[FRIAM] Could this possibly be true?

[David Eric Smith]

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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