The main requirement (of issuing the EUA) is that there must be an official state of emergency from the governments (of the countries).
Jakarta (ANTARA) - The National Agency of Drug and Food Control (BPOM) has prepared three alternative strategies to support the provision of drugs and vaccines for treating monkeypox in Indonesia.

This was conveyed by Head of the BPOM Penny K. Lukito while attending a hearing meeting with Commission IX of the Indonesian House of Representatives (DPR) here on Tuesday.

The first strategy is implementing an expanded access scheme for clinical trials where the subjects are monitored and their immune response is measured.

However, for vaccines and drugs which are still being researched, permission will be granted through the Special Access Scheme (SAS).

The clinical trials will be carried out by the pharmaceutical industry in Indonesia to examine the efficacy, safety, and quality of the vaccines and drugs.

Meanwhile, the second strategy is issuing emergency-use authorization (EUA)—the same permit that allowed the use of COVID-19 vaccines.

"It can be issued soon within 20 working days according to the results of the evaluation of various countries which have given the permission. The main requirement (of issuing the EUA) is that there must be an official state of emergency from the governments (of the countries)," the BPOM head said.

Some monkeypox vaccines whose provision can be expedited through EUA in Indonesia include the Jynneos/Imvanex/Imvamune vaccine, which has been approved in several countries.

The third strategy also involves SAS. However, under this strategy, SAS will be utilized to grant permits for vaccines and medicines that have been approved in several countries in limited quantities and whose use is controlled by health programs, Lukito added.

During the same meeting, Health Minister Budi Gunadi Sadikin informed that the government has ordered two thousand doses of the monkeypox vaccine produced by Denmark-based Bavarian Nordic to protect the public from infection.

"Assisted by the Indonesian Embassy in Denmark, we have ordered two thousand doses of the vaccine from Bavarian Nordic," he said.

Related news: Indonesia has ordered 2,000 monkeypox vaccine doses: Health Minister
Related news: First Indonesian monkeypox patient has recovered: Health Minister

Translator: Andi Firdaus, Uyu Liman
Editor: Rahmad Nasution
Copyright © ANTARA 2022