One of the myths and misconceptions about Pfizer is that it developed a covid vaccine. It didn’t. BioNTech developed the vaccine and Pfizer markets it.
In March 2022, 466 pages of Pfizer non-clinical submission (animal studies) to the US Food and Drug Administration was obtained by Judicial Watch in response to a Freedom of Information request. Sasha Latypova, a former executive of a pharmaceutical Contract Research Organisation, reviewed these documents for a second time at the beginning of the year. One of her findings was that “Pfizer waived major categories of safety testing for their product altogether using a self-serving interpretation of WHO recommendations from 2005.”
However, as Robert Kogon explains below, it is not Pfizer who developed the “vaccine,” but BioNTech. So, it is BioNTech that waived major categories of safety testing, not Pfizer.
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In an informative Substack post, Sasha Latypova asks “Did Pfizer Perform Safety Testing for its Covid-19 mRNA Vaccine in Preclinical Studies?” and comes to the conclusion that the company simply skipped important categories of preclinical testing, i.e. testing on animals, in order to move on to the clinical, i.e. human, trials.
This is undoubtedly true, except that it was not Pfizer that did this, but rather BioNTech, the German firm that is the owner of what is erroneously known as the “Pfizer” vaccine and that was solely responsible for the preclinical program.
There is no need to take my word for it. The founders of BioNTech, CEO Ugur Sahin and CMO Özlem Türeci, say so themselves in The Vaccine: Inside the Race to Conquer the COVID-19 Pandemic: the auto-hagiographical account of their efforts to develop a Covid-19 vaccine that they co-authored with the journalist Joe Miller.
Thus, on page 43 of The Vaccine, we read that the preclinical phase of the drug’s development was “entirely under BioNTech’s control.” The 466-page FDA submission on the preclinical program discussed by Latypova is in fact Pfizer’s submission on BioNTech’s behalf.
As detailed in The Vaccine, BioNTech developed its preclinical program in consultations with the German regulatory agency, the Paul Ehrlich Institute (PEI), with which, as the book likewise makes clear (pp. 44-45), it already had a longstanding and, let’s say, somewhat cosy relationship. And Latypova is right – i.e., right about BioNTech even though she says “Pfizer” – BioNTech was indeed in a rush to get past the preclinical, animal testing, phase, in order to start with the human trials.
But this had nothing whatsoever to do with the US government’s Operation Warp Speed, as Latypova suggests. On Sahin and Türeci’s account, BioNTech launched its own project to develop a Covid-19 vaccine, dubbed “Project Lightspeed,” already in late January 2020 – less than a month after the first Covid-19 cases had been reported in Wuhan and before the outbreak had even been designated a pandemic by the WHO! This was, moreover, roughly five months before the US government would officially launch Operation Warp Speed in May.
Chapter 7 of The Vaccine, titled “First in Human,” narrates Sahin and Türeci’s fevered efforts to abbreviate the preclinical testing phase. On his own account, the need to complete a preclinical toxicology study on animals prior to injecting his vaccine candidate into humans was particularly irksome to Sahin. Sahin wanted the toxicology study rather “to be run simultaneously with clinical trials or skipped altogether”.