印尼病学专家称临床试验需要时间,不能匆忙完成 Indonesian Medical Experts Say Clinical Trials Take Time and Cannot be Completed in a Hurry

佐科维总统周二(7月21日)下午在总统府会见了帕贾贾兰大学(Unpad)医学院研究小组。

研究小组主任库斯南迪(Kusnandi Rusmil)会后说明,佐科维总统特别指示,希望从中国进口的新冠疫苗可以在三个月内广泛应用。目前该疫苗仍处于临床试验阶段。 然而,研究小组无法满足总统的要求。库斯南迪说,新冠疫苗临床试验研究小组非常仔细和谨慎地工作,以致不可能在短短三个月内完成。

虽然佐科指示3月内疫苗上,库斯南迪及其团队估计,临床试验过程最快只能在2021年1月完成。Unpad大学与Bio Farma制药厂和卫生部研发机构合作进行临床试验,新冠肺炎疫苗将被注射到1620名18-59岁的接受试验者身上。Unpad 大学被选择是因为它被认为是进行疫苗临床测试的最有经验的教育机构。如果该临床试验成功,那么Bio Farma药厂将批量生产该疫苗。

尽管社区非常需要这种疫苗,但库斯南迪强调,他的研究团队在进行临床试验时不会仓促行事,因为世卫组织已经规范了新冠肺炎疫苗临床试验程序,必须按部就班,不能加速进行,以免对监测疫苗的效益和副作用有所疏漏而产生不好的结果。

Jokowi President met with the research team of the University of Pajajaran (Unpad) School of Medicine at the Presidential Palace on Tuesday (July 21) afternoon. The director of the research team, Kusnandi Rusmil, explained after the meeting that President Jokowi specifically instructed that the Covid-19 vaccine imported from China could be widely applicated within three months. The vaccine is still in clinical trials. However, the research team could not meet the president’s request. Kusnandi said that the Covid-19 vaccine clinical trial research team worked so carefully and cautiously that it could not be completed in just three months.

Although Jokowi President instructs the vaccine to be launched within 3 months, Kusnandi and his team estimate that the clinical trial process can only be completed as early as January 2021. The clinical tests on the potential COVID-19 vaccines will be held at the medical R&D facility at Padjadjaran University’s Faculty of Medicine, which was chosen as it has been deemed to be the most experienced in carrying out clinical tests for vaccines. Bio Farma explains that the upcoming clinical test will sample 1,620 subjects that will be chosen based on certain criteria, one of which is that it must be from people aged between 18 to 59 years old. If the clinical trial is successful, Bio Farma Pharmaceuticals will mass produce the vaccine.

Although the community is in great need of this vaccine, Kusnanti emphasized that his research team will not rush into clinical trials. Because of WHO has standardized the clinical trial procedures of the Covid-19 vaccine, it must be done step by step and cannot be accelerated, in order to avoid omissions and produce bad results in monitoring the effectiveness and side effects of the vaccine.

References:
1. https://mp.weixin.qq.com/s/w5OsNLxXZpr_LgyZpbb_kg
2. https://www.idnfinancials.com/news/35310/bio-farma-start-coronavirus-vaccine-clinical-trial-august

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