Tuberculosis remains the leading cause of death from a single infectious agent worldwide, with an estimated 10.7 million people falling ill in 2024 and 1.23 million deaths. In the United States, TB rates have been climbing for several years. Final data from the U.S. Centers for Disease Control and Prevention (CDC) for 2024, released in December 2025, showed 10,388 cases, reflecting a 7.9% increase in cases and a 6.9% rise in rates compared to 2023, which recorded 9,622 cases . While the U.S. still maintains some of the lowest TB rates globally, the upward trend signals a troubling shift and highlights why vaccine innovation has become urgent.

Why Is TB Making a Comeback in America?

Several factors are driving the resurgence. The World Health Organization (WHO) Global Tuberculosis Report 2025 highlighted significant detection gaps, with approximately 2.4 million people either undiagnosed or unreported, especially in high-burden settings . Additionally, a February 2026 study published in Nature Medicine raised concerns about diagnostic accuracy, suggesting that many reported TB cases globally may be inaccurate due to limitations in testing tools. This underscores the urgent need for improved detection methods. In the U.S., localized outbreaks persist, such as one reported in January 2026 at Archbishop Riordan High School in San Francisco, demonstrating that TB remains a real threat even in developed nations .

Access to TB vaccines has also been constrained. The only widely available TB vaccine has been the Bacillus Calmette-Guérin (BCG), which has been in use since 1921 and is administered to hundreds of millions of people annually worldwide . However, BCG has significant limitations. While the WHO recommends administering BCG at birth in high-incidence countries for protection against severe childhood forms of TB, such as TB meningitis, it provides limited or no protection against pulmonary TB, the most common form of the disease .

What New Vaccines Are on the Horizon?

The pipeline for TB prevention is transforming. As of early 2026, at least 17 vaccine candidates are in clinical development, with six already in Phase III trials, the final stage before potential approval . These advanced candidates include:

M72/AS01E: A recombinant vaccine candidate designed to provide broader protection against TB infection and disease.
MTBVAC: A live attenuated vaccine approach that aims to improve upon traditional BCG formulations.
VPM1002: An improved BCG variant engineered to enhance immune response against tuberculosis.
GamTBvac: A vaccine candidate developed through advanced biotechnology platforms.
Immuvac/MIP: Another promising candidate in late-stage development.

The diversity of approaches reflects the scientific community's commitment to finding solutions that work where BCG falls short. These candidates represent years of research aimed at creating vaccines that can prevent pulmonary TB, the form that spreads most easily between people .

How Are Experts Addressing the Vaccine Supply Crisis?

While waiting for new vaccines to reach the market, health authorities have taken interim steps. In February 2025, the FDA authorized an Expanded Access Program for a recombinant BCG vaccine called TUBERVAC-rBCG, developed by the Serum Institute of India in partnership with ImmunityBio . As of early 2026, this vaccine is offered at approximately 57 urology centers nationwide, enrolling patients and administering doses . However, it's important to note that the recombinant BCG vaccine is not currently used for TB prevention in the general population but rather for specific medical applications.

The shortage of the traditional TICE BCG strain, produced by Merck since 2012, has been a persistent challenge. In the U.S., the CDC considers BCG vaccination only in specific high-risk situations, such as for children continuously exposed to untreated or ineffectively treated TB cases when separation is not feasible . This cautious approach reflects both the vaccine's limitations and the supply constraints that have plagued the market.

What Does the Future Hold for TB Control?

The World Health Organization's Executive Board made a significant advancement in the global fight against tuberculosis by approving the development of a post-2030 End TB Strategy during its 158th session in January 2026 . This decision indicates a long-term commitment to sustain and accelerate progress beyond the existing 2030 targets. The 2026 World TB Day theme, "Yes! We can end TB!", serves as a call to action emphasizing the need for decisive leadership by countries, increased investment, and the prompt adoption of WHO recommendations to combat the rising TB epidemic .

The convergence of rising case numbers, diagnostic improvements, and vaccine innovation creates a critical moment. As new vaccine candidates advance through clinical trials, they offer genuine hope for breaking the cycle of TB transmission. The challenge now lies in ensuring that when these vaccines become available, they reach the populations that need them most, whether in high-burden countries or in vulnerable communities within developed nations like the United States.

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