Health Minister Enlightens Public about Drug, Vaccine Production
Date 4 Agustus 2020
Ministry of Health through Acting Head of Health Research and Development Agency Slamet, provides thorough explanation regarding the mechanism of drug production and progress of clinical trials of COVID-19 vaccine.
In general, the process of drug production covers the following stages:
First, potential substances for the drug must be found through several research;
Second, the potential substance must undergo various tests such as, substance activity tests, in vitro and in vivo toxicity tests for preclinical trial, as well as clinical trials phase I, phase II, and phase III;
Third, process to obtain distribution license;
Fourth, the drug/vaccine will be produced by adopting good manufacturing methods (GMP) and will be controlled during marketing process.
“Many international and national institutions are striving to develop COVID-19 drug or vaccine. Some vaccine candidates have entered the final stage of clinical trials,” Slamet said.
However, he added that no countries and institutions have successfully found the cure and vaccine for COVID-19.
“Currently, Indonesia and some other countries are joining the World Health Organization (WHO) Solidarity Trial to obtain stronger and valid clinical evidence of the effectiveness and safety in treating COVID-19 patients.
He went on to say that prospective COVID-19 vaccine developed by Chinese biotech firm Sinovac will undergo clinical trial phase III at Faculty of Medicine of Padjadjaran University, West Java.
“To comply with international standards and requirements of the Indonesian Food and Drug Monitoring Agency (BPOM) in registering drug/vaccine, protocols used in the research must obtain ethics approval from the research site, namely the Padjadjaran University,” Slamet explained.
The University Ethics Commission has also reviewed the protocols of clinical trial phase III for the vaccine and is obliged to monitor the implementation of research. Ethics approval of the clinical trial was announced by Padjadjaran University on 27 July 2020 meaning that underlying data for the trial is accepted scientifically, risks of clinical trial subject have been minimized, and it is expected to bring great benefits for the public.
In the meantime, the Government reminded the public not to believe in vague information. They must look for information in reliable sources and verify the information before sharing it.
“To all parties, particularly public figures, please enlighten the public about COVID-19, not the other way around by creating new pros and cons,” Slamet concluded. (Ministry of Health PR/EN)
Translated by : Rany Anjany
Reviewed by: Mia Medyana