Assessment of Comirnaty Injections of Pregnant Women in the Manufacturer’s Risk Management Plan and by the European Medicines Agency: Mandatory Injections for Caregivers in France

Abstract

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 ran from late 2020 to early 2022, the safety profile of the vaccine was not known in pregnant women. In the second phase, which ran from early 2022, the RMP and the EMA report data that were considered reassuring for short-term safety, but were limited. Long-term safety remains still unknown. The RMP is cautious and suggests that intentional injection of pregnant women will remain limited. The detailed analysis of risk management by the manufacturer, the EMA and the French authorities reveals, to varying degrees, a lack of rigor. The EMA has disregarded certain elements of prudence maintained by the manufacturer, while the manufacturer has allowed the only real clinical trial that might determine any benefit-risk balance to lapse. What is more the only study was restricted to the third trimester of pregnancy. The French authorities recommended mandatory injection of pregnant women caregivers and health-related professionals at a time when the manufacturer and the EMA could provide no guarantees.