August 31, 2021

Poor Data for Covid Approval

Timothy Birdnow

Here is an interesting article about the poor data used to approve the Covid shot, and how the vaccine fails to meet some basic standards - like a lasting immunity.

From the article:

Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or nine months.

The "six month” preprint based on the 7% of trial participants who remained blinded at six months

The final efficacy timepoint reported in Pfizer’s preprint is "from four months to the data cut-off.” The confidence interval here is wider than earlier time points because only half of trial participants (53%) made it to the four month mark, and mean follow-up is around 4.4 months (see footnote).

This all happened because starting last December, Pfizer allowed all trial participants to be formally unblinded, and placebo recipients to get vaccinated. By 13 March 2021 (data cut-off), 93% of trial participants (41,128 of 44,060; Fig 1) were unblinded, officially entering "open-label followup.” (Ditto for Moderna: by mid April, 98% of placebo recipients had been vaccinated.)

Despite the reference to "six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy "up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up ("8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%.

It is hard to imagine that the <10% of trial participants who remained blinded at six months (which presumably further dwindled after 13 March 2021) could constitute a reliable or valid sample to produce further findings. And the preprint does not report any demographic comparisons to justify future analyses.

Severe disease

With the US awash in news about rising cases of the Delta variant, including among the "fully vaccinated,” the vaccine’s efficacy profile is in question. But some medical commentators are delivering an upbeat message. Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board, said: "Remember, the original premise behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease and hospitalization. And that was the data that came out of the initial clinical trials.”

Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itselfcharacterized the "severe covid-19” endpoint results as "preliminary evidence.” Hospital admission numbers were not reported, and zero covid-19 deaths occurred.

In the preprint, high efficacy against "severe covid-19” is reported based on all follow-up time (one event in the vaccinated group vs 30 in placebo), but the number of hospital admissions is not reported so we don’t know which, if any, of these patients were ill enough to require hospital treatment. (In Moderna’s trial, data last year showed that 21 of 30 "severe covid-19” cases were not admitted to hospital; Table S14).

And on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).

The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine’s efficacy against severe disease.

Read the whole thing; it's worth your time.

Posted by: Timothy Birdnow at 07:16 AM | Comments (4) | Add Comment
Post contains 610 words, total size 6 kb.

1 First, the purpose of a vaccine is to stop the spread of a disease. If it allows infection and permits the vaccinated person to spread the virus, it has utterly failed in its mission. It’s efficacy might as well be zero, as for all practical purposes it is not a vaccine at all.

It is universally acknowledged that the Corona virus vaccines do not effectively prevent infection, as promoters are now only claiming that it prevents "serious illness, hospitalization and death.” They tell us that unvaccinated people will "become much sicker that those who are vaccinated,” rather than claiming that those who are not vaccinated will not become sick.

They have never had any idea of the efficacy, even back when their claims amounted to saying that it was actually a vaccine. (i.e. That it prevented infection.) The tests they ran cited the number of people in test group and control group, but they never knew how many in either group had been exposed to the virus.

So, if 94% of the test group was not infected they claimed 94% effectiveness, but how many of those 94% were not infected merely because they were never exposed to the virus? How many of them would have been infected if they had been exposed to the virus? The answers are unknown, as is the effectiveness of the "vaccine,” which is not a vaccine at all.

Posted by: Bill H at August 31, 2021 08:57 AM (/sW5m)

2 There you go again Bill! Don't you know you aren't supposed to make sense like that!

Posted by: Timothy Birdnow at September 01, 2021 07:10 AM (D28R3)

3 Thanks for sharing, I am very impressed with your post.

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Posted by: FrankieViolet at January 12, 2022 10:55 PM (s6I/7)

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