WHO launches toolkit to include pregnant and lactating women in TB research
On 13 October 2026 the World Health Organization released an online TB-in-pregnancy-and-lactation research toolkit with practical guidance for trial sponsors, ethics committees and regulators — follow-up to its 2025 consensus on earlier inclusion of these groups.
The World Health Organization launched on 13 October 2026 a TB in pregnancy and lactation research toolkit — an online resource meant to help researchers, trial sponsors, ethics committees and regulators include pregnant and lactating women earlier and more appropriately in tuberculosis drug and vaccine studies.
Why it exists
Pregnant and lactating women have long been excluded from many TB trials, leaving sparse evidence on dosing, safety and efficacy for a population at high risk of severe TB. The toolkit follows a WHO-led global consensus process (2024–2025) that produced the August 2025 consensus statement on optimal and early inclusion and a related Call to Action; developing a TB-specific toolkit was listed as a priority action.
What it covers
According to WHO, modules address pharmacokinetics during pregnancy, postpartum and lactation; outcome measures and sample-size considerations; recruitment and retention; regulatory aspects; TB vaccine trial considerations; and surveillance and registries. It sits alongside broader WHO/HRP guidance on including pregnant and lactating women in clinical research.
Limitations
This is guidance and tools, not a new clinical trial result or treatment recommendation. Local ethics and regulatory rules still apply. The article is not personal medical advice; people who are pregnant or breastfeeding and have TB concerns should talk with a clinician.
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