The Department of Health has welcomed progress towards a new tuberculosis (TB) vaccine, while confirming preparatory work to ensure timely access for South Africans as part of ongoing efforts to eliminate the epidemic as a public health threat by 2030.
This comes after the ongoing trials of the M72/AS01E vaccine showed promise in Phase 1 and Phase 2. The vaccine is now in Phase 3 trials in South Africa, Kenya, Zambia, Malawi and Indonesia.
According to the department, 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.
“Once approved, it will be the first TB vaccine introduced in over a century, because currently we have only the Bacille Calmette-Guérin (BCG) vaccine, which is given to newborn infants and children under 5 years old and offers limited protection later in life.
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“Therefore, to ensure we can offer protection to South Africans at the earliest opportunity if the trial is successful, the Department of Health is proactively preparing for registration and introduction of the new vaccine.”
The department said it had been informed by officials from the Gates Medical Research Institute and the Bill & Melinda Gates Foundation that an agreement had been reached with the world’s largest vaccine manufacturer, the Serum Institute of India, on the number of doses of the TB vaccine to be produced and sold globally.
The agreement also provides for progressive production by pharmaceutical partners in South Africa and Indonesia over time, which the department said would consequently boost the economic growth of the country.
“This is arguably a major step toward a new TB vaccine — the first significant advance since BCG more than 100 years ago.
“The department welcomes this important agreement and stands ready to support the production and introduction of the M72/ASO1E vaccine in South Africa once the trial results are known, and the vaccine has been registered by the South African Health Products Regulatory Authority (SAHPRA).”
