Reporting from mui.or.id, the Central MUI Fatwa Commission finally determined that the corona virus disease 2019 (COVID-19) vaccine produced by Sinovac Lifescience Co Ltd was halal & sacred. However, the use of this vaccine is still waiting for safety permission from the Food and Drug Supervisory Agency (BPOM). This was decided after holding a closed plenary meeting at the Sultan Hotel, Jakarta on January 8, 2021.
“Regarding halal aspects, after a long discussion based on data and facts collected by the LPPOM MUI auditor team and the MUI Fatwa Commission, the Fatwa Commission meeting agreed that the COVID-19 vaccine produced by Sinovac Lifescience Co Ltd, whose certification was submitted by Biofarma was sacred and halal,” said KH. Asrorun Niam Sholeh, Chairman of MUI Fatwa.
Ivon Widiahtuti, Corporate Secretary Manager of LPPOM MUI, emphasized that the necessary documents and data have been reviewed and traced by the LPPOM MUI auditor team in detail and submitted to the MUI fatwa commission.
“Although the assessment and tracing of vaccine product data is not as simple as products in general. However, alhamdulillah, the company was quite cooperative so it entrusted information and data to the LPPOM MUI auditor team. The data provided is also sufficient to provide the information needed for the determination of fatwas. It’s just that now it’s just a matter of waiting for permission to use the vaccine from BPOM,” said Ivon.
Niam further explained that in principle, halal and thayyib go hand in hand. Therefore, even though it is halal and sacred, the use of the COVID-19 vaccine produced by Sinovac is still waiting for BPOM’s decision regarding the thayyib aspect, which includes safety, quality, and efficacy. After BPOM issues a permit, this vaccine fatwa will be issued in full and the vaccine can be used.
Meanwhile, Penny Kusumastuti Lukito, Head of BPOM, explained that the granting of permission to use vaccines by drug authorities during the COVID-19 pandemic can be given in the form of Emergency Use Authorization (EUA). The vaccines given must be supported by sufficient efficacy and quality.
“After the administration of this EUA, strict monitoring of the efficacy and safety of the vaccine must also be carried out in a longer period of time. The requirement for administering EUA is that the vaccine must have complete clinical trial data 1 and 2, as well as interim data on clinical trials 3 to show the efficacy and safety of the vaccine,” penny said during a press conference on January 8, 2021.
Lucia Rizka Andalusia, Spokesperson for COVID-19 Vaccination from BPOM, said that the phase 3 clinical trials carried out today will enter the finalization of the interim analysis report, which is a report every three months after the injection of phase 3 clinical trials. This is what will be the basis for the application to obtain an EUA. This means that the vaccine has been declared suitable for use in terms of safety and has also had an effect on protecting or immunity in the body of the person who gets it.
“Currently, BPOM is waiting for researchers to finalize the interim analysis report. Once completed, BPOM will immediately review. We have also evaluated the data that has been entered before (rolling submission),” Lucia told CNN Indonesia on January 6, 2020.
The previous data in question included the implementation of phase 1 and phase 2 pre-clinical trials. In that phase, it has been seen whether the vaccine can form antibodies to create immunity in the body. Furthermore, it must also be tested whether the antibodies can fight the COVID-19 virus or not.
“In addition, we also followed the standards from WHO which set a minimum standard for phase 3 interim anaalasis with three months of monitoring. This is the same as other vaccines that have received EUA first. Therefore, BPOM must wait until it gets the three-month data,” said Lucia.
Until now, the Government has distributed the COVID-19 vaccine to several regions in Indonesia. This is an effort by the Government to speed up the process of preparing vaccines in the regions. Although the distribution has been carried out, but for the injection, you still have to wait for the EUA from BPOM.
Determination of Vaccine Halalness
The Fatwa Commission determined this halalness after previously reviewing in depth the audit report from the LPPOM MUI and MUI auditor teams. The team consists of the Central MUI Fatwa Commission and the MUI LPPOM. The team has previously been experienced in the audit process of MR Vaccines and other vaccines.
The team was previously part of the Ministry of Health, Biofarma, and BPOM teams since October 2020. They and another team visited the Sinovac plant and audited the halalness of the vaccine there.
After returning to Indonesia, the team was still waiting for some missing documents. The document was received in full by the MUI team on Tuesday (05/01) via electronic mail. On the same day, the team also completed a field audit at Biofarma which will later produce this vaccine en masse. The team then reported the results of the audit to the Central MUI Fatwa Commission for a religious study to determine the halalness of the vaccine. (YN)
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