Exploring regulatory data sets of the Comirnaty vaccine - 11a

Defining the effectiveness outcomes that matter

In this post, we will list and define the effectiveness outcomes that matter in the assessment of Comirnaty. In posts 11b and 11 c, we will compare our definitions with those reported in the package inserts (11b) and regulatory documents (11c). 

The outcomes are listed in order of increasing severity- i.e. danger to life and the community (Our previous post-10C) showed no transmission trials, so we have not included any postexposure prophylaxis outcomes).

Exploring regulatory data sets of the Comirnaty vaccine - 10c

Covid 19 case

A subject with symptoms of influenza-like illness (ILI), such as fever, cough, shortness of breath, and malaise, has a positive PCR laboratory test.

This is defined as a positive viral culture, meaning a positive cytopathogenic effect with a positive polymerase chain reaction (PCR) or, alternatively, a positive PCR on its own with a cycle threshold below 25. A professional takes the nasopharyngeal swab sample within four days of symptoms onset following a protocol to minimise contamination. The PCR assay used has been previ…