The parent of the Pharmaceutical SOE Holding, Bio Farma, will soon carry out Phase 3 Clinical Trials of the SOE Vaccine for COVID-19 prevention in early June 2022. The declaration was marked by a Kick-off held at the Faculty of Medicine, Diponegoro University (FK UNDIP), on June 9, 2022.

This activity was attended by SOE Minister Erick Thohir, Deputy Minister of Health Dante Saksono Harbuwono who was accompanied by the Secretary of the Directorate General of Pharmaceuticals Dita Novianti S.A., Head of BPOM Penny K. Lukito, UNDIP Rector represented by Vice Rector IV Prof. Dr. Ir. Ambariyanto, M.Sc., Dean of FK UNDIP Dr. dr. Dwi Pudjonarko, M.Kes., Sp.S (K), President Director of Bio Farma Honesti Basyir and President Commissioner of Bio Farma Tanri Abeng.

The SOE vaccine 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 SOE vaccine uses Recombinant Protein Subunit (Receptor Binding Domain / RBD protein) technology, is made in Indonesia, and will be used as a primary vaccine, after obtaining an Emergency Use Authorization (EUA) from the POM at the end of July 2022.

The phase 3 clinical trial was conducted after Bio Farma received the Clinical Trial Implementation Approval (PPUK) for phase 3 clinical trials, which was signed by the Head of POM Penny K. Lukito, on June 6, 2022. In addition to being conducted in Semarang, phase 3 clinical trials were also conducted in Jakarta in collaboration with the University of Indonesia Faculty of Medicine, in Padang in collaboration with the University of Andalas Faculty of Medicine, and in Makassar in collaboration with Hasanuddin University Faculty of Medicine.

Penny K. Lukito said the COVID-19 vaccine is the first vaccine whose development from upstream to downstream was developed in Indonesia by Bio Farma.

“This is a big step for us towards the independence of drugs and vaccines, to fulfill Presidential Instruction Number 6 of 2016, so we certainly thank the industry that has followed the standards of the POM Agency because we want what is developed in Indonesia are products that are globally competitive, especially with Bio Farma's credibility that has been more than 130 years both at the international and regional levels,” said Penny.

He emphasized that the SOE's COVID-19 Vaccine is the first vaccine developed in Indonesia from the vaccine seed, and developed at Bio Farma again into a vaccine that meets GMP (Good Manufacture Practices) standards to become a commercial vaccine. This is also a process of strengthening our science in the field of vaccine development and of course increasing the capacity of the pharmaceutical industry in the field of vaccines in Indonesia.

Meanwhile, Deputy Minister of Health Dante Saksono said that one of the capital to make a new breakthrough in handling COVID-19 is the manufacture of vaccines. The vaccine initiated by SOEs is one of the projects that will enter stage 3 clinical trials.

In the health transformation promoted by the Ministry of Health, there is a pillar of health system resilience. In it, there is pharmaceutical sector resilience as part of the transformation of the health resilience system. This shows the importance of pharmaceutical independence in our health system. The Ministry of Health also plays a role in facilitating the pharmaceutical industry and vaccine development by providing support for the implementation of clinical trials to research institutions or the pharmaceutical industry. Our hope is that in the coming year pharmaceutical preparations will be accessible, affordable, available when needed and sustainable.

“We welcome this phase 3 clinical trial, and hopefully this phase 3 clinical trial can be completed perfectly so that later it will get an EUA from the POM so that it can be used. I hope this vaccine will not stop at the use of primary vaccines in clinical trials, but must also be used for booster vaccines,” said Dante.

Dante continued that we do not know when this pandemic will end. Therefore, we need several things, which must support that this pandemic will remain under control, one of which is the provision of support for booster vaccines.

“We support and support Bio Farma, so that the BUMN COVID-19 vaccine can be used for booster vaccine activities, especially in the future,” concluded Dante.

Bio Farma President Director Honesti Basyir expressed his gratitude for the support of all parties who have supported the research and development of this state-owned vaccine, which is a form of Indonesia's independence during the COVID-19 pandemic.

Honesti also added that this phase 3 clinical trial is a major milestone, especially for the health industry in Indonesia, where we will kick off the phase 3 clinical trial of the SOE COVID-19 vaccine, whose upstream to downstream production process is carried out in Indonesia.

“SOE vaccine is one of the works of the nation's children, because starting from the development of working seed vaccines, it is carried out in Indonesia and carried out by experts from Indonesia, of course we hope that this phase 3 clinical trial can run smoothly as planned and provide optimal results,” said Honesti.

He added that in the future, if the phase 3 clinical trial goes well, Bio Farma will apply for an Emergency Use Authorization (EUA) to the POM Agency by the end of July 2022, and will be registered for Emergency Use Listing (EUL) to the World Health Organization, for the purpose of exporting the COVID-19 vaccine.

In his closing remarks, Erick Thohir encouraged Bio Farma to be more competitive to transform into a modern health industry through collaboration, to reduce dependence on medicinal raw materials, and we are also encouraging, how herbs can be an alternative to reduce dependence on medicinal raw materials.

“We want the Indonesian people to be sovereign for health. COVID-19 proves how our dependence is very burdensome, therefore we must collaborate so that we can be sovereign in our health as a nation,” said Erick.

Erick concluded, “The Ministry of SOEs continues to encourage and one of them is that we can start phase 3 clinical trials, then we also encourage the use of booster vaccines, and then we will also encourage the implementation of other technologies such as mRNA and viral vectors and also upgrading production facilities at Bio Farma”.

This phase 3 clinical trial was conducted after the results of clinical trials 1 and 2, which provided satisfactory results, began in February 2021 for three months. The phase 1 clinical trial provided safe results for volunteers, and provided a significant increase in the body's immune response up to 28 days after the second vaccination. This clinical trial 1, involved 175 subjects aged 18 years and over after the second dose.

As for the second clinical trial, it was carried out to evaluate and select the best vaccine formula to continue into phase 3, involving 360 subjects aged 18 years and over, which began April 13, 2022. It will now begin to enter the long-term safety monitoring period up to 6 months after the second dose.

This phase 3 clinical trial of the SOE vaccine, serves to evaluate the safety and immunogenicity of the vaccine compared to the comparator vaccine by involving volunteers of 4,050 subjects, aged 18-70 years whose recruitment began in the first week of June 2022. Each volunteer will be given two doses with a 28-day gap between the first and second doses, and will continue to be monitored up to 1 year after the second dose. This activity was closed with a review of the implementation of phase 3 clinical trials in the UNDIP Faculty of Medicine laboratory by the Minister of BUMN and his entourage.