JAKARTA – Indonesia’s BPJPH could issue halal certification for the COVID-19 vaccine developed by China’s Sinovac as soon as one week once the fatwa is issued by LPPOM MUI, Prof. Sukoso, head of the national halal agency told Salaam Gateway.
“We have already received the halal certification application documents of the Sinovac COVID-19 vaccine and we conducted a field inspection in China involving representatives from Bio Farma, BPOM and LPPOM MUI,” said Prof. Sukoso.
Indonesia received on December 6, 1.2 million doses of the COVID-19 vaccine developed by China’s Sinovac. The doses will be stored by Bio Farma, the state-owned biopharmaceutical company and the country’s only vaccine manufacturer. Bio Farma will also locally process the raw materials shipped by Sinovac for 45 million doses of the vaccine.
The process of inspection and assessment also includes BPOM – the National Drug and Food Agency – and LPPOM MUI, which is the Indonesia Ulema Council’s Assessment Institute for Foods, Drugs and Cosmetics that issues the fatwa required for halal certification.
“Based on the inspection, all ingredients including active and supporting ingredients, are all free from gelatine. In the past, all ingredients using gelatine were replaced by non-gelatines. The Sinovac vaccine uses genetic engineering as replacement. This will become the basis for the next step, the fatwa trial by LPPOM-MUI. Once they complete the trial, we can issue the halal certificate,” said Prof. Sukoso. Non-halal gelatines, such as pork-derived ingredients, are more often used in pharmaceutical products.
Coordinating Minister for Human Development and Culture Muhadjir Effendy told local press during a virtual press conference on Monday (Dec 7) that the vaccination process for the public can only start after evaluation and assessments by BPOM and BPJPH are completed.
"We have been updated that there is some progress made regarding halal certification for the Sinovac vaccine from the BPJPH and LPPOM MUI. All the inspections have been completed and we are waiting for the fatwa trial by LPPOM MUI now," said the minister.
The government will begin to prepare the distribution of the vaccine to each region in the next two weeks at the earliest, after the regulation detailing priority COVID-19 vaccine beneficiaries is issued. Vaccination will be prioritized for certain groups.
"In accordance with the recommendations of the National Immunization Expert Advisory Committee, the priority is first given to those on the front lines, medical officers and non-medical personnel such as the national armed forces and the national police. Second are high-risk groups, who are workers including market traders, shop assistants or sales clerks, and employees in the industrial or factory sector, and office employees," said the Coordinating Minister for Human Development and Culture.
PHASE 3 TRIALS
Phase 3 trials for the Sinovac vaccine are being conducted in Indonesia, Bio Farma CEO Honesti Basyir told Salaam Gateway.
"Currently we and UNPAD (Padjadjaran University) are testing 1,620 volunteers and we expect to get an effectiveness report in May or June 2021 to get approval and a circulation permitt from BPOM," said Honesti.
However, he said the vaccine could be rolled out earlier.
"But in other scenarios, BPOM can issue an EUA (Emergency Use Authorization) if they want to start the vaccination earlier, maybe in January, by using current available result data from Sinovac that already conducted tests in Brazil with the Butantan Institute," said the Bio Farma CEO.
The halal certification process starts after BPOM approval, said Honesti.
Prof. Sukoso agrees that the halal certification process will follow BPOM's approval, either with or without the EUA.
*The section under "Phase 3 trials" was inserted as an update to the original article
(Reporting by Yosi Winosa; Editing by Emmy Abdul Alim [email protected])
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