Arya News - The clinical trials for a tuberculosis vaccine candidate developed with funding from the Gates Foundation are taking place in Indonesia under close monitoring by multiple national and international institutions and researchers, according to the Health Ministry.
JAKARTA – The Health Ministry has dismissed concerns surrounding the safety of clinical trials of a tuberculosis (TB) vaccine whose development is funded by the Gates Foundation, chaired by Microsoft cofounder and philanthropist Bill Gates.
Ministry spokesperson Aji Muhawarman asserted that the vaccine trial was safe and conducted professionally.
“Everything is closely monitored by the World Health Organization [WHO], the Food and Drug Monitoring Agency [BPOM], the Health Ministry as well as national and global TB vaccine experts,” he said on Thursday, as quoted by Tempo.co .
He added that the vaccine candidate, identified by its code M72/AS01E, had gone through all stages of clinical trials before being tested in Indonesia.
Before being administered to humans, the substance had been tested on animals. After being considered safe, the testing proceeded to the first phase of trials on humans, involving a small group of 20 to 50 participants.
The next trial phase involves a larger group of up to 300 participants. The third and final phase of the clinical trial, which will involve tens of thousands of participants from multiple countries including Indonesia, will kick off after the substance is declared safe in the previous stages.
Data from the phase 2b study showed that a two-dose administration of the substance was successful in reducing the development of active TB disease with 50 percent efficacy in adults with latent infection of Mycobacterium tuberculosis , the bacteria causing TB.
The phase 2 trial was launched in high TB burden countries of South Africa, Kenya and Zambia in which the vaccine candidate was administered on people aged 18 to 50 years.
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In a separate occasion, Health Minister Budi Gunadi Sadikin said, as quoted by Kompas.id , that the government was interested in hosting a clinical trial of the vaccine candidate to see whether the substance is suitable for most Indonesian populations, as vaccine efficacy is often affected by genetic factors.
He also argued that participating in the trials would allow the government to gain access to the technology, as several researchers from Padjadjaran University and the University of Indonesia are involved in the trials.
Giving space for trials for the vaccine candidate may also strengthen the country’s leverage for a future bargaining process to win the contract for developing the substance within the country.
The third clinical trial for M72/AS01E had been ongoing since March 2024. But the topic resurfaced recently following Gates’ meeting with President Prabowo Subianto in Jakarta on Wednesday. During the meeting, the President appreciated the philanthropist’s commitment to help Indonesia in eradicating the disease, including by launching clinical trials for the vaccine candidate in the country.
According to the WHO’s 2024 Global TB Report, around 1.1 million TB cases were reported in Indonesia in 2023, with more than 130,000 patients dying in the same year due to the disease.
The M72/AS01E is expected to complement immunization against TB. Vaccination against the disease has been for decades utilizing the BCG vaccine, which offers partial protection for infants and young children against severe TB forms, but does not protect teens and adults who account for the majority of the disease transmission.