Tuesday, April 20, 2021

VAKSINASI & KELAS SOSIAL


Vaksinasi yang sedang digeber Pemerintah untuk mengatasi Covid-19 perlu diapresiasi, didukung, dan tentu saja, disosialisasikan dengan baik. Nah bagian yg terakhir itulah yang belakangan  menjadi perkara penting untuk diperhatikan. Segala macam informasi, baik yang bagus, setengah bagus, agak bagus, maupun yang tidak bagus, tentang vaksinasi tsb bertebaran terutama di jagad maya. Dan saya yakin, penyebaran informasi itu tidak semua berdampak positif bagi upaya Pemerintah di atas atau upaya penaggulangan pandemi Covid-19 secara keseluruhan.

Saya termasuk manula yang sudah mendapat vaksinasi dua kali dan tentunya harus bersyukur kepada Tuhan dan berterimakasih kepada Negara dan Pemerintah. Tetapi saya juga warganegara yang merasa bertanggungjawab terhadap suksesnya program vaksinasi tsb melampaui kepentingan saya pribadi dan keluarga. Sebab pada akhirnya harus disadari bahwa virus Covid-19 dan pandemi yang ditimbulkannya adalah sebuah bencana yg bukan pilih-pilih; ia adalah sebuah peristiwa global yang berdampak sistemik dan mampu mengubah seluruh pola kehidupan dan tatanan masyarakat.

Karenanya, soal vaksinansi bukan hanya urusan Pemerintah doang atau aparat-aparatnya yang terkait dalam ihwal pemberantasan dan penanggulangan pandemi ini. Ia juga masalah kita bersama, pribadi maupun kolektif. Dengan demikian wacana dan praksis vaksinasi juga mesti melibatkan seluruh aspek kehidupan; dan yang ingin saya singgung dalam status ini adalah kaitannya dengan kelas sosial.

Ini bukan sebuah renungan atau analisis akademis, tetapi pengalaman hidup sehari-hari. Yakni bahwa kendati vaksinasi adalah upaya penting, mulia, dan sangat terpuji, namun dalam kenyataannya ia harus dilaksankan dan diterapkan dengan tetap menyadari kondisi masyarakat yang menjadi sasaran. Dengan kata lain, program vaksinasi hanya akan efektif jika para petugas dan penerima memiliki kesepahaman dan saling percaya. Target "Herd immunity", yang disepakati akan terjadi jika 70% penduduk sebuah negara telah tervaksinasi, hanya mungkin tercapai jika para peserta juga memiliki rasa percaya (trust) terhadap program tsb., di samping adanya ketersediaan vaksin yang cukup.

Kita umumnya  terbiasa menganggap bahwa jika vaksinasi Covid-19 akan diberikan kepada kita, maka kita akan merasa lega dan berharap segera mendapat jadwal atau giliran disuntik di Puskesmas atau di manapun tempat yang disediakan. Jarang atau tak lazim kita menyadari bahwa soalnya tak sesederhana itu. Sebab ternyata tidak semua orang dalam kelas sosial yang berbeda akan bersikap antisipatif dan bahkan gembira seperti yang, misalnya, saya alami.

Pengalaman isteri saya (I) yang sering ngobrol dengan para tetangga menjadi pelajaran penting dalam hal ini. Suatu hari ia bertemu salah sorang tetangga (sebutlah Empok B) yang kebetulan seorang penjual sayur-sayuran. Sambil memilih-milih sayuran yang akan dibeli, istri saya mengajak ngobrol beliau:

I : "Mpok sudah dapat panggilan giliran divaksin?"
B: "Sudah Bu"
I: "Asyik, udah yang kedua kali atau baru sekali, kayak saya?"
B: "Enggak Bu, saya gak mau datang divaksin."
I (heran): "Lho kok, kan mPok sangat beruntung bisa dapat panggilan vaksinasi? Banyak yang belum dapat lho."
B: "Biarin Bu, saya gak mau. Kalau dipaksa vaksinasi ya lari aja nanti.."
I (makin heran): "Kenapa? Wong gak sakit ini. Saya baru kemarin sama Bapak juga divaksinasi yang pertama."
B: "Beda Bu."
I (kaget): "Beda bagaimana wong saya juga ke Puskesmas dan dapat panggilan lewat daring dari kantor Pak RT."
B: "Ah Ibu kayak gak tahu saja. Itu vaksinnya yang dikasi ke Ibu dan Bapak beda dengan yang akan dikasi ke saya. Resikonya beda Bu. Saya kan masih menanggung anak-anak dan gak punya uang banyak. Kalau malah sakit gimana? Siapa yang tanggung jawab?"
I: "Siapa bilang vaksinnya beda-beda Mpok?"
B: "Saya takut aja Bu, kalau kabar-kabar itu benar bahwa vaksin yg diberikan ada yang untuk orang atas dan orang bawah kayak saya. Mendingan saya gak datang aja lah.. Ogah..!"

Tentu saja ini hanya satu kasus di antara para tetangga saya (yang kebetulan memang kelas sosialnya bervariasi). Tetapi jangan-jangan kasus yang mirip juga ada di masyarakat lain di Indonesia. Dan ini adalah fakta yang perlu dicermati. Yaitu bahwa vaksinasi yang sangat penting dan mulia tsb ternyata dimakmai berbeda secara sosial, termasuk secara kelas sosial. Inilah pentingnya sosialisasi, penerangan dan penyebarluasan informasi yang benar dan efektif.

Saya khawatir model Mpok B yang enggan, menolak, dan kalau perlu lari dari vaksinasi ini berjumlah cukup besar dan, pada gilirannya, akan memengaruhi target "herd immunity" yang dipatok oleh Pemerintah. Dan ini baru salah satu kasus yang berkaitan dengan kelas sosial, yaitu kepercayaan (trust) dan informasi yang tepat. Bagi anggota masyarakat seperti saya, barangkali aneh kalau ada orang menolak vaksinasi. Tetapi bagi Mpok B, menolak vaksinasi juga sebuah pilihan "rasional", karena soal trust yang rendah dan ditambah informasi yang tak jelas. Bagi beliau melanjutkan aktivitas keseharian seperti biasa adalah pilihan yang lebih penting ketimbang ikut vaksinasi tapi diiringi keragu-raguan.
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Saturday, April 17, 2021

“VAKSIN NUSANTARA”: A LOOK FROM A CONCERNED SCIENTIST

By. Lily Hikam*)

I pictured myself as a virus or a cancer cell and tried to sense what it would be like.” Jonas Salk, M.D.- inventor of the Polio vaccine.

For some, the COVID-19 pandemic is a blessing in disguise. The SARS-CoV2 virus and the disease it caused, COVID-19, was so novel and severe that they wreaked havoc in almost every compartment of society. The severity and the impact of this pandemic is not nearly as frightening as the uncertainty on when or if this pandemic will ever end. For reference, the last pandemic of this scale was the Spanish influenza pandemic that lasted approximately two years, from 1918-1920. Prior to that was the Bubonic Plague which decimated 25-60% of the European continent population and lasted for seven years (1346-1353) [1]. Adding to this uncertainty is the prospect that this virus might be here to stay and be part of our lives for the future, just like every other virus that has been unleased unto the world.

It is no wonder, then, that people are desperate for a cure, a way to mitigate this disaster, anything that can help them feel like they have some control over their lives that have been upended by a submicroscopic microorganism that can’t even replicate without a host. In times like these, countries and societies turn to their oftentimes forgotten members of society: the scientists and researchers who dedicated their lives studying these diseases to cure them and prevent their occurrence in the general population, but largely relegated to the backburner because their research is usually deemed “too expensive” or a “waste of money and time”.

The lack of understanding and appreciation to science, research and development, and the scientific method have long been a feature within the Indonesian society. Sure, we tell our kids to excel in Mathematics and hard sciences for the prestige of it and so they have an easier time navigating through the college admissions process, but that’s the extent of it. Our research and development (R&D) expenditure as percentage of GDP was reported at 0,226 % in 2018 [2]. Compare this to the R&D expenditure of one of our closest neighbors, Malaysia, which is at 1,44% of their GDP and we are at a significant disadvantage when it comes to advancing our scientific capabilities [3]. And it has become exceedingly obvious now more than ever with the pandemic ripping off the veneer of scientific readiness and capabilities and exposed how woefully unprepared we are in handling a large-scale disaster such as a pandemic.

In Indonesia, it is not an understatement to say that the government half-heartedly enforced a lockdown policy, and at times the policies seem paradoxical to each other (i.e. prohibitions on mudik yet re-opening tourist attractions) and economic aid is inadequate at best with people who are supposed to be on the receiving end receiving less than what was promised. Adding to this is the uncertainty on what it would take to cure this disease. The potential of a vaccine to defeat the coronavirus by way of generating herd immunity has been discussed almost as soon as the disease is declared a pandemic. Indonesia has spent the better part of the pandemic developing our own variants of vaccines, the most famous and talked about in the media is the so-called Red and White Vaccine (Vaksin Merah Putih) based on a recombinant protein technology, under the auspices of the Eijkman Institute for Molecular Biology and Bio Farma, the state-owned enterprise specializing in vaccine manufacturing. Now, this vaccine is still under pre-clinical development with an expected availability date of April 2022 [4].

Certainly this seems like a long ways away and for the people who are anxious for some relief, but thankfully other vaccine options are available for use now. The most widely available vaccine at the moment is the Sinovac vaccine, whose raw materials were imported to Indonesia from China and mass produced by Bio Farma. Other vaccines such as the AstraZeneca vaccine whose usage was marred by controversy regarding its halalness have also been administered.

Recently, a new type of vaccine have also been elevated to the public consciousness, but not because of its efficacy. This new vaccine variant, named Vaksin Nusantara and championed by former Minister of Health Terawan Agus Putranto, captured the public’s attention because of the way its developer tried to advertise it as the only type of vaccine that can confer lifetime immunity to its recipient [5].

Its name Nusantara also carried the connotation that this vaccine is developed by Indonesian scientists, when in reality it was developed by a Biotechnology company based in Irvine, CA, United States. So, what is Vaksin Nusantara? Can we even classify it as a vaccine based on how it works? And does it actually confer lifetime immunity, like the promoter claims?

The technology behind Vaksin Nusantara is the same technology underlying cancer immunotherapy. Nowadays, cancer research has been focused on training the patients’ immune system to recognize cancerous cells in the body, attack it and destroy it, with the hopes that doctors can avoid the use of medications and treatments such as chemotherapy and radiotherapy which causes significant adverse side effects on the patients.

Cancer immunotherapy ranged from engineering T-Cells to carry a chimeric antigen receptor (CAR) specific to the type of cancer cell to be targeted. These engineered T-cells, called CAR-T cells, are originally T-cells (white blood cells) obtained from the patient or a healthy donor’s bloodstream and isolated via leukocyte apheresis. These cells will then be cultured in a petri dish until their numbers are high enough before they’re transduced (given) with a vector containing the protein construct of the chimeric antigen the researcher would like the engineered T-cells to express. Once the CAR-T cells are ready, they will be injected back to the patient to start the immunotherapy process. Cancer immunotherapy using CAR-T cells have been approved by the US FDA since 2017 for treating B cell acute lymphoblastic leukemia. To date, there are five cancer immunotherapies using this method that have been approved for use by the US FDA [6,7].

In addition to engineering T-cells, cancer immunotherapy has also been expanded into looking at the possibility of engineering other cells in the immune system for the same application. Dendritic cells (DCs) whose main function is presenting an antigen (foreign materials like pieces of an invading virus) to the T-cell to induce adaptive immune response is the next hot topic in cancer immunotherapy. This DCs-based therapy, or vaccine, is the technology behind the Nusantara vaccine. The premise is simple: isolate DCs from patients, expose the DCs to to the SARS-CoV2 spike protein then inject it back to the patient so these engineered DCs will present the SARS-CoV2 spike protein to the T-cells which will activate the T-cells to target and destroy the spike protein if the individual is exposed to SARS-CoV2 later on [8]. Sounds like a good enough strategy for a vaccine development. So what’s the problem?

For one, this DCs-based vaccine will be expensive. Very expensive. The process of isolating DCs from the body, culturing them then engineering them is an expensive and laborious process that requires a clinical laboratory facility which complies with good clinical practices (GCP) that, quite frankly, aren’t yet available in Indonesia. They also rely on culture reagents and stimulatory molecules that are not GMP-grade and are very expensive to import to Indonesia. An estimate of the cost of one of the variants of CAR-T cell therapy, Yescarta, is around $375,000 and $475,000 (approximately IDR 5.447.587.500.00 – 6.900.277.500.00) [9]. In a time when what we need is a vaccine that will be widely available for everybody in the country, developing a therapy that is costly and exclusive is not a good approach to achieving herd immunity, rather what this will do is further highlight the gap between the haves and have-nots in this country and further demonstrate that healthcare equity is still a big issue in this country.

Two, pre-clinical data on this vaccine is very scant and limited. There hasn’t been any peer-reviewed published paper regarding the safety, efficacy and suitability of this vaccine. Instead what we have is the words of the promoter, former Minister of Health Terawan Agus Putranto, that this vaccine is the work of Indonesian scientist, which have since been proven false, and that it will elicit lifetime immunity, yet another false claim by the former Minister. The technology behind this vaccine was pioneered by an American biotechnology company called Aivita Biomedical that according to filings at ClinicalTrials.gov is one of the collaborators and have been developing this DCs-based therapy for application in cancer, not COVID-19. Filings in the ClinicalTrials.gov also showed that the study is still in phase I trial to establish whether this vaccine is safe, hence it’s a bit too early to be making claims about immunity and efficacy [10]. There are still phases II and III to conduct which will shed more light on the efficacy and the suitability of this vaccine to help prevent COVID-19 infections.

Finally, the proposed protocol is an “autologous” mode of administration, which means that a patient’s DCs will be isolated, treated then injected back to that same patient. This is a highly personalized and exclusive approach in therapy since only one person, and usually it will be a person with significant means, wealth or prestige, who will be able to use the therapy. Contrast this with the “allogeneic” approach which includes all of the other vaccine variant wherein the same therapy can be used by as many people as possible as the therapy is not personalized for the use of one person. Once again, this approach excludes large portions of the population who have no means to use or purchase this therapy due to systemic and monetary reasons imposed upon them. This approach will just put a roadblock in the effort to achieve herd immunity in the population by eroding public trust and significantly impact pandemic recovery efforts.

In closing, I will leave you with this joke by Gus Dur that my father once told me and has a profound impact on me as a researcher ever since I first heard it. Gus Dur told the story of a Minister of Research and Technology who went to a pesantren in East Java and bragged about how his Ministry has successfully developed a rocket that could fly to the sun. Of course, this is a big achievement seeing as how the Sun is located 149.6 million km away from Earth and has a surface temperature of 5,778 Kelvin [11]. When he told of his achievement, no one in his audience applauded or even gasped in amazement. Annoyed, he asked one of the santris why he and his peers didn’t think this was a big deal. With a shrug, the santri answered “All you have to do is fly the rocket after Maghrib, right? What’s the big deal?” The moral of this Gusdurian joke is that it doesn’t matter how technologically advanced or how cutting edge your research is if your country and your people can’t benefit from it. It would have been a waste of energy and resources if your research doesn’t bring something beneficial for your people and only serve to advance a political cause or personal goals. It is easy to get lost in the scientific pursuit of research just for the sake of research, that sometimes it’s good to reflect on how our works will impact others.

*) PhD in Biomedical Science, University of California, Irvine, USA

Footnotes:

1.     https://www.who.int/health-topics/plague#tab=tab_1

2.     https://data.worldbank.org/indicator/GB.XPD.RSDV.GD.ZS?locations=ID

3.     https://data.worldbank.org/indicator/GB.XPD.RSDV.GD.ZS?locations=ID-MY&name_desc=false

4.     https://www.antaranews.com/berita/2105138/bpom-vaksin-merah-putih-eijkman-produksi-massal-semester-2-tahun-2022

5.     https://www.cnnindonesia.com/nasional/20210217175237-20-607537/antibodi-vaksin-nusantara-terawan-diklaim-tahan-seumur-hidup

6.     Srivastava S, Riddell SR (August 2015). "Engineering CAR-T cells: Design concepts"Trends in Immunology36 (8): 494-502. doi:10.1016/j.it.2015.06.004PMC 4746114PMID 26169254.

7.     Sadelain M, Brentjens R, Rivière I (April 2013). "The basic principles of chimeric antigen receptor design"Cancer Discovery3 (4): 388–98. doi:10.1158/2159-8290.CD-12-0548PMC 3667586PMID 23550147.

8.     Saadeldin MK, Abdel-Aziz AK, Abdellatif A. Dendritic cell vaccine immunotherapy; the beginning of the end of cancer and COVID-19. A hypothesis. Med Hypotheses. 2021 Jan;146:110365. doi: 10.1016/j.mehy.2020.110365. Epub 2020 Nov 9. PMID: 33221134; PMCID: PMC7836805.

9.     Lyman, Gary H.; Nguyen, Andy; Snyder, Sophie; Gitlin, Matthew; Chung, Karen C. (2020-04-06). "Economic Evaluation of Chimeric Antigen Receptor T-Cell Therapy by Site of Care Among Patients With Relapsed or Refractory Large B-Cell Lymphoma"JAMA Network Open3 (4). doi:10.1001/jamanetworkopen.2020.2072ISSN 2574-3805PMC 7136832PMID 32250433.

10.  https://clinicaltrials.gov/ct2/show/NCT04685603

11.  Williams, D.R. (1 July 2013). "Sun Fact Sheet"NASA Goddard Space Flight CenterArchived from the original on 15 July 2010. Retrieved 12 August 2013.

 

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Sunday, April 11, 2021

SEMINAR "ANCAMAN TERORISME DI INDONESIA"


Hari ini, Sabtu 10 April 2021, saya memberanikan diri utk bergabung dalam seminar OFFLINE, pertama kali dalam kurun setahun terakhir. Semoga aman dan safe.

Seminar yang bertema  "Indonesia di Tengah Tantangan Terorisme" tersebut diselenggarakan oleh Institut Demokrasi Republikan (IDR) sebuah LSM yang aktif dalam upaya deradikalisasi & kontraradikalisme. Saya mendapat bagian bicara mengenai ancaman terorisme sebagai ancaman dan bahaya yang nyata dan hadir (a clear and present danger), kendati dalam suasana pandemi di seluruh dunia. Negara seperti Indonesia dan negara2 ASEAN masih tetap akan menjadi target aksi dan gerakan teror transnasional kendati ISIS mengalami kekalahan dan kehancuran di Syria dan Irak. Bahkan dalam Indek tentang Ancaman Bahaya Terorisme Internasional pada 2019, Indonesia masih termasuk dalm kategori negara yang "menengah" dalam hal ancaman aksi terorisme.

Peristiwa penyerangan di kota Marawi, Filipina Selatan, di kota Palma, Mozambique, Afrika, dan aksi teror klmpk JAD di kota Makassar dan lone wolves di beberapa tempat lainnya, bisa dijadikan bukti aktifnya jejaring kelompok jihadi yang berafiliasi dengan jejaring terorisme transnasional seperti ISIS.

Karena itu, segenap upaya yang dilakukan Pemerintah untuk menguatkan kapasitas dalam penanggulangan ancaman tsb, seperti melalui pembentukan Perpres no 7/2021 (dikenal dengan singkatan Ran PE) perlu diapresiasi dan sekaligus dicermati: Bagaimana nanti dalam pelaksanaannnya di lapangan. Sebab kendati ada kebijakan yang bagus di atas kertas, jika tidak berjalan di lapangan, juga akan muspro.

Bagi saya, penanggulangan ekstremisme yang mengarah pada terorisme bukan hanya perlu didekati dengan hard power (kekuatan keras) saja, tetapi juga soft power (kekuatan lunak) danbahkan  smart power (kekuatan cerdas), gabungan dari yang pertama dan kedua. Perpres Ran PE memang ditujukan pada penguatan soft power tsb, namun dalam pandangan saya, masih berorientasi kepada aparat negara sebagai sumber dan leading sectornya. Ini mungkin karena Perpres tsb memang ditujukan sebagai rujukan aparat bagi lembaga-lembaga Pemerintahan (pada aras Kabinet, LPNK, sampai Pemda).

Meski demikian, saya berharap bahwa dalam realisasinya nanti sektor masyarakat sipil dan komponennya adalah yang harus mendapat perhatian lebih besar dan menjadi pusat sebuah Gerakan Deradikalisasi Nasional (GDN). Ia bukan hanya sekedar sebuah program apalagi proyek belaka.

Simak tautan ini:

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Tuesday, March 30, 2021

GUS DUR, LAKU, & LATAR AGAMA


Saya tak pernah jemu untuk mengingat-ingat kata bijak almaghfurlah Gus Dur yang satu ini: "Tidak penting apapun agama atau sukumu... Kalau kamu bisa berbuat BAIK untuk semua, orang-orang tidak pernah tanya apa AGAMAMU." Kata bijak ini sangat relevan dalam rangka mendorong sikap pluralistik dan mengayomi serta berfikir dan berlaku atau bertindak tanpa dibingkai sekat-sekat identitas. Laku baik adalah sebuah tanggungjawab pribadi dan sosial yang TAK PERLU diklaim dan dipertanyakan latar belakang identitas pelakunya!

Namun saat ini, ketika terjadi laku jahat terhadap kemanusiaan, bangsa, dan negara RI, dalam bentuk terorisme seperti di Makassar atau wilayah lain sebelumnya, saya dihadapkan oleh wacana penghadapan antara identitas agama dan pelaku serta gagasan di baliknya. Pertanyaan atau pernyataan bernada menggugat "Apa agama dan kitab suci para teroris tsb" atau "kenapa pemeluk agama tertentu sering melakukan aksi yg hina tsb" atau tudingan pseudo ilmiah bahwa "agama tertentu memang mengajarkan kekerasan dibanding agama lainnya"dst... dsb... bermunculan terutama di media sosial.

Seolah kata bijak almaghfurlah GD kemudian menjadi sebuah klaim yg satu arah belaka. Seolah peringatan Gus Dur hanya berlaku untuk laku baik saja. Jika demikian, kata bijak tersebut menjadi relatif, bukan sebuah norma etika tanggung jawab yg universal. Karena jika ada laku dan sikap jahat, seolah kita PERLU bertanya: "Apa agama para pelaku aksi jahat tsb?"

Jika mau konsisten dg norma tanggungjawab yg diutarakan almaghfurlah GD, mungkin tak bermanfaat juga untuk mempertanyakan, menghujat, dan menuduh soal latar belakang agama, suku, ras dari para pelakunya. Kalaupun mereka mengklaim bhw agama tertentu sebagai motivator atau inspirator atau bahkan instruktor, itu hanya sekedar klaim kosong. Dan orang tak perlu repot-repot menanyakan apa latar belakang agamanya. Apalagi menuding bhe agama tertentu bertanggungjawab atas sikap dan laku merusak tsb!

Membaca dan memahami kalimat bijak almaghfurlah GD memerlukan kemampuan utk juga memahami implikasinya secara lebih mendalam. Kata "berbuat baik" bisa saja dipahami dengan sebaliknya. Sehingga efeknya menjadi lebih dahsyat, yakni bahwa gagasan dan aksi serta laku baik dan buruk keduanya adalah tanggungjawab pribadi dan sosial para pemili dan pelakunya.

Wacana dan debat tentang agama yg dikaitkan dg aksi teror lantas tak produktif atau mengajak kita mencari solusi bersama sebagai manusia, bangsa, ummat beragama, dan warganegara. Wacana tsb malah akan dikapitalisasi oleh para pelaku teror dan organisasinya sebagai keberhasilan utk memecah belah, adu domba, saling tuding dsb.!

Saya tentu saja tidak melarang wacana dan debat publik tentang agama dan tanggungjawab sosial dalam kehidupan: ideologi, politik, ekoomi, dan sosial budaya. Namun perlu ada sebuah fokus dan prioritas yg ditujukan kepada pencapaian kemaslahatan kemanusiaan, kebangsaan, dan individual.

Dengan cara demikian kata-kata bijak almaghfurlah GD akan makin relevan secara aktual karena menjadi norma dasar etika tanggungjawab yg universal. IMHO.🙏🤲
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Monday, March 22, 2021

ON THE MUI’S VIEW OF “TRYPSIN ORIGIN” IN THE ASTRAZENECA’S COVID-19 VACCIN


By Lily Hikam*)

Let me start with a rather perplexed statement. When I read the MUI reports on findings on the use of trypsin of porcine origins in the AstraZeneca COVID-19 vaccine, I admit there is some *confusion* on my part when the MUI insisted that the vaccine contained porcine trypsin while AstraZeneca affirmed that their vaccine contained “no material of human or animal origin are used in the growth medium or feed (including no materials manufactured with animal-derived material)” (COVID-19 Vaccine Astra Zeneca Public Assessment Report, pg. 17.)

So, I went and did some research of my own. I read the COVID-19 Vaccine Astra Zeneca Public Assessment Report (1) submitted to the European Medicines Agency (EMA), which is also one of the documents referenced by the MUI in its own report. Unfortunately I couldn’t find the WHO dossier that was sent to BPOM (also referenced in the MUI report). Curiously, I found no reference and no mention of “trypsin”, “porcine trypsin” or any of the tables the MUI report referenced in the document submitted to EMA (Table 2 and Table 3).

However, I did find a reference to how the vaccine was made and “separated from the host”. AstraZeneca claimed that the harvesting process (page 16) involves a detergent-based cell lysis, which is just a fancy way of saying harvesting the cell’s contents by destroying the cell membrane, then treating with nucleases (enzymes that degrade the host cell’s DNA, but not the DNA that will be used as the vaccine) then clarified using depth filtration and then downstream processes to further purify and concentrate the vaccine. Trypsin *was not mentioned at all.* Perhaps because the harvest process described previously negates the use of trypsin that is usually needed to detach cells from the petri dish. And if trypsin was used at all, it is in the process of passaging and maintaining the cell line they used to produce the virus seed.

Next, I looked up the use of T-REx™-293 Cell Line, which is the cell line used to produce this recombinant virus (2). This virus is a genetically modified version of a cell line that we use often in laboratories to produce proteins or expression vectors due to its efficiency in producing them. This T-REx™-293 cell line is propagated using normal culture media and under normal culture conditions. One of the necessary items to maintain this culture is Trypsin, required to detach cells from the petri dish if the researcher wants to move the cells to a bigger dish or do some experiments on the cells. On the manufacturer’s protocol, Trypsin EDTA was listed as “Required item not supplied”. But they wrote it as “Trypsin EDTA or other trypsin solution”, which means the user would have freedom of choice as to which type of Trypsin they utilize for this process. The screenshot provided by MUI’s report is of the “Related Materials” at the end of the product manual which only listed Trypsin-EDTA. *This seems misleading* to me as it gives the impression that this cell line can only be maintained using Trypsin-EDTA, while in reality Trypsin-EDTA or other trypsin solution would suffice.

Biologics nowadays are required to be manufactured in accordance to current good manufacturing practices (cGMP). One of the tenets of cGMP is that materials that are destined for use in the human body (i.e drugs, vaccines, saline solution, vitamins) need to be sterile and free of animal components (xeno-free) or components derived from another species to avoid any adverse reactions by the immune system. As such, there have been many xeno-free reagents or synthetic reagents that have been developed to support this cGMP requirement to replace the conventional use of animal-derived reagents and enzymes. Reagents with animal components in them are usually only used during the research stage (because they’re cheaper) and would not be used during any of the manufacturing process. Even someone like me, who is a novice drug developer, know to avoid any reagents that have animal components during the development process, so I’m quite sure that a multibillion dollar company like AstraZeneca would know better than to use regular Trypsin.

Drawing from the evidence gleaned so far, I remain *unconvinced by MUI’s claims that trypsin of a porcine origin was used in the manufacturing process.* Perhaps more data will be forthcoming in the upcoming days, but for now I remain unconvinced as I’m unable to verify MUI’s assertion using the submitted dossier to the EMA.

*) PhD in Biochemistry, University of California at Irvine (UCI).

 Footnotes:

1. https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-astrazeneca-epar-public-assessment-report_en.pdf

2. https://www.thermofisher.com/order/catalog/product/R71007#/R71007

3. https://www.thermofisher.com/document-connect/document-connect.html?url=https%3A%2F%2Fassets.thermofisher.com%2FTFS-Assets%2FLSG%2Fmanuals%2Ftrexcells_man.pdf&title=VXNlciBHdWlkZTogR3Jvd3RoIGFuZCBNYWludGVuYW5jZSBvZiBULVJFeCBDZWxsIExpbmVz

4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5609845/

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