WHO launches toolkit to bring pregnant and breastfeeding women into TB research
Nairobi,Kenya,October 2026 -The World Health Organization has released a new online toolkit aimed at making tuberculosis research include pregnant and lactating women, a group long left out of TB drug and vaccine trials.
The TB in pregnancy and lactation research toolkit is meant for researchers, trial sponsors, ethics committees, regulators and others involved in TB studies. WHO says the exclusion of these women has left gaps in evidence about how safe and effective TB treatments and vaccines are during pregnancy and breastfeeding, and how they should be dosed. As a result, mothers and their infants are often among the last to benefit from new advances.
Dr Tereza Kasaeva, who directs WHO’s Department for HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections, said the toolkit should help close these gaps and speed up progress toward ending TB for everyone.
The toolkit offers practical guidance on a range of topics, including:
- ethics and community engagement
- preclinical considerations
- trial design and drug behavior in the body during pregnancy, postpartum and lactation
- outcome measures and sample sizes
- recruiting and keeping participants
- regulatory matters
- TB vaccine trials
- surveillance and registries
It also includes case studies and resources drawn from completed and ongoing research.
The toolkit follows a WHO-led global consensus process held through working groups and consultations in 2024 and 2025, with experts from all WHO regions examining barriers to inclusion. That effort produced a consensus statement on the early and optimal inclusion of pregnant and lactating women in TB research, along with a call to action, both published in August 2025. Creating a TB-specific toolkit was named as a priority in that call to action.
The new resource complements WHO’s broader knowledge portal on including pregnant and lactating women in clinical trials across all health conditions. Where the portal sets out general principles, the TB toolkit applies them to the specifics of TB research. More information on the wider initiative is available through WHO’s Human Reproduction Programme.
