By: Namira Eka Saraswati
The Covid-19 vaccine made in Indonesia is proven to be safe and has good immunogenicity. This is a form of success and contribution of the Indonesian nation in overcoming the Covid-19 pandemic that has hit the world community.
The Covid-19 pandemic that has hit the world since the end of 2019 has become one of the extraordinary health disasters that mankind must face in this modern era. Various ways are carried out by each party to deal with this pandemic. The methods taken by the world community to deal with the pandemic start from improving health facilities, to educating the public about the importance of implementing health protocols in all aspects of people’s lives, such as washing hands, maintaining distance, and applying cough etiquette.
Efforts to overcome Covid-19 are also carried out by creating Covid-19 vaccines from various pharmaceutical companies in various countries. The creation of a Covid-19 vaccine is important so that people in a community have immunity to the corona virus. Indonesia is also trying to create a Covid-19 vaccine so that the Covid-19 pandemic in the country is under control, and the Indonesian people can have immunity to the corona virus with all the subvariants resulting from its mutation.
This domestically made Covid-19 vaccine continues to be improved in quality. This Covid-19 vaccine was developed by Universitas Airlangga (Unair) together with PT Biotis Pharmaceutical Indonesia and the state-owned company PT Bio Farma. This vaccine is adapted to the virus circulating in Indonesia.
It is known that the Covid-19 vaccine has passed the second phase of clinical trials showing good safety and immunogenicity. This Covid-19 vaccine is entering its third phase of testing on hundreds of volunteers. Head of Surveillance and Clinical Trials Division, dr. Rini Mulia Sari said that all stages of clinical trial results from the first phase to the third phase, must obtain Clinical Trial Implementation Approval (PPUK) from the POM which is valid per stage.
Before starting the first phase, the tested vaccine must first apply for PPUK by submitting a preclinical test report. The submission of the second phase of PPUK is based on the first phase of clinical trials. Furthermore, the submission of the third phase of PPUK is based on the report of the second phase of clinical trials. The Head of the Surveillance Division added that in the current pandemic conditions there are exceptions where the submission of reports for each phase of clinical trials can be carried out in parallel, by submitting interim reports, or interim reports.
From the results of the second phase of clinical trials, the Covid-19 vaccine made by this nation’s children has good safety and immunogenicity. Volunteers who are also research subjects in this vaccine trial are in the stage of long-term safety monitoring for up to six months after the second dose is injected.
Bio Farma, as the executor of the vaccine trials, is currently completing the third phase of clinical trials, and has registered the third phase of clinical trials as part of the process to obtain an Emergency Use Authorization (EUA) from the POM Agency. Bio Farma expects the results to be out in the not too distant future.
For information, the first phase clinical trial of the Indonesian Vaccine has given good results. Furthermore, clinical testing of the vaccine enters the second phase, starting in April 2022. This second clinical trial aims to evaluate and select vaccine doses that can be used. Then vaccine testing continues into the third phase, with two candidate formulas. The second phase of the Covid-19 vaccine clinical trial made in Indonesia involved 360 subjects, with an age range of 18 years and over.
According to the Medical Advisor of the BUMN Covid-19 Vaccine Clinical Test Team, Prof. Dr. dr. Soedjatmiko, SpA (K), M.Sc., the Covid-19 vaccine using recombinant protein sub unit technology or Receptor Binding Domain (RBD) protein, must go through a long journey to be used by the general public. According to WHO and BPOM vaccine clinical trial standards, all new vaccines must go through three stages of clinical trials.
Clinical trials were conducted to scientifically prove that this Covid-19 vaccine is safe and can produce levels of antibodies that can fight the Covid-19 virus. The Covid-19 vaccine is also expected to have the efficacy (efficacy) of protecting the subject from serious illness and death due to Covid-19 in accordance with the standards of the POM.
This Covid-19 vaccine made in Indonesia can be used for the general public and can be mass produced if it has completed the third phase of clinical trials and has received EUA. This vaccine will also be compared with CoronaVac which has received EUA first and then received Emergency Use Listing (EUL) from the World Health Organization (WH0).
We all hope that the results of this third phase of clinical trials can run smoothly and the results can be obtained soon. Hopefully in the future this vaccine can be registered with WHO and can become an export product. To
