Penny K. Lukito, the Chairwoman of BPOM. (Image via Rakyat NTT)

Nusantara Vaccine's 2nd clinical trial disapproved, BPOM: No clinical principles

Indonesia's National Agency of Drug and Food Control (BPOM) disapproved the second phase of the clinical trial of Nusantara Vaccine for the novel coronavirus disease (COVID-19). The first phase of the clinical trial seemed to not obey the clinical principles on the research and development for the COVID-19 vaccine.

Speaking on Wednesday during the Joint Work Meeting with the 9th Commission broadcast through the official YouTube channel of the People's House Representative Council (DPR), the Chairwoman of the BPOM, Penny K. Lukito, stated that there were differences in the locations of the vaccine research facility, once pioneered by the former Health Minister, Terawan Agus Putranto, and former parties once formed as the ethical committee.

While the research was done at dr. Kariadi Central General Hospital (RSUP), Semarang, Central Java, the ethical committee gathered at Gatot Subroto Army Hospital (RSPAD), Jakarta. According to the clinical principle for vaccine development, Penny said that each research team has to be supervised by an ethical committee, responsible for the implementation and safety of the research subjects, at the same location.

Moreover, there were discrepancies in the data submitted by Nusantara Vaccine's clinical trial team, shown during Wednesday's meeting. Penny said that BPOM has finished the review of the first phase of Nusantara Vaccine's clinical trial, and submitted the result to the Health Ministry and research team in Semarang.

However, regarding the result of the first clinical trial of Nusantara Vaccine, Penny did not reveal any details. Next, BPOM will hold a meeting with a panel of experts and the research team of Nusantara Vaccine on the upcoming 16 March 2021.

Moreover, the Nusantara Vaccine had not passed through the pre-clinical trial on animals and went straight to the first clinical trial on humans. Therefore, BPOM did not give its approval to the second and third clinical trial for Nusantara Vaccine. Penny asserted that BPOM still supports the research and development of COVID-19's medicine and vaccines.

Previously, Nusantara Vaccine finished the first phase of the clinical trial on 30 human participants with the research team formed on 12 October 2020. The injection began on 11 January 2021 with the monitoring and evaluation phase on 3 February 2021.

Reportedly, Nusantara Vaccine aims to form cellular immunity in T-lymphocyte cells through the autologous dendritic cells or parts of the white blood cells or leukocytes which will then be exposed to antigens from SARS-CoV-2. Technically, each participant's blood will be taken as a sample to be exposed to the vaccine formed by dendritic cells. The antigens-exposed cells will enter the incubation phase for 3-7 days.

The output will then be injected back to the participant's body. In the body, the dendritic cells will trigger the other immune cells to form immunity memory against SARS-CoV-2.

Source: https://bit.ly/30zjVLP