Page 230 - Uji Klinik Fase III Vaksin COVID-19 di Indonesia

Judul : COVID-19 vaccine to be registered after clinical trials conclude

Nama Media : antaranews.com

Tanggal : 12 Agustus 2020

Halaman/URL : https://en.antaranews.com/news/153962/covid-19-vaccine-to-be-
registered-after-clinical-trials-conclude

Tipe Media : Online

The COVID-19 vaccine from Sinovac will
be registered with the Indonesian Food
and Drug Monitoring Agency (BPOM) on
conclusion of the phase III clinical trials
planned to last six months.

"Currently, we are waiting for the next six
months. We seek support and prayers for
the vaccine development. I ensure that this
vaccine is halal. God willing, if the phase III
clinical trials go well, we will prepare to register it with the BPOM to be produced en
masse and be administered to overcome the COVID-19 pandemic," Chief Executive
of the Committee for Handling Covid-19 and National Economic Recovery
(KPCPEN) Erick Thohir stated at the Faculty of Medicine, Padjadjaran University,
Bandung, on Tuesday.
Thohir made the statement while accompanying President Joko Widodo to witness
the administration of the vaccine to 20 volunteers during the phase III clinical trials at
the Faculty of Medicine, Padjadjaran University.

The vaccine will be injected to 1,620 volunteers targeted for all clinical trials,
including authorization from the BPOM, to be completed in January 2021.

"I thank the volunteers, Bio Farma, and Sinovac laboratory team as well as the
University of Padjadjaran that facilitated this crucial stage to take place," Thohir
noted.

President Widodo, in the company of Thohir, Health Minister Terawan Agus
Putranto, West Java Governor Ridwan Kamil, and Bio Farma President Director
Honesti Basyir, also observed the facilities and production capacity of the COVID-19
vaccine at Bio Farma.
"We are proud of the ability of state-owned company Bio Farma collaborating with
the Sinovac Institute from China since it has entered the third phase of clinical trials.
Not many countries or research institutions have reached clinical trials at this stage,"
Thohir affirmed.

Phase III of clinical trials is a stage that all pharmaceutical products, including drugs
and vaccines, have to necessarily go through.