All volunteers participating in the phase three COVID-19 vaccine trial at Padjadjaran University (Unpad) have been injected with the potential vaccine twice. The trial, which commenced in August, involves 1,620 volunteers.
Unpad School of Medicine professor Kusnandi Rusmil, who heads the research team for the clinical trial, said the potential vaccine had been administered to the patients, and the researchers were currently monitoring the development.
He explained that his team would take blood samples from the volunteers within two weeks or six months after they received the vaccine. The blood test is conducted to assess how many anti-COVID-19 agents will appear as well as how effective and safe the vaccine is.
“Some of them are receiving a placebo, so we will compare the results to see how many volunteers injected with the placebo will fall ill,” Kusnandi said.
He went on to say that the Sinovac Biotech vaccine efficacy result could not be determined from its research results in Indonesia alone, especially since the phase III clinical trial for the vaccine was also conducted in Brazil, India and Turkey.
“We have to use thousands of data from the experiment subjects to determine the efficacy,” Kusnandi said.
Indonesian Technical Advisory Group on Immunization chairman Sri Rezeki Hadinegoro, explained that the clinical trial during the pandemic was different from tests taking place under normal conditions.
“The pre-clinical trials alone could take up to two or three years before entering the first, second and third phase, which could take 10 years until it can be produced,” Sri said.
However, in the pandemic situation, the clinical trial process could take less time by following existing protocols and standards.
“The objective is to reduce the death rate before entering the herd immunity stage. In order to reduce the death rate, we need vaccines,” Sri said, adding that the clinical trial in Bandung complied with existing standards and procedures.
Sri also stated that Sinovac used inactivated virus technology, which had been implemented by PT Bio Farma. An inactivated virus allows the immune system to recognize the virus without infecting the host body.
“Once the first and second phases have been completed, there is no need for a long experiment. We only need to supervise the third phase of the clinical trial,” she said.
As for the duration for the clinical trial research, which is projected to complete by March next year, Sri explained that it depended on the observations made by the clinical research team.
“We want to assess the number of cases, how many people become ill in response. If the observation period is too short, the result will not be optimal,” she added. (adi/dpk)
Editor’s note: This article is part of a public campaign by the COVID-19 task force to raise people’s awareness about the pandemic.
