Hence, after getting the EUA from BPOM, Bio Farma will immediately proceed to get the EUA from WHOJakarta (ANTARA) - State-owned pharmaceutical company 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 due to the lack of volunteers.
"Currently, it is difficult to find volunteers (for the efficacy study). According to the latest (antibody serology survey) data, 92 percent of Indonesian people have had antibodies," the corporation's director, Honesti Basyir, stated here on Monday.
Usually, clinical trial for COVID-19 vaccines requires efficacy studies to measure the effectiveness of the vaccine against the disease, he noted.
The efficacy study requires volunteers with no antibodies to COVID-19 in their bodies and those who have not been vaccinated.
Bio Farma's decision not to conduct the efficacy study is based on the World Health Organization's (WHO’s) policy that has changed the provisions of the clinical trial process to only include vaccine safety and immunogenicity tests.
Phase three of the clinical trials of the Merah Putih Vaccine only aims to assess the amount of antibodies produced and the neutralization process of the virus, the enterprise’s director stated.
Currently, several Red and White COVID-19 vaccines are still in the development process, including the vaccines produced by Airlangga University (Unair) and PT Biotis; the ones developed by Eijkman Institute for Molecular Biology (LBM) and PT Bio Farma; as well as the ones manufactured by PT Bio Farma and Boulevard Medicine.
All the vaccines will soon enter the final clinical trial phase, and they are targeted to receive the emergency-use authorization (EUA) from the National Agency of Drug and Food Control (BPOM) by the end of July 2022.
Basyir noted that in addition to obtaining the EUA from the BPOM, the vaccines also need an EUA from the WHO as a requirement to be able to export the vaccines.
“Hence, after getting the EUA from BPOM, Bio Farma will immediately proceed to get the EUA from WHO," he remarked.
Basyir has ensured the use of halal materials during the entire production process of the Red and White Vaccine in accordance with the sharia law.
"After (obtaining) the EUA from BPOM, (we) will proceed to get the halal certification," the corporation’s director stated.
Assessment for the halal certification process will be conducted by the Indonesian Ulema Council (MUI), he noted.
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Translator: Andi Firdaus, Uyu Liman
Editor: Sri Haryati
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