Bio Farma Explains Stages of Covid-19 Clinical Trials



Laila Afifa

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  • TEMPO.CO, Jakarta - Bio Farma explained the stages of creating a vaccine. Head of Corporate Communications of Bio Farma, Iwan Setiawan, said that phase three of the clinical trials for making the Covid-19 vaccine aims to ensure the benefits of the vaccine.

    "This is related to benefits, whether it produces antibodies or not," he told Tempo, Wednesday, July 23.

    Iwan said there are at least four stages that must be passed in vaccine production. The first stage is Pre-clinical, which is testing the vaccine on animals. Once the animal testing stage is passed, it proceeds to Phase 1 until 3 of the Clinical Trials.

    "Phase one is related to safety, to ensure that the vaccine has no side effects and so on. Stage two is related to dossiers; how much is the dose, which is also a safety aspect, "Iwan said.

    Iwan revealed that Sinovac Biotech, a pharmaceutical company from China, has conducted all of those phases. Bio Farma took part in Phase 3 of Clinical Trials, which is also done in Brazil, Bangladesh, Turkey, and Indonesia. "The results must be the same," he said.

    Iwan said that in the development of the Covid-19 vaccine from Sinovac, Bio Farma acts as the sponsor for Phase 3 Clinical Trials in Indonesia. Bio Farma appointed Padjadjaran University's Faculty of Medicine, as an independent institution, to conduct clinical trials.

    Clinical testing will be carried out by sampling 1,620 subjects, selected based on certain criteria, including age criteria of 18 to 59 years.

    Vaccine development is one of Bio Farma's five scenarios to participate in handling the spread of Covid-19. Simultaneously, Bio Farma is also preparing Real-Time Polymerase Chain Reaction (RT-PCR), Covalent Plasma Therapy, BSL 3 Mobile Laboratory, and Manufacturing Viral Transport Media (VTM).

    Read: Govt to Import COVID-19 Vaccine from UK

    Ahmad Fikri (Contributor)