中国疫苗运抵印尼将展开第三阶段临床试验 Chinese Vaccines Arrived in Indonesia to Start Phase III Clinical Trials

印尼外交部代理发言人费扎萨(Teuku Faizasyah)表示,由中国北京科兴生物制品公司(Sinovac Biotech)生产的新冠肺炎疫苗已于周日(7月19日)运抵印尼,并已移交给Bio Farma公司进行临床测试。费扎萨周一(20日)被记者问及此事时说:是的,星期日抵达的疫苗已移交给Bio Farma公司。为了研发这种疫苗,印尼通过国际合作渠道与中国合作。

费扎萨说,短期战略是确保准备生产时能获得疫苗,这是通过国际合作实现的。作为独立生产疫苗的中长期战略,印尼成立了一个国家财团。

此前,国营制药企业Bio Farma公司与中国北京科兴生物制品公司合作生产了针对新冠病毒的疫苗。Bio Farma公司总裁霍内斯蒂(Honesti Basyir)表示,由北京科兴生产的新冠疫苗已通过一期和二期临床试验,三期临床试验不久将包括印尼在内的多个国家进行。

霍内斯蒂上周四(16日)在总统秘书处的新闻发布会上说,新冠肺炎疫苗生产技术从北京科兴转移到Bio Farma是在临床试验的第三阶段进行的。

霍内斯蒂说,Bio Farma公司将与Padjadjaran大学和卫生研究与发展局(Balitbangkes)合作,为第三阶段临床试验做好准备。并将与食品和药物监管局进行协调,如果研发出的疫苗获得监管局批准,将于2021年第一季度用于紧急情况。

除了与北京科兴合作外,Bio Farma还在国家研究与创新局(BRIN)组成的国家财团的支持下开发本地疫苗。

据印尼国有企业Bio Farma科技公司负责人Honesti Basyir透露,将竭尽全力监督这项临床试验的过程,确保能够生产这种疫苗,待完成试验后,Bio Farma生物首阶段生产4000万剂。目标是在2021年1月前完成临床试验。印尼国有企业Bio Farma科技公司显得正在建立生产疫苗建设设备,疫苗最大生产能力可达到年产2.5亿剂。 据霍内斯蒂估计,这种本地疫苗最快要到2022年年初或年中才能在社区中普及应用。

Team involved in the Chinese vaccines sent to Indonesia (19/7/2020)

The Spokesperson of the Ministry of Foreign Affairs of Indonesia, Teuku Faizasyah, stated that the Covid-19 vaccine produced by China’s Beijing Sinovac Biotech has arrived in Indonesia on Sunday (July 19) and has been handed over to Indonesia, and it has been handed over to Bio Farma for clinical testing. In order to develop this vaccine, Indonesia has cooperated with China through international cooperation channels.

Faizasyah said that the short-term strategy is to ensure that vaccines are available when they are ready for production, and this is achieved through international cooperation. As a medium and long term strategy for independent production of the vaccines, Indonesia had established a national consortium.

Prior to this, the Indonesia state-owned pharmaceutical company Bio Farma Pharmaceutical and China’s Beijing Kexing Biological Products Co.,Ltd (Beijing Sinovac Biotech) has cooperated to produce a vaccine against the new coronavirus. Honesti Basyir, President of Bio Farma, said that the Covid-19 vaccines produced by China’s Beijing Kexing Biological Products Co.,Ltd has passed Phase I and Phase II clinical trials, and Phase III clinical trials will soon be conducted in many countries including Indonesia.

Honesti said at a press conference of the President’s Secretariat last Thursday (16th) that the Covid-19 vaccine production technology transfer from Beijing Sinovac Biotech to Bio Farma was carried out in the third phase of clinical trials.

Honesti said that Bio Farma will work with Padjadjaran University and the Health Research and Development Agency (Balitbangkes) to prepare for the third phase of clinical trials. It will also coordinate with the Food and Drug Administration. If the vaccine is approved by the Administration, it will be used in emergency situations in the first quarter of 2021.

Except cooperating with Beijing Sinovac Biotech, Bio Farma is also developing local vaccines with the support of a national consortium formed by the National Bureau of Research and Innovation (BRIN).

According to Honesti Basyir, head of the Indonesian state-owned company Bio Farma Pharmaceutical Company, he will do his best to supervise the clinical trial process to ensure that the vaccine can be produced. After the test is completed, Bio Farma will produce 40 million doses in the first phase. The clinical tests are scheduled to be completed by January 2021, while the company is preparing a production facility to start the mass-production of the vaccine that is expected to be able to have a maximum production capacity up to 250 million doses. According to Honesti, he estimates this local vaccine will not be widely used in the community until the beginning or the middle of 2022 at the earliest.

References:
1. https://mp.weixin.qq.com/s/uxzpbqsBvmX4TxpJBXPt_g
2. https://www.thejakartapost.com/news/2020/07/20/potential-covid-19-vaccine-arrives-in-indonesia-for-clinical-trial.html
3. https://en.tempo.co/read/1367439/bio-farma-to-run-clinical-trials-on-sinovac-covid-19-vaccine
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