Taiwanese vaccine producer Adimmune Corp. said on Monday that it has gained approval from the Indonesian government to conduct Phase 2 clinical trials for its COVID-19 vaccine candidate, with results expected to be released next year.
Adimmune said the Phase 2 trial for its vaccine candidate, AdimrSC-2f, has been recently approved by the National Agency of Drug and Food Control of Indonesia or Badan Pengawas Obat dan Makanan.
The upcoming trial will feature 240 participants, and will be working with the Faculty of Medicine and Health Sciences in Universitas Gadjah Mada, according to Adimmune's press release.
The company is hoping that the trials will help it to determine the exact doses of the vaccine candidate that is needed to form enough protection against variants of the COVID-19 coronavirus and to prove its efficacy.
If everything goes well, Adimmune said, it will continue Phase 3 clinical trial in Indonesia.
The Taichung-based company said it chose to work with Indonesia because the Southeast Asian country is currently combating the spread of the highly infectious Delta variant of the COVID-19 virus.
Also, with more than 250 million people, Indonesia has the largest Muslim population of all countries in the world.
The company added that its vaccine candidate is halal and safe for Muslims, so it is hoping to gain access to Indonesia and other Muslim countries and the wider international market if clinical trials later prove to be successful.
Adimmune's latest announcement came months after it announced in February that it will not apply for emergency use authorization (EUA) for its COVID-19 vaccine candidate, like two other local vaccine makers did, but will instead go through a normal vaccine approval process by completing all three phases of clinical trials.
The company will also shift its focus to developing vaccines targeting new variants of the virus.
Adimmune's current COVID-19 vaccine entered phase 1 clinical trials in August 2020, but has since fallen behind Taiwan's other two local vaccine makers, Medigen Vaccine Biologics Corp. and United Biomedical Asia (UBI Asia).
Medigen's COVID-19 vaccine has gained EUA from Taiwan's Food and Drugs administration and has been administered since last month, while UBI Asia's EUA request was denied.
Source: Focus Taiwan News Channel