Exploring regulatory data sets of the Comirnaty vaccine - 6

Review of package inserts at the EMA, MHRA, Health Canada and the FDA.

In addition to reviewing clinical study reports, we reviewed the vaccine's package inserts of four major regulators: the UK, EU, Canada, and the US, comparing the content of the harms regulator by the regulator.

In the EU and the UK, we reviewed the summary of product characteristics (SmPC), which is a vital part of the marketing authorisation of all med…