Unsupported: It is premature to claim that “the COVID-19 vaccine will use experimental technology”. Scientists worldwide are developing more than 100 vaccine candidates and many of them are based on classical, well-established approaches. Until all clinical trials are completed, we will not know which vaccine(s) will show a sufficiently high level of safety and efficacy to make it to the market.
AFFIRMATION COMPLETE: “Bill Gates explains that the COVID vaccine will use experimental technology and permanently alter your DNA”; “RNA vaccines would carry the danger of triggering autoimmune reactions, meaning the body basically goes to war against itself”
SUMMARY
A claim that RNA vaccine technology, which is being used to develop a COVID-19 vaccine candidate, will “permanently alter your DNA” was published in an article by Waking Times in May 2020, forming the basis for many viral posts on social media. The claim has received more than 200,000 views at the time of this review’s publication. Although the original article has since been corrected following a fact-check by PolitiFact, the posts that reshared the article’s content have not been corrected and continue to propagate this claim (see an example here).
Scientists who examined the claim’s scientific credibility told Health Feedback that the claim is inaccurate and results from a fundamental misunderstanding of how RNA vaccines work and how nucleic acids (DNA and RNA) interact with the human body.
Robert Carnahan, an associate professor at Vanderbilt University and associate director of the Vanderbilt Vaccine Center, explained that while “RNA vaccines represent a new innovation, they are based on longstanding foundational scientific principles.” RNA serves as the recipe or blueprint that instructs cells to make a particular protein. After it has served its purpose, “cells in the body have innate mechanisms of degrading this RNA and not allowing it to persist,” he said. Therefore, any RNA injected from a vaccine will not persist long enough to cause autoimmune disorders, which are chronic diseases. A 2017 study published by Science Advances estimated that RNA used as protein blueprints (messenger RNA or mRNA) generally lasted for a mere two minutes in yeast cells[1]. Another study in mice found that mRNA decayed after about three days post-injection[2].
Carnahan also pointed out that RNA is chemically different from DNA, making it virtually impossible for RNA to directly integrate into DNA to change a person’s genome.
While concerns over the safety profile of the potential vaccines are natural, given the accelerated vaccine development timeline imposed by the urgency of the COVID-19 pandemic, Sanjay Mishra, a staff scientist and project coordinator at Vanderbilt University Medical Center, explained that RNA vaccines are considered to be extremely safe based on past research[3,4]. “Safety studies have concluded that there is little concern for integration of DNA into genomes. mRNA vaccines are even safer and advantageous because RNA itself cannot integrate into genomic DNA without the presence of a retrovirus element, such as reverse transcriptase and integrase,” he said.
In fact, we can recognize that the fear of foreign DNA or RNA integrating into and changing our own genome is unfounded when we remember that we come into daily contact with a large amount of foreign DNA and RNA from other organisms in the environment. For example, we ingest DNA and RNA in our food. In addition, our bodies host billions of microorganisms, such as bacteria and fungi, which colonize different tissues and organs, such as our skin and digestive tract. Furthermore, in people who have received blood transfusions or organ transplants, scientists have not observed the DNA of the donor to integrate into the recipient’s DNA, let alone alter it.
Angéline Rouers, a research fellow at the Singapore Immunology Network, said that given the well-established safety profile of nucleic acid vaccines, scientists are instead more concerned with whether the vaccine would provide long-lasting immunity against SARS-CoV-2, although there is also some indication that RNA vaccines might be able to provide a better response against viral infection than conventional vaccines containing a viral protein. RNA vaccines “have the advantage of eliciting both cellular (cytotoxic and helper T cells) and humoral immunity (antibodies), while classical vaccines (based on protein) usually focus more on antibody production to the detriment of cellular immunity[3,4],” she said. “In the case of immunity against a virus such as SARS-CoV-2, the T cell response is particularly important.”
The claim that an RNA vaccine can provoke an autoimmune response is also not supported by scientific evidence. Mishra acknowledged that while DNA or RNA vaccines could theoretically cause autoimmunity, observations in published studies have shown the opposite and highlight the potential of RNA vaccines for treating autoimmune disorders instead. “Pre-clinical testing and careful clinical monitoring have shown DNA vaccines not only do not induce or worsen auto-immunity, they in fact therapeutically benefit in autoimmune diseases such as diabetes mellitus and multiple sclerosis[5,6],” he said.
It is also inaccurate to liken an RNA vaccine to gene therapy. Gene therapy is specially designed to introduce DNA into a patient’s genome for the sake of treating a disease, involving the use of viral vectors which provide the molecular machinery for introducing and integrating the DNA into a patient’s genetic material. From the U.S. National Library of Medicine:
“Gene therapy is designed to introduce genetic material into cells to compensate for abnormal genes or to make a beneficial protein. If a mutated gene causes a necessary protein to be faulty or missing, gene therapy may be able to introduce a normal copy of the gene to restore the function of the protein.
A gene that is inserted directly into a cell usually does not function. Instead, a carrier called a vector is genetically engineered to deliver the gene. Certain viruses are often used as vectors because they can deliver the new gene by infecting the cell. The viruses are modified so they can’t cause disease when used in people. Some types of virus, such as retroviruses, integrate their genetic material (including the new gene) into a chromosome in the human cell. Other viruses, such as adenoviruses, introduce their DNA into the nucleus of the cell, but the DNA is not integrated into a chromosome.
The vector can be injected or given intravenously (by IV) directly into a specific tissue in the body, where it is taken up by individual cells. Alternately, a sample of the patient’s cells can be removed and exposed to the vector in a laboratory setting. The cells containing the vector are then returned to the patient. If the treatment is successful, the new gene delivered by the vector will make a functioning protein.”
However, RNA is not used in gene therapy and viral vectors are not used in RNA vaccines, which makes the comparison to gene therapy fundamentally faulty.
The claim that the “COVID vaccine will use experimental technology” is unsupported and misleading. Scientists worldwide are using different approaches to maximize the chances of developing a successful vaccine quickly. Some of these approaches are well-established, like classical vaccines which use proteins to elicit an immune response, while others are more novel like the RNA vaccine. Media attention has contributed to high expectations for RNA vaccine technology in addressing the COVID-19 pandemic, but it is still unknown exactly which vaccines will show a sufficiently high level of safety and efficacy to be approved for the market until clinical trials are completed. In fact, Gates pointed out in his blog that “we don’t know yet what the COVID-19 vaccine will look like.”
The New York Times Coronavirus Vaccine Tracker has compiled details about the various COVID-19 vaccine candidates under development, including the technique used and how far each one has risen through the succession of clinical trial stages. As of 30 June 2020, more than 100 vaccine candidates are being developed and tested.
In summary, the claim that RNA vaccines can alter our DNA is scientifically unfounded. Chemical differences prevent RNA from directly integrating into our DNA, and studies examining the potential integration of nucleic acid vaccines into DNA have confirmed that such changes are not known to occur[3,4]. The claim that RNA from a vaccine can cause autoimmunity is also unsupported, as RNA has a very short lifespan, being quickly degraded after it has been used to make a protein. This means that RNA does not persist long enough to cause chronic problems like autoimmune disorders. Taken together, these characteristics make RNA vaccines a generally safe option for inducing immunity against infectious diseases, although its efficacy against COVID-19 has yet to be determined.
SCIENTISTS’ FEEDBACK
While there is a theoretical possibility of DNA (or RNA) vaccines causing autoimmunity or that the DNA would integrate into the human genome, pre-clinical testing and careful clinical monitoring have shown DNA vaccines not only do not induce or worsen auto-immunity, they in fact therapeutically benefit in autoimmune diseases such as diabetes mellitus and multiple sclerosis[5,6]. Unlike viral vectors for gene therapy, the nucleic acid vaccines are considered so safe that they do not need to be evaluated by the National Institutes of Health (NIH) Recombinant Advisory Committee prior to human clinical trials.
Safety studies have concluded that there is little concern for integration of DNA into genomes. mRNA vaccines are even safer and advantageous because RNA itself cannot integrate into genomic DNA without the presence of a retrovirus element (reverse transcriptase and integrase). It is possible that some recipients of an mRNA vaccine might be already infected with a retrovirus (e.g., HIV), where theoretically such integration could happen. But the risk of integration, like a “gene therapy”, is extremely unlikely for mRNA, and is not a significant concern for plasmid DNA. From a regulatory perspective, DNA and mRNA vaccines do not count as gene therapy products.
In many cases, the principle of a given vaccine is to expose the body to a key protein, called an antigen, that leads to the development of a long-term immunity to the pathogen from which the antigen protein originates. In the case of RNA vaccines, rather than directly giving the body the actual protein, an RNA which instructs cells in the body as to how to make the antigen protein is given.
Though these RNA vaccines represent a new innovation, they are based on longstanding, foundational scientific principles. RNA itself is used in all cells in the body as a short-lived blueprint for building proteins within the cells. That is a key safety advantage for using it to provide a message encoding the antigen protein. The cells in the body have innate mechanisms of degrading this RNA and not allowing it to persist. Moreover, though RNA is related to DNA, it is chemically distinct and is not able to integrate into the DNA. This means that these vaccines will not modify the DNA of the cells, and also will not be present for prolonged periods to cause other long-term effects like autoimmune disorders.
Angéline Rouers, Research Fellow, Singapore Immunology Network:
These viral Facebook posts are based on an article written by Alex Pietrowski for Waking Times and it reports two citations: one from Bill Gates about the uncertainties of the RNA vaccine under development to protect against COVID-19, and the other from a journalist named Jon Rappoport, claiming that nucleic acid vaccines, which include both RNA and DNA vaccines, can modify the genome or lead to autoimmune reactions and are therefore unsafe.
The citation of Bill Gates (from his blog GatesNotes) has clearly been misinterpreted and taken out of context. It is true that not much is known about RNA vaccines, such as the one under development by a company called Moderna, among many other vaccine candidates in the world, but the uncertainty is more about the ability of the vaccine to protect efficiently against SARS-CoV-2, rather than its safety. “How many doses will be required?” or “Is the immunity long-lasting?” are the kind of questions still pending.
Nucleic acid vaccines are actually incredibly safe, which was a part of their success at the time of their discovery. You have to imagine that you simply give the blueprint (genetic code) to your body to construct the viral protein on its own, so it can learn how to fight against the virus. In terms of manufacturing, it is easier and faster than producing the protein used in classical vaccines. That’s the reason why some companies like Moderna chose this option in the context of the current COVID-19 pandemic—to enable them to release a vaccine as fast as possible.
Even if not much is known about the expected efficiency of RNA vaccines, they have the advantage of eliciting both cellular (cytotoxic and helper T cells) and humoral immunity (antibodies), while classical vaccines (based on protein) usually focus more on antibody production to the detriment of cellular immunity[3,4]. In the case of immunity against a virus such as SARS-CoV-2, the T cell response is particularly important.
The claim by Jon Rappoport is simply misinformation and is not based on any scientific evidence. DNA or RNA vaccines are considered as carriers of information, but there is no chance that these molecules would incorporate into the human genome.
Part of his claim is that “RNA vaccines would carry the danger of triggering autoimmune reactions, meaning the body basically goes to war against itself”, which is also completely false. I suspect that this may stem from a confusion based on the fact that RNA vaccines guide the body to create a protein, which the body’s own immune system will target. The principle of autoimmunity is that our body recognizes and destroys our own components. However, in the case of the RNA vaccine, the protein made by our body is something unrelated with our own proteins, so there is no chance of an autoimmune reaction but a reaction against something unknown to teach our body to fight against it. This illustrates the very principle of vaccination.
REFERENCES
- 1 – Baudrimont et al. (2017) Multiplexed gene control reveals rapid mRNA turnover. Science Advances.
- 2 – Probst et al. (2007) Spontaneous cellular uptake of exogenous messenger RNA in vivo is nucleic acid-specific, saturable and ion dependent. Gene Therapy.
- 3 – Pardi et al. (2018) mRNA vaccines — a new era in vaccinology. Nature Reviews Drug Discovery.
- 4 – Schlake et al. (2012) Developing mRNA-vaccine technologies. RNA Biology.
- 5 – Gottlieb et al. (2013) Clinical optimization of antigen specific modulation of type 1 diabetes with the plasmid DNA platform. Clinical Immunology.
- 6 – Garren et al. (2008) Phase 2 trial of a DNA vaccine encoding myelin basic protein for multiple sclerosis. Annals of Neurology.
