commercially are primarily regulated by the Environmental Protection Agency (EPA), under laws designed for toxic chemicals, not living, self-replicating organisms. Most GMMs not intended for commercial sale are effectively unregulated and untracked.

Meanwhile, many countries including the US, UK, Canada, and Australia have been deregulating gene-edited organisms, particularly those that don’t introduce DNA from another species. The authors argue this creates a dangerous blind spot, since gene editing can still cause unpredictable genetic changes, large deletions, chromosomal rearrangements, and unintended mutations, whether or not foreign genes are introduced.

As the U.S. Department of Homeland Security has acknowledged, the speed of innovation has outpaced American regulatory policy, and that gap needs to close.

What the Authors Are Calling For

The researchers propose a structured “biosafety workflow”, essentially a checklist of questions that should be answered before any GMM is created or released:

  • What is the GMM’s intended function, and are there safer alternatives?
  • What are the potential routes of escape or spread?
  • How might the GMM interact with human microbiomes?
  • What are the risks to soil, water, and wild ecosystems?
  • What monitoring will occur after release?

Above all, they urge regulators to adopt the precautionary principle, the idea that when something carries significant potential for irreversible harm, the burden of proof should fall on demonstrating safety before release, not after.  (See link for article)

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