European health organisations step up tuberculosis countermeasures

Tuberculosis (TB) has re-emerged as the world’s leading killer from a single infectious agent, overtaking COVID-19 in 2023, according to the World Health Organization (WHO). To strengthen the prevention and treatment of TB, particularly among children, Global Health EDCTP3, a European and African research partnership focused on reducing the burden of infectious diseases, has joined forces with the European Commission’s Health Emergency Preparedness and Response Authority (DG HERA) and the European Medicines Agency (EMA).

Deaths caused by TB declined by just 29% between 2015 and 2024, far below the WHO End TB Strategy target of a 75% reduction by 2025. Childhood tuberculosis cases have simultaneously risen by 10% in Europe, according to the European Centre for Disease Prevention and Control (ECDC).

Although TB is preventable and curable, eradication efforts are hindered by slow research and innovation (R&I) and lack of essential tools, from vaccines to diagnostics and medicines. This is also driving TB drug resistance, with the United Nations High-Level Meeting on antimicrobial resistance (AMR) recognising drug-resistant TB as a critical component of the global AMR response. Only one licensed TB vaccine is currently in use (BCG), and it was developed more than a century ago.

Turning TB research into practice

Against this backdrop, Global Health EDCTP3 has moved to strengthen the TB medicines pipeline through targeted funding calls. In 2026, it launched a €30 million call to support the development of TB drugs for treatment and chemoprophylaxis in adults and children in sub-Saharan Africa, alongside a €46 million call for vaccine development launched in 2025. These calls are intended to support late-stage multi-country clinical trials and encourage global public-private partnerships and co-investments.

To date, the Global Health EDCTP3 portfolio comprises 12 projects with a main focus on TB, supported by a €49 million investment, with various innovative health technologies close to regulatory approval and market launch. However, these final clinical product development steps from the laboratory to the patient can be a major hurdle.

'High-cost and limited funding have created a bottleneck in advancing promising medical countermeasures through expensive late-stage clinical trials. To combat this bottleneck, we must leverage innovative financing and adaptive trial designs to accelerate regulatory approval and generate essential safety/efficacy data. Our goal is to expedite market entry while ensuring products are affordable and tailored to regional needs.'

Dr Michael Makanga, Executive Director, Global Health EDCTP3

Need for real-world evidence

Treatment-decision algorithms, conditionally recommended by WHO, offer frontline health workers structured guidance where diagnostic capacity is limited, but evidence of their performance in real-world African settings remains scarce. This gap is particularly acute in paediatric TB, where diagnosis is most challenging.

'If the treatment decision algorithms perform well, they could be more widely used to identify thousands of children with tuberculosis who are currently being missed and often die as a result.'

Amani Mori, senior researcher at the University of Bergen and spokesperson for the Global Health EDCTP3-funded project Optimising childhood TB treatment decision algorithms in sub-Saharan Africa (OPTIC-TB).

Over 40% of Global Health EDCTP3 projects on TB focus on children and adolescents, aiming to tackle persistent barriers in diagnosis and access to appropriate care at primary and community levels.

EU response to TB medicines shortages

While TB challenges are most acute in high-burden countries, the disease continues to pose public health and access challenges in Europe. More than 38,000 people are affected across the European Union and European Economic Area, according to ECDC. Despite a long-term decline, TB notifications rose slightly in 2022-2023.

That is why DG HERA has stepped up the fight against TB through targeted R&I investments and stronger coordination with EU and global partners, including via Global Health EDCTP3.

'By supporting the development of tuberculosis medical countermeasures, we strive to enhance treatments and take a pivotal step towards eradicating tuberculosis for future generations and combatting antimicrobial resistance.'

Florika Fink-Hooijer, Director General, DG HERA

Beyond research, DG HERA has launched targeted EU4Health calls, including €12.5 million to support the development of a novel TB vaccine, and is exploring joint procurement to improve access to antibiotics.

Access challenges are particularly acute for child-friendly formulations, where regulatory pathways are more complex. In this context, the European Medicines Agency (EMA) employs several tools to address this unmet medical need. These include paediatric investigation plans, scientific advice provided by the EMA’s Emergency Task Force, the PRIME scheme, which supports innovative products development, and support for small and medium enterprises.

Despite these regulatory tools, significant work remains to deliver child-friendly TB medicines. The EMA says the average time lag between a new TB medicine reaching the market for adults and the first marketing authorisation for children aged 12 years and older is seven to ten years, and it is even longer before medicines reach the youngest children.

'There remains a significant unmet need for new tuberculosis treatments in the EU, especially for children. EMA has played an active role with its EU partners in advancing development and availability of new TB medicines, but we now need developers to act: engage early to make full use of EMA’s scientific and regulatory support and bring medicines forward for evaluation.'

Emer Cooke, Executive Director, European Medicines Agency (EMA)

To address this unmet need, DG HERA has awarded €5 million to support the development of paediatric fixed-dose combination TB medicines, particularly in dispersible tablet form to facilitate administration and adherence.

As well as working together to accelerate the uptake of new tools, Global Health EDCTP3, DG HERA and the EMA will continue to push for the stronger links between research, implementation and access required to win the battle against TB and AMR.

Published in Science|Business