Polio is a serious
disease. The fate of infected children is: death 10%, mild paralysis 30%, moderate-severe paralysis 30%, and severe paralysis
30%. All over the world 10-20 million live with disabilities due to polio. Polio remains endemic in only 6 countries with
sizeable Muslim populations: Nigeria, India, Pakistan,
and Egypt. A recent polio outbreak in
India raises serious concerns because
it has affected Muslims disproportionately. Muslims are 20% of the Indian population but they account for 66% of polio cases.
Rumors circulate in some Muslim communities that polio vaccination campaigns are an anti-Muslim plot. Community leaders have
turned to religious authorities for guidance regarding response to the epidemic and the targeted vaccination campaigns.
The paper starts
by reviewing the background about polio vaccination world-wide and in India
and then discusses technical details about the polio vaccine: manufacture, use, indications, contraindications, and use. The
polio vaccine used is manufactured by growing the polio virus in monkey kidney cells until the virus is weakened and can not
cause disease if introduced into the body. The vaccine has no preservatives but has residues of antibiotics that may cause
allergies. It also may have other ingredients that should be ascertained from the manufacturer.
is the main component of the vaccine. Preservatives and adjuvants may also be added. The trivalent oral polio vaccine (tOPV)
protects against the three types of polio. The monovalent oral polio vaccine (mOPV) protects against one type. It is mOPV
that is currently used in the Indian polio outbreak. OPV is manufactured b growing viruses in monkey kidney cells until the
virus loses virulence. It has no preservatives but residues of antibiotics may be found. Contamination by other substances
or other viruses is possible. The vaccine is not given to people with previous allergy to OPV, those allergic to neomycin,
streptomycin, or polymyxin B; pregnant women; the immune deficient, or in the presence of certain diseases. The OPV used in
India has a small risk of causing paralysis.
The risk of paralysis from OPV is 1/500,000 on the first dose and 1/12,000,000 on the second dose. Paralysis tends to occur
in areas where vaccination coverage is low. Because of the low risk of paralysis from OPV developed countries like the US and the UK
have stopped using it and have reverted to the earlier killed virus. Polio vaccination is recommended at 6, 10, and 14 weeks
from birth. In endemic areas vaccination at birth is recommended. Booster doses can also be given ages 4-6 years. Extra mass
immunization can be carried out when there are outbreaks. Pulse polio is a special program started by the government of India in 1994 to vaccinate all children below the
age of 5. The program has been criticized for taking away recourses from other public health activities. The program was achieving
its objectives until 2005/2006 when polio outbreaks occurred in some states of India
The paper argues
that vaccination of susceptible children is waajib when disease risk is high and
the vaccine has been proved beyond doubt to give protection and its benefits far outweigh its risks. This ruling is based
on the purpose of the shari’at to protect life, the principle of the shari’at to relieve harm, al dharar yuzaal; and the principle
of the shari’at of public interest, maslahat.
The individual being vaccinated may experience minor side effects but this does not prevent immunization because building
up herd immunity by vaccination of as many people as possible is in the public interest and public interest takes precedence
over individual interest. The paper argues an independent investigation of the situation among Muslims in Bihar
and UP. The investigation should focus on Muslim acceptance of vaccination and what barriers exist to their access. It should
also investigate technical aspects of the vaccination process by visiting the manufacturer’s factory to make sure that
all products used are halal. Manufacturers may ingredients in the vaccine that
are a trade secret and are not publicized unless requested specifically. Sanofi Pasteur India Private Limited is a polio vaccine
manufacturer working at address PO Box 10815 Mehraulih New Delhi 110030 Tel 91-1121658111 and website: www.sanofipasteur.in . Checks are also needed in the endemic areas of Bihar
and Uttar Pradesh on the operation of the cold chain to make sure that the vaccine remains viable until use. Specific studies
should be made about vaccine uptake and viral excretion in Muslim children to discover why they are at a higher risk.
1.1 POLIO ERADICATION
AT THE INTERNATIONAL LEVEL
In 1988 polio was endemic in 125 countries with a total of 350,000 children
paralyzed by polio every year. In that year the World Health Assembly made a decision to eradicate polio. Since then the Global
Polio Eradication Project undertaken by the World Health Organization and other organizations has reduced polio incidence
by 99%[i] at a cost of USD4 billion over 20 years[ii]. At the moment only 6 countries of the world are still endemic and these are either
Muslim majority countries (Nigeria, Pakistan,
and Egypt) or are countries with substantial Muslim populations (India). Rumors circulate in some Muslim communities in Pakistan that polio vaccination campaigns are an anti-Muslim
plot[iii]. Claims have also been made in Northern Nigeria
that polio vaccines are contaminated by sterilizing agents that will prevent birth in the future[iv]. There are also unproved hypotheses linking polio vaccination to HIV/AIDS[v]. These reports cannot be verified at the moment and we cannot take action without
further proof. However the suspicions were strong enough to make the Kano State Government suspend polio vaccination in August
2003[vi]. Polio cases increased after the ban. The ban was not lifted until a new batch of
the polio vaccine was received from Indonesia
a fellow Muslim country[vii].
OUTBREAK IN INDIA
polio has been eradicated in virtually all countries of the world and is now found only in a few countries like India, Afghanistan, and Nigeria. The recent outbreak of polio in India has been found concentrated in 2 states, Uttar Pradesh and Bihar.
The number if cases recorded so far in the year 2006 is 522 of which 438 from UP and 40 from Bihar.
By comparison the number of cases recorded in India
the whole of 2005 was 66[viii]. As a response a mass polio vaccination campaign has been launched in the affected
districts of the 2 states. Two authors from the company that manufactures mOPV1 (Panacea
Biotec Ltd, New Delhi 110044) made the case for using the
monovalent vaccine to deal with the outbreak[ix]. The government of India
has introduced use of the monovalent oral polio vaccines (mOPV1 & mOPV3) to deal with the situation[x]. It was reported that mOPV1 was given in India to 40 million children in the month of April 2005[xi]. Production of mOPV is funded by the Gates Foundation[xii].
NATIONAL POLIO SURVEILLANCE PROJECT OF INDIA
The National Polio
Surveillance Project (NPSP) was launched in India
in 1997[xiii]. It is part of the World Health Polio Eradication Effort (PIE) under the
motto ‘a world without polio’. The global project has succeeded in polio eradication in several countries and
regions that have been declared by WHO to be polio free. NSPS is funded by aid organizations in the US,
UK, Denmark, Japan, and other countries. The Rotary club is among the sources
of financial support. The NPSP strategies are: vaccination of all children with the oral polio vaccine (OPV) that is given
3 times at ages 6, 10, and 14 weeks of infancy to provide protection against all three forms (1,2,& 3) of polio virus.
In addition to this, National Immunization Days (NID) are conducted especially in the affected states of UP and Bihar. Additional doses of OPV are given to every child aged below 5 years at intervals of 4-6 weeks.
This is strategy called polio pulse immunization (PPI) aims at flooding the area with OPV to interrupt any transmission. PPI
is provided at both stationary centers and also by house-to-house search for children. The effort is supplemented by surveillance
for Acute Flaccid Paralysis (AFP). These data are alarming because polio had been decreasing before. Before the current campaign
started 35,000-100,000 cases were reported all over India
annually. By 2005 there were only 66 cases country-wide. Then in 2006-2007 a surge reaching over 30,000 annually was seen.
IN UTTER PRADESH AND BIHAR
For the period January 2006 to February 2007,
32033 cases of AFP were reported all over India.
The highest numbers were in the states of UP 12,487 cases and Bihar 7246 cases with 65% being
in children below 2 years of age. The 2 states have high population densities. The socially disadvantaged Muslim communities
have had a disproportionately higher burden of the disease. Whereas Muslims constitute 20% of the Indian population, they
account for 66% of the cases. The reasons for the recent surge have been given as: decreased house to house coverage of vaccination
attributed to vaccination avoidance by the Muslim community, high population density facilitating child-to-child transmission,
and poor sanitation facilitating transmission. The expert opinion was that the vaccine was effective but that not everybody
received it. British researchers from the Department of Infectious Disease Epidemiology, Imperial College London found that
persistent polio in Bihar and UP despite multiple doses of immunization was due to high population
density and poor sanitation. They suggested use of monovalent vaccines to eradicate the disease[xiv]. The monovalent vaccine has been found to be more effective than the trivalent vaccine
in Uttar Pradesh and Bihar[xv]
1.5 MUSLIM CONCERNS
of polio in Muslim populations both outside and inside India
raises serious issues that require explanation. Without detailed data our explanations can only be tentative and speculative.
It is possible that Muslims generally avoid immunization programs and with low herd immunity they are more susceptible to
polio transmission and paralysis because of low herd immunity. It is also possible that Muslims live in medically under-served
areas and that they have no access to vaccination services. The possibility of discrimination should also be considered that
national vaccination campaigns do not make sufficient efforts to reach all Muslims.
2.0 THE ORAL POLIO
2.1 FACTS ABOUT
VACCINES IN GENERAL
OF AN IDEAL VACCINE
An ideal vaccine
is safe in not causing the disease being prevented or causing side effects due to other components of the vaccine product.
It must be able to provide adequate protection for the individual on being challenged by the organism in question. It must
also contribute to herd immunity at the population level so that disease transmission can be interrupted. These effects must
be long-lasting so that immunization does not have to be repeated frequently. The vaccine must be cheap and easy to administer.
OF A VACCINE
The antigen is
the main component of the vaccine. It is the material that will stimulate the body’s natural immune mechanisms to produce
either cell-mediated or humoral immunity. The antigen may be in the form of an intact organism that is either killed or is
treated to be incapable of causing disease but is still able to elicit immune reaction. The antigen may also be a subunit
vaccine either recombinant DNA proteins or synthetic peptides. Adjuvants are materials added to the vaccine. Preservatives
may also be added. OPV has no preservatives.
2.1 POLIO VIRUS
There are 3 types
of polio virus that cause disease: 1,2, and 3. Type 2 is the easiest to eradicate and its transmission has been interrupted
since 1999. Types 1 and 3 are responsible for the current residual endemicity. Type 3 is now localized in India, Afghanistan and Southern Niger and
Northern Nigeria that are inhabited by the Muslim Hausa tribe.
Oral polio vaccines
can be trivalent or monovalent[xvi]. The trivalent Oral Polio Vaccine (tOPV) provides immunity against all three
types. A single dose of tOPV produces 50% immunity and three doses produce 95% immunity[xvii].
It was found that
the tOPV was less effective because there is competition among the 3 types. To increase effectiveness of monovalent vaccines
(mOPV) have been introduced. Since they consist of only 1 type they give consistently higher protection. mOPV can be used
in a more targeted way because the geographical distribution of virus types is known so only the appropriate vaccine is given
in a given locality. Indian authorities have decided to use mOPV especially in the endemic areas.
The polio viruses
are grown in monkey kidney cells. This attenuates them (makes them too weak to cause disease). They however still retain the
ability to stimulate the body to produce immunity against the virus. The vaccine is dispensed in a plastic container. It has
no preservatives but it contains minute amounts of the antibiotics streptomycin and neomycin[xviii]. Manufacture of mOPV1 is undertaken using funding from the Gates Foundation.
Its quality is controlled by the World Health Organization, the United Nations Children Emergency Fund, Agence Francaise Pour
La Securite Sanitaire des Aliments et des Produits de Sante, National Organization for Drug Control and Research of Egypt,
the Central Drugs Standard Control Organization of India.
OPV is given in
childhood as a preventive measure. It is given as part of mass vaccination during outbreaks of polio. Non-immune adults traveling
to polio endemic areas are also given the vaccine.
People with allergies
to neomycin, streptomycin, and polymyxin B should not take the virus because these antibiotics are found in small quantities
in the vaccine. Children who have had a previous reaction to polio vaccine should not be vaccinated. Immune suppressed children
should not be vaccinated with OPV. Pregnant women and women who are breast-feeding should preferably not be given OPV. In
case of illness it is recommended to wait until recovery before giving the vaccine.
2.7 SIDE EFFECTS
The OPV used in
India has a small risk of causing paralysis.
The risk of paralysis from OPV is 1/500,000 on the first dose and 1/12,000,000 on the second dose. This is because the virus
is live but has been treated to weaken it and stop it from causing disease. Sometimes this does not happen but the risk as
shown above is very low. Paralysis tends to occur in areas where vaccination coverage is low. Because of the low risk of paralysis
from OPV developed countries like the US and the UK have stopped using it and have reverted to the earlier killed virus. The reasoning
being that the risk is high given that polio transmission has been interrupted in those countries.
are prepared in monkey cells and may be contaminated by the SV40 virus that has been suspected but not proved to cause certain
forms of cancer. Large scale studies have not shown an increased risk of cancer in those vaccinated so we can discount this
2.8 THE IMMUNIZATION
is recommended at 6, 10, and 14 weeks from birth. In endemic areas vaccination at birth is recommended. Booster doses can
also be given ages 4-6 years. Extra mass immunization can be carried out when there are outbreaks. Pulse polio is a special
program started by the government of India
in 1994 to vaccinate all children below the age of 5. The program has been criticized for taking away recourses from other
public health activities. The program was achieving its objectives until 2005/2006 when polio outbreaks occurred in some states
BASIS OF IMMINIZATION AS THE CONCEPT OF PREVENTION OF DISEASE, a; ta asil al islami
li al tat’im huwa al wiqaaya min al amraadh
TREATMENT IS PART OF QADAR AND IS NOT CONTRARY TO QADAR
treatment is part of qadar[xxi]. Seeking treatment does not contradict qadar or tawakkul. Disease treatment is part of qadr. The principle that applies
here is reversal of qadar by another qadar
, rad al qadr bi al qadr.
3.2 THE CONCEPT
OF PREVENTION IN THE QUR’AN
has used the concept of wiqaya in many situations to refer to taking preventive
action against entering hell-fire, wiqaya min al naar, against punishment, wiqaya min al adhaab[xxii], against evil, wiqaya min al sharr[xxiii], against greed, wiqaya min al shuhhu[xxiv], against bad acts, wiqayat min al sayi’at[xxv], against injury/harm, wiqayat min al adha[xxvi], against jealousy, wiqayat min al hasad, against oppressive rulers, wiqaya min al taghoot[xxvii], against annoyance, wiqayat min al adha[xxviii], and against heat, wiqayat min al
harr[xxix]. Prevention is therefore one of the fixed laws of Allah in the universe, sunan
llah fi alkawn. Its application to medicine therefore becomes most obvious.
PREVENTION AND QADAR
be prevented before occurrence or could be treated after occurrence. The concept of prevention, wiqayat, does not involve claiming to know the future or the unseen, ghaib,
or even trying to reverse qadar. The human using limited human knowledge attempts
to extrapolate from the present situation and anticipates certain disease conditions for which preventive measures can be
taken. Only Allah knows for sure whether the diseases will occur or not. The human uses knowledge of risk factors for particular
diseases established empirically to predict disease risk. Preventive action usually involves alleviation or reversal of those
risk factors. For example stopping cigarette smoking can prevent lung cancer and ischemic heart disease. Obeying fire regulations
can prevent fire accidents. Careful driving prevents road traffic accidents and trauma. Immunization prevents viral and bacterial
IS A FORM OF DISEASE PREVENTION
of three forms of prevention. Primary prevention is taking measures to stop disease from being initiated. Immunization is
a form of primary prevention. Secondary prevention is detection and treatment of disease which prevents further progress of
the disease. Tertiary prevention is rehabilitation which prevents further complications of the disease.
AND PURPOSES OF THE LAW, al tat’iim min mandhuur maqasid al shari’at
4.1 THE PURPOSE
been proved effective in preventing childhood infectious diseases. It therefore fulfills the purpose of preserving life. Its
benefits are both individual and community. The individual gets individual immunity against the disease. The community develops
what is called herd or population immunity in that the disease cannot be transmitted. Even if an immunized person gets the
disease, he cannot transmit it any further because many who come into contact with him are immune and the organism will die
if it gains entrance to their bodies.
4.2 THE PURPOSE
a very cost-effective way of dealing with infectious disease. The cost of immunization is only a small fraction of the cost
of treating the disease and its complications. Also to be counted are costs of pain, suffering, anxiety, and loss of earnings
during recovery from disease. In some cases residual disability occurs even after recovery.
IN IMMUNIZATION AND THE PRINCIPLES OF THE LAW, qadhaayat al tat’iim min mandhuur
qawa’id al shari”at
PRINCIPLE OF HARM, QAIDAT AL DHARAR
is justified on the basic principle is that injury, if it occurs, should be relieved, al dharar yuzaal. Immunization
is justified under the principle that injury should be prevented or mitigated as much as is possible, al dharar yudfau
bi qadr al imkaan. However injury should be minimized according to the principle of la dharara wa la dhirar. When
an injury is found in a patient it is presumed to be of recent origin unless there is evidence to the contrary, al dharar
la yakuun qadiiman. It therefore must be alleviated. Thus focal polio outbreaks should be treated and it should not be
assumed that they are endemic and should be left alone. Immunization to prevent disease should not leads to side effects of
the same magnitude as the disease, al dharar la yuzaal bi mithlihi.
In a situation
in which immunization has side effects, we follow the principle that prevention of a harm has priority over pursuit of a benefit
of equal worth, dariu an mafasid awla min jalbi al masaalih. If the benefit has far more importance and worth than
the harm, then the pursuit of the benefit has priority. In the case of polio the benefits far outweigh the risks that are
in any case very rare. In the case of polio vaccination there is no haram material
but if there were, we would be in a situation in which halaal (immunization) and haram
(prohibited materials) co-exist. The guidance of the Law is that the prohibited has priority of recognition over the permitted
if the two occur together and a choice has to be made, idha ijtama'a al halaal wa al haram ghalaba al haraam al halaaal.
There are 2 evils in the immunization program. The bigger injury is the disease
and the lesser injury are the side effects of immunization. In such a case and without an alternative, the lesser harm is
committed, ikhtiyaar ahwan al sharrain. A lesser harm is committed in order to prevent a bigger harm, al dharar
al ashadd yuzaalu bi al dharar al akhaff. Polio immunization as described before builds up population immunity to interrupt
disease transmission. Vaccinated children release the virus in their stools and unvaccinated children who get into contact
also acquire immunity. Therefore vaccination is in the public interest. Medical interventions that in the public interest
have priority over consideration of the individual interest, al maslahat al aamat muqaddamat ala al maslahat al khaassat.
The individual may have to sustain some risk in order to protect public interest, yatahammalu al dharar al khaas li dafiu
al dharar al aam. In the course of preventing polio and fighting its outbreaks, the state cannot infringe the rights of
the public unless there is a public benefit to be achieved, al tasarruf ala al ra'iyat manuutu bi al maslahat.
5.2 THE PRINCIPLE
of hardship is applied to immunization only in the situation of interrupting the lives of the families who have to go to vaccination
centers or allow vaccinators into the home. It would have found wider application if there was prohibited materials in the
vaccine. Necessity legalizes the prohibited, al dharuraat tubiihu al mahdhuuraat.dharuurat. In the medical setting
a hardship is defined as any condition that will seriously impair physical and mental health if not relieved promptly. Hardship
mitigates easing of the sharia rules and obligations, al mashaqqa tajlibu al tayseer. This is predicated on the general
principle of Islam as an easy religion that cannot be made difficult and a burden for its followers, al ddiin yusr wa lan
yashaada hadha al ddiin illa ghalabahu. The law is relaxed in restrictive situations, al amr idha dhaaqa ittasa.
The law is restrictive in lax situations, al amr idha ittas’a dhaqa. Committing the otherwise prohibited action
should not extend beyond the limits needed to preserve the Purpose of the Law that is the basis for the legalization, al
dharuraat tuqaddar bi qadriha. Necessity however does not permanently abrogate the patient’s rights that must be
restored or recompensed in due course; necessity only legalizes temporary violation of rights, al idhtiraar la yubtilu
haqq al ghair. The temporary legalization of prohibited medical action ends with the end of the necessity that justified
it in the first place, ma jaaza bi ‘udhri batala bi zawaalihi. This can be stated in al alternative way if the
obstacle ends, enforcement of the prohibited resumes, idha zaala al maniu, aada al mamnuu’u.
5.3 THE PRINCIPLE
Certainty, yaqeen, as a situation when there is no shakk
or taraddud, does not exist in medicine. Everything is probabilistic and relative.
Vaccinated children may get polio and the unvaccinated may not get the disease even if exposed to it. Using the best available
medical evidence we adopt practical procedures. This provides for stability and a situation of quasi-certainty without which
practical procedures will be taken reluctantly and inefficiently. In this case we apply the principle of the Law that a certainty
cannot be voided, changed or modified by an uncertainty, al yaqeen la yazuulu bi al shakk. When an assertion is an
established truth, it should not be changed by a mere doubt being raised about all or some of its components. Existing assertions
should continue in force until there is compelling evidence to change them, al asl baqau ma kaana ala ma kaana. All
medical procedures are considered permissible unless there is evidence to prove their prohibition, al asl fi al ashiya
al ibaaha. Exceptions to this rule are conditions related to the sexual and reproductive functions. All matters related
to the sexual function are presumed forbidden unless there is evidence to prove permissibility, al asl fi al abdhai al
SITUATION OF MUSLIMS IN INDIA
The situation of
polio in India is unique being found in
a higher proportion among Muslims and in specific areas of the country. The paper argues an independent investigation of the
situation among Muslims in Bihar and UP. The investigation should focus on Muslim acceptance
of vaccination and what barriers exist to their access. It should also investigate technical aspects of the vaccination process
by visiting the manufacturer’s factory to make sure that all products used are halal
and checking the cold chain to make sure that the vaccine remains viable until use. Specific studies should be made about
vaccine uptake and viral excretion among Muslim children.
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[ii] Aylward RB, Sutter RW, Heymann DL. Policy. OPV cessation--the final step to a "polio-free"
world. Science. 2005 Oct 28;310(5748):625-6.
[viii] The Times of India
February 27, 2007
[ix] Chatterjee A, Chawla A. Monovalent polio immunisation--a strategy for India. J Indian Med Assoc. 2005 Dec;103(12):682-5.
[x] Anonymous. Progress toward poliomyelitis eradication--India, January 2005-June 2006. MMWR Morb Mortal Wkly Rep. 2006 Jul 21;55(28):772-6.
[xi] Aylward RB, Sutter RW, Heymann DL. Policy. OPV cessation--the final step to a "polio-free"
world. Science. 2005 Oct 28;310(5748):625-6.
[xii] Indian J Med Sci. 2005 Jan;59(1):46-7.
[xiii] http://www.npspindia.org accessed 24th February 2007. This is the official website of the National
Polio Surveillance Project a collaborative effort with the World Health Organization.
[xiv] Grassly NC, Fraser C, Wenger J, Deshpande JM, Sutter RW, Heymann DL, Aylward RB.
New strategies for the elimination of polio from India.
Science. 2006 Nov 17;314(5802):1150-3.
[xv] www.nature.com News@Nature Number 13, pages 8-9 28th December 2006 – accessed
4th March 2006
[xxi] Tirmidhi K26 B21, K30 B12
[xxii] Qur’an 2:201, 3:16, 3:191, 3:34, 13:37, 40:7, 40:9, 40:21, 44:56, 52:18, 52:27,