Exploring regulatory data sets of the Comirnaty vaccine - 11b

What do the MHRA package insert and SmPC report about the outcomes that matter?

In our previous post, 11a, we established the importance of understanding the Comirnaty vaccine's effectiveness outcomes for informed decision-making. Now, let's delve into the package inserts to reveal what these five outcomes truly mean. 

The patient information leaflet in the UK states, ‘The vaccine stimulates the immune system to produce antibodies and blood cells that combat the virus, thereby offering protection against COVID-19.’ However, it does not elaborate further on the vaccine's effectiveness. 

The Summary of Product Characteristics (SmPC) reports Efficacy for 50% neutralizing antibody titres (NT50), the geometric mean ratio (GMR) and noninferiority based on differences in seroresponse rates.  

The population for the primary efficacy endpoint included 36 621 participants 12 years of age and older who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. At the time of the primary efficacy analysis, participants had been followed for s…