BPOM Issues EUA for Sinovac COVID-19 Vaccine
Date 11 Januari 2021
The Food and Drugs Monitoring Agency (BPOM) has officially issued the EUA (Emergency Use Authorization) for CoronaVac, a COVID-19 vaccine developed by China’s Sinovac Biotech.
“The results of clinical trials show that CoronaVac is safe with mild to moderate side effects, including local side effects such as pain, induration, redness, and swelling as well as systemic side effects such as myalgia, fatigue, and fever,” Head of the BPOM Penny Lukito stated during a press conference via BPOM RI’s YouTube channel, Monday (11/01).
These side effects, she added, are not dangerous.
Head of the BPOM said that the results of clinical trials for the safety of CoronaVac are obtained from phase three clinical studies in Indonesia, Turkey, and Brazil which were monitored for a period of 3 months after injection of the second dose.
The vaccine, she said, has shown its ability to produce an antibody that has the ability to kill or neutralize the viruses (immunogenicity), as seen from phase 1 and 2 clinical trials in China with a monitoring period of up to 6 months.
“In phase 3 clinical trial in Bandung, immunogenicity data showed good results. Up to 3 months, the number of subjects who has antibodies is still high, namely 99.23 percent,” she stated.
In addition, an analysis of the efficacy of CoronaVac from phase three clinical trials shows that the vaccine has met the WHO’s requirement of a minimum 50 percent efficacy. The results of clinical trial in Bandung demonstrate a 65.3 percent efficacy, while similar trial in Turkey demonstrates a 91.25 percent efficacy, and 78 percent for trial in Brazil.
“The vaccine’s efficacy of 65.3 percent from the results of clinical trial in Bandung shows hope that this vaccine is able to reduce the COVID-19 contraction by 65.3 percent,” Penny said.
To ensure the vaccine’s quality, the BPOM has also conducted an evaluation of vaccine quality data, which includes supervision starting from raw materials, manufacturing processes to finished vaccine products in accordance with internationally accepted vaccine quality assessment standards.
The decision to issue the EUA was based on comprehensive evaluation and discussion on supporting data and scientific evidence that supports the safety, efficacy, and quality aspects of vaccines.
Penny further said that the Agency always prioritizes prudence, integrity, and independence, as well as transparency in making this decision in order to protect public health.
“Let’s support the COVID-19 vaccination program, because the success of COVID-19 handling is our success as a nation,” she stated. (PR of BPOM/UN) (FI/MMB)