he World Health Organization (WHO) has issued a strong appeal to the global health community to prioritize pregnant and lactating women in tuberculosis (TB) research and vaccine development. TB remains the world’s deadliest infectious disease, and yet this vulnerable group continues to be excluded from critical studies.
🚨 Urgent Need for Inclusion in TB Research
According to WHO estimates, over 200,000 pregnant or postpartum women develop TB annually, but they are largely absent from clinical trials and research. This exclusion creates dangerous gaps in medical evidence, delaying access to life-saving treatments and vaccines for mothers and their newborns.
Pregnant and postpartum women face a higher risk of TB infection compared to the general population. TB during pregnancy is linked to increased maternal complications, birth-related risks, and higher rates of neonatal illness and mortality.
“The benefits of TB research must flow to all people with TB, including pregnant and lactating women,” said Dr. Tereza Kasaeva, Director of WHO’s Department for HIV, TB, Hepatitis, and STIs. “It is time to prioritise their inclusion — not as an afterthought, but as a fundamental step toward equitable, evidence-based care.”
📜 WHO Releases Global Consensus Statement
To address this gap, WHO has published a Consensus Statement developed by over 80 global experts. The document outlines a strategic framework to ensure equitable access to TB innovations, focusing on five key areas:
- Preclinical TB research
- TB drug and therapeutic trials
- TB vaccine development
- Maternal TB surveillance
- Advocacy and community engagement
✅ Key Recommendations for TB Research Reform
The WHO urges researchers, regulators, and policymakers to:
- Close data gaps through improved surveillance of TB in pregnancy and postpartum
- Initiate preclinical studies to evaluate safety and efficacy of TB treatments and vaccines for pregnant populations
- Include pregnant and lactating women in all stages of TB drug and vaccine trials, especially for candidates with favorable risk-benefit profiles
- Address legal and ethical barriers by empowering affected communities and ensuring informed participation
🛠️ Roadmap for Action
The statement provides a clear roadmap for stakeholders — including product developers, study sponsors, ethics committees, government health programs, and civil society — to advance inclusive TB research and ensure no population is left behind.