The participants of the Merah Putih (Red and White) vaccine’s clinical trial will be observed for one year, lead researcher for the clinical trial at Airlangga University Dominicus Husada told ANTARA on Wednesday.
The clinical trial of the Merah Putih COVID-19 vaccine is being conducted by many universities in Indonesia. Airlangga University conducted the trial on February 9, 2022, during which 90 people received the vaccine at Dr. Soetomo General Hospital in Surabaya, East Java, Husada informed.
“Then, the next step is a one-year observation,” he said.
Airlangga University developed the Merah Putih vaccine in cooperation with PT Biotis Pharmaceuticals Indonesia and Dr. Soetomo Hospital, he added.
The vaccine candidate is based on an inactivated virus and is currently in Phase 1 of the clinical trial, he said.
Six other teams are developing the Merah Putih vaccine: the University of Indonesia, Bandung Institute of Technology, Gadjah Mada University, Padjadjaran University, former Indonesian Institute of Sciences (LIPI), and Eijkman Institute for Molecular Biology. All of them have been included in the national consortium for vaccine development.
During the trial for Airlangga University’s vaccine candidate, researchers took blood samples from participants before and after they were injected with the vaccine, Husada said.
“Before the first injection, (each recipient’s) blood was taken,” he said.
According to Husada, Phase 1 is aimed at testing the vaccine’s safety. If the results are satisfactory, the trial will move to Phase 2 and Phase 3, he said. If the clinical trial goes smoothly and as scheduled, then Phase 3 is expected to be completed in 2023, he informed.
Thereafter, Airlangga University will submit the Merah Putih clinical trial results to the National Agency of Drug and Food Control (BPOM) for further evaluation, he said.
If the results of the clinical trial meet the safety and efficacy requirements, BPOM will issue an emergency-use authorization (EUA) for the Merah Putih vaccine, Husada informed.
Source: Antara News