As noted in my last article on BioNTech’s “brazen” avoidance of safety testing of its Covid-19 vaccine, BioNTech founders Ugur Sahin and Özlem Türeci claim in their book The Vaccine that the company’s Covid-19 vaccine project got underway on January 27, 2020. But documentary evidence released in response to a FOIA request (and included in the so-called “Pfizer documents”) shows that this is not true and that the company had in fact already begun preclinical, i.e. animal, testing nearly two weeks earlier, on January 14.
BioNTech R&D STUDY REPORT No. R-20-0072 is available here. The report is also referenced and discussed in an FDA submission on the preclinical study program that is available here. The below screenshot shows the study dates from p. 8 of the report.
In the book, Sahin claims furthermore that he only even became interested in the outbreak in Wuhan on January 24, after reading an article in the German weekly Der Spiegel (p. 4) and/or a submission to The Lancet (p. 6). But look again at the study dates above. BioNTech had already completed the first preclinical study for its Covid-19 vaccine the day before!
January 24, 2020 was a Friday. On Sahin’s account, he took the decision to launch his Covid-19 vaccine project over the weekend and unveiled his plans to his collaborators at BioNTech’s headquarters in Mainz, Germany on the following Monday: January 27 (ch. 2 passim and p. 42; see screencap below).
Sahin claims (p. 33) that it was at this January 27 meeting that he asked BioNTech’s animal testing team to prepare the preclinical program that was in fact already underway!
It should be noted that January 14, 2020, the start-date of the first preclinical study, was just two weeks after the first report of Covid-19 cases in Wuhan and just a day after the release of the full SARS-CoV-2 genome (drafts had been released previously).
BioNTech’s first preclinical study was evidently prepared before publication of the genome and in anticipation of it. As explained in the summary of the study (p. 6), its purpose was to test BioNTech mRNA formulated in lipid nanoparticles produced by the Canadian firm Acuitas. But the mRNA was here encoding a proxy antigen (luciferase), not the spike protein of SARS-CoV-2 that would later serve as the target antigen.
The study looked at both biodistribution and immune system activation. As the FDA submission on the preclinical program puts it, “Platform properties that support BNT162b2 were initially demonstrated with non-SARS-CoV-2 antigens” (2.4 NONCLINICAL OVERVIEW, p. 7).
In The Vaccine, which was written with the journalist Joe Miller, Sahin and Türeci talk about the need to obtain the Acuitas lipids, which, they say, were more suitable for intramuscular injection than BioNTech’s own in-house lipids. But, again, they postdate the matter. Thus, on p. 52, we read: “The missing piece was still Acuitas, who had not yet consented to the use of their lipids. Then, on the morning of Monday 3 February, [Acuitas CEO] Tom Madden offered his help.” But BioNTech was already running tests using the Acuitas lipids three weeks earlier!
Furthermore, BioNTech was not able to formulate its mRNA into the lipids itself, but depended on the Austrian company Polymun to do this for it. As noted in The Vaccine (p.51), Polymun’s facilities are an 8-hour drive from BioNTech’s headquarters in Mainz. In the book, Sahin and Türeci describe the first batch of mRNA for the vaccine tests proper being packed up and driven by car to Polymun outside Vienna: “A couple of days later, a small Styrofoam box containing frozen vials full of vaccine would be driven back over the border to BioNTech” (pp. 116-117).
But presumably this same back-and-forth had to have occurred with the mRNA encoding the luciferase. This means that as a practical matter “Project Lightspeed” must have gotten underway even earlier: at least several days before the January 14 start date of the study.
Why did Sahin and Türeci postdate the launch of their Covid-19 vaccine project in their book? Well, undoubtedly because the actual start date – and we do not know when exactly the actual start date was – would have seemed far too soon. Based on the above considerations, it must have been at the latest just days after the first December 31, 2019 report of Covid-19 cases in Wuhan.
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