Impact of vaccines for use in pregnancy
Understanding the suitability and potential impact of vaccines that could be used in pregnancy and lactation requires a structured assessment across three core domains: pathogen impact on the pregnant woman, fetus and neonate, vaccine platform safety data, and implementation feasibility.
Impact of the target pathogen on pregnant woman and fetus
Evaluating pathogen impact early—across the whole population—ensures that maternal infection risks, including maternal and fetal mortality, trimester-specific vulnerability, vertical transmission, and potential effects during lactation, are addressed before vaccines reach late-stage development. Failure to do so may mean that critical issues only emerge later, as illustrated by malaria vaccines (Box 1) and novel tuberculosis (TB) vaccines (Box 2).
Box 1 – Malaria vaccines and pregnancy - RTS, S/AS01 and R21/Matrix-M

Box 2 – Novel TB vaccines and evidence gaps for pregnancy and lactation

Sub-sections