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Judul : BPOM: Still awaiting Brazil data on Sinovac vaccine

Nama Media : antaranews.com

Tanggal : 21 November 2020

Halaman/URL : BPOM: Still awaiting Brazil data on Sinovac vaccine - ANTARA
News

Tipe Media : Online

Indonesia’s Food and Drug Monitoring Agency (BPOM) said it is still waiting for the
results of Phase 3 clinical trials of Sinovac's COVID-19 vaccine in Brazil as it mulls
granting it emergency-use authorization.

The agency will combine research data from the Phase 3 clinical trials for the
Chinese vaccine candidate in Brazil and Indonesia to determine its safety,
effectiveness, and immunogenicity, BPOM head Penny K Lukito said at an online
press conference that ANTARA joined from Jakarta on Thursday.

"We have not yet received the research data of Phase 3 clinical trials of Sinovac's
COVID-19 vaccine conducted in Brazil. We often communicate with related
authorities there. Like Indonesia, Brazil also conducted Phase 3 clinical trials [for the
vaccine],” she informed.

In fact, Brazil commenced trials earlier than Indonesia, she said, adding that the
issuance of emergency-use authorization (EUA) must be done by vetting thorough