COVID-19 Pandemic: COVID-19 Vaccine Types Are Regulated by the Indonesian Government
On 3 December 2020, Indonesia’s government has addressed several types of COVID-19 vaccine which are permitted to be used within the Indonesia area through a decree issued by the Minister of Health of the Republic of Indonesia (“MoH”).
Legal Frameworks: Our below executive summary refers to MoH Decree No. HK.01.07/MENKES/9860/2020 on the Determination of Vaccine Types for the Implementation of Corona Virus Disease 2019 (COVID-19) Vaccinations (“MoH Decree”)
Main Keys on Indonesia’s COVID-19 Vaccination: We have managed to provide you the following main keys regarding Indonesia’s COVID-19 Vaccination.
Vaccine Types and Producers: The MoH allowed for the utilization of the following types of vaccine:
- PT Bio Farma (Persero);
- AstraZeneca;
- China National Pharmaceutical Group Corporation (Sinopharm);
- Moderna;
- Pfizer Inc and BioNTech; and
- Sinovac Biotech Ltd.
(collectively referred to as “Vaccines”)
However, we note that the MoH may adjust this list from time to time based on the issuance of further recommendation from the Indonesian Technical Advisory Group on Immunization/Komite Penasehat Ahli Imunisasi Nasional and in consideration of the opinion of the Committee for COVID-19 Mitigation and National Economic Recovery/Komite Penanganan COVID-19 dan Pemulihan Ekonomi Nasional (Point 4 of the MoH Decree 9860/2020).
The Requirement of Vaccines Distribution: We note that prior to its distribution to the public, Vaccines must have fulfilled the following conditions:
- Must be in the third phase of clinical testing or have completed the third phase of clinical testing; and
- Have secured a distribution permit or emergency use authorization from the Indonesian Food and Drug Authority/Badan Pengawas Obat dan Makanan (BPOM) (Points 2 and 3 of MoH Decree).
The Organizer of COVID-19 Vaccination Program: We note that the COVID-19 vaccination program will be organized by the following institutions:
- MoH, for a mass public vaccination program; and
- Minister of State-Owned Enterprises, for individual vaccinations.
The article above was prepared by Marshall S. Situmorang (Partner) and Aniendita Rahmawati (Associate).