BPOM: COVID-19 Vaccine EUA Issuance Awaits Phase-3 Clinical Trial Results
TEMPO.CO, Jakarta - Food and Drug Monitoring Agency (BPOM) Head Penny Lukito confirmed she was waiting for the results of the phase-3 clinical trial of the Sinovac COVID-19 vaccine in Bandung before issuing an Emergency Use Authorization (EUA).
“We are still waiting for the data on the results of the phase-3 clinical trial in Bandung for the 3-month interim observation that will be given today,” Penny said in a press conference, Friday, Jan. 8, 2021.
She added that once the report arrived, her team would immediately discuss it in a short time. “Hopefully, [the discussion] will be finalized soon and we will announce the EUA.”
The research team of the vaccine clinical trial from Padjadjaran University submitted an interim report on the phase-3 clinical trial of Sinovac vaccine to state-owned pharmaceutical giant Bio Farma on Thursday night, January 7, 2021.
Bio Farma as the sponsor then delivered the report to the BPOM, which is authorized to issue an EUA.
The report is one of the prerequisites to apply for the EUA. If the permit is published, the COVID-19 vaccination program can be started. On the other hand, the government previously announced that the vaccination would start on Wednesday, January 13, 2021.