5 Covid-19 Vaccines Awaiting Indonesia's EUA Approval
8 April 2021 23:32 WIB
TEMPO.CO, Jakarta - Head of the Food and Drugs Monitoring Agency (BPOM) Penny Lukito said in a House of Representatives (DPR) hearing on Thursday that a number of Covid-19 vaccines is waiting for the emergency use of authorization (EUA).
“Apart from the seven brand of vaccines issued under the Health Ministry Regulation (Permenkes), there are a number of vaccines that are not listed in the Permenkes related to the brands that its purchase is approved by the government,” said Penny Lukito in the House Hearing on April 8.
Firstly is the AstraZeneca vaccine registered through a bilateral route from Germany and Siam Bioscience Thailand. From the Europe side, the vaccine has entered the final trial phase while the one from Thailand is being prepared to be registered and will undergo GMP inspection on April 19-22, 2021.
The second vaccine is produced by Sinopharm registered by Kimia Farma which awaits evaluation from additional data on its efficacy, safety, and quality. This vaccine is expected to get the EUA in May 2021.
The third vaccine in the process of being used under the Indonesian EUA is Russia’s Sputnik V that is registered by PT Prapata Nirmala that also partners with Indofarma. The BPOM expects the permit could be issued in April.
Other vaccines that are in the process of being issued under Indonesia’s emergency use authorization are Covaxin from India’s Bharat Biotech (May); Novavax from the Serum Institute of India (June).
BPOM Head Lukito in the hearing said the agency is pinning its hope for the five vaccines to fulfill Indonesia’s future need for Covid-19 vaccines.
Read: More than 13mn Doses of Covid-19 Vaccines Injected; Indonesia at Number 8