Pfizer’s Covid Vaccine Trial in Pregnancy Finally Published Its Results
Exploring regulatory data sets of the Comirnaty vaccine - 6b
In part 6a of our series on Comirnaty, we reviewed the content of package inserts relating to administering the vaccine in pregnancy. We looked at the inserts for four regulators, UK, EU, Canada, and the US, comparing the content by regulator.
At the time, we concluded that all regulators were 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).
We then examined the messages from the NHS, the UKHSA, and the CDC to determine whether they reflected the package insert content, which is the essential information on medicines that should reach patients. None of these organisations sat on the fence: “It's safe to have the vaccine during any stage of pregnancy.”
At the time, the absence of data from Pfizer …
