Prepared by Mawlana Dr. Mateen A. Khan, MD and Dr. Ramzan Judge, PharmD
Summary
Permissible influenza vaccines in the US for 2020-2021 season
FluadTM Trivalent
FluadTM Quadrivalent
Fluzone High-DoseTM Quadrivalent
AfluriaTM
FluarixTM
FluLavalTM
FluzoneTM Quadrivalent
Impermissible influenza vaccines in the US for 2020-2021 season
FlublokTM
FluMistTM
FlucelvaxTM
Discussion
Background on Influenza
Influenza (commonly known as the flu) is a seasonal viral illness carrying significant health, economic, and social burden. For the past nine years, the Centers for Disease Control and Prevention (CDC) estimates that every year 9.3-49 million symptomatic illnesses, 4.3-23 million medical visits, 140,000-960,000 hospitalizations, and 12,000-79,000 deaths are attributed to seasonal influenza. For the 2017-2018 season, which was considered high severity, a study estimated influenza vaccination prevented:
7.1 million illnesses
3.7 million medical visits
109,000 hospitalizations (10% of expected overall and 41% among young children)
In addition to providing immunity to healthy individuals, the vaccine benefits the sick by decreasing the amount of exposure from other individuals (herd immunity). Hence, the CDC, along with most American medical organizations, recommends that every person above six months old receive a seasonal influenza vaccine yearly.[ii]
Improving vaccination rates among Muslims has been a struggle. Muslim majority countries find their populations hesitant. [iii] Similar issues are faced among Muslim minority populations in the West over a concern for the presence of impermissible ingredients in the vaccine.[iv]
The United States currently offers nine different commercially prepared vaccines. We reviewed package inserts and public records for the vaccines to evaluate methods of production and the presence of impermissible products. When necessary, we corresponded with the manufacturers. The results are compiled in Table 1. The vaccines vary in their methods of production and ingredients, which may pose religious challenges for Muslims.
Issue #1 – Methods of Production
Influenza vaccines are prepared through three different processes. Most strains are prepared through an egg-based manufacturing process. This involves injecting vaccine viruses into fertilized chicken eggs. Essentially, the egg is commandeered as a factory by the viruses as they use the egg’s resources to replicate themselves. The viruses are extracted and purified.[v] Islamically, this process per se is not an issue as eggs are considered permissible.
Flucelvax™, a product by Seqirus, is made by incubating influenza viruses in a particular animal cell line, Madin-Darby Canine Kidney (MDCK).[vi] The MDCK cell line was initially isolated in 1958 from an adult Cocker Spaniel dog.[vii] Dogs, like all predators, are ḥarām as Sayyidunā Ibn `Abbās (May Allah be pleased with him) narrated that Allah’s Messenger ﷺ prohibited every predator possessing canine teeth.[viii] Further, when cells like MDCK are removed from an animal, they are considered maytah (carrion) in Islamic terminology. The Prophet ﷺ informed us, “Whatever is cut from an animal while it is alive is carrion.”[ix] Surah al-An`ām states a ruling of najis and ḥarām for carrion.
“Say, “I do not find, in what has been revealed to me, anything prohibited for anyone who eats it, unless it be carrion or blood that pours forth, or flesh of swine – because it is impure.”[x]
Hence, the initially harvested canine cells were najis and ḥarām. Since 1958, the cell line has undergone countless replication cycles in artificial environments, and the parent cells have long died off. Still, being the progeny cells, they will be impure and impermissible.
The MDCK cells used in Flucelvax™ are grown in a medium in which no human or animal-derived materials are used.[xi] After an incubation period, the cells are processed through lysis, and the virus proteins undergo extraction and purification. Despite this, residual amounts of the cells capable of inducing allergic reaction in susceptible patients remain, per the package insert. For these reasons, Flucelvax™ vaccine made from this method is impermissible.
FlublokTM manufactured by Sanofi, is produced by genetically engineering proteins expressed by influenza into an alternate virus, baculovirus (Autographa californica). It is then used to infect an insect cell line (ExpresSF+) derived from the fall armyworm (Spodoptera frugiperda), which produces the desired influenza proteins. This vaccine is especially valuable to those who have severe allergies to eggs. [xii] Insects, like the armyworm, fall into the category of al-khabā’ith explicitly mentioned in the Qur’an as ḥarām in Surah al-A`rāf.
[He ﷺ] makes unlawful for them impure things (al-khabā’ith).[xiii]
Similar to animal cell lines discussed previously, the progeny ExpresSF+ cells are impure and impermissible. Hence, FlublokTM vaccine made from this method is also impermissible.
Issue #2 – Porcine Gelatin as a Stabilizer
Two of the vaccines available in the United States, FluMistTM and Flucelvax™, contain porcine gelatin. The gelatin is added as a stabilizer for the viral vaccine protein. Gelatin is hydrolyzed collagen, which is extracted from collagen-containing tissue like skin and bones. At the outset, the Qur’an declares that all porcine parts are najis and ḥarām.
Say, “I do not find, in what has been revealed to me, anything (out of the cattle under discussion) prohibited for anyone who eats it, unless it be carrion or blood that pours forth, or flesh of swine – because it is impure – or there be an animal slaughtered sinfully by invoking on it the name of someone other than Allah. (Surah al-An`ām:145)[xiv]
He has but prohibited for you the carrion, the blood, the flesh of swine and what has been invoked upon with a name other than that of Allah. (Surah al-Naḥl:115)[xv]
In earlier times, gelatin was prepared in homes through a process of cooking, causing the collagen to hydrolyze and break into peptides of varying lengths. Although the process today is commercialized and done through a series of chemical reactions, extraction, and purification, the result is not much different from home preparations. These peptides do not constitute a significant change from the original porcine collagen. Instead, gelatin is just fragmented hydrolyzed collagen. The resulting gelatin is impermissible.[xvi] Hence, FluMistTM and Flucelvax™ are impermissible particularly when other permissible alternatives exist.
Exceptional Cases
If someone is unable to take or obtain one of the permissible influenza vaccines, and they are relatively healthy, they should not take an impermissible vaccine.[xvii] However, if a strong need exists, then they may take those vaccines that are normally impermissible. An example of a strong medical need is when there is a high likelihood (ghalabah al-ẓann) of significant morbidity or mortality in contracting influenza such as in the very old or patients with pre-existing significant comorbidities. Ideally, the Sharī`ah prefers a competent Muslim physician to determine this need based upon the evidences at hand. The physician should be pious and have a basic understanding of the relevant Sharī`ah rulings.[xviii] Vaccinations mandated by the government, work places, or schools may also constitute a strong need.[xix] In any of these situations, one may take (in order of preference) FlublokTM, FluMistTM, and FlucelvaxTM.
Conclusion
Of the ten commercially available influenza vaccines available in the US for the 2020-2021 season, seven are Islamically permissible: FluadTM Trivalent, FluadTM Quadrivalent, Fluzone High-DoseTM, AfluriaTM, FluarixTM, FluLavalTM, and FluzoneTM Quadrivalent. The Muslim public is advised to avoid FlublokTM, FluMistTM, and FlucelvaxTM.
In exceptional cases, as outlined above, one may take FlublokTM, FluMistTM, and FlucelvaxTM in that order.
Of note, vaccine formulations are subject to change year to year. The research presented here is accurate for the 2020-2021 season.
Table 1: 2020-2021 Influenza Vaccines
[i] Rolfes, M.A. (2019). Effects of Influenza Vaccination in the United States During the 2017–2018 Influenza Season. Clinical Infectious Diseases, ciz075, doi.org/10.1093/cid/ciz075.
[iii] Ahmed, A. (2018) Outbreak of vaccine-preventable diseases in Muslim majority countries. Journal of Infection and Public Health, 11 (2), 153-155. doi.org/10.1016/j.jiph.2017.09.007
[xi] European Medicines Agency Assessment Report on Flucelvax Tetra. 18 Oct. 2018. Pg. 14.
[xii] Barr, I. G. (2018). Cell culture-derived influenza vaccines in the severe 2017-2018 epidemic season: a step towards improved influenza vaccine effectiveness. NPJ vaccines, 3, 44. doi:10.1038/s41541-018-0079-z
[xvi] Respectfully, the minority opinion considering gelatin to have undergone a significant transformation (tabdīl al-mahiyah) rendering its ruling changed seems doubtful for the reasons outlined. This is an extensive discussion. However, with the availability of clearly ḥalāl alternatives, the opinion given in this article is more cautious.
[xvii] The authors are currently unaware of any clinical scenario in which an Islamically permissible vaccine is contraindicated. The CDC recommends egg cultured vaccines even in patients with prior anaphylactic reactions to eggs. (See: https://www.cdc.gov/flu/prevent/egg-allergies.htm) This statement is included as a hypothetical clinical scenario.
Prepared by Mufti Adil Farooki, MD, Shaykh Mateen Khan, MD and Dr. Ramzan Judge, PharmD
Summary:
The injectable vaccine Typhim Vi is permissible for Muslims as a vaccine for typhoid fever and is preferred over oral Vivotif.
Background:
Enteric fever, also known as “typhoid fever”, is a severe systemic illness characterized by fever and abdominal pain caused by the bacteria Salmonellaenterica serotype Typhi. Typhoid fever infects roughly 21.6 million people (incidence of 3.6 per 1,000 population) and kills an estimated 200,000 people every year[1].
“People who are actively ill with typhoid fever and people who are carriers of the bacteria that cause typhoid fever can both spread the bacteria to other people. When someone eats or drinks contaminated food or drink, the bacteria can multiply and spread into the bloodstream, causing typhoid fever.
Typhoid fever can be a life-threatening disease. Symptoms of infection include persistent high fever, weakness, stomach pain, headache, diarrhea or constipation, cough, and loss of appetite.
People who do not get treatment can continue to have fever for weeks or months. As many as 30% of people who do not get treatment die from complications of typhoid fever. There are fewer antibiotic treatment options as drug-resistant typhoid bacteria has become more common in many parts of the world.
Typhoid fever is common in many regions of the world, including parts of East and Southeast Asia, Africa, the Caribbean, and Central and South America. Typhoid fever is not common in the United States.”
CDC Indications for Vaccination:
According to the CDC, routine typhoid vaccination is not recommended in the United States, but is recommended for[3]:
Travelers to parts of the world where typhoid is common. (NOTE: typhoid vaccine is not 100% effective and is not a substitute for being careful about what you eat or drink.)
People in close contact with a typhoid carrier.
Laboratory workers who work with Salmonella typhi bacteria.
Vaccines Available in the United States
There are two typhoid vaccines available in the United States: Vivotif, an oral vaccine, and Typhim Vi, an injectable vaccine.
Contains: purified Vi polysaccharide, formaldehyde, phenol, polydimethylsiloxane, disodium phosphate, monosodium phosphate, sodium chloride, sterile water
Culture Medium: semi-synthetic medium. Casein derived raw materials are used early in manufacturing during the fermentation process
Discussion and Recommendations:
For Muslims who require typhoid vaccination, the injectable form, Typhim Vi, is permissible to use. The capsule form, Vivotif, contains bovine gelatin, which is hydrolyzed collagen extracted from collagen-containing tissue like skin and bones. The cows from which this material is derived are not slaughtered in accordance with Islamic law. Due to the difference of opinion regarding bovine gelatin’s permissibility for consumption, it is preferable and more cautious for Muslims to use the injectable form of the vaccine.
From an Islamic perspective, preventing a health threat such as typhoid fever in high-risk patients is considered to be a necessity[6]. People for whom typhoid vaccination is indicated are considered to be at high risk for getting the infection with a significant potential for serious complications[7], and infections may be difficult to treat due to rising antibiotic resistance[8]. Although the injectable form is preferred, Muslims may use the oral form if the injectable form is not accessible or is contraindicated (due to allergies or hypersensitivity).
A vaccine is a “product that stimulates a person’s immune
system to produce immunity to a specific disease, protecting the person from
that disease”[1]. Vaccination
is the process of administrating a vaccine, most commonly by an injection, with
the immediate goal of achieving “active immunity” in the recipient of the
vaccine. Active immunity involves the “stimulation
of the immune system to produce antigen-specific humoral (antibody) and
cellular immunity”, and can last for many years, sometimes even a lifetime[2]. Vaccination
benefits the immunized patient directly and also indirectly benefits
unimmunized people through “community immunity”. This occurs when there are enough people who
are immune to an infection to decrease the risk of its transmission, and it
also protects people who cannot receive vaccines due to young age or other
contraindications[3].
Studies have shown that vaccination is one of the most
effective preventative health measures. After
routine childhood vaccines were introduced, the number of cases for most
vaccine-preventable diseases has dropped by over 90% in the United States[4].
According to statistical models, for children born between 1994 and 2013, it is
estimated that routine vaccination will prevent 322 million illnesses, 21 million hospitalizations,
and 732,000 deaths over the course of their lifetimes[5].
Issue: Impermissible Ingredients in Vaccines
Based on the above findings the benefits of vaccination are
clear. In the United States, routine
vaccination is required for public-school children in all 50 states, with possible
exemptions varying by state.[6]
In certain industries such as healthcare, employees are required to receive
vaccination for their own protection as well as the protection of patients. However,
many vaccines contain ingredients that are considered impermissible for Muslims
to consume, regardless of whether they are ingested or injected. Some examples
are porcine gelatin, calf serum and material from growth mediums that include
human, chicken, and monkey cells[7].
If a permissible version of a particular vaccine is not available, then a
question arises: is it permissible for a Muslim to receive that vaccine, given
that he or she does not currently have that disease and is not guaranteed to be
infected by it in the future?
Principle: Necessity Permits the Unlawful
A general principle in Islamic law is that: “الضرورات تبيح المحظورات”, or “necessity permits the forbidden”, to the extent of the need[8]. Preservation of health and safeguarding of possessions are considered to be a necessity (ضرورة), and this includes protection from serious illness and death. Something that is otherwise unlawful can be allowed to occur when a person fears that his health or possessions would be harmed, even if he does not have absolute certainty the harm will actually occur. In other words, the expectation of a particular outcome (غلبة الظن) is considered to be sufficient. According to the principles of Islamic law, this “expectation” is simply defined as thinking that an outcome is more likely to occur than not occur. [9] In other words, if there is greater than a 50% expectation that a particular outcome will occur, then this is considered to be “ غلبة الظن ”.
For example:
If a person is sick and (based on his experience or on
the advice of a doctor) he expects to get worse if he fasts during Ramadan, he
would be excused from fasting that day and can make up the fast after Ramadan.[10]
If a person is sick and he expects (based on his
experience or the advice of a doctor) that performing wudu would make his
sickness worse or prolong it, he can perform tayammum[11]
A person performing salah must break his salah if he fears
that a blind person may fall into danger and he is able to prevent that
person from falling into harm. [12]
A person performing salah can break his salah if he
fears that a thief will steal his possessions if he were to remain busy in
prayer[13]
The Importance of Avoiding Populational Harm
These examples apply to the preservation of an individual’s
health and safeguarding of possessions. In each case, the threat of harm to an
individual (ضررخاص) permitted something that is normally unlawful. According to
the principles of Islamic law, the preservation of populational health and
wealth is even more important and emphasized. Therefore, avoiding populational harm is given
preference to avoiding harm to an individual[14].
There are numerous examples in which something that is otherwise unlawful and causes
harm to an individual is allowed or even required to occur in order to preserve
the health and wealth of (i.e. prevent harm to) a group of people[15]. This applies even when there is an expectation
(غلبة
الظن)
of some populational
harm, not only when the harm is already occurring or is certain to occur.[16]
Examples include:
Forcing landowners to create a dam around a river on
their property when there is fear that the water will flood and harm other
people[17],[18],[19]
Putting restrictions on the type of business
transactions that a person can engage in when it is feared that he will harm
others by his reckless spending habits, cheating or inability to conform with rules
of Islamic law[20]
Preventing a doctor from practicing or a judge from
ruling due to their ineptitude in order to prevent potential harm to others
Forcibly taking down the wall of a privately-owned
building when the wall is leaning on a public path and there is fear that it
will collapse onto the path and harm people[21]
Forcibly selling the possessions of a person in debt in
order to avoid continued harm to those whom he owes money [22]
Forcibly selling the food of a person who is hoarding it
in times of famine in order to aid the general population, even if he refuses
to sell it[23]
Application
of these Principles to Vaccination
The
examples above illustrate the following principles of Islamic law:
Necessity
permits the unlawful, to the extent of the need
Preservation of
health is considered to be a necessity, therefore avoiding serious
threats to health is also
considered to be a necessity
An expectation
of harm is sufficient to be considered as a threat to health, defined as being
more likely than not that the harm would occur (greater than 50% expectation).
Based on #2 and
#3, an expectation of harm can be considered necessary to avoid and therefore
can allow for the unlawful to be permitted when there is no permissible
alternative
The preservation
of populational health is emphasized more than the preservation of individual
health
Based on
these principles, we have seen that in order to prevent a potential harm to the
larger population (ضرر عام), a subset of the population is subjected to something that is
normally unlawful (ضرر خاص). These principles can be
applied to determine if Muslims can use vaccines when there is only an
impermissible version of the vaccine available. If it is determined that a necessity (ضرورة) exists, then this vaccine
would be administered to a portion of the population in order to prevent harm
(in terms of morbidity/mortality) to the general population. In other words, something that is unlawful and
involves consumption of impermissible ingredients (ضرر
خاص) would be
permitted to be used in order to prevent harm to the greater population (ضرر
عام) if
necessity is established.
Also, as in
the examples discussed, there is an expectation(غلبة
الظن)
that the harm will
occur, but not certainty. This expectation
of harm is based on the known epidemiology of the infection and on clinical
trials. And as in the examples above, the
use of something that is unlawful is only allowed to the extent of the
need. In the case of vaccination, if a version
of the vaccine with permissible ingredients becomes available, then it would no
longer be necessary to use versions with impermissible ingredients to achieve immunization.
In that case, Muslims would be required to only use the version with
permissible ingredients. This is in line with rulings given by contemporary Islamic
scholars stating that vaccines with impermissible ingredients can be used when
there is no permissible alternative if there is a need to use the
vaccine.
Variables
to Consider for an Infectious Disease and its Vaccine
In order to
apply these principles to an infectious disease, it is necessary to establish
that there is a necessity (ضرورة) to be immunized from it. Multiple
variables need to be considered in order to establish this, such as:
Morbidity and Mortality
This data needs to be analyzed in order to understand the
level of necessity (ضرورة) for immunization from
that infection. The examples discussed
earlier do not mention a specific number of people that need to be saved from
death or illness, but rather stress the importance of preventing harm to a
group of people. In these examples, only
a small group of people was threatened compared to the general population, such
as in the case of a structure being removed if an unstable wall threatens
people passing by, and this was still considered to be potential populational
harm (ضرر
عام). In the case of infectious diseases, medical
data needs to show that there is a significant impact on the morbidity and
mortality of the population, such as serious illness requiring hospitalization
or resulting in death.
Population-Specific Data
The level of risk to the general vs specific populations needs
to be analyzed. In some cases, the level
of morbidity and mortality may not affect a significant proportion of the general
population but may be higher in a subset of the population. An example would be
the pneumococcal vaccine for adults, which is recommended for ages 65 and above
and those with certain chronic medical conditions[24]. In these subsets of the population, there is
a greater prevalence of and risk of complications from the infection compared
to healthy adults under 65. Therefore,
the data may show that necessity (ضرورة) for the vaccine is limited to a subset of the
population.
Effectiveness of the Vaccine
Data on the impact of the vaccine on reducing the morbidity
and mortality of an infection needs to be analyzed. In the examples we have discussed, an unlawful
action can be allowed due to necessity only because it is expected to prevent a
harm. For this to apply to a vaccine,
data needs to support that there is a significant decrease in the morbidity or
mortality from the infection that is immunized against.
Example: Data for Routine Childhood Vaccinations
Routine childhood vaccination under the “Vaccines for
Children” program began in 1993 and initially included vaccines for diphtheria,
tetanus, pertussis, polio, Haemophilus influenzae type b disease, hepatitis B,
measles, mumps, and rubella. Five additional vaccines were later added to the
program: influenza, hepatitis A, varicella, pneumococcal disease, rotavirus. The program provides cost-free vaccines to
children in the United States who lack health insurance or are otherwise unable
to pay for vaccines[25].
Data was analyzed for vaccines
administered through this program, and as mentioned above, statistical models
estimate that for children born between 1994 and 2013, 21 million
hospitalizations and 732,000 deaths will be prevented during their lifetimes. Data for each individual infection is
presented in the table below, with cases measured in the thousands:
(Click image to enlarge. Table is reproduced from MMWR 2014 Apr;63(16):352-5.)
Applying the principles discussed earlier, we first need to establish that there is a necessity (ضرورة) for immunization from diseases for which vaccination with impermissible ingredients is being considered. As stated above, this can be established by data on morbidity and mortality, both of which can be derived from the table above. Serious illness requiring hospitalization and deaths represent morbidity and mortality from these infections that would be expected to occur (غلبة الظن) if the vaccine was not administered.
We also need to establish that the vaccine is effective in
removing the expected harm from the infection.
The data above can be used for
this purpose as well, as it represents morbidity and mortality that is expected
to be prevented by the use of each vaccine.
We also need to determine if there is a need to use a form of
a vaccine that has Islamically impermissible ingredients. This can be
determined by analyzing the ingredients of each form that is available on the
market and accessible to patients. If a form
of the vaccine with permissible ingredients is available, then there would be
no need to use the one with impermissible ingredients. For example, analysis of influenza vaccines
for the 2019-2020 flu season found that permissible
forms are available in the United States[26].
Therefore, impermissible forms cannot be used by Muslims unless an impermissible
form is specifically required in individual circumstances.
Some vaccines are only available in combination with others. In that case, the combined data for the
infections that are immunized against should be considered.
Below are some examples of infections for which necessity (ضرورة) can be established based on
the data presented. In each case, the data leads to an expectation (غلبة
الظن) of
significant populational harm (ضرر عام):
Diphtheria, Tetanus, Pertussis: the vaccine for
diphtheria is only available in combination with either tetanus or tetanus and
pertussis for young children in the United States[27].
In combination, these infections are expected to cause approximately 7.8
million hospitalizations and 528,000 deaths if the vaccine is not given.
Measles, Mumps, Rubella: the vaccines for these
infections are only available in combinations in the United States[28]. In combination, these 3 infections are
expected to cause approximately 144 million hospitalizations and 58,000 deaths
if the vaccine is not given.
Hepatitis B: this infection is expected to cause
623,000 hospitalizations and approximately 60,000 deaths if the vaccine is not
given
Pneumococcus-related diseases: Infections in the form of pneumonia, otitis
media and invasive disease are expected to cause approximately 900,000
hospitalizations and 55,000 deaths if the vaccine was not given
Once necessity (ضرورة) is established for
immunization from these infections, then further investigation into the available
forms of the vaccines for these infections can be done to determine if Muslims have
permissible options, or if an impermissible form must be used, as discussed
above.
Conditions
for Applicability
For a
vaccine that contains impermissible ingredients to be considered permissible to
use, the following conditions must be met:
Need for immunization from the
infection– this can
be established based on epidemiologic data on morbidity and mortality
Definition of the Target Population: is the need for immunization
established for the general population vs a subset of the population?
Effectiveness of Vaccine: The vaccine needs to have a
significant impact on the morbidity/mortality of the target population
Lack of availability of a permissible
alternative – if a form
of a particular vaccine is produced and is accessible for the target
population, then there would no longer be a necessity to use the impermissible form
Limitations
This work
is not meant to be a legal verdict (or fatwa) regarding the permissibility of
any specific vaccine. Rather, it
provides a legal basis upon which a potential verdict can be given. A verdict can be given for a particular
vaccine based on analysis of medical data and based on recommendations of
medical personal in consultation with Islamic scholars
Conclusion
Based on
the principles of avoiding populational harm and of necessity permitting the
unlawful, Muslims may receive necessary vaccines with impermissible ingredients
when there is no alternative form with permissible ingredients.
[5] Whitney
CG, Zhou F, Singleton J, Schuchat A, Centers for Disease Control and Prevention
(CDC). Benefits from immunization during the vaccines for children program era
– United States, 1994-2013, MMWR 2014 Apr;63(16):352-5.
[9], دار الفكر القواعد
الفقهية وتطبيقاتها في المذاهب الأربعة 1:97
والشك: هو التردد بين النقيضين بلا
ترجيح لأحدهما على الآخر، أو هو التردد في وقوع الشيء وعدم وقوعه على السواء،
وبينه وبين اليقين الظن، أو الظن الغالب.
وهو ترجيح أحد الطرفين على الآخر بدليل
ظاهر يبني عليه العاقل أموره، لكن لم يطرح الاحتمال الآخر، ويقابل الظنَّ الوهمُ،
وهو الجانب المرجوح لدليل أقوى منه، والفقهاء يريدون بالشك مطلق التردد سواء كان
الطرفان سواء أو أحدهما راجحاً، وعلماء الأصول يفرقون بين الشك والظن.
مطلب قطع الصلاة يكون حراما ومباحا
ومستحبا وواجبا.[تتمة] نقل عن خط صاحب البحر على هامشه أن القطع يكون حراما ومباحا
ومستحبا وواجبا، فالحرام لغير عذر والمباح إذا خاف فوت مال، والمستحب القطع
للإكمال، والواجب لإحياء نفس.
[14] الْأَشْبَاهُ وَالنَّظَائِرُ, دار الكتب العلمية 1:75
[24] CDC.
Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal
polysaccharide vaccine for adults with immunocompromising conditions:
recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR
Morb Mortal Wkly Rep. 2012;61(40):816.
Prepared by Shaykh Mateen A. Khan, MD and Dr. Ramzan Judge, PharmD
Summary
Permissible influenza vaccines in the US for 2019-2020 season:
Fluad™
Fluzone High-Dose™
Afluria™
Fluarix™
FluLaval™
Fluzone™ Quadrivalent
Impermissible influenza vaccines in the US for 2019-2020 season:
Flublok™
FluMist™
Flucelvax™
Discussion
Background on Influenza
Influenza (commonly known as the flu) is a seasonal viral illness carrying significant health, economic, and social burden. For the past nine years, the Centers for Disease Control and Prevention (CDC) estimates that every year 9.3-49 million symptomatic illnesses, 4.3-23 million medical visits, 140,000-960,000 hospitalizations, and 12,000-79,000 deaths are attributed to seasonal influenza. For the 2017-2018 season, which was considered high severity, a study estimated influenza vaccination prevented:
7.1 million illnesses
3.7 million medical visits
109,000 hospitalizations (10% of expected overall and 41% among young children)
8,000 deaths1
In addition to providing immunity to healthy individuals, the vaccine benefits the sick by decreasing the amount of exposure from other individuals (herd immunity). Hence, the CDC, along with most American medical organizations, recommends that every person above six months old receive a seasonal influenza vaccine yearly.2
Improving vaccination rates among Muslims has been a struggle. Muslim majority countries find their populations hesitant.3 Similar issues are faced among Muslim minority populations in the West over a concern for the presence of impermissible ingredients in the vaccine.4
The United States currently offers nine different commercially prepared vaccines. We reviewed package inserts and public records for the vaccines to evaluate methods of production and the presence of impermissible products. When necessary, we corresponded with the manufacturers. The results are compiled in Table 1. The vaccines vary in their methods of production and ingredients, which may pose religious challenges for Muslims.
Challenge #1 – Methods of Production
Influenza vaccines are prepared through three different processes. Most strains are prepared through an egg-based manufacturing process. This involves injecting vaccine viruses into fertilized chicken eggs. Essentially, the egg is commandeered as a factory by the viruses as they use the egg’s resources to replicate themselves. The viruses are extracted and purified.5 Islamically, this process per se is not an issue as eggs are considered permissible.
Flucelvax™, a product by Seqirus, is made by incubating influenza viruses in a particular animal cell line, Madin-Darby Canine Kidney (MDCK).6 The MDCK cell line was initially isolated in 1958 from an adult Cocker Spaniel dog.7 Dogs, like all predators, are ḥarām as Sayyidunā Ibn `Abbās (may Allah be pleased with him) narrated that Allah’s Messenger ﷺ prohibited every predator possessing canine teeth.8 Further, when cells like MDCK are removed from an animal, they are considered maytah (carrion) in Islamic terminology. The Prophet ﷺ informed us, “Whatever is cut from an animal while it is alive is carrion.”9 Surah al-An`ām states a ruling of najis and ḥarām for carrion.
“Say, “I do not find, in what has been revealed to me, anything prohibited for anyone who eats it, unless it be carrion or blood that pours forth, or flesh of swine – because it is impure.”10
Hence, the initially harvested canine cells were najis and ḥarām. Since 1958, the cell line has undergone countless replication cycles in artificial environments, and the parent cells have long died off. Still, being the progeny cells, they will be impure and impermissible.
The MDCK cells used in Flucelvax™ are grown in a medium in which no human or animal-derived materials are used.11 After an incubation period, the cells are processed through lysis, and the virus proteins undergo extraction and purification. Despite this, residual amounts of the cells capable of inducing allergic reaction in susceptible patients remain, per the package insert. For these reasons, Flucelvax™ vaccine made from this method is impermissible.
Flublok™ manufactured by Sanofi, is produced by genetically engineering proteins expressed by influenza into an alternate virus, baculovirus (Autographa californica). It is then used to infect an insect cell line (ExpresSF+) derived from the fall armyworm (Spodoptera frugiperda), which produces the desired influenza proteins. This vaccine is especially valuable to those who have allergies to eggs.12 Many insects, like the armyworm, fall into the category of al-khabā’ith explicitly mentioned in the Qur’an as ḥarām in Surah al-A`rāf.
[He ﷺ] makes unlawful for them impure things (al-khabā’ith).13
Similar to animal cell lines discussed previously, the progeny ExpresSF+ cells are impure and impermissible. Hence, Flublok™ vaccine made from this method is also impermissible.
Issue #2 – Porcine Gelatin as a Stabilizer
Two of the vaccines available in the United States, FluMist™ and Flucelvax™, contain porcine gelatin. The gelatin is added as a stabilizer for the viral vaccine protein. Gelatin is hydrolyzed collagen, which is extracted from collagen-containing tissue like skin and bones. At the outset, the Qur’an declares that all porcine parts are najis and ḥarām.
Say, “I do not find, in what has been revealed to me, anything (out of the cattle under discussion) prohibited for anyone who eats it, unless it be carrion or blood that pours forth, or flesh of swine – because it is impure – or there be an animal slaughtered sinfully by invoking on it the name of someone other than Allah. (Surah al-An`ām:145)14
He has but prohibited for you the carrion, the blood, the flesh of swine and what has been invoked upon with a name other than that of Allah. (Surah al-Naḥl:115)15
In earlier times, gelatin was prepared in homes through a process of cooking, causing the collagen to hydrolyze and break into peptides of varying lengths. Although the process today is commercialized and done through a series of chemical reactions, extraction, and purification, the result is not much different from home preparations. These peptides do not constitute a significant change from the original porcine collagen. Instead, gelatin is just fragmented hydrolyzed collagen. The resulting gelatin is impermissible.16 Hence, FluMist™ and Flucelvax™ are impermissible particularly when other permissible alternatives exist.
Exceptional Cases
If someone is unable to take one of the permissible vaccines (e.g., an egg allergy), but they are relatively healthy, they should not take an impermissible vaccine. However, if a strong need exists, then they may take those vaccines that are normally impermissible. An example of a strong medical need is when there is a high likelihood (ghalabah al-ẓann) of significant morbidity or mortality in contracting influenza such as in the very old or patients with pre-existing significant comorbidities. Ideally, the Sharī`ah prefers a competent Muslim physician to determine this need based upon the evidences at hand. The physician should be pious and have a basic understanding of the relevant Sharī`ah rulings.17 Vaccinations mandated by the government, work places, or schools may also constitute a strong need.18 In any of these situations, one may take (in order of preference) Flublok™, FluMist™, and Flucelvax™.
Conclusion
Of the nine commercially available influenza vaccines available in the US for the 2019-2020 season, six are Islamically permissible: Fluad™, Fluzone High-Dose™, Afluria™, Fluarix™, FluLaval™, and Fluzone™ Quadrivalent. The Muslim public is advised to avoid Flublok™, FluMist™, and Flucelvax™.
In exceptional cases, as outlined above, one may take Flublok™, FluMist™, and Flucelvax™ in that order.
Of note, vaccine formulations are subject to change year to year. The research presented here is accurate for the 2019-2020 season.
Acknowledgment
We request Allah ta`āla to send special blessings on Mufti Faisal al-Mahmudi for his invaluable assistance.
Table 1: 2019-2020 Influenza Vaccines
1 Rolfes, M.A. (2019). Effects of Influenza Vaccination in the United States During the 2017–2018 Influenza Season. Clinical Infectious Diseases, ciz075, doi.org/10.1093/cid/ciz075.
3 Ahmed, A. (2018) Outbreak of vaccine-preventable diseases in Muslim majority countries. Journal of Infection and Public Health, 11 (2), 153-155. doi.org/10.1016/j.jiph.2017.09.007
11 European Medicines Agency Assessment Report on Flucelvax Tetra. 18 Oct. 2018. Pg. 14.
12 Barr, I. G. (2018). Cell culture-derived influenza vaccines in the severe 2017-2018 epidemic season: a step towards improved influenza vaccine effectiveness. NPJ vaccines, 3, 44. doi:10.1038/s41541-018-0079-z
16 Respectfully, the minority opinion considering gelatin to have undergone a significant transformation (tabdīl al-mahiyah) rendering its ruling changed seems doubtful for the reasons outlined. This is an extensive discussion. However, with the availability of clearly ḥalāl alternatives, the opinion given in this article is more cautious.
