Tuberculosis vaccine(Aeras Technologies LLC)

The Unified Health System ( Sistema Único de Saúde , SUS) is a cornerstone of Brazil’s public health, offering universal care and playing a critical role during crises such as the COVID-19 pandemic and climate emergencies. Climate change poses escalating threats to public health, intensifying vulnerabilities and increasing the burden of diseases like tuberculosis. This study focuses on the analysis of events resulting from heavy rains in the state of Rio Grande do Sul, addressing the impacts of climate change, strategies for continued tuberculosis control, logistical and operational challenges and prospects for strengthening the SUS in times of climate crises. With Brazil’s high tuberculosis prevalence, climate events, such as the severe 2024 floods in Rio Grande do Sul, disrupted healthcare infrastructure, delayed tuberculosis diagnosis and treatment and worsened health inequities. The floods in Rio Grande do Sul affected 96% of municipalities, displacing over 160 000 people and damaging health centres. Efforts to maintain tuberculosis care included deploying mobile units, relocating diagnostic equipment and implementing extended medication dispensing. The SUS demonstrated resilience, but gaps in real-time case monitoring and health infrastructure persist. Addressing these gaps is critical, especially as climate change exacerbates social vulnerabilities. The need for an effective tuberculosis vaccine has become urgent in mitigating climate-related health crises. Additionally, adopting the one health approach, improving cross-sector collaboration, investing in digital health technologies and empowering communities are essential for building a resilient health system. Integrated policies addressing climate change impacts can safeguard public health and equity in Brazil.

Current licensure trials of new vaccines to prevent tuberculosis disease use bacteriologically confirmed symptomatic tuberculosis disease as the primary endpoint. Globally, the incidence of symptomatic tuberculosis disease is low, making licensure trials large, long, and expensive. New data suggest that bacteriologically confirmed asymptomatic tuberculosis disease might occur more frequently than symptomatic tuberculosis disease. Therefore, if vaccines have efficacy against asymptomatic disease, tuberculosis vaccine licensure trials could include it in the primary endpoint, potentially leading to smaller or shorter trials. We describe the potential benefits and risks of this inclusion in the primary endpoint of tuberculosis vaccine licensure trials. We also simulate licensure trial endpoint accrual and summarise feedback from anonymous regulators and policy makers on the knowledge needed to consider this proposal and research studies needed to fill these evidence gaps. If bacteriologically confirmed asymptomatic tuberculosis disease could be included in the primary endpoint of tuberculosis disease licensure trials, it could lead to cheaper and more rapid tuberculosis vaccine development.