BPOM Gives M72 Vaccine Clinical Trial Permit, Indonesia Becomes Phase 3 Research Location

JAKARTA - The Food and Drug Supervisory Agency (BPOM) has officially approved the implementation of phase three clinical trials of the M72 tuberculosis (TBC) vaccine in Indonesia.

This approval aims to test the effectiveness of vaccines in providing protection against tuberculosis, which is still a huge health burden in Indonesia.

The head of BPOM, Taruna Ikrar, explained that Indonesia's involvement in this clinical trial is an important step in updating its approach to handling TB.

Currently, Indonesia occupies the second position in the world in the number of TB cases after India. Conventional TB treatments use combinations of drugs such as isionizid, rifampicin, and etambutol, which have been used for years.

"This treatment combination has indeed been used for a long time, but in practice the healing process often takes a long time and the results are not optimal. Although it cannot be called resistance, this condition makes it difficult for the patient to recover," the cadet said as quoted by ANTARA.

The Calmette-Guerrin (BCG) Bacillas vaccine, which has been used so far, is also considered less effective, especially in adults. Therefore, according to Taruna, the development of the M72 vaccine brings new hope for TB control efforts in Indonesia.

Furthermore, he revealed that Indonesia's involvement in this clinical trial also has the potential to pave the way for domestic vaccine production, given the possibility of obtaining intellectual property rights from the results of cooperation. This is expected to reduce dependence on imports of medicinal raw materials, which currently still reaches around 94 percent.

"Indonesia's participation provides great opportunities. If this vaccine proves effective, then we can produce it domestically and expand people's access to vaccines," said Taruna. He also said that the TB cases in Indonesia had reached almost two million, making this vaccine very much needed.

In this phase three clinical trial, around 2,000 volunteers from Indonesia will be involved, while globally the total participants reach 20,000 people.

The cadets emphasized that all participants were voluntary and free of charge. The research was conducted using the double-blind method, namely researchers and participants did not know whether they received the vaccine or placebo, to ensure objective and scientific results.

After clinical trials are complete, Biofarma is planned to produce this vaccine domestically under strict supervision from BPOM to ensure production standards that comply with good manufacturing practices (GMP).

Biofarma President Director, Shadiq Akasya, said that this effort was a big achievement because no TB vaccine had been successfully developed until phase three in the last 30 years. The BCG vaccine that has been used has proven to be less effective in protecting adults from active tuberculosis.

Phase three is a big step and should be appreciated. We hope that clinical trials will run smoothly and have the support of the BPOM and the Gates Foundation so that local production can be realized," said Shadiq.

Meanwhile, Senior CMC Advisor for Vaccine Development from the Gates Foundation, Rasayam Prasad, said that vaccine development must be accompanied by efforts to expand access. He also hopes that Indonesia can become a global vaccine production center for other diseases such ascampura, rubella, pneumonia, rotavirus, and polio.

"We hope that in the future Indonesia will not only develop vaccines, but also become a distribution center for the world," added Rasayam.