WHO Calls for Inclusion of Pregnant Women in TB Research

The World Health Organization (WHO) has issued a call to action for the global health community to prioritise pregnant and lactating women in tuberculosis (TB) research and vaccine trials. According to WHO data, approximately 200,000 pregnant or postpartum women develop TB annually, yet they are often excluded from research and clinical trials. This omission creates significant gaps in evidence, hindering access to crucial treatments and vaccines for these vulnerable populations.

Pregnant and postpartum women are at an elevated risk of developing TB compared to the general population. TB during pregnancy is linked to higher rates of maternal morbidity, complications during childbirth, and increased perinatal morbidity and mortality. Furthermore, neonates born to mothers with TB face a greater risk of contracting the disease.

Urgent Need for Inclusion in Research

“The benefits of TB research must flow to all people with TB, including pregnant and lactating women,” stated Dr. Tereza Kasaeva, Director of the WHO Department for HIV, TB Hepatitis, and Sexually Transmitted Infections. She emphasised that it is crucial to include these women in research frameworks, stating, “It is time to prioritise their inclusion — not as an afterthought, but as a fundamental step toward equitable, evidence-based care.”

In response to this pressing issue, the WHO released a Consensus Statement that outlines a comprehensive framework aimed at ensuring equitable access to TB innovations for all, particularly those most at risk. Developed with input from over 80 global experts, the statement addresses five key themes: preclinical TB research, TB therapeutics research, TB vaccine trials, maternal TB surveillance, and advocacy.

Key actions outlined in the statement include addressing data gaps regarding TB in pregnancy and postpartum through enhanced surveillance and reporting. Additionally, there is a call for initiating timely preclinical studies to assess the efficacy and safety of new TB compounds and vaccines among pregnant women.

Advocating for Comprehensive Research

The WHO urges global researchers to include pregnant and lactating women at all stages of TB drug trials and to involve them in adult TB vaccine research for candidates deemed to have a favourable risk-benefit profile. The initiative also calls for the removal of legal, ethical, and regulatory barriers that currently hinder the participation of affected communities in these studies.

The Consensus Statement offers a roadmap for stakeholders including product developers, study sponsors, researchers, regulators, ethics committees, government programs, funders, and civil society. The aim is to take decisive actions to enhance the inclusion of pregnant and lactating women in TB research initiatives, ultimately ensuring that advancements in TB treatment and prevention benefit all members of society.

As the WHO continues to advocate for these vital changes, the focus remains clear: to enhance research efforts that safeguard the health of both mothers and their children in the fight against tuberculosis.