By Robert Kogon*
In an informative Substack submit, Sasha Latypova asks, “Did Pfizer Perform Safety Testing for its Covid-19 mRNA Vaccine in Preclinical Studies?” and involves the conclusion that the corporate skipped essential classes of preclinical testing, i.e., testing on animals, to maneuver on to the medical, i.e., human, trials.
This is undoubtedly true, besides that it was not Pfizer that did this, however somewhat BioNTech, the German agency that’s the proprietor of what’s erroneously generally known as the “Pfizer” vaccine and that was solely answerable for the preclinical program.
There isn’t any have to take my phrase 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 web page 43 of The Vaccine, we learn that the preclinical part of the drug’s growth was “entirely under BioNTech’s control.”
The 466-page FDA submission on the preclinical program mentioned by Latypova is actually Pfizer’s submission on BioNTech’s behalf.
As detailed in The Vaccine, BioNTech developed its preclinical program in consultations with the German regulatory company, the Paul Ehrlich Institute (PEI), with which, because the e book likewise makes clear (pp. 44-45), it already had a longstanding and, let’s say, considerably cozy relationship.
And Latypova is correct – i.e., proper about BioNTech though she says “Pfizer” – BioNTech was certainly in a rush to get previous the preclinical, animal testing part with the intention to begin with the human trials.
But this had nothing to do with the US authorities’s Operation Warp Speed, as Latypova suggests.
On Sahin and Türeci’s account, BioNTech launched its personal challenge to develop a Covid-19 vaccine, dubbed “Project Lightspeed,” already in late January 2020 – lower than a month after the primary Covid-19 circumstances had been reported in Wuhan and earlier than the outbreak had even been designated a pandemic by the WHO!
This was roughly 5 months earlier than the US authorities would formally 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 part.
On his personal account, the necessity to full a preclinical toxicology examine on animals earlier than injecting his vaccine candidate into people was significantly irksome to Sahin.
Sahin wished the toxicology examine somewhat “to be run simultaneously with clinical trials or skipped altogether” (p. 158).
Astonishingly, Germany’s PEI agreed to the previous proposition – though the entire level of the preclinical toxicology examine is to make sure that it’s secure to proceed to human trials!
The justification given by BioNTech relied on a 2017 WHO draft report on vaccines for the far deadlier Ebola virus.
The 2017 draft report and the 2018 last report (p. 132) counsel that interim information from an incomplete preclinical toxicology examine “may be sufficient” to proceed to a Phase 1 medical trial throughout a public well being emergency.
All the foregoing transpired earlier than BioNTech had even recruited Pfizer as a companion to shepherd its vaccine candidate by way of the medical a part of the authorization course of and commercialize it on some (however not all) markets as soon as accepted.
According to Sahin and Türeci (p. 51), BioNTech first met with the PEI to debate their plans on February 6.
The preclinical toxicology examine would get underway on March 17 (p. 161) – maybe not coincidentally, the very day that the BioNTech-Pfizer collaboration settlement was concluded.
Barely one month later, on April 23, BioNTech itself would provoke a Phase 1 human trial in Germany and, n.b., nonetheless with none involvement of Pfizer. (The EU Clinical Trials Register entry is right here.)
According to Sahin and Türeci (p. 171), the requisite interim report on the preclinical toxicology examine was accomplished in simply two months.
But there’s an apparent downside: the dates don’t add up. Two months from March 17 would take us to May 17. Contrary to the advice within the WHO Ebola vaccine report, BioNTech would seem to have moved on to human trials with the PEI’s blessing even earlier than the interim report was accomplished.
As the FDA submission mentioned by Latypova makes clear, a number of different classes of preclinical testing have been omitted altogether.
These embody so-called security pharmacology research, which, per 2005 WHO pointers, are meant to analyze the results of a candidate vaccine on “physiological functions (e.g. central nervous system, respiratory, cardiovascular and renal functions) other than those of the immune system.”
It is these 2005 WHO pointers which can be cited by Pfizer within the FDA submission to justify the absence of any security pharmacology research.
Among different locations, the reference is discovered, as an example, in an appendix that’s titled exactly “Justification for the absence of studies.”
The similar pointers are additionally cited by the European Medicines Agency in its February 2021 Comirnaty evaluation report, the place it notes that “No security pharmacology research have been performed with BNT162b2.
The Applicant refers to that they aren’t thought of obligatory in response to the WHO guideline (WHO, 2005).”
As within the US Biologics License Application to the FDA, by the way, “the applicant” right here is BioNTech, not Pfizer.
But do the 2005 WHO pointers actually justify omitting the research as “not necessary?” In his new e book Die mRNA Maschine (The mRNA Machine), David O. Fischer examines the related passages of the WHO pointers, in addition to these of earlier 2001 EMA pointers to which the WHO pointers refer, and he comes to exactly the alternative conclusion:
specifically, that the rules require such research, “in particular for novel pharmaceutical approaches” reminiscent of mRNA vaccines (p. 85).
Fischer (a pseudonym for a biologist and former pharma trade government) writes: “By eliminating any sort of safety pharmacology studies, BioNTech violated these general requirements in a way that can only be described as brazen” (p. 85).
(Translations from German by the writer.)
Postscript: As alluded to above, of their e book, Ugur Sahin and Özlem Türeci declare that BioNTech’s Covid-19 vaccine challenge received underway on January 27, 2020. But documentary proof launched below the American Freedom of Information Act tells a distinct story. A BioNTech examine report included within the so-called “Pfizer Documents” exhibits that BioNTech actually already started animal testing on January 14 – simply at some point after the publication of the SARS-CoV-2 genome! See p. 8 of the report for the examine dates.
* Robert Kogon is a pen title for a widely-published monetary journalist, a translator, and researcher working in Europe. Follow him at Twitter right here. He writes at edv1694.substack.com.
This submit was revealed first right here.