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The COVID-19 vaccine Pfizer-BioNTech rolled out to the world was not the same version that the vaccine maker used for its clinical trials, but an inferior formulation with significant impurities, according to Josh Guetzkow, Ph.D., assistant professor at the Hebrew University of Jerusalem.
These impurities stem from a different manufacturing process and may be responsible for many of the injuries and deaths reported after the administration of the COVID-19 vaccine.
Guetzkow discussed these claims in a video podcast last week hosted by John Campbell, Ph.D., a prominent internet lecturer, retired emergency room nurse, teacher and author of two nursing textbooks.
Guetzkow, who admitted to not being an expert on “all of the biology and the manufacturing methods,” identified the two methods Pfizer-BioNTech used: Process 1 and Process 2.
Process 1 — used to manufacture the vaccine for clinical trials — was made by using a PCR (polymerase chain reaction) process to duplicate DNA. The DNA was then used to generate the mRNA strands via in vitro transcription.
“It’s relatively clean to do it that way and they were also using a very, very high-quality system [of] magnetic beads to take out any impurities,” Guetzkow said.
Campbell reminded viewers the PCR test was used during the pandemic to sample RNA from the nose and duplicate it — first turning into DNA via reverse transcriptase — in order to determine the presence of SARS-CoV-2.
“Of course, there’s a debate about that and how much it should be duplicated and whether that can give rise to false positive results,” he added.
In Process 2, Guetzkow said, a DNA template is inserted into a plasmid inside E. coli bacteria cells. The bacteria multiply, replicating the plasmids, which in turn multiply their DNA payload. The DNA is then extracted, linearized (chemically snipped from its circular form) and used to synthesize the mRNA strands for the vaccines.
Guetzkow said Process 2 is a more cost-effective, scalable way to make RNA. “Instead of having to put it in a PCR machine, you just have these big vats,” he said.
The problem with this method, according to Guetzkow, is that because the plasmid DNA and the bacteria are still mixed after replication, they need to be cleaned and purified.
“And that’s where they seem to have done a terrible job,” he said.
Guetzkow told Campbell he pieced together his findings from documents submitted by Pfizer to regulators like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and from clinical trial data released by the FDA, Freedom of Information Act requests to regulators like the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and from leaked and hacked EMA data and published studies.
#Plasmidgate and toxic by-products
Guetzkow noted the recent revelations of plasmid DNA being found in Pfizer’s vaccine vials, a finding replicated by “more and more researchers around the world,” he said.
He was referring to what many are now calling #plasmidgate.
Urgent Expert Hearing on Reports of DNA Contamination with @JanciToxDoc, @Kevin_McKernan, @P_McCulloughMD, @CaudeHenrion, @JesslovesMJK, and more! #plasmidgate https://t.co/SxQ9mtPPCJ
— World Council for Health (WCH) (@FreeWCH) October 9, 2023
According to a press release from the World Council For Health, scientists have discovered bacterial DNA in the mRNA vaccines, including SV40 — the cancer-promoting genetic sequence used in gene therapy to deliver therapeutic genes to target cells — plus other foreign protein-producing DNA strands and contaminants.
Dr. Ah Kahn Syed (pseudonym) wrote in his Substack that these discoveries prove that the pharmaceutical companies and government were lying when they said the COVID-19 vaccine would “have a short-lived (days) effect at most” and that “it isn’t gene therapy.”
Guetzkow said the vials also contained “some residual lipopolysaccharides [from] the membrane [of] the … E. coli bacteria,” and that these “gram-negative bacteria” are “highly inflammatory.”
“They’re called endotoxins for a reason,” he said, adding this “might be linked to some of the adverse events” that were rarely seen in the trials.
As an example of the dangers of manufacturing such biologicals, Guetzkow reminded Campbell of the “Cutter Incident” where Jonas Salk turned over his polio vaccine in the 1950s to a company that did not fully understand how to make it, resulting in live polio virus being given to 2 million children.
Of those 2 million children, 200,000 developed short-lived polio, several hundred developed a permanent condition and several children died.
It was vaccine advocate Dr. Paul Offit — the “high priest of vaccinology in the U.S.,” Guetzkow noted — who documented the incident.
Vaccine study protocol changed mid-trial, avoided elderly subjects
In what Guetzkow called a “bait and switch,” Pfizer in October 2020 changed its study protocol to test the COVID-19 vaccines made by Process 2. Its stated intention was to compare its efficacy and reactogenicity to that of Process 1.
However, there is no evidence Pfizer did any pre-clinical studies on Process 2 doses, Guetzkow said. “It was never tested in animals.”
Guetzkow said the Process 2 vaccine was administered to only 252 people between the ages of 16 and 55, according to documents provided to the FDA.
Only four of the 252 subjects had their antibody responses analyzed, which took place a month after the second dose, according to Guetzkow. All were 22 years old or younger.
“This was planned, this wasn’t accidental,” Guetzkow said.
Pfizer told the FDA it would not be able to include data from Process 2 prior to the Emergency Use Authorization of the vaccine, but promised to deliver the data several months later.
No safety or efficacy testing was performed on elderly subjects.
“You would think that you would preferentially want to test the immunogenicity and the safety of the new process … on the elderly population,” Guetzkow said. “Well not only did they never do that — they never planned to do that.”
In September 2022, Pfizer updated its protocol, stating it would no longer compare Process 1 and Process 2 vaccines for efficacy or adverse events.
Guetzkow performed his own statistical analysis, comparing those who during clinical trials received Process 2 doses against everyone who received Process 1 vaccines.
Controlling for variables such as age, sex and comorbidities, he told Campbell, “I found that the adverse event rate in that comparison was much higher for those people who got those Process 2 doses than for the other [Process 1] treatment subjects.”
In mid-December 2020, Pfizer started giving the Process 2 vaccine to people in the placebo group, thereby destroying the ability to compare long-term side effects between treatment and control groups.
According to Pfizer’s clinical study report submitted to the FDA, Guetzkow said, those in the placebo group who received the vaccine had significantly higher numbers of adverse events than the original treatment subjects. “Quite a bit higher, in fact. And we don’t know why.”
No Process 1 shots were ever given to the public, Guetzkow said.
Process 2 mRNA integrity slipped after early lots
In January 2021, there was a data breach at the EMA that revealed some EMA scientists expressed concerns over the integrity of the mRNA in some of the vaccine batches, Guetzkow said.
Specifically, some earlier batches had around 70-80% integrity in their mRNA strands, while newer batches had only 50-60% integrity.
Concerns about integrity between vaccine batches date back to Nov. 10, 2020, when Marco Cavaleri of the EMA in an email to colleagues shared discussions he was having with the FDA about problems with the quality of manufacturing, according to Trial Site News.
On Nov. 23, 2020, EMA scientific administrator Evdokia Korakianiti sent an email to her colleagues stating that “a significant difference in %RNA integrity/truncated species has been observed between the clinical batches.”
The quality variation observed between the lots was substantial — 78% integrity in the initial batches versus just 55% in the new batches.
Cavaleri responded the same day, downplaying the variation, saying “The issue on the mRNA content not perceived as major.”
A Nov. 25, 2020, EMA email stated, “FDA and Health Canada indicated that the safety concerns associated with variable species of mRNA/proteins are more of a theoretical concern.”
Documentation showed Pfizer’s attempt to improve integrity was not successful.
Instead of requiring Pfizer-BioNTech to improve their manufacturing and quality control methods, EMA regulators simply lowered the bar for acceptable mRNA integrity levels — without clear basis or evidence that the lower quality would be efficacious or safe, Guetzkow said.
Despite the ongoing quality issues, both the EMA and FDA approved emergency use of the Process 2 Pfizer-BioNTech COVID-19 vaccine in December 2020.
Variability across Process 1, 2 and later lots correlated with adverse event severity
Guetzkow noted that different vaccine lots demonstrated different adverse event profiles. This topic, he said, was reported on in a Danish study and was also featured on a July Campbell podcast.
“It’s quite possible that this Process 2 manufacturing method only … lends itself to increasing the variability across lots,” he speculated.
Guetzkow mentioned a new study in the mainstream journal Science Advances reporting 13.1% of premenstrual women, 3.3% of postmenopausal women and 14.1% of perimenopausal women experiencing unusual vaginal bleeding after vaccination, half within 4 weeks.
He contrasted the premenstrual bleeding percentage in this study — 13.1% — with the reported premenstrual bleeding in the clinical trials — 0.7% — according to his calculations.
“How do you get from 0.7% to 13.1%?” Guetzkow asked.
There are two ways, he said: “1. You’re giving them a different product that makes them much more likely to experience menstrual bleeding; or 2. You have failed miserably to track adverse events in your trial … because … you’re doing a terrible job.”
Guetzkow speculated about the biological mechanisms that could be involved with these symptoms, but said, “The fact of the matter is that the percentage in the population that got the Process 2 jabs are reporting [adverse events] at a much higher rate.”
He said cases of lymphadenopathy and anaphylaxis were also reported at much higher rates with Process 2 shots.
The anaphylactic reactions caused health authorities to suddenly recommend a person sit for 15-30 minutes after vaccination, he said, because “they were using a different product — a safer product, frankly.”
But Guetzkow tempered that with “Now, I don’t want to paint a rosy picture about Process 1 … the entire mRNA paradigm and the transfection and the use of lipid nanoparticles — all of this comes with its own baggage and problems.”
‘Nobody could have given informed consent’
Guetzkow questioned the strategy the pharmaceutical companies used to dissemble about adverse events when they said “We didn’t observe that in the trial.”
“If you’re giving a different product than you did in the trial, you can’t make that inference,” he said.
Guetzkow said:
“Everybody in the U.K. and around the world got these Process 2 lots [but] nobody was informed about this. … Nobody was told that they were actually getting a product that is different than the one that the clinical trial was run on.
“So what that means, essentially, is that nobody could have given informed consent, because they were kept in the dark.
“You could have followed all of the ins and outs of the clinical trial reports. You could have read that New England Journal of Medicine study. You could have known about the relative risk versus the absolute risk — everything — and you still would have been in the dark. You still would not have been able to give your full informed consent.
“And that’s a real egregious violation of people’s basic rights and dignity under established treaties and the Nuremberg Code.”
Guetzkow and colleague Retsef Levi wrote a “rapid response” letter to The BMJ last year about this issue.
Guetzkow’s Substack, “Research Rebel,” where he details his research, can be found here.
Watch Campbell’s interview with Guetzkow:
