Health department prepares for roll-out of promising M72 TB vaccine

The Health Department says it is preparing for rapid introduction of a new tuberculosis (TB) vaccine after recent progress in trials. Officials described the M72/ASOIE vaccine as a potential breakthrough that could change TB control strategies if trials and regulatory review succeed.

What the department says

National health spokesperson Foster Mohale said preparatory work is under way to ensure timely access for South Africans should the vaccine be approved. Mohale described a vaccine that prevents TB in adolescents and adults as a “game-changer for TB control and elimination, both globally and here in South Africa.”

“The Department of Health welcomes progress made towards a new tuberculosis (TB) vaccine and confirms preparatory work to ensure timely access for South Africans as part of ongoing efforts to eliminate this epidemic,” Mohale said.

Where the vaccine stands

The department said the M72/ASOIE vaccine is currently in phase three trials and named the five countries taking part: South Africa, Kenya, Zambia, Malawi and Indonesia. Mohale noted earlier phase 1 and phase 2 trials showed promise.

The department emphasised that, if approved, this would be the first TB vaccine introduced in over a century. The statement noted that the only currently used TB vaccine is Bacille Calmette-Guérin (BCG), which is given to newborn infants and children under five and “offers limited protection later in life.”

Production and regulatory plans

Mohale said officials from the Gates Medical Research Institute and the Bill & Melinda Gates Foundation informed the department that an agreement has been reached with the Serum Institute of India about the number of doses to be produced and sold globally.

“This agreement also provides for progressive production by pharmaceutical partners in South Africa and Indonesia over time, and this will consequently boost the economic growth of our country,” Mohale said.

The department said it stands ready to support production and introduction of the M72/ASO1E vaccine in South Africa once trial results are known and the vaccine has been registered by the South African Health Products Regulatory Authority (SAHPRA).

Next steps

According to the department’s statement, preparations are focused on registration and introduction processes to allow an expedited roll-out if the trial is successful and regulatory approval follows.