JAKARTA, Indonesia
As Indonesia enters the seventh month since reporting its first COVID-19 case, the country is pinning its hopes on the development of a COVID-19 vaccine.
Among the ongoing developments are Phase 3 clinical trials of the Sinovac candidate vaccine at Padjadjaran University’s Medical Faculty in Bandung, West Java involving 1,620 volunteers.
The candidate vaccine is the result of a collaboration between PT Bio Farma, a leading biopharmaceutical company in Indonesia, and Chinese provider of biopharmaceutical products Sinovac Biotech Ltd.
The two companies have also agreed to supply at least 40 million doses of the vaccine for Indonesia.
According to the World Health Organization, the Sinovac candidate vaccine is one of 26 candidate vaccines that were in clinical evaluation as of Oct. 2. Sinovac Biotech is also conducting trials in Turkey and Brazil.
In an exclusive interview with Anadolu Agency, Kusnandi Rusmil, head of the COVID-19 Vaccine Clinical Trial Research Team at the Medical Faculty of Padjadjaran University, said the efficacy or ability to form antibodies of the Sinovac vaccine candidate is likely to be concluded in March 2021.
However, there is a possibility that the effectiveness of this candidate vaccine in forming antibodies is lower than during clinical trials in China, considering that there is a chance that the SARS-CoV-2 virus circulating in Indonesia has mutated.
The Indonesian government aims to mass-produce the vaccine starting in December this year or early 2021.
Anadolu Agency: How is the progress of the Phase III clinical trials of the Sinovac candidate vaccine?
Kusnandi Rusmil: The progress is good. Everything is going well. So far, more than 1,400 volunteers have registered. The recruitment process has been completed. The process took approximately six months. By the end of January, we will release a report about its immunogenicity, safety and efficacy.
Q: When will the clinical trials be completed?
Rusmil: In March [2021]. We can expect to know the immunogenicity, safety and efficacy of the first 540 volunteers early next year.
Q: How many volunteers have received the vaccine so far?
Rusmil: Currently there are 1,447 volunteers registered. 1,089 volunteers had received the first shot, while 646 volunteers had received the second shot. 250 volunteers had blood drawn after the second shot.
Q: To whom will you report the results of the clinical trials?
Rusmil: I will report it to Bio Farma. Later, the company will forward it to the Food and Drug Agency (BPOM), who are responsible for analyzing the results. Our research centers have been examined by BPOM, Bio Farma and Sinovac. The results are good. According to them, each center is running smoothly. They did not find any technical issues.
Q: Some time ago, one of the volunteers tested positive for COVID-19 after traveling. How does the issue affect clinical trials?
Rusmil: As the person has contracted the coronavirus, his participation was canceled. He did not get the second injection. However, we will continue to monitor him until the end of the program.
Q: A student in his 20s reportedly could not continue to participate because he developed a rash and itching after the shot. Did other volunteers experience the same thing?
Rusmil: I do not have any reports yet. I will check it later.
Q: What side effects have you seen in the volunteers so far?
Rusmil: So far, there is nothing serious. Some volunteers develop swelling, redness and fever. No shock was reported.
Q: The government is expecting to mass produce the vaccine starting December 2020 or January 2021. Can these targets be met?
Rusmil: It is not our capacity to determine that. Bio Farma will report the results to BPOM and they will evaluate whether the results will be used or not. I will evaluate the research results at the end of the year and release the report early next year. In March, all volunteers will finish the whole process. In conclusion, we only run clinical trials, while the government and BPOM are the ones who make the decision.
Q: So the clinical trials will continue as scheduled even though the government wants them to be completed sooner?
Rusmil: We will continue to run the clinical trials according to the procedures and initial timeline.
Q: The vaccination process is not easy. It does not guarantee that we will be free from the pandemic and is not necessarily effective. What do you think?
Rusmil: Whether this vaccine will be effective or not, there has been no result. But I believe vaccines that use this inactivation method usually have good results as our bodies will form anti-substances. But we will wait for the results until January. Based on my experience, it usually turns out well.
The disease already exists. Many have died. We, as health workers, are trying to find ways to deal with this pandemic, reducing the mortality rate so people won’t lose their father, mother and family.
The fastest vaccine to be developed is for Ebola. It took four years. Vaccines usually take up to 12 years to be developed. Because this pandemic has a great impact, the whole world wants to develop a vaccine in one year. You can imagine how troublesome it is, being chased by everyone asking to finish it quickly. But even though we are asked to be quick, we cannot compromise with clinical trial procedures so as not to harm humans.
Q: Is the vaccine candidate being developed compatible with the SARS-CoV-2 mutation spreading in Indonesia?
Rusmil: We've only known about this virus for six months, not even a year since it was discovered in Wuhan in December 2019. It's always mutating, but it hasn't changed much in shape. It's like, if we think of it as a sedan, one is a Mini Cooper and the other is a VW beetle. Although they’re different, both can fit in the same garage.
Likewise, vaccines for viruses that have minor mutations. It would be different if the virus has been around for decades. For example, there are so many types of influenza mutations that we need different vaccines each year. It is also possible that later this virus has a lot of mutations and will be different. There is not much difference between the virus [spreading] in Wuhan and the one spreading in Indonesia since it hasn't been around for one year. It is as if the virus is still a sedan; it has not been turned into a truck. If it has changed into a truck, we can no longer fit it inside the existing garage.
This virus mutates little by little. Based on my experience, I can say that the vaccine candidate can still be compatible with the virus circulating in Indonesia. That's why we researched this. In Wuhan, the effectiveness of a vaccine [in clinical trials phase 1 and 2] is around 94%-97%. From clinical trials in Bandung, it might decrease [in effectiveness] to around 85%-90%. It will be lower compared to the one in Wuhan because there were mutations. However, this vaccine will still be compatible as the mutations have not changed that much.
My research aims to compare the effectiveness of the vaccine back in Wuhan with the current one so that we can predict how long it will take us to develop a new vaccine again.
Q: Does this mean that vaccine development has to continue after the third stage of clinical trials?
Rusmil: We will see. If the effectiveness turns out to be below 80%, then we have to re-evaluate sooner. Maybe after five years, the vaccine will no longer be effective. The fewer mutations, the longer the immune term.
If the effectiveness reaches 90%, I am optimistic that this vaccine will last for a long time. But if it is much lower than the one developed in Wuhan, it means that the mutation is going fast, so we have to be careful, prepare ourselves, and the vaccine must always be upgraded.
Q: What percentage of effectiveness is needed for this Sinovac vaccine to pass?
Rusmil: My target is above 80%. Even though in some countries there are ones with only 50% [effectiveness], I want the vaccine in Indonesia to be 80% [effective] in order to lower the infection number.
*Writing by Maria Elisa Hospita and Rhany Chairunissa Rufinaldo from Anadolu Agency's Indonesian-language service in Jakarta
