BPOM Head: Indonesia Owns Two Options in COVID-19 Vaccine Development
Head of the Food and Drug Supervisory Agency (BPOM) Penny K. Lukito elaborated on Indonesia’s two options in developing the COVID-19 vaccine.
The first option is to develop the Merah Putih vaccine developed by Ministry of Research and Technology, the National Research and Innovation Agency, and the Eijkman Institute for Molecular Biology.
Furthermore, the BPOM Head explained that the BPOM has made a roadmap for the stages of vaccine development needed to meet the preclinical data, clinical data, and quality requirements of the vaccines to be made.
“So that the stages of development of the vaccine are in accordance with the time frame we have planned, including its acceleration, to immediately meet the needs for the national program,” she explained during a press conference at the Presidential Office, Jakarta, Tuesday (1/9).
The second option is to develop international cooperation. The collaborations under the BPOM assistance include the collaboration between Sinovac with Biofarma, Sinopharm, and Kimia Farma with Group 42 (G42) from the United Arab Emirates (UAE), and Genexine with Kalbe Farma. In addition, communication with other countries has been also established for the next stages of development.
The clinical trial of the vaccine of the Sinovac-Biofarma collaboration was started on 11 August 2020 by a team of researchers from the Faculty of Medicine of Padjajaran University with as many as 1,620 clinical trial subjects.
“Currently there are 1,800 volunteers who have registered, and until the end of August 2020 there are around 500 directors who have reached the injection stage,” Penny explained.
The BPOM, she said, is ready to oversee the approval of clinical trial protocols, its implementation, the evaluation of clinical trial results for emergency situations, and the preparation of production facilities at Biofarma to transfer technology required to make the vaccine a commercial product.
Regarding the Sinopharm – G42 vaccine, the UAE is committed to providing 10 million vaccines for Indonesia and it is expected to be achieved by the end of 2020.
The BPOM, Penny stated, has visited the UAE’s Ministry of Health. “We see that the phase 3 of vaccine clinical trial is very well organized, there are many positive aspects with the participation of 22 thousand participants with various nationalities; there are 119 nationalities who have been involved in the clinical trials,” she said.
After the phase 3 clinical trial of the vaccine, it is possible for the Indonesian pharmaceutical industry to become part of the technology transfer for vaccine production. She also saw an opportunity for cooperation in developing the vaccine industry between the UAE and Indonesia.
In the near future, an MoU will be created between the BPOM and the UAE’s Ministry of Health which will ensure the speed of vaccine access through a more targeted regulatory process that meets international standards.
“In conclusion, we will also encourage investment in the pharmaceutical industry both in the UAE and Indonesia as bilateral cooperation,” she continued. (Communication Team of the COVID-19 Handling Committee and PEN/EN)
Translated by: Fairuzzamani Inayatillah
Reviewed by: Mia M. Bonaedy