BPOM Grants Emergency Use for Sinopharm Vaccines

TEMPO.CO, Jakarta - The Indonesian Food and Drugs Monitoring Agency (BPOM) on Friday, April 30, has officially issued an emergency use authorization (EUA) for Sinopharm vaccines imported from China. 

“The EUA has been granted for vaccine productions from Beijing Bio Institute Biological Product, which is a unit in Sinopharm, a subsidiary of China National BioTech Group,” said BPOM Head Penny Lukito.

The Sinopharm vaccine in Indonesia is registered and distributed by Kimia Farma as Sars-CoV-2 Vaccine Vero Cell Inactivated.

The safety and efficacy of the vaccine have been evaluated thoroughly with the experts at the National Committee on Vaccine Assessment Covid-19 and ITAGI along with other clinicians, said the BPOM head.

She also claimed the efficacy of Sinopharm is deemed positive after its third clinical trial was held in the United Arab Emirates (UAE) and other partnering countries involving around 42,000 volunteers. The trials revealed efficacy levels up to 78 percent. 

Penny Lukito said there were only 0.01 percent of volunteers showing severe side effects such as headache and muscle aches, which she said is still within the category of mild symptoms. 

The use of Sinopharm will accompany other Covid-19 vaccines used in Indonesia such as Sinovac and AstraZeneca. 

Read: Indonesia Gets 6 Mn Sinovac Vaccine, Nearly Half Million Sinopharm Vaccine

EGI ADYATAMA