Page 79 - Persetujuan Pelaksanaan Uji Klinik (PPUK) Perdana Untuk Vaksin Merah Putih_Neat

Judul : BPOM Allows Clinical Trials on Merah Putih Vaccine
Nama Media : Tempo.co
Tanggal : 7 Februari 2022
Halaman/URL : https://en.tempo.co/read/1558202/bpom-allows-clinical-trials-
on-merah-putih-vaccine
Tipe Media : Online

The Food and Drug Monitoring Agency (BPOM) released approval for the
implementation of phase I and II clinical trials (PPUK) on the Merah Putih Vaccine.
The COVID-19 vaccine is developed by researchers from Airlangga University and PT
Biotis Pharmaceutical.

“BPOM has approved PPUK for the Merah Putih Vaccine using an inactivated virus
platform,” said the agency head Penny K. Lukito at a press conference on Monday,
Feb. 7.

Penny said the clinical trials would be carried out at Dr. Soetomo Hospital, Surabaya.
The phase I clinical trial would involve 90 subjects and phase II would involve 405
subjects. The subjects, she added, would be divided into three groups to be given
different doses.

If deemed eligible, the clinical trials will continue to phase III in April 2022.

Penny targeted that BPOM will issue an emergency use permit for this COVID-19
vaccine in mid-July 2022. “It is hoped that the vaccine can be produced soon and the
public can access it,” she concluded.