COVID-19 – Indonesia’s vaccine enters final stage of clinical trial
This stage is the final step of the vaccine development which is expected to obtain an Emergency Use Authorization (EUA) in the country.
Bogor, W Java (Indonesia Window) – Indonesia’s domestic COVID-19 vaccine named Merah Putih developed by researchers from Airlangga University in Surabaya city, East Java province, and a national pharmaceuticals company, Biotis, is entering the third phase of clinical trial.
This stage is the final step of the vaccine development which is expected to obtain an Emergency Use Authorization (EUA) in the country.
The entire process from the third phase of the clinical trial is expected to last for six months, said the main researcher of the Merah Putih vaccine at Airlangga University, Dominic Husada, at a launch of the phase 3 clinical trial, according to Antara news agency.
“However, we can launch the results based on the data obtained 28 days after the second injection. So, if it starts tomorrow, then in two months the data can be released,” he added.
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Dominic said that Airlangga University had prepared 4,005 subjects consisting of one group of volunteers receiving the control vaccine, and two groups of recipients of the Merah Putih vaccine to assess the progress of the vaccine batch.
These subjects are needed to evaluate the equivalence of immunogenicity or the ability of the Merah Putih vaccine to trigger an immune response from the human body.
Dominic said the research team did not conduct any efficacy study of the vaccine in the third stage clinical trial process because the number of COVID-19 cases in Indonesia was recorded to be low.
This is in accordance with the World Health Organization (WHO) circular issued on March 30, 2022. “We are allowed to evaluate the equivalence of immunogenicity with the vaccine group that is used as a comparison and not rely on efficacy calculations, because the number of cases is getting lower,” he said.
However, Dominic continued, WHO still requires that the vaccine being tested must be accepted by at least 3,000 volunteers to assess the vaccine’s safety factor. So, based on statistics, there are about 1,000 control (comparison) vaccines, 1,000 treatment vaccines (Merah Putih vaccine recipients) and 2,000 (volunteers) who will receive treatment vaccines.
The first phase of the clinical trial required comparison volunteers to come to the research laboratory up to ten times, while the third phase of the trial only required them to come five times to check the safety of the vaccine, Dominic said.
Airlangga University has facilitated research laboratories in a number of hospitals, namely Dr Soetomo Hospital in Surabaya, Unair Hospital in Surabaya, Saiful Anwar Hospital in Malang (East Java), Jember Pulmonary Hospital (East Java), and Subandi Hospital in Jember (East Java).
On the same occasion, the head of Airlangga University’s Merah Putih vaccine research team, Prof. Fedik Abdul Rantam, said that the Merah Putih vaccine developed by the university since May 12, 2020, has an inactive virus platform.
In the vaccine development, Airlangga University cooperates with PT Biotis that provides clinical test facilities.
Reporting by Indonesia Window
