令人振奋之Bio Farma 生产的新冠肺炎病毒疫苗将按时完成–Exhilarating! COVID-19 Vaccines Made by Bio Farma Will Be Completed On Time

为了克服这一流行病情,Bio Farma(8月6日,星期四)宣布,从中国北京科兴生物有限公司寄来印尼的新冠肺炎病毒疫苗的第三阶段临床试验今天正式开始。

“我们于今天星期四(8月6日)诞辰130周年纪念日祈祷我们将开始落实新冠肺炎病毒疫苗研发的临床试验,”Bio Farma总裁Honesti Basyir在星期四(2020/08/06)说道。

据Honesti称,似乎在竞争提供疫苗的几乎所有国家都在热切地等待这种新冠肺炎病毒疫苗。

他继续称道,“为什么? 因为只有疫苗才能够使我们恢复到正常的生活。我们毕竟不希望总是戴口罩、戴面罩、保持距离、社区隔离,因为这肯定会损害我们的社会互动,并且因为人类是属于社会生物、群体生物”。

他请求各方的支持,以便新冠肺炎病毒疫苗的临床试验顺利实践,以便Bio Farma和印尼国营制药控股公司的另成员,即 Kimia Farma 和 Indofarma 可以立即实现新冠肺炎病毒疫苗生产,从而在印度尼西亚会呈现更好的生活。

作为第三阶段临床试验的初始阶段,来自中国北京科兴生物有限公司的2400剂疫苗已于2020年7月19日到达Bio Farma,因此,得益于国有企业部的支持及外交事务部在将把疫苗列为外交商品方面的角色。

于2020年8月落实临床试验之前,其到达印尼的疫苗仍需通过几个阶段。仍然需要通过的阶段包括在Bio Farma实验室进行的测试与其他几项执照。

新冠肺炎病毒疫苗的临床试验将于UNPAD医学院临床试验中心实践,该临床试验将对在18-59岁之间年龄范围,并符合许多特定标准的1620名受试者进行抽样。其疫苗余剂将用于多个实验室的实验室测试,包括Bio Farma和国家食品与药物机关测试中心的实验室。

在新冠肺炎病毒疫苗的临床试验中,Bio Farma担任和作为赞助方,包括与印度尼西亚卫生部之卫生研究与发展局(Balitbangkes)及各方携手同行合作,担任医学顾问并实施抗体滴度中和测试。

据安塔拉(Antara)报道,除了与印尼卫生研究与发展局合作之外,Bio Farma还与印度尼西亚共和国的药品和食品控制局机关合作,把它当作监管机构,接着当然还有UNPAD医学院,它既是在印度尼西亚实施疫苗临床试验最有经历的高等教育机构。

In order to overcome the pandemic, Bio Farma announced the commencement of the third phase clinical trials of the COVID-19 vaccine from Sinovac China today, Thursday (6/08).

“We prayed on our 130th anniversary today, Thursday (6/8) that we will start the clinical trials for COVID-19 vaccine development,” said the President Director of Bio Farma, Honesti Basyir on Thrusday (6/08/2020).

According to Honesti, almost all countries that are seemed competing to deliver a vaccine are eagerly awaiting this COVID-19 vaccine.

“Why? Because only the vaccine can bring us back to normal life. We of course don’t want to always wear masks, face shields, keep our distance because it will certainly damage our social interactions, and because humans are social beings,” he said.

He asked for support from all parties so that the clinical trial of the COVID-19 vaccine would run well, so that Bio Farma and members of the BUMN pharmaceutical holding, Kimia Farma and Indofarma, could immediately realize the COVID-19 vaccine for a better life in Indonesia.

As the initial stage of the third phase of clinical trials, 2,400 doses of vaccine from Sinovac, China, had arrived at Bio Farma on July 19, 2020, thanks to the support of the Ministry of State-Owned Enterprises and the role of the Ministry of Foreign Affairs in including vaccines as diplomatic goods.

The vaccines arrived still require several more stages before the clinical trials can be carried out in August 2020. The stages that still need to be passed through include testing in the Bio Farma Laboratory and several other permits.

The clinical trial of the COVID-19 vaccine, will be carried out at the Clinical Test Center at the Faculty of Medicine, UNPAD, which will take sample of 1,620 subjects with an age range between 18 – 59 years, and with certain criterion. Meanwhile, the residuals of the vaccine will be used for lab tests in several labs, including the ones at Bio Farma and the National Food and Drug Testing Center (PPOMN).

In the clinical trial of the COVID-19 vaccine, Bio Farma acts as a sponsor, collaborating with various parties, including the Indonesian Health Research and Development Agency (Balitbangkes) of the Ministry of Health as medical advisor and implemention of antibody titer neutralization tests. 

Apart from Baltbangkes, reported by Antara, Bio Farma is also working with National Agency of Drug and Food Control of Republic of Indonesia as a regulator and of course with Faculty of Medicine of UNPAD as an institution that has experiences in implementing clinical trials of vaccines circulating in Indonesia.

Reference:
1. https://babe.topbuzz.com/a/6857809785224430082?app_id=1124&c=wa&gid=6857809785224430082&impr_id=6857996323528280322&language=id&region=id&user_id=6816675003284554754
2. https://www.netralnews.com/news/nasional/read/219333/menggembirakan..vaksin.covid.19.buatan.b

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