Issue Sinovac Vaccine Emergency Use Permit, BPOM: Its Efficacy Is In Accordance With WHO Recommendations

JAKARTA - The Food and Drug Administration (BPOM) revealed that based on the results of phase III clinical trials, the COVID-19 vaccine made by a Chinese pharmaceutical company, Sinovac, has an efficacy or efficacy level of the Sinovac corona vaccine of 65.3 percent.

In line with this, BPOM today officially issued a permit for the emergency use of the COVID-19 vaccine or emergency use authorization (EUA) for the vaccine made by the Chinese pharmaceutical company.

"The results of the analysis of the efficacy of the COVID-19 vaccine tested clinically in Bandung showed 65.3 percent, which is based on reports of the efficacy of vaccines in Turkey of 91.25 percent, and 78 percent in Brazil," said Head of BPOM Penny Lukito in an online press conference , Monday, January 11th.

Penny said the results were in accordance with WHO requirements that the minimum vaccine efficacy was 50 percent. This efficacy, said Penny, shows hope that vaccines can reduce the incidence of COVID-19 by 65.3 percent.

"The reduction in the incidence of COVID-19 infection with the vaccine will be very meaningful in our efforts to get out of the pandemic crisis. In addition to preventive efforts such as 3M enforcement, namely wearing masks, washing hands, maintaining distance," he said.

Furthermore, Penny explained, based on the results of the evaluation of supporting safety data obtained from third phase clinical studies in Indonesia, Brazil, and Turkey as a whole, it shows that the Sinovac vaccine is safe with the incidence of mild to moderate side effects.

These side effects include pain, irritation, and swelling that is not dangerous and can recover the next day. Based on the results of the efficacy evaluation, the Sinovac vaccine is able to form antibodies in the body.

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

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