The clinical trials for a tuberculosis (TB) 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.
he 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.
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