THE DUPLICITOUS DESIGN OF DOSE, DISTRIBUTION, AND DURATION

How much did I receive, where did it go, how long will it last, and what are the risks?

I was recently thinking about the pharmacokinetics of the mRNA drugs from Pfizer and Moderna (the Covid “vaccines”) and realized and then discovered in the course of doing on-line research there is relatively little written about the subject. Pharmacokinetics is a term that describes what is known about how a drug is handled by the body - its absorption, how it distributes within the body, its mechanism of action, how it is metabolized and excreted, and upon which organs it may have beneficial or adverse effects. The available information regarding the mRNA drugs mostly comes from the drug companies or the CDC and has been shown to be deceptive and manipulative.

VACCINE VS PHARMACEUTICAL DRUG

The reason for this apparent lack of interest in the pharmacokinetic specificities of the mRNA drugs lies in the terminology of what they are called and the FDA process leading to the Emergency Use Authorization for these drugs. The terminology used by the CDC, Big Pharma, and the FDA was determinant in how the drugs were “approved” and how they are viewed by the public. That determinant term is “vaccine”. Let me explain.

From an Italian article in The International Journal of Molecular Science

“Defining the nature of COVID-19 mRNA vaccines is not just a matter of confrontation of scientific opinions. Regulatory agencies have defined these products a priori as conventional vaccines, and as a consequence, they referred to the applicable product guidelines when it came to evaluating applications for COVID-19 vaccines for subsequent marketing authorization. Guidelines on evaluation of vaccines obviously focus on their ability to stimulate the immune system, since they are intended to deal with just antigens and antigen preparations with no other expected activities, while guidelines on evaluation of pharmaceutical drugs require a global assessment of pharmacodynamics, pharmacokinetics and clinical pharmacology.” (emphasis mine)

There was, and is, a psychology involved in calling these pharmaceutical drugs “vaccines”. In the minds of the masses that make up the world population, calling these drugs “vaccines” attaches an undeserved innocence to their novel and experimental origin, and has inspired a naive confidence in their acceptance, safety, and effectiveness based upon historical experience with conventional vaccines such as smallpox, polio, MMR, and DPT.

So there is the psychology manipulation and then there is the manner of taking advantage of the regulatory requirements of vaccines as opposed to pharmaceutical drugs. Initiating the “approval” process of the mRNA drugs under the guise they are like conventional vaccines, allowed Pfizer and Moderna to avoid the more rigorous standards imposed upon the approval of pharmaceutical drugs. Consequently, preclinical assessment of these products did not include any secondary pharmacodynamic studies, safety pharmacology studies, pharmacodynamic drug interaction studies, traditional pharmacokinetic or biodistribution studies and/or genotoxicity studies.

Under the standards for approval of vaccines, clinical assessment primarily deals with immunogenicity (ability to produce an immune response) and the resultant protective efficacy of the vaccine. Thus, as soon as Pfizer could proclaim “95% effective” in preventing symptomatic Covid 19, they were on the way to the Emergency Use Authorization. Of course, the 95% number was a public relations and political propaganda stunt as it is a relative risk reduction that represents a statistical sleight of hand. The actual risk reduction was only 0.9% less risk of symptomatic Covid compared to placebo.

Pre and post vaccination laboratory testing is not required during the clinical phases of the regulatory process regarding vaccines but is required for pharmaceutical drug approval. The lack of testing for proinflammatory cytokines, cardiac enzymes, platelet activation, and other risk markers represents a missed opportunity in the evaluation of risk. As an example, and as we all know now, myocarditis is a significant risk of these injections, particularly in young males. Elevation of post “vaccination” troponin levels (a protein released from an injured heart muscle) and inflammation markers would have been notable safety signals using simple blood tests that might have saved hundreds, if not thousands of lives.

The post approval safety monitoring and threshold for investigations are also different for vaccines compared to pharmaceutical drugs. Vaccines enjoy an innocent until proven guilty approach with a high plausibility threshold where reported adverse events are assumed to have causes other than the vaccine. Post marketing vigilance for adverse events from pharmaceutical drugs are quite different and take a guilty until innocent approach requiring more aggressive investigation.

To summarize safety monitoring, establishing post-marketing safety assessment of COVID-19 mRNA vaccines only upon spontaneous (i.e. passive) adverse event reporting systems is likely biased by an unprecedented level of underreporting. In addition, using the WHO AEFI (World Health Organization Adverse Event Following Immunization) guidelines as a basis for causality assessment is limited by the requirement of narrow time windows after vaccinations, and the biased attitude of identifying previous disease and/or comorbidities as alternative explanations rather than merely contributing causes. We have seen this play out in real time by Fauci and the public health bureaucracy discounting and discrediting the underreported events in the CDC’s VAERS (Vaccine Adverse Events Reports) data.

As patients, we take a lot for granted when we receive a prescription for a pharmaceutical drug from our physician or other health care provider. We assume the drug was rigorously tested by the FDA and found to be safe when used as directed, was manufactured in a pharmaceutical facility using sterile techniques free from contaminates, and the entire process overseen by qualified medical professionals. Furthermore, it is assumed the dose of the medication is precise and appropriate for the condition being treated. Physicians and other prescribing health care providers make these same assumptions and become knowledgeable and comfortable with the drugs they commonly prescribe.

Drugs that go through the process to achieve FDA approval (not Emergency Use Authorization, but actual approval) are considered to be rigorously tested for safety and efficacy that begins with testing on animals and then on to phase 1, phase 2, and then phase 3 trials, each comprised of increasing numbers of humans in each phase of the investigational trial. Interim reports are to be provided at the end of each phase to assess initial safety and efficacy.

Volunteer test subjects are recruited and randomized between treatment with the study drug or to a “control” group that usually involves taking a placebo. The study should be “blinded”, meaning none of the test subjects nor the researchers know whether a test subject is taking the active drug being tested or the placebo. The blinding process reduces the chance of introducing bias into the study. There is an unblinded researcher or research group that is monitoring the study for safety signals.

Biodistribution studies are done to determine how and where the drug distributes through the body. Reproductive toxicology studies are conducted to assess safety in pregnancy and in reproductive age females. Oncogenesis studies are completed to look for the potential of cell mutations that might lead to cancer. Dose ranging studies are done which establishes the optimal dose of a drug in order to achieve the desired clinical outcome with the least risk.

As I mentioned above regarding post approval safety monitoring, the use of CDC and FDA systems have historically been effective in removing from market approved drugs that were found to be injurious. There is also a Data Safety Monitoring Board (DSMB) independent from the CDC, FDA and pharmaceutical companies that look for safety signals that might indicate adverse reactions to emerging medications and vaccines. However, there is an increasing chorus coming from epidemiologists, virologists, and others that these systems have not been effective in responding to the massive and mounting injuries and deaths recorded around the world regarding the mRNA drugs.

In addition to the different regulatory requirements for vaccines as opposed to pharmaceutical drugs, there have been concerns of incompetence and corruption regarding the Pfizer and Moderna study trials. There were no animal studies, phase 1 was collapsed into phase 2 which was merged into phase 3 and the entire study duration was but 4-5 months. There were no reproduction toxicology studies, children and persons of advanced age were excluded from the study trial as were people with prior Covid infection. To top it all off, the control group was eliminated at the end of the study in December, 2020, by offering them the “vaccine”. In addition, the DSMB has been missing in action and apparently is not independent from Pfizer (be sure and watch the video attached to this link as it exposes the quality and integrity of the intellect behind these drugs).

As I explained above, vaccines undergo a different FDA process from other drugs because they are biologic agents (a virus or bacterium) that do not treat an existing disease but rather invoke a person’s immune system to create immunity to the virus or bacterium of concern.

When a person receives a vaccine for a virus (usually as an injection), that person is receiving a known quantity of biologic protein (antigens) that represents the entirety of the proteins of the virus that has been killed or rendered non-infectious. The person’s immune system reacts to all those proteins and immunity is established to that virus if later encountered by the person. The dose or quantity of each vaccine has been well established in order to achieve the expected immune response and clinical outcome while minimizing adverse reactions and complications. Enzymatic and immune destruction of the foreign protein occurs as the immune system is reacting and establishing immunity.

So now let’s turn our attention to the mRNA “vaccines”. The first thing to realize is it was necessary for the CDC to change the definition of a vaccine when it became apparent these drugs were not establishing “immunity”.

Historical definition of vaccine: “A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.” New definition of vaccine: “A preparation that is used to stimulate the body’s immune response against diseases.” So, “vaccines” may no longer result in “immunity”, but they do “stimulate” the immune system.

“Vaccination” definition also was changed from the act of producing “immunity” to an act of producing “protection”. This was obviously a recognition that the mRNA drugs do not result in immunity because any “protection” that is created is short lived (a few weeks perhaps) and that “protection” must be re-created with an endless series of “boosters” of declining effectiveness and increasing risk.

MECHANISM OF ACTION

When considering the mechanism of action of the Pfizer and Moderna Covid SARS-2 products, the rational conclusion is that these are genetic drugs rather than vaccines. In fact, the millions (?billions) of mRNA containing lipid nanoparticles (LNPs) that are in each shot do not cause the immune reaction. In that sense, the substance that is injected into the deltoid muscle of the shoulder is a prodrug, which is a drug or substance that must be transformed into something else in order to become pharmacologically active. I suspect you have not heard of the Covid “vaccines” referred to as a “prodrug”. But, more on that later.

An even cursory review of the medical literature of the past 25 years will lead one to believe the mRNA drugs should not have been “approved” under the process reserved for vaccines. As you will see, the pharmacokinetics of the mRNA drugs are more in alignment with pharmaceutical and genetic drugs.

OK, so I did the unthinkable and compared the stuff in the Pfizer and Moderna jabs with genetic drugs. Why is that unthinkable, you ask? Internet search the following: “Are Covid shots genetic drugs?” Results will show there is a plethora of “fact check” articles that were rushed out in late 2020 and throughout 2021 that loudly proclaim these are in no way genetic drugs. Reminds me of the Shakespearean line from Hamlet “The lady doth protest too much, methinks”. In this case, the “lady” is the fact check organizations and all the usual suspects that have actively promoted anything and everything the CDC, Fauci, and Big Pharma have proclaimed.

But seriously, these mRNA drugs are the offshoot or culmination of 25 years of research into the development of what the researchers have called “genetic drugs”. Of course, one must look in the literature prior to November, 2020 to find the remnants of objectivity and truth that inhabited medical publications prior to the propaganda and censorship of the past 3 years. Much of the genetic drug research has been directed towards treatment of cancer. Interest in using it for infectious disease began with research into HIV a few years back but nothing was brought to successful completion until 2020 when Trump offered up several billion dollars to the drug companies which initiated the empirical “gunslinging” (Operation Warp Speed) that resulted in the Covid jabs a few months later.

So are the Covid jabs “genetic drugs”? They certainly had their origins in the genetic drug research of the past 25 years. They are based upon delivering a computer generated nucleotide sequence called mRNA to the cytoplasm of a person’s cells where that faux or synthetic mRNA genetic sequence enlists the cell to produce a specific protein that mimics the spike protein of the SARS Covid 2 virus. In a 2018 Nature review article is the following sentence by the authors: “Nucleic acid therapeutics have emerged as promising alternatives to conventional vaccine approaches.” DNA and RNA are nucleic acids - it does get any more genetic than that.

But the fact checkers and CDC groupies say these drugs are not genetic because the synthetic mRNA does not enter the cell nucleus and interact with the cell’s DNA and is incapable of doing so. But that narrow definition does not alter the fact that the delivered faux mRNA is a genetic structure that enters the cells of the body where it flips the switch to turn on the cellular machinery to produce a protein, just as the DNA in the nucleus does when it produces an mRNA sequence that results in a protein produced by the same cellular structures. To say these are not genetic drugs sounds like a propaganda distinction without a logical or substantive difference.

One last point in all this genetic discussion that takes controversy to a white hot level. All of us have an enzyme in our cells called reverse transcriptase (RT). This is an enzyme that changes RNA into DNA. As an example, the virus that causes HIV is a retrovirus and is capable, by means of its mRNA and RT, of inserting its nucleotide sequence into the host’s DNA. When it became evident in 2020 that the developing “vaccine” for the SARS Cov2 virus was an mRNA drug, legitimate scientific concern emerged that the administered mRNA could be reverse transcribed back into our DNA. This concern was initially expressed in various articles but was rapidly suppressed by the CDC and various academics.

A 2022 study and review paper by Feliciello is titled “mRNA Vaccines - Why Is The Biology of Retroposition Ignored?” “Retroposition” is a term referring to the reverse transcription process leading to DNA insertion. This quote by the author summarizes his concern:

“The statement that vaccine mRNAs do not pose a risk for genome integration, and consequently, that there is no insertional mutagenesis risk, is another commonly listed advantage of mRNA-based vaccines, especially when contrasted with the safety profile of DNA-based therapeutics. This claim prompted me to look more carefully into the mRNA vaccine literature to find a rationale for it. Surprisingly, I was not able to track down any experimental or theoretical study that specifically addresses the possibility of genome integration of mRNA therapeutics.”

I reviewed numerous articles regarding whether or not viral, or perhaps “vaccine” mRNA can be reverse transcribed into the genomic DNA residing in the nucleus of our cells. If further interested, there is a sampling of these articles here, here, here, here. This literature is fascinating but very technical and a tough read. My takeaway from all this is that there has been in vitro (lab and cell culture) evidence that Covid viral mRNA can be reverse transcribed (inserted) into DNA in the nucleus, but no in vivo or clinical human evidence.

Keep in mind, and I will shortly explain, there is a genetic difference between legacy Covid viral mRNA and the synthetic mRNA that was created in a lab. But like Dr. Feliciello noted in the above reference quote, this issue regarding “vaccine” mRNA does not appear to have been studied with the scientific rigor it deserved prior to the inoculation of people around the globe with these drugs. The lack of investigation for evidence reminds me of the axiom, the absence of evidence is not evidence of absence.

BIODISTRIBUTION

The next thing to consider is the biodistribution of these drugs. They do not stay in the deltoid as we were told, but rather, distribute throughout the entire body. The lipid nanoparticles (LNPs) containing the mRNA genetic instructional code are taken up by the lymph system and drain to the axillary lymph nodes and then on to the spleen, liver, ovaries and testes, and elsewhere. This happens within a few days and the LNPs seem to have a predilection for the ovaries and are known to concentrate there. We weren’t told this back in December, 2020.

As the LNPs spread throughout the body, they are taken up by the various cells that make up our tissues and organs whereupon the synthetic mRNA that was within the LNPs attaches to ribosomes in our cells and that is when the real action begins. Ribosomes are structures within the cytoplasm of our cells and their function is to produce proteins when instructed to do so. The synthetic mRNA delivers to the ribosomes the genetic code to produce a protein that is approximately the same as the spike protein that makes up the spike of the original Wuhan Covid SARS 2 virus. That counterfeit spike protein is then expelled from the cell and resides on the surface of the cell or becomes free-flowing within blood vessels, or taken up by particles called exosomes that carry the spike all over the body. Our immune system recognizes this pseudo viral protein as foreign and reacts by forming antibodies to this protein that was manufactured by our own cells. You do not need to be a geneticist or virologist to understand this is an orchestrated genetic process and not merely an immune response to an administered foreign protein.

So now, you should also understand why the stuff that was jabbed into your deltoid muscle is a prodrug. It is nothing like any vaccine you have ever received. The immune inciting agent is the downstream counterfeit spike protein that is manufactured by the genetic apparatus in your own God-given cells that are following instructions from a synthetic mRNA interloper delivered to the cells in a manufactured lipid envelope.

DOSAGE

OK, so now the concepts of prodrug and bio distribution of these mRNA drugs has been explained. Let us now talk about the dosage you received in your “jab”. Pfizer says adults received 30 mcg in each shot and Moderna says it provides 100 mcg in each adult shot. What does that mean when the billions of LNPs containing all that mRNA are destined to be converted into trillions of spike proteins? That’s right! Trillions of counterfeit foreign spike protein throughout your body.

And it has been well established the spike protein is the lethal component of a Covid infection. It is the spike, and the immune reaction to it, that results in the inflammation, hyper inflammation, thrombosis (clot development), myocarditis, heart attacks, strokes, and autoimmune disorders. Much more spike protein (albeit pseudo or counterfeit) results from the jab than is the result of a Covid infection. Perhaps that explains why people with a history of Covid infection who subsequently (and needlessly) take the mRNA “vaccines” have a 3-4 times higher occurrence of vaccine injury.

It has been observed there have been clinical response differences to the drugs that seem to be dependent upon the lot numbers of the mRNA drug shipments. Lot numbers refer to the manufacturing identity of a shipment of the drugs and presumably identify the date and location of the drug production. Clinical response differences refer to observed regional differences in mRNA “vaccine” side effects or subsequent Covid infection rates or regional differences in all cause mortality, taking into account the Covid “vaccination” rates. The link above related to lot numbers and the chart below, is very interesting and informative.

It has been observed the death rates from the VAERS data when correlated with the lot numbers in those who died, reveals the presence of “hot” outlier lots with death rates 1000% higher (or more) than the baseline reported death rates in other lots. The higher mortality in those “hot” lots persisted into different states where those lot numbers were administered and implicates the contents in those lot vials rather than other confounding variables. Could this be an issue with the dose in those lot vials?

So aren’t all these drugs the same, you ask? Probably not, is the short answer. They are manufactured in different facilities all over the world. Contaminates have been noted in some of the lots. Go to the CDC website and look at the summary of how the drugs must be handled. There are multiple opportunities for mishandling the vials that would result in loss of viability (and dose) of the drugs. There are several staged and extreme temperature requirements, they must be protected from light, stored upright, and once a vial is punctured with a needle, the remaining drug must be used or discarded within 12 hours.

The complexity of the handling all the way from the manufacturing facility to the syringe and needle allows for the inevitability of human error, thus altering the injected dose and subsequent clinical response. Clinical response is also dependent upon a myriad of individual characteristics, co-mordidities, and age. But don’t forget, according to the CDC, one size fits all.

DURATION OF ACTION

In this discussion of the pharmacokinetics of these mRNA drugs, duration of action represents another big fat lie, or to be generous, breathtaking incompetence. They told us the drugs would stay in the deltoid muscle of the shoulder for a few days as the immune system did its magic and then the LNPs with their mRNA would be dissolved, or metabolized, or whatever. But it would be gone and we would just be left with the desired immunity which would protect us from the dreaded Covid virus and certain death. 95% effective and completely safe, they said.

The duration of action seems to be highly variable from person to person and has been observed to be anywhere from a few days to several months. And I am not talking about the effectiveness now, but rather, how long the counterfeit spike protein continues to be produced by the cells of the body and how long the synthetic and, altered from natural, mRNA and the counterfeit spike protein have been found in lymph nodes and other tissues.

Recent investigations, using needle biopsies, have shown the “vaccine” mRNA persists in axillary lymph nodes for at least 60 days. They didn’t test any longer than that, so it could be far longer. The levels of spike protein produced was also found to be far higher than expected and lasted for at least 60 days and now has been found to be present at 15 months post injection.

This duration of action is a very important point in regards to whether an adverse event is assigned to the “vaccine” or to an alternative cause, which seems to be the CDC’s and the pro vaccine crowd’s default position. In the original studies of these drugs and in various studies during the past 2 years, any adverse events after 21-28 days following the second shot are not ascribed to the “vaccine”.

But the persistence of the mRNA and the spike protein makes it difficult to use temporal proximity to the injections as a basis for suspecting vaccine injury. Also, clinical manifestations of inflammatory organ injury such as myocarditis, may be delayed for months or even years at which time the patient may present with congestive heart failure, arrhythmias, or sudden death.

Dr. Robert Malone has explained how the mRNA was altered from natural mRNA by the addition of pseudouridine rather that uridine:

“So, what we now know is that pseudouridine can cause RNA to behave in ways that are absolutely not like natural RNA, as I had originally proposed,” Malone says. “The RNA is typically degraded within a couple of hours, so if people were to have adverse events, the inciting molecule would be gone and physicians could elect not to readminister it.

But in the current formulation with the pseudouridine incorporated throughout the entire backbone of the RNA, which is something that never happens in a natural situation, they do suppress the acute inflammatory response, but they also seem to suppress overall adaptive immune responses or immune function.

This may be something that’s contributing to the immunosuppression that’s observed after dosing with these products. That’s unresolved, but there’s no question that adverse event exists, that nonspecific immunosuppression.”

Malone makes the point the pseudouridine causes the mRNA to be resistant to degradation and has a much longer duration of action than we were told.

RISKS

A discussion of pharmacokinetics would not be complete without a consideration of risks and effects on organs and other body tissue. It is important to realize that the toxic component of the Covid virus is the spike protein. It is what binds the virus to our cells by attaching to a specific cellular receptor (the ACE 2 receptor). The spike protein can cause a hyper-inflammatory response within our body as our immune system reacts to its presence.

The spike protein attached to our cells can result in an autoimmune phenomenon characterized by our immune system attacking and destroying our own cells, tissue, and organs. Biopsy and autopsy tissue studied under the microscope with special stain techniques, reveal the presence of spike protein and a plethora of inflammatory cells that destroy heart myocardial cells (myocarditis) that can lead to rhythm abnormalities, weakness of the heart muscle, congestive heart failure, and sudden death. There are similar findings in nerve and brain tissue.

Data now reveal these problems are much more likely following the mRNA drugs than after a Covid infection. Have you noticed all the reports and seen the videos of healthy people in the 15-50 year old group suddenly collapsing or dying unexpectedly in their sleep? “Physicians baffled”, “sudden heart attack”, “cause of death unknown” (CODU), “sudden adult death syndrome” (SADS) are comments that accompany these reports with a notable absence of any mention of when they received their last mRNA shot or what the autopsy revealed.

And it is not just cardiac complications as a result of the trillions of counterfeit spike proteins produced in our bodies following administration of the Covid genetic drugs. Arterial and venous clots, neurologic abnormalities, endocrine and rheumatological disorders, and an increase in aggressive cancers or recurrence of those in remission, have all been reported following these jabs.

So what is the dose, what is the duration of action, and what is the full significance and risks of the extensive distribution within our bodies? I wonder if anyone really knew three years ago because these are unprecedented and inadequately studied experimental genetic drugs that were rushed to market under an Emergency Use Authorization that continues to be extended beyond the presence of a “pandemic”. They have been and continue to be promoted by a public health bureaucracy and CDC duplicitous propaganda campaign designed to create in the minds of the masses that they are receiving a vaccine just like they did for smallpox, polio, MMR, and DPT. But it is important for all to realize these drugs are nothing like those vaccines in their pharmacokinetics, efficacy, or risks.

It is through the control of language that minds and behavior can be controlled. It is through truth, education, transparency, and self-reflection that hearts and minds can be changed to initiate and sustain the needed groundswell of peaceful protest and opposition to the medical tyranny and subterfuge of the last 3 years.