The Department of Health says it is already preparing for registration and rollout of M72/AS01E, a tuberculosis vaccine candidate now in phase 3 trials in South Africa, Kenya, Zambia, Malawi and Indonesia.
If it clears approval, it would be the first new TB vaccine in more than a century. South Africa currently has only BCG, given to infants and young children, which offers limited protection later in life.
Spokesperson Foster Mohale said the department is preparing proactively rather than waiting for results.
Interesting insights on new TB vaccine
The phase 3 trial began in March 2024 and reached full enrolment in April 2025, eleven months ahead of schedule, with roughly 20,000 participants across 54 sites. GSK's earlier phase 2b, running 3,575 participants, showed about 50% protection against progression to active pulmonary TB over three years in TB-infected HIV-negative adults aged 18 to 50.
The WHO estimates a vaccine at that efficacy could prevent 76 million cases and save 8.5 million lives over 25 years. Gates MRI signed the manufacturing agreement with the Serum Institute of India on 16 July, with SII committing more than $100m of its own money and GSK supplying the AS01E adjuvant.
What others are saying about new TB vaccine
BusinessTech reported the department's preparations and the 2030 elimination target. Gates MRI confirms the manufacturing work is starting deliberately ahead of trial results, while Wellcome, which co-funds the trial, sets out the efficacy profile behind the WHO modelling.
Building the factory before you know it works
Worth being clear that nothing is approved and the trial has not reported. The genuinely interesting decision is that SII is spending over $100m on capacity anyway.
The historic bottleneck for diseases like this was never really the science; it was the years lost between approval and actual supply reaching the people who needed it. Paying to compress that gap with private capital is a better model than the one that governed the last few decades.
For South Africa, the question is sharper: the department says local pharmaceutical partners will progressively produce the vaccine, which would test whether SA can be a manufacturing site rather than only a trial site and an end market. TB killed 56,000 South Africans in 2023. Hosting the trial is not the same thing as owning a piece of the supply chain.
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