Declared Safe, BPOM Officially Issues A Permit For Emergency Use Of Sinovac Vaccines

JAKARTA - The Food and Drug Administration (BPOM) officially issued an emergency use authorization (EUA) for the COVID-19 vaccine made by a Chinese pharmaceutical company, Sinovac.

Head of BPOM Penny Lukito explained, with the issuance of an emergency permit for use, the Sinovac vaccine had received permission to be used in the vaccination program.

"Today, the POM has given approval for use in emergency conditions, emergency use authorization for the first COVID-19 vaccine for the Corona vax vaccine produced by Sinovac Biotech Incorporated in collaboration with PT Bio Farma," he said in an online press conference, Monday. , January 11.

Penny said this emergency use permit was granted after BPOM reviewed the results of the Phase III clinical trial conducted in Bandung. In addition, BPOM also reviewed the results of the Sinovac vaccine clinical trials conducted in Turkey and Brazil.

The results of the third phase of clinical trials in Indonesia showed that the efficacy rate of the Sinovac vaccine reached 65.3 percent. The results of clinical trials in Turkey showed the efficacy rate of CoronaVac reached 91 percent and 78 percent in Brazil.

According to Penny, the results of this clinical trial in Indonesia are in accordance with the requirements of the World Health Organization, WHO. "These results are in accordance with WHO requirements, the minimum efficacy is 50 percent," he said.

Based on an analysis of the results of clinical trials, BPOM has confirmed that the COVID-19 vaccine from Sinovac products is safe.

"Overall, it shows that the corona vax vaccine is safe with the incidence of side effects being mild to moderate," he said.

Penny also said that the immunogenicity data of the Sinovac vaccine showed good results. According to him, the injection of the vaccine at 14 days produced 99.74 percent antibodies and at three months after injection showed 99.23 percent ceropisitive results.

"This shows that the number of subjects who have antibodies for three months is still high, namely 99.23 percent," he said.