Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine (technical results of clinical trials suggest the vaccine could be ineffective in 9 months)

...Between July 27, 2020 and October 29, 2020, 45,441 ≥16-year-olds were screened, and 44,165 randomized at 152 sites (US [n=130], Argentina [n=1], Brazil [n=2], South Africa [n=4], Germany [n=6], Turkey [n=9]) in the phase 2/3 portion of the study. Of these participants, 44,060 were vaccinated with ≥1 dose (BNT162b2, n=22,030; placebo, n=22,030), and 98% received dose 2 (Fig.1). During the blinded period, 51% of participants in each group had 4 to <6 months of follow-up post dose 2; 8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2. During blinded and open-label periods combined, 55% of BNT162b2 recipients had ≥6 months follow-up post-dose 2....

Figure 2 Efficacy of BNT162b2 against COVID-19 Occurrence after Dose 1 During the Blinded Placebo-controlled Follow-up Period.

During the blinded, controlled period, 15 BNT162b2 and 14 placebo recipients died; during the open-label period, 3 BNT162b2 and 2 original placebo recipients who received BNT162b2 after unblinding died. None of these deaths were considered related to BNT162b2 by investigators. Causes of death were balanced between BNT162b2 and placebo groups (Table S4).

There is a LOT of data and syntax here. Here's the Cliffs Notes version: this vaccine offers no statistical prevention against dying from COVID19, we still have no idea what can happen in the long run after getting these shots, and it looks like it won't stop you from getting the virus nine months after the second dose, with effectiveness falling below the FDA's minimum threshold by six months.

But it's approved.

1. While the vaccine may be effective to prevent COVID-19 caused by SARS-CoV-2 i, basically the same number of people died in the vaxx and placebo groups - that's what Table S4 shows, which is basically hidden as supplementary material. Perhaps most importantly, one person getting the vaccine died of COVID and two in the placebo group died of COVID - a statistical equivalency.

Reported Cause of Deatha	BNT162b2 (N=21,926) n	Placebo (N=21,921) n
Deaths	15	14
Acute respiratory failure	0	1
Aortic rupture	0	1
Arteriosclerosis	2	0
Biliary cancer metastic	0	1
COVID-19	0	2
COVID-19 pneumonia	1	0
Cardiac arrest	4	1
Cardiac failure	1	0
Cardiorespiratory arrest	1	1
Chronic obstructie pulmonary disease	1	0
Death	0	1
Dementia	0	1
Emphysematous cholecystitis	1	1
Hemorrhagic	0	1
Hypertensive heart disease	1	0
Lung cancer metastic	1	0
Metastases to liver	0	1
Missing	0	1
Multiple organ dysfunction syndrome	0	2
Myocardial infarction	0	2
Overdose	0	1
Pneumonia	0	2
Sepsis	1	0
Septic shock	1	0
Shigella sepsis	1	0
Unevaluable event	1	0

2. At the bottom of the table in the picture, the final three rows show that the Vaccine Efficacy (VE, or one minus the ratio of the vaxx group's infection rate and the placebo group's infection rate) decays across the three checkpoints after the second dose -

a) it starts at 96.2% at the seven day to two month point (based on this disclosure and my understanding of surveillance time, it looks like an average of 48 days),
b) falls to 90.1% at the two to four months point (about 95 days on average), and
c) falls to 83.7% at the final/more than four months after the second dose point (about 125 days on average).

I was able to build a simple polynomial model across these three data points to estimate the VE as a function of the number of days after the second dose (the formula is VE = 97.236 -0.0011* # of days squared + 0.0328 * # of days). Using this formula, VE hits zero, i.e., the vaccine becomes ineffective, around nine month after the second dose. It hits 50% VE (what NBC reported as the minimum acceptable VE for FDA approval) around six months after the second dose.

And we still don't know what happens in the long run, e.g., does your big toe fall off at the 15 month marker?

What is it?

It is a messenger RNA elixir that tricks your body into defending itself against the bug for a few months, with a protection rate that is better than the placebo.

The FDA approved it because, I guess, they had a longer observation period for this trial vs that underpinnng the EUA, but it's still not the standard multiple year timeframe.

The trade-off, is it offers no statistical guard against dying from the bug, you'll probably need a booster after about a half a year (assuming a mutation doesn't come along that is immune to the shot), and because the FDA sidestepped their usual multi-year clinical trial timeline we don't know what'll happen to recipients in the long run.

For some people, that's good enough for them. For others, NFW. Your mileage may vary.

QUOTE: “I was able to build a simple polynomial model across these three data points to estimate the VE as a function of the number of days after the second dose (the formula is VE = 97.236 -0.0011* # of days squared + 0.0328 * # of days). Using this formula, VE hits zero, i.e., the vaccine becomes ineffective, around nine month after the second dose. It hits 50% VE (what NBC reported as the minimum acceptable VE for FDA approval) around six months after the second dose.”

A) Why would you assume a polynomial is the best fit for 3 data points? Usually, a straight line (linear reqression) is the approach for only 3 points of data. In that case,
VE = 104.2451 - 0.15946d (where d = number of days after 2nd dose).
THEN, at 9 months (d=270), VE = 61.2 %
A far cry from Zero.

B) Your polynomial equation yields the following:
VE = 97.236 - 0.0011(d squared) + 0.0328d
At 9 months (d=270), VE = 25.902
I assume this is already stated in percentage (25.9 %), otherwise, it makes no sense.
But regardless, it’s still far from zero.
That would be 3 post-vax infections for every 4 placebo infections, roughly.

C) But other than an assumption, or an incorrect equation, that the VE falls to zero at some point, what evidence do you have that the VE doesn’t instead simply flatten out (stabilize) at about 80% (or other non-zero but significantly above 50% number)? That is, decline at an asymptotic rate that approaches a steady number over time, instead of always falling. We simply do not know. This is a biological issue, not a physical materials issue, and biology with numerous variables acts a whole lot different than physics.

D) Reliance on the “deaths reported after vaccination” is hogwash, and that table you presented is proof one. EVERY single person in the grave has “cardiac arrest.” EVERY single person in the grave has “cardiorespiratory failure.” Their hearts have stopped/failed and they don’t breath. They’re dead! Those are NOT causes of death, they are entries on a death certificate by someone who doesn’t know what a cause of death is and hasn’t determined it for that patient. Sadly, that’s about 95% of the physicians in the USA filling out death certificates. Likewise, myocardial infarction, pneumonia, multi-organ dysfunction, sepsis, and septic shock are NON-SPECIFIC and are always due to something else, that is, they are NOT causes of death; whatever caused THEM is the cause of death. Every one of those is the result of something else—a gunshot, a stabbing, a car crash, cancer, poisoning, an incomplete drowning, a fall with hip fracture, a bacterial infection, a fungal infection, automimmune disease, etc., etc., and yes, a viral infection. Just because someone screens positive for the presence of COVID-19 in their nose, assuming that test isn’t a false positive and actually works and can tell the difference between influenza and COVID-19 or even between the several other known common COVID types and COVID-19), and has sepsis or an MI or a pneumonia, doesn’t mean the death is from COVID-19. You can die with something, or you can die from something, and most of the COVID-19 “deaths” are in people with significant pre-existing conditions that can cause all of those conditions noted above and can kill (and do kill) without COVID (hypertension, obesity, diabetes, COPD esp.). And “Death” as a “cause of death”??? Get real. No, the “deaths” after vaccination, as reported to the CDC, cannot be relied on in any fashion with which to make conclusions about COVID and vaccinations.

Just pointing out the obvious, here.

Thanks for the feedback. The use of polynomial vs linear was based on studies of VE over time I read, that showed a non-linear pattern, primarily of high VE early then a meaningful decay as time from the shot moves along. I don't have the links handy but I can provide them later.

On the math, I need to go check my Excel calculation - thanks for the validation (which is why I put this kind of stuff out there...FR peer review).

As for deaths, I'm simply pointing out that while the vaccine does what it's stated is it's intent - protect against contracting the virus - it doesn't seem to protect against dying from the virus vs placebo. And that's ok, insofar as that's not what it was designed to do. But many promoters of the shot make that claim...I'm simply saying that wasn't the case here.

Off to work. More later. Thanks for the review.

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