There are mounting concerns over the validity of the data that led to the approval of BioNTech/Pfizer’s mRNA vaccine, according to the German news outlet Welt.
Questions have been raised about the pivotal phase 3 study, with doubts growing over the documentation that was submitted for approval.
“BioNTech/Pfizer’s mRNA vaccine approval may have been based on incorrect documentation. There are increasing doubts about the data from the pivotal phase 3 study, reads the Welt publication’s byline. “Pfizer dodges the allegations and refuses to review.”
The case of Augusto Roux, a lawyer from Buenos Aires who was a test subject, has particularly drawn attention.
Roux suffered severe symptoms during the final testing phase in September 2020 and pulled out of the trial. With almost 6,000 subjects worldwide, Buenos Aires was a crucial location for the vaccine’s third and final test phase.
However, the Pfizer study center in Buenos Aires experienced significant irregularities that have now put the entire study on the efficacy and side effects of the Biontech/Pfizer vaccine in a different light.
Roux received the first dose of the mRNA vaccine in August 2020 at the military hospital, where his arm began to hurt and swell.
He subsequently experienced nausea, difficulty swallowing, and changes in his sense of smell, stools, and urine.
Two days after vaccination, Roux reported to his test doctors, who noted in the protocol, “Undesirable effect of toxicity level 1.”
Three weeks later, Roux received the second dose and later suffered from shortness of breath, burning chest pain, nausea, fever, and pericarditis (inflammation of the heart).
Roux was hospitalized and tested negative for Covid-19 several times, but his medical records were reinterpreted to suggest that he had pneumonia and anxiety.
His medical history was not mentioned in the approval study from December 2020, and his case does not appear in later evaluations either.
The Roux case was not the only incident in the Buenos Aires test center.
Fifty-three subjects were removed from the trial on August 31, 2020.
The Pfizer study protocol only allows for unblinding participants in emergencies, yet the test management informed the 53 subjects about their vaccination status.
However, the approval study does not mention this incident.
Moreover, 302 volunteers from the vaccine group were eliminated from the study after the second vaccination, with 200 of them coming from Buenos Aires.
The Argentine health authority ANMAT inspected the military hospital twice, as they suspected that things were not going as they should.
There were also two deaths in the vaccine group that raised concerns.
Patient no. 11621327 was found dead in his apartment three days after the second dose, and patient #11521497 died 20 days after vaccination.
“According to the current state of science, these two cases would be assigned to the vaccination,” said the Berlin pharmaceutical specialist Susanne Wagner.
The pivotal trial’s validity has been questioned by pharmacology expert David Healy, who believes that the approval studies are unreliable and that there is fraud and suppression of harm in clinical trials.
Healy found that there were 21 vaccine group deaths that were deemed “not due to the vaccine.”
Andrew Ullmann, the health policy spokesman for the FDP, called for the clarification of irregularities in studies, while Klaus Stöhr, a former Novartis vaccine program manager, emphasized the need for these incidents to be discovered and taken into account.
Pfizer responded promptly to these concerns, stating that regulatory authorities worldwide have approved their COVID-19 vaccine based on a robust and independent review of quality, safety, and efficacy scientific data, including the Phase 3 clinical trial.
However, emails from the EMA show that the FDA, British MHRA, and EMA had already agreed on the date of approval before they could review the Pfizer papers, indicating that time was of the essence due to the pandemic.