Jakarta, Indonesianpost.com – Indonesia’s Food and Drug Monitoring Agency (BPOM) has approved phase 3 clinical trials for the M72 tuberculosis vaccine, marking a significant step in the country’s fight against TB, which has the world’s second-highest caseload after India.
BPOM head Taruna Ikrar announced on Thursday that the trials involve 2,000 Indonesian participants among 20,000 global volunteers. “This double-blind study will test the vaccine’s effectiveness compared to placebos,” Ikrar explained, noting current TB treatments face growing drug resistance issues.
Addressing Treatment Challenges
The new vaccine development comes as standard TB drugs like isoniazid, rifampicin and ethambutol face increasing resistance, while the century-old BCG vaccine shows limited effectiveness. “This new vaccine technology could revolutionize TB management,” Ikrar added.
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Local Production Potential
The trials could lead to domestic vaccine production through state-owned Biofarma. “Participating countries may gain intellectual property rights for local manufacturing,” Ikrar noted. Biofarma President Director Shadiq Akasya pledged strict quality control and thanked the Gates Foundation for their support.
Rasayam Prasad of the Gates Foundation highlighted Indonesia’s growing role in global vaccine development: “We envision Indonesia becoming a production hub for vaccines against TB, measles, rubella and other diseases.”
The trial results could significantly impact global TB eradication efforts, particularly in high-burden countries like Indonesia. (BL/Antara)