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.
Coffee the Christian way: Promised Grounds
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.
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Five Things New “Preppers” Forget When Getting Ready for Bad Times Ahead
The preparedness community is growing faster than it has in decades. Even during peak times such as Y2K, the economic downturn of 2008, and Covid, the vast majority of Americans made sure they had plenty of toilet paper but didn’t really stockpile anything else.
Things have changed. There’s a growing anxiety in this presidential election year that has prompted more Americans to get prepared for crazy events in the future. Some of it is being driven by fearmongers, but there are valid concerns with the economy, food supply, pharmaceuticals, the energy grid, and mass rioting that have pushed average Americans into “prepper” mode.
There are degrees of preparedness. One does not have to be a full-blown “doomsday prepper” living off-grid in a secure Montana bunker in order to be ahead of the curve. In many ways, preparedness isn’t about being able to perfectly handle every conceivable situation. It’s about being less dependent on government for as long as possible. Those who have proper “preps” will not be waiting for FEMA to distribute emergency supplies to the desperate masses.
Below are five things people new to preparedness (and sometimes even those with experience) often forget as they get ready. All five are common sense notions that do not rely on doomsday in order to be useful. It may be nice to own a tank during the apocalypse but there’s not much you can do with it until things get really crazy. The recommendations below can have places in the lives of average Americans whether doomsday comes or not.
Note: The information provided by this publication or any related communications is for informational purposes only and should not be considered as financial advice. We do not provide personalized investment, financial, or legal advice.
Secured Wealth
Whether in the bank or held in a retirement account, most Americans feel that their life’s savings is relatively secure. At least they did until the last couple of years when de-banking, geopolitical turmoil, and the threat of Central Bank Digital Currencies reared their ugly heads.
It behooves Americans to diversify their holdings. If there’s a triggering event or series of events that cripple the financial systems or devalue the U.S. Dollar, wealth can evaporate quickly. To hedge against potential turmoil, many Americans are looking in two directions: Crypto and physical precious metals.
There are huge advantages to cryptocurrencies, but there are also inherent risks because “virtual” money can become challenging to spend. Add in the push by central banks and governments to regulate or even replace cryptocurrencies with their own versions they control and the risks amplify. There’s nothing wrong with cryptocurrencies today but things can change rapidly.
As for physical precious metals, many Americans pay cash to keep plenty on hand in their safe. Rolling over or transferring retirement accounts into self-directed IRAs is also a popular option, but there are caveats. It can often take weeks or even months to get the gold and silver shipped if the owner chooses to close their account. This is why Genesis Gold Group stands out. Their relationship with the depositories allows for rapid closure and shipping, often in less than 10 days from the time the account holder makes their move. This can come in handy if things appear to be heading south.
Lots of Potable Water
One of the biggest shocks that hit new preppers is understanding how much potable water they need in order to survive. Experts claim one gallon of water per person per day is necessary. Even the most conservative estimates put it at over half-a-gallon. That means that for a family of four, they’ll need around 120 gallons of water to survive for a month if the taps turn off and the stores empty out.
Being near a fresh water source, whether it’s a river, lake, or well, is a best practice among experienced preppers. It’s necessary to have a water filter as well, even if the taps are still working. Many refuse to drink tap water even when there is no emergency. Berkey was our previous favorite but they’re under attack from regulators so the Alexapure systems are solid replacements.
For those in the city or away from fresh water sources, storage is the best option. This can be challenging because proper water storage containers take up a lot of room and are difficult to move if the need arises. For “bug in” situations, having a larger container that stores hundreds or even thousands of gallons is better than stacking 1-5 gallon containers. Unfortunately, they won’t be easily transportable and they can cost a lot to install.
Water is critical. If chaos erupts and water infrastructure is compromised, having a large backup supply can be lifesaving.
Pharmaceuticals and Medical Supplies
There are multiple threats specific to the medical supply chain. With Chinese and Indian imports accounting for over 90% of pharmaceutical ingredients in the United States, deteriorating relations could make it impossible to get the medicines and antibiotics many of us need.
Stocking up many prescription medications can be hard. Doctors generally do not like to prescribe large batches of drugs even if they are shelf-stable for extended periods of time. It is a best practice to ask your doctor if they can prescribe a larger amount. Today, some are sympathetic to concerns about pharmacies running out or becoming inaccessible. Tell them your concerns. It’s worth a shot. The worst they can do is say no.
If your doctor is unwilling to help you stock up on medicines, then Jase Medical is a good alternative. Through telehealth, they can prescribe daily meds or antibiotics that are shipped to your door. As proponents of medical freedom, they empathize with those who want to have enough medical supplies on hand in case things go wrong.
Energy Sources
The vast majority of Americans are locked into the grid. This has proven to be a massive liability when the grid goes down. Unfortunately, there are no inexpensive remedies.
Those living off-grid had to either spend a lot of money or effort (or both) to get their alternative energy sources like solar set up. For those who do not want to go so far, it’s still a best practice to have backup power sources. Diesel generators and portable solar panels are the two most popular, and while they’re not inexpensive they are not out of reach of most Americans who are concerned about being without power for extended periods of time.
Natural gas is another necessity for many, but that’s far more challenging to replace. Having alternatives for heating and cooking that can be powered if gas and electric grids go down is important. Have a backup for items that require power such as manual can openers. If you’re stuck eating canned foods for a while and all you have is an electric opener, you’ll have problems.
Don’t Forget the Protein
When most think about “prepping,” they think about their food supply. More Americans are turning to gardening and homesteading as ways to produce their own food. Others are working with local farmers and ranchers to purchase directly from the sources. This is a good idea whether doomsday comes or not, but it’s particularly important if the food supply chain is broken.
Most grocery stores have about one to two weeks worth of food, as do most American households. Grocers rely heavily on truckers to receive their ongoing shipments. In a crisis, the current process can fail. It behooves Americans for multiple reasons to localize their food purchases as much as possible.
Long-term storage is another popular option. Canned foods, MREs, and freeze dried meals are selling out quickly even as prices rise. But one component that is conspicuously absent in shelf-stable food is high-quality protein. Most survival food companies offer low quality “protein buckets” or cans of meat, but they are often barely edible.
Prepper All-Naturals offers premium cuts of steak that have been cooked sous vide and freeze dried to give them a 25-year shelf life. They offer Ribeye, NY Strip, and Tenderloin among others.
Having buckets of beans and rice is a good start, but keeping a solid supply of high-quality protein isn’t just healthier. It can help a family maintain normalcy through crises.
Prepare Without Fear
With all the challenges we face as Americans today, it can be emotionally draining. Citizens are scared and there’s nothing irrational about their concerns. Being prepared and making lifestyle changes to secure necessities can go a long way toward overcoming the fears that plague us. We should hope and pray for the best but prepare for the worst. And if the worst does come, then knowing we did what we could to be ready for it will help us face those challenges with confidence.
