Learning to Read the Labels...and In Between the Lines: What's In the New mRNA Vaccines?
I got my first and only flu shot in college. Not long after, my life changed forever. Within two weeks, I was diagnosed with pleurisy and walking pneumonia. I had a trip coming up to Hawaii over spring break for an anthropology course. There was no way I was going to miss it. Desperate, my doctor put me on a strong antibiotic in an attempt to heal my body quickly for travel. That's when I went into anaphylaxis. Since then, I have been plagued with autoimmune issues and gas lit by almost every doctor who examined me by their unwillingness to explore the nexus between that flu vaccine and the onset of my health issues. The dogma of "vaccines are safe and effective" is not one many are willing to abandon. After going through my own adverse reactions, I gave the benefit of the doubt to parents who insisted their children began to suffer from symptoms of autism spectrum disorder after having been vaccinated. While mainstream science states that the connection between autism and vaccines has been "debunked," I've never been so sure and believe that causal connections are poorly understood, require a complex recipe of factors, and are never as simply dismissible as they are made out to be. I would have been better off getting the flu. It was a harsh lesson in the treatment being worse than the disease. I didn't research what they put into that vile they shot into my arm. I have wished since then that I would have. Growing up in the 80s and 90s, we were always warned of the dangers of "street drugs" and not knowing what was in them. Yet, we trust scientists with a legitimized profit motive. I don't see much difference, except that at least a street hustler is honest about their motives.
About eight years later, I went to Walgreens for something. I can't remember what...probably over the counter allergy medicine. One of the clerks at check-out asked me if I was interested in their free flu shot clinic. I asked to see the package insert for the vaccine, and was sent over to the pharmacy, where one of the pharmacy techs attempted to give me a Fact Sheet. I pointed out that the Fact Sheet was not the Package Insert. I wanted to see the insert. Their response? They got the lead pharmacist who came out and explained to me that the PI was supposed to stay with the batch of vials until the last shot was administered. I had no idea if that was true, but this to me was not a satisfactory response; if I was going to have something injected into me, I demanded full informed consent via the PI. The pharmacist tried to explain to me the "learned intermediary doctrine" (which, as a lawyer, I was already familiar with). Basically, the PI was for my physician, not the patient, who would then explain it to me. I pointed out that this was ridiculous under the circumstances of a walk-in free flu clinic. Wouldn't I need the PI to take to my doctor for discussion? I wanted to compare the Fact Sheet to the PI. I demanded to see the PI. Relenting in a very put-out manner, the pharmacist retrieved the PI for my inspection but told me when I was done, he needed it back. It was entirely in fine print and two feet longer than the Fact Sheet. I sat there and read the thing. The flu shot they proposed to give me was not recommended for people with autoimmune issues, inflammatory problems, or egg allergies; none of that information was on the Fact Sheet. Yet again, where is the true, voluntary informed consent when the full disclosure of critical information is lacking on the Fact Sheet? My argument is that there is none. Make it make sense.
What are in these new mRNA vaccines? How do they differ from traditional vaccines? Ever the skeptic, I decided to start digging to help my family and friends get the critical information they needed to make a truly voluntary and informed decision. The articles I found on the vaccine ingredients were sorely lacking. They would list the ingredients, say they were lipids, say cursorily what the job of the lipids (or some other ingredient) was, and then move on. "Nothing too surprising there,” said Dr. Matthew Heinz, a hospitalist based in Tucson, Arizona. “It’s a normal way of packaging up medications for people.” Really? If it's so normal, how is it novel? Or, "the mRNA is the only active ingredient." Phew. That makes me feel so much better. Inquiry solved. In other words, nothing to see here, folks.
That's not good enough for me or my family and I'm not sorry about that. I wanted to know what these ingredients were, how they worked, how they were manufactured, by who, and I was determined to learn as much as possible. I started with the Pfizer PI, which is a deceptively short ingredient list. In fact, most of these drive-by articles touted this as a good thing: no aluminum or thermiserol adjuvants! (Wait...if that's a good thing, then is this a tacit admission that those things are not healthy, good things to be injecting into our bodies?) No complex list of ingredients! The implication was that these are sleek, elegant, and simple in their design. After hours of research spread over numerous weeks, my opinion is that nothing could be further from the truth. Here's what I have discovered to date:
First, there are a number of lipids in these new vaccines. The lipids are all synthetic, and their job is to deliver the mRNA code into the cells.
The first, and arguably most important lipid, is (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), also referred to as ALC-0315. It's a cationic synthetic lipid nanoparticle that includes hexane. Yeah, I know. I had no clue what that meant, either. Basically, it's the delivery vehicle for the mRNA code; it is positively charged, while the mRNA is negatively charged, and through an electro-static process, the synthetic lipid delivers the mRNA through the cell wall and into the cell where the mRNA can do its thing. Without it, the mRNA could not penetrate the cell wall to deliver its message. This process is called transfection, a "technique used to insert foreign nucleic acid (DNA or RNA) into a cell, typically with the intention of altering cellular properties." Most often, this process has been utilized in gene therapy. The Washington Post has previously blamed the lack of vaccine availability on this ingredient, which used to be a small niche market. With ten steps that takes weeks to produce, this is no simple ingredient. The exploding demand of mRNA vaccines means these lipids are also in high demand. The companies that used to corner the market and hold the patents are now outsourcing via "proprietary licensing" contracts to various different manufacturers to meet the demand for these lipids, however, the financial arrangements are shrouded in secrecy and many of the companies refused to comment for the article. A few manufacturers were mentioned; mostly Canadian, American, and European companies. Notably absent were the Chinese companies, namely Sinopeg. Could the secrecy be due to outsourcing of crucial ingredients to labs in China? Time will tell, but if I am to inject these things into my body, I'd like to know who is manufacturing them and where they come from. The substance was patented in 2018 for application in mRNA vaccines, with other vaccine applications already listed for such things as malaria and cancer. If the list is any indication, other vaccines with synthetic lipid delivery systems are in the works and it behooves us to gain familiarity with these synthetic delivery systems.
The next lipid is (2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, also known as ALC-0159, or PEG2000. This is the compound believed to trigger the severe allergic adverse reactions some have had to the vaccine. It has never been used in a vaccine before, though it has been used in cosmetic applications (but banned for certified organic cosmetics in Europe), and so it is believed that its allergenic effect is understated. While PEGs are generally considered safe, their manufacturing process is not, as it generates dangerous pollutants. If humans are to care about the environment as much as they claim, we must be wary of manufacturing processes that bring us our most cherished products. The manufacturing process, because of the industrial waste generated, also creates concern surrounding contamination of the end-product with pollutants, some of which are known carcinogens. Many such industrial manufacturers are in China, which has a pollution problem due to more lenient restrictions. This is why it is important to understand where the component ingredients come from, and why it's important to consider a broader picture: as we demand mass vaccination with synthetic delivery systems, but also strive towards a "carbon neutral" future, how can these two demands be reconciled? PEG is also used as a hydrogel. The purpose of the hydrogel is to simulate human tissue to stabilize the delivery lipids. Interestingly, hydrogels were set to be approved for use in early detection of disease when used in conjunction with nanosensors. This is a project being developed by a company called Profusa in conjunction with DARPA. Even more interesting are that the use of hydrogels in self-healing applications specifically in conjunction with vaccines to allow for prolonged and sustained immune response. Further, the hydrogels have the capability to keep biological sensors from escaping into the environment. These are the potential applications of this ingredient. What does this ingredient actually do in the mRNA vaccine? I guess we will have to wait and see.
The third lipid is 1,2-Distearoyl-sn-glycero-3- phosphocholine, also referred to as DSPC, which is a phospholipid. This is the "head" that transmits the lipid delivery systems into the cell wall and delivers the mRNA material into the cell (as previously demonstrated in other studies).
The final lipid is cholesterol, a fat that rounds out the lipid coating surrounding the mRNA active ingredient. The virus itself is enveloped, meaning it has a fatty coating that protects it. The cholesterol is the final lipid ingredient to round out the synthetic fatty coating that mimics the coating of the virus and protects the mRNA code as it travels to the cells.
Next, are the salts: potassium chloride, monobasic potassium phosphate, sodium chloride, and dibasic sodium phosphate dihydrate. The stated purpose of these salts is to balance the acidity of the body during the introduction of the vaccine. Potassium chloride is only toxic in large quantities, and in smaller doses, is used for proper heart and kidney function. The potassium phosphate has much the same purpose as potassium chloride. Sodium chloride is just the chemical name for salt. Dibasic sodium phosphate can be hazardous if exposed to too large of a dose, with the dose administered in the vaccine being very low. It is generally administered prior to a colonoscopy to assist the body in cleaning out the colon prior to imaging. Extra hydration is strongly recommended, and the list of adverse effects, potential drug interactions, and the potential for kidney problems are given as cautions.
The sucralose, or sugar, is added to the vaccine to stabilize the molecules when the vaccine is frozen for shipping, transport, and storage.
Now that we have explored what these ingredients are in greater depth, let's figure out what the mRNA component consists of and where it came from. First, a virus has "spike proteins" that the virus uses to enter cells. Spike proteins are the component that hijack the cells in order to replicate the virus. Okay, easy enough to conceptualize. My next question was how they isolated this viral spike protein to determine if it is an RNA virus or a DNA virus? That answer is far more convoluted.
We begin with an analysis of the "gold standard" for identifying a pathogen and causally linking it to a disease, otherwise known as Koch's Postulate. In summary, Koch's Postulate requires four things: "1. A microbe suspected as the causal agent of a particular disease must be found in all subjects suffering from a similar disease but must be absent in clinical specimens from healthy individuals. 2. The suspected microorganism can be isolated from the diseased individual and grown in pure culture. 3. When this isolated suspect microbe is injected into healthy, susceptible animals (some human volunteers were also reportedly used by Robert Koch), signs and symptoms of a disease similar to the disease under investigation must develop in the infected animal. 4. The microbe cultured from the infected animal must be morphologically and physiologically identical to the strain initially isolated from the patient (in point 1)." This method is also used in virology, but with modification, otherwise known as River's Postulates. The modifications are as follows: "The viral agent must be found either in the host’s (animal or plant) body fluids at the time of disease or in cells showing lesions specific to that disease; [t]he host material with the viral agent used to inoculate the healthy host (test organism) must be free of any other microorganism; [t]he viral agent obtained from the infected host must – (1) Produce the specific disease in a suitable healthy host, [a]nd/or (2) Provide evidence of infection by inducing the formation of antibodies specific to that agent; and [s]imilar material (viral particle) from the newly infected host (test organism) must be isolated and capable of transmitting the specific disease to other healthy hosts." So...have these rigors been followed with regard to SARS-COV-2, and if so, when, by whom, and to what result?
A study published in the New England Journal of Medicine titled: A Novel Coronavirus from Patients with Pneumonia in China, 2019 (January 24, 2020), describes how the scientists arrived at the idea of COVID-19. Lung fluid samples were taken from a deceased patient suspected of having the virus. They then extracted RNA using the PCR test. The study admits that the coronavirus failed Koch’s postulates: “Further development of accurate and rapid methods to identify unknown respiratory pathogens is still needed … our study does not fulfill Koch’s postulates.” Likewise, in a July 2020 report (later updated in December 2020) the CDC's "2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel" admits that "[s]ince no quantified virus isolates of the 2019-nCoV were available for CDC use at the time the test was developed and this study conducted, assays designed for detection of the 2019-nCoV RNA were tested with characterized stocks of in vitro transcribed full length RNA (N gene; GenBank accession: MN908947.2) of known titer (RNA copies/μL) spiked into a diluent consisting of a suspension of human A549 cells and viral transport medium (VTM) to mimic clinical specimen.” (pg.43, emphasis added). Last June, the CDC admitted that the virus was manufactured: "Whole-Genome Sequencing. We designed 37 pairs of nested PCRs spanning the genome on the basis of the coronavirus reference sequence (GenBank accession no. NC045512). We extracted nucleic acid from isolates and amplified by using the 37 individual nested PCRs.” Why are they using a reference sequence? Digging deeper, this is a process called "de novo genome assembly." An original paper published by Corman-Drosten in early 2020 stated that, "[i]n the present case of 2019-nCoV, virus isolates or samples from infected patients have so far not become available to the international public health community.” Interestingly, this paper was subject to all manner of review and requests for retraction. One of the most damning review assertions is that, "The first and major issue is that the novel Coronavirus SARS-CoV-2 (in the publication named 2019-nCoV and in February 2020 named SARS-CoV-2 by an international consortium of virus experts) is based on in silico (theoretical) sequences, supplied by a laboratory in China , because at the time neither control material of infectious (“live”) or inactivated SARS-CoV-2 nor isolated genomic RNA of the virus was available to the authors. To date no validation has been performed by the authorship based on isolated SARS-CoV-2 viruses or full-length RNA thereof." Numerous doctors have signed on to this criticism as of November 2020 - after the applications for emergency use were filed with the FDA for the vaccines, and just weeks prior to the vaccine roll out. "Because companies that work with messenger RNA don’t need the virus itself to create a vaccine, just a computer that tells scientists what chemicals to put together and in what order, researchers at Moderna, BioNTech, and other companies got to work." Wired magazine makes this sound like a good thing, but the foregoing doctors aren't so sure. Additional flaws in this PCR research were further outlined here. It thus appears that the mRNA used to formulate the vaccines has been manufactured from a computer simulation, not a true isolate adhering to Koch's or River's Postulates. Synthetic mRNA. If this is wrong, and you are reading this and have proof of an actual isolate, please post a link in the comments below or send me an email through this website. Now that it appears likely that the vaccine is premised upon a theoretical computer-generated genome, let's continue. Once the vaccine's delivery system bumps up against a cell, the mRNA code is transmitted into the cell and instructs the cell to replicate the spike proteins, which are recognized by the immune system in order to create antibodies that will recognize later contact with the virus. While I could find no evidence that the Pfizer (or Moderna) vaccines utilized stem cells in their vaccines, Pfizer and Moderna did use fetal stem cells in clinical trials for the purpose of testing whether the vaccine worked (by contrast, Johnson & Johnson and AstraZeneca do use the fetal stem cells in their actual vaccines). The fetal stem cells used are replicated from one or a few specimens taken in the 1960-70s, rather than a continuously fresh batch of cells from recent abortions. For Christian/Catholic and/or pro-life readers, diverse philosophical analysis can be found here, here, and here. What does all this mean? Well, it appears that the Pfizer vaccine (and likely - as well, though Moderna was not analyzed with the rigor Pfizer's was in this article) are almost entirely genetically and synthetically engineered. It is premised on a virus that many medical and scientific professionals dispute exists, thus calling into question whether a vaccine is necessary or prudent. If the virus was never properly isolated, then do we really have confirmation that it is an RNA rather than a DNA virus? How do we know for sure it is not a special type of enzymatic virus like HIV that can transcribe from RNA to DNA to alter DNA to perpetuate itself in our bodies...or that the science would make this possible? You might ask why someone would even do such a thing. I am wondering why we would do any of this in the first place; just because we have the capabilities does not necessarily mean we should, especially with such haste. Some doctors are skeptical that the vaccines serve a primary immunological purpose and have questioned what the long-term implications of such therapies could be for humanity. I have been able to research and provide some substantiation for their concerns (above) but many more questions can only be answered, if at all, with time. While some might consider this to be alarmist or seek to censor the questioning as misinformation or disinformation inappropriately dissuading people from taking the vaccines, yet again, I believe full discourse is necessary. Hopefully the reader can discern from the wide range of sources cited in this piece that all avenues have been explored from multiple political and philosophical angles. Lastly, for those who do opt that the vaccine is right for them, know that a database already exists. A registry managed by the CDC keeps track of all inoculations in the US. We need to consider how this information will be used, by whom, and for what as we move forward with the debate over vaccine passports. For more analysis on that, please see my prior post. May your thinking be broad and unrestrained and may your heart as well as your mind guide you through these heavy decisions for yourself, your family, and your friends.