Bogor – Based on the results of a document review conducted by The Assessment Institute of Food, Drug, and Cosmetics, Indonesian Council of Ulama (LPPOM-MUI) on the use of ingredients from porcine in the process of making COVID-19 AstraZeneca produced by SK Bioscience Co. Ltd., Korea, concluded that this vaccine uses trypsin that is derived from porcine in the manufacturing process.
This AstraZeneca Vaccine Study is based on Astra Zeneca Registration through the CEROL-SS23000 online certification system with registration number 76579 on February 19, 2021, by PT. Bio Farma (Persero), which was appointed as the distributor for the procurement of AstraZeneca vaccines.
In the AstraZeneca Vaccine review process, LPPOM MUI assigned two Lead Auditors for Drugs and Vaccines with expertise in Bioprocess Engineering and Industrial Microbiology to conduct audits at the National Agency of Drug and Food Control (BPOM) in order to assess the composition and production process of making Astra Zeneca vaccines.
This process is carried out through the AstraZeneca vaccine dossier document sent by WHO to BPOM. This data is sent by WHO because the procurement of this vaccine is through multilateral channels.
Furthermore, the auditors then conducted a study of AstraZeneca’s scientific publications which can be accessed via the web with the title: Assessment report COVID-19 Vaccine AstraZeneca Common name: COVID-19 Vaccine (ChAdOx1-S [recombinant]) Procedure No. EMEA / H / C / 005675/000, 29 January 2021 EMA / 94907/2021, Committee for Medicinal Products for Human Use (CHMP). From this point, LPPOM MUI auditors continue their search for the media used in publications no. 2 via the internet.
During AstraZeneca vaccine review, LPPOM MUI found the following results:
1. Vaccine production consists of the preparation of HEK 293 host cells, development of recombinant vaccine seed inoculum (ChAdOx1-S [recombinant]), preparation of vaccine production media, vaccine production using ChAdOx1-S [recombinant] vaccine seed inoculum on HEK 293 host cells on sterile media, separation and purification process of bulk vaccine, vaccine formulations with the addition of excipients, aseptic filtration, and filling into ampoules.
2. Ingredients from porcine are used:
a) In the virus-host preparation stage, there is the use of material from porcine in the form of trypsin from the swine pancreas. This material is used to separate the host cell from its microcarrier.
b) In the preparation of recombinant vaccine seeds (research virus seed) until they are ready for use for production (master seed and working seed stages), there is a use of trypsin from porcine as a component in the media used to grow E. coli with the aim of regenerating transfection plasmid p5713 p -DEST ChAdOx1 nCov-19.
Both information is listed in the dossier studied in Table 2. Materials of Animal Origin Used in Non-GMP Host Cell Line Culture and Banking (there is the information: trypsin purified from the porcine pancreas) and Table 3. Materials of Animal Origin Used in Pre- GMP Virus Seed Development (there is an explanation that says: LB Broth containing bovine peptone and porcine enzyme).
In addition, retrieval of scientific publication data shows the same information (tracking data is attached).
With the AstraZeneca study as mentioned above, it can be concluded that based on the MUI fatwa the use of composition from porcine at any stage of the production process is not allowed. Thus the audit process is not continued to the factory. The report on the results of the study is directly submitted to the MUI Fatwa Commission to determine its halal-haram status.
The complete explanation can be downloaded, here. (*)
Bogor, 21 March 2021
Executive Director of LPPOM MUI
MUTI ARINTAWATI
