The Department of Health has welcomed progress towards the development of a new tuberculosis (TB) vaccine, saying preparations are under way to ensure South Africans can access it if clinical trials prove successful.
The M72/ASO1E vaccine, which aims to prevent TB disease among adolescents and adults, is currently undergoing phase three trials in South Africa, Kenya, Zambia, Malawi and Indonesia.
The department said the vaccine could be a major breakthrough in the fight against TB, both globally and in South Africa, where the disease remains a significant public health challenge.
Currently, the only available TB vaccine is the Bacille Calmette-Guérin (BCG) vaccine, which is administered to newborn infants and children under five years old. However, it provides limited protection against TB later in life.
Departmental spokesperson Foster Mohale said the department was proactively preparing for the possible registration and introduction of the vaccine.
“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,” Mohale said.
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 production and global supply of TB vaccine doses.
It said the agreement also allowed for progressive production by pharmaceutical partners in South Africa and Indonesia, which could contribute to economic growth.
Mohale said the agreement represented a significant step towards developing a new TB vaccine.
“This is arguably a major step toward a new TB vaccine, the first significant advance since BCG more than 100 years ago,” he said.
TB remains one of the leading infectious disease killers worldwide, with South Africa among the countries carrying a high burden of the disease. The government has set a target of eliminating TB as a public health threat by 2030.
Mohale said the department was ready to support the production and introduction of the vaccine once the trial results were available and regulatory approval had been granted.
“The Department of Health 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),” Mohale said.
The vaccine will still need to complete phase three trials and receive approval from SAHPRA before it can be made available to the public.
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