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FDA booster

FDA Relied On Wildly Incorrect Booster Estimates


The efficacy of interventions against COVID has been one of the pandemic’s most important considerations.

Many government-imposed policies and mandates have unfortunately rested on assumptions and estimates provided in studies, yet with a complete disregard of the extent to how poorly conducted or misleading they may have been.

Whether it be applied to masks, vaccine efficacy, or other potential policies, a tremendous amount of research has been published or posted claiming to show benefits from government-preferred interventions.

The same applies to vaccines and boosters.

In fact, these might be the most commonly studied subjects, since many politicians relied on efficacy estimates to impose inexcusable discriminatory practices barring unvaccinated individuals from businesses, jobs, or schools. 

And turns out, some of these estimates have been hopelessly overestimated in order to give cover to those who demand endless booster doses, which of course includes the CDC, an organization that is now openly signaling its intention to demand annual COVID shots.

Some of these estimates have been repeatedly used by the US FDA, one of the world’s most influential public health organizations, which relied on an unbelievably misleading study to promote their policy goals.

The powerhouse team of Tracy Høeg and Vinay Prasad are at it again. 

Høeg and Prasad were joined by Ram Duriseti, an MD from Stanford University, to examine a published study from December 2021 that claimed a monumental mortality benefit to those receiving booster doses. 

Studies like the 2021 examination were frequently used by experts, politicians and administrators to justify booster mandates, since they seemed to indicate that additional doses were inarguably more protective and even more effective at “saving lives.”

Except as with so much of COVID research, the ends justified the inaccurate means.

First, it’s important to understand the claims that were made based on the initial research. And they are dramatic.

Essentially, the study from “Arbel et al.” claimed that among those who’d received a Pfizer booster dose, there was a 90 percent lower rate of mortality due to COVID.

Using observational methods, Arbel et al. (Dec. 23, 2021, issue)1 calculated an adjusted 90% lower mortality due to Covid-19 among participants who received a first BNT162b2 vaccine (Pfizer–BioNTech) booster than among those who did not receive a booster. They found 65 Covid-19–associated deaths (reported as 0.16 per 100,000 persons per day) among participants in the booster group and 137 (reported as 2.98 per 100,000 persons per day) among those in the nonbooster group — a 94.6% difference. In a subsequent letter (March 10, 2022, issue),2 Arbel et al. reported 441 deaths not related to Covid-19 in the booster group and 963 deaths not related to Covid-19 in the nonbooster group.

Essentially, these results implied that the initial claims of 90+% efficacy from the two-dose vaccination series could be reestablished by getting a booster dose. Never mind the fact that waning efficacy, especially against new variants, was a problem that these researchers chose to ignore.

The calculations underlying these optimistic 90 percent estimates were used to indicate a “markedly lower incidence of adverse health outcomes in the booster group.” And a closer reading of the data shows where the problems with this influential study lie.

The mortality not related to Covid-19 was calculated as (441/65)×0.16=1.09 per 100,000 persons per day in the booster group as compared with (963/137)×2.98=20.95 per 100,000 persons per day in the nonbooster group. This corresponds to a 94.8% lower mortality not related to Covid-19 among participants in the booster group and indicates a markedly lower incidence of adverse health outcomes in the booster group.

The key is hidden in the first sentence.

The mortality not related to Covid-19 was calculated as (441/65)×0.16=1.09 per 100,000 persons per day in the booster group as compared with (963/137)×2.98=20.95 per 100,000 persons per day in the nonbooster group.

The differences in non-COVID-related mortality between the two groups was astronomical. 

What does that mean exactly? Well if the people who received the booster had a 95 percent lower non-COVID mortality rate, it implies that they were significantly healthier than the group that didn’t receive the booster dose.

And therein lies the problem with attempting to calculate vaccine efficacy by observing two different groups. They might have significantly variable underlying, pre-existing health conditions.

Healthier people, in the initial examination, chose to get boosted. Therefore, they were less likely to die.

But if you’re attempting to show a benefit against COVID-related outcomes, you have to adjust for such vast health disparities. The initial authors didn’t.

Høeg, Prasad and Durati reference this exact problem, defined as a “healthy vaccinee bias.”

The unadjusted differences in mortality related to Covid-19 and mortality not related to Covid-19, according to vaccination status, were essentially the same in the 2021 study by Arbel and colleagues. These findings arouse strong concern regarding unadjusted confounding. The adjusted 90% lower mortality due to Covid-19 reported among the participants who received a booster cannot, with certainty, be attributed to boosting. “Healthy vaccinee bias” in this population may have also led to overestimates of vaccine effectiveness in similar studies from Clalit Health Services.

The results claimed by the initial authors, the results relied upon by the FDA to justify their booster campaign, were likely based on biased methodology that stacked the deck in favor of vaccine efficacy. As they explain in the above passage, the adjusted mortality benefits due to vaccination “cannot, with certainty, be attributed to boosting.” 

Because those that were boosted were less likely to die, regardless of whatever actions they did to protect themselves against COVID.

Another Example of Systemic Errors

On the one hand, it’s difficult to believe it took this long for someone to notice the underlying, methodological errors involved in the initial study. 

But on the other hand, it’s clearly emblematic of systemic failures from regulatory bodies, “experts,” and other organizations and administrators throughout the pandemic. 

A combination of wishful thinking, poor process, relying on unreliable results, and in some cases, a malicious desire to control and compel behavior has contributed to the disgraceful mess we now see playing out.

“Experts” called for boosters, tacitly acknowledging that the original vaccination series wasn’t as effective in reality as they believed it would be, so they relied on catastrophically flawed research to promote their agenda. All the while, undoubtedly, realizing that it wasn’t able to make the claims they wanted it to make.

At this point it’s a cliché to say that it’s impossible to lose enough trust in experts. Given this study’s importance and influence, it’s more accurate to wonder how we ever had any trust in them to begin with.

Reposted from Substack

Published under a Creative Commons Attribution 4.0 International License
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