JAKARTA - PT Bio Farma Persero did not conduct an efficacy study of the Red and White Vaccine in the third phase of the clinical trial process because it was constrained by the need for volunteers who were difficult to find.
"The problem is, it's hard to find volunteers now. The latest data (antibody serology survey), 92 percent of Indonesians already have antibodies," said Director of PT Bio Farma Persero Honesti Basyir, quoted by Antara, Monday, June 6.
In fact, Honesti said, initially clinical trials of COVID-19 vaccines required provisions for efficacy studies to measure the effectiveness of vaccines against diseases that infect humans.
The efficacy study requires volunteers with a number of criteria, including those who do not have antibodies and have not been vaccinated.
Bio Farma's decision not to conduct a Red and White Vaccine efficacy study is based on the policy of the World Health Organization (WHO) which has changed the clinical trial provisions only on vaccine safety tests and immunogenicity or the ability of the vaccine to trigger an immune response from the human body.
"So, we don't include efficacy again (in clinical trials), because we have to look for people who have never been vaccinated, have never had a disease and have never been exposed to antibodies," he said.
The phase three clinical trial of the Merah Putih Vaccine is only aimed at studies of how large the antibodies appear and the neutralization of the virus, Honesti said.
Until the transition phase from pandemic to endemic, the domestic COVID-19 vaccine is still in the development process. The vaccines include the Red and White Vaccine developed by researchers from Airlangga University (Unair) and PT Biotis, the Red and White Vaccine from the Eijkman Institute for Molecular Biology (LBM) and PT Bio Farma, as well as the Red and White Vaccine PT Bio Farma and Boulevard Medicine.
The vaccine will soon enter the final clinical trial in phase three. It is targeted that by the end of July 2022, all of these vaccines will receive an EUA certificate from BPOM RI.
Honesti added that in addition to completing the Red and White Vaccine with the EUA BPOM RI, Bio Farma also requires the WHO EUA as a condition for importing vaccines.
"After getting EUA from BPOM RI, Bio Farma will also immediately continue EUA from WHO for imports," he said.
Honesti ensures that the entire production process of the Red and White Vaccine uses materials that are halal according to sharia law. "This is a new clinical trial. After the EUA, BPOM will take care of halal certification. What is certain is that none of the raw materials for domestic vaccines contain pork enzymes. So, materially the production process is halal," he said.
The halal certification process for the Red and White Vaccine was carried out through a separate audit stage by the Indonesian Ulema Council (MUI) after the EUA from BPOM RI was published.
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