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Jakarta Post

Bio Farma aims to submit interim review on Sinovac vaccine in January

  • News Desk


Jakarta   /   Sat, November 21 2020   /  01:00 am
A nurse holds China's Sinovac vaccine, a potential vaccine for the coronavirus disease (COVID-19), at the Sao Lucas Hospital of the Pontifical Catholic University of Rio Grande do Sul (PUCRS), in Porto Alegre, Brazil August 8, 2020. (REUTERS/Diego Vara)

PT Bio Farma has announced that the state-owned pharmaceutical company plans to submit its interim results from the third and final trial phase of the Sinovac vaccine to the Indonesian Food and Drug Monitoring Agency (BPOM) in January 2021. The interim report is to include the results of the phase three clinical trials of the vaccine conducted in China and Brazil, which started prior to the trials in Indonesia. The interim results are intended to provide a basis for the BPOM to approve the issuance of emergency use authorization (EUA) for the vaccine. “Hopefully, we will obtain emergency [use] approval in the third or fourth week in January,” Bio Farma president director Honesti Basyir said on Thursday. He added that the third phase trials of the Sinovac vaccine involved 1,620 volunteers at six research centers in Bandung, West Java, with 1,603 volunteers receiving t...