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

Pfizer enrolled 44,000 people across 270 clinical sites in the 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 pediatric 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 Argentine parliament.

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 succeeded in gaining access to internal Pfizer records about 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 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.