ABOUT NEW TB VACCINES

Background

THE WORLD URGENTLY NEEDS NEW TB VACCINES

TB remains a major global health threat. In 2022, an estimated 10.6 million people became sick with TB and 1.3 million people died from TB.

The only licensed vaccine to prevent TB – the 100-year old BCG vaccine – provides moderate, although important, protection against severe TB in infants and young children, but it does not adequately protect adolescents and adults, who are most at risk for developing and spreading TB.

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Multiple new TB vaccines that work across all populations and age groups, particularly among adults and adolescents, will be critical to eliminate TB by 2030 and meet the WHO End TB targets.

NEW VACCINES ARE ESSENTIAL TO END TB

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Vaccines are one of the most successful and cost-effective public health interventions for reducing and even eliminating deadly infectious diseases. Yet, the only licensed vaccine against TB is the century-old Bacille Calmette-Guérin (BCG). While it provides some important protection against severe forms of TB in infants and young children, BCG is ineffective in adolescents and adults, who are most at risk of developing and spreading TB.

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TACKLING DRUG RESISTANT TB

Drug-resistant TB (DR-TB) is a key driver of the growing public health threat of antimicrobial resistance (AMR). In 2022 there were an estimated 410,000 new cases of multidrug-resistant TB (MDR-TB).

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New TB vaccines would contribute to efforts to address DR-TB in several ways:

  • They are likely to be equally effective against DR-TB and drug-sensitive TB, thus reducing incidence and transmission of MDR-TB
  • By preventing TB disease, vaccine would reduce the need for antibiotics
  • Therapeutic vaccines, used in combination with drugs, could reduce treatment duration and reduce the risk of recurrence

NEW VACCINES ARE ACHIEVABLE

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Ninety percent of otherwise healthy individuals infected with TB do not progress to TB disease, indicating that the human body can already protect itself from TB in some cases. Scientists hope to replicate this innate resistance in a vaccine. The current vaccine, BCG, does offer partial protection, which is a positive indicator that it is possible to develop vaccines that offer better protection.

Recent positive results from two Phase 2b clinical trials, progress across the clinical pipeline, promising results of novel vaccine candidates in preclinical models, and enhanced understanding of the human response to Mtb infection support the feasibility of developing new, more effective vaccines.

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SUCCESS WILL REQUIRE INCREASED INVESTMENT

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Vaccine development is a lengthy and expensive process. Substantial and sustained resources are needed to support and enhance the full continuum of research and development. It is estimated that at least $1.25 billion will be needed per year for TB vaccine development, as outlined in the Global Plan to End TB 2023-2030.

This represents a fraction of the estimated $19.65 billion per year that the Global Plan requires for prevention (excluding rollout of new vaccines), diagnosis and treatment and would accelerate the development of this lifesaving intervention. But, despite the urgent need for new vaccines and continued progress in the field, TB vaccine research funding has never exceeded $145 million annually.

Vaccine development is a lengthy and expensive process. Substantial and sustained resources are needed to support and enhance the full continuum of research and development. It is estimated that at least $1.25 billion will be needed per year for TB vaccine development, as outlined in the Global Plan to End TB 2023-2030.

This represents a fraction of the estimated $19.65 billion per year that the Global Plan requires for prevention (excluding rollout of new vaccines), diagnosis and treatment and would accelerate the development of this lifesaving intervention. But, despite the urgent need for new vaccines and continued progress in the field, TB vaccine research funding has never exceeded $145 million annually.

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