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.
In another vaccine development effort, state-owned drugmaker Kimia Farma is collaborating with the China National Pharmaceutical Group Corp. (Sinopharm) and G42 Healthcare, a subsidiary of the Abu Dhabi-based artificial intelligence company Group 42 (G42). The United Arab Emirates government has reportedly promised to provide a supply of at least 10 million doses of the Sinopharm vaccine to Indonesia by the end of the year.
The BPOM made an official visit to the UAE on Aug. 24 to 26 to obtain details of the vaccine, which has been certified as halal and has also received authorization for emergency use from China's National Medical Products Administration (NMPA).
Penny said that the BPOM would join Sinopharm and G42 in evaluating the safety and effectiveness of the final vaccine.
The agency would also ensure the transfer of vaccine technology from foreign producers to Indonesian firms for future development of locally made vaccines, she added.
