Bio Farma Files Emergency Use Authorization for January's Vaccine Production
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1 October 2020 12:14 WIB
TEMPO.CO, Jakarta - State pharmaceutical holding firm Bio Farma is eyeing to file for an emergency use authorization in January of 2021 for the production of COVID-19 vaccine in Indonesia as the firm is currently waiting for the candidate-vaccine’s clinical test results from the Padjadjaran University research team.
It has been reported that the third and final phase of the vaccine development had undergone for one month involving 1,447 volunteers as of Wednesday, September 30. Bio Farma plans to submit authorization for its emergency use to the Indonesian Food and Drug Monitoring Agency (BPOM).
Bio Farma president director Honesti Basyir said in Wednesday’s statement that BPOM is scheduled to audit the vaccine’s production process in the Bio Farma production facility and its initial developer, Sinovac Biotech, in Beijing in November this year.
“Bio Farma will also conduct a direct inspection to Sinovac prior to the BPOM audit,” wrote Honesti Basyir.
Further plans suggest Bio Farma will be able to create a vaccine production line by November or December 2020 with an expected production capacity of over 250 million doses by 2021.
Read also: Bio Farma to Receive Millions of COVID-19 Vaccine Concentrates
AHMAD FIKRI
