Bogor, West Java (Indonesia Window) – The clinical trial phase 3 of the COVID-19 vaccine by Indonesia’s national holding company in the pharmaceutical sector, Bio Farma, will be held in mid-August 2020, starting with a kick-off meeting on Thursday at the Faculty of Medicine, Padjadjaran University (Unpad) Bandung (West Java), as one of the venues for the test.
A statement from Bio Farma received by Indonesia Window here on Thursday mentioned that the initial meeting was a simulation before the implementation of the clinical trial phase 3 in mid-August 2020.
The clinical trial phase 3 of the COVID-19 vaccine will involve several institutions, namely, Bio Farma as the national holding of state-owned company in the pharmaceutical sector which serves as a sponsor, collaborating with the Faculty of Medicine of the Padjadjaran University, and the Health Research and Development (Litbangkes) under the supervision of National Agency of Drug and Food Control as a regulator.
The implementation of clinical trials should meet scientific aspects and honour research ethics according to the Guidelines for Good Clinical Trials.
“As a regulator, the agency is committed to supervise the entire COVID-19 vaccine test in Indonesia, starting from the clinical trial phase, registration for distribution permits, production and distribution,” Head of the National Agency of Drug and Food Control Penny K. Lukito said.
Meanwhile, Bio Farma’s Director Honesti Basyir said the national vaccine and serum manufacturing company had prepared 2,400 doses of vaccine for the clinical trials phase 3.
The vaccine made by the Chinese company arrived in Indonesia on July 19, 2020.
“Praise be to God, we have obtained ethical counselling from the Faculty of Medicine and the approval of clinical trials from the National Agency of Drug and Food Control,” Honesti said.
The next step, he added, will be the clinical trial phase 3 by the Padjadjaran University research team in the second week of August 2020.
“Hopefully this stage will run smoothly for the next six months,” he said, adding that, if this clinical trial goes well, the next step is to apply for a distribution permit to the National Agency of Drug and Food Control.
After the distribution permit is obtained, Bio Farma will begin mass production of the vaccine in the first quarter of 2021.
Bio Farma has also communicated with the Fatwa Commission and the Food and Drug Research Instituteof the Indonesian Ulema Council (MUI) to jointly study the COVID-19 vaccine concerning the halal (permissible in the Islamic Law) certification.
That effort is Bio Farma’s commitment in producing halal vaccines.
“We care about this aspect. Therefore, in vaccine research and development we will use non-animal origin materials,” Honesti noted.
“Bio Farma is ready with a COVID-19 vaccine production capacity of 100 million doses, and is preparing an additional production facility with a capacity of 150 million doses which will be completed in December 2020,” he said.
Honesti pointed out that in early 2021, Bio Farma’s COVID-19 vaccine production capacity can reach 250 million doses a year.
Meanwhile, Dean of the Faculty of Medicine of the Padjadjaran University, Dr. med. Setiawan, said, Bio Farma and the university have long collaborated in clinical trials of several vaccines.
“We hope that this clinical trial phase 3 will run well, and we can achieve what we expect. It is a COVID-19 vaccine that is safe, effective and can be used by people,” Setiawan said.
Reporting by Indonesia Window