台湾国光生物科技股份有限公司的新冠肺炎候选疫苗已获准进行第一期临床试验,预计会收60名健康的受试者。这是台湾首间获准第一期人体试验的厂商。
台湾的卫生福利部食品药物管理署周一公布,核准有关的临床试验。
食药署指,经日前召开疫苗临床试验审查专家会议,审查国光生物候选疫苗“AdimrSC-2f vaccine (COVID-19 S蛋白片段)”的第一期临床试验计划,认为国光生技有条件执行该项试验,但疫苗是否有效仍待试验结果进一步评估。
食药署药品组科长张连成表示,国光生物可先筛选合格受试者,待补齐安全性数据,经卫福部审查通过后,就可进行试验;60名受试者预计由台大医院收案,并先做安全性和毒性试验。
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