A total of 1.2 million doses of COVID-19 vaccine produced by China’s Sinovac Biotech are currently stored in a warehouse of state-owned pharmaceutical company PT Bio Farma in Bandung, West Java, after being flown in to Soekarno-Hatta International Airport in Tangerang, Banten, on Dec. 6.
Indonesia has firm orders of around 160 million vaccine doses, 140 million of which are manufactured by Sinovac Biotech. The remaining orders were given to Novavax, a United States firm, officials have said.
The government is waiting for the Food and Drug Monitoring Agency (BPOM) to issue emergency use authorization (EUA) for Sinovac's CoronaVax vaccine, which, unlike some other candidate vaccines, has not disclosed interim efficacy data.
The BPOM said it was expecting the interim results in January next year.
BPOM head Penny Kusumastuti Lukito said in a video published on the Forum Merdeka Barat 9 YouTube channel on Thursday that the agency was currently observing Sinovac's CoronaVax vaccine.
She explained that the observation period usually took one, three and six months, hence the EUA could not be released soon.
However, she said Sinovac’s vaccine met the quality standards for producing medicines.
“There are no critical side effects,” she added.
Penny also shared that the COVID-19 vaccine inspection team, which comprises the BPOM, the Health Ministry, the Indonesian Ulema Council (MUI) and representatives of Bio Farma, had flown to China on Oct. 14 to inspect the quality and halal status of the Sinovac and Cansino vaccine candidates.
However, the agency seeks to check the efficacy to see if the vaccine improves antibodies and neutralizes the virus.
The observational period includes a laboratory test of the subjects’ blood samples.
“It’s counted from the second [injection]. The subject will return to the community and we will check how many cases [appear],” Penny said.
Penny explained that the agency would issue the EUA in line with guidelines of the World Health Organization (WHO) and US Food and Drug Administration (FDA).
An efficacy rate of at least 50 percent would be needed for the vaccine’s approval.
It would not be the first time for the BPOM to issuing EUA to contain the spread of COVID-19.
Previously, the agency has issued EUA for two antiviral drugs, favipiravir and remdesivir, to treat COVID-19 patients.
The BPOM also granted permits in September to several pharmaceutical companies to produce the drugs.
PT Beta Pharmacon (Dexa Group) received a permit to produce favipiravir, locally sold under the Avigan brand, meanwhile, state-owned drug manufacturer PT Kimia Farma received the permit to produce a generic favipiravir product. (jes)
Editor’s note: This article is part of a public campaign by the COVID-19 task force to raise people’s awareness about the pandemic.
