Indonesia issues emergency use authorization for Sinovac’s CoronaVac vaccine

Penny K. Lukito, head of Indonesia’s Food and Drugs Monitoring Agency (BPOM), announces emergency use authorization for CoronaVac on. Jan. 11, 2021. Photo: Video screengrab
Penny K. Lukito, head of Indonesia’s Food and Drugs Monitoring Agency (BPOM), announces emergency use authorization for CoronaVac on. Jan. 11, 2021. Photo: Video screengrab

Indonesia can now go ahead with its COVID-19 mass vaccination program after the Food and Drugs Monitoring Agency (BPOM) approved the only vaccine against the disease that’s currently available in the country.

In a press conference today, BPOM said it has issued an emergency use authorization (EUA) for CoronaVac, a COVID-19 vaccine developed and produced by Chinese pharmaceutical firm Sinovac. 

“On the whole, CoronaVac has been shown to be safe, with side effects ranging from light to moderate. These light side effects include aches, irritation, and bruising, as well as systemic side effects such as muscle aches, fatigue, and fever. Heavier side effects such as headaches, skin problems, and diarrhea were only reported in 0.1 percent to 1 percent of cases. These side effects are not harmful and subjects can fully recover from them,” BPOM Head Penny K. Lukito said during a press conference today.

Penny added that CoronaVac has fulfilled WHO’s COVID-19 vaccine safety requirements.

BPOM’s EUA came after the Indonesian Ulema Council (MUI), the highest clerical body in the nation, gave the vaccine its halal stamp, meaning that it’s permissible for use by Muslims, on Friday. 

Indonesia has secured 125 million doses of CoronaVac, with 3 million doses having arrived in the country in recent weeks. Final efficacy data from Indonesia’s trial of the vaccine, which is being carried out on 1,600 participants in Bandung, West Java, is not yet available. However, Penny said CoronaVac has an efficacy rate of 63.5 percent based on available data from the local trial.

BPOM admitted to have issued the EUA at least partly based on clinical trial results from elsewhere, namely Brazil and Turkey, which scored efficacy rates of 78 percent and 91.25 percent, respectively. BPOM says it will continue to monitor Indonesia’s trial of the vaccine, which is expected to conclude in February at the earliest.

President Joko Widodo is set to get Indonesia’s mass vaccination program rolling by being the first person in the country to get the jab on Wednesday, Jan. 13. 

Even before BPOM’s EUA, initial batches of CoronaVac have been distributed throughout Indonesia’s 34 provinces, with the hope that prominent figures in the healthcare industry, public officials, and religious leaders will lead by example with Jokowi and be among the first to get inoculated.

That said, Vice President Ma’ruf Amin, who is 77 years old, will not be among the first to be vaccinated as Indonesia does not yet have data on CoronaVac’s efficacy on the elderly, with its clinical trial only involving participants aged between 18 and 59.  

As such, unlike the US and the UK, who were among the first in the world to begin vaccinations against COVID-19, Indonesia will prioritize vaccinating working age adults over the elderly.

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