The kick-off of the third phase of the clinical trials (of Merah Putih vaccine) is according to the government’s program to manufacture domestic vaccines by involving a number of (local) institutions.
Jakarta (ANTARA) - The Merah Putih (Red and White) COVID-19 vaccine developed by Airlangga University (Unair) and PT Biotis has entered the last or third phase of clinical trials for obtaining emergency-use authorization (EUA) in Indonesia.

"It is hoped that all processes of the third phase of clinical trials will be completed in about six months," the main researcher of the Merah Putih vaccine from Unair, Dr. Dominicus Husada, SpA(K), said at the launch of Phase 3 of the clinical trial, which was accessed from here on Monday.

Unair has roped in 4,005 volunteers for the trial, who have been divided into three groups to evaluate the ability of the Merah Putih vaccine to encourage an immune response from the body, he informed.

Two groups of volunteers will receive the Merah Putih vaccine to assess their inter-batch development, while one group will be administered a vaccine developed by other producers for comparison.

However, Husada informed that his team is not conducting an efficacy study for the vaccine in the third phase since of late, the number of COVID-19 cases in Indonesia has been low, in accordance with the circular issued by World Health Organization (WHO) on March 30, 2022.

"We are allowed to evaluate the equivalence of immunogenicity (of the Merah Putih vaccine) by comparing with other vaccines and not relying on the efficacy evaluation as the number of cases is getting lower," he said.

Still, the WHO requires the vaccine to be tested on at least three thousand volunteers to assess its safety, he added.

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On the same occasion, the head of UNAIR’s Merah Putih Vaccine Research Team, Prof. Fedik Abdul Rantam, informed that the vaccine developed in collaboration with PT Biotis as the provider of clinical test facilities since May 12, 2020, uses an inactivated virus platform.

"The kick-off of the third phase of the clinical trials (of Merah Putih vaccine) is according to the government’s program to manufacture domestic vaccines by involving a number of (local) institutions," he said.

In addition to Unair, the other institutions are the University of Indonesia (UI), Bandung Institute of Technology (ITB), Gadjah Mada University (UGM), Padjadjaran University (Unpad), and Indonesian Institute of Sciences (LIPI), he added.

Meanwhile, Head of the National Agency of Drug and Food Control (BPOM) Penny K. Lukito said that she was proud of the development of the Merah Putih vaccine.

"Hopefully, the third phase (of the clinical trials) will go smoothly," she added.

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Translator: Andi Firdaus, Uyu Liman
Editor: Rahmad Nasution
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