Coronavirus: Asia

Indonesia grants emergency approval for Sinovac vaccine

A medical worker administering a jab as part of a Covid-19 vaccination drill yesterday in Bali, Indonesia.
A medical worker administering a jab as part of a Covid-19 vaccination drill yesterday in Bali, Indonesia. PHOTO: EPA-EFE

The Indonesian food and drug monitoring agency yesterday issued emergency authorisation for the coronavirus vaccine developed by China's Sinovac Biotech after it was found to be 65.3 per cent effective in a local clinical trial.

This paves the way for the world's fourth most populous country - worst hit by the pandemic in South-east Asia - to roll out its vaccination programme across its 34 provinces from Thursday.

A trial of CoronaVac in Bandung, the capital of West Java province, revealed it had a 65.3 per cent efficacy rate. "This is in line with the World Health Organisation (requirement of) a minimum efficacy of 50 per cent," said the head of drug monitoring agency BPOM, Dr Penny K. Lukito, in a virtual media briefing.

Dr Rizka Andalucia, BPOM's drug registration director, added: "The clinical trial still continues, and if more data comes in, the efficacy rate would be updated."

Indonesia has received three million CoronaVac doses and expects 15 million more this week.

It has also secured a total of 100 million doses from Pfizer-BioNTech and AstraZeneca for delivery later this year.

Other countries planning to use Sinovac's vaccine include Brazil, Ukraine, Thailand and Singapore.

Indonesia's phase three clinical trial - the last stage before a vaccine can be distributed and given to the public - was conducted jointly by the University of Padjadjaran in West Java province and vaccine maker Bio Farma, and involved about 1,600 participants. It started in mid-August last year.

The trial had earlier been criticised as the university did not work with other parties or higher education institutes, including those in Jakarta, which has the highest prevalence of the virus in the country. The number of trial participants was also criticised for being too small, dwarfed by the more than 10,000 volunteers in Brazil's trials and 7,000 in Turkey's.

Brazil had earlier announced that its local trials found CoronaVac to be 78 per cent effective, while Turkey said it was 91.25 per cent effective. These nations recruited most volunteers from high-risk groups like medical workers, taxi drivers and minimart cashiers.

Tomorrow, President Joko Widodo and his Cabinet members will be the first in the country to receive the vaccine. Vaccination for medical workers and public officials in all 34 provinces will start from Thursday.

Three groups will receive the shots in the initial phase: high-ranking officials, committee members of medical workers' associations, and prominent medical doctors and religious leaders, Health minister Budi Gunadi Sadikin said last week.

Dr Penny said the 65.3 per cent efficacy rate meant the vaccine is likely to reduce the rate of infections by about 65 per cent, which is "very meaningful".

She added that further monitoring will be conducted after people receive it, to find out its effectiveness outside trial conditions.

"There will be a separate measure, the effectiveness rate, to reflect the effect of the vaccine in the real population," she told reporters. "Efficacy rate is from a clinical trial. It is an estimate."

Indonesia yesterday reported a total of 836,718 cases of Covid-19, with 24,343 deaths.

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A version of this article appeared in the print edition of The Straits Times on January 12, 2021, with the headline Indonesia grants emergency approval for Sinovac vaccine. Subscribe