A Theory on Pfizer-BioNTech Fraud

or How Pfizer and BioNTech Squared the Circle to Achieve Higher Efficacy with Lower Toxicity

One of the most important discoveries in Peter Doshi’s seminal BJM article on Pfizer-BioNTech’s famous 95% efficacy claim was that five times more participants were excluded  from data analysis for protocol deviations in the vaccine arm of the clinical trial than in the placebo arm: 311 in the vaccine arm as compared to 60 in the placebo. Interestingly, as Doshi notes, no such disparity is to be found in the Moderna trial. Indeed, only 36 participants in all were excluded from the Moderna trial – just 10% of the exclusions in the Pfizer-BioNTech trial! – and of these, twice as many (24 to 12) were in the placebo arm. As Michael Yeadon and others have pointed out, the huge imbalance in exclusions in the Pfizer-BioNTech trial is perhaps the most striking prima facie evidence of fraud that we have: a “smoking gun,” in effect.

So, were Pfizer-BioNTech the only ones to cheat¹ and if so, what was the motive? Well, there is a relatively obvious answer to the latter question now that ex post observation has taught us more about both of these vaccines and given one key detail that we have known about them from the start: namely, that the Moderna dose is much higher. 100 μg versus 30 µg. What we now know is that this higher dose appears, not surprisingly, to confer longer-lasting protection than the lower Pfizer-BioNTech dose and/or greater protection against later variants.² Presumably, this should entail its also having conferred greater protection against the Alpha variant from the outset. And yet – somehow – per the clinical trial data, it did not: Pfizer-BioNTech even managing just barely to edge out Moderna in the efficacy competition 95% to 94.5%! This trial data is contradicted by a recent observational study, which finds, as one would expect, that Moderna also outperformed Pfizer-BioNTech in the Alpha period.³

Whereas in the ex post observational competition, Moderna thus clearly outperforms Pfizer-BioNTech in terms of efficacy, it also, on the other hand, wins a more dubious prize: namely, that for toxicity. A wide variety of data and several studies show Moderna being associated with a higher risk of adverse reactions and, most notably, a higher risk of myocarditis: the most widely-acknowledged adverse effect of the mRNA vaccines. The difference is probably not so great as a couple of highly-publicized – and, in certain respects, highly anomalous – European studies suggested late last year. (On these, see my “Something is Rotten in Denmark” here.) But that there is some difference appears undeniable, and given the higher dose, this is again hardly surprising. Both raw and verified VAERS data suggests a myocarditis reporting rate ratio between the two vaccines of around 1.5:1 in relevant demographics, and this is in line with the findings of the new Lancet preprint by Goddard et al. here.⁴ Note that since this refers to risk per dose and, as noted above, Moderna confers longer-lasting protection, it does not entail that the cumulative risk of Moderna, supposing repeat dosing, is any higher. Indeed, it could even be lower, supposing “boosters” are administered at intervals reflecting Moderna’s longer-lasting protection.

Robert Malone famously suggested that Moderna may have “gotten the dose wrong.” But the fact of the matter is that there does not appear to be any “right” dose for these mRNA vaccines. There is rather a trade-off between efficacy and safety. The more effective they are, the less safe they are, and vice-versa. So, how did Pfizer and BioNTech manage to square the circle in their clinical trial and achieve as high or higher efficacy than Moderna while using a less toxic, lower dose? It would appear they did so by cheating.

1. I abstract here from the built-in rigging of the results by censoring infections that occurred within 14 days after the 2nd dose, since this was part of the official rules of the game that applied for both vaccines.

2. On durability of protection, see, for instance, Nordström, et al., “Effectiveness of Covid-19 Vaccination…”, which finds (p. 11) that the protection conferred by Moderna is twice that of Pfizer-BNT at 6 months and that “[f]rom 7 months and onwards, no effectiveness of BNT162b2 could be detected.” On relative protection against Delta, see Tang et al., “BNT162b2 and mRNA-1273 COVID-19 vaccine effectiveness…”, which finds that Pfizer-BioNTech barely achieved 50% effectiveness against Delta infection after 2nd dose (whereas Moderna was at nearly 75%), and Puranik et al., “Comparison of two highly-effective mRNA vaccines…”. On Omicron, see Andrews et al., “Covid-19 Vaccine Effectiveness…”, p. 12 of PDF or under heading “Vaccine Effectiveness, Omicron Variant”.

3. Dickerman et al., “Comparative Effectiveness of BNT162b2 and mRNA-1273…”.

4. Goddard et al., “Risk of myocarditis and pericarditis…”. For VAERS myocarditis data that has been verified according to the CDC’s own criteria, see Oster et al., “Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination…”, especially Table 2.