Gelatin

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Vaccines

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Summary

For Muslims, is porcine gelatin OK in vaccines?

One line is that there is a WHO 2001 letter quoting a 1995 conference ruling involving more than 100 Islamic scholars that porcine gelatin is halal, and this settles the matter (eg gelatin is fine to eat, and no medical justification for eating it is required).

However Islamic opinion is not uniform on the matter - it is currently very much divided on the central question: whether the process of turning pork into gelatin is sufficiently "transforming".

For instance, in Indonesia (certainly from 2009) there is a very clear ruling that porcine gelatin is haram (unclean) - and so its use for medical purposes is only allowed in cases of medical necessity. This is not an isolated case, and if there is a consensus at the moment it is that porcine gelatin is not halal.

And if porcine gelatin must qualify under necessity, rather than just being generally allowed by default, then Fluenz (for instance) does not appear to pass the necessity test.

The Issues In Detail

Is it permissible to use gelatin derived from pigs in vaccines under Islam? It can be possible under two grounds:

  • Transformation ("Istihalah"): if gelatin can be viewed as a completely different substance, and so is inherently clean
  • Necessity: if there is no alternative, it's still OK to use gelatin for important medical purposes

Transformation ("Istihalah")

What all scholars agree on is that something that is haram like pork or beef can become halal if a complete change is made in the structure of the molecules. This transformation is termed "Istihalah".

The difference of opinion comes on pronouncing whether gelatin production goes through enough changes to be regarded as a "complete" change.

One criterion is whether you can still distinguish the source. Eg you have pure table salt (sodium chloride) where the original molecules came from pork. If the salt is pure sodium chloride, you cannot tell whether the salt came from a pig or some other source - the change is then "complete". However, it is possible to distinguish porcine from bovine gelatin, so porcine gelatin fails this criterion.

However you might view a "complete" transformation as one which alters the nature of the substance fundamentally and irreversably. This is a less stringent test, and the process of gelatin manufacture certainly satisfies this criterion.

Incidentally, there is an additional, secondary difference of opinion also on whether only "natual" transformations are necessary. Eg if a pig decomposes in a salt marsh you end up with halal salt eventually - but a chemical process to refine pork to salt in a factory would not qualify - even if the end result would be exactly the same. Clearly gelatin is not halal under this interpretation of "Istihalah", since gelatin production is not a natural process. However this interpretation does seem to be something of a minority view.

Necessity

Medical necessity allows the use of haram ingredients in medicine where:

  • It is reasonably known that the medicine will be effective, and is needed
  • There is no permissible alternative reasonably available
  • This has been established by an expert Muslim doctor who is at least outwardly upright and god-fearing (or, alternatively, it is clearly generally accepted knowledge according to an equivalent standard)

Medical necessity covers cases such as:

  • porcine insulin for managing diabetic health
  • mandatory meningitis vaccinations in order to carry out an obligatory hajj pilgrimage (those making the pilgrimage for the first time)

But medical necessity would not cover such things as a Fluenz vaccination for healthy children - it would fail on at least two counts - that of need (flu does not carry a high level of threat of permanant injury or death to the recipient) and of alternatives (halal flu vaccinations do exist, although they are somewhat less effective).

In general the necessity argument beoomes less clear as we move from vaccines against meningitis, measles, etc (arguably necessary since both diseases can kill) to vaccines more like Fluenz for healthy childen (flu can be very unplesant for anyone but is not practically life-threatening for healthy kids in general).

Islamic Jurisprudence: Multiple Schools (Madhab)

Islam does not operate under a single monolithic set of rulings, eg like the Catholic Church. This means it doesn't really make sense to think in terms of a definitive ruling either for or against porcine gelatin.

The major schools of thought ("Madhab") are:

  • Hanafi (Sunni) - oldest and largest
  • Maliki (Sunni)
  • Shafi'i (Sunni)
  • Hanbali (Sunni)
  • Ja'fari (Shia)
  • Zaidi (Shia)
  • Ibadi (Ibadhi)
  • Zahiri (Sunni)

Positions

UK Government Position

Vaccines and gelatine: PHE response

In 2001, the World Health Organization consulted with over 100 Muslim scholars and confirmed that the gelatine used in medicines is considered transformed. A summary report on the findings of more than one hundred Islamic legal scholars who met in 1995 to clarify Islamic purity laws states the following:

Transformation which means the conversion of a substance into another substance, different in characteristics, changes substances that are judicially impure into pure substances, and changes substances that are prohibited into lawful and permissible substances.

These rulings are accepted widely by Jews and Muslims in many parts of the world, including in the U.S. where a vaccine the same as Fluenz® has been used successfully for over ten years. However, Public Health England (PHE) has consulted the Muslim Council of Great Britain, and acknowledges the diversity in thought within the British Muslim community. We understand, therefore, that some individuals may still consider the porcine gelatine product to be forbidden. In this circumstance, these individuals would still be able to accept some pharmaceutical products containing gelatine but only if there was no suitable alternative and if the product was considered life-saving.

Supporting Scholars

[1]

Some scholars who support the purity of gelatin are:

Pro: Kuwait 1995

July 2001 Letter by the Regional Office of the World Health Organization (WHO) for the Eastern Mediterranean

Decision from a 1995 seminar by the Islamic Organisation for Medical Sciences in Kuwait on "The Judically Prohibited and Impure Substances in Foodstuff and Drugs". Attended by 112 jurisprudents and experts. Drugs and vitamin capsules containing gelatin both OK.

It states that the transformed gelatin in medicine is OK to eat, with no reservation as to purpose (see section 8a):

The Gelatin formed as a result of the transformation of the bones, skin and tendons of a judically impure animal is pure, and it is judically permissible to eat it.

This is by contrast with insulin from pigs, which is only allowed by medical necessity, due to the absence of an alternative (see section 7):

Treatment of diabetes with insulin obtained from a pig source is permissible because of "necessity"

Religious Leaders Approval of Use of Vaccines Containing Porcine Gelatin

Jumping off point for Islam and Judaism

other voices

Anti: Islamic Fiqh Council 1998

This is part of the Muslim World League, a Wahhabi-aligned movement involving 22 countries (with Saudi Arabia providing the largest single contribution to funding). Jurisprudence-wise, Hanbali is closest.

Resolutions of the Islamic Fiqh Council - 15th Session 1419H

The Islamic Fiqh Council during its 15th session held in Makkah Mukarramah between 11-14 Rajab 1419H (31 October – 4 November 1998, studied the issue of gelatin and found that gelatin is a substance which is used in manufacturing the sweets and some kinds of medicine, and it is extracted from animal bone and skin.

After a thorough discussion, the Council decided the following:

First:

It is permissible to use gelatin extracted from the lawful materials as well as from animals slaughtered in accordance with the rulings of Islamic Shari’ah. However, it is not permissible to use gelatin extracted from any prohibited animals or materials such as pig skin and bone.

Second:

The Council recommends to all Muslim countries and companies working in these countries to avoid the import of any thing that is prohibited in the Islamic Shari’ah and provide Muslims with the stuff that is good and lawful (Halal).

Chairman of the Islamic Fiqh Council Abdul Aziz Ibn Abdullah Ibn Baz

Deputy Chairman of the Islamic Fiqh Council Dr. Abdullah Ibn Saleh Al-Obaid

Members: Muhammad Ibn Jubair Abdullah Abdurrahman Al-Bassam Abdurrahman Hamzah Al-Marzooqi Dr. Bakr Abdullah Abu Zaid Mustafa Ahmad Al-Zarqa Dr. Saleh Ibn Fauzan Al-Fauzan Muhammad Ibn Abdullah Al-Subayil Dr. Muhammd Rasheed Al-Qabbani Muhammad Salem Abdul Wadood Dr. Yusuf Abdullah Al-Qardhawi Dr. Muhammad Habeeb Ibn Al-Khojah Mabrook Masood Al-Awaadi Dr. Ahmad Fahmi Abu Sinnah Abul Hasan Ali Al-Nadwi

Research On Distinguishing Porcine Gelatin: Dec 2009

http://www.halal.upm.edu.my/english/images/publications/abstract_IMTGT/3rd%20IMT-GT%20Proceedings.pdf?bcsi_scan_bd03d28dfb03a2fc=0&bcsi_scan_filename=3rd%20IMT-GT%20Proceedings.pdf

2009: INTERNATIONAL SYMPOSIUM ON IMT-GT HALAL SCIENCE AND MANAGEMENT 3

3: Potential Use of Amino Acids Analysis for Distinguishing Bovine And Porcine Gelatins (Norakasha, R., Hashim, D.M., Che Man, Y.B., Shuhaimi, M., and Noorfaizan A.)

21: Comparison of Bovine and Porcine Skin Gelatin based on Amino Acid Composition, Polypeptide Pattern and Gel Strength (Raja Mohd Hafidz, R.N., Che Man, Y.B., Anuar, N.)

Anti: Indonesia 2009-10

MUI : meningitis vaccination not allowed except in emergencies, ANTARA News, Thu, July 23 2009 14:41

The Indonesian Ulema Council (MUI) has issued an edict declaring the use of swine-enxyme-containing meningitis vaccine haram (banned) except in emergencies.

"The use of meningitis vaccine is allowed for those doing an obligatory hajj pilgrimage (those making the pilgrimage for the first time). The vaccine itself remains haram," MUI Chairman KH Ma`ruf Amin said here on Thursday.

[http://www.thejakartapost.com/news/2010/07/20/two-brands-meningitis-vaccine-halal-says-mui.html Two brands of meningitis vaccine halal, says MUI (The Jakarta Post, July 20 2010) ]

The Indonesian Ulema Council (MUI) declared Monday two brands of meningitis vaccine as halal according to Islamic law, thereby allowing its use on Muslims travelling to undertake the haj.

Muslims previously used a vaccine produced by GlaxoSmithKline, which the MUI said contained traces of pig products and had been declared haram, for pre-haj vaccinations.

MUI leader Amidhan Shaberah told The Jakarta Post in a telephone interview that the meningitis vaccine produced by Swiss company Novartis and Chinese company Tian Yuana had been discovered to be halal.

He said that MUI had conducted visits to the factories where the vaccine was made and discovered that Novartis and Tian Yuan vaccines did not involve any elements of pig products in their manufacturing.

Amidhan said that Indonesia had for years been using the Glaxo vaccine, which was declared haram by MUI two years ago because, despite having no traces of swine elements in the final result, the production process included the use of those elements.

“Last year, there was no alternative to Glaxo and since it was considered an emergency, its use was allowed. Since then, [former health minister] Siti Fadilah Supari promised to provide halal vaccines,” he said.

[http://www.thejakartapost.com/news/2010/08/08/no-halal-vaccine-yet-top-pharmacist-says.html No halal vaccine yet, top pharmacist says, (The Jakarta Post, August 08 2010)]

But the top executive of a state-owned vaccine and serum producer said Saturday the ability to produce a porcine-free vaccine was still very far away.

While repeatedly emphasizing his respect for the religious council, Iskandar, the president director of Bandung-based PT Bio Farma insisted that there were currently no halal meningitis vaccines available in the world.

He also said that Indonesia remained the only country where the vaccine remains controversial. In other Islamic or predominantly Muslim countries such as Malaysia and Saudi Arabia, the vaccine has been widely accepted because of the lack of an alternative.

“We fully realize that in producing halal meningitis vaccines we must start with halal seed and nowhere in the world does one exist that is not synthesized from pigs,” Iskandar said on the sidelines of the 6th annual meeting of the Islamic Development Bank on Vaccine Production Self Reliance in Bandung, West Java.

Some of the participants from 12 Islamic countries also expressed surprised at the controversy, saying they allowed the use of the vaccine in cases of emergency and if it served a good purpose. The meningitis vaccine was first produced in 1930s by using swine enzymes.

“In Saudi Arabia, the vaccine did not spark a debate. In Malaysia, it is also no longer an issue. It seems the MUI is very committed to declaring it haram, but that remains the authority of the MUI,” Iskandar said.

Saudi Arabia requires all haj pilgrims — including those on the minor (umroh) pilgrimage — to be inoculated against meningitis. For 10 years, the government allowed the use of GlaxoSmithKline’s vaccine. But last month, the MUI declared the vaccine haram, despite the absence of any traces of swine in the final product. Fifteen Muslim-majority countries including Iran, Egypt, Saudi Arabia, Malaysia and Iraq allow the use of the vaccine.

The MUI recommended replacing the vaccine with ones from Swiss Novartis and China’s Mevac, which it said were halal. MUI leader Amidhan Shaberah told The Jakarta Post he was confident that the two products were halal after visiting the laboratories.

Anti: Malaysia 2011

Istihalah: Analysis on The Utilization of Gelatin in Food Products, 2011 2nd International Conference on Humanities, Historical and Social Sciences IPEDR vol.17 (2011) © (2011) IACSIT Press, Singapore

Paper from Halal Products Research Institute, Universiti Putra Malaysia

Generally, most of Muslim jurist agreed that gelatin derived from slaughtered and permitted animals is halal. However, there is argument on gelatin that is derived from pig and carrion. The halal and haram sources of this matter have been debated among Muslim jurists. Some of them agreed that gelatin extracted from the prohibited sources is haram. Whereas the other opinion supported the idea that gelatin from haram sources is halal because it does already undergo Istihalah process (Hammad, 2004).

All gelatin derived from halal sources and slaughtered according to Islamic Law is permitted for Muslim. Meanwhile, gelatin extracted from pig and not slaughtered animal are prohibited. This prohibition based on the characteristics of gelatin that remains unchanged chemically; hence Istihalah or transformation process in gelatin is not completely occurred. Therefore, the opinion of Muslim jurist that claim gelatin derived from pork are permitted by Istihalah process are not acceptable because it is not parallel with scientific evident.

Anti: Muslim Food Guide (UK)

Islamic Law Regarding Gelatine

If the source of Gelatine is derived from a Halaal source then its usage is permissible, whilst if the source is Haraam or Mashqook [doubtful] then it will be considered Haraam. The hide matrix or gelatine protein is basically a piece of skin, which is hydrollised, washed, melted and extracted, purified, evaporated, sterilised, chilled, dried and granulated for further shelf life and easy use. Alkaline treatment tends to remove amide groups present on certain amino acid residues on the collagen protein chains resulting in a lowering of the isoelectric point and consequently an alteration not a transformation of the chemical and physical properties of the protein occurs. Despite the above method of changing a raw product into gelatine under tremendous chemical pressure still retains much of its chemical equation. The collagen triple helix structure is lost during this procedure but the resultant Gelatine product retains the original coil structure. The aspect of Tabdeel-e-Mahiyyat does not take place.

Muslims should avoid choosing Haraam and doubtful ingredients. If a comparable medication is available in tablet or liquid form it would be advisable to ask for them instead of taking capsules. In the area of food we have such a vast selection of products whereby foregoing a certain brand containing Gelatine should pose no problem. In the UK it is a legal requirement to list ingredients in products and a reference to this guide will indicate what can be consumed or not. Muslim countries as well as local associations should provide finances to initiate and promote research to develop alternate forms to Gelatine to overcome this problem.

Still Under Discussion: 2012

Aasim Padela. (2012). Fiqh Councils & Health Policy Actors: Gaps in the Applied Islamic Bioethics Discourse around Vaccines with Porcine Components. QScience Proceedings: Vol. 2012, Islamic Bioethics: The Interplay of Islam and the West, 4

Published online: 24 Jun 2012

Abstract

During a 1995 meeting of the Islamic Organization for Medical Sciences [IOMS] medical experts and Islamic jurists deliberated on “Judically (sic) Prohibited and Impure Substances in Foodstuffs and Drugs.” The seminar resulted in the religious declaration that “gelatin formed as a result of transformation…of a judicially impure animal (e.g. pig)…is permissible to (consume).” This verdict was disseminated to health policy stakeholders by the Regional Office of the World Health Organization for the Eastern Mediterranean, so as to “relieve all Muslims…from the embarrassment they feel” when taking medicines with gelatin-based products.

More than a decade later in 2009, the Indonesian Ulema Council (MUI) issued a religious verdict, fatwa, declaring the GlaxoSmithKline meningitis vaccine to be impermissible, haram, as a result of the vaccine having porcine gelatin components. This judgment caused an uproar within the pharmaceutical industry and the Indonesian health ministry, as not only was a multi-million dollar market at stake, but the ability of Indonesians to fulfill the religious rite of the Hajj, for which the vaccine is required, was at-risk. The following year the MUI issued another fatwa declaring meningitis vaccines produced by Novartis and Tian Yuana to be porcine-free and thus halal.

In this paper we apply a policy-oriented, applied Islamic bioethics lens to the Islamic bioethical deliberations around the use of vaccines with porcine components. We will illustrate areas of an incomplete dialogue between the biomedical community, the Islamic jurist community, and the health policy community that contribute to misunderstandings and misappropriation of Islamic juridical concepts and rulings. As we analyze these arguments, we will discuss how the biomedical community can help inform about the usage and definition of the concepts of istihala (transformation) and darurah (necessity), as used by jurists in their verdicts. We will then highlight how understanding the roles of the hakim (state authority), the differences between tayyib (pure and good) and halal (permissible), and between the normative ideal and contingent ruling within Islamic ethico-legal debate, can inform the biomedical and health policy communities about the application of Islamic bioethical verdicts.

In this manner, we hope to contribute to efforts aimed at an engagement between science and religion where health promotion is valued, while fidelity to Islamic ethico-legal tradition is maintained. A continued dialogue in the encounter between the Islamic tradition, globalized medicine, and public health will enable Islamic legists to develop an enhanced technoscientific image, and will facilitate health actors to gain greater literacy with the pluralistic Islamic ethico-legal tradition, such that Islamic verdicts and health policies better meet the needs of Muslim communities.

UK Vaccines

MMR: 2003

Muslim babies' MMR jabs have traces of pork Injections illegal under Islamic law, says imam, Herald, Thursday 26 June 2003

The vaccine with gelatin which is used widely in Britain is made by Aventis Pasteur, while Merck makes another vaccine containing porcine gelatin which is used widely across the world, but not in the UK. Another vaccine used in the UK is made by Priorix and is free of the material. However, usage of either one depends on availability. Between them, Aventis Pasteur and Merck have offices in 41 countries across the world, including Arab nations such as Egypt, the Gulf and Saudi Arabia, as well as Indonesia, the world's most populous Muslim nation.

A spokesman for Aventis Pasteur admitted the company was aware of the possible implications of using such ingredients for religious groups. He claimed it was not a problem because the gelatin was broken down into peptides, and was therefore refined and not pure gelatin. He confirmed there was no vegetarian option. He declined to comment on when the company first began using porcine gelatin in MMR. Merck was unavailable for comment.

However, Muslims said the ingredient still would be a concern because it was sourced from pig, and said an alternative to porcine gelatin, such as agar, should be used, or a warning given to all parents who were considering the jab for their child. Mohammad Faroghul Quadri, imam at the Khazra Mosque, Glasgow, said: "The gelatin may be broken down, but those ingredients still come from pork originally. This gelatin from pork is totally illegal under Islamic law."

Fluenz: 2013

Vaccine reasoning claims rejected, Herald, Senior reporter.Saturday 5 October 2013

Dr Syed Ahmed, consultant in public health ­medicine at NHS Greater Glasgow and Clyde, has said all the ­communications used locally were produced by the Scottish ­Government, adding that there are more than 700 medicinal ­products currently in use that contain similar gelatine.

He also said that in England and Wales parents are given a take-it-or-leave-it choice with Fluenz, and reaffirmed Muslim scholars ruled in 2001 that gelatine products were permitted. He insisted there was no need ­apologise and that parents had not been misled.

The Muslim Council of ­Scotland (MCS) said a 2001 ruling cited by health chiefs and ministers for not revealing the vaccine contained pork gelatine actually only allowed the use of pig-derived products if the individual was already ill and no other medicine was available.

The MCS said Islamic Law had the same message, and as the vaccine being rolled out in Scotland's biggest ever immunisation programme was only a precautionary measure, it was advising against its use.

Dr Salah Beltagui, of the MCS, said: "This 2001 ruling on several counts doesn't pass the test. We don't see there is a necessity for using something that has a product which is not halal because this is only a precaution.

"It is not treating a person who is already ill. There is also an alternative available, and for these reasons we have advised against its use. The authorities have a public duty of service under equality legislation to fully inform where something impacts upon religion."

He also said that if the vaccine had been administered to children without the full consent of parents, given facts about the ingredients there should be a full apology.

One problem there is that the ruling is actually from 1995. So has Dr Beltagui actually read the ruling?

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