Serious irregularities in Pfizer trials in Argentina: Augusto Roux case

A cache of 80,000 pages of Pfizer-BioNTech COVID-19 vaccine documents released by the US Food and Drug Administration (FDA) sheds light on Pfizer’s extensive vaccine trials in Argentina, including the unusually large size of the trials and the story of a trial participant whose reaction to the vaccine was “disappeared”.

The Augusto Roux case in Argentina suggests that, in at least one case, a trial participant whose symptoms were determined to be related to the COVID-19 vaccine was later listed in official records as having experienced adverse events unrelated to the vaccine. vaccination.

Vaccine trials in Argentina also appear to have overlooked adverse events suffered by other trial participants and the possible connection between the adverse events and the vaccine.

On 2 May, the FDA released the latest set of documents, pertaining to Pfizer’s Emergency Use Authorisation for the vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act request filed in August 2021. The documents included report forms included case report forms from Pfizer’s COVID injection trials in the US and the ‘third interim report’ from BioNTech trials conducted in Germany, which list adverse events suffered by participants in trials in the US and Germany.

Many of these adverse events were listed as ‘unrelated’ to the injections, even in cases where patients were healthy or had no medical history related to the injuries they suffered.

Story of ‘missing Argentine patient’ goes public

Online researchers questioned several aspects of the Argentine injection trials, pointing out that the number of participants in the Argentine trials dwarfed that of other, generally smaller trials elsewhere in different countries.

They also noted that the large number of participants appeared to have been recruited for the trial in a remarkably short time and questioned the connections between one of the key figures in the Argentine trial with vaccine manufacturers Big Pharma and the Bill and Melinda Gates Foundation.

The large number of trial participants in Argentina may be related to the fact that the trial appears to have been conducted simultaneously in 26 hospitals.

The large number of participants is revealed in another of the documents published this month, where on page 2245 begins the list of randomised participants at trial site 1231, while on page 4329 begins the list of participants at trial site 4444.

Site 1231 refers to the location of the main trial site and 4444 ( page 24 ) most likely refers to the different hospitals participating in the trial outside the main site.

Commenting on the disclosure, David Healy wrote :

“Around 5,800 volunteers were enrolled, half of whom received the active injection. This is almost 4 times more than the next largest site in this trial.

“Remarkably, 467 physicians were enrolled and trained almost instantly as assistant investigators in the study.”

In total, 4,501 patients participated in the Argentinian trials, representing 10% of all Pfizer trial participants worldwide.

Complete information on adverse events during this large trial in Argentina does not appear to have been published at the time of writing.

However, Roux’s experience has since been made public.

Roux, often referred to as the “missing” patient, volunteered for the trial (volunteer number 12312982) and received his first dose of Pfizer’s vaccine on 21 August 2020.

According to Healy, Roux “felt pain and swelling in his arm right after the injection. Later that day she had nausea, difficulty swallowing, and a hangover”.

After a series of symptoms, Roux, during a clinical trial visit on 23 August 2020, was classified as experiencing a “grade 1 toxicity adverse effect”.

However, she received her second dose on 9 September 2020.

According to Healy:

“On the way home in a taxi, he started to feel unwell. By 19:30, he was short of breath, had a burning pain in his chest and was extremely fatigued. He lay down on his bed and fell asleep. He woke up at 21:00 with nausea and fever (38-39 C) and could not get out of bed because of fatigue.

“For the next two days, he reports a high fever (41 C) and feels delirious.

“On 11 September he was able to get out of bed and go to the toilet when he noticed that his urine was dark (like Coca-Cola). He felt as if his heart was expanding, had a sudden shortness of breath and fell unconscious on the floor for about 3 hours.

“Once he recovered, he felt tired, uncomfortable, had a high heart rate with minor movements, became dizzy when changing posture. He had chest pain that radiated down his left arm and back.”

On 12 September 2020, Roux was admitted to the German Hospital, where he stayed for two days. He was initially thought to have COVID-19, but tested negative for the virus. His symptoms were also found not to be consistent with viral pneumonia.

After a series of x-rays, CT scans and urinalysis, Roux was discharged on 14 September 2020, after being diagnosed with an adverse reaction, specifically, an unequivocal pericardial effusion, to the coronavirus vaccine (high probability), according to her doctor. discharge summary .

The doctor who altered Roux’s record had ties to Gates, NIH and big pharma.
However, on 17 September, Dr Fernando Polack , Pfizer’s principal investigator for the Argentine trials according to a Pfizer document released in December 2021, reported in Roux’s record that her “hospitalisation was not related to the vaccine”.

Even after Roux’s discharge, his health problems continued. As reported by Healy:

“On November 13 [2020], she had negative IgG and IgM SARS COV-2 (QML technique), which is unusual after vaccination.

“On 24 February 2021, a liver scan showed a minor degree of abnormality. In March 2021 and February 2022, his liver enzymes remained abnormal.”

Roux ultimately lost 14 kilograms (30.8 pounds) over a three- to four-month period and continued to suffer from fever and episodes of shortness of breath for several months afterward.

Polack, who reported that Roux’s hospitalisation was not related to vaccination, is known for his close ties to several vaccine manufacturers, pharmaceutical companies and the Bill and Melinda Gates Foundation.

For example, he is listed as a lead author on a 31 December 2020 New England Journal of Medicine (NEJM) article on the purported efficacy of the Pfizer COVID-19 vaccine.

According to Healy, Polack also appears to be the founder of iTRIALS , a trial site management company, and another organisation located in the same physical location, the INFANT Foundation .

Healy wrote:

“When COVID hit Argentina, [Polack] and his Foundation became involved in a trial of immune plasma, taken from patients who had recovered from COVID, administered to patients who had recently acquired the disease.

“In May 2020 he speculated that this would make COVID like a common cold and the Gates Foundation would offer financial support. He used high-profile press conferences to spread his message.”

The conclusion of the study published in the NEJM after the plasma study reads:

“Funded by the Bill and Melinda Gates Foundation and the INFANT Pandemic Fund Foundation; Directorate of Blood and Transfusion Medicine of the Ministry of Health number, PAEPCC19, Platform for Computerized Health Research Registry number, 1421, and number, NCT04479163.”

According to Healy, “[a] subsequent systematic review and meta-analyses were unable to confirm these findings and noted ‘very serious imprecision concerns’.”

Healy noted that Polack, in his NEJM disclosure statement, did not indicate any conflict of interest or financial interest in the COVID-19 vaccine trials in Argentina, but:

“Polack reported grants from Novavax and personal fees from Janssen, Bavarian Nordic A/S, Pfizer, Sanofi, Regeneron, Merck, Medimmune, Vir Bio[technology], Ark Bio, Daiichi Sankyo outside the submitted work.

“At least eight of these companies are engaged in research on RSV vaccines for infants and pregnant women. Fernando has mentioned a combined RSV, influenza and COVID vaccine”.

And, regarding Polack’s relationship with the Bill & Melinda Gates Foundation, Healy reported:

“[Polack] also fails to mention his extensive financial involvement with the Bill & Melinda Gates Foundation. This organisation supports industry vaccine trials, including Covid and RSV. Polack is heavily involved through his Gates-sponsored INFANT Foundation in Buenos Aires in RSV trials and research.

“Gates invested $82,553,834 in Novavax’s RSV vaccine ResVax, which proved ineffective in clinical trials in pregnant women.”

Polack’s own biography from a 2017 medical conference states that “[his] work is funded by the Bill and Melinda Gates Foundation, the National Institutes of Health [NIH], the Thrasher Research Fund, the Optimus Foundation and other international organisations.”

That same year, Polack testified at a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), where he “acknowledged having financial interests or professional relationships with some of the affected companies identified for this meeting, namely Janssen [producer of Johnson & Johnson COVID, Novavax and Bavarian Nordic]”.

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