The government is presently planning to conduct a phase 3 clinical trial on a Covid-19 vaccine claimant imported from China. Several countries in Africa, Latin America, India and others are currently conducting similar vaccine tests developed by Sinovac Biotech. Therefore, let's see, is the Covid-19 vaccine potent for Indonesian in dealing with Covid-19?
Prof. dr. Tri Wibawa, Ph.D., Sp.MK (K)., as a Microbiologist from UGM Faculty of Medicine, Public Health, and Nursing (FKKMK) stated that it is still unknown, whether the vaccine from China is effective for Indonesians or not. In this third phase of a clinical trial conducted in this country is a step to determine the effectiveness of vaccines in preventing SARS-Cov-2 coronavirus infection to Indonesian.
"Through the third phase, we will see whether the vaccine is safe and whether it can build antibodies to protect our society or not," he explained on Thursday (7/23).
The UGM Professor explained that there were four stages in vaccine clinical trials. In the first phase of clinical trials, the vaccine tested in a population of 5-50 people who were not at risk of Covid-19 infection. The tests conducted to determine the safety aspects and the ability to cause immunity. Then, phase 2 clinical trials conducted with the same objectives as in the previous phase. However, this phase attempted in a larger population of between 25-1,000 people and populations that had local transmission.
Next, the phase 3 clinical trial tested on a population of 100-10,000 people who are at risk of becoming infected to see the effectiveness of vaccines in preventing new types of coronavirus infections—tests conducted on populations that will be specially protected.
"So, China has conducted the first and second phase of clinical trials. Then, phase 3 is carried out on a specific population that will be protected, such as Indonesia, we will see its safety and its level of protection. If the result turns out are not effective, then BPOM will not issue a distribution permit to the community," he explained.
If the vaccine passes in phase 3, then it is continued with phase 4 clinical trials. In this phase, there will be monitoring to see the long-term effects of the vaccine (post-marketing surveillance). If there are side effects when it is used in the community, the vaccine will be withdrawn.
Tri Wibawa said there were differences in the genome sequence of the SARS-Cov-2 coronavirus in China and Indonesia. Even so, he hopes the virus still stimulates the same immune response. He cited the Bacillus Calmette-Gurin (BCG) vaccine developed for tuberculosis (TB) infection.
"For example, in BCG, it is other species instead of tuberculosis, but because it has the same nature in causing an immune response in humans, it can stimulate the same immune response process. Now, we need to prove this case either. Therefore, we will prove it through 3 phases," he explained.
As long as we have not obtained the vaccine and drugs for Covid-19, Tri Wibawa urges people always to be disciplined in complying with health protocols. We can begin from running physical and social distancing, wearing masks, and implementing a healthy lifestyle.
"So, during the condition when we have not found the effective vaccines and drugs, the only way to protect ourself is to remain in compliance with health protocols," he said.
Author: Ika
Photo: AFP-Nicholas Asfouri / kompas.com
Translator: Natasa A