South Africa is laying the groundwork to introduce a new tuberculosis vaccine that could transform the fight against the disease, the Department of Health has announced.

The M72/AS01E vaccine, currently in Phase 3 trials across five countries including South Africa, has shown promise in earlier testing and could become the first new TB vaccine to reach the market in over 100 years.

The department confirmed it is taking proactive steps to ensure South Africans can access the vaccine quickly once trial results are finalised and regulatory approval is secured from the South African Health Products Regulatory Authority.

“A vaccine that prevents TB disease in adolescents and adults will be a game-changer for TB control and elimination, both globally and in South Africa,” the department said.

First new TB vaccine in a century

South Africa, along with Kenya, Zambia, Malawi and Indonesia, is hosting Phase 3 trials of the vaccine. The trials follow successful Phase 1 and Phase 2 results that demonstrated the vaccine’s potential.

Currently, the only TB vaccine available is the Bacille Calmette-Guérin (BCG) vaccine, which has been in use for more than a century. BCG is given to newborn infants and children under five years old but offers limited protection later in life, leaving adolescents and adults vulnerable to the disease.

The new vaccine would fill this critical gap and support South Africa’s goal of eliminating TB as a public health threat by 2030.

Production deal with vaccine giant

Officials from the Gates Medical Research Institute and the Bill & Melinda Gates Foundation have informed the department that an agreement has been reached with the Serum Institute of India, the world’s largest vaccine manufacturer, on production and global distribution.

The deal includes plans for progressive production by pharmaceutical partners in South Africa and Indonesia over time.

Economic boost expected

The department said local vaccine production would not only improve access for South Africans but also contribute to the country’s economic growth.

“This is arguably a major step toward a new TB vaccine — the first significant advance since BCG more than 100 years ago,” the department said.

The vaccine will need to complete trials and receive registration from SAHPRA before it can be introduced in South Africa.

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