JAKARTA – The Food and Drug Administration (BPOM) has opened its voice regarding the halalness of the new polio vaccine Oral Poliomyelitis Vaccine Type 2 (nOPV2). According to BPOM, the vaccine produced by Biofarma does not yet have a halal certificate.
“But, of course, in the manufacturing process and in the selection of raw materials, nothing contains or comes into contact with haram ingredients,” said the Director of Safety, Quality and Export Inspection for the Importation of Drugs, Narcotics , Psychotropics, Precursors and Addictive Materials at BPOM, Nova Emelda, in an online talk show, Thursday (8/8).
He explained that nOPV2 halal certification could be in the process. He said this needs to be further confirmed by the manufacturer.
In addition, he said that the nOPV2 vaccine has been proven safe. The reason is, nOPV2 has received a distribution license from BPOM from December 2023. Before that, nOPV2 also received a distribution license Emergency Use Permit (EUA) or authorized for use in emergency situations.
“Before you get a license, there must be data that guarantees aspects of efficiency, safety and quality,” said Nova.
Not only that, he continued, nOPV2 has met the requirements Pre-qualification (PQ) from World Health Organization (WHO) and can be transferred to different countries. nOPV2 safety trials have also been conducted in other countries.
According to the official website of the Ministry of Health (Kemenkes), nOPV2 is a drop vaccine that is used specifically to treat Special Cases (KLB) of type 2 polio.
Based on data from the Ministry of Health, from 2022 to 2024 up to 12 cases of paralytic polio were reported. A total of 11 cases were caused by polio virus type 2 and one case was caused by polio virus type 1. These cases were spread across eight districts.
2024-08-08 12:35:11
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