Indonesia's State-owned COVID-19 Vaccine Enters Final Clinical Trial

TheIndonesia.id - The Indonesian Food and Drug Supervisory Agency (BPOM) issued a permit to develop a final-stage clinical trial of a State-Owned Enterprise Vaccine, a collaboration of PT Bio Farma, Baylor College of Medicine, and Eijkman. The developer hopes that in July 2022, this COVID-19 vaccine will get an emergency use authorization.

"The first State-owned Enterprise Vaccine in Indonesia is the work of the nation's children in preclinical development until this last or third phase. We have given permission and have met the stages of a good clinical trial method," said Head of BPOM RI Penny K Lukito in a press conference for SOE Vaccine Phase 3 Clinical Trial Kick Off, in Jakarta, Thursday, June 9, 2022.

Penny said BPOM has assisted the development of BUMN Vaccines from production facilities to the use of vaccines that have met the standard procedures for Good Manufacturing Practices (GMP) or good production methods according to regulations. "Hopefully it can be completed soon and given an Emergency Use Authorization (EUA) for the best results and produced commercially and so vaccines are safe, quality, effective, efficacious, and competitive," she said.

At the same event, Principal Researcher of the Semarang Center, Faculty of Medicine, Diponegoro University (Undip) Dr Yeti said the final phase of the clinical trial involved 4,050 subjects aged 18 to 70 years.

President Director of PT Bio Farma Honesti Basyir targets BUMN Vaccines to obtain EUA in July 2022. Currently, Bio Farma has prepared a production capacity of 120 million doses per year for BUMN Vaccines and will produce as needed.

"Currently, we are doing clinical trials for the primary vaccine first. The possible priority is for the need for a booster (third dose) and for children. We still lack the supply of vaccines for children," he said.

As is known, the BUMN Vaccine in collaboration with PT Bio Farma, Baylor College of Medicine, and Eijkman uses a sub-unit recombinant protein platform.