Here's The Reason Why Nusantara Vaccine Has Not Yet Passed BPOM Inspection

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Petir Garda Bhwana

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  • Head of the Food and Drug Supervisory Agency (BPOM) Penny Kusumastuti Lukito provides a press statement regarding the development of a clinical trial for a new combination drug for COVID-19 in Jakarta, Wednesday, August 19, 2020. The head of BPOM stated the results of the phase three clinical trial for a new combination drug for COVID-19 The results of the collaboration between the Indonesian Army, BIN and Airlangga University (Unair) are not yet valid. His party asks researchers to revise and improve their research results according to the rules that have been determined by BPOM. ANTARA / Nova Wahyudi

    Head of the Food and Drug Supervisory Agency (BPOM) Penny Kusumastuti Lukito provides a press statement regarding the development of a clinical trial for a new combination drug for COVID-19 in Jakarta, Wednesday, August 19, 2020. The head of BPOM stated the results of the phase three clinical trial for a new combination drug for COVID-19 The results of the collaboration between the Indonesian Army, BIN and Airlangga University (Unair) are not yet valid. His party asks researchers to revise and improve their research results according to the rules that have been determined by BPOM. ANTARA / Nova Wahyudi

    TEMPO.CO, Jakarta - The Food and Drugs Monitoring Agency (BPOM) on Tuesday stated that they do not favor any vaccine brands as it oversees clinical trials for public use, which includes the Nusantara vaccine initiated by the former health minister and physician Terawan Agus Putranto - who was replaced by Budi Gunadi Sadikin in the current administration. 

    “The BPOM does not pick sides. The agency will support any form of research if it has entered clinical trials and we will accompany it closely. But surely with the foundation from existing standards,” the BPOM head Penny Lukito asserts in the workshop on another Indonesian vaccine currently being developed touted as ‘merah putih vaccine.’

    She contends that the Nusantara vaccine cannot yet progress to clinical trials due to a number of basic requirements that the vaccine has yet fulfilled such as good clinical practices, proof of concept, good laboratory practice, and good manufacturing practice. 

    The BPOM head made it clear that developments on vaccines will receive support from the agency as long as it meets the basic requirements for safety, quality, and mainly efficacy. 

    She also claimed the agency had inspected the development of the Nusantara vaccine and that there will be challenges upon progressing to a higher development stage if the implementation of clinical trials does not meet its standards. 

    “These steps cannot be ignored and many of the aspects were neglected in conducting the dendritic vaccine’s phase 1 clinical trials. This was addressed to the team of researchers [of the nusantara vaccine] and there were surely corrective actions and preventive actions since the beginning but they were ignored,” said Penny Lukito.

    The BPOM chairperson also said Nusantara vaccine’s proof of concept has not been fulfilled and the antigen equipment used for its development was not pharmaceutical grade. She also revealed that the vaccine’s claimed ability to improve the antibodies was not convincing enough to progress to the next step of clinical trials. 

    The agency has not issued a permit for the Nusantara vaccine to progress to the second phase clinical trials.

    Read: DPR Slams BPOM over Nusantara Vaccine Development 

    ANTARA