Now that the pandemic has ended, researchers are urging regulatory agencies to consider the safety issues associated with the rapid approval of COVID-19 vaccines—and to correctly classify messenger RNA (mRNA) vaccines as gene therapy products (GTPs) to prevent pharmaceutical companies from bypassing regulatory standards.
According to a paper published in Nature on June 22, COVID-19 mRNA vaccines, by mode and action, are gene therapy products and should adhere to different regulatory standards. Yet U.S. and European regulatory agencies have not classified COVID-19 mRNA vaccines as gene therapy products, which has allowed them to be regulated as vaccines against infectious diseases instead of being subjected to the more stringent regulation of GTPs.
Because current regulatory guidelines either do not apply, do not mention RNA therapeutics, or do not have a widely accepted definition for these products, regulatory agencies adopted a modified and accelerated approval process for COVID-19 vaccines in the form of a “rolling review.”
A rolling review is a regulatory tool typically used during a public health emergency to speed up the assessment of data for medicines or vaccines. It allows data to be reviewed as it becomes available—without the complete data package or specific controls.
This process led to broad and continuous biodistribution of mRNA COVID-19 vaccines that were not thoroughly studied and yielded tests with noncompliant results regarding purity, quality, and batch homogeneity. Manufacturers are now planning to replace classic vaccines with mRNA vaccines using the same process—starting with influenza vaccines.
Vaccines With mRNA Technology Are Gene Therapies
The Centers for Disease Control and Prevention currently defines a “vaccine” as a preparation used to stimulate the body’s immune response against diseases. However, the agency’s definition was changed in 2021 out of concern it didn’t apply to COVID-19 vaccines.
A vaccine must contain an antigen to trigger the body’s natural immune response. Pfizer and Moderna’s mRNA vaccines do not contain antigens. The active substance used to elicit an immune response in these vaccines is the mRNA—a form of nucleic acid and the genetic material of the SARS-CoV-2 virus that provides instructions to the body for producing antigens—spike proteins.
In other words, the mRNA is not the substance causing active immunization. Instead, the mRNA must be translated into protein by the cells of the person vaccinated, and that person’s immune system must produce its own antigens to trigger an immune response.
The U.S. Food and Drug Administration (FDA) states that gene therapy seeks to “modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.” Moderna’s Q2 2020 filing with the Securities and Exchange Commission acknowledged that mRNA is “considered a gene therapy product by the FDA.” In addition, BioNTech founder Ugur Sahin, in a 2014 article stated, “One would expect the classification of an mRNA drug to be a biologic, gene therapy, or somatic cell therapy.”
According to the FDA, mRNA vaccines are comparable to the TypeIA of prodrugs—substances that, after administration, are converted in the body into pharmacologically active drugs.
This “prodrug property” could suggest that additional controls should be applied in addition to those required for vaccines. However, neither the FDA nor the European Medicines Agency (EMA) have referenced these qualifications for mRNA COVID-19 vaccines.
“With a conventional vaccine, you have the antigen, and you inject it into a person, and that is the thing that your immune system looks at and says, ‘ah ha,’ we need to make antibodies, T-cells, and other immune system components to what’s being injected,” said Dr. David Wiseman, a research scientist with a background in pharmacy, pharmacology, and experimental pathology, in an interview with The Epoch Times.
“The prime reaction of an mRNA vaccine is that it instructs the body how to make the antigen of interest. So, it’s similar to a prodrug, which is converted inside the body via metabolism and enzymes into the desired drug effect. The substance you’re injecting isn’t doing the final action; it leads to the thing that does the final action. With a prodrug, the molecule you inject does not get changed into the final molecule of the antigen, it simply provides instructions because it’s gene therapy.”
Wiseman said the FDA and EMA guidance and regulations that discuss gene therapy all define gene therapies “more or less” the same way. However, a number of years ago, the FDA decided to exclude vaccines for infectious diseases from its various guidance for unknown reasons, including vaccines made from gene therapy technology. Vaccines, in essence, were given their “own set of rules.”
However, the FDA can “change or exclude whatever they want from regulatory guidance, but it doesn’t change the biologic definition of the product,” said Wiseman. “Since Pfizer and Moderna COVID-19 vaccines meet the definition of gene therapy, they should be handled according to gene therapy guidelines.”
mRNA COVID-19 Vaccines Bypassed Essential Studies
According to the paper, because mRNA COVID-19 vaccines were not classified as gene therapy, necessary tests required for GTPs were not performed for the following:
- Genotoxicity.
- Genome integration.
- Germ-line transmission.
- Insertional mutagenesis.
- Tumorigenicity.
- Embryo/fetal and perinatal toxicity.
- Long-term expression.
- Repeated toxicity.
- Excretion in the environment, such as shedding through seminal fluid or breast milk.
“The long-term safety monitoring of GTPs is required over several years whereas, for vaccines, it is generally only carried out over a few weeks,” wrote Dr. Helene Banoun with the French Institute of Health and Medical Research in the paper. “This should not be acceptable, given the persistence of the drug product and the expressed protein.”
In addition, known results of anti-cancer therapies that use gene therapy technology and mRNA vaccines could lead us to anticipate safety and efficacy problems, she added.
In the EU, gene therapy medicinal products are required to undergo “tests or trials to evaluate the risk of genome integration and germ-line transmission, even if this integration is unlikely,” and tests and clinical trials to evaluate the risk of “insertional mutagenesis, tumorigenicity, embryo/fetal and perinatal toxicity, and long-term expression.”
EMA requires “extensive studies on both the nucleic acid and the vector particle/delivery system that includes biodistribution, dose study, potential target toxicity, the identification of the target organ to obtain biological activity, toxicity linked to the expression of structurally altered proteins.”
It is necessary to insist pharmacokinetic studies be performed to determine how the body interacts with the administered substance during the entire duration of exposure—even though they are generally not required for vaccines unless there’s a new formulation or a vaccine contains novel adjuvants or excipients (inactive substances such as preservatives).
For GTPs, shedding studies are also needed to determine excretion and dissemination in the body, and biodistribution studies are needed to assess where injected compounds—such as lipid nanoparticles, the delivery system used to deliver mRNA—travel in the body and which tissues or organs they accumulate in.
After assessing Pfizer and Moderna’s COVID-19 vaccine documents obtained by attorney Aaron Siri through the Freedom of Information Act, Wiseman noted many studies listed in nonclinical summaries that should have been performed but were not.
“Several studies should have been done but weren’t done because they fell under the auspices of vaccines. But if you read the guidelines, it doesn’t say these studies are unnecessary, just that circumstances may deem them unnecessary,” Wiseman said. “We need laws for products that say you can’t just exclude them from regulations because you feel like it—because they are still gene therapies,” he said.”We are hijacking the machines of our bodies to produce spike proteins in an uncontrolled, undefined way—there are too many things we don’t know about.”
Article cross-posted from our premium news partners at The Epoch Times.
Sound off about this story on my End Medical Tyranny Substack.
Two Storms, One Harvest
Every food crisis in living memory has been a one-shock event. The 2008 price spike was a commodity bubble. The 2020 shortages were a logistics failure. The 2022 grain scare was a war on one exporter’s ports. Each time, the system bent, adjusted, and recovered, and each time the experts assured us afterward that global markets are simply too big and too diversified to fail.
What nobody in Washington seems eager to discuss is that 2026 is shaping up to be something the modern food system has never actually faced. Two independent shocks, one climatic and one geopolitical, are converging on the same harvest cycle at the same time. Not sequentially. Simultaneously.
Start with the weather. The Pacific Ocean is currently building toward what forecasters now openly call a record event. NOAA’s Climate Prediction Center puts the odds of at least a strong El Niño near 88 percent, with roughly two in three odds it reaches “very strong” status, the tier reserved for perhaps three or four events in the entire satellite era. Every major global model now projects a median peak in Super El Niño territory, and most of them project it exceeding the 2015-16 event, which until now held the modern record. Sea surface anomalies were already brushing the super threshold in mid-July, months before these events normally peak. The atmosphere has already shifted into El Niño mode, and the event is forecast to crest in late fall and early winter.
This is not about “climate change.” It’s about the standard cycles of weather, and the cycle we’re currently in is one that has likely devastated societies in the past. We’re better prepared as a society today, but not all Americans are equally prepared.
Serious households have started doing the quiet math on their own. Grocery bills tell part of the story, and the forecast maps tell the rest, which is why long-term food storage has moved from fringe hobby to mainstream line item in the family budget, with established suppliers like Heaven’s Harvest seeing demand from people who five years ago would have rolled their eyes at the idea. That instinct is not paranoia. It is pattern recognition, and the pattern is worth walking through carefully.
Editor’s Note: Heaven’s Harvest IS a sponsor, but the warnings of this article are real and would be written even if we didn’t have a survival food sponsor. With that said, those who take advantage of what they offer can use promo code “Patriot” for 15% off.
The Fertilizer Clock Is Already Running
While the Pacific warms, the second shock has been unfolding in the Strait of Hormuz. The conflict with Iran turned the world’s most important energy chokepoint into a contested waterway, and the consequences reach far beyond the gas pump. Roughly a third of global fertilizer trade moves through Hormuz, and the disruption sent urea prices up 86 percent year over year by March, with a 53 percent jump in a single month.
The World Bank projects energy prices rising about 24 percent in 2026 and fertilizer about 31 percent. By its own accounting, fertilizer prices ran 35 percent higher in the first five months of this year than the same period last year.
Here is the mechanism the nightly news will not explain. Fertilizer is not a grocery item. It is a time-delayed input. The nitrogen a farmer in Iowa or Punjab could not afford to apply this spring does not show up as a problem this spring. It shows up as a thinner harvest six to twelve months later.
The World Bank’s own food security brief concedes that the effects of reduced applications earlier this season “are likely to become visible only later in harvest outcomes.” Translate that from institutional language into plain English and it means this. The damage is already done, it is already in the ground, and we are simply waiting for it to arrive on the shelf.
Now check the calendar. Six to twelve months from the spring planting season lands us squarely in late 2026 and early 2027. Which is precisely when the strongest El Niño in the instrumental record is forecast to peak, bringing its signature droughts to Southeast Asia, Australia, southern Africa, northern Brazil, and South Asia, the very regions that grow the world’s rice, sugar, and oilseeds.
The World Bank warns openly that a strong El Niño “could disrupt multiple crop belts simultaneously” on top of the conflict-driven input costs. Their baseline projection assumes the Middle East disruptions ease by autumn. What in the last two years of Middle East history suggests that assumption is safe?
The System Has No Slack Left
The comfortable answer is that global markets always adjust. But adjustment requires slack, and the slack is gone. Global cereal production is expected to decline from last year’s records even before El Niño does its work. The UN World Food Programme, hardly a den of right-wing preppers, is calling this the most significant disruption to its supply chains since Covid and the invasion of Ukraine, and its supply chain director put the stakes bluntly.
Today’s supply chain challenges are tomorrow’s hunger crisis.
There is also a political dimension that markets cannot price. When food gets scarce, governments do not behave like economists. They behave like politicians. Export bans, hoarding mandates, and panic buying at the national level turned the modest rice shortfall of 2008 into a global crisis, and analysts are already warning that import-dependent nations are the first dominoes.
The 2015-16 Super El Niño, a far weaker event than what is now forecast, threw tens of millions into food stress across Africa and Asia. This one is projected to be stronger, and it arrives with fertilizer already rationed by price and shipping lanes already contested by missiles.
What Joseph Knew
Scripture does not treat preparation for lean years as faithlessness. It treats it as wisdom delivered in advance to those willing to act on it.
Behold, there come seven years of great plenty throughout all the land of Egypt: And there shall arise after them seven years of famine; and all the plenty shall be forgotten in the land of Egypt.
Joseph did not respond to that warning with a hashtag or a committee. He stored grain during the years of abundance, and when the famine came, Egypt stood while its neighbors begged. The lesson is not that famine is certain. It is that the time to prepare is precisely when preparation still looks optional.
Nobody who filled a pantry in a year of plenty has ever regretted it, and nobody standing in an empty aisle has ever been glad he waited for certainty.
None of this calls for panic, and panic is the enemy of sound judgment anyway. It calls for the same unglamorous prudence our grandparents considered ordinary. Keep some cash margin, know your local growers, and put real food in deep storage while it is cheap and available, because the entire arc of this story is that cheap and available is a closing window.
Families looking for a straightforward place to start can visit Heaven’s Harvest and use promo code Patriot for 15 percent off long-term storable food. The forecasts may yet soften, the strait may yet reopen, and we should pray they do. But hope is a fine thing to hold and a foolish thing to eat.
Oh wow, NATURE rag finally published a non—communist, non—CCP influenced, non—Big PHARMA paper?!?!