[COPY] Exploring regulatory data sets of the Comirnaty vaccine - 11f

Where’s the plague?

NOTE: Apologies to our freebie readers. This post was accidentally sent by a doddering old geezer to payers only. So we are sending it out again for all to enjoy.

Yes, we are back on the Comirnaty series; even old geezers need some light relief. 

This post is brief; the first part has a background, some facts, and a question. There’s a short second part with what we think is remarkable about the facts. Not clear? Wait.

Part 1 

In July 2024, we posted this, 11d in the Comirnaty series: 

Exploring regulatory data sets of the Comirnaty vaccine - 11d

In it, we explained some of the uses of data from placebo arms in randomised controlled trials. Although controlled (as in, run by researchers following a protocol) and on selected populations, placebo arms tell you much about what is going on without the intervention (drug, vaccine, device, whatever). A real placebo is an inert substance that is visually the same as the real stuff. In the Comirnaty case, it was a saline placebo.

So in 11c 

Exploring regulatory data sets of the Comirnaty vaccine - 11c

and 11d, we looked at the definition of the effectiveness outcomes (vague) and the incidence of Covid according to the Pfizer BioNTech trial, which was very low. At the time, we were looking at mid-2021 data presented to regulators. 

The panic meter was in the red, and consequently, Comirnaty had received an EUA or CMA (regulatory speak for emergency registration on both sides of the Atlantic); by now, you know these cussed respiratory viruses obey Farr’s Law;  they go up, and they go down. So maybe this was a predominantly down phase (never mind the panic meter run by the media and CDC). 

However, one night, a clinical study report fell into our laps. While we typically enjoy diving into such extensive documents—often spanning tens of thousands of pages—let's be honest: we immediately focused on the Integrated Summary of Efficacy BNT162b2 (Part 2.7.3), which contained all the essential information we needed.

Our eyes fell on this:

The table screams at you that vaccine effectiveness is very high, over 95%. But in reality, when the table was assembled in November 2020, it showed more or less the same as the later table: 165 cases 7 days after dose 2 in 18,570 people, i.e. roughly 9 cases per 1,000 weekly. 

So, where’s the plague gone?

Part 2

This case rate is almost certainly an overestimation. The definitions reported in the clinical study report and those used by the EMA in its EPAR have no cutoff for the likelihood of viral load; hence, infectivity is assumed, not proved. Many so-called cases could be contaminated or past-infected and do not exclude co-infection with another agent.

No one remarked on this strange phenomenon, not the EMA, the FDA, or the secret squirrels of the MHRA, who were supposed to examine the harms data. However, to make a decision, you have to assess benefits-to-risk ratios. At low case rates, the plague disappears, making the relative measures look impressive. This means that any absolute expression of the effect also disappears.

For more background, also see this:

Two puzzled old geezers wrote this post.