Comirnaty Vaccine Files - Part 2
Pharmacokinetics
Pharmacokinetic (PK) studies are essential for understanding how any pharmaceutical intervention works in the body. They provide insight into how the human body responds to inhaled, swallowed, or injected substances. When Comirnaty was registered, the PK evidence was derived from studies conducted on rats rather than humans.
What makes up the Comirnaty Vaccine?
As reported by the MSF, Comirnaty consists of lipid nanoparticles (LNP) and modified messenger RNA (modmRNA). It also contains several other ingredients (see Table 9, page 18 of the report).
Lipid nano particles (LNPs)
Lipid nanoparticles (LNPs) are small fatty structures designed to protect the core component, modified mRNA (modRNA), from our immune system while delivering it to its target location. Think of LNPs as the packaging that safeguards your parcels.
LNPs encapsulate the modified mRNA (modmRNA) that encodes a version of the spike glycoprotein from the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). When injected, the LNPs attach to the plasma membrane of cells and release the SARS-CoV-2 spike protein modmRNA into the cell. The cell's protein synthesis machinery then translates the mRNA to produce the SARS-CoV-2 spike protein, which stimulates the immune system to generate an immune response.
LNPs are widely used in gene therapies and vaccines, and several types are currently undergoing clinical trials. Two specific types of LNPs are ALC-0315 and ALC-0159, which are combined with additional substances to stabilize their structure. This stability is crucial for ensuring that the modmRNA is effectively dispersed throughout the body.
Biodistribution studies investigate the movement of LNPs after injection and their quantity in animals. Unlike traditional vaccines, LNPs exhibit a wide distribution throughout the bodies of rats. The main sites where LNPs are found, in order of frequency, are the liver, spleen, heart, kidneys, and ovaries. The Japanese PMDA reported that LNPs are quickly distributed to the liver within 24 hours following administration, with an estimated distribution rate of approximately 20% to 60% of the administered dose. In contrast, vaccine particles are generally not found in many internal organs; instead, they are typically concentrated around the injection site.
The link shows a biodistribution report (study 185350). These studies ask where the LNPs go once they are injected and in what quantity in animals.
There is significant disinformation about LNPs' properties. One common misconception is that they remain primarily around the vaccination site, which is not true.
A close look at the 77-page study 185350 (available from the Public Health and Medical Professionals for Transparency (PHMPT) repository) shows that the LNPs go everywhere in a rat’s body.
The first study was small and rushed, lacking a proper dose-ranging assessment. Unfortunately, the initial experiment was unsuccessful; the rats were overdosed, resulting in the death of one rat and leaving the other two in very poor health after 30 hours. This outcome is exactly what one wants to avoid in a pharmacokinetic (PK) study. It indicates that the researchers did not understand the product's safety margin, which is crucial. Toxicity is related to the concentration of the product, and it tends to be highest in the ovaries and liver. The overall concentrations in single organs may be low, but that’s because they are so widespread.
The study primarily examined LNPs rather than their contents or the entire product. It focused on the vehicle itself rather than the vehicle and its passengers. While it is well known that LNPs play a crucial role in protecting modified messenger RNA, they also assist in evading immune responses for both the vehicle and the cargo. This aspect is less frequently highlighted.
Immune concerns
Previous exposure to LNPs was an exclusion criterion for participation in the registration trials. The manufacturers were concerned about repeated exposure, likely due to the potential for a dose-response effect.
Provisional licensing for Comirnaty was based on Study C4951001 and trial BNT162-01. The report on trial BNT162-01 highlighted that participants with a history of exposure to lipid nanoparticles were excluded. Further analysis of the clinical study reports (CSRs) reveals that prior participation in other studies involving interventions containing LNPs was also an exclusion criterion for study C4951001, the larger phase 3 trial.
A 2022 review examined the role of lipid components in lipid nanoparticles (LNPs) used for vaccines and gene therapy, suggesting that these components may have been excluded due to concerns about immune responses. A subsequent review published in Nature focused on the immunogenicity of lipid nanoparticles and their impact on the efficacy of modmRNA vaccines. This review indicated that repeated delivery of LNPs could lead to increased adverse effects.
The structure of the ionizable lipids used largely influences the immunogenicity of LNPs. Consequently, controlling the size of the LNPs during their preparation is essential, as it significantly impacts the pharmacokinetics and biodistribution of the nanoparticles. In addition to Apolipoprotein E (APOE), a protein that facilitates the transport of cholesterol and other fats in the body, other plasma components also play a role in the uptake of LNPs by liver cells and various cell types.
The review noted several lines of evidence supporting LNPs acting as an adjuvant. Yet, what is noticeable is the lack of understanding of the mechanisms of immune stimulation, tolerability, and immunogenicity. Notably, evidence is lacking in humans.
The half-life of LNPs
An important question is how long lipid nanoparticles (LNPs) last in the body. The half-life refers to the time it takes for the amount of the vaccine's active substance in your body to reduce by half. The European Medicines Agency (EMA) noted the long half-life of ALC 0315 but was largely non-committal regarding its significance. However, they also mentioned that their experience with LNPs in humans is “limited.”
According to the Japanese PMDA, the half-lives of ALC-0159 and ALC-0315 in plasma were estimated to be 1.7 hours and 1.6 hours during the distribution phase, respectively. Regarding the elimination phase (removing the administered vaccine from the body), the half-lives were 72.7 hours and 139 hours.
Modified mRNA
The second component of Comirnaty is modified mRNA or modmRNA which tells the cell host to produce the antigen: S spike protein. ModmRNA is made as follows:
RNA is harvested from SARS-CoV-2;
The spike protein component (SPC) of the RNA is snipped from the complete viral RNA (the SPC is the template for producing the spike viral component);
The SPC is modified either in a lab or naturally—the speed with which this was done points to a synthetic origin of the modified RNA. According to experts, you must do this to enhance stability and replication capacity.
Reverse transcribe modified RNA to DNA;
As a large quantity of DNA is needed, amplification is done by inserting it into a plasmid, and then inserting it into friendly bacteria that produce tons of DNA.
The bacteria and plasmids are broken down and the DNA is harvested
DNA starts the production of modified modmRNA
The modmRNA is put into the LNP.
Put in other bits and pieces, and the product will be ready.
Is Corminaty a vaccine or a drug?
The Japanese regulator PMDA (Pharmaceuticals and Medical Devices Agency) is one of the best sources of regulatory data and a counterfactual checking point to its Western colleagues. PMDA produced a Report on the Deliberation of Results. On page 1 of the report, the regulator states that the vaccine product and its active substance are classified as “powerful drugs”.
Are the Vaccines carcinogenic?
One or more of their ingredients are considered carcinogenic, which raises the question of whether the LNPs are toxic to human genes. Given the lack of carcinogenic studies in animal models before provisional licensing, it is difficult to justify and answer whether the vaccines are carcinogenic.
Unanswered questions
Why does the MHRA “enabler” not know anything about the metabolism of the LNPs and modmRNA, the vigilance of Covid vaccine harms or the rate of underreporting potential harms?
The UK MHRA “enabler” claims not to know anything about either the metabolism of the LNPs and modmRNA but a list of questions were sent to the manufacturers by the Expert Working group. The questions and answers are secret, and MHRA has refused to release them to Parliament.
This secrecy on the properties of a global intervention touted by WHO and governments is deeply concerning, especially in the light of the expected finding of the persistence of SPC in the blood for over 700 days.
We came up with a list of 15 PK questions that need answering:
The lipid “excipients” ALC-0315 and ALC-0159 were new. Regulators note the limited experience with these compounds.
Whose job is it to close the gap in evidence and ensure patient safety when new experimental compounds are included in vaccines?
Experience of their use in humans was limited. They act as the carriers; the RNA is a different story. The metabolites were found everywhere in the rats’ organs (liver, spleen, ovaries and so on). The significance of their widespread distribution is unclear for humans, but the concentrations were very high in the liver and ovaries and almost certainly toxic.
Does this hold for humans, too?
What is the possible toxicity of LNPs in humans, especially after repeated exposures?
Vaccine particles (antigens, adjuvants, and excipients) are not usually found in many internal organs; they are typically concentrated around the injection site. We are unclear about the half-life, although the EMA seems to think it is long.
Is there a dose-response?
What is the half-life of modmRNA in the elimination phase in different organs?
What happens to the modmRNA in humans in different organs?
One or more of their ingredients are considered carcinogenic.
Why were no carcinogenic studies carried out in animal models before provisional licensing?
Why were no genotoxicity studies carried out in animal models before provisional licensing?
Nanoparticles are vastly different, and some are toxic, which is concerning. Our understanding of their behaviour in complex biological systems is extremely limited.
Where are the postmarketing studies following up on the cancer risk?
The Japanese regulator considers Comirnaty as a “powerful drug”: a formulation consisting of tozinameran encapsulated in LNP.
Should modmRNA vaccines be classified as a drug?
Why is a modified messenger RNA abbreviated to mRNA, which we are taught stands for messenger?
The Japanese regulator reports Pfizer’s explanation that the pharmacokinetics of modmRNA formulation encapsulated in LNP is dependent not on the encapsulated modmRNA but on the LNP.
Is the LNP inert as Pfizer claims it is?
The MHRA enabler (formerly a regulator) does not know anything about the metabolism of the nanoparticles or the modmRNA, nor do they hold vigilance data for the Covid vaccine harms, and they know nothing about the rate of underreporting of harms.
Whose job is it to ensure patient safety if the regulator/enabler is wilfully ignorant of the evidence of harm at the approval stage of novel vaccines?
There are no published studies of Cominarty in pregnant women. All the regulators report in the package insert that “No data are available yet regarding use during pregnancy” (EMA and MHRA) or “the available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy” (US FDA).
Why has the only randomised controlled trial on pregnant women not been published?
Why does the messaging to the public differ from what is reported in the package inserts for pregnancy?
Sources of data
Public Health and Medical Professionals for Transparency (PHMPT) repository.
This is populated by the submission to the FDA/CBER BLA. BLA stands for Biologic(s) Licensing Application. CBER, or the Center for Biologics Evaluation and Research, is the branch of the FDA that examines biologics such as vaccines and monoclonal antibodies and licenses them if appropriate.
The Japanese regulator PMDA (Pharmaceuticals and Medical Devices Agency) Report on the Deliberation of Results.
This includes a small Japanese trial on 160 people (Study C4591005). As one example, a 77-page study of Wistar-Han rats.
PK studies we could find
Articles referred to:
Nanocarrier imaging at single-cell resolution across entire mouse bodies with deep learning. Nat Biotechnol. 2025 Jan 14. doi: 10.1038/s41587-024-02528-1.
The role of lipid components in lipid nanoparticles for vaccines and gene therapy. Adv Drug Deliv Rev. 2022 Sep;188:114416. doi: 10.1016/j.addr.2022.114416.
Immunogenicity of lipid nanoparticles and its impact on the efficacy of mRNA vaccines and therapeutics. Exp Mol Med 55, 2085–2096 (2023). https://doi.org/10.1038/s12276-023-01086-x
MSF. Access Campaign. Process-cost modelling for producing 100 million COVID-
19 mRNA vaccine doses per year at injectable medicines manufacturing sites. 2021
I've posted these before. Dr Segalla, chemist, has made 3 videos on LNPs, which, according to Pfizer's own paperwork, state they are for research purposes only, not to be used with humans and animals, or used parenterally (by injection). What more evidence is needed? rumble.com/user/DOCTORSEGALLA/videos
Thank you so much for all of your hard work. I always wish I was adept at understanding these nuggets of information. I knew that Alnylam Pharmaceuticals sued Moderna and I believe pfizer separately for patent infringement of the LNP’s. My understanding was Alnylam wasn’t ready to bring the LNP’s to market because of safety concerns. I’m shot injured and so very angry that the regulators knew nothing about these novel shots but made proclamations about the safety and effectiveness including to pregnant women. In hindsight it’s obvious they couldn’t have known. I was just stupid and bought it. When I read your link I picked out a few things that happened to the rats as I experienced the same. For many months after the shot, I stopped sweating. Being exposed to light was painful and couldn’t abide any loud noise.
What was incredibly astounding, unbelievable actually, was there was no independent, active data collection after the roll out of the shots to look for signals of adverse effects, which would be an obvious safety measure to implement and there’s still no post marketing studies despite higher cancer rates. As an aside, can you tell me what radioactivity means in regards to the shot?