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MUI and BPOM Permit the Use of AstraZeneca


By: Alfisyah Dianasari ) *

The Astrazeneca vaccine has been shown to have greater benefits than the risks, this is reinforced by the license to use the vaccine from MUI and BPOM. So that its use needs to be continued to save lives.

The Indonesian Ulema Council (MUI) has stated that the Covid-19 AstraZeneca vaccine produced by SK Bioscience in Andong City, South Korea can be used in an emergency even though it contains trypsin from pigs.

              The head of the MUI for Fatwa, Asrorun Niam, in his press conference said, the first legal provision for the AstraZeneca Covid-19 vaccine is haram because in the production stage it uses trypsin from pigs.

              Even so, the second legal provision, the use of the Covid-19 vaccine from AstraZeneva is currently legally permitted.

              Asrorun revealed five reasons why the vaccine can be used in an emergency.

              First, currently Indonesia is in a state of emergency sharia, where there is information from competent and trusted experts about the dangers or fatal risks of not getting the Covid-19 vaccination.

              Then, the availability of the Covid-19 vaccine that is halal and holy is not sufficient for the implementation of the Covid-19 vaccination to realize herd immunity.

              In addition, the government guarantees the security of its use in accordance with the explanation given at the fatwa commission meeting.

              The last reason is that the government does not have the freedom to choose the Covid-19 vaccine given the limited vaccines available both in Indonesia and at the global level.

              Asrorun also emphasized that the ability to use the Covid-19 vaccine, products of AstraZeneca, will no longer be valid if no reasons have been mentioned.

              So, the government still has an obligation to continue to make efforts to provide the Covid-19 vaccine that is halal and holy.

              Meanwhile, the Food and Drug Administration (BPOM) has released the results of their study of the AstraZeneca vaccine. Based on the evaluation of the safety, quality and efficacy of the AstraZeneca vaccine, the BPOM stated that the UK-produced vaccine is safe to give to the public.

              However, there must still be a number of health conditions for the Covid-19 vaccine recipients.

              The BPOM has also issued an Emergency Use Authorization (EAU) for the use of the AstraZeneca Covid-19 Vaccine.

              BPOM Covid-19 Vaccine Spokesperson Lucia Rizka Andalusia in her press conference said, based on an evaluation of the safety, efficacy and quality data of the vaccine, the BPOM has issued an approval for use during an emergency or EUA on February 22, 2021.

              The evaluation process was carried out together with a team of experts from the National Committee for Drug Evaluation, The National Immunization Technical Advisory Group (NITAG), and several other relevant experts.

              The results of the evaluation of safety efficacy based on the results of clinical trial data presented as a whole, state that the administration of vaccination in AstraZeneca will be carried out in two doses.

              The interval used was 8 to 12 weeks in a total of 23,745 safe and well-tolerated subjects.

              Lucia said the results of the efficacy evaluation showed that the AstraZeneca vaccine could stimulate the formation of antibodies in both the adult and elderly population.

              The mean antibody titer or geometry after the second dose was 32 times in adults and 21 times in elderly people over 65 years.

              He said the efficacy of the vaccine with 2 standard doses calculated from 15 days of the second dose to 2 months of monitoring showed an efficacy of 62.1 percent.

              Meanwhile, BPOM has also conducted a thorough review of the quality documents submitted for the results of quality evaluation. Starting from the quality control of the initial ingredients, the process of making antigens and vaccine products, testing methods and test results for antigens and vaccine products, additional formulas and packaging materials, to the stability of antigens and vaccine products.

              The vaccine has apparently been registered with BPOM through two channels, namely the bilateral route by PT AstraZeneca and the multilateral route or through the Covax facility mechanism registered by PT Bio Farma.

              Several countries in the world have also approved the use of the AstraZeneca vaccine, such as Malaysia, Morocco, Brazil, England and several other European countries.

              The public certainly does not need to hesitate about the AstraZeneca vaccine, because MUI and BPOM have given permission and guaranteed that the AstraZeneca vaccine is safe and efficacious.             

) * The author is a citizen living in Bogor

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