TEMPO.CO, Jakarta – Head of the Molecular Biology Institute (LBM) Eijkman Amin Soebandrio explained the Red and White vaccine. According to him, this March has entered the deadline that has been targeted.
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“At the end of March, we are already in the transition process of handing over the vaccine seeds to PT Bio Farma“He said when contacted, Tuesday, March 16, 2021.
LBM Eijkman is one of six institutions that are developing the Covid-19 vaccine locally. The other five institutions are the Indonesian Institute of Sciences (LIPI), Gadjah Mada University (UGM), the University of Indonesia (UI), the Bandung Institute of Technology (ITB), and Airlangga University (Unair).
LBM Eijkman is also touted as the fastest Red and White vaccine developer compared to other institutions.
However, Amin, who is also a Professor of Clinical Microbiology at the Faculty of Medicine, University of Indonesia (FKUI), added that after the vaccine seeds were given to PT Bio Farma, there were still other processes that had to be done. “This is done in an industry that has facilities for the correct manufacturing methods,” said Amin.
This means that the winner of a Ph.D from Osaka University / Kobe University, there will be a process in the industry, including pre-clinical trials, clinical trials one, two, and three. According to him, it still takes about one more year. “It is hoped that by the middle of next year we will get an emergency use of authorization,” said the man who was born in Semarang, 67 years ago.
This was also previously conveyed by the spokesperson and corporate secretary of PT Bio Farma, Bambang Heriyanto, who estimates that the clinical trial process for the Red and White vaccine will only be completed in the third quarter of 2022.
He added that currently the company is awaiting regulation from the government. “Later in Bio Farma, optimization will be carried out first, then preclinical trials, phase 1 clinical trials, phase 2 clinical trials and phase 3 clinical trials. It is estimated that it will only be completed in the third quarter of 2022,” said Bambang, February 13, 2021.
Previously, the government estimated that the Red and White vaccine would be produced this year. However, the postponement of its production schedule to mid-2022 cannot be avoided.
Currently, LBM Eijkman is still completing the initial process, namely seeding. With the method used, Eijkman isolated one virus that was obtained in April 2020, then studied other viruses, developed them further in cell form, and sent them in the form of seeds to Bio Farma.
Meanwhile, Spokesperson for the Covid-19 Task Force from the Ministry of Health, Siti Nadia Tarmidzi, said that mass production must wait for an emergency use authorization (EUA) from the Food and Drug Administration (BPOM).
Meanwhile, the BPOM’s emergency use permit for the Red and White vaccine is likely to be issued in mid-2022. Previously, the Ministry of Research and Technology / National Research and Innovation Agency targeted that in the middle of this year the clinical trial of the Red and White vaccine would be completed and could be mass produced by the end of 2021.
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