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Judul : BPOM: COVID-19 Vaccine EUA Issuance Awaits Phase-3
Clinical Trial Results

Nama Media : tempo.co

Tanggal : 9 Januari 2021
Halaman/URL : https://en.tempo.co/read/1421336/bpom-covid-19-vaccine-eua-
issuance-awaits-phase-3-clinical-trial-results

Tipe Media : Media Online

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.