Jakarta: The National Research and Innovation Agency (BRIN) confirmed that the pre-clinical trials of the BRIN Merah Putih Vaccine, in collaboration with PT Bio Farma, were targeted to start at July end or August 2022.
"The pre-clinical trial test is expected to start in late July or in August 2022," Head of the BRIN Health Research Organization, Ni Luh P. Indi Dharmasanti, stated at a webinar titled "The Utilization of Health Research-Innovation for Accelerating Independence in the Indonesian Pharmaceutical and Medical Devices Industry," attended virtually in Jakarta, Tuesday.
Dharmasanti noted that the preclinical tests included immunogenicity tests on mice, immunogenicity tests on macacas, acute toxicity tests, subchronic toxicity tests, and challenge tests on macacas.
Immunogenicity tests were conducted to determine the ability of vaccine candidates to trigger a targeted immune response, while preclinical testing aimed at determining the safety of the scientific efficacy of vaccine candidates.
If the preclinical test yielded a satisfying result, then it could continue to clinical trials in humans with three phases.
The laboratory phase in the development of the BRIN Merah Putih Vaccine was completed since October 2021. The vaccine seeds were earlier developed by the Eijkman Institute for Molecular Biology, which has been integrated into BRIN.
From vaccine research in the laboratory phase, the scientists were able to obtain vaccine seeds that consistently expressed RBD protein and had a high yield of 600 mg/L.
The Merah Putih vaccine seeds, based on yeast cells, have also been characterized, including easy to purify, capable of binding to the ACE2 receptor, stable at four degrees Celsius for six weeks and longer when frozen at -20 degrees Celsius and -80 degrees Celsius, and being immunogenic since it can induce an immune response and antibodies in mice.
The vaccine seeds have been handed over to PT Bio Farma and are currently in the downstream stage by PT Bio Farma, Dharmasanti stated.