Oxford University Press publishes takedown of Big Pharma funded pro-COVID vaccine study

Someone may well lose their job over this one. The American Journal of Epidemiology, one of the top journals for epidemiology and published by the prestigious Oxford University Press, had this year published a Johns Hopkins study (Kitano et al.) concluding that the COVID-19 vaccines are still worth the risk in the Omicron era, for basically all groups. Source. Big Pharma effectively provided funding for the study, with Merck and Johnson & Johnson having provided grants to the last listed author (in academia this is typically the most senior author). AJE have also kindly published a follow-up article, by a totally legitimate expert (Lataster, that’s me…), with zero funding from Big Pharma, explaining that there were quite a few things wrong with the study. Source.

• The study employs peculiar timeframes, such as “Less than 5 months (days 14–149) after the primary 2 doses versus no doses.” No explanation is given. Recall a recent series of journal articles on counting window issues, likely leading to exaggerated efficacy and safety estimates in clinical trials and observational studies, that I was involved with.

• I note that “there can be no valid reason why adverse effects caused by the vaccine, in the several months between the 1st injection and 14 days after the 2nd injection, should be ignored”, pointing to an anaphylaxis death occurring very soon after vaccination.

• “The authors themselves made reference in their article to a Japanese study, Suzuki et al., which concerns deaths “within seven days after COVID-19 vaccination”, including myocarditis deaths, and found that several of these deaths did “show a causal relationship to vaccination”. Not only are the authors inexplicably omitting relevant data from their analysis, they knowingly do so.”

• It’s not just when the counting windows begin that is the problem, but their length as well. “The authors only consider vaccine effectiveness and safety up to around 5 months after the last injection. This is problematic with regards to effectiveness as the vaccine is known to rapidly decline in effectiveness around that time and can even become negatively effective. This is also problematic with regards to safety as the vaccine’s long-term safety profile is still, by definition, unknown. We do know that the vaccines can cause myocarditis, however, a potentially long-term and deadly issue. While the authors effectively assume no myocarditis deaths due to a lack of data, there are recent studies that do provide some data on myocarditis deaths caused by the mRNA vaccines, meriting a reanalysis.”

• Even with the data as limited and selected as it is, “the stated net benefits of the vaccines are minute”, as “the smallest gain was found to be 18.7 QALY “per 100,000 vaccinees in the 4–5 months after vaccination” (5-11 year old males with no comorbidities, third dose vs. no third dose, Pfizer vaccine), or less than 2 hours per person”. “And even these are subject to the uncertainties and estimations admitted to by Kitano et al, to say nothing of the aforementioned criticisms, all of which may well reduce these QALY gains to effectively zero, or even negative figures.” Read that again. By having very limited data, and by being very selective with that data (just ignoring highly relevant data, because why not…), their stated net benefits are almost nothing. The actual net benefit could be zero, or even less than zero. Worth potentially risking your life for?

• I conclude: “While attempting to argue that COVID-19 vaccination is still worthwhile, the authors inadvertently demonstrate that in the omicron era COVID-19 is now extremely benign, and that the potential benefits to the vaccines are minimal at best, at least in the young and healthy.”

Okay then.

But wait, there’s more. Kitano et al. were supposed to have a response published at the same time (a common phenomenon with my articles…) but I see no response as yet. However, a few more papers were published in AJE about this study, which may be of interest to you. Japanese experts (Shiraishi et al.) also seemed put off by the incredibly small counting windows, noting that “mid- or long-term follow-up should not be disregarded”, pointing to cases of vaccinees developing confirmed and suspected venous malformation, whilst also reminding us of the risk of “thromboembolic events and hemorrhagic stroke”, as well as myocarditis and pericarditis. Source. Another response (Kleebayoon & Wiwanitkit) notes that “The results of Kitano et al.’s investigation need to be supported by additional clinical research.” Source. Apparently it’s not just conspiracy theorists that are asking the big questions.

Okay then.