Drug and Vaccine Distribution Permits Must Go Through Clinical Trials

Jakarta, InfoPublik - Based on data from the World Health Organization (WHO) as of 19 October, 44 candidates for COVID-19 vaccine have entered clinical trials. A total of 154 vaccine candidates are in the pre-clinical trial stage.

Vaccines from Sinovac, Sinopharm, Astra Zeneca, and Moderna have entered their third clinical trial. However, until now there is no vaccine that has received a distribution permit and all candidates are still in the process of developing the clinical trial stage.

Togi Hutadjulu, Deputy for Drug and Narcotics, Psychotropic, Precursors and Addictive Substances Control at the Indonesian Food and Drug Administration (BPOM) Wednesday, 28 October said that her administration has standards in granting permission for drugs and vaccines.

"It must go through a clinical trial process to prove its efficacy and safety. It also has to meet the requirement of product quality through results and evaluation of quality requirements and assurance of the vaccine production process by Good Manufacturing Practice (GMP),” said Togi.

After the whole process has been passed and is deemed to have met the efficacy, safety and quality aspects requirements, the POM will grant a use permit in the form of Emergency Use Authorization (EUA) or marketing authorization.

The COVID-19 pandemic has made it possible to grant EUA to drugs and vaccines in the handling of COVID-19. EUA is given because all drugs and vaccines that will be used in COVID-19 handling are still in the development stage.

Supervision is also carried out through evaluation of reports on the realization of importation, production and distribution of drugs as well as side effects reporting which will be submitted to the POM by doctors and health workers.

"The POM is very careful in ensuring the safety, efficacy, and quality aspects of vaccines amid the accelerated availability of drugs and certainty in getting access to vaccines," Togi said.

Reporter/Writer: Putri