By : Adi Pratama )*
In order to pursue herd immunity and end the pandemic, the independent production of Covid-19 vaccines must still be pursued. The community also supports domestic vaccine production so that Indonesia does not depend on other countries.
PT Bio Farma (Persero) will apparently prepare three state-owned Covid-19 vaccine production facilities. This facility is located in Bandung. Honesti Basyir as President Director of Bio Farma, said that the facility could produce 100 million doses of vaccine by 2022.
Later, the number of vaccines produced will continue to increase until 2024. However, this number of vaccines does not include children aged 6 to 11 years. This is because the government has just launched the vaccine program. Honesti hopes to get an emergency use permit (EUA) for BUMN vaccines in July 2022.
In an emergency situation like today, research on the Covid-19 vaccine can be accelerated, while still showing the safety, efficacy or efficacy and quality standards issued by BPOM.
Honesti also said that by 2022, his party will prepare 100 million doses. This number will increase in 2023 as much as 120 million doses in 2024, his party will prepare 200 million doses per year.
It should be noted that Indonesia will start producing the Covid-19 vaccine independently. Bio Farma, as the holding company for pharmaceutical SOEs, will produce vaccines from upstream to downstream.
The Covid-19 vaccine research, which is the result of Bio Farma’s global collaboration with Baylor College of Medicine, USA, has been registered in the WHO Covid-19 vaccine candidate development stage since June 2021. This BUMN vaccine is made in Indonesia and will use the Recombinant protein subunit method.
This vaccine will be a vaccine with alum adjuvant for a booster or third dose indication, or as a primary vaccine for the first and second doses in formulas with a novel adjuvant (alum+CpG). However, before being given to the public, both of them still have to run a series of tests, namely preclinical trials and phase 1,2 and 3 clinical trials.
For the purpose of indication of booster vaccine in vaccines with alum adjuvant, clinical trials as parallel booster vaccines were conducted after obtaining interim results of phase 3 clinical trials as primary vaccines.
Then, for SOE vaccines with adjuvant alums, now they have obtained Approval for the Implementation of Clinical Trials (PPUK) for phase 1 clinical trials from BPOM. For alum-based vaccines, the process has entered the first phase of clinical trials. Meanwhile, the first injection was carried out on December 13, 2021.
The total subjects who will be involved in this phase 1 clinical trial consist of 60 subjects, which are divided into two groups, namely 30 subjects in the test vaccine group (Calin vaccine BUMN) and 30 subjects as a control vaccine group (vaccines that have received EUA).
Meanwhile, BUMN vaccines that use alum + CpG adjuvants to be used as primary vaccines are undergoing a series of preclinical immunogenicity tests on rodent and non-human primate (Macaca) test animals, toxicity and challenge tests on Macaca.
This series has started to be implemented on November 10, 2021 and will end in February 2022. If the pre-clinical test results are good, then in February 2022 phase 1 clinical trials will begin, followed by clinical trials 2 and 3 in adults and the elderly at the end of March 2022 with a total of 4,250 subjects.
The basic difference between these two vaccines is that they come from adjuvants or additives to strengthen or modulate the immune response to antigens. In the primary vaccine, alum and CpG adjuvants were given to reduce the vaccine dose and frequency.
For the purpose of producing BUMN vaccines, Bio Farma has prepared three production facilities, which are located at Bio Farma Bandung.
In addition to holding mass vaccinations, SOEs also take part in producing the Covid-19 vaccine. This effort shows that SOEs take part not only as a form of social responsibility, but also a reflection of the government’s presence in realizing herd immunity and restoring the national economy. It is hoped that this can make Indonesia return to normal along with increasing economic activity in Indonesia.
)* The author is a contributor to the Circle of the Equator
