An 80,000-page cache of Pfizer-BioNTech COVID-19 vaccine documents released by the U.S. Food and Drug Administration sheds light on Pfizer’s extensive trials in Argentina, including the unusually large trial size and the story of a trial participant whose vaccine reaction was suppressed.
By Michael Nevradakis, Ph.D.
An 80,000-page cache of Pfizer-BioNTech COVID-19 vaccine documents released by the U.S. Food and Drug Administration (FDA) sheds light on Pfizer’s extensive trials of Pfizer vaccines in Argentina , including the unusually large size of the trials and the story of one trial participant whose vaccine reaction “disappeared”.
The case of Augusto Roux 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 who experienced adverse events that were not related to vaccination.
Vaccine trials in Argentina also appear to have glossed over adverse events experienced by other trial participants and the potential link between the adverse events and the vaccine.
On May 2, the FDA released the latest cache of documents, which relate to Pfizer’s vaccine emergency use authorization, as part of a court-ordered disclosure schedule stemming from a request expedited under the Freedom of Information Act filed in August 2021.
As previously reported by The Defender , the documents included case report forms from Pfizer’s US COVID vaccine trials and the ” third interim report ” from BioNTech’s trials in Germany, both of which listed adverse events. suffered by participants in the American and German trials.
Many of these adverse events were listed as “unrelated” to the vaccines – even in cases where the patients were healthy or had no medical history related to the injuries they suffered.
The story of a “missing patient” becomes public
Several bloggers and online researchers have questioned various aspects of Argentina’s vaccine trials, pointing out that the number of participants in Argentina’s trials dwarfs that of other, usually smaller, trials in other locations in different countries.
They also pointed to the large number of participants who appeared to have been recruited for the trial in a remarkably short time, and questioned the links between one of the key figures in the Argentine trial and vaccine makers, Big Pharma and the Bill & Melinda Gates Foundation . 1 million copies sold — ‘The Real Anthony Fauci’ — The book that started a movement. BUY TODAY!
The large number of trial participants in Argentina may be related to the fact that the trial appears to have taken place simultaneously in 26 hospitals .
The large number of participants is revealed in another of the documents published this month, where on page 2,245 the list of participants randomized to trial site 1231 begins, while on page 4,329 the list of participants at the 4444 trial site begins.
Site 1231 refers to the location of the primary trial site and 4444 ( page 24 ) most likely refers to the disparate hospitals participating in the trial outside of the primary location.
Commenting on the revelation, blogger David Healy wrote :
“About 5,800 volunteers were recruited, half of whom received the active vaccine. This is almost 4 times more than the second largest center in this trial.
“Amazingly, 467 physicians were almost instantly enrolled and trained as adjunct investigators in the study. »
A total of 4,501 patients participated in the Argentine trials , representing 10% of all Pfizer trial participants worldwide.
Full information on adverse events that occurred during this large trial in Argentina does not appear to have been published at the time of this writing.
However, Roux’s experience has since become public knowledge .
Roux, often referred to as the “missing” patient, volunteered for the trial (volunteer number 12312982) and received his first dose of the pfizer vaccine on August 21, 2020.
According to Healy, Roux “felt pain and swelling in her arm right after the injection. Later that day, he had nausea, difficulty swallowing, and was hungover.
After a series of symptoms, Roux – during a clinical trial visit on August 23, 2020 – was classified as experiencing a “grade 1 toxicity adverse reaction”.
He nevertheless received his second dose on September 9, 2020.
According to Healy:
“On the taxi ride home, he started feeling unwell. By 7:30 p.m., he was short of breath, had burning pain in his chest, and was extremely tired. He lay down on his bed and fell asleep. He woke up at 9:00 p.m. with nausea and a fever (38-39 C) and could not get out of bed due to fatigue.
“Over the next two days, he reports a high fever (41C) and feels delirious.
“On September 11, he was able to get out of bed and go to the bathroom when he observed that his urine was dark (like coca-cola). He felt like his heart was enlarging, had sudden shortness of breath, and fell unconscious on the floor for about 3 hours.
“Once he recovered, he felt tired, was uncomfortable, had an elevated heart rate on minor movements, was dizzy when changing posture. He had chest pain that radiated to his left arm and back. »
On September 12, 2020, Roux was admitted to Hospital Alemán, where he remained for two days. He was initially thought to have COVID-19, but tested negative for the virus. His symptoms were also not consistent with viral pneumonia.
After a series of X-rays, CT scans and urine tests, Roux was discharged on September 14, 2020, after being diagnosed with an adverse reaction – specifically, an unequivocal pericardial effusion – to the coronavirus vaccine (strong probability), according to its output summary .
Doctor who changed Roux’s file had ties to Gates, NIH, Big Pharma
However, on September 17, Dr. Fernando Polack , Pfizer’s principal investigator for the Argentine trials according to a Pfizer document published in December 2021, reported in Roux’s filing that his “hospitalization was unrelated to the vaccine” .
Even after Roux was released, his health issues continued. As Healy reported:
“On November 13 [2020], he was SARS COV-2 IgG and IgM (QML technique) negative, which is unusual after the vaccine.
“On February 24, 2021, a liver scan showed a minor degree of abnormality. In March 2021 and February 2022, his liver enzymes remained abnormal.
Ultimately, Roux lost 14 kilograms (30.8 pounds) over a period of three to four months and continued to suffer from fever and shortness of breath for several months thereafter. It’s time to follow the science. Join our campaign!
Polack, who reported Roux’s hospitalization was unrelated to the vaccination, is known for his close ties to various vaccine makers, pharmaceutical companies and the Bill & Melinda Gates Foundation.
For example, he is listed as the lead author in a December 31, 2020 New England Journal of Medicine (NEJM) article on the alleged efficacy of Pfizer’s COVID-19 vaccine.
According to Healy, Polack also appears to be the founder of iTRIALS , a trial site management company, and another organization at the same physical headquarters, Fundación INFANT .
Healy wrote:
“When COVID hit Argentina, [Polack] and his Fundación were involved in a trial of immune plasma, taken from patients who had recovered from COVID, given to patients who had recently contracted the disease.
“In May 2020, he speculated that it would make COVID like a common cold and that the Gates Foundation would offer financial support. He used high profile press conferences to spread his exciting message. »
The conclusion of the study published in the NEJM following the plasma study reads:
“Funded by the Bill and Melinda Gates Foundation and the Fundación INFANT Pandemic Fund; Dirección de Sangre y Medicina Transfusional del Ministerio de Salud number, PAEPCC19, Plataforma de Registro Informatizado de Investigaciones en Salud number, 1421, and ClinicalTrials.gov number, NCT04479163. »
According to Healy, “[a] subsequent systematic review and meta-analysis failed to confirm these findings, noting ‘very serious concerns of imprecision'”.
Healy pointed out 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 of the submitted work.
“At least eight of these companies are engaged in RSV vaccine research in babies and pregnant women. Fernando mentioned a combined vaccine against RSV, influenza and COVID.
And, regarding the relationship with the Bill & Melinda Gates Foundation, Healy reported:
“[Polack] also does not mention his extensive financial involvement with the Bill & Melinda Gates Foundation. This organization supports industry vaccine trials, including Covid and RSV. Fernando is heavily involved through his Gates-sponsored Fundación INFANT in Buenos Aires in RSV trials and research.
“Gates sunk $82,553,834 into Novavax’s ResVax RSV vaccine, which was found to be ineffective in clinical trials in pregnant women. »
His own biography from a 2017 medical conference states that “[t]he work is funded by the Bill & Melinda Gates Foundation, the National Institutes of Health [NIH], the Thrasher Research Fund, the Optimus Foundation and others. International organisations “.
That same year, Polack testified at a meeting of the FDA’s Vaccines and Related Biologicals 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 the johnson & Johnson COVID vaccine ], Novavax and Bavarian Nordic”.
According to Dr. Joseph Mercola, Polack “also happens to be a consultant for the U.S. Food and Drug Administration’s Vaccines and Related Biologicals Advisory Committee (VRBPAC)” and “a current assistant professor at Vanderbilt University in Tennessee”.
By Michael Nevradakis, Ph.D.
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