In post 11a, we listed the definitions of the Cominarty effectiveness outcomes that mattered to us, 

while in 11b, those that are reported in the package inserts.

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Here, we report the same according to the regulatory data used as a main source, the original Protocol C4591001 (PF-07302048) Statistical Analysis Plan (SAP), part of Clinical_Study_Report_Part_2 and Appendices at pdf page 529 of the same document.

These all relate to trial C 4591001, the registration trial for Comirnaty.

We explained at the beginning why and how we would do our exploration in the first four posts of our series:

Here are the definitions given by the Pfizer documents

We were unable to identify the definition of a COVID-19 death.

NAAT stands for Nucleic Acid Amplification Tests, and here is a list of them. However, in practice the most widely used and cited in the Pfizer documents is PCR. The EPAR reports the following text, which is more detailed:

The primary endpoint (laboratory-confirmed symptomatic COVID-19 in participants with no serological or virological evidence of past SARS-CoV-2 infection up to 7 days after receipt of the second dose, and then in all participants regardless of serostatus) is considered relevant for establishing vaccine efficacy. 

SARS-CoV-2 genomic RNA has been detected in nasal swab samples using Cepheid Xpert Xpress SARS-CoV-2 PCR assay on the GeneXpert Molecular Diagnostic System. This method detects 2 structural genes of SARS-CoV-2: E and N2. A validation of this method was performed, and in addition, the test was issued an EUA by FDA. In order to assess the analytical detection limit, live virus and commercial control (AccuPlexTM SARS-CoV-2) were used. Clinical sensitivity and specificity were evaluated in comparison with results obtained using another FDA authorised real-time RT-PCR method with positive or negative clinical specimens and pre-pandemic samples. Results showed that Cepheid Xpert Xpress PCR assay is a sensitive and specific method for the detection of SARS-CoV-2 RNA in nasal swabs. The positive rate of self-swab is similar to site-swab, 3.7% and 4.7% positive from self-swab and site-swab, respectively in the BNT162b2 group. 

and  COVID-19 Case Definitions 

Participants who developed any potential COVID-19 symptoms were to contact the site immediately and, if confirmed, to participate in an in-person or telehealth visit as soon as possible (within 3 days of symptom onset and at the latest 4 days after symptom resolution). At the visit (or prior to the visit, if a self-swab was used), investigators were to collect clinical information and results from local standard-of-care tests sufficient to confirm a COVID-19 diagnosis. Investigators were to obtain a nasal swab (mid-turbinate) for testing at a central laboratory using a validated reverse transcription–polymerase chain reaction (RT-PCR) test (Cepheid; FDA approved under EUA) to detect SARS-CoV-2. If the evaluation was conducted by telehealth, the participant was to self-collect a nasal swab and ship it for assessment at the central laboratory. A local nucleic acid amplification test (NAAT) result was only acceptable if it met protocol-specified criteria and if a central laboratory result was not available. 

Comparing these definitions with our own, we see that no cutoff for the likelihood of viral load and, hence, infectivity is given, nor do they exclude co-infection with another agent.

In other words, Pfizer is using a black box test to confirm the clinical diagnosis. As a consequence, we do not really know the role of SARS-CoV-2 in these “cases,” nor do we know if they are active and infectious, the only real type of case of interest when you are trying to prevent disease and transmission (which they did not test).  

We found no definition of a Covid death but found this:

Source: Pfizer-BioNTech COVID-19 Vaccine VRBPAC Briefing Document (page 41)

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So, we wonder how they adjudicated these deaths if there are no definitions of Covid deaths.

To sum up the effectiveness outcomes are an if and maybe, a situation which is difficult to understand given the importance of the trial. What is more is the apparently supine acceptance of the unclear definitions and subsequent conclusions drawn by regulators.

Summary of outcomes based on the CSR Pivotal trial  

• Covid 19 case

• Progressively severe Covid 19 case

• Covid-19 Hospital admission 

• Covid 19 Death

• ​​All-cause mortality

Impersonators did not write this post, which is not commercial in confidence. It is not carcinogenic and will not self-disrupt or autodelete. We are not on the payroll of any pharmaceutical company, and given the content of our posts, we have been notified that HMG will award us the order of the boot. Yesterday, we were further notified that our first-class Golden Boot awards will be upgraded to the Order of the Concrete Boot. We apologise to MEDSAFE and can now confirm that their book of straight answers is the second smallest book in the library. The first place is now occupied by the book of evidence of interruption of SARS-CoV-2 transmission by Comirnaty.