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) .