WHO issues call to action: Prioritize pregnant and lactating women in TB research

19 August 2025 | Geneva — The World Health Organization (WHO) has issued a bold Call to Action alongside a Consensus Statement, urging the global health community to end the routine exclusion of pregnant and lactating women from tuberculosis (TB) research. This landmark initiative, developed through a global consensus process, outlines a comprehensive framework to ensure equitable access to TB innovations for all, including those most at risk.

Each year, an estimated 200,000 pregnant or postpartum women develop TB, yet they remain largely invisible in research and clinical trials. This exclusion leaves critical gaps in evidence, delaying access to life-saving treatment and vaccines for these populations.

“The benefits of TB research must flow to all people with TB, including pregnant and lactating women,” said Dr Tereza Kasaeva, Director of the WHO Department for HIV, TB Hepatitis and Sexually Transmitted Infections. “It is time to prioritize their inclusion – not as an afterthought, but as a fundamental step toward equitable, evidence-based care.”

Key actions in the call include:

• Closing data gaps on TB in pregnancy and postpartum through improved surveillance and reporting
• Initiating timely preclinical studies to assess efficacy and safety of novel TB compounds and vaccines in pregnancy
• Including pregnant and lactating women in all stages of TB drug trials
• Including pregnant and lactating women in adult TB vaccine research for candidates with a favourable risk-benefit profile and plan for rollout and monitoring
• Creating enabling environments by addressing legal, ethical, and regulatory barriers
• Engaging and empowering affected communities to ensure research is inclusive, respectful, and responsive.

The consensus statement and call to action are the result of a WHO-led consensus process involving over 80 global experts covering five themes:  preclinical TB research, TB therapeutics research, TB vaccine trials, maternal TB surveillance and advocacy. The documents provide a roadmap for product developers, study sponsors, researchers, regulators, ethics committees, government programmes, funders, and civil society to act decisively to advance inclusion of pregnant and lactating women in TB research.

For more TB updates, check out the TB CAB Weekly Newsletter (Issue #26, 19 August 2025).

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