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TB vaccine R&D: an urgent need for stepping up EU investments

Today we celebrate World Tuberculosis Day. It is an opportunity to raise awareness about the devastating health, social and economic consequences of tuberculosis (TB) and to warn of the chronic lack of funding in the fight against TB, particularly in the field of research and development (R&D).

TB is an airborne bacterial disease that affects 10 million people each year, killing over 1.5 million people, mostly in low- and middle-income countries. The difficulty of diagnosing and successfully treating people with TB significantly contributes to antimicrobial resistance (AMR). In a recent brief, the TB Vaccine Advocacy Roadmap (TB VAX ARM) stresses the urgent need to invest in TB vaccines R&D to tackle this pressing issue.

Drug-resistant TB is an urgent global health problem. The number of new cases of MDR/RR-TB rose by 3% in 2021 to an estimated 450,000 people, mainly due to the fact that there was an overall increase in TB incidence caused by the COVID-19 pandemic. Drug-resistant TB can be caused by a simple mutation, incorrect prescription by health care providers, by the use of poor-quality drugs, and by premature stop of treatment, which could be caused by the gruelling nature of treatment regimens, insufficient treatment support, or interruptions to drug supply. Despite substantial improvement in the standard of care, treatment for drug-resistant TB remains lengthy and dependent on the efficacy of a limited number of antibiotics. Addressing drug-resistant TB through treatment alone is both costly and insufficient. New effective TB vaccines would make a major difference.

It is estimated that, without further action, 31.8 million TB deaths will occur by 2050. Developing new TB vaccines by 2030 is within reach if decision-makers prioritise TB vaccine R&D as a signature piece of global health and AMR agendas. One study estimates that new TB vaccines could avert over a third of deaths attributable to bacterial AMR. By preventing TB, new vaccines would reduce the need for antibiotics, and thus reduce the development of drug resistance and onward transmission. Currently, the only available TB vaccine is the century-old Bacillus Calmette-Guérin (BCG) vaccine, which is mostly ineffective in adolescents and adults, who are most at risk of developing and spreading TB.

In July 2022, WHO published an urgent call to use and develop new vaccines to tackle AMR, highlighting that the development of more effective vaccines against TB should be accelerated. Given the urgent need, the WHO calls for the accelerated development of more effective vaccines against TB, with the highest level of ‘Priority 1: critical’ in the 2020 Action Framework on Leveraging Vaccines to Reduce Antibiotic Use and Prevent Antimicrobial Resistance.

In December 2022, WHO published an investment case presenting eight health and economic arguments for investing in new TB vaccines. Every $1 invested in the development and rollout of new TB vaccines for adolescents and adults will return $7 to the global economy over 25 years.

The European Commission new Global Health Strategy does mention TB among its priorities for health equity, and the European One Health Action Plan against AMR explicitly connects resistant strains of TB to AMR. However, the Health Emergency Preparedness and Response Authority (HERA) does not include TB research as part of the priority it places on AMR, and the Horizon Europe Health Work Programme for 2023-2024 does not mention TB even once.

Europe’s One Health Action Plan against AMR calls on the European Union (EU) and its Member States (MS) to invest in “infection prevention and control in vulnerable groups, in particular to tackle resistant TB strains,” including investments for new vaccines. Europe has invested in TB research, but the EU and most MS are far behind their fair share targets. In fact, the majority barely cover half of their targets.

The UN high-level meeting on TB planned for 22 September 2023 presents a major opportunity to raise awareness among decision-makers of current needs and challenges and to hopefully secure new and ambitious political and financial commitments to the fight against TB. In particular, we call on EU and Member States to substantially increase their investments in TB vaccine R&D, in line with their fair share targets. This will advance the TB vaccine pipeline and enable new TB vaccines to be available as early as 2025, saving money, saving lives, and preventing massive economic losses. This includes creating new financing mechanisms for late-stage vaccine evaluation, vaccine introduction, manufacturing capacity development, and evaluation of new vaccine effectiveness and impact in real-world settings.