TEMPO.CO, Jakarta - A total of 2,095 Indonesians from adolescent to adult age groups have undergone clinical trials for the TB or tuberculosis vaccine M72. This number is accumulative from the first phase of the vaccine clinical trials developed by American entrepreneur Bill Gates last year.
At present, the clinical trials for this vaccine have completed the third phase, or the final phase before the vaccine is officially distributed. "Indonesia has completed the participant recruitment process for the third phase clinical trials of the TB vaccine," said Aji Muhawarman, Head of the Ministry of Health's Public Communication and Information Bureau, to Tempo on Thursday, May 8, 2025.
Aji explained that clinical trials for this type of TB vaccine have been conducted in five countries. In total, the participants in the clinical trials up to this final phase are 20,081 people. The breakdown is as follows: South Africa contributed the most, with 13,071 people, followed by 3,579 from Kenya, 2,095 from Indonesia, 889 from Zambia, and 447 from Malawi.
Aji added that in Indonesia, clinical trials for the TB vaccine started on September 3 last year in several renowned hospitals, including Persahabatan Central Hospital, Cempaka Putih Jakarta Islamic Hospital, Universitas Indonesia Hospital (RSUI), Faculty of Medicine of Universitas Padjadjaran (FK Unpad) Bandung, and Faculty of Medicine of Universitas Indonesia (FKUI).
"The official participant recruitment process was completed as of April 16, 2025," said Aji.
He explained that the clinical trials conducted by the Ministry of Health aimed to evaluate the safety and effectiveness of the M72 vaccine in preventing pulmonary TB in adults with latent TB infection who are not infected with HIV. According to him, the vaccine has been developed since the early 2000s and has shown a good safety profile in previous studies.
Currently, there are approximately 15 TB vaccine candidates being developed globally. Of this number, Aji stated, M72 is the most advanced candidate as it has reached the third phase, or the final phase before the vaccine can be widely used.
The trials cover all stages of vaccine clinical trials. The first phase, he said, is called pre-clinical trials and is tested on animals. After that, the vaccine will enter the first phase of trials involving a small number of human participants, ranging from 20 to 50 people.
Entering the second phase, the clinical trials will involve a larger number of participants, around 200 to 300 individuals, and in the third phase, it will involve even more, reaching tens of thousands of participants from different countries. Aji stated that the TB clinical trials developed by Bill Gates are targeted to be completed by 2028.
"Clinical trials are a crucial stage in the vaccine development process to ensure safety, effectiveness, and to identify potential side effects before being used by the public," he said.
Aji urged the Indonesian public not to worry about being used as "guinea pigs" or being exposed to anything dangerous. All samples, he said, are closely monitored by the World Health Organization (WHO), the Indonesian Food and Drug Authority (BPOM), the Ministry of Health, as well as national and global TB vaccine experts.
Aji mentioned that Indonesia's involvement in this research reflects the nation's commitment to supporting global efforts to eradicate TB, which is still one of the leading causes of death in the world.
Previously, President Prabowo Subianto stated that Microsoft founder Bill Gates will make Indonesia a site for the trial of the TB vaccine, which he is developing. Prabowo mentioned it while receiving Bill Gates and several Indonesian conglomerates at the Merdeka Palace, Jakarta, on May 7, 2025.
"He is currently developing a TB vaccine for the world, and Indonesia will be one of the trial sites," said Prabowo.
Prabowo stated that the development of this vaccine is positive because TB claims nearly 100,000 lives each year. Therefore, he welcomed Bill Gates' commitment to assist Indonesia in vaccination. In addition to the TB vaccine, Bill Gates is also developing a malaria vaccine.
Bill Gates mentioned that the world needs a TB vaccine, and he is concerned about the TB figures in Indonesia. He stated that trials for the TB vaccine have begun, including in Indonesia. Besides Indonesia, India and Africa are also trial sites for the TB vaccine developed by Gates.
"We have two trial sites for the vaccine here, and that will help us determine the effectiveness of the vaccine," he said.
Eka Yudha contributed to the writing of this article.
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