WHO Leads Global Call to Include Pregnant, Lactating Women in TB Research

Published On 2025-08-23 02:45 GMT   |   Update On 2025-08-23 09:17 GMT
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The World Health Organization (WHO) has released a powerful Call to Action and Consensus Statement urging an end to the routine exclusion of pregnant and lactating women from tuberculosis (TB) research. Published as part of a global consensus initiative, the documents—developed by over 80 international experts—outline a strategic framework aimed at ensuring equitable access to TB innovations for all, particularly those most vulnerable.

Each year, approximately 200,000 pregnant or postpartum women develop TB globally. Despite this high burden, they have been largely excluded from research trials involving new TB drugs and vaccines. This exclusion creates critical evidence gaps that delay access to life-saving interventions 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.”

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The WHO-led consensus process focused on five key thematic areas: preclinical TB research, TB therapeutics, vaccine trials, maternal TB surveillance, and advocacy. It included scientists, regulators, ethics committees, and civil society groups, all united in the call for inclusive TB research protocols.

The recommendations call for immediate action to close data gaps by improving maternal TB surveillance and reporting. It also advocates for the inclusion of pregnant and lactating women at all stages of TB drug and vaccine trials, particularly for candidates with a favorable risk-benefit profile. Additionally, the framework emphasizes the importance of creating enabling environments by addressing legal, ethical, and regulatory barriers, and by empowering affected communities.

This bold initiative offers a clear roadmap for governments, research institutions, funders, and regulatory bodies to ensure pregnant and lactating women are no longer left behind in TB research and care.

Reference: https://www.who.int/publications/i/item/B09518

https://www.who.int/publications/i/item/9789240112858


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