[FRIAM] Could this possibly be true?

[Pieter Steenekamp]

Thank you Eric.

On Wed, 15 Sep 2021, 9:00 am David Eric Smith, <desmith at santafe.edu> wrote:

> Pieter,
>
> On its own, I don’t think the statement means anything.  You have to know
> what the cohort was and what the null model was.  I think that in all these
> trials, to be seeking approval for multiple age groups, they must have
> tested in multiple age groups as well.  Sometimes old people die, no matter
> what you are doing.  (Sometimes people who are not old die too, but to have
> significant numbers of people who just happen to die in a trial is not in
> itself surprising if the trial has an old or fragile cohort.)  Numbers like
> 14 and 15 are very small in any clinical trial, which should have been run
> with some thousands to tens of thousands of participants.  Even if the
> numbers of vaccine and placebo in the whole sample were quite different,
> those numbers are so small that they might be in the sampling noise for any
> conclusion.
>
> Apologies that I don’t have time to read the report, and thank you for
> circulating.  This is the sort of question for which it would be good to
> have one of these public-health professors who write community-information
> articles, to go back and round up all the other data that are needed to
> determine what the null model is, whether there is any excess in either
> number you post, and then what the sample noise is for this statistic.  In
> principle, any of us could do it.  But people who do this for a living know
> rapidly where to find the relevant statistics, what data sources are
> properly curated, how to weight background statistics to match the tested
> cohort, what other systematic sample biases to look for, etc., which is
> important in interpreting any of these statistics as evidence for a
> causation question.
>
> I will hope that nothing I have said above is wildly wrong, but of course
> we should look for a better source than me,
>
> Eric
>
>
> On Sep 15, 2021, at 3:24 PM, Pieter Steenekamp <pieters at randcontrols.co.za>
> wrote:
>
> In the Phizer report "Six Month Safety and Efficacy of the BNT162b2 mRNA
> COVID-19 Vaccine" (
> https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.full.pdf
> <https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fwww.medrxiv.org%2fcontent%2f10.1101%2f2021.07.28.21261159v1.full.pdf&c=E,1,l1mASX-DLApZIhUOYFgy-r7F74HlDesTNgutDt0LykvRihqhyjrzAGpEqJwx8jOzFnbbUQdx3BQTfd8osCdHSXyPMjhkpPHcBs-mpPzlecdaEIt50MlLoyIK8g,,&typo=1>)
> , I picked up the following:
>
> "During the blinded, controlled period, 15 BNT162b2 and 14 placebo
> recipients died"
>
> Does this mean the Phizer vaccine did not result in fewer total deaths in
> the vaccinated group compared to the placebo unvaccinated group?
>
> I sort of can't believe this, I obviously miss something.
>
> But of course, there are clear benefits in that the reported vaccine
> efficacy was 91.3%
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