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

Overview

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 evidence on the safety of vaccinations in pregnant and lactating women. This request related to uncertainties about the safety of vaccination – whether intended or inadvertent – of pregnant women during mass vaccination campaigns. Such evidence would be particularly important in situations where manufacturers do not recommend the vaccination of pregnant women on solely precautionary grounds. However, evidence related to this issue is limited, as pre-licensing clinical trials of vaccines do not usually include pregnant and lactating women. Reports available also provide limited post-licensing data, as once again, pregnant women are usually not included in clinical trials. This in turn has limited the ability to make evidence-based decisions and provide optimal guidance on the use of vaccines in this population.