Accelerating research to end tuberculosis in pregnant and lactating women: a call to action

This call to action outlines priority measures to accelerate the inclusion of pregnant and lactating women in tuberculosis (TB) research and to address longstanding evidence gaps affecting the prevention, diagnosis and treatment of TB during pregnancy and the postpartum period. Developed through a WHO-led consensus process involving thematic working groups on preclinical research, therapeutics, vaccines, surveillance and advocacy, the document responds to the continued exclusion of these populations from TB drug and vaccine trials despite their increased risk of TB-related morbidity and mortality. The publication highlights the need for equitable access to safe and effective TB interventions and emphasizes that the routine exclusion of pregnant and lactating women from research is no longer ethically or scientifically justifiable.

The document presents a coordinated framework and targeted actions for researchers, regulators, product developers, funding agencies, ethics committees, national programmes, health care providers and affected communities. Key recommendations include strengthening maternal TB surveillance systems, conducting timely developmental and reproductive toxicity studies, integrating pregnant and lactating women into TB therapeutic and vaccine trials, harmonizing safety monitoring, addressing legal and ethical barriers, and promoting meaningful community engagement. The publication also proposes frameworks for the earlier inclusion of pregnant and lactating women in prelicensure TB drug and vaccine trials and calls for sustained collaboration to build an inclusive evidence base for TB care.