JAKARTA – BUMN vaccine producer, PT Bio Farma is still monitoring the process phase 3 clinical trial for the Covid-19 vaccine from Sinovac in Bandung, West Java. Bio Farma is still waiting for the final results of the clinical trial to then prepare the Sinovac vaccine production facility in the country.
Operations Director of PT Bio Farma M Rahman Roestan said that this vaccine clinical trial was in collaboration between the Faculty of Medicine (FK) Padjadjaran University (Unpad) as a clinical trial center and the Health Research and Development Agency (Balitbangkes) of the Ministry of Health (Kemenkes) as an expert medical adviser as well as neutralization test.
“Then Bio Farma also conducts essays and monitors to be ready for production. So in addition to this clinical trial. We are also making preparations for production facilities,” said Rahman during a virtual conference with the clinical Test research team Covid-19 Vaccine and the Food and Drug Administration. (BPOM), Thursday (26/11).
He added, BPOM is also intensely monitoring the readiness of Bio Farma when it is ready for vaccine production. Then, Bio Farma will summarize and report to BPOM to get a review and process for approval of an emergency distribution permit (EUA).
“This schedule is tight but until now it is on the right track,” said Rahman.
More Than One Thousand People Become Research Subjects for Vaccine Test
In this stage, 3 clinical preliminary, 1,620 individuals they exposed to an examination on the Covid-19 Sinovac antibody in Bandung. And the cycle is as yet continuous right up ’til today. Up until now, the clinical preliminaries of the antibody are as yet protected and have not made results in volunteers. Who have gotten the Sinovac immunization.
“For now, we can say that the clinical preliminary of the Sinovac antibody is protected on the grounds. That there is no mischief to the subject,” said Kusnandi Rusmil. Head of the Covid-19 Vaccine Clinical Research Team from Unpad.
He admitted that around 20 percent of the volunteers had a slight cold and dizziness. However, he claimed, this complaint disappeared within two days.
The team from Unpad will continue to follow the clinical trial development until the end of the study. Then they will report the results of the clinical trial to BPOM.
“We expect the support of all parties so that this research can run well,” said Kusnandi.
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