Safety Assessment of Comirnaty Vaccination of Pregnant Women in the Manufacturer's Risk Management Plan and at the European Medicines Agency. Impact on the Mandatory Vaccination of Caregivers in France.

The objective of this note is to analyse the safety assessment of Comirnaty vaccination of pregnant women in the manufacturer's risk management plan (RMP) and in the European Medicines Agency (EMA) fact sheet, and to measure the impact on the recommendations that led to the mandatory vaccination of pregnant women caregivers and health-related professionals in France.The evaluation of this safety was carried out in two phases. In the first phase, which runs from late 2020 to early 2022, the safety profile of the vaccine is not known in pregnant women. In the second phase, which runs from early 2022, the RMP and the EMA report data that are considered reassuring for short-term safety, but are limited. Long-term safety is still unknown. The RMP remains cautious and expects that intentional vaccination of pregnant women will remain limited.The detailed analysis of risk management by the manufacturer, the European Agency and the French authorities reveals, to varying degrees, a lack of rigour. The EMA has disregarded certain elements of prudence maintained by the manufacturer, while the latter has allowed the only real clinical trial capable of determining an individual benefit-risk balance to lapse, which was, moreover, restricted to the third trimester of pregnancy. The French authorities recommended mandatory vaccination of pregnant women caregivers and health-related professionals at a time when the manufacturer and the EMA provided no guarantees.