More than a century after the BCG vaccine was licensed, new tuberculosis vaccines could arrive in 2029. Gavi says the groundwork has to start now.
TB remains one of the world’s deadliest infectious diseases, causing around 1.2 million deaths every year – equivalent to roughly one death every 26 seconds. Africa still records the highest rates of cases and deaths of any region. The burden remains substantial despite progress in diagnosis, treatment and prevention.
For more than 100 years, the only licensed defence has been the Bacille Calmette-Guérin (BCG) vaccine.
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But now, a new generation of vaccines could offer a major breakthrough in the fight against the disease, potentially saving 7.3 million lives between 2030 and 2050, according to Gavi, the Vaccine Alliance. The opportunity, however, will depend on more than scientific progress. This will include ensuring that vaccines reach the countries and communities that need them most, which will require early planning, sufficient manufacturing capacity, sustainable financing and equitable access.
The next-generation TB vaccines will potentially become available from 2029. Gavi is urging governments and global health partners to prepare now, before the first products are approved.
Closing the gaps in TB prevention
Africa has made significant progress in expanding access to diagnosis, treatment and prevention. However, significant gaps remain, with many people diagnosed late or not at all, while others struggle to access treatment.
Emily Kobayashi, Director of Vaccine Programmes at Gavi, the Vaccine Alliance, said these gaps allow TB to continue spreading within communities, particularly among people living in poverty, overcrowded environments and areas with fragile health systems.
“Too many people with TB are diagnosed too late, or not at all, and others fail to access treatment,” she said.
Closing those gaps, Kobayashi said, will take both stronger delivery of proven interventions and new tools. She said that the existing BCG vaccine remains vital in protecting infants and young children against severe forms of TB. However, it has limited impact on pulmonary TB in adolescents and adults, who account for most TB transmission.
“New vaccine candidates are being developed specifically to address this gap,” she said. “If successful, they could represent the first major breakthrough in TB prevention in more than a century.”
She said that the vaccines could offer a real opportunity to dramatically reduce transmission, save millions of lives and accelerate progress towards ending one of the world’s deadliest infectious diseases.
Next-generation vaccines, if proven safe and effective, could complement existing prevention, diagnosis and treatment efforts by reducing the number of people who develop infectious TB.
“Next-generation TB vaccines can help to further bend the curve, meaningfully reducing the number of people getting sick with TB,” she said. “In practical terms, it means millions of families being spared the devastating consequences of TB, with fewer parents, teenagers and breadwinners becoming seriously ill or dying from a disease that remains one of the world’s leading infectious killers.”
For countries with a high TB burden, she said, a successful vaccine could also reduce pressure on health systems, lower treatment costs and boost economic productivity by helping adolescents and adults stay healthy during their most productive years. However, Kobayashi cautioned that the ultimate impact would depend on the characteristics of the vaccines approved and how quickly countries could introduce them.
She said the projected 7.3 million lives saved highlights why new TB vaccines are considered one of the most significant public health opportunities in decades.
Preparing for demand and securing supply
For Africa, where TB continues to cause significant illness and death, the question is not only whether new vaccines will work, but whether they will be accessible and affordable when they become available.
Kobayashi said that figure shows where the new vaccines must be prioritised. “The greatest health impact will come from reaching the communities where the disease continues to cause the most illness and death,” she said.
That is why Gavi’s focus from the outset has been on readiness. If a vaccine is successfully developed and approved, the countries carrying the heaviest burden need to be able to access and introduce it as quickly as possible. “Working with governments and partners,” she said, “we want those most affected by TB to benefit first.”
Gavi’s Early Market Shaping Roadmap for Novel TB Vaccines suggests demand could average 86 million vaccination courses a year, with high-burden countries needing substantial supplies during the initial rollout.
The roadmap estimates that global demand could average 86 million vaccination courses annually. The vaccines could also generate up to US$135 billion in economic benefits for low- and middle-income countries, according to Gavi analysis.
One of the principal risks, said Kobayashi, is uncertainty over future demand. Manufacturers must be confident that sufficient demand will exist to justify investing in production capacity before a vaccine receives regulatory approval.
Manufacturers need confidence that there will be sufficient demand for the vaccine to justify investments in production capacity before a vaccine is licensed. Without that confidence, there is a risk that supply may not increase quickly enough to roll out the vaccine broadly after the evidence comes from the ongoing trials. That is why early planning is so important, she said. Working with countries, manufacturers and partners to describe future demand and likely introduction timelines, which she said can help reduce uncertainty and encourage investments that then support adequate supply.
Between now and 2029, Kobayashi said, several things must happen in parallel.
First, vaccine candidates must successfully complete clinical trials and demonstrate that they are safe and effective. At the same time, country governments, manufacturers and global health partners need to prepare for widespread access to the vaccine. This includes understanding future demand for the vaccine, planning how it will be delivered to communities, assessing manufacturing needs, developing policy recommendations and ensuring financing is available the moment a vaccine is licensed.
“The key lesson from previous vaccine introductions is that preparation cannot start after approval,” she said. “It needs to begin well in advance.”
Kobayashi pointed to the malaria vaccine rollout as an example of how early coordination among partners can support rapid scale-up, with preparations taking place while vaccines were still undergoing trials. It resulted in one of the fastest rollouts in Gavi’s history.
For African countries, this means considering how potential vaccines would be integrated into existing immunisation and TB programmes, which populations should be prioritised and what resources would be needed to deliver doses effectively.
Beyond preventing illness and death, next-generation TB vaccines could also contribute to efforts to address antimicrobial resistance (AMR), including drug-resistant TB.
Drug-resistant TB is one of the most challenging forms of the disease because it is difficult, lengthy and expensive to treat. It can take a significant toll on individuals and families, often requiring prolonged treatment and time away from work or school. By preventing TB disease in the first place, she said, vaccines can reduce the number of people requiring treatment and help limit opportunities for drug resistance to develop or spread.
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Kobayashi said that is why vaccination is increasingly recognised as an important part of the broader response to AMR alongside diagnosis, treatment and infection control. Vaccines can help reduce reliance on antibiotics and contribute to long-term efforts to combat AMR.
Making sure access is equitable
The risk with any new vaccine is that it reaches wealthier or lower-risk populations first. Gavi said its focus is on the countries with the highest TB burden, most of which are low- and middle-income.
Drawing on more than two decades of experience supporting vaccine introductions and shaping vaccine markets, she said the goal is “to help ensure that public health need drives access.” If a new vaccine becomes available, she added, the countries hardest hit “should be among the first to benefit.”
Why now?
Kobayashi said the urgency of preparing for new TB vaccines was underscored by the continuing toll of the disease, which claims around 1.2 million lives globally each year. Africa bears a disproportionate share of the burden, with the region continuing to face high rates of TB cases and deaths despite progress in prevention, diagnosis and treatment.
At the same time, she said, the world was closer than it had been in decades to developing a new vaccine that could protect the communities most affected by TB and responsible for much of its transmission.
“This combination of urgent need and scientific progress makes now the moment to start preparing,” said Kobayashi.
She warned that the decisions made before the vaccines become available, including forecasting demand, planning delivery strategies and ensuring adequate supply, would help determine how rapidly people will benefit from these vaccines and how much impact they can ultimately have on reducing the global burden of TB.
