Dodgy data: COVID vaccine clinical trials show counting window issues, exaggerating safety

Everyone debating the merits of the COVID-19 vaccines needs to take these 4 journal articles into account. The Journal of Evaluation in Clinical Practice’s hugely important unofficial series of articles on exaggerated COVID-19 vaccine effectiveness and safety claims, involving BMJ editor Peter Doshi and myself, has now concluded. The initial Fung, Jones, and Doshi paper outlines statistical biases, such as the case counting window bias, that likely lead to the COVID vaccines’ effectiveness being exaggerated in observational studies. The subsequent paper by Lataster (that’s me) then explained the situation is worse, as the case counting window bias is often accompanied by a definitional bias, and noted that this could exaggerate vaccine safety as well. Doshi and Fung then returned with a further paper indicating that numerous cases in the vaccinated were overlooked in the clinical trials, likely leading to exaggerated effectiveness estimates. The fourth and final article in this ‘series’, again by myself, notes that this also appears to apply to safety estimates in the clinical trials, whilst also confirming my earlier concerns about safety estimates in observational studies, and noting that the myocarditis issue alone could mean that the jabs are not worth the risk in the young and healthy. Highlights of the open access article (thanks again to the wonderful University of Sydney):

• Safety estimates appeared to be exaggerated in a recent observational study championing the use of the jabs in the omicron era, which OTN readers will already know all about.

• I again state that Doshi’s team may have understated things. While they expect that effectiveness was exaggerated in the clinical trials, I note that “numerous issues with the clinical trials and FDA briefing documents had gone unmentioned. For example, there are a significant number of trial participants lost to follow-up, and Pfizer also acknowledged ‘3410 total cases of suspected but unconfirmed COVID-19 in the overall study population’ in the FDA briefing document on their vaccine trial, split almost evenly between the treatment and placebo groups, which would have drastically brought down treatment efficacy estimates.”

• Counting windows for adverse effects in the clinical trials were incredibly short, going against long-established norms, especially with the treatment and placebo groups quickly merged, and reliant on unsolicited reporting, as well as the opinions of researchers paid by BioNTech and Pfizer (like cardiovascular deaths being written off as unrelated to the jab when we now know the jab does cause cardiovascular deaths). I note the concerning “large number of trial participants lost to follow-up” and that “deceased trial participants will not be contacting the researchers to describe their issues”. Wrap your head around that one. You’re in the vaccinated group. You die, thanks to the jab. As a result, you don’t report this to Pfizer. Your death is not included in the data, as with the potentially many other jab-caused deaths. With relatively few adverse reports the jab is declared safe. It’s a bit like how we can’t refer to many of the adverse event reports as they’re perpetually unverified.

• Couldn’t avoid again referring to the Fraiman et al. and Benn et al. articles indicating that, with the data as unreliable as it is, the trials indicated an excess of deaths and “serious adverse events of special interest” in the vaccinated groups, relative to the unvaccinated groups.

• I note that increasing research on myocarditis alone appears to indicate that the risks of the jabs outweigh the benefits in the young and healthy, the topic of my BMJ rapid response.

• I reveal that Pfizer acknowledges myocarditis risks and limitations of their study. And that Pfizer is currently running a trial, again plagued by counting window issues, to “determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted”. Would this information have been handy before you got jabbed, and before the jabs were universally declared “safe and effective”, and before people were fired for not submitting?

• I conclude that there is more than enough here to “nullify the claim that the benefits of the vaccines still outweigh the risks in all populations”. Source.

Just remember that the claims about these COVID-19 vaccines being safe and effective were, at best, based on these clinical trials and observational studies.

Okay then.

Extra: A summary of the whole series, JECP4, is here.