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。
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.
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)