Indonesia OKs 'private research' of COVID-19 vaccine after barring Phase II trial

April 21, 2021, 08.00 AM | Source: Reuters
Indonesia OKs 'private research' of COVID-19 vaccine after barring Phase II trial


COVID-19 - JAKARTA. Indonesia has approved private research of COVID-19 vaccine candidate Nusantara that is backed by a former health minister, after recently saying a mid-stage trial for it could not proceed amid safety and data integrity issues.

Just this month, Indonesia's drug and food agency (BPOM) said approval for a Phase II trial for the vaccine, developed by local firm PT Rama Emerald Multi Sukses and America's Aivita Biomedical, would not be granted as its sponsors had failed to fulfil Phase I clinical trial requirements.

The nod for private research comes amid mounting political pressure to approve the trial for the vaccine, which is backed by former minister Terawan Agus Putranto who enjoys the support of some in Indonesia's political and military elite.

Some parliamentarians have even volunteered to provide blood samples and participate in the study in a show of support.

But Indonesian scientists and public health experts are worried this sets a wrong precedent for global pharmaceutical firms looking for opportunities to fast track their drugs.

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"Indonesia aspires to be a hub for innovation, including in the biomedical space, but for it to be taken seriously, it needs to establish a conducive ecosystem," said Ines Atmosukarto, a molecular biologist who works on vaccine development.

Terawan, who initially downplayed the seriousness of the COVID-19 pandemic before being replaced in December, was not immediately available for comment. Rama Emerald Multi Sukses and Aivita were also not available to comment.

The Nusantara vaccine uses a dendritic cell method commonly used in research for cancer treatment and is built upon immune cells drawn from patients' blood.

Editor: Yudho Winarto

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