The Department of Health says it is laying the groundwork to ensure South African adults can access a new tuberculosis (TB) vaccine as quickly as possible if ongoing clinical trials prove successful and the vaccine receives regulatory approval.

The department said the M72/AS01E vaccine, currently in Phase 3 clinical trials, has the potential to transform TB prevention among adolescents and adults and could play a significant role in South Africa’s goal of eliminating TB as a public health threat by 2030.

The vaccine is being tested in South Africa, Kenya, Zambia, Malawi and Indonesia after showing promising results in earlier trial phases.

If approved, it would become the first new TB vaccine introduced in more than a century.

At present, the only available TB vaccine is the Bacille Calmette-Guérin (BCG) vaccine, which is administered to newborns and children under five, but provides limited protection later in life.

To prepare for a possible rollout, the Department of Health said it has already begun planning for the vaccine’s registration and introduction in South Africa.

The department has also welcomed news from the Gates Medical Research Institute and the Bill & Melinda Gates Foundation that an agreement has been reached with the Serum Institute of India, the world’s largest vaccine manufacturer, to produce and distribute doses of the vaccine globally.

According to the department, the agreement also includes plans for the gradual manufacture of the vaccine by pharmaceutical partners in South Africa and Indonesia, a move expected to support local economic growth and strengthen vaccine production capacity.

The Department of Health said it stands ready to support the production and introduction of the M72/AS01E vaccine once clinical trial results are available and the vaccine has been approved by the South African Health Products Regulatory Authority (SAHPRA).