New Delhi, Aug 21 The World Health Organization (WHO) has urged the global health community to prioritise pregnant and lactating women in research and vaccine trials of tuberculosis (TB) -- the world's most infectious disease.
As per WHO data, every 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.
Pregnant and postpartum women have an increased risk of developing TB compared with the general population. Moreover, TB disease in pregnancy is also associated with an increased risk of maternal morbidity, complications during birth, and perinatal morbidity and mortality. TB disease puts neonates born to mothers with TB at higher risk of the disease.
“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 prioritise their inclusion -- not as an afterthought, but as a fundamental step toward equitable, evidence-based care,” Kasaeva said.
The WHO also released a Consensus Statement, which outlines a comprehensive framework to ensure equitable access to TB innovations for all, including those most at risk. Prepared by over 80 global experts, it covers five themes: preclinical TB research, TB therapeutics research, TB vaccine trials, maternal TB surveillance, and advocacy.
The key actions required in the statement 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.
It called on global researchers to include pregnant and lactating women in all stages of TB drug trials and include them in adult TB vaccine research for candidates with a favourable risk-benefit profile and plan for rollout and monitoring.
Further, it urged addressing legal, ethical, and regulatory barriers by engaging and empowering affected communities.
The document also provides 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.
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