Pfizer enrolled 44,000 people across 270 clinical sites in phase 3 clinical trials for the Pfizer/BioNTech Comirnaty vaccine. The largest of these sites by far was number 1231 in Buenos Aires, under the direction of the paediatric infectious diseases specialist Fernando Polack. The Argentine operation appears to have been plagued by substantial irregularities and is the subject of an ongoing inquiry by the Argentinian parliament.
Before getting to the dodgy trial documentation, it’s worth recalling the conditions under which Pfizer gained approval for its “vaccine” in Argentina.
In 2020, when Pfizer requested the National Administration of Medicines, Food and Medical Technology (“ANMAT”) to authorise the distribution of its vaccine in Argentina, Minister of Health Ginés González García said:
ANMAT “requires all the documentation of the studies that have been done” to authorise it, although he was hopeful given that said medication had its approval in England.
“If they did it in England, they have comfortably everything they have to have.”
Regarding the process that will now take place at ANMAT compared to what happened in England, the official said “regulatory agencies have more or less the same requirements.”
The Minister of Health stated that, unlike other medicinal products, Pfizer requested “a faster authorisation for pandemic reasons.”
Pfizer asked ANMAT to authorise its coronavirus vaccine in Argentina, Minuto NQN, 2 December 2020
It would appear Argentina’s Minister of Health was comfortable relying on the UK’s approval process rather than following the country’s own approval process to ensure all the documentation of studies was in order.
On 2 December 2020, the UK became the first country in the world to grant emergency use authorisation for Pfizer-BioNTech’s covid “vaccine.” This was the same day Minuto NQN reported the Argentine Health Minister’s statements above.
In the UK, the body responsible for approving drugs is the Medicines and Healthcare products Regulatory Agency (“MHRA”). We revealed in July 2021 that the MHRA had a blatant and critical conflict of interest: The Bill & Melinda Gates Foundation was the primary funder of the MHRA while at the same time, the Gates Foundation also owned major shares in both Pfizer and BioNTech. It was only after selling some of his shares in BioNTech, and making a huge profit, that Bill Gates criticised covid injections, stating they don’t block infection, aren’t effective against variants and have “very short duration.”
In addition to the Minister’s seemingly blasé attitude towards the safety and efficacy of a never before used mRNA technology, in February 2021 the UK-based Bureau of Investigative Journalism reported that Pfizer had been accused of bullying Latin American governments in covid “vaccine” negotiations. Officials from Argentina said the company’s negotiators demanded additional indemnity against any civil claims citizens might file if they experienced adverse effects after being injected. In Argentina and Brazil, Pfizer asked for sovereign assets – such as embassy buildings and military bases – to be put up as collateral for any future legal costs.
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Welt report uncovers evidence of serious irregularities in the Pfizer phase 3 Comirnaty trial, suggesting systematic attempts to cover up adverse events at the Argentine clinical site
Yesterday, Welt reporter Elke Bodderas published a report shedding further light on what appear to be systematic efforts to cover up or reclassify adverse events among trial participants.
The centrepiece of their reporting is patient number 12312982, a 36-year-old Buenos Aires resident named Augusto Roux, who participated in the vaccine arm of the trial and experienced significant adverse reactions following both doses of the vaccine.
His most severe symptoms followed the second jab; they included shortness of breath, nausea, fever and darkened urine, and required hospitalisation. Throughout both sets of reactions, he tested negative for Covid. A trial doctor judged his symptoms very likely to be an adverse reaction to vaccination, and there are compelling reasons to think he suffered pericarditis.
Roux promptly dropped out of the trial, and his lawyers succeeded in gaining access to internal Pfizer records of his case. These reveal that Buenos Aires researchers recorded Roux as testing positive for Covid following dose 1, despite multiple negative PCR tests. To cover for his September hospitalisation, meanwhile, they listed him as suffering from a “severe anxiety attack.”
Welt finds other irregularities in data from the Argentine clinical site as well. Following the first dose at the end of August, they removed 53 trial participants; internal documents give nothing but vague, contradictory excuses for the purge.
Following the second dose, Buenos Aires researchers removed a further 200 participants – two-thirds of all removals across the entire trial.
Irregularities appear to extend beyond the shady Buenos Aires operation. As a friend notes on Twitter, the fact that there were more deaths in the vaccine than the placebo arm of the Pfizer trial has always been considered an awkward coincidence by the fact-checkers. Upon closer examination, though, it begins to look like deaths from severe vaccine injuries were actually what put the vaccine arm over the top:
[Pharmacology expert and head of the “Data Based Medicine” network and the vaccine injury support organisation React-19] David Healy has … questions about the trial beyond the Augusto Roux case and other events at Buenos Aires. He wonders about a total of 21 vaccine group deaths that are said to be “not due to vaccination.” In at least two of these deaths, this conclusion doesn’t seem to be fully justified. WELT has documents showing that patient No. 11621327 was found dead in his home three days after the second dose, apparently a stroke. Patient No. 11521497 died 20 days after vaccination, diagnosed with cardiac arrest. “According to the current understandings, these two cases would be attributed to vaccination,” says Berlin-based pharmaceutical specialist Susanne Wagner, “especially since the US health authority CDC is currently investigating strokes in vaccinated people and it is known that blood clots can trigger sudden deaths following vaccination.”
In response to Welt inquiries, Pfizer responded that:
“Regulatory authorities around the world have approved our Covid-19 vaccine. These approvals are based on a robust and independent assessment of the scientific data on quality, safety, and efficacy, including the phase 3 clinical trial.”
Thomas Mertens, head of the German vaccine regulator STIKO, demanded clarification from Pfizer, while the Berlin Charité immunologist Andreas Radbruch suggested the pharmaceutical should be sanctioned to preserve faith in vaccination and trust in regulators.
I doubt very much that will happen.
Further reading: Serious irregularities in Pfizer trials in Argentina: Augusto Roux case, Elcolectivodeuno, 30 May 2022