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After questioning Terawan's vaccine, drug regulator faces political pressure

“The data we received kept changing. This affects the validity aspect and our trust in the process and results [of the trial],” said BPOM head Penny K. Lukito.

Ardila Syakriah (The Jakarta Post)
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Jakarta
Thu, March 11, 2021

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After questioning Terawan's vaccine, drug regulator faces political pressure Elderly people await pre-COVID-19 vaccination screenings at a community health center in Palmerah, West Jakarta, on Feb 25. (JP/Ardila Syakriah)

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fter questioning the data and rigor of the initial trials of a candidate vaccine backed by former health minister Terawan Agus Putranto, the Food and Drug Monitoring Agency (BPOM) has faced increased political pressure to allow the controversial jab to enter mid-stage trials.

Terawan began his efforts to develop the vaccine, called Nusantara, while he was in office last year. The Health Ministry was touted as a sponsor, alongside American biotechnology firm AIVITA Biomedical and Gresik-based pharmaceutical company Rama Emerald Multi Sukses in East Java.

The candidate vaccine employs a unique mechanism. It is tailored to each recipient through the use of their own antigen-presenting dendritic cells. Such cells have been used in cancer therapies.

“Since 2015, I have been personally developing dendritic cell-based vaccines at the Cell Cure Center of the Gatot Subroto Army Hospital,” Terawan said during a Wednesday meeting with House of Representatives Commission IX overseeing health and manpower.

Terawan, a military doctor known for his unconventional “brain-cleaning” treatment for stroke patients, was a director at Gatot Subroto from 2015 to 2019.

Read also: Jokowi announces end-of-year Cabinet reshuffle

But the BPOM has raised concerns about questionable procedures and claims from the first-stage clinical trials of the candidate vaccine in humans, which were carried out by researchers at the Dr. Kariadi General Hospital in Semarang, Central Java, the training hospital of Diponegoro University.

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