South Africa is preparing for what could be one of the most significant health advances in a century. The Department of Health has welcomed clear progress towards a new tuberculosis (TB) vaccine and confirmed that it is already doing the groundwork to make sure South Africans can access it quickly once it is approved.
The optimism centres on the M72/AS01E vaccine candidate, which has shown promise in Phase 1 and Phase 2 trials and is now in large Phase 3 trials in South Africa, Kenya, Zambia, Malawi and Indonesia.
The first new TB vaccine in over 100 years
According to the department, a vaccine that prevents TB disease in adolescents and adults would be a genuine game-changer for TB control and elimination, both in South Africa and globally.
“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,” the department said.
That gap has long been one of the biggest challenges in the fight against TB. The BCG jab protects the very young, but adolescents and adults have had no vaccine to shield them, which is why a successful M72/AS01E rollout would be so important for a country that has carried a heavy TB burden for generations.
Getting ready before the results are in
Rather than waiting for the trials to conclude, the Department of Health is preparing now. “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.
There is encouraging news on supply too. 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 Serum Institute of India, the world’s largest vaccine manufacturer, on the number of doses to be produced and sold globally.
Crucially, the agreement also provides for progressive production by pharmaceutical partners in South Africa and Indonesia over time. The department said this local manufacturing element would, in turn, help boost the country’s economic growth, adding a welcome industrial dividend to a public-health win.
A step towards the 2030 goal
South Africa has committed to eliminating TB as a public health threat by 2030, and the department framed this progress as a major move in that direction. “This is arguably a major step toward a new TB vaccine, the first significant advance since BCG more than 100 years ago,” it said.
The department stressed that it “stands ready to support the production and introduction of the M72/AS01E 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).”
For millions of South Africans, the message is one of hope: a century-old wait for better protection against TB may finally be nearing its end, and the country is getting ready to move the moment the science says go.
Photo: commons.wikimedia.org
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