WHO Urges Bold Action for Equitable Access to Novel TB Vaccines Amidst Looming Supply Shortages

A new World Health Organization (WHO) report, launched on November 6, 2025, on the sidelines of the G20 Health Ministers Meeting in Limpopo, South Africa, calls for robust financing and access strategies for novel tuberculosis (TB) vaccines. The report emphasizes the urgent need to ensure these life-saving vaccines reach adolescents and adults in high-burden countries, according to a WHO news release.

The comprehensive report, titled "Catalysing solutions for equitable global access for sustainable financing for novel tuberculosis vaccines for adults and adolescents," presents a first-of-its-kind analysis. Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, stated that new TB vaccines possess the potential to save millions of lives and fundamentally alter the course of the epidemic.

A critical finding within the report highlights a projected imbalance where global demand for novel TB vaccines is expected to significantly outpace supply during the initial years following licensure. This anticipated shortage risks delaying access and diminishing the overall public health impact, as detailed by the WHO.

Tuberculosis continues to be the world's deadliest infectious killer, with over 10 million people falling ill and more than a million dying annually, primarily in low- and middle-income nations. The WHO Global Tuberculosis Report 2024 indicated that a staggering 70% of this disease burden affects G20 countries and regions.

To counter these challenges, the report, developed by the TB Vaccine Accelerator Council's Finance and Access Working Group, outlines six priority actions. These include mobilizing essential financing, advocating for regional manufacturing capabilities, and promoting greater market transparency, the who reported.

Significant momentum is building in TB vaccine innovation, with at least 16 new candidates currently in clinical development as of September 2025, including six in advanced Phase III trials. This progress offers substantial hope for the introduction of the first new TB vaccine for adults and adolescents in decades, according to a SAGE September 2025 outcome report.

• Background and Historical Context: The existing Bacille Calmette-Guérin (BCG) vaccine, developed over a century ago, provides crucial protection against severe TB in infants and young children. However, its effectiveness against pulmonary TB in adolescents and adults is limited and variable, underscoring a long-standing need for more potent vaccines for these age groups, as highlighted by the Stop TB Partnership in February 2024. This gap has driven intensive research into novel candidates.

• Key Stakeholders and Collaborative Efforts: The report was a collaborative effort, co-convened by the WHO, the Government of South Africa, and Gavi, the Vaccine Alliance, under the umbrella of the TB Vaccine Accelerator Council's Finance and Access Working Group. This multi-sectoral partnership emphasizes the necessity of coordinated action among international organizations, national governments, and vaccine financing mechanisms to overcome complex access barriers.

• Economic and Social Implications: The financial investment required for novel TB vaccine procurement alone is estimated to be between US$5–8 billion over the decade from 2030 to 2040, not including costs for delivery and health system strengthening. Researchers at the Harvard T.H. Chan School of Public Health projected in May 2025 that an effective adolescent/adult TB vaccine could yield up to US$474 billion in economic benefits by 2050, underscoring the significant return on investment.

• Challenges in Development and Access: Despite a promising vaccine pipeline, substantial obstacles persist, including insufficient funding for research and development, intricate regulatory pathways, and the imperative for robust manufacturing capacity. Manufacturers also face considerable uncertainty regarding country-level demand and financing, which could hinder the timely and equitable rollout of new vaccines, as noted by the Clinton Health Access Initiative in October 2025.

• The Global Plan to End TB and Funding Gaps: The Global Plan to End TB 2023-2030 outlines a strategic framework for the development and deployment of new TB vaccines, stipulating an annual investment of US$1.25 billion for vaccines by 2027. However, historical funding levels have consistently fallen short, with less than 20% of the 2018 UN target for vaccine R&D achieved by 2022, according to the Stop TB Partnership.

• Timeline and Future Developments: The TB vaccine landscape is rapidly evolving, with several promising candidates in late-stage clinical trials, some potentially ready for licensure as early as 2028. The M72/AS01E vaccine, a leading candidate, demonstrated nearly 50% efficacy in Phase 2b trials and is currently undergoing a large-scale Phase 3 trial, as reported by globalrph in May 2025.

• Impact on High-Burden Countries: The report underscores that high-burden countries will be the primary drivers of demand for novel TB vaccines, with global demand anticipated to surpass 3 billion regimens between 2030 and 2040. Ensuring equitable access in these regions is paramount to maximizing public health impact and addressing existing health disparities, a point emphasized by a WHO analysis in September 2025.

• Strategic Actions for Equitable Access: The WHO report identifies six critical actions to facilitate equitable access, including the development of catalytic financial instruments and the generation of country-level evidence to inform policy. These strategies aim to harmonize demand and supply, overcome production limitations, and guarantee that vaccines are available promptly upon approval, according to the WHO.