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Title
Permissibility of Boostrix
Question
بسم الله الرحمن الرحيم
I am trying to determine if some vaccines and medications are permissible to use, but one issue that several of them have is that they are produced through bacteria in cellular mediums. These mediums have cells of either human or animal origin and would be considered impure/impermissible. But the final product is filtered to remove the medium and other material. Here is an example, taken from the information provided by the manufacturer for the vaccine "Boostrix": "Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration." So that last part says that the desired toxins are isolated through the methods mentioned. The final list of "ingredients" of the vaccine does not list any components from the cellular medium as being included: "Each 0.5-mL dose is formulated to contain 0.3 mg aluminum (not more than 0.39 mg by assay) as aluminum hydroxide as adjuvant, 4.4 mg of sodium chloride, ≤100 mcg of residual formaldehyde, and ≤100 mcg of polysorbate 80 (Tween 80)." But the issue is that there does not seem to be any data or studies that have evaluated if the final product is actually completely free of the impure medium components. The manufacturer states that following about the presence of animal material in the final product: https://www.gskusmedicalaffairs.com/docviewer.html?cmd=GSKMedicalInformation&medcommid=MED--US-1402&token=23108-caf1af07-640d-478c-a81e-89c1720de814&dns=gsk-medcomms.veevavault.com Basically, no "analytical verification" about the presence of animal products in the vaccine. So I guess the issue is, if we know for sure that there is impurity present prior to the isolation process, can we just assume that it has been removed and therefore say that the final product would be ok? I am wondering if you can find any reference for this type of situation, for example a situation in which 99.9% of an impurity is removed. I am hesitant to give a ruling based on assumption without some type of textual backing.
Answer
الجواب حامدا ومصليا

The vaccine “Boostrix” is administered to protect against whooping cough, tetanus, and diphtheria. Regarding its manufacturing process, the FDA states the following:

Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.”

Boostrix involves the usage of mediums that are derived from bovine casein, but it also goes through an extensive filtration process with the final list of active and inactive ingredients for a 0.5 mL dose containing the following:

  • No less than 2 IU of diphtheria toxoid;
  • No less than 20 IU of tetanus toxoid;
  • 8 micrograms of pertussis toxoid, 8 micrograms of pertussis toxoid, 8 micrograms of filamentous haemagglutinin, and 2.5 micrograms pertactin;
  • Aluminum hydroxide;
  • Aluminum phosphate;
  • Formaldehyde polysorbate 80;
  • Sodium chloride; and
  • Glycerin and water for injections.[1]

Although the final list of ingredients does not state if any bovine extract remains, other vaccines, such as the IPOL vaccine, also follow similar aspects of preparation with an extensive filtration process. However, residual amounts of bovine serum are found in the final product.[2] Additionally, no conclusive verification has taken place to certify if any animal-based material has been filtered out.

Due to these factors, we have been unable to ascertain whether the end product is truly free of any haram ingredients, and one cannot assume that the Boostrix is free of such ingredients after knowing that it contained them. Therefore, in such a scenario, one cannot take this vaccine. If an expert Muslim doctor informs one that no other vaccine containing only halal ingredients is available and there is a medical necessity to take such a vaccine, then it would be permissible to do so.[3]

And Allah knows best.

Mf. Ozaifa Chohan
Graduate, Darul Iftaa Chicago

Checked and Approved:

Mf. Abrar Mirza
Head Mufti, Darul Iftaa Chicago


[1]“Boostrix” FDA, accessed November 14, 2022
https://www.fda.gov/vaccines-blood-biologics/vaccines/boostrix

“Medicines/pharmaceuticals of animal origins” Queensland Health, accessed November 14, 2022
https://www.health.qld.gov.au/__data/assets/pdf_file/0024/147507/qh-gdl-954.pdf

“Boostrix- Vaccine for Whopping Cough, Tetanus and Diphtheria” Clinical Trials Arena, accessed November 14, 2022
https://www.clinicaltrialsarena.com/projects/boostrix-vaccine-whooping-cough-tetanus-diphtheria/

“Boostrix Vaccine” Immunization Info, accessed November 14, 2022
https://immunizationinfo.com/boostrix-vaccine/

“Boostrix” Medical News Today, accessed November 14, 2022
https://www.medicalnewstoday.com/articles/boostrix#about

“Boostrix” MedSafe, accessed November 14, 2022
https://www.medsafe.govt.nz/Consumers/cmi/b/boostrix.pdf

[2]“IPOL- Poliovirus Vaccine Inactivated (Monkey Kidney Cell)” FDA, accessed November 14, 2022
https://www.fda.gov/vaccines-blood-biologics/vaccines/ipol-poliovirus-vaccine-inactivated-monkey-kidney-cell

[3]التداوي بلبن الأتان إذا أشار إليه لا بأس به هكذا ذكر في بعض المواضع وفيه نظر لان لبن الأتان حرام والاستشفاء بالمحرم حرام.
(الفتاوى الولوالجية، كتاب الكراهية، الفصل الثامن: ٢/٣٤٣؛ العلمية)

التداوي بلبن الأتان إذا أشاروا إليه لا بأس به هكذا ذكر صدر الشهيد رخمه الله تعالى وفيه نظر لأن لبن الأتان حرام والاستشفاء بالحرام حرام وما قال صدر الشهيد فهو غير مجرى على إطلاقه فإن الاستشفاء بالمحرم إنما لا يجوز إذا لم يعلم أن فيه شفاء أما إذا علم أن فيه شفاء وليس له دواء آخر غيره يجوز الاستشفاء به
(المحيط البرهاني، كتاب الكراهية والاستحسان، الفصل التاسع عشر:٨/٨٢؛ إدارة القرآن)

[بمحرم كالخمر ونحوها] قيل يجوز التداوي بالمحرم كالخمر والبول ان أخبره طبيب مسلم أن فيه شفاء والحرمة ترتفع بالضرورة فلم يكن متداويا بالحرام فلم يتناوله حديث النهي كما في حاشية أخي حلبي لكن فيه كلام كما لا يخفى تأمل
(مجمع الأنهر، كتاب الكراهية، فصل في المتفرقات: ٤/١٧٧؛ العلمية)

ولا بأس بأن يسعط الرجل بلبن المرأة ويشربه للدواء وفي شرب البن المرأة للباغ من غير ضرورة اختلاف المتأخرين كذا في القنية ولو أن مريضا أشار إليه الطبيب بشرب الخمر روي عن جماعة من أئمة بلخ أنه ينظر إن كان يعلم يقينا أنه يصح حل له التناول وقال الفقيه عبد الملك حاكيا عن أستاذه أنه لا يحل التناول كذا في الذخيرة ولا يجوز أن يداوي بالخمر جرحا أو دبر دابة... يجوز للعليل شرب الدم والبول وأكل الميتة للتداوي إذا أخبره طبيب مسلم أن شقائه فيه ولم يجد من المباح ما يقوم مقامه مسلم أن شقائه فيه ولم يجد من المباح ما يقوم مقامه
(الفتاوى الهندية، كتاب الكراهية، باب التداوي والمعالجات: ٥/٤٣٥؛ العلمية)

وقال في موضع آخر إن أهل الطب يثبتون نفعا للبن البنت للعين وهي من أفراد مسألة الانتفاع بالمحرم للتداوي كالخمر واختار في النهاية والخانية الجواز إذا علم فيه الشفاء ولم يجد دواء غيره بحر
(رد المحتار، كتاب البيوع، مطلب في التداوي بلبن البنت للرمد قولان: ٥/٧١؛ سعيد)

ومعنى قوله عليه الصلاة والصلام السلام لم يجعل شفائكم فيما حرم عليكم نفي الحرمة عند العلم بالشفاء دل عليه جواز إساغة اللقمة بالخمر وجواز شربه لإزالة العطش
(الفتاوى البزازية، كتاب الكراهية، الخامس في الأكل: ٢/٤٨٣-٤٨٤؛ العلمية)

(فتاوى محمودية، كتاب الحظر والإباحة، كتاب التداوي والمعالجة: ١٨/٣٤٧؛ الفاروق)

July 11, 2024 Food & Drink