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 medicines. It is the basis of information for healthcare professionals on using medicine safely and effectively. As new efficacy or safety data emerge, SmPCs are updated throughout the vaccine's lifecycle. SmPCs are also the basis for preparing package leaflets.

In the US, we analysed the FDA’s vaccine package insert, and for Health Canada, we looked at the  Product Monograph and Product label.

These documents are the essential information on medicines that should reach patients. Below are the sources. As we have said, names differ slightly (e.g., Summary of Product characteristics, product label, etc.), but the meat should be the same.

MHRA…