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Report exposes many oddities in Nusantara vaccine development

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Tempo - April 14, 2021

Syailendra Persada, Jakarta – A number of House of Representatives (DPR) legislators plan to be vaccinated with the Nusantara vaccine – which has not passed local health agency inspection – at the Gatot Soebroto army hospital in Central Jakarta.

Representing the group, Commission IX DPR deputy speaker Melkiades Laka Lena said they were willing to be injected with the yet to be approved vaccine because of their faith and confidence in the former health minister Terawan Agus Putranto.

"Because it is good, that's why we will do it," said Lena on Tuesday, April 13. The East Nusa Tenggara legislator said he returned from his constituency to receive the experimental vaccine shot.

This comes as a concern as the report from the Food and Drug Monitoring Agency (BPOM) inspection team that Tempo managed to obtain showed a number of oddities regarding the vaccine's development.

Questionable findings

The oddities involve basic requirements that need to be fulfilled in the field of scientific studies such as the lack of validation and testing method standardization. The results produced by Terawan's vaccine development team also showed varying results with different measuring instruments being used.

Moreover, the report states that the vaccine production was not made in a sterile condition. Other notes include the use of antigen equipment that are not guaranteed for its sterilization and are only permitted for lab research uses and not for human subjects.

"The BPOM concludes that the validity of the research is unable to be accepted," the official BPOM document reads.

Foreign researchers in Nusantara's development

The same document also stated that not one of the Indonesian researchers involved in the Nusantara vaccine was able to answer the questions asked by the National Commission for Drug Evaluation on Tuesday, March 16. It states that all of the questions were answered by a foreign researcher from Aivita Biomedica Inc.

In another part of the BPOM document stated that clinical trials subjecting Indonesian subjects were conducted by foreign researchers who were not able to show their research permit. Not only were the researchers foreign nationals, Nusantara vaccine's main components were also largely imported from the United States.

This BPOM document was confirmed by the agency's chairperson Penny Lukito who also added that the researchers could not be certain that the dendritic method studied was a vaccine or therapy.

"The researchers were not able to answer this," said Penny Lukito.

Meanwhile, the Nusantara vaccine initiator Terawan Agus Putranto in a House hearing claims that he had conducted dendritic cell developments since 2015 when he led the Army Hospital and claims his research had advanced positively.

Muhammad Karyana, a researcher in the Nusantara vaccine development, said the team has explained its research and answered every question that arose in the House of Representatives hearing.

Source: https://en.tempo.co/read/1452439/report-exposes-many-oddities-in-nusantara-vaccine-developmen

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