Prepared by Mufti Adil Farooki MD, Mawlana Mateen A. Khan MD, Dr. Ramzan Judge PharmD, and Dr. Hamdi Lababidi PharmD.
Summary
Menactra, MenQuadfi, Menveo, and Trumenba are permissible (ḥalāl). We cannot issue a ruling on Nimenrix and Bexsero.
Discussion
Quadrivalent and MenB meningococcal vaccines and are highly effective in preventing the spread of meninigitis caused by Neisseria meningitidis. It is routinely mandated in healthcare settings and travel, including hajj. There are currently three approved meningococcal quadrivalent vaccines in the United States, Menactra, MenQuadfi, and Menveo. (Menactra seems to have been discontinued at the time of this article’s publishing. We have retained its discussion below for the sake of posterity.) Nimenrix, is available outside the US. Additionally, there are two Serogroup B meningococcal (MenB) vaccines, Bexsero and Trumenba.
Menactra
In the packet insert of Menactra, the manufacturer describes it as “a sterile, intramuscularly administered vaccine that contains N. meningitidis serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein.” The relevant highlights of the process include growing the bacteria responsible for a particular type of meningitis, Neisseria meningitidis, in agar and media containing beef extract and bovine milk casein. Once enough bacteria are grown, the desired bacterial antigens are isolated from the rest of the bacteria and growth media through repeated washing and purification by centrifugation, detergent precipitation, alcohol precipitation, solvent extraction, and diafiltration. [i]
The antigens are attached to inactivated diphtheria toxin to invoke a greater immune response. The toxin is derived from another bacteria, Corynebacterium diphtheriae, grown in modified Mueller and Miller medium containing beef heart extract. Once enough bacteria are grown, the toxin is washed and purified by ammonium sulfate fractionation and diafiltration.
In essence, the bacteria, permissible by default[ii], are grown in media containing impermissible ingredients.[iii] Both bacteria strains, Neisseria meningitidis and Corynebacterium diphtheriae, have human and animal sources. Since bacteria are of a different essence (māhiya or ḥaqīqah)[iv] from their animal hosts and they are neither a product nor a part (juz) of the hosts, we consider the bacteria to carry an altogether different ruling. The active vaccine elements – antigens and toxoids – are bacterial components that have been sufficiently isolated and purified from impermissible media ingredients. Inactive excipient components of the vaccine are synthetic and permissible.
MenQuadfi
In the packet insert of MenQuadfi, the manufacturer describes it as “a sterile liquid vaccine administered by intramuscular injection that contains Neisseria meningitidis serogroup A, C, W, and Y capsular polysaccharide antigens that are individually conjugated to tetanus toxoid protein.” The antigen and toxoid are bacterially derived and undergo a process of centrifugation, detergent precipitation, alcohol precipitation, solvent extraction, and diafiltration.[v] As with Menactra, the active vaccine elements – antigens and toxoids – are bacterial components that have been sufficiently isolated and purified from impermissible media ingredients. Inactive excipient components of the vaccine are synthetic and permissible.
Menveo
In the packet insert of Menveo, the manufacturer describes it as a sterile liquid vaccine administered by intramuscular injection that contains N. meningitidis serogroup A, C, Y, and W-135 oligosaccharides conjugated individually to Corynebacterium diphtheriae CRM197 protein.”[vi] In a process like Menactra described above, the Neisseria meningitidis and Corynebacterium diphtheriae bacteria are grown in Franz Complete media and CY medium respectively. Rather than diphtheria toxin, the antigens are linked to CRM197 protein. This antigen complex undergoes washing and purification to compose the final vaccine. The vaccine contains no other ingredients.[vii]
Nimenrix
In the packet insert of Nimenrix, the manufacturer describes it as “a tetravalent meningococcal polysaccharide conjugated vaccine consisting of Neisseria meningitidis capsular polysaccharides A, C, W-135 and Y each coupled to tetanus toxoid as a carrier protein.” The vaccine contains sucrose and trometamol as a preservative. [viii] Unfortunately, we could not locate any further information about its manufacturing process. Thus, we cannot issue a ruling about it.
Trumenba
In the package insert of Trumenba, the manufacturer describes it as “a sterile suspension composed of two recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B, one from fHbp subfamily A and one from subfamily B (A05 and B01, respectively). The proteins are individually produced in E. coli.” The proteins are extracted and purified through a series of column chromatography steps. The final drug product contains the proteins, polysorbate 80, and chemical preservatives.[ix] These ingredients are permissible.
Bexsero
Bexsero is formulated with three Neisserial recombinant proteins individually produced in E. coli and outer membrane vesicles antigenic component produced by N. meningitidis. The proteins are separated by centrifugation, filtration, serial chromatography, and filtration. We have not been able to locate information to know whether the membrane vesicles were washed and purified from any potential impermissible ingredients in the growth media. The excipients are aluminum hydroxide, histidine, sodium chloride, and sucrose.[x] The excipients are permissible. Since the status of the membrane vesicles remain unknown, we cannot comment on the permissibility of Bexsero.
[i] Menactra Package Insert: https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Package-Insert—Menactra.pdf
Gotschlich EC, Liu TY, Artenstein MS. Human immunity to the meningococcus. 3. Preparation and immunochemical properties of the group A, group B, and group C meningococcal polysaccharides. J Exp Med. 1969 Jun 1;129(6):1349-65. doi: 10.1084/jem.129.6.1349. PMID: 4977282; PMCID: PMC2138651.
METHOD OF PRODUCING MENINGOCOCCAL MENINGITIS VACCINE FOR NEISSERIA MENINGITIDIS SEROTYPES A, C, Y, and W-135. https://patents.google.com/patent/US20080318285A1/en
FISEK NH, MUELLER JH, MILLER PA. Muscle extractives in the production of tetanus toxin. J Bacteriol. 1954 Mar;67(3):329-34. doi: 10.1128/jb.67.3.329-334.1954. PMID: 13142999; PMCID: PMC357228.
MuslimMed Position Statement: Permissible & Impermissible Antigens, Purification of Permissible Antigens Mixed with Impure Solutions. https://muslimmed.org/2023/11/21/position-statement/
[ii] إِنَّمَا حَرَّمَ عَلَيْكُمُ الْمَيْتَةَ وَالدَّمَ وَلَحْمَ الْخِنزِيرِ وَمَا أُهِلَّ بِهِ لِغَيْرِ اللَّهِ ۖ فَمَنِ اضْطُرَّ غَيْرَ بَاغٍ وَلَا عَادٍ فَلَا إِثْمَ عَلَيْهِ ۚ إِنَّ اللَّهَ غَفُورٌ رَّحِيمٌ (البقرة 173)
احسن الفتاوى، 8:106
اصل ثانی : اشیاء میں اصل اباحت ہے، جب تک حرمت کا یقین نہ ہو۔
[iii] بدائع الصنائع في ترتيب الشرائع، أبو بكر بن مسعود بن أحمد الكاساني الحنفي، كتاب الذبائح والصيود، ج 5، ص 40.
ولا يكره أكل الدجاج المحلي وإن كان يتناول النجاسة؛ لأنه لا يغلب عليه أكل النجاسة بل يخلطها بغيرها وهو الحب فيأكل ذا وذا، وقيل إنما لا يكره؛ لأنه لا ينتن كما ينتن الإبل والحكم متعلق بالنتن؛ ولهذا قال أصحابنا في جدي ارتضع بلبن خنزير حتى كبر: إنه لا يكره أكله؛ لأن لحمه لا يتغير ولا ينتن فهذا يدل على أن الكراهة في الجلالة لمكان التغير والنتن لا لتناول النجاسة ولهذا إذا خلطت لا يكره وإن وجد تناول النجاسة؛ لأنها لا تنتن فدل أن العبرة للنتن لا لتناول النجاسة
[iv] الموجز في أصول الفقه مع معجم أصول الفقه، محمد عبيد الله الأسعدي، دار السلام، ص 151
واصطلاحا : هو كل لفظ يستعمل بمعناه الموضوع له سواء كان الوضع لغة أو شرعا ، أو عرفا أو اصطلاحا ، ففي أي من هذه الجهات الأربع إذا وضع لفظ بإزاء معنى واستعمل فيه من تلك الجهة يسمى « حقيقة »
[v] MenQaudfi Package Insert: https://www.fda.gov/media/137306/download?attachment
MenQuadfi EMA Assessment Report: https://www.ema.europa.eu/en/documents/assessment-report/menquadfi-epar-public-assessment-report_en.pdf
[vi] Menvio Package Insert: https://www.fda.gov/media/78514/download
MenACWY Vaccine (Meningococcal group A, C, W-135 and Y conjugate vaccine). Vaccine Knowledge Project. https://vk.ovg.ox.ac.uk/vk/menacwy-vaccine
[vii] ATCC Medium MD-2906. https://www.atcc.org/~/media/C7BADCCF3D3F42FB969B09D4E8BDB9D1.ashx
[viii] NIMENRIX® Product Monograph. https://pdf.hres.ca/dpd_pm/00043969.PDF
MenACWY Vaccine (Meningococcal group A, C, W-135 and Y conjugate vaccine). Vaccine Knowledge Project. https://vk.ovg.ox.ac.uk/vk/menacwy-vaccine
[ix] Trimenba Package Insert: https://www.fda.gov/media/89936/download
[x] Bexsero Package Insert: https://www.fda.gov/media/90996/download
Bexsero EMA Assessment Report: https://www.ema.europa.eu/en/documents/product-information/bexsero-epar-product-information_en.pdf
Deghmane AE, Taha MK. Product review on the IMD serogroup B vaccine Bexsero®. Hum Vaccin Immunother. 2022 Dec 31;18(1):2020043. doi: 10.1080/21645515.2021.2020043. Epub 2022 Feb 22. PMID: 35192786; PMCID: PMC8986181.
muslimmed.org 