Exploring regulatory data sets of the Comirnaty vaccine - 7

Where is the randomised trial on pregnant women?

In Cominarty 6 and 6a, we pointed out the stark disparity between what the regulators report and what bodies say—we do not know why. We also showed that much of the evidence is limited because pregnant women were not included in vaccine trials, and very few studies report maternal and neonatal outcomes after each dose of the vaccine and according to trimester at vaccination.

Exploring regulatory data sets of the Comirnaty vaccine - 6a

However, all is not lost because, in February 2021, Pfizer and BioNTech commenced a global  Global Clinical Trial to Evaluate COVID-19 Vaccines in Pregnant Women.

The Phase 2/3 trial was a randomized, placebo-controlled, observer-blind study of approximately 4,000 healthy pregnant women over 18 who were vaccinated during 24 to 34 weeks of gestation. The study aimed to evaluate the safety, tolerability, and immunogenicity of two doses of BNT162b2 or placebo administered 21 days apart (the study identifier is  NCT04754594).

In February  2023, the BMJ reported that the results of the trial NCT04754594 (1), which ended i…