JAKARTA - The main researcher of the Red and White vaccine clinical trial at Airlangga University (Unair) Surabaya, Dominicus Husada, said that the phase 1 clinical trial of the Unair Merah Putih vaccine began on February 8, 2022.
"Preparations are 'on track' (according to the plan)," he said when contacted by Antara, Jakarta, Friday, January 28.
He explained that as many as 90 participants will take part in phase 1 clinical trials with ages 18 years and over. The clinical trial of the vaccine candidate will be conducted at the Regional General Hospital (RSUD) Dr Soetomo Surabaya, East Java.
"Phase 1 clinical trials are planned for a year, aimed at evaluating the safety and resulting immunity of the vaccine candidate," he said.
The candidate for the Merah Putih vaccine made by Unair, he said, would undergo three phases of clinical trials, in which each phase is planned to be carried out for a year.
"The volunteers who took part in the phase 1 clinical trial mostly came from East Java, especially Surabaya," he said.
Regarding the preparation of phase 1 clinical trials, he said all aspects are currently according to plan, which include, among others, candidate test participants, completeness of buildings and equipment, medical equipment, staff readiness, administrative readiness, and funding readiness.
Approval for conducting clinical trials of the vaccine candidate will be issued by the Food and Drug Supervisory Agency (BPOM). Airlangga University developed the Merah Putih vaccine for COVID-19 using an inactivated virus-based platform.
In addition, Unair has handed over vaccine seeds to PT Biotis Pharmaceuticals Indonesia to be prepared for the implementation of clinical trials of the vaccine.
The Red and White vaccine seeds developed by Unair have gone through phase 1 and 2 preclinical trials. Phase 1 preclinical trials using mice and phase 2 using macaca or monkey animals.
After successfully going through phase 1, 2, and 3 clinical trials, it is hoped that the Merah Putih vaccine will be able to obtain an emergency use authorization or EUA from BPOM, said Dominicus Husada.
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