The main factory of Pharmaceutical BUMN, Bio Farma, will soon carry out Phase 3 Clinical Trial of the BUMN Covid-19 Vaccines for the prevention of Covid-19 in early June 2022. The declaration was marked by a Kick-off which was held at the Central Lab of the Diponegoro National Hospital (RSND), Faculty of Medicine (FK), Diponegoro University (UNDIP) on Thursday (09/06). Diponegoro University (Undip) is one of the universities involved in the research and development of BUMN Covid-19 Vaccines.
The kick off event was attended by Minister of BUMN, Erick Thohir; Vice Minister of Health, Dante Saksono Harbuwono; Head of BPOM, Penny K Lukito; Undip Rector represented by Vice Rector IV for Research and Innovation, Prof. Dr. Ir. Ambariyanto, M.Sc; Dean of Faculty of Medicine Undip, Prof. Dr. dr. Dwi Pudjonarko, M.Kes., Sp.S(K).; Principal Researcher of Semarang Center, dr. Yetty Movieta Nency, Sp.A(K); President Director of Diponegoro National Hospital (RSND), Dr. dr. Sutopo Patria Jati, M.M., M.Kes. along with his staff; President Director of Bio Farma, Honesti Basyir along with the Board of Executives of Bio Farma; and President Commissioner of Bio Farma, Tanri Abeng.
In his remarks, the Undip Rector, represented by the Vice Chancellor IV for Research and Innovation, Prof. Dr. Ir. Ambariyanto, M.Sc., expressed his pride and gratitude to all parties for involving Diponegoro University in the research and development of the BUMN Covid-19 Vaccines.
“We express our greatest gratitude to all parties who have involved Undip in the research and development of BUMN Covid-19 vaccines. Of course we are very proud to have our nation’s own Covid-19 vaccine and we hope that this third clinical trial process will run smoothly and successfully,” said Prof. Ambariyanto.
In addition, Undip is also trusted to design electric buses that have Covid-19 virus free facilities. Later this electric bus will be used at the G20 event in Bali. “We were given the task by the President through the Ministry of Education which was conveyed by the Director General to build an electric bus that will be used at the G20 peak event in Bali next October. And if all the plans go smoothly, Insyaallah, there will be an electric bus from Undip which also has the Covid-19 Virus Free facility,” explained Prof. Ambariyanto.
“We apply Undip’s design work, the result of collaboration from the Faculty of Medicine, Faculty of Science and Mathematics, and Faculty of Engineering. We collaborated with PO Sumber Alam and one of the Karoseri in Semarang who succeeded in making the Bio Smart & Safe Bus which has been brought to the Ministry of Education and was tried by the Minister of Transportation to take a look around Undip Tembalang campus. We make sure that Undip is very ready to be asked for further cooperation in other fields,” continued Prof. Ambariyanto.
The BUMN Covid-19 Vaccines is the result of a global collaboration between Bio Farma and Baylor College of Medicine, USA, which has been registered in the WHO Covid-19 vaccine candidate development stage since June 2021. The BUMN Covid-19 vaccines use Recombinant Protein Subunit (Receptor Binding Domain / RBD protein) technology, which is made in Indonesia and will be used as a primary vaccine, after obtaining an Emergency Use Authorization (EUA) from BPOM at the end of July 2022.
Head of BPOM, Penny K Lukito explained that this BUMN Covid-19 vaccine was the first vaccine whose development from upstream to downstream was developed in Indonesia by Bio Farma. “This is a big step for us towards drug and vaccine independence, to fulfill Presidential Instruction No. 6 of 2016, so we would like to thank the industry that has followed BPOM standards because we want what is developed in Indonesia to be products that are globally competitive,” said Penny.
Furthermore, the Vice Minister of Health of the Republic of Indonesia, Dante Saksono said that one of the new breakthroughs in handling Covid-19 was the manufacture of vaccines. “We welcome this phase 3 clinical trial, and hopefully this phase 3 clinical trial can be completed perfectly so that later we will get EUA from BPOM so that it can be used. I hope this vaccine will not stop at primary vaccines in clinical trials, but should also be used for booster vaccines,” said Dante.
President Director of Bio Farma, Honesti Basyir expressed his gratitude for the support of all parties who have supported the research and development of this vaccine. This is a manifestation of the independence of the Indonesian nation during the Covid-19 pandemic. This phase 3 clinical trial is a major milestone for the Health Industry in Indonesia because the production process from upstream to downstream is carried out in Indonesia.
“We also thank the research team from Undip, dr. Yetty Movieta Nency, Sp.A(K), has done a great job. We can report that the implementation of the phase 3 clinical trial is carried out in 4 centers, the first is at the Faculty of Medicine (FK) Undip and it will manage 2 locations, namely Semarang and Lombok,” said Honesti.
In addition, phase 3 clinical trial was also carried out in the city of Jakarta in collaboration with the Faculty of Medicine, University of Indonesia, in Padang in collaboration with the Faculty of Medicine, Andalas University, and in Makassar in collaboration with the Faculty of Medicine, Hasanuddin University.
Meanwhile, BUMN Minister, Erick Thohir in his speech said that the Ministry of BUMN continues to encourage transformation in the health industry to be more modern and competitive through collaboration, so that it will reduce dependence on medicinal raw materials.
“We want the Indonesian nation to be sovereign for health. Covid-19 proves how burdensome our dependence is, therefore we must collaborate so that we can be sovereign in our health as a nation. In addition, I would like to thank the university leaders who have also encouraged and tried to conduct research or clinical trials in the early stages, which is nothing but proof of our love for the nation,” said Erick.
The Principal Researcher of the Semarang Center who is also a lecturer at the Faculty of Medicine Undip, dr. Yetty Movieta Nency, Sp.A(K), reported that this phase 3 clinical trial was conducted after the results of phase 1 and 2 clinical trials gave satisfactory results. Phase 1 clinical trials started on February 16, 2022 with 175 subjects aged 18 years and over in Semarang and in Jakarta. Phase 1 clinical trial results provide safe results for volunteers and provide a significant increase in the body’s immune response up to 28 days after the second vaccination.
Meanwhile, phase 2 clinical trials were conducted to evaluate and select the best vaccine formula to proceed to phase 3. Starting April 13, 2022, involving 360 subjects aged 18 years and over from Semarang, Padang and Makassar. Currently we are entering a period of long-term safety monitoring for up to 6 months after the second dose.
The phase 3 clinical trial of this BUMN Covid-19 Vaccines aims to evaluate the safety and immunogenicity of the vaccine compared to the comparison vaccine by involving 4,050 volunteers aged 18-70 years whose recruitment begins in the first week of June 2022. Each volunteer will be given two doses with a 28-day interval between the first and second doses and will continue to be monitored for up to 1 year after the second dose. “We started our phase 3 clinical trial after obtaining a research permit from BPOM, then we checked the immunogenicity and compared it with other registered comparison vaccines,” clear dr. Yetty.
On this occasion, dr. Yetty thanked all parties for the trust that had been given. “We express gratitude to the Ministry of BUMN and PT Bio Farma for trusting us the researchers to take part in this history. Then we thank our leaders who have fully supported this research. Also thanks to the Health Research Ethics Commission (KEPK) FK Undip and other universities that were involved and also gave ethical permission,” she concluded.