South Africa’s Department of Health confirmed on 2 August 2026 that it is preparing for the possible introduction of the M72/AS01E tuberculosis vaccine, contingent on the success of ongoing phase 3 clinical trials and registration by the South African Health Products Regulatory Authority (SAHPRA). The vaccine candidate, described by the department as the most advanced TB vaccine in development globally, is being tested across 54 sites in South Africa, Kenya, Zambia, Malawi, and Indonesia.
The phase 3 trial began in March 2024 and reached full enrolment of 20,000 adolescents and adults aged 15 to 44 by April 2025, according to the Gates Medical Research Institute, which is overseeing the study. Participants include people living with HIV, a critical factor for South Africa, where TB and HIV co-infection remains a leading cause of mortality.
National Health spokesperson Foster Mohale said preparations were under way for a speedy rollout once the vaccine is approved. Speaking on 3 August 2026, Mohale said: “A vaccine that prevents TB disease in adolescents and adults will be a game-changer for TB control and elimination, both globally and here in South Africa.”
The Department of Health noted that once approved, M72/AS01E would be the first new TB vaccine introduced in over a century. The only existing TB vaccine, BCG, has been administered to newborns in South Africa since the mid-20th century but offers limited protection against pulmonary TB in adults, the most common and infectious form of the disease.
Independent scientific reporting, published in Nature, confirmed that an earlier phase 2b study showed M72/AS01E reduced progression to pulmonary TB by approximately 50%. However, that result does not guarantee phase 3 success, and definitive efficacy data from the current trial are not expected until late 2028, with regulatory submissions possible from 2029 onward if the vaccine proves safe and effective.
On 16 July 2026, the Gates Medical Research Institute announced an agreement with the Serum Institute of India to manufacture M72/AS01E at scale, signalling confidence in the programme despite results still being years away. Claims that the vaccine will eliminate TB as a public health threat by 2030, or that it will be provided free of charge similar to Covid-19 vaccines, remain unverified projections rather than confirmed policy commitments.
What remains unknown is whether phase 3 results will replicate the promise shown in earlier studies, how SAHPRA will time its regulatory review, and what the vaccine will cost South Africa if approved. Cape Flats journalist Nadia Adams will check back when trial investigators release interim safety data, expected in 2027, or when the Department of Health publishes its rollout plan, whichever comes first.