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Judul : BPOM drafts accelerated 'road map' for Merah Putih vaccine
production by 2021 Tri Indah Oktavianti

Nama Media : thejakartapost.com
Tanggal : 2 September 2020

Halaman/URL : https://www.thejakartapost.com/news/2020/09/02/bpom-drafts-
accelerated-road-map-for-merah-putih-vaccine-production-by-
2021.html

Tipe Media : Online

The Food and Drug Monitoring Agency
(BPOM) is to accelerate its regulatory
process to facilitate the country’s efforts to
develop a COVID-19 vaccine and ensure
that it is ready for mass production and
distribution by 2021.

A national consortium led by the Research
and Technology Ministry is currently
developing the "Merah Putih" vaccine,
named after the nation's iconic red-and-white flag.

President Joko Widodo told a limited Cabinet meeting on Sept. 1 that the vaccine's
development was 30 to 40 percent complete, and that the government was aiming to
start mass production by mid-2021 following clinical trials early next year.
―The BPOM has created a road map for the development of the [Merah Putih]
vaccine to meet the requirements for preclinical and clinical data, as well as quality
[standards],‖ agency head Penny Lukito said on Tuesday during a press briefing at
the State Palace.

Penny added that the agency had submitted the "vaccine road map" on Aug. 14 to
the Research and Technology Ministry for review, and expressed hope that the
vaccine production ―will be able to follow the accelerated timeline to meet the needs
of the national vaccine program by 2021‖.

In a separate effort, state-owned pharmaceuticals Bio Farma is aiming to mass
produce by early 2021 at least 150 million doses of a potential vaccine it is
developing in partnership with Chinese company Sinovac Biotech.

Whether the pharmaceutical holding company can realize the plan, however,
depends on the progress of the phase III clinical trial currently under way in
Bandung, West Java.

―[The BPOM] has protocols for the clinical trials of potential vaccines, and is also
monitoring the process. We will evaluate the results of the trials before authorizing
emergency use [of the final vaccine],‖ said Penny.