Vaccine maker Adimmune Corp (國光生技) has gained an approval from Indonesia’s health regulator to conduct phase 1 and 2 clinical trials for its experimental COVID-19 vaccine in the Southeast Asian country, as it aims to tap the Muslim-based market with halal certification, the company said yesterday.
The trials in Indonesia would be Adimmune’s first overseas human tests for its experimental COVID-19 vaccine, after the Ministry of Health and Welfare ordered it to redo its phase 1 trial in Taiwan in December last year to determine the optimal dosage.
Adimmune yesterday said that the Indonesian trials would determine the optimal dosage for its vaccine to generate adequate protection against COVID-19 variants and prove its efficacy.
Photo courtesy of Adimmune Corp
The company plans to recruit 240 healthy adults aged between 18 and 65 to participate in the phase 2 trials, spokesman Pan Fei (潘飛) told the Taipei Times yesterday.
Despite encountering a setback in Taiwan, Adimmune did not modify the formula of its COVID-19 vaccine, dubbed AdimrSC-2f, nor its recombinant protein manufacturing technology, Pan said.
Adimmune’s candidate was developed in spring last year, before the emergence of the SARS-CoV-2 Delta variant. However, the company said it had tested its candidate against the variant in animal tests earlier this year, and that it showed good potential.
Unlike most finished clinical trials, which provide participants with two doses of an experimental vaccine, Adimmune’s clinical trials in Indonesia would give participants three doses, Pan said, adding that the company’s phase 2 trial would require more time and results are expected to be released next year.
The company is to produce the experimental COVID-19 vaccine at its factory in Taiwan and export it to Indonesia for the human trials, in collaboration with the Faculty of Medicine and Health Sciences at Universitas Gadjah Mada, Pan said.
Adimmune said it expects to complete the phase 1 and 2 trials early next year, but it would not seek emergency use authorization (EUA) upon completion, Pan said.
Instead, the company plans to apply to the Indonesian regulator to conduct a phase 3 trial there, he said.
“Timing for applying for an EUA has passed, as there are many available COVID-19 vaccines on the market,” Pan said. “Besides, an EUA is temporary. We aim to conduct the clinical trials without missing any steps and apply for a marketing approval that is valid for a long time.”
If Adimmune gains marketing approval from Indonesia for its COVID-19 vaccines, there is a good chance that the company would be able to provide its vaccine to other Muslim markets, Pan said, adding that the company has obtained a halal certification with its COVID-19 vaccine candidate.
Indonesia has the world’s largest Muslim population, consisting of about 87 percent of its 270.6 million inhabitants.
As with Moderna Inc, Adimmune would consider combining its flu vaccine into COVID-19 vaccine if its candidate is approved, although that mixture would not be a focus for research and development at this time, Pan said.
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