JAKARTA - Indonesian food and drug monitoring agency (BPOM) on Monday (Jan 11) issued emergency use authorisation for the vaccine developed by China's Sinovac Biotech, after a local clinical trial found it is 65.3 per cent effective against the coronavirus.
This paves the way for the world's fourth-most populous country, which is the worst hit by the pandemic in South-east Asia, to roll out its vaccination programme across its 34 provinces starting on Thursday (Jan 14).
The clinical trial of Sinovac's vaccine CoronaVac in Bandung, capital of West Java province, reveal that the CoronaVac had a 65.3 per cent efficacy rate.
“This is in line with the World Health Organisation that requires a minimum efficacy of 50 per cent,” BPOM's head, Dr Penny K. Lukito, said in a virtual media briefing on Monday.
Dr Rizka Andalucia, BPOM’s drug registration director, said the 65.3 per cent efficacy rate is based on the 25 participants of the total 1,600 volunteers in the trial that contracted the virus.
“That is from the interim analysis. The clinical trial still continues and if more data comes in, the efficacy rate would be updated.”
Indonesia has received 3 million doses of CoronaVac and will receive 15 million more this week. It has also secured 50 million doses of vaccines each from Pfizer-BioNTech and AstraZeneca for delivery later this year.
Other countries that plan to use Sinovac's vaccine include Brazil, Ukraine, Thailand and Singapore.
Indonesia's Phase 3 clinical trial - the last stage before a vaccine candidate can be distributed and administered for the public - was jointly conducted by the University of Padjadjaran in Bandung, West Java province, and vaccine maker Bio Farma, and involved about 1,600 participants. It started in mid-August.
The trial had earlier been criticised as the University of Padjadjaran did not work with other parties or universities, especially those in Jakarta, where the coronavirus prevalence is the highest in the country.
The number of participants in the trial was also criticised as too small, dwarfed by the over 10,000 volunteers in Brazil's trials and the more than 7,000 in Turkey.
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 two countries recruited most of the trial volunteers from high-risk groups, such as medical workers, taxi drivers and minimart cashiers.
President Joko Widodo and his Cabinet members will be vaccinated on Wednesday, the first in the country. 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, prominent medical doctors and religious leaders, the health minister said on Jan 5.
Dr Penny explained that the 65.3 per cent rate means that the vaccine would likely reduce the incidence rate of people catching the virus by about 65 per cent, which is very meaningful.
She added that the remaining 35 per cent would have to rely on other prevention measures, including strict health protocols.
She also said that further monitoring would be conducted after the people received the vaccine, to get what is called a vaccine's effectiveness rate.
“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 number,” Dr Penny explained.
Indonesia on Monday (Jan 11) reported a total of 836,718 cases of Covid-19, with 24,343 deaths.