Eijkman Hopes Red And White Vaccine Get Emergency Use Permit By The End Of 2022
JAKARTA - Head of the Institute for Molecular Biology Eijkman Amin Soebandrio hopes that the Merah Putih vaccine will receive an emergency use authorization (EUA) from the Food and Drug Supervisory Agency (BPOM) by the end of 2022 or the third quarter of 2022.
"It is hoped that around the third quarter of 2022 (the Red and White vaccine) will be able to get the EUA," Amin said in a virtual discussion on Saturday, September 18.
Amin explained that the development of the recombinant protein-based vaccine made by Eijkman has now succeeded in producing the vaccine seed.
"So we have completed the RNA phase, have succeeded in making the vaccine seed, just transition to the industry and this is still in the process of scaling up, then optimization and also increasing its yield (productivity)," said Amin.
Currently, Eijkman is still conducting preclinical trials on the second stage of animals until the end of 2021. Then, the third stage of clinical trials will be continued in early 2022.
According to him, the third phase of clinical trials that are injected into humans will last 9 months. So, the estimated EUA will be obtained at the end of 2022.
"Of course we hope that the clinical trial which is targeted for 8 to 9 months can be completed. In fact, before phase 3 is completed, if the results are good, we can get the EUA," he said.
For information, the Merah Putih vaccine was developed by a number of institutions and universities, including LBM Eijkman, Universitas Airlangga (UNAIR), but also the University of Indonesia (UI), Gadjah Mada University (UGM), Bandung Institute of Technology (ITB), Padjadjaran University (UNPAD), and the Indonesian Institute of Sciences (LIPI).
Even though they both develop the Red and White vaccine, the platforms used by each institution and university are different, so the results will also be different.