BPOM Issues Clinical Trial Approval for Merah-Putih Vaccine

By Office of Assistant to Deputy Cabinet Secretary for State Documents & Translation     Date 7 Februari 2022
Category: News
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Head of the BPOM Penny K. Lukito. (Source: screenshot)

In a bid to speed up the research and development of domestic vaccines, the Indonesian Food and Drug Administration (BPOM) has authorized the first Clinical Trial Implementation Approval for the locally developed COVID-19 vaccine, known as the Merah-Putih (Red and White) vaccine.

It takes data from non-clinical studies in the form of safety and immunogenicity in test animals to advance to the clinical trial phase. The BPOM has evaluated data on the safety and immunogenicity of the vaccine in mice and macaca fascicularis (long-tailed monkeys).

“The result of research study shows the vaccine is safe and tolerable and there is no death or organ abnormality in test animals. As for immunogenicity, there is an immune response that shows the formation of antibodies after the vaccination,” Head of the BPOM Penny K. Lukito said in a press statement in Jakarta, Monday (02/07).

The BPOM, Penny continued, continues to oversee the clinical trial of the Merah-Putih Vaccine to comply with approved standards and protocols. “The vaccine is of good quality since it is produced in production facilities that have met the requirements for Good Manufacturing Practices of Medicine (GMP),” she added.

According to Penny, if it goes according to the plan and the interim results of phase I/II clinical trials meet the requirements, then phase III clinical trials can be resumed in April 2022 and the vaccine can proceed to submit emergency use authorization (EUA) approval from the BPOM around mid-July 2022 as well as obtain a commercial scale GMP certificate in April 2022.

For the record, the Merah-Putih vaccine is developed by researchers from Airlangga University in collaboration with PT Biotis Pharmaceuticals Indonesia. The vaccine is developed using inactivated virus of SARS-CoV-2 virus originating from a COVID-19 patient in East Java provincial capital Surabaya.

To date, the BPOM has approved thirteen COVID-19 vaccines that have obtained EUA and several have been used in national vaccination programs. However, all of the vaccines are imported ones developed from abroad.

“Let us make the Merah-Putih Vaccine as our driving force for the development of other vaccines in Indonesia,” she remarked. (PR of BPOM/UN) (GWH/MUR)

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