BPOM: Interim Data of Nusantara Vaccine Not Sufficient to Enter Next Stage



Mahinda Arkyasa

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  • TEMPO.CO, JakartaThe Food and Drug Monitoring Agency (BPOM) said that the interim data on the phase 2 clinical trial of the Nusantara vaccine was not sufficient to be considered as the basis to continue the research to the next stage.

    BPOM Head Penny Lukito said that her team found the lack of safety and ability of the vaccine to form antibodies and proofs of the quality of the dendritic cell vaccines.

    Penny, therefore, emphasized that to obtain a clear research basis, a preclinical test is necessary as an initial stage. "Preclinical study should be accompanied by the Ministry of Research and Technology or National Agency for Research and Technology (BRIN) in accordance with the agreement at the DPR's hearing," said Penny as quoted from Thursday, April 15, Edition of Koran Tempo.

    The Nusantara vaccine initiated by former health minister Terawan is being developed by using a dendritic cell method. It consists of three main ingredients, dendritic cells, antigen Covid-19 spike protein, and granulocyte-macrophage colony-stimulating factor (GMCSF). The last two materials are produced by two companies based in the United States.

    As reported in Koran Tempo, BPOM discovered changes in data on antibody measurements, or immunoglobulin (IgG) antibodies, in the preclinical study. The result of the antibody response was also inconsistent with the dose of the candidate vaccine given.

    In addition, the IgG antibody response also increased only in the group of animals that were given the combination of dendritic cell vaccine and GMCSF. This condition, BPOM went on, raised the assumption that the increase in antibodies in animal groups was due to GMCSF, instead of dendritic cell vaccines. "However, this cannot be ascertained given that in this preclinical study, there is no comparison with the administration of GMCSF alone," it concluded.