BPOM's Document Reveals Irregularities in Terawan's Nusantara Vaccine Research

TEMPO.CO, Jakarta - The Food and Drug Monitoring Agency (BPOM) head Penny Kusumastuti Lukito met with a number of members of the House of Representatives (DPR) Health Commission on Wednesday, March 17, 2021. During the meeting, Penny explained the agency’s study on the Nusantara vaccine initiated by former Health Minister Terawan Agus Putranto.

The DPR Health Commission member from the PDIP faction, Muchamad Nabiel Haroen, said the informal meeting was held to mediate the BPOM and the research team of the Covid-19 vaccine and obtain a more complete picture of the vaccine. 

“To avoid clashing against one another,” said Nabil as quoted from Tempo Magazine’s March 22, 2021 edition.

The copy of the document disclosed various irregularities in the Nusantara vaccine research, such as the lack of validation and standardization of the testing method and different results of the research as it utilized different tools of measurement.

Additionally, the vaccine product was not made in a sterile environment. The antigen used was not guaranteed to be sterile and intended for use in the laboratory only, not for human subjects. “The BPOM declares that the validity of the research result is not acceptable,” wrote the document.

It was also noted that not one Indonesian researcher was able to answer the question being asked during a meeting with the National Committee on Drug Evaluation on March 16. All questions were only answered by foreign researchers from Aivita Biomedica Inc.

Moreover, the clinical trial towards Indonesian nationals was done by foreign researchers who could not present the appropriate research permit. All the main components of the vaccine production were imported from the United States. 

Penny Lukito confirmed the document, adding that researchers could not even verify whether the dendritic cells-based method being researched is a vaccine or therapy.

Nusantara vaccine initiator Terawan in a hearing at the DPR claimed that he had been engaging in dendritic cell development since 2015 when he was head of Gatot Soebroto Army Hospital (RSPAD). He claimed the research has been yielding positive results. “Everything is going well, giving us confidence.”

A member of the Nusantara vaccine research team, Muhammad Karyana, said his team has explained the research and answered every question during the hearing.

Read: BPOM Approves AstraZeneca Vaccine for Use

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