South Africa is laying the groundwork for the possible introduction of a new tuberculosis (TB) vaccine that health authorities believe could significantly strengthen efforts to eliminate the disease as a public health threat by 2030.
The Department of Health has confirmed that preparations are already underway to ensure the country can rapidly register and introduce the M72/AS01E vaccine if ongoing Phase 3 clinical trials prove successful and regulatory approval is granted.
Health officials say the candidate vaccine represents the most significant breakthrough in tuberculosis prevention since the Bacille Calmette-Guérin (BCG) vaccine was introduced more than 100 years ago.
If approved, M72/AS01E would become the first new TB vaccine available in over a century and could provide protection for adolescents and adults—groups that remain particularly vulnerable to the disease.
TB vaccine could transform disease prevention
National Department of Health spokesperson Foster Mohale described the vaccine as a potential “game-changer” for tuberculosis control, both in South Africa and globally.
The vaccine has already demonstrated encouraging results during Phase 1 and Phase 2 clinical trials and is now undergoing large-scale Phase 3 testing in South Africa, Kenya, Zambia, Malawi and Indonesia.
Unlike the existing BCG vaccine, which is administered primarily to infants and young children and offers limited long-term protection, the new vaccine is designed to reduce the risk of TB disease in older age groups.
To prepare for possible approval, the Department of Health has begun planning regulatory processes and implementation strategies to ensure South Africans can gain access to the vaccine without unnecessary delays.
The department said it has been working closely with the Gates Medical Research Institute and the Bill & Melinda Gates Foundation following an agreement between the institute and the Serum Institute of India, the world’s largest vaccine manufacturer.
The agreement secures future global production of the vaccine while also creating opportunities for gradual manufacturing by pharmaceutical partners in South Africa and Indonesia.
Officials believe local production could strengthen vaccine supply while supporting pharmaceutical manufacturing capacity and contributing to economic growth.
South Africa continues to face one of the world’s highest TB burdens
The announcement comes as South Africa continues to battle one of the world’s most severe tuberculosis epidemics.
According to the Department of Health, the country remains among the 30 highest-burden nations for tuberculosis, TB linked to HIV and drug-resistant TB.
In 2023, an estimated 270,000 people developed tuberculosis in South Africa, including approximately 13,000 drug-resistant cases. More than half of all notified TB patients were also living with HIV, highlighting the close relationship between the two epidemics.
Although expanded access to antiretroviral therapy has helped reduce TB infections, the disease still claimed around 56,000 lives during 2023.
Since 2015, South Africa has reduced its TB incidence rate by 57%, while treatment coverage has increased to 79%. However, health authorities acknowledge that significant challenges remain, particularly in reducing mortality and improving access to affordable treatment.
To strengthen disease control, the Department of Health has launched the nationwide End TB Campaign, which aims to test five million people for tuberculosis during the 2025/26 financial year through expanded community and healthcare facility screening programmes.
Health officials say continued investment in early diagnosis, treatment and vaccination will be essential if South Africa is to achieve its goal of eliminating tuberculosis as a public health threat by the end of the decade.
Source: Department of Health