If you took the Pfizer COVID vaccine, would you be surprised to learn that the product you were injected with was never tested at scale in a randomised controlled trial before being approved for use? Believe it or not, this is not a hypothetical question. It all comes down to a bait and switch.
The ‘bait’ is the Pfizer’s vaccine manufactured by ‘Process 1’, which involved high quality In Vitro Transcription of synthetic DNA to make the spike-producing mRNA. Process 1 doses were administered to almost all of the participants in Pfizer’s landmark randomised controlled trial (RCT) on which regulatory approvals for its COVID vaccine were based.
The ‘switch’ occurred when Pfizer changed to ‘Process 2’ to mass manufacture billions of vaccines for the worldwide rollout. Process 2 involves growing DNA plasmids in E. coli bacteria, from which the vaccine mRNA is then produced.
Almost all of the 43,448 participants in Pfizer’s RCT received the Process 1 vaccine, while only 252 participants in the trial received the Process 2 vaccine. This means that the vaccine doses rolled out to billions of people around the world were never tested at scale before being approved for use.
“This realisation is a real gut punch,” says criminologist Dr. Guetzkow, who co-authored a rapid response drawing attention to Pfizer’s bait and switch, published in the British Medical Journal (BMJ) in May 2023. “Nobody was told that they’re actually getting a product that was different from the one that the clinical trial was run on, and so that means, essentially, that no one could have given informed consent.”
One might argue if there is no difference between the Process 1 and 2 products, then there’s no problem. But an increasing number of scientists from independent labs claim to have found excessive levels of plasmid DNA contamination in the vaccines, which is a by-product of the Process 2 scale up.
This includes the presence of an SV40 promoter, a DNA sequence known in the scientific literature for its effectiveness at driving DNA into the cell nucleus in gene therapies. The Canadian drug regulator, Health Canada, recently acknowledged the DNA contamination (and the SV40 promoter specifically) in the Pfizer vaccines in emails to The Epoch Times.
A data leak from the European Medicines Agency (EMA) in December 2020 revealed that the commercial (Process 2) Pfizer vaccines had been found to have substantially lower mRNA integrity than expected. A Danish study found significant variability in the rate of serious adverse events across Pfizer vaccine batches, underscoring the importance of understanding the impacts of production processes on product safety.
Australian scientist Dr. Geoff Pain and US-based toxicologist Dr. Janci Lindsay also warn that it is possible that the Process 2 vaccines are contaminated with endotoxin, a potentially life-threatening by-product of growing DNA plasmids in bacterial E. coli.
The key issue, says Dr Guetzkow, is that when dealing with highly complex biological medical products, “the process is the product.”
There is no better example of this than the cautionary tale of the Cutter Incident, which US vaccine expert and co-inventor of the rotavirus vaccine RotaTeq, Dr. Paul Offit, describes as “one of the worst biological disasters in country’s history.”
The Cutter polio vaccine, manufactured at Cutter Laboratories in California, was a version of Jonas Salk’s ground breaking polio vaccine, which had been declared safe and highly effective after a huge field trial in the US involving 1.8 million children.
Salk’s vaccine promised to be a remarkable success, and the manufacture protocols were sent to commercial vaccine makers around the country to scale up for the rollout. However, the five-page vaccine ‘recipe’ allowed for some variations in method, and the quality control tests were not sensitive enough to pick up minor divergences in the final product.
Most importantly, the poliovirus contained in the vaccines was supposed to be ‘dead’, but in the case of Cutter’s vaccine, some batches were released with live poliovirus. What ensued was a modern medicine tragedy.
Precise numbers vary from report to report, but Dr. Offit, who wrote a book on the Cutter Incident, has stated that about 120,00 children were injected with live, fully virulent poliovirus in Cutter’s vaccine. Some 40,000 children developed ‘abortive’ (or short-lived) polio and 200 children became permanently paralysed. 10 children were killed by the vaccine before the regulators halted the vaccine program until the problem could be identified.
In a 2016 interview, Dr. Offit clarified that while the Cutter vaccine was responsible for the worst of the damage, other labs had also produced dangerous lots due to “wiggle room” in the manufacturing recipe.
In court, Cutter was found by a Judge be liable but not at fault, as they had not known they were producing a dangerous product. “They thought they were making safe vaccines,” said Dr. Offit. “The people who did the safety testing gave these vaccines to their own children. I think that tells you everything you need to know.”
Rather than blaming the manufacturers, Dr. Offit laid blame on the scale up process. The main problem lay in the switch from a slow and high-quality filtration process used to make the vaccine doses for the field trial, to a “much faster, but much less thorough” process for the mass rollout.
“It shouldn’t have been called the Cutter Incident, it should have been called the ‘scale up incident’, because that was really what the problem was”. We just had trouble scaling up that vaccine,” said Dr. Offit.
Dr. Guetzkow draws parallels between the Cutter Incident and Pfizer’s COVID vaccine scale up. “The problem Dr. Offit identified was a switch from a slow, high quality filtration method to something faster and not as good,” he told Umbrella News. Pfizer “did the same thing with the switch from Process 1 to 2, where the filtration method in process 2 [to remove contaminants from the manufacture process] is lower quality.”
Dr. Offit has stated that much tighter regulations were developed for vaccine manufacture in response to the Cutter Incident. However, Dr. Geutzow and his BMJ rapid response co-author, analytics expert Prof. Retsef Levi, told Umbrella News that they believe the warp speed development and emergency use approval pathways for the COVID vaccines created conditions for key safety concerns to be overlooked.
Dr. Geutzow notes that “the safety testing was very limited, since the placebo group was given the vaccine just a few months into the Pfizer/BioNtech trial.” Moreover, “the switch to Process 2 meant that whatever safety testing was done was essentially meaningless, since it was done on a different product.”
Prof. Levi is of the opinion that the regulators “completely dropped the ball” when it comes to ensuring the integrity and safety of the manufacture of these vaccines. “It is striking,” he says, how the “painful lessons of the Cutter Incident, as well as decades of regulatory practices,” were neglected.
We know that the regulators were aware of Pfizer’s switch from Process 1 to Process 2, because the protocol amendment is documented in Pfizer’s submissions to the regulators. Dr. Guetzkow and Prof. Levi noted in their BMJ response that while Pfizer had stated that immunogenicity and safety analyses would be conducted to compare the outcomes of the Process 1 and 2 products, there was no publicly available report on this comparison at the time.
Six months on, a response from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to a Freedom of Information (FOI) request for Pfizer’s report comparing Processes 1 and 2 is suggestive that it was never done – or, if it was done, that it was never provided to the regulator.
On 21 September 2023, the MHRA advised that, “this process comparison was not conducted as part of the formal documentation within the protocol amendment.” It reasoned that such a comparison had been determined unnecessary, “due to the extensive usage of vaccines manufactured via ‘Process 2’.” In other words, the public were the test subjects for the Process 2 vaccine.
“It is obvious that the regulatory agencies mismanaged this critical issue, and allowed a potentially unsafe and unreliable manufacturing process to be used at scale to manufacture billions of vaccine doses that were administered to people around the globe,” summarises Dr. Levi.
This is the “real gut punch” realisation. So now what?
Dr. Guetzkow says that the regulators should do what they did in the case of the Cutter Incident, and “recall the products from the market immediately,” until independent studies can be carried out, including a large-scale human trial as should have been done in the first place.
Dr. Offit did not respond to a request for comment.