Jakarta. Indonesia will begin a Phase III clinical trial of a tuberculosis (TB) vaccine candidate developed with support from the Bill & Melinda Gates Foundation, involving 2,000 participants, authorities confirmed on Thursday.

The decision comes less than a week after Bill Gates visited Indonesia and met with President Prabowo Subianto.

Head of the Food and Drug Supervisory Agency (BPOM), Taruna Ikrar, said Indonesia will also take part in the vaccine's global production if the trial proves successful.

The candidate, known as M72, will be tested in five countries: Indonesia, South Africa, Kenya, Zambia, and Malawi.

“BPOM has approved the Phase III clinical trial of the vaccine,” Taruna said, adding that the vaccine has already passed safety testing in earlier phases. The final trial will assess its effectiveness.

The initial phase of the trial in Indonesia will target healthcare workers to ensure adherence to "good clinical practice" standards, Taruna noted.

Indonesia has one of the highest TB burdens in the world, with nearly 2 million cases and an estimated 100,000 deaths annually. Hosting the Phase III trial will grant the country priority access once the vaccine is ready for global distribution, he added.

Health Minister Budi Gunadi Sadikin said earlier that Indonesia has a strong interest in joining the trial due to the nation’s high TB rates and genetic considerations in vaccine efficacy.

“When we weren’t involved in the development of the malaria vaccine, it ended up being ineffective for most Indonesians,” Budi said on Friday.

The TB vaccine trial will involve multiple universities and cover participants ranging from adolescents to adults.

If the M72 vaccine proves successful, state-owned pharmaceutical company Bio Farma will be proposed as a partner in its global manufacturing, Budi added.

The Gates Foundation said in its website that if proven effective, the M72 vaccine could potentially become the first new vaccine to help prevent pulmonary TB, a form of active TB, in more than 100 years.

“The only TB vaccine in use today, bacille Calmette-Guérin (BCG), was first given to people in 1921. It helps protect babies and young children against severe systemic forms of TB but offers limited protection against pulmonary TB among adolescents and adults,” it said.

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