COVID
Pfizer’s Failure to Conduct Proper COVID Vaccine Toxicology Tests Called ‘Irresponsible and Unethical’
Veteran toxicologist Helmut Sterz, in a recent interview with John Leake, criticized the rapid development of the Pfizer-BioNTech COVID-19 vaccine. He claimed that normal and proper toxicology studies were not performed — especially on pregnant women — leading to spontaneous abortions, disabilities and deaths.
According to a veteran toxicologist, the process that led to the development and safety testing of the Pfizer-BioNTech COVID-19 vaccine was “irresponsible and unethical.”
Helmut Sterz, who spent over three decades conducting toxicology research for major pharmaceutical companies — including Pfizer — claimed that proper and customary toxicology studies were not performed on the mRNA vaccine before its widespread distribution.
In an interview Monday with John Leake on the “Courageous Discourse” podcast, Sterz criticized the rapid development process and argued that health authorities failed to protect the public by accepting inadequate safety data.
Sterz’s background and expertise
Sterz brings decades of pharmaceutical industry experience to his critique of the COVID-19 vaccine development process. After completing his veterinary medicine studies, he spent three years in virology research before embarking on a career in toxicology.
Sterz’s career path led him through several major pharmaceutical companies, including Servier in France, where he became director of an institute with 125 employees and scientists. He later joined F. Hoffmann-La Roche in Basel, Switzerland, as head of its toxicity institute.
In 2001, Sterz moved to Pfizer in France, where he was responsible for toxicity centers in both France and England. He remained with Pfizer until 2008 when the company closed his work site.
Sterz was enjoying private life until the COVID-19 pandemic began when he became concerned about “all the different measures that were imposed on us.”
‘Fear and panic’ plus government pressure drove vaccine development rush
In 2020, Sterz was an early critic of the rapid vaccine development process, including the U.S. effort, dubbed “Operation Warp Speed,” a name that raised concerns for some observers.
“If a company can develop such a compound within less than 10 months, I was very critical with this and I was sure that I would never get the injection,” Sterz said.
Leake agreed, recalling how at age 50 he thought, “I’m not sure if I want to receive an injection of a new product based on a new technology … developed at warp speed.”
Sterz’s analysis of the development process, based on information from the vaccine creators themselves, revealed that speed — not safety — was the primary driver.
He explained that BioNTech co-founder Ugur Sahin pushed for shorter toxicology studies to accelerate the process.
“Sahin asked his toxicologists to reduce the length of the study in the only general toxicity study … because … he wanted to start with phase one [by April 2020 to] be able to launch the compound by the end of the year,” Sterz said.
The rush to develop the vaccine was further fueled by public statements from influential figures. Sterz recalled German Chancellor Angela Merkel saying something along the lines of, “We will never go back to normality or to peace as long as we don’t have a vaccine.”
This pressure, combined with what Sterz described as a climate of “fear and panic,” created an environment where safety concerns were overlooked in favor of getting the mRNA product to market quickly.
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Death counts ‘tremendous’ for a vaccine
Sterz’s critique of the COVID-19 vaccine development process centers on the lack of thorough toxicology studies. He explained that under normal circumstances, toxicology experiments involve extensive planning and strategy.
“I have always insisted on having a brainstorming session before doing any toxicology experiments where all the information on chemistry of pharmacology and all relevant disciplines went into the discussion,” he said.
This approach allows researchers to “define which aspect of toxicology or safety was the most important and what … we [would] have to observe.”
However, Sterz found that the studies performed for the Pfizer-BioNTech vaccine were wholly inadequate. “There was just this one two-week study, and there was a reproductive toxicology study, which was ongoing at the moment of launch of the compound,” he noted.
The toxicologist was particularly alarmed by a document Pfizer released in February 2021, reporting on the first two months of the vaccine’s use.
“There, the side effects became very obvious,” Sterz said. “Amongst others, there were 1,200 deaths.”
He acknowledged that not all these deaths could be directly attributed to the vaccine but emphasized that the number was “tremendous” for a vaccine. “Normally for a vaccine, one should not have more than 1 in a million who dies,” he said.
Sterz also pointed out that the developers seemed to apply a cancer treatment model to a vaccine intended for widespread use. Given the life-threatening nature of the disease, that model typically involves a higher tolerance for side effects and risks in medications.
“In cancer development, safety does not at all have the same importance as for normal compounds or even a vaccine,” he explained, comparing it to the less-virulent COVID-19. “The less the virus or the disease is killing people, the more your compound must be safe.”
Sterz ‘speechless’ over doctors vaxxing pregnant women
Sterz was especially alarmed about the vaccine’s use in pregnant women, noting that pregnancy is a unique physiological state requiring special consideration in drug development.
“Pregnancy is a special state and we all know that the hormonal situation drastically changes the physiological functions [as they] adapt to the baby,” Sterz explained.
“Pfizer started a study in pregnant women, but they couldn’t get enough volunteers and they aborted the study,” he said.
He noted that when the U.S. Food and Drug Administration accepted Moderna’s vaccine for use in pregnant women, Pfizer followed suit without additional studies. “This is incredible,” he said.
According to Sterz, additional studies that are normally a part of experiments with pregnant animals include not only data collection throughout pregnancy but also during the postnatal development of the offspring — including behavioral tests.
He noted that VAERS (the Vaccine Adverse Event Reporting System) showed “tens of thousands of interferences with the menstrual cycle” and “thousands of babies [spontaneously] aborted.”
Sterz said he understood why authorities continued the vaccination program in 2021 but argued that the growing evidence indicated “there was something going wrong” and that they should have stopped the program, especially for pregnant women.
He said:
“In this context, it is really surprising that the medical doctors, gynecologists and so on said, OK, yes, you should get vaccinated.’ … I just can’t understand why these people took away their … basic knowledge about their profession and followed the lemmings. … I’m speechless.”
Leake called the ongoing vaccination of pregnant women “the single most astonishing social, psychological phenomenon in all of this.”
‘No doubt’ of link between mortality and vaccination
Sterz discussed recent studies examining all-cause mortality rates following the vaccine rollout, noting that mortality rates appeared to increase after the start of mass vaccination campaigns.
“2020 was not a year of extra mortality,” he said. “It started more or less with just after the beginning of the massive vaccination campaign.”
The patterns were consistent across multiple countries with high vaccination rates, he said.
“For me, there is no doubt that there is a link between mortality and intensity of the vaccination,” he said. “And this holds also true for countries with very high vaccination levels, such as Israel and others.”
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Health authorities ‘made the vaccine catastrophe possible’
Sterz leveled strong criticism at both the pharmaceutical companies and health authorities involved in the vaccine’s development and approval.
“My conclusion regarding the strategy of BioNTech and Pfizer regarding the preclinical safety testing [is that it] was irresponsible and unethical,” Sterz declared.
He argued that health authorities “made the vaccine catastrophe possible by accepting the inadequate preclinical safety data from the sponsors.”
Sterz believes that these actions have had severe consequences. “They bear responsibility for millions of vaccine side effects, some of which have caused severe lifelong disabilities and death.”
He accused health authorities of violating their duty of care toward the public and favoring manufacturers they were supposed to monitor.
In light of these concerns, Sterz called for greater public awareness and critical thinking.
“I think the most important thing is that people are not so much influenced by the media and by certain politicians, but that they think for themselves,” he advised.
He hoped this experience would lead people to “wake up and decide for themselves what they want to tolerate and what not.”
Leake, in the brief article accompanying the interview, drew parallels between the rapid vaccine development and historical instances of scientific hubris.
He referenced the story of Pandora’s Box and Dr. Frankenstein, suggesting that the developers of the COVID-19 vaccine may have “created the Pharma Lab equivalent of a Pandora’s Box that has released a host of sickness and death on mankind.”
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