So far, we are still analyzing the result from phase 1 of the clinical trial. We are also reporting this process to the Food and Drug Supervisory Agency (BPOM). So far, it is going wellJakarta (ANTARA) - Data from Merah Putih Vaccine's phase-1 clinical trial for COVID-19 whose vaccine seeds are developed by Unair, is currently in the analysis stage, Airlangga University's (Unair's) COVID-19 Vaccine Development Head, Professor Fedik Abdul Rantam stated.
"So far, we are still analyzing the result from phase 1 of the clinical trial. We are also reporting this process to the Food and Drug Supervisory Agency (BPOM). So far, it is going well," Rantam noted during the National Health Resilience Webinar: Merah Putih Vaccine Development here, Wednesday.
Unair is collaborating with PT Biotis Pharmaceutical Indonesia to develop a COVID-19 vaccine with an inactivated virus platform and is currently undergoing phase 1 of clinical trials, with 90 volunteers receiving the vaccine injection.
If the results of phase 1 of the clinical trial yield good results, then it can be continued to phase 2, with 405 test participants, and followed by phase 3, with five thousand test participants.
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Rantam affirmed that the implementation of clinical trials for vaccine candidates required large funds and adequate resources. Several parties involved in this vaccine development comprise PT Biotis, the Ministry of Health, Dr. Soetomo Hospital, and the BPOM.
If all clinical trials run smoothly according to the schedule on August 2022, the vaccine will be able to obtain an emergency use authorization from BPOM.
Meanwhile, Rantam targets mass production to start after obtaining an emergency use permit. He is optimistic of the vaccine being directly used in the community.
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"We hope everything would be okay. Guidance from BPOM cannot be separated in this process because it helps us to locate our errors in this vaccine development," he stated.
Unair has also readied a management system for the cell bank and seed virus bank for the production of vaccines for the next three years. This management system is expected to secure the supply of cells and virus seeds.
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Translator: Martha Herlinawati S, Resinta
Editor: Fardah Assegaf
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