The authorisation came after interim data from a late-stage human trial in Indonesia showed the vaccine was 65.3% effective, Penny K. Lukito, who heads the country’s food and drugs regulator BPOM, said
Indonesia's food and drug agency on Monday granted emergency use approval to a Covid-19 vaccine developed by China's Sinovac Biotech, making it the first country outside China to give the regulatory greenlight to the vaccine.
The authorisation came after interim data from a late-stage human trial in Indonesia showed the vaccine was 65.3% effective, Penny K. Lukito, who heads the country's food and drugs regulator BPOM, said.
"These results meet the requirements of the World Health Organisation of a minimum of efficacy of 50%," she said, noting trial results in Brazil and Turkey.
A Brazil-based trial showed last week that Sinovac's vaccine candidate is 78% effective while Turkish researchers said in December the vaccine showed 91.25% efficacy based on interim analysis.
Indonesia is struggling with the worst Covid-19 outbreak in Southeast Asia and authorities are relying on a vaccine to help alleviate dual health and economic crises ravaging the country.
It has reported 836,718 Covid-19 infections and 24,343 deaths.
Indonesia has received 3 million doses of Sinovac's vaccine, named CoronaVac, and is slated to receive some 122.5 million more that will come in bulks.