Optimal and early inclusion of pregnant and lactating women in tuberculosis research: consensus statement

This consensus statement outlines approaches for the earlier and optimal inclusion of pregnant and lactating women in tuberculosis (TB) treatment and vaccine research. Developed through a WHO-led consensus process involving thematic working groups, evidence reviews and consultations with researchers, regulators, funders, advocates and affected communities, the document addresses the longstanding exclusion of pregnant and lactating women from TB clinical trials and the resulting gaps in evidence for prevention, diagnosis, treatment and vaccination. The publication reviews current challenges related to ethics, regulation, liability, surveillance and advocacy, and highlights the increased burden and adverse maternal and perinatal outcomes associated with TB during pregnancy and the postpartum period.

The document presents consensus-based recommendations covering preclinical research, therapeutics, vaccine trials, maternal TB surveillance and advocacy. Key approaches include earlier developmental and reproductive toxicity studies, integration of pregnancy and lactation into clinical development plans, inclusion of pregnant and lactating women in TB trials by default unless exclusion is justified, strengthening pharmacokinetic and safety data collection, and expanding surveillance systems. The statement also emphasizes stakeholder engagement, harmonized data collection, ethical inclusion in research and the need for sustained funding and accountability to improve evidence generation and equitable access to TB innovations.