iGene, mRNA COVID-19 Vaccine Booster Shot Clinical Phase 1/2a Trial Plan Approved in Australia
[Asia Economy Reporter Hwang Yoon-joo] iGene announced on the 21st that it has received approval for a Phase 1/2a clinical trial plan in Australia to develop its messenger ribonucleic acid (mRNA) COVID-19 vaccine candidate 'EG-COVID' as a booster shot (additional dose).
iGene stated, "The probability of a clinical trial drug receiving final approval as a pharmaceutical product is statistically known to be about 10%," adding, "There is a possibility that the results during the clinical trial and product approval process may not meet expectations, and accordingly, the company may change or abandon its commercialization plans."
In Phase 1 clinical trials, iGene plans to divide 20 healthy adults aged 19 and older who have previously received authorized COVID-19 vaccines into two groups and administer 'EG-COVID' to confirm safety, tolerability, and immunogenicity.
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In Phase 2a, the booster shot efficacy of EG-COVID will be explored in an additional 100 participants, with 30% of them being vaccine-naive individuals.
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