A recent report by Robert Kogon has resurfaced, shedding new light on the Pfizer-BioNTech vaccine batches used in the European Union (EU). While much attention has been given to the variability in toxicity levels among different batches, Kogon highlights an important detail that was overlooked in previous discussions: the possibility that some batches may have been “placebos” in the sense that they lacked the crucial mRNA component.
Contrary to popular belief, Kogon explains that a placebo does not necessarily mean a saline solution. In the context of the Pfizer-BioNTech vaccine, a placebo could refer to a solution containing all the ingredients of the drug except for the mRNA, which is responsible for triggering an immune response. The lipid nanoparticles that serve as the delivery system would be empty, devoid of any active drug substance. This revelation raises questions about the integrity of certain batches and the potential collusion between the German regulator, Paul Ehrlich Institute (PEI), and BioNTech, the developer of the mRNA platform.
Kogon points out that the focus of his report was not solely on the batch variability study conducted in Denmark but on the fact that the PEI did not subject most of the “yellow” batches, which were found to be mostly innocuous, to quality control testing. This supports the suspicion that these batches may have been something akin to placebos, leading to speculation that the PEI was aware of their harmlessness and therefore skipped testing. Interestingly, according to EU law, placebos are allowed to contain all excipients except for the active substance, in this case, modified RNA.
Critics attempted to debunk the placebo hypothesis by arguing that the “yellow” batches were associated with higher rates of adverse events than reported in the Danish study. However, Kogon demonstrates that these objections fail when closely examining the arguments and data. Furthermore, he highlights the correlation between the untested “yellow” batches and their harmlessness, suggesting that adverse reactions, if any, could be attributed to the excipients, including the lipid nanoparticles.
The possibility that some batches may have lacked mRNA raises concerns about collusion between the PEI and BioNTech. The unredacted version of the Advanced Purchase Agreement (APA) between the European Commission and the Pfizer-BioNTech consortium reveals that BioNTech, along with its subcontractors, was responsible for supplying all the mRNA used in the EU. However, the APA allows for manufacturing and supply from facilities outside Europe if necessary to expedite production. This exception may explain the chronological rollout of different batches, with the highly-toxic “blue” batches potentially containing mRNA from Pfizer's Andover facility in Massachusetts.
Kogon raises the question of whether the toxicity levels in the U.S. supply, which likely includes mRNA from Pfizer-Andover, display a similar pattern over time. This information adds another layer to the ongoing discussion surrounding the Pfizer-BioNTech vaccine and calls for further investigation into batch integrity and transparency.
In conclusion, Kogon's report brings to light important details regarding the Pfizer-BioNTech vaccine batches. The possibility that some batches may have lacked mRNA raises concerns about collusion and calls into question the integrity of the regulatory process.