Safety of special populations

Safety of special populations

Safety before and during pregnancy and after baby arrives

Medicines and immunization in pregnancy aim to reduce illness and death among pregnant women as well as their young infants. This is true in both, high- as well as low and middle-income countries. Particularly in these latter, access to basic health services is limited.

The Pharmacovigilance team is involved in monitoring the safety of medicines and vaccines to ensure preventing adverse events both for the mother and the infant.

In particular, following the introduction of vaccines during pregnancy, e.g., vaccines against influenza, allowed to directly protect the foetus and infants via the antibodies transferred from the mothers. 

During pregnancy and breastfeeding, medicines uptake especially for over-the-counter medicines, is known to be increased. Potential maternal and neonatal outcomes can be avoided by safety and efficacy evaluation.

 

Section Heading Edit More WHO Pharmacovigilance webinar - September 2024

The content of this report was presented in a webinar organized by WHO in September 2024 to highlight the technical work that needs to be done to integrate systems of Member States for universal health coverage and for response in emergencies.
Different systems (spontaneous reporting, registries and electronic clinical records) of data collection are presented to show their complementary nature, and how support pharmacovigilance review and risk assessments of medicinal products. This is an opportunity to reflect upon the importance of quality of data, pharmacovigilance resources that are available to us and those that are being developed and how these could be used optimally in monitoring the safety of new medicines and vaccines in subpopulations such as pregnant women and neonates. 

Publications

The global smart 
pharmacovigilance strategy

Trust in regulated medical products (medicines, vaccines and other health products) to protect health, is mostly based on a number of principles: the...

Landscape analysis of pregnancy exposure registries in low- and middle-income countries

Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries...

COVID-19 Vaccines: safety surveillance manual. Module on safety surveillance of COVID-19 vaccines in pregnant and breastfeeding women

The module provides an overview of factors to consider when monitoring the safety of COVID-19 vaccines administered to pregnant and breastfeeding...

Protocol template to be used as template for observational study protocols for cohort event monitoring (CEM) for safety signal detection after vaccination with COVID-19 vaccines.

WHO has published the COVID-19 vaccines: safety surveillance manual to guide the processes for collecting, analysing and sharing safety data and information...

Safety of immunization during pregnancy: a review of the evidence: Global Advisory Committee on Vaccine Safety 

The Strategic Advisory Group of Experts (SAGE) of WHO asked the Global Advisory Committee on Vaccine Safety (GACVS) to provide support to a review of...