070401P - ISLAMIC LEGAL GUIDELINES ON POLIO VACCINATION IN INDIA

Source:  070401P - ISLAMIC LEGAL GUIDELINES ON POLIO VACCINATION IN INDIA    Tag:  polio epidemiology

Expert opinion presented to the 16th Session of the Fiqh Academy of India held at Jamia Islamia darul Uloom Muhazzabpur Azamghar near Varanasi India on 01st April 2007 by Professor Dr Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Islamic Medicine at the Institute of Medicine University of Brunei Darussalam and Visiting Professor of Epidemiology University of Malaya

SUMMARY
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, Afghanistan, Niger, 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.

The antigen 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.

1.0 BACKGROUND
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%[1] at a cost of USD4 billion over 20 years[2]. At the moment only 6 countries of the world are still endemic and these are either Muslim majority countries (Nigeria, Pakistan, Afghanistan, Niger, 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[3]. Claims have also been made in Northern Nigeria that polio vaccines are contaminated by sterilizing agents that will prevent birth in the future[4]. There are also unproved hypotheses linking polio vaccination to HIV/AIDS[5]. 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[6]. 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[7].

1.2 POLIO OUTBREAK IN INDIA
Childhood 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[8]. 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[9]. The government of India has introduced use of the monovalent oral polio vaccines (mOPV1 & mOPV3) to deal with the situation[10]. It was reported that mOPV1 was given in India to 40 million children in the month of April 2005[11]. Production of mOPV is funded by the Gates Foundation[12].

1.3 THE NATIONAL POLIO SURVEILLANCE PROJECT OF INDIA
The National Polio Surveillance Project (NPSP) was launched in India in 1997[13]. 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.

1.4 POLIO 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[14]. The monovalent vaccine has been found to be more effective than the trivalent vaccine in Uttar Pradesh and Bihar[15]

1.5 MUSLIM CONCERNS
High endemicity 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 VACCINE
2.1 FACTS ABOUT VACCINES IN GENERAL
2.1.1 CHARACTERISTICS 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.

2.1.2 CONTENTS 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 SEROTYPES
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.

2.2 TRIVALENT VACCINE
Oral polio vaccines can be trivalent or monovalent[16]. 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[17].

2.3 MONOVALENT VACCINE
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.

2.4 MANUFACTURE OF OPV
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[18]. 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.

2.5 INDICATIONS OF OPV
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.

2.6 CONTRAINDICATIONS OF OPV
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 OF OPV
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.

Polio vaccines 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 risk altogether[19].

2.8 THE IMMUNIZATION SCHEDULE
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[20].

3.0 ISLAMIC 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
3.1 DISEASE TREATMENT IS PART OF QADAR AND IS NOT CONTRARY TO QADAR
Disease treatment is part of qadar[21]. 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
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[22], against evil, wiqaya min al sharr[23], against greed, wiqaya min al shuhhu[24], against bad acts, wiqayat min al sayi’at[25], against injury/harm, wiqayat min al adha[26], against jealousy, wiqayat min al hasad, against oppressive rulers, wiqaya min al taghoot[27], against annoyance, wiqayat min al adha[28],  and against heat, wiqayat min al harr[29]. 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.

3.3 DISEASE PREVENTION AND QADAR
Disease could 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 infections.

3.4 IMMUNIZATION IS A FORM OF DISEASE PREVENTION
Physicians conceive 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.

4.0 IMMUNIZATION AND PURPOSES OF THE LAW, al tat’iim min mandhuur maqasid al shari’at
4.1 THE PURPOSE OF LIFE
Immunization has 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 OF RESOURCES
Immunization is 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.

5.0 ISSUES IN IMMUNIZATION AND THE PRINCIPLES OF THE LAW, qadhaayat al tat’iim min mandhuur qawa’id al shari”at
5.1 THE PRINCIPLE OF HARM, QAIDAT AL DHARAR
Medical treatment 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 DIFFICULTY
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 OF CERTAINTY
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 tahriim.

6.0 SPECIAL 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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[13] 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.
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[15] www.nature.com [email protected] Number 13, pages 8-9 28th December 2006 – accessed 4th March 2006
[16] http://www.polioeradication.org/content/meetings/MediaMaterials_12OctMediaEvent/mOPVFactSheetfinal.2005.pdf. Website of the Global Polio Eradciation Initiative accessed on 24th February 2007
[17] http://sprojects.mmi.mcgill.ca/tropmed/disease/polio/vaccine.htm fact CDC factsheet on poliomyelitis accessed on 24th February 2007

[18] http://sprojects.mmi.mcgill.ca/tropmed/disease/polio/vaccine.htm fact CDC factsheet on poliomyelitis accessed on 24th February 2007
[21] Tirmidhi K26 B21, K30 B12
[22] Qur’an 2:201, 3:16, 3:191, 3:34, 13:37, 40:7, 40:9, 40:21, 44:56, 52:18, 52:27, 70:11)
[23] Qur’an 86:11
[24] Qur’an 59:9, 64:16
[25] Qur’an 40:9, 40:45
[26] Qur’an 16:81
[27] Qur’an 3:28
[28] Qur’an 16:81
[29] Qur’an 16:81