The Indonesian Food and Drug Authority (BPOM) has approved phase-three clinical trials for the M72 tuberculosis (TB) vaccine developed by the Bill and Melinda Gates Foundation.
The planned implementation of this clinical trial has sparked mixed reactions among the public.
Responding to the debate, Dr. Riris Andono Ahmad, MD, an epidemiologist from the Center for Tropical Medicine at UGM, stated that such differences of opinion are normal and reflect the public’s growing concern about the vaccine trial.
The epidemiologist, known as Dr. Donnie, acknowledged the circulating concern that the public would be treated as “guinea pigs” in this clinical trial. However, he emphasized that this term is misleading, as it suggests that people are powerless to refuse participation.
“In the context of clinical trials, participation cannot be forced, as it is entirely voluntary. There are also specific eligibility criteria, so even if someone is willing, they cannot take part unless those criteria are met,” the physician explained on Tuesday (May 20).
According to him, one of the most frequently raised concerns is the safety of the clinical trials. In this regard, Dr. Donnie clarified that the TB vaccine trial has gone through several phases.
The upcoming trial is the third phase, focusing on the vaccine’s effectiveness in preventing TB.
He assured that safety testing was already conducted in the first and second phases and that failure to meet safety standards would have prevented the trial from reaching this stage.
“All phases of the study are also monitored by independent bodies, both nationally and internationally, which help detect any potential risks,” he added.
Indonesia ranks second in the world for TB burden, with one million TB cases annually and approximately 130,000 related deaths.
Dr. Donnie stressed that this makes the country a key stakeholder in the clinical trial to ensure the TB vaccine is safe and effective for the Indonesian population.
“With such a high TB burden, the need for this vaccine to help prevent transmission and reduce mortality is also extremely high,” he said.
Another issue raised by the public is the urgency of developing a new TB vaccine when the BCG vaccine already exists for children.
Dr. Donnie explained that the BCG vaccine does not fully protect against TB transmission. Instead, it is mainly effective in reducing the severity of TB in children but does not protect them into adulthood.
“So, we need a better vaccine to protect against transmission. And to obtain one, clinical trials must be conducted first,” Dr. Donnie noted.
He also addressed Bill Gates’ involvement in Indonesia’s TB vaccine clinical trial and viewed Gates’ role as remaining within philanthropic and humanitarian boundaries.
According to him, Gates has donated funds to combat various diseases, and while it is not unusual for some to suspect financial motives behind such initiatives, the broader aim should not be overlooked.
Dr. Donnie hopes the ongoing debates do not overshadow the opportunity to contribute to TB control efforts.
“People need to see the benefits of this clinical trial. If the potential advantages outweigh the manageable risks, it is only right to support it, as ultimately the Indonesian public will be the one to benefit,” he concluded.
Author: Lazuardi
Editor: Gusti Grehenson
Post-editor: Afifudin Baliya