BPOM: The Sinovac Vaccine Is Safe But Not Certainly Effective

Sinovac vaccine arrived in Indonesia last December 6, 2020 (Photo: BPMI Setpres / Muchlis Jr.)

JAKARTA - Head of the Food and Drug Administration (BPOM) Penny Lukito said the Sinovac vaccine imported from China is safe to use. However, the effectiveness aspect of this vaccine is not yet known because it is still in the testing phase until now.

"From the safety aspect, the COVID-19 vaccine is good. Now the effectiveness aspect is still waiting for us," Penny said as quoted from his written statement to reporters, Thursday, December 17.

To determine the effectiveness of this vaccine, analysis will be carried out by taking blood samples and testing in the laboratory on people who have been vasxinated.

"From there then we will see how much the vaccine gives effectiveness to increasing our antibodies. There are standards that must reach a certain number so that it is said that the vaccine is effective in terms of increasing antibodies and then its ability to neutralize viruses that enter our bodies," he explained.

Regarding the safety and effectiveness of the COVID-19 vaccine, his party will follow the standards and regulations previously implemented by the World Health Organization (WHO) and the FDA (Food and Drug Administration).

The safety of this vaccine has also been audited before the vaccine is shipped to Indonesia. At that time, his party had also conducted inspections to China with several teams such as the team from the Indonesian Ulema Council (MUI) for halal audits; PT Bio Farma; and the Ministry of Health.

Furthermore, the safety of the vaccine is also seen because there are no critical side effects in the clinical trial process which is still being carried out. However, BPOM will continue to evaluate the results of clinical trials before issuing an emergency use authorization (EUA) or an emergency permit for vaccine use. The evaluation process is carried out after the vaccine volunteers return to the community to carry out their normal activities.

"After the subject returns to society, the evaluation process is usually calculated within three months, six months by paying attention to the cases that occur. As for the EUA, we can see it within three months. But it could be, if the pandemic is not too intensive like in China, that is usually it will be longer than the evaluation period, "he explained.

In the future, to ensure that people are willing to receive the COVID-19 vaccine, Penny said the government is always committed to providing safe and quality vaccines.

"I believe in the government's commitment to only providing safe, efficacious, and quality vaccines. Thus, we only need to wait so we can get sufficient data and the POM will only provide EUA if the data is related to safety, quality, and these properties are quite complete and we certainly analyze them with experts, "he said.