Bio Farma Clinical Trials Phase 3 Of BUMN COVID-19 Vaccine On 465 Residents Of South Sulawesi

MAKASSAR - PT Bio Farma conducted a phase 3 clinical trial of the BUMN COVID-19 vaccine in South Sulawesi, to 465 residents consisting of 113 people in Makassar City and 352 people in Jeneponto Regency.

The Director General of Pharmaceuticals and Medical Devices at the Ministry of Health, Dr. Lucia Rizka Andalucia, during a phase 3 clinical trial visit at the Binamu Health Center, Jeneponto, South Sulawesi, said that the implementation of clinical trials was the most important thing in making vaccines towards vaccine independence in Indonesia.

"Producing a vaccine is not easy, there are very important stages that must be passed, namely clinical trials," he said, quoted by ANTARA, Tuesday, July 12.

According to Doctor Rizka, vaccines will be meaningless without obtaining permission. Meanwhile, this permit really requires community participation in Indonesia, such as the contribution shown by the Jeneponto community through clinical trials.

For Rizka, this clinical trial is a very important moment for health workers at the puskesmas and the community because they can conduct international clinical trials which are expected to be recognized by the WHO or the World Health Organization.

"Your contribution is very large for the country, including other countries that have been waiting for the COVID-19 vaccine by Indonesian SOEs towards vaccine independence," he said.

The same thing was also conveyed by M Rahman Roestan, Director of Operations at Bio Farma that the people who were involved in the clinical trial stage had made history in the Independence of the COVID-19 Vaccine in Indonesia.

As one of the state-owned enterprises engaged in the pharmaceutical sector, Bio Farma has also conducted phase 2 clinical trials in Jeneponto Regency with a total of 57 subjects.

"Without the community's contribution, of course we have not received sufficient data to produce a COVID-19 vaccine product," he said.

The BUMN COVID-19 vaccine that has been researched has been welcomed by the POM Agency to universities. So that the implementation of clinical trials in five cities in Indonesia also involved universities, one of which was Hasanuddin University for the South Sulawesi region.

Main Researcher or Principal Investigator from the Faculty of Medicine, Hasanuddin University, Dr. dr. Martira Maddeppungeng, Sp.A(K) said that there were no significant reports of the results of the phase 2 clinical trial. However, the subjects would continue to be monitored for up to a year.

"So we start from Jeneponto, which is involved in phase 2 and continue to monitor how many levels of antibodies are formed. In phase 3, this is carried out in two stages, the subjects are spread out in 10 health centers and we also do it in parallel," he said.