Exploring regulatory data sets of the Comirnaty vaccine - 6a

What do Cominarty package Inserts say about administration during pregnancy

As we anticipated in Cominarty 5, we are reviewing the vaccine's package inserts of four major regulators: the UK, EU, Canada, and the US, comparing the content by the regulator.

Here, we look at the available data regarding use during pregnancy.

Although the language differs slightly by regulator, the message is the same - we are sitting on the fence.

“No data are available yet regarding  use during pregnancy” (EMA and MHRA); or “the available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy” (US FDA); or  “The safety and efficacy of COMIRNATY in pregnant women have not yet been established” (Health Canada).