WHO is pleased to present the draft module on safety surveillance of COVID-19 vaccines in pregnant and breastfeeding women, to be added to the COVID-19 vaccines safety surveillance manual.
WHO welcomes organizations and individuals to review and provide comments/suggestions on this document.
Please provide your feedback no later than 19 April 2021, 12PM CEST, by email to iessan@who.int. It is important that you provide us with your name and affiliation when sending your comments. Please note that comments will only be considered if they are received before the deadline mentioned above.
The module on safety surveillance of COVID-19 vaccines in pregnant and breastfeeding women was developed following recommendations made by the Global Advisory Committee on Vaccine Safety (GACVS) during the 43rd meeting on the 1 to 3 December 2020. This module was developed using the principles described in the Global vaccine safety blueprint, the WHO’s Global manual on surveillance of adverse events following immunization and the CIOMS guide to active vaccine safety surveillance.
The module provides an overview of factors to consider when monitoring the safety of COVID-19 vaccines that are specific to pregnant and breastfeeding women. The module provides an outline of different approaches for active safety surveillance of COVID-19 vaccines in this population, and it describes adaptions that need to be made in routine surveillance systems to detect and monitor adverse events that have been reported following COVID-19 vaccine exposure during pregnancy.