Curie Brief
Turn on cookies to sign in
Signing in saves your progress to your Curie account. We can only do that with cookies on — turn them on to continue.
News
Pregnant and lactating women have long been left out of TB drug and vaccine trials — and the WHO wants to change that. The organization has launched a new online research toolkit offering practical guidance to help researchers, regulators, and ethics committees better include this population in TB studies. The goal: fill critical evidence gaps on safety, dosing, and effectiveness so women and their infants aren't the last to benefit from TB advances.
Pregnant and lactating women have historically been excluded from tuberculosis (TB) drug and vaccine trials, leaving major gaps in evidence around safety, dosing, pharmacokinetics, and treatment effectiveness for this population. To address this, the World Health Organization (WHO) has launched the TB in Pregnancy and Lactation Research Toolkit — a free, online resource designed to help researchers, trial sponsors, ethics committees, and regulators systematically include pregnant and breastfeeding women in TB research.
The toolkit was developed following a WHO-led global consensus process in 2024–2025, which brought together experts from all WHO regions to identify barriers and practical solutions. It builds on a consensus statement and a Call to Action published in August 2025, both of which flagged the development of this toolkit as a priority.
Key Takeaways:
Why it matters: When pregnant and lactating women are excluded from clinical trials, they and their infants are among the last to access life-saving innovations. This toolkit is a concrete step toward ensuring TB research reflects the full population it aims to protect.
