TEMPO.CO, Jakarta - Spokesperson of the COVID-19 Vaccine Clinical Trial Research Team, Rodman Tarigan, said the phase-3 trial of the vaccine developed by Chinese pharmaceutical firm Sinovac is running safely.

“There have been no reports of Post-Immunization Accidents (KIPI) or Serious Adverse Event (SAE) or any unwanted events allegedly related to vaccines or vaccinations from volunteers thus far,” said Rodman as quoted from Bio Farma’s release on Wednesday, November 11, 2020.

A member of Bio Farma’s pharmacovigilance team, Novilia, said people could also experience SAE after getting an injection of vaccines that have been marketed. Such an incident occurring during the clinical trial phase would be directly reported to the Ethics Committee, the Food and Drug Monitoring Agency (BPOM), and the Data Safety Monitoring Board (DSMB).

“Meanwhile, if it occurs due to vaccine products that have been marketed, the investigation and analysis will be carried out by independent institutions such as KOMNAS KIPI (KIPI National Committee), and reported to the BPOM, to determine the main cause whether it is associated to the vaccine, or other factors (coincidental event),” she explained.

Novilia mentioned that the serious adverse event that recently happened in Brazil, which was the death of a trial volunteer, required further investigation and suspension of the clinical trial.

Sinovac claimed via its website that it was communicating with Brazil about the reported incident, believing the SAE was not related to the COVID-19 vaccine.

Read: Bio Farma Denies Rumors Sinovac COVID-19 Vaccine Is Cheaper in Brazil

AHMAD FIKRI (CONTRIBUTOR)