COVID-19 Vaccine, Ministry Of Health: Phase Three Research Protocols Are Under Review
JAKARTA - Acting (Plt) Head of the Health Research and Development Agency of the Ministry of Health, Slamet said that the third phase of the clinical trial for the COVID-19 vaccine, which is the result of collaboration between PT Bio Farma and a pharmaceutical company from China, Sinovac, is currently in the stages of drafting a protocol.
"We are currently reviewing the research protocol for the third phase of the vaccine," Slamet said as quoted from his written statement, Tuesday, August 4.
He said, in accordance with international standards and the regulations of the Food and Drug Supervisory Agency (BPOM) to register drugs and vaccines, this research protocol must obtain ethical approval from the research location to be addressed, in this case, the Faculty of Medicine, Padjadjaran University (FK UNPAD).
Furthermore, if the data that underlies the implementation of this third phase of clinical trials are scientifically accepted, the risks to the subject can be minimized, and the benefits are expected to be obtained, Unpad will issue an Ethical Approval and must monitor the implementation of the research.
"If the statistically generated data (efficacy) shows significant success, then it can be registered with BPOM," he said.
It is known, clinical trials are systematic studies of various medical interventions carried out in humans to see the effectiveness and possible side effects of vaccines.
In clinical trials, the absorption, distribution, metabolism and excretion of pharmaceutical substances that are introduced into the human body are also studied in order to obtain information about the efficacy and safety of these pharmaceutical products.
In phase I clinical trials, the safety and immunogenicity of vaccines was carried out on several low-risk people, generally healthy young adults, to test for vaccine tolerability.
Phase II clinical trials are intended to monitor vaccine safety, potential for adverse effects, immune response, determine the optimal dose and schedule for vaccination.
Phase III clinical trials are aimed at looking at the efficacy of vaccines, in preventing targeted diseases and further observation of vaccine safety by involving a more diverse population and for a longer period of time.
Previously, the government officially announced a collaboration between PT Bio Farma and the Chinese pharmaceutical company Sinovac Tech to conduct a third phase clinical trial in Indonesia. The Sinovac clinical trial was not only carried out in Indonesia but also in several other countries such as Brazil and Bangladesh.