As discussed in my last article, BioNTech, the German owner and legal manufacturer of what is more commonly called the ‘Pfizer’ COVID-19 vaccine, was determined to be not just the drug’s legal manufacturer but, at least in Europe, also the physical manufacturer of the mRNA, which is the active drug substance. Thus, with the financial help of the German Government, the company purchased a manufacturing facility in Marburg in autumn 2020 – before the drug had even been authorised for use. By April 2021, after being refitted for mRNA manufacturing by the German tech company Siemens, production at BioNTech’s new factory in Marburg had already begun.
But careful readers will have noticed another problem with this timeline: vaccine rollout in Europe began already in December 2020 – oddly enough in its own right, just days after authorisation. The European Medicines Agency (EMA) authorised the BioNTech-Pfizer vaccine for use in the EU on December 21st; vaccine rollout officially began in Germany, for instance, on December 27th.
So, where did the mRNA in the earlier batches, the batches released between December and April, come from?
Well, the answer is buried in the EU’s ‘hidden contract’ with the BioNTech-Pfizer consortium (which I wrote about here). Thus, section I.6.3 of the contract or Advance Purchase Agreement, which was concluded in November 2020, specifies that vaccine supply “‘shall incorporate RNA produced at BioNTech controlled manufacturing sites”. It adds, however, that “the Contractor [i.e., BioNTech and Pfizer jointly] may manufacture at and supply from facilities outside Europe… to hasten supply”. See the full paragraph below, which, incidentally, is almost entirely redacted in the version of the contract published by the European Commission.
As annexes to the contract and EMA documents make clear, “facilities outside Europe” undoubtedly refers to Pfizer’s manufacturing facility in Andover, Massachusetts.
But this raises a further issue in turn. It will be recalled from the famous Danish batch variability study that at least the batches of the BioNTech-Pfizer vaccine used in Denmark broke down into three large groups in terms of toxicity: the highly toxic ‘blue’ batches, associated with an extraordinarily high number of adverse events; the moderately-toxic ‘green’ batches, associated with a relatively high number of adverse events; and the virtually harmless ‘yellow’ batches, associated with a very low number of adverse events (and, in some cases, literally none).
Furthermore, we know from the authors of the study that the ‘blue’, ‘green’ and ‘yellow’ batches were not rolled out simultaneously but rather consecutively: the ‘blue’ batches were the earliest ones. This also appears to be evident in the seriality of the batch numbers, as seen in the below table prepared by the German Chemistry Professors Gerald Dyker and Jörg Matysik.
So, does this mean that the highly toxic ‘blue’ batches were the batches containing mRNA from Pfizer Andover? In theory, the manufacturing process used at Pfizer Andover is supposed to be identical with the one used at BioNTech Marburg. Could BioNTech have somehow changed the recipe, perhaps simply using less than the official dose, when rolling out production at the Marburg facility in April?
Could the ‘blue’ batches have contained ‘Pfizer mRNA’, the ‘green’ batches a lower dose of ‘BioNTech mRNA’ and the ‘yellow’ batches no mRNA at all?
Regarding the ‘yellow’ batches, as discussed here, this is in fact what Prof. Dyker was hinting at when he first noted that the batch release authority, Germany’s PEI, had not subjected them to quality control testing and said that they could be “something like placebos“.
Finally, if the ‘blue’ batches were indeed the batches containing mRNA from Pfizer Andover, does this mean that the U.S. market continued to be supplied with the most highly-toxic formulation?
Robert Kogon is the pen name of a widely-published journalist covering European affairs. Subscribe to his Substack.
Stop Press: Vibeke Manniche, one of the authors of the Danish study, has tweeted this article and confirmed that, in her view, the explanation “makes sense”.
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