Biofarma Explains Reasons For Clinical Trials Of New Sinovac Vaccine To Be Held In Early August

JAKARTA - Bio Farma Corporate Secretary Bambang Heriyanto explained the reason why the third stage clinical trial of the COVID-19 vaccine in collaboration with a Chinese company, Sinovac, which involved thousands of volunteers could not be carried out immediately.

According to him, even though it had arrived since last Sunday, July 14, the 2,400 doses of the vaccine imported from China had to be quarantined first.

"It cannot be used directly because it must be quarantined first. Then there are several tests or tests to confirm that this vaccine is still good after traveling," said Bambang in a discussion that was broadcast online on YouTube, Sunday, July 26.

The quarantine process, said Bambang, would be carried out at least two weeks after the vaccine arrived in Indonesia. So, it is estimated that the clinical trial process that will involve 1,620 volunteers prepared by the Faculty of Medicine, Padjajaran University will only be held in early August.

"This vaccine is with us and later after the clinical trial team from Unpad Faculty of Medicine is ready to carry out the test, we will give the vaccine to the FK Unpad clinical trial team," he said.

Bambang explained that the vaccine that came from China was already in the form of a unit dose that was ready to be injected into the volunteers participating in the clinical trial. "The dose is a single dose, we just need to use the packaging so we call it PFS, Pre Fill Syringe," he explained.

"So the vaccine is already in the syringe package so it only remains to be injected into volunteers," he added.

Furthermore, the epidemiologist from the University of Indonesia (UI) Pandu Riono explained the work system in the third phase of the clinical trial.

He said, at this stage, the effectiveness of vaccines would be seen again in providing protection from the threat of viruses, especially COVID-19. The hope is that at this stage the vaccine can effectively fight the virus by up to 70 percent.

"The hope is that he will give effectiveness of more than 70 percent. If it is still below 50 percent, it means that it is not yet effective," he said.

This expert also explained that the clinical trial must be followed by large numbers of volunteers so that its effectiveness can be seen. "Because if the sample is small the side effects are not detected but in the large sample the side effects are more detectable," he said.

"Then the positive or negative reactions may vary from different types of ethnicity and ethnicity. Because we have different races and genetics," added Pandu.

Previously, the government officially announced a collaboration between 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.