Exploring regulatory data sets of the Comirnaty vaccine - 10a

Decoding the mystery: what insights do the package inserts hold about transmission?

Part 6 of this series introduced our review of the package inserts. Just to remind you, this includes the four major regulators: the UK, EU, Canada, and the US,

Exploring regulatory data sets of the Comirnaty vaccine - 6

Here, we review what the inserts say about the ability of Cominarty to reduce onward transmission.

The MHRA, EMA, FDA, and Health Canada say nothing about transmission or post-exposure prophylaxis in the package inserts or the Summary of Product Characteristics.

The FDA in the indications and usage, report states, “the vaccine prevents coronavirus disease 2019 (COVID-19)  caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.”  No mention of the impact on onward transmission.

The MHRA, EMA and Health Canada report the therapeutic indication is “for active immunisation to prevent COVID-19 caused by SARS-CoV-2” Active immunity means “when exposure to a disease organism triggers the immune system to produce antibodies to that disease.”