This article was last updated on July 5, 2023
mRNA Therapeutics – Should They Be Classified as Gene Therapy or Vaccines?
A recent paper entitled “mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues” that appeared in the International Journal of Molecular Sciences on June 22, 2023:
…examines the issue of whether or not the COVID-19 mRNA vaccines should be classified as gene therapy and whether they were sufficiently scrutinized by government regulators, one of the key questions that has been shuffled off to the “conspiracy theory hinterland” by the mainstream media, fact checkers and government health officials.
Let’s start by defining a gene therapy product (GTP):
1.) According to the United States Food and Drug Administration, gene therapy is a medical intervention based on the modification of the genetic material of living cells. Cells may be altered in vivo by gene therapy given directly to the subject.
2.) According to the European Medicines Agency (EMA) (2009), a GTP:
(a) contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; and
(b) in its therapeutic, prophylactic or diagnostic effects, relates directly to the recombinant nucleic acid sequence it contains, or to the product of the genetic expression of this sequence.
Now, let’s look at the definition of a vaccine:
1.) According to the United States CDC, a vaccine is “a preparation that is used to stimulate the body’s immune response against diseases.” This definition was changed in September 2021 and previously read “a product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.”
2.) According to European regulations, vaccines are products capable of producing active immunity and contain antigens capable of inducing active immunity against an infectious agent.
Keep in mind that according to the EMA, the active substance in the COVID-19 mRNA vaccines is mRNA, not an antigen which means that mRNA products should not be considered to be vaccines.
The paper by Helene Banoun, an independent French researcher with a lengthy publishing record that you can see here opens with this:
“COVID-19 vaccines were developed and approved rapidly in response to the urgency created by the pandemic. No specific regulations existed at the time they were marketed. The regulatory agencies therefore adapted them as a matter of urgency. Now that the pandemic emergency has passed, it is time to consider the safety issues associated with this rapid approval….
Some of the tests they have undergone as vaccines have produced non-compliant results in terms of purity, quality and batch homogeneity. The wide and persistent biodistribution of mRNAs and their protein products, incompletely studied due to their classification as vaccines, raises safety issues. Post-marketing studies have shown that mRNA passes into breast milk and could have adverse effects on breast-fed babies. Long-term expression, integration into the genome, transmission to the germline, passage into sperm, embryo/fetal and perinatal toxicity, genotoxicity and tumorigenicity should be studied in light of the adverse events reported in pharmacovigilance databases. The potential horizontal transmission (i.e., shedding) should also have been assessed. In-depth vaccinovigilance should be carried out. We would expect these controls to be required for future mRNA vaccines developed outside the context of a pandemic.“
As we should all be aware, the COVID-19 mRNA vaccines were the first mRNA vaccines marketed to the public and, as a new class of vaccines, should be subject to additional scrutiny given that they are based on new technologies. That said, mRNA vaccines against an infectious disease have been excluded from gene therapy product (GTP) regulations by regulations in both the United States and the European Union, largely because mRNA therapeutics are not mentioned in the current guidelines.
In this study, the author compared the controls required by GTP regulations with those that were actually applied to the COVID-19 mRNA vaccines. and found that because the COVID-19 mRNA vaccines were not classified as gene therapy, tests normally required for gene therapy products were not following including the following (among others):
1.) Long-term expression
2.) Integration into the genome
3.) Transmission to the germline (i.e. semen, gonads, gametes)
4.) Passage into embryo/fetal and perinatal toxicity,
7.) Shedding studies/transmission to a third party
8.) Excretion in the environment
The COVID-19 mRNA vaccines were rushed into production and distribution in response to the perception of a global health emergency in a matter of months with rolling reviews where data is submitted to and reviewed by government health bodies as they become available, prior to the full data package is available to regulators and the general public. The final trial phases were not and still have not been completed until months or years after the mRNA products were injected into the arms of billions of humans.
According to the FDA, a long-term follow-up of adverse events associated with GTPs must be performed for at least five years for new clinical conditions including new malignancy(ies), new incidence or exacerbation of a pre-existing neurologic disorders, new incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, new incidence of a hematologic disorder and new incidence of infection (potentially product- related).
The application of stringent guidelines to mRNA therapeutics is of critical importance given that Big Pharma, particularly Moderna, is planning to release mRNA influenza “vaccines” as well as anti-cancer “vaccines” as shown on this graphic which shows that several of these vaccines are already in Phase 2 trials:
What is of even greater concern is that Big Pharma is planning to replace traditional vaccines with mRNA vaccines.
Let’s close with some additional quotes and the conclusion from the paper by Helene Banoun with my bolds:
“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. This should not be acceptable, given the persistence of the drug product and the expressed protein. The known results of anti-cancer therapies and mRNA vaccines could lead us to anticipate problems of safety and efficacy. In the case of anti-cancer mRNAs, the vast majority of open-label clinical trials have been carried out on very small numbers of patients, with either unpublished or negative results. Randomized studies also showed negative results, reporting more frequent adverse events in the treatment group…
From a public health point of view, and knowing that anti-COVID-19 mRNAs considered as vaccines have not undergone all the strict controls required for GTPs, one could object that a product intended for the majority of the world’s healthy population should be subject to more stringent regulation than a GTP intended for a few rare people suffering from a rare disease or cancer…
The role of regulatory agencies is to ensure the safety and efficacy of medicines. The COVID-19 pandemic emergency has accelerated the timetable for the production and clinical use of COVID-19 vaccines; it is, therefore, possible that certain safety aspects have not been fully addressed. It is, therefore, important to take these aspects into account in the future, so as not to undermine public confidence in vaccines in general….
In the future, it should be discussed whether all mRNA-based products should be subject to the same regulations and controls, whether or not they are considered vaccines. It is not justifiable to subject therapeutic mRNAs to strict controls when they are intended for patients representing a small proportion of the human population, and to exclude from these controls mRNA vaccines intended for the majority of the healthy human population.”