Here we go again – I keep seeing the new anti-vaxxer claim that the mRNA COVID-19 vaccines from Pfizer and Moderna are not, in fact, vaccines but are either “medical devices” or “gene therapy.” I keep trying to stay up with every single myth and trope pushed by the anti-vaxxers, but I swear that there’s a new one every day.
I would really love to write about something other than COVID-19 vaccines – I’ve got a ton of articles I want to write about GMOs, supplements, and cancer that are just sitting in a virtual pile on my desk. Unfortunately, I’m very worried that the anti-vax hatred of these new vaccines will allow this pandemic to keep going. That’s why many of us keep doing the best we can to stamp out the myths.
Just to be clear, the Pfizer and Moderna COVID-19 mRNA vaccines are actually vaccines – they are biological preparations that provide active acquired immunity to an infectious disease, in this case, COVID-19. But, I’m going to have to debunk these myths.
What is a vaccine?
I’m not going to pretend that I can give you the perfect definition of what a vaccine is. I guess I’ll go with “if it looks like a duck, and quacks like a duck, it must be a duck!” Vaccines are the same, it’s pretty hard to confuse them with “gene therapy” or “medical devices.”
Here’s how Wikipedia defines a vaccine:
A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. A vaccine typically contains a biological preparation from disease-causing microorganisms, or since the beginning of the 21st century, made synthetically that resembles it. This preparation is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body’s immune system to recognize the agent as a threat and starts producing antibodies against it, so as to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future. Vaccines can be prophylactic (to prevent or ameliorate the effects of a future infection by a natural or “wild” pathogen), or therapeutic (to fight a disease that has already occurred, such as cancer).
The CDC also defines vaccines pretty clearly:
Vaccine: A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease. Vaccines are usually administered through needle injections, but can also be administered by mouth or sprayed into the nose.
Vaccination: The act of introducing a vaccine into the body to produce immunity to a specific disease.
Immunization: A process by which a person becomes protected against a disease through vaccination. This term is often used interchangeably with vaccination or inoculation.
The FDA also provides a clear definition of a vaccine:
Vaccines work by mimicking the infectious bacteria or viruses that cause disease. Vaccination stimulates the body’s immune system to build up defenses against the infectious bacteria or virus (organism) without causing the disease. The parts of the infectious organism that the immune system recognizes are foreign to the body and are called antigens. Vaccination exposes the body to these antigens.
Some vaccines contain weakened versions of a bacteria or virus, other vaccines contain only part of the bacteria or virus. Some vaccines contain only the genetic material for a specific protein and direct the body to produce a small amount of that protein. The body’s immune system reacts defensively once it detects this protein.
After vaccination, the immune system is prepared to respond quickly and forcefully when the body encounters the real disease-causing organism.
Like the metaphorical duck, the vaccines look and sound like vaccines based on how real scientists define vaccines. I should just stop this article right here because anyone who claims that the Pfizer and Moderna COVID-19 vaccines are anything but vaccines really isn’t stating facts. They are just inventing nonsense pull out of the thin air.
But let’s proceed and point out how these mRNA vaccines are neither medical devices nor gene therapy.
Pfizer and Moderna COVID-19 vaccines are not gene therapy
Anti-vaccine crackpot Joe Mercola seems to have started this nonsense (again, I don’t link to these pseudoscience websites, so if you want to Google it, that’s on you, but please don’t give his garbage any clicks). His claim, of course, relies upon a complete misunderstanding (or intentional misinformation) about how mRNA vaccines work.
And, our other favorite anti-vaccine nutjob, Andrew Wakefield, has pushed the same fake “science” on how the Pfizer and Moderna COVID-19 mRNA vaccines work.
Based on their beliefs, they think that these vaccines should be classified as “gene therapy,” but not vaccines. They do this because there is nothing that frightens people more than talking about genetic modification of anything – I’ve written dozens of articles debunking myths about genetically modified foods because it’s a thing.
So, let me repeat what I’ve written before – the mRNA fragments in these vaccines will not and cannot change your DNA. It is as close to “impossible” as I can imagine in science.
All about mRNA and COVID-19 mRNA vaccines
Before we can start with this debunking, let’s discuss what mRNA is and how it works with the Pfizer and Moderna COVID-19 vaccines.
These mRNA vaccines rely upon an mRNA, or messenger RNA, molecule to induce an immune response. However, it does not do this directly, and this is where the whole fear of “gene therapy” arises.
Normally, during the process called transcription, RNA polymerase makes a copy of a gene from its DNA to a corresponding mRNA fragment whenever required by the cell. In other words, the mRNA sequences in the cell usually correspond directly to the DNA sequences in our genes. These mRNA sequences “carry” that genetic message to a ribosome for translation, where tRNA triplets, which code for one amino acid, attach to the appropriate mRNA triplet, adding one amino acid to the protein chain.
As in DNA, genetic information in mRNA is contained in the sequence of nucleotides, which are arranged into codons consisting of three ribonucleotides each. Each codon codes for a specific amino acid, except the stop codons, which terminate protein synthesis.
At this point, note that the mRNA does nothing to the DNA strand in your genes – it merely reads the DNA sequence that represents the gene. I cannot stress this enough – mRNA does nothing to the DNA, it just reads it passively.
Yes, that’s a lot of cell biology, but I’m just scratching the surface because I don’t want any of you to fall asleep. If you want to take a deep dive into the science of mRNA and mRNA vaccines, my friend Edward Nirenberg wrote two articles that will satisfy your desires – he makes it clear how this all works and doesn’t work.
Alan McHughen, in his outstanding book, “DNA Demystified: Unraveling the Double Helix,” describes how mRNA works:
When an mRNA strand exits the nucleus and enters the cytoplasm, it attaches to ribosomes, and this is where protein synthesis progresses. The ribosome reads the base sequence of the mRNA, three bases at a time. Each three-base triplet, called a codon, specifies a particular amino acid, except for a few with regulatory functions (e.g., UGA =“Stop!”).
If the first three-base codon is AUG, then a molecule of the amino acid methionine is brought into place. If the next triplet is AAA, that brings in the amino acid lysine. The methionine and lysine molecules are attached together. The next triplet is, say, GCC, and that brings in alanine, which is attached to the lysine. The ribosome has read nine bases, AUGAAAGCC, and compiled a short chain of three amino acids, abbreviated Met-Lys-Ala, or MKA (see amino acid abbreviations here).
The ribosome continues reading all of the mRNA bases until it hits a stop signal—which is also a triplet codon such as UGA—and the now long chain of amino acids falls loose. This chain may be a functional protein immediately, or, more usually, it might undergo some additional post-translational processing by enzymes to become active.
Once the mRNA fragment has created a protein, it is then ripped apart by enzymes in the cell, so that the individual RNA nucleotides can go back to being reused in a whole new mRNA sequence. The cellular machinery of translating DNA into proteins is constantly recirculating itself.
The mRNA vaccine technology relies upon a specific mRNA sequence to kickstart the endogenous production of proteins that are structurally equivalent to the viral antigens. The mRNA sequences in the vaccine enter the cell (with a carrier protein), heads to the ribosomes to create the SARS-CoV-2 antigens. These antigens will depart the cell and will trigger the body’s adaptive immune system to produce antibodies effective against the actual target, in this case, the S-protein or spike on the SARS-CoV-2 virus.
One more thing – the antigens produced by these mRNA sequences are biologically inert. They will induce an immune response, but they will not cause any other biological effect including becoming pathogenic.
So, let’s summarize. The mRNA vaccines make use of the cell’s ribosome to create the S-protein of the SARS-CoV-2 virus. That antigen induces an adaptive immune system response that will “remember” that antigen allowing the immune system to quickly attack the virus if it shows up.
Someone used this analogy to describe how mRNA works. Let’s say you have a book that represents the genetic code (lots of people describe our genetic code as the official manual of our person). You then scan that book in a copy machine, and now you have a bunch of papers that are an image of the original book. The copy does not change the original book. It can’t.
Will the mRNA vaccine change my DNA like gene therapy?
Based on how the mRNA fragment is handled by every cell, the answer is a near-absolute no. (Real scientists don’t write in absolutes, so I’ll say “near” absolute no, but the chances are so tiny that it would be better to bet on winning the lottery.)
Again, the mRNA molecule merely reads the DNA information and carries it to the ribosome. It does not change the DNA message in any way, it’s not how the whole process of translation works.
Furthermore, the mRNA from the mRNA vaccines do not interact with your DNA in any way. They cause the ribosome to produce the S-protein antigen, and that’s it. Once molecules of S-protein are produced within the ribosome from that strand of mRNA from the vaccine, that vaccine mRNA strand is broken down into individual nucleotides to be reused by the cell.
And in case you were wondering, RNA nucleotides are the same whether they’re manufactured “naturally” by your cells or in a vaccine. They are molecularly exactly alike, so they will be reused to make some new mRNA molecules for any of the millions of proteins in your body.
If mRNA could functionally change the DNA, it would open up a whole world of genetic medicine. We could fix all kinds of genetic diseases with this mechanism.
But that’s not how mRNA works, so we can’t.
There are other reasons why these mRNA vaccines are not going to affect your DNA:
- Your cells’ genome (DNA) is contained within the nucleus of the cell, which is surrounded by a double-membrane. It allows for large molecules, such as mRNA which has read the DNA, to leave the nucleus, but blocks large molecules from entering it. So the S-protein mRNA from the vaccine will not enter the nucleus until it is broken down into individual nucleotides, at which point, they are exactly the same as all of the other nucleotides.
- Even if the mRNA molecule could affect the DNA and even if it could get into the nucleus, there are all kinds of error correction machinery in our DNA to keep out random bits of code. With trillions of cells in each human, each containing billions of DNA base pairs, there are naturally a lot of errors that could kill a human if the quality control machinery of the DNA didn’t keep close watch over errors.
- Similarly, this mRNA cannot get into the mitochondria (which have their own DNA) and cause damage to its DNA. Even though the mitochondrion lacks a cell nucleus, it does have its own ribosomes and genes, and they would react to the S-protein mRNA in the same ways as the cell – it would not change its DNA.
Science overwhelmingly supports the fact that the Pfizer and Moderna COVID-19 mRNA vaccines are vaccines. They are not gene therapy because they have zero effect on genes.
Pfizer and Moderna COVID-19 vaccines are not medical devices
Dr. David Gorski explains how this myth arose from the depths of the anti-vaccine lunacy – it also makes no sense. Part of it is that the anti-vaxxers claim that classifying these vaccines as “vaccines” means that it’s easier to get approved. AND, they think that these vaccines are really “medical devices” which they claim are more difficult to get FDA approval.
Excuse me, but what?
Like with vaccines, there are official definitions of what is a “medical device.” The FDA says:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
A vaccine does achieve its primary intended purpose through a “chemical action” within or on the body of man or other animals. Just on that point, a vaccine is not a medical device.
And as for the point that vaccines are easier to approve than medical devices – that’s simply not true. Medical devices are regulated under different laws than drugs and biologicals (under which vaccines are grouped). Originally, medical devices were separated from other medical products to encourage innovation. Of course, the large medical device companies took advantage of these differences to make FDA regulation much less onerous. Any claim that medical devices have stronger regulations than drugs or vaccines is not based on anything factual.
Without jumping into the weeds too deeply, medical devices do not go through the whole investigational new drug (IND) process that I discussed previously concerning vaccines – under normal circumstances, it takes 5-10 years to get from discovery to FDA approval. And each step, from the preclinical studies to phase 3 trials has FDA review and they could tell the sponsoring company to stop because of safety or effectiveness issues. The review process for drugs and biologics is so careful that nearly 90% of drugs that start phase 1 clinical trials ever get FDA approval.
What makes getting FDA approval for a device so easy is that any new product just has to show it is equivalent to a previous device to get the approval. It does not require large clinical trials, usually, it’s just less than 100 patients. Moreover, because it’s a device, these are not double-blinded, randomized clinical trials usually.
There are generally two different ways to get medical device approval:
- Premarket Approval (PMA) – Most Class III (high risk) devices require Premarket Approval (PMA) before they may be legally marketed. This database includes devices with Premarket Approval and includes the approval order, Summary of Safety and Effectiveness, and labeling for the approved device (original PMAs and panel-track supplements).
- Premarket Notification 510(k) – Most Class II (moderate risk) devices require 510(k) clearance from the FDA before they may be legally marketed. This database includes releasable 510(k) information.
The PMA is a bit more difficult to get FDA clearance than a 510(k), but it doesn’t take a decade or more as we see with drugs and vaccines. Some 510(k) applications get approval within a month, and PMA applications take around a year.
All the medical device company has to do is show that their new product is functionally equivalent to a prior product, submit labeling, packaging, and a few other things, and voila, your application is done.
For example, an artificial cardiac pacemaker is a PMA medical device. The first pacemaker was developed in the mid-1950s, and every single modern pacemaker, which has batteries, computers, and other technology that makes the 1950s version look like it’s from the 1950s, has its PMA based on that original version.
If I were a vaccine company, I’d love to be considered a medical device.
It’s a vaccine
The anti-vaxxers can try all day long to tell us that the Pfizer and Moderna COVID-19 mRNA vaccines are not vaccines. But by every definition of vaccine, from the CDC to the FDA, they are vaccines. And by every definition of what is not a vaccine, the two vaccines are still vaccines.
And it’s also clear that neither the Moderna nor Pfizer vaccines are gene therapies or medical devices. They’re still vaccines.
I guess the silver lining is that if anti-vaxxers think that the COVID-19 vaccines are medical devices, they should be good to go because they only hate vaccines.
