By Jeanne Rungby, specialist doctor.
Photo by Jametlene Reskp.
Pfizer and Moderna switched from process 1 to process 2 after the conditional approval was granted, without the authorities ensuring corresponding new scrutiny of the manufacturing process.
Process 1 and process 2 are significantly different.
The famous phase 3 trials that all researchers discuss are based on process 1. But the Covid-19 vaccine, which was given to large parts of the world's population, is based on process 2.
It therefore becomes absurd and irrelevant to discuss the phase 3 trials of process 1.
These phase 3 trials were apparently designed to trick us into thinking the vaccines were safe and effective.
This charade only succeeded because our health authorities played along in the deception.
The authorities and ministers have imposed on the population a product, based on genetically engineered organisms, which has never been tested in a phase 3 trial on humans before approval.
In this, health authorities and health ministers globally have completely failed the trust of their populations.
What we are now experiencing from the bought press, authorities and governments is a panicked attempt to explain away and sweep the consequences of their own failure under a carpet.
What is process 2?
During the last six months of 2023, it has emerged that the manufacturing process used to manufacture the Covid-19 vaccines (process 1.), which is the basis for the conditional approval of these mRNA vaccines in the EMA , was changed to process 2, in connection with the mass production of the mRNA vaccines (1, 7).
Process 1 was based on PCR technique, a cleaner process where purification for DNA was easier. There was not the same risk of contamination with whole plasmid DNA nor with capsule fragments from coli bacteria, the so-called endotoxins that can cause anaphylactic shock and cytokine storm that characterize process 2
Process 2 literally takes place in a gigantic pile of faeces, in which genetically modified E-coli bacteria are grown, which must then generate mRNA for the vaccines. In order to produce tons of these vaccines with this method, a number of conditions are required for these bacteria. They must be antibiotic resistant so that they divide faster. Therefore, their DNA not only contains the code for spike protein but also the genetic code for antibiotic resistance to kanamycin and neomycin.
The method used in process 2 was never scrutinized according to the Good Manufacturing Practice (GMP) regulations of the European Medicines Agency (EMA)(2, 3, 4). When the actual manufacturing process of a product is changed, a medical product must undergo a new scrutiny for GMP, as if it were a completely new product.
Strict rules apply for the approval of medical products, as they must comply with Good Manufacturing Practice, GMP. Authorities such as the Danish Medicines Agency and the European Medicines Agency (EMA) have a duty to carry out good regulatory practice (GRP) according to prescribed rules.
They must thus ensure that a number of well-defined studies have been carried out on the product, for example, it must be investigated where in the body the product ends up (biodistribution studies), what effect or possible damage it has on various organs and whether the product can change the genes, affect fetuses in pregnant women, affect fertility or trigger cancer.
Why were these studies not conducted?
The EMA, FDA and national health authorities chose to bypass this process, after which the product was conditionally approved and given to the majority of the world's population, including children and pregnant women.
In particular, there is now evidence that process 2 involves injection with a genetically modifying organism (GMO) (1). "GMO" refers to a medical product produced on the basis of genetically modified organisms. The requirements for the approval of GMOs are even stricter and more rigid than the requirements for ordinary medicines. These requirements were not met when the vaccines were approved. In Australia, Pfizer and Moderna are being sued for not having registered the product as GMO (5).
Process 1 was made unblinded after a few months. When experiments are made unblinded by vaccinating the control group, this means that the control group is no longer valid for comparison, after which long-term side effects and effects cannot - or will later be - assessed. There is thus no properly conducted preclinical blinded randomized trial on humans based on these mRNA vaccines from Pfizer.
The fact that the vaccine manufacturers switched to Process 2 was not revealed to the public until it was discovered in April 2023 by an accident by Kevin McKernan, who has a BS in Biology from Emory University with many years of experience in the Human Genome Project, CSO and founder of Medical Genomics with experience in sequencing technology.
Using gene sequencing, McKernan discovered that there was significant contamination of both Moderna's and Pfizer's bivalent booster Covid-19 vaccines with Plasmid DNA, which originates from the production process itself 2 (1, 6). The plasmid DNA found constitutes the entire genome from a certain laboratory-created E-Coli bacterium, which was specially composed of varying gene sequences (GMO), including containing, among other things, the Simian Virus 40 promoter (SV40), which is known to promote the development of cancer (1, 6). Thus, the public discovered for the first time which manufacturing method the manufacturers had used for the vaccines. This has since been confirmed through document inspections.
The Danish Medicines Agency admitted that there is plasmid DNA in the vaccines(6).
Based on this unregulated approval of Pfizer's vaccines, I have asked the Minister of Health for an explanation. She has pushed the question on to the Danish Medicines Agency, which responds as follows.
"It is not correct that Pfizer and Moderna have changed/changed the manufacturing process without the authorities having assessed that the manufacturing meets the requirements of GMP.... The Covid-19 vaccines are also tested by an EU authority laboratory before releasing a vaccine batch in EU. Each vaccine batch is thus analyzed twice (by the manufacturer and by the authorities). A batch will be released in the EU if both tests are acceptable.”
These two processes and the associated risks are not identical and should therefore be subject to separate GMP (Good Manufacturing Practice). It appears from the following that neither Pfizer, the FDA nor the EMA have carried out the alleged analyses.
In the final report from Pfizer, which was released on 19 - 20 December 2023, published on the EMA website, it appears that "process 2" was exempted from good manufacturing practice (GMP) (1, 2). This does not harmonize with the Danish Medicines Agency's assurance that the vaccines meet the applicable requirements for GMP, as no randomized blinded trials on humans applicable to "process 2" have been carried out.
In the report (2, 3), the following excerpt can be read on page 3:
"... as agreed with FDA and EMA. Updated schedules of assessments and protocol text to identify study visits, …no longer need to be completed… Removed the objective to describe the safety and immunogenicity of prophylactic BNT162b2 in individuals 16 to 55 years of age vaccinated with study intervention produced by manufacturing “Process 1 ” or “Process 2” because of the volume of BNT162b2 now distributed and administered globally using manufacturing “Process 2,” making this comparison unwarranted.”
On page 42 of the same document (1, 2) it also states:
“…. because the study is now being fully unblinded with no control arm, making it observational in nature, and with the active safety surveillance period for the majority of participants completed, following agreement with the FDA and EMA, the study will be concluded early.”
As can be seen from the quotes above, Pfizer chose, in agreement with the EMA and the FDA, to omit the control of "process 2" due to the large volume of the vaccine already administered globally. In addition, they chose to stop all further control of the test individuals. This happened, among other things, because the original randomized study was made unblinded (after a few months) and therefore no longer fell under the definition of a randomized study, but instead became an observational study. That decision was against the study protocol and what had already been agreed. This destroyed the possibility of a follow-up safety evaluation as planned. This was in practice a failure of both GMP and GRP on both processes. This made the possibility of concluding something about safety and effectiveness, including long-term side effects and mortality in a randomized material, impossible.
To ensure that I have understood the above correctly, I have consulted with a specialist in the field, Joshua Guetzkow, Ph.d. and associate professor at the Department of Sociology and Anthropology and Institute of Crimonology at the Hebrew University, Tel Aviv. Joshua Guetzkow has carried out a detailed study of Pfizer's documents relating to “process 2”. (7).
The conclusions of this report by Guetzkow were as follows:
• The mRNA vaccines used in Pfizer/BioNTech's clinical randomized studies, which form the basis of the regulatory reviews, were produced using process 1. The vaccines that were granted temporary conditional and later unconditional approval were produced using process 2.
• There are important differences between these 2 production processes that can affect safety and efficiency. These differences include contamination with plasmid DNA, in particular a partial sequence of SV40, which was not properly notified by Pfizer to the authorities and also not properly compared.
• Out of 22,039 test subjects aged 16 - 55 in the clinical randomized studies, only 252 test subjects were given the vaccine produced on the basis of process 2.
• The trial protocol for the randomized study of trial subjects in process 2 compared to trial subjects in process 1 states that it will compare safety and immune response in both processes. This comparison was never performed, nor was any description of results from preclinical studies based on process 2 ever submitted.
• Based on a comparison made of the incidence of side effects in subjects of the two processes, the incidence of side effects in process 2 was 2.5 times higher. This difference was statistically significant.
It thus appears from Guetzkow's report that the two processes are not directly comparable, which is why separate GMP is required for the two processes (7). It is against GRP, Good Regulatory Practice, to approve medicinal products where the clinical studies have been carried out with a different production method and potentially different properties than what is intended to be marketed.
A group of European parliamentarians have addressed the EMA in an open letter to ask for the EMA's explanation.
EMA in their letter to MEP Graff (4) maintained, as I interpret it, that the two processes did not differ significantly from each other and that there was therefore no reason to carry out separate GMP and GRP on "process 2".
EMA writes: "the adapted vaccines are not new vaccines with marketing authorizations separate from those of the originally authorized vaccines. Any theoretical environmental risk they may pose is considered to be the same.”
EMA thus confirms that no separate GMP has been carried out on process 2.
It also appears from the letter from EMA to MEP Graff that the national regulatory authorities are responsible for the final environmental control (GMP) of the vaccines. EMA writes: "national authorities approve clinical trials in the EU and would therefore be the authorities to receive any environmental risk assessments required before the start of a clinical trial".
The immediate interpretation of this statement must naturally be that the overall responsibility for carrying out environmental risk assessment for vaccine control lies at national level.
My last question for the minister is the following:
1. Can the minister provide documentation that the production of the vaccine by "process 2" meets applicable requirements for both GRP and GMP when tested in an EU authority laboratory or in a national laboratory?
The Minister and the Danish Medicines Agency have not provided documentation for the alleged thorough GRP and GMP. It must therefore be concluded that we have been victims of a huge deception
The question is whether the Health Authorities have misled the Danish Parliament in this matter.
Sources
2. https://clinicaldata.ema.europa.eu/web/cdp See Comirnaty (Tozinameran), (PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001Final Protocol Amendment 20, 15 September 2022)
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