正在等待科兴疫苗 Waiting for Sinovac

2020 年7月22日,星期三
作者:Dahlan Iskan

中国制造的抗Covid-19疫苗上,当周一抵达万隆之后,我们下一步该怎么办?

首先是寻找大量的志愿者,即自愿注射新疫苗的志愿者。

他们都被称为第三阶段临床试验志愿者的人。特别是对于第三阶段的试验,志愿者的数量应该需要很大。假设尽可能多,如果可能的话最多可以达到3,000人,并至少有300人。

300,这个数字越多越好,这样我们就可以获得最佳的评估结果。根据第三阶段试验的评估,世界机构相关的实体将会签发与发布其新药/疫苗的上市许可或分销许可证。

只有在获得许可证和执照后,才能普遍地使用该疫苗。该术语尚未被称为“正式允许使用”,而是进入“第四阶段审判”。不过,在第四阶段的试验中,目标不再是寻找志愿者了。任何人都可以用新的疫苗注射,而由世界新药物与疫苗授权机构,其疫苗会继续被监测和监督。

这就是为什么发明新药非常钱贵的原因。此第四阶段试验仅的费用就可能高达2000亿印尼盾。如果拿西方国家来说,即使没有地区选举,要找到志愿者并不容易,因为他们非常担心而害怕新药的副作用。就像我们印尼这里的省区或总统选举志愿者一样,有这种类型的志愿者类似,他们都需要付费。

除了需要营养外,他们还必须签署很多文件条款:例如,如果其药物或疫苗导致任何问题或副作用,他们将不会发起任何投诉。他们首先也得经过全面的体检。即使注射过了一个月,注射后的检验最多也会进行两次,即2个月期间。

即使该第三临床试验成功,也意味着它将在本年10月份最快的时间,才能获得世界机构的大规模使用许可。假设在11月份,即佐科维总统就任总统满一年的正当月份,则可以允许该疫苗大量生产。那么,此事就算非常、特别、十分快了!

新冠肺炎病毒入侵中国武汉后,仅仅10个月便发明了一种疫苗,并可以普遍采用。若是在西方世界通常情况下,那样的新药物或疫苗只能以在五年内最快的速度滑向市场。

似乎是历史记录。 如果不是中国,那将是不可能的。不仅许可很快,而且在那里找到志愿者并不需要一个推动成功的团队。尤其是处于第一阶段试验的志愿者来说,该试验恰恰重于副作用这么危险的影响。在此阶段,并需要时间与研究来确定新药是否安全。

该试验由第二阶段仍在继续,就为找出成功的程度,其志愿者人数可达到60人。这一切都已在中国成功而完成的。然后实践第三阶段临床试验的目标不应仅在一个国家或地区。因此,如果发生在西方世界,成本会非常值钱。

这样通过在许多国家进行的临床试验,新药或疫苗的有效性才会尽人皆知。无论对于各种类型的人,具有不同、各类不一的基因和血型血液的人。我很感谢和高兴,因为印度尼西亚被选为第三阶段临床试验的许多国家其中之一。这表明我们以后可以生产自己国家的疫苗药物。

那么,美国和印度的名声和机缘如何呢?这两国家的省区选举确实挺多。

我们印尼这里可能还会发生抗议,就问怎么把我们成为豚鼠啊。

在印尼寻找志愿者是否有困难?他们会像当地的志愿者一样起诉吗?

此事应该很容易,不需要付费。 我想要免费从事疫苗试验的志愿者,但我的年龄却不符合规范了。

本第三阶段的志愿者必须来自各种各样的人,例如:年龄不大的儿童,青少年,年轻人,中年人和老年人,可是不要那么老的。各人是不一性别,就是说男人、女人或半男半女,嘿嘿!他们的起源也得从城市、村庄以及其他方面有所不同的,就像Rhoma Irama 的歌曲里的歌词,都有称爪哇人、孙达人、巴塔克人、武吉士人等等。

疫苗名称尚未正式采取,只是通用名称叫“ Sinovac疫苗”,既是来源于一家中国北京科兴有限公司研制的一种疫苗。其疫苗临床试验是由印尼国营制药企业 Biofarma来实施,就在印尼爪哇到、万隆市一场十分大的实验所。

Biofarma located in Bandung City, West Java with it’s large R&D laboratory.

Biofarma在这一领域上具有丰富的经验了。尤其,当印尼专家发挥了禽流感疫苗时,难道本禽流感疫苗是在艾尔朗加大学发明的吗?果然,Biopharmaceuticals 是起源发明者。

Biofarma确实有一片特殊的养鸡场,其中的鸡蛋用于研究,甚至还有相当的老鼠和兔子场。位于万隆的帕贾贾兰大学(UNPAD),一定很幸运能靠近Biofarma实验所。UNPAD的专家可以直接参与第三阶段的试验过程,特别是处于收罗志愿者方面。

过去,我们曾一直在等待 Christin Panjaitan 11月的大雨。现在我们在等待11月份来临因为本“科兴疫苗”。

After the anti-Covid-19 vaccine made in China arrived in Bandung last Monday, what will be done?

First of all is looking for volunteers in large numbers. Namely the volunteers who want to be injected with the new vaccines.

It’s the person whom called the third-phase clinical trial volunteer. Especially for phase three trials, the number of volunteers should be huge. Let’s say as many as possible, if it’s possible can up to 3,000 people, and at least 300 people.

The more of the 300 in numbers, are the better, so that we can get the best evaluation results. Based on the evaluation of phase three trials, the world bodies will issue marketing authorization or distribution license, which is an entity that is associated to new drug / vaccine.

Only after the permit and license are issued, the vaccine can be used in general. The term will be not yet called ‘official allowed to be used’ but rather ‘stage four trial’. But in the phase four trial, the target is not to find volunteers anymore. Anyone can be injected with the new vaccine, while the vaccine’s continuing to be monitored by the world’s new drug / vaccine licensing agencies.

That is why the discovery of new medicine is very expensive. The cost could reach up to Rp 200 billion for this phase 4 trial alone. If let’s say in the Western countries, even though there were no local elections. Because it is not easy to find volunteers. They are very afraid of the side effects of the new drug. And there is a similar type of volunteers like there to our Election / Presidential Election volunteers here, whom need to be paid.

Besides having to have nutrition, they also have to sign a lot of documents: for example, they won’t demand anything if there were any problems occurred with the medicine or vaccine. They must first undergo a complete medical examination too. Even after a month of injection, examination after injection can be up to two times, which means 2 months.

Even if this phase 3 trial is successful, it means it would take the soonest in October, that mass usage permit from the world bodies issued. Let’s assume in November, that is the exact month of Jokowi President took his position as a president for a year, then the vaccine could be allowed to mass produce. That should be really, extremely, and extraordinary rapid and fast.

Only in 10 months period after Covid-19 invaded Wuhan, China, a vaccine had been found and it could be used in general. Normally, in the western world, vaccine or even new drug like that, can only the fastest glide to the market in five years.

It seems like all-time record. It will not have been possible if it had not been the China. Not only the licensing is fast, but finding volunteers there doesn’t need a successful team. Especially for volunteers on phase one trial, which focused on the side effects impact, which also how dangerous that was. At this stage, time and research were needed to determine whether a new medicine is safe or not.

It still continues with the second phase of the trial: to find out the level of success, with the number of volunteers up to 60 people. All of that has been successfully done in China. And then the phase three trials, that the targets should not be in only one country. That’s why the cost is super expensive if it occurred in the Western world.

With trials in many countries, the effectiveness of a new drug or vaccine can be widely known. Even to various types of humans, whose genes and blood vary. I am grateful that Indonesia was chosen as one of many other countries for the third phase of the trial. It is a sign that we will be allowed to produce ourselves later.

What about the America and India? There are so many local and state elections. 
There also may be protests from us: how come we are made guinea pigs.

Is finding volunteers in Indonesia not difficult? Will they make a sue as usual as volunteers for local elections? It must be easy and not needed to pay. I want it for free charge, but my age is no longer presentable.

This third phase volunteers must be from various kinds of humans, such as children, teenagers, adolescents, young people, middle-aged people and seniors that not too old. Each with different sex: male, female and the half ones. Their origins must be different too, from cities, villages, and other aspects, like in Rhoma Irama’s songs: there are Javanese, Sundanese, Chinese, Bataks, Bugis and others.

Laboratory clinical tests on Covid-19 vaccine developed by Sinovac Biotech
Laboratory clinical tests on Covid-19 vaccine developed by Sinovac Biotech

The vaccine name is yet not available, just the common name called ‘Sinovac Vaccine’ — a vaccine made by a Chinese company called Sinovac Biotech Ltd., In Indonesia, the trial is conducted by PT. Biofarma, a state-owned company with a large laboratory in Bandung.

Biofarma has a long experience in this field. Especially as Indonesian experts discovered the bird flu vaccine — was it from the experts at Airlangga University? Biopharmaceuticals was the origin inventor.

Biofarma does have a special chicken farm, whom the eggs are used for research, as well as it’s rat and rabbit farm. Padjadjaran University which is located Bandung, is certainly very fortunate to be close to Biofarma. Experts from UNPAD can get involved directly in this phase 3 trial process, specifically in raising volunteers.

In the past, we’d ever waited for the rains of Christin Panjaitan in November. Now we are waiting for November because of the Sinovac vaccine. (Dahlan Iskan)

源自:https://www.disway.id/r/1010/menanti-sinovac

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