Prepared by Mawlana Mateen A. Khan MD, Ramzan Judge PharmD, and Mufti Adil Farooki MD.

Quadrivalent meningococcal vaccines 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 two meningococcal quadrivalent vaccines available in the United States, Menactra and Menveo. A third, Nimenrix, is available outside the US.

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]

To invoke a greater immune response, the antigens are attached to inactivated diphtheria toxin. The toxin is derived from another bacteria, Corynebacterium diphtheriae, which is 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, which are 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.

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.”^[v] 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.^[vi]

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.^[vii] Unfortunately, we could not locate any further information about its manufacturing process. Thus, we cannot issue a ruling about it.

In summary, Menactra and Menveo are permissible (ḥalāl). We cannot issue a ruling on Nimenrix.

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[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.

[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] 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

[vi] ATCC Medium MD-2906. https://www.atcc.org/~/media/C7BADCCF3D3F42FB969B09D4E8BDB9D1.ashx

[vii] 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