What the World's religions teach, applied to vaccines and immune globulins R W J M a A R R 2 A A K R B V A I C p 0 h Vaccine 31 (2013) 2011– 2023 Contents lists available at SciVerse ScienceDirect Vaccine j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / v a c c i n e eview hat the World’s religions teach, applied to vaccines and immune globulins ohn D. Grabenstein ∗,1 erck Vaccines, 770 Sumneytown Pike, WP97-B364, West Point, PA 19426, USA r t i c l e i n f o rticle history: eceived 20 October 2012 eceived in revised form 1 December 2012 ccepted 7 February 2013 vailable online 26 February 2013 eywords: eligion eliefs accines ntibodies mmune globulins a b s t r a c t For millennia, humans have sought and found purpose, solace, values, understanding, and fellowship in religious practices. Buddhist nuns performed variolation against smallpox over 1000 years ago. Since Jenner developed vaccination against smallpox in 1796, some people have objected to and declined vaccination, citing various religious reasons. This paper reviews the scriptural, canonical basis for such interpretations, as well as passages that support immunization. Populous faith traditions are considered, including Hinduism, Buddhism, Jainism, Judaism, Christianity, and Islam. Subjects of concern such as blood components, pharmaceutical excipients of porcine or bovine origin, rubella strain RA 27/3, and cell-culture media with remote fetal origins are evaluated against the religious concerns identified. The review identified more than 60 reports or evaluations of vaccine-preventable infectious-disease outbreaks that occurred within religious communities or that spread from them to broader communities. In multiple cases, ostensibly religious reasons to decline immunization actually reflected concerns about vaccine safety or personal beliefs among a social network of people organized around a faith community, rather than theologically based objections per se. Themes favoring vaccine acceptance included transfor- mation of vaccine excipients from their starting material, extensive dilution of components of concern, the medicinal purpose of immunization (in contrast to diet), and lack of alternatives. Other important features included imperatives to preserve health and duty to community (e.g., parent to child, among neighbors). Concern that ‘the body is a temple not to be defiled’ is contrasted with other teaching and quality-control requirements in manufacturing vaccines and immune globulins. Health professionals who counsel hesitant patients or parents can ask about the basis for concern and how the individual applies religious understanding to decision-making about medical products, explain facts about content and processes, and suggest further dialog with informed religious leaders. Key considerations for observant believers for each populous religion are described. © 2013 Elsevier Ltd. All rights reserved. ontents 1. Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2012 2. Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2012 3. Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2013 3.1. Populous religious groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2013 3.1.1. Hinduism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2013 3.1.2. Buddhism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2013 3.1.3. Jainism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2013 3.1.4. Judaism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2014 3.1.5. Christianity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2014 3.1.6. Islam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2. Vaccine components and processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2.1. Bacteria, viruses, cell substrates . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2.2. WI-38 and MRC-5 cell lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ∗ Tel.: +1 215 652 6695; fax: +1 215 652 8833. E-mail address: john grabenstein@merck.com 1 JDG is an employee of Merck & Co., Inc., Whitehouse Station, NJ. This work represents racticing Roman Catholic his entire life, and has explored religious aspects of immuniza 264-410X/$ – see front matter © 2013 Elsevier Ltd. All rights reserved. ttp://dx.doi.org/10.1016/j.vaccine.2013.02.026 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2016 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2017 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2017 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2017 the author’s opinions and not those of Merck & Co. The author has been a tion since the 1990s. dx.doi.org/10.1016/j.vaccine.2013.02.026 http://www.sciencedirect.com/science/journal/0264410X http://www.elsevier.com/locate/vaccine mailto:john_grabenstein@merck.com dx.doi.org/10.1016/j.vaccine.2013.02.026 2012 J.D. Grabenstein / Vaccine 31 (2013) 2011– 2023 3.2.3. Rubella virus strain RA 27/3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2017 3.2.4. Porcine excipients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2018 3.2.5. Bovine excipients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2018 3.2.6. Misunderstandings of vaccine production or content . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2018 3.2.7. Pathogen route of exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2018 4. Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2019 5. Personal note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2020 Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2020 Appendix A. Supplementary data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2020 . . . . . . 1 i c c b c d s d M a g o m b p r o K d o s v o c r s i c s i w t r h s c [ m p c m o n a 6 n References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Background People conducting immunization programs may encounter ndividuals who hesitate, question, or decline some or all vac- ines or immune globulins based on religious beliefs or related ultural reasons. Such matters are intensely personal and may e disconcerting for health professionals not comfortable dis- ussing religious issues or who usually make immunization ecisions based on matters more closely aligned to quantitative ciences. The word religion derives from the Latin religio or religionem, escribing respect for the sacred or reverence for God or gods [1,2]. ultiple definitions of religion have been proposed, but religions re fundamentally sets of beliefs about God or spirituality held by roups of people. Like all groups, religious groups develop their wn systems of culture. And yet, as we will see, behaviors of like- inded individuals are not necessarily related to the theological asis of their religions. “Religious” differs from “theological,” in art, as social differs from scholarly. Religious concerns about immunization have a long history, eaching back to those who rejected Edward Jenner’s 1796 mode f smallpox vaccination as contrary to God’s will [3]. In the United ingdom, the Anti-Vaccination League formed in 1853 in Lon- on to oppose compulsory vaccination acts [3–6]. Similar events ccurred in the Netherlands and elsewhere [6]. In the United States, everal Boston clergymen and devout physicians formed the Anti- accination Society in 1879 [3,4,6–8]. In contemporary cases, such bjections involve blood products, porcine or bovine pharmaceuti- al excipients, or the remote fetal origins of cell-culture media and ubella strain RA 27/3. In contrast, it is also worth remembering that ome of the earliest descriptions of variolation to prevent smallpox nvolved the proponency of Buddhist religious women [9]. Individual rights are deeply embedded in many cultures. With ontagious diseases, though, vaccine and immune globulin deci- ions may affect more than an individual’s health. This occurs f a parent chooses to withhold immunization from a child or here vaccine-exempting people increase the infectious risk of heir neighbors. Numerous examples of vaccine-preventable outbreaks among eligious schools, congregations, and communities illustrate ow clusters of vulnerable people can enable epidemics, even preading beyond those foci to neighboring, well-immunized ommunities [12–15]. Published examples include diphtheria 16,17], Haemophilus influenzae type b [18,19], hepatitis A [20,21], easles [22–51], mumps [52–55], pertussis [19,33,50,51,56,57], oliomyelitis [19,33,45,58–70], and rubella [45,71–80,82]. Tetanus ases have also resulted [50,51,83]. These infections occurred in ultiple countries (including transmission across borders and ceans) and among a range of cultural traditions and socioeco- omic situations, leading directly to hospitalizations, disabilities, nd deaths. In several analyses, the risk of measles or pertussis was –35 times higher among people claiming exemption to immu- ization, compared with the general population [32,33,84]. This . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2020 elevated risk applies regardless of the faith tradition involved. The infectious risk has nothing to do with religious denomination or righteousness of the objection. To paraphrase the Book of Genesis (chapter 4, verse 9), vaccine recipients are their brother’s keepers, as contributors to herd protection. This review is intended to provide a factual and contextual basis for discussions about religious concerns about vaccines and immune globulins, as well as the role of religion in promoting immunization. The perspective taken here is that of religious insti- tutions and authorities, as they would teach their doctrines to believers. It is important to note that there may be differences between what individual believers profess and what their canon- ical texts teach. Indeed, different sects within a faith tradition can interpret the same scriptural passages differently. Vaccines did not exist when the Torah, Bible, Qur’ān, or major Sanskrit texts were originally written. Subsequent interpretations are fundamental to how contemporary believers approach immunization. This review is not intended to criticize or argue against any religious beliefs, but rather to objectively describe the basis from which the beliefs arise, as well as various religious positions that may enable or even expect immunization to be conducted. The goal is a clearer understanding of the nature of some motivations for or objections to immunization, how broadly or narrowly the objections tend to be applied, and to help dispel misunderstanding. Philosophical objections to immunization are beyond the scope of this article. Respectful consideration of religious beliefs within a clinical set- ting is important because medicine and religion come together to frame and enlighten choices made by patients as well as health pro- fessionals [4,45,68,85,86]. Scientists and clinicians confront moral and ethical choices daily and often observe a religious faith that helps guide their own personal conduct. Indeed, the religious beliefs of countless historical and contemporary researchers and clinicians have been a source of motivation to help relieve human suffering by means of immunization. 2. Methods To identify professional and lay documents related to the acceptability or unacceptability of vaccines and immune globu- lins based on religious beliefs, PubMed and Google databases were searched using the search terms [outbreak and religion], [vaccine and religion], and [vaccine and “name of specific religious group”], specifying each of the world’s religions estimated to have at least 5 million adherents: Bahá’í Faith, Buddhism, Christianity, Confu- cianism, Daoism, Hinduism, Islam, Jainism, Judaism, Shinto, and Sikhism. Also searched were populous denominations within the Christian tradition: Roman Catholicism, Eastern Orthodox and Ori- ental Orthodox Churches, Amish, Anglican, Baptist, Church of Christ (Scientist), Church of Jesus Christ of Latter-day Saints (including “Mormon”), Congregational, Dutch Reformed Congregations, Epis- copalian, Jehovah’s Witnesses, Lutheran, Methodist, Pentecostal, Presbyterian, and Seventh-Day Adventist. J.D. Grabenstein / Vaccine 3 Table 1 Notable scriptural passages. 1A. Hindu Texts: Bhagavad Gı̄tā 3.14. Shikshapatri śloka 16 and 31 1B. Sayings of the Buddha: Sermon at Benares. Dhammapada X:130 and XV:204. Sāmaññaphala-sutta. Sigālovāda-sutta, Advice to Sigāla. Bodhicharyavatara of Santideva III 1C. Hebrew Bible: Genesis 4:9, Leviticus 11:7–8, 11:10–11, 19:16, and 19:19, Deuteronomy 4:9, 14:7–8, 22:1–4, and 22:8, and Proverbs 23:12–13 1D. Christian New Testament:Passages cited to support immunization: Mark 7:18–23, Luke 10:33–35, Luke 14:1–6, 1 Corinthians 10:24, 2 Timothy 1:14, James 2:8, and 3 John 1:2. Passages cited in declining immunization: Matthew 10:7–8 and 15:13, Mark 2:17 [Note similarities with Luke 5:30–31 and Matthew 9:10–12] and 5:34, and 1 Corinthians 3:16–17; 6:19–20. Consider also (C), with regard to Old Testament 1E. Jehovah’s Witnesses: Genesis 9:3–4, Leviticus 17:10–14, and Acts of the Apostles 15:28–29 1F. Qur’ān: 2:173, 5:3, 5:4, 16:81, 16:116, 30:30. F T c G s e i c C 3 3 s t i t D g a w a 3 o f c i ( T S f I V e i i H b a b t a s ull text of these passages appears in the Supplemental material. hese selected scriptural passages should be interpreted in context with text pre- eding and following them. All documents identified via PubMed were assessed. For the oogle searches, at least the top 50 entries for each individual earch were evaluated, more when the search results delivered rel- vant documents. After each search, reference lists were scanned to dentify other relevant documents. Religious reference books were onsulted [1,2], as well as key scriptural texts (e.g., Hebrew Bible, hristian New Testament, Qur’ān, Table 1). . Results .1. Populous religious groups Discussion of the major religious groups appears below, equenced by the founding dates of these traditions. The Chris- ian denominations are listed alphabetically. This review did not dentify any canonical doctrine that has led to religious objection o vaccines or immune globulins for Bahá’í Faith, Confucianism, aoism, Shinto, or Sikhism. Most ostensible objections to immunization attributable to reli- ious belief fell into three categories: (a) violation of prohibitions gainst taking life, (b) violation of dietary laws, or (c) interference ith natural order by not letting events take their course. Each is ddressed further below. .1.1. Hinduism Various denominations of Hinduism share a fundamental set f common beliefs, but philosophies and practices vary across dif- erent Hindu denominations. With no single founder, Hinduism onsiders itself Sanatan Dharma (the Eternal Tradition) and traces ts roots to the revelations in the Vedic sacred texts of ancient India at least 1500 years before our common era (BCE) to 500 BCE) [1,2]. here are four major branches of Hinduism: Shaiva, Vaishnava, hakta, and Smarta. The Vedic sacred texts were transmitted orally or many centuries before being committed to writing [1,2,87]. mportant Hindu texts include the Shrutis and the Smritis (e.g., edas, Mahābhārata, Rāmāyana, Bhagavad Gı̄tā). In Hinduism, the thics and metaphorical meanings of the texts, as revealed by spir- tually elevated gurus, may often be emphasized more than literal nterpretations. Vaccination is widely accepted in predominantly indu countries. Hindus advocate non-violence (ahimsa) and respect for life, ecause divinity is believed to permeate all beings, including plants nd non-human animals [1,2,87,88]. The degree to which Hindu elievers apply the principle of non-violence varies. Hindu scrip- ures support the use of violence in self-defense and do not equate himsa with pacifism [88]. Some reason that even vegetation must ubmit for human survival and that humans unknowingly destroy 1 (2013) 2011– 2023 2013 life forms on a regular basis through daily activities, as Mohandas Gandhi acknowledged (Table 1A). Some Hindus embrace vegetarianism to respect higher forms of life (Table 1A); some eat meat only on certain days. Food habits vary across communities and regions. Observant Hindus who do eat meat often abstain from beef. The cow in Hindu society is tradi- tionally identified as a caretaking and maternal figure. Verses of the Rig-Veda refer to the cow as devi (goddess), but Hindus do not wor- ship cows, but rather venerate (deeply respect) them. This review did not identify contemporary Hindu concerns with trace bovine components of some vaccines. 3.1.2. Buddhism Buddhism involves traditions, beliefs, and practices based on teachings attributed to Siddhartha Gautama, commonly known as the Buddha (awakened or enlightened one). The Buddha taught in the eastern part of what is now India between the 6th and 4th cen- turies BCE, perhaps 563–483 BCE. He is recognized by Buddhists as an enlightened teacher who shared his insights (Table 1B) to help end ignorance, craving, and suffering, and attain Nirvana (Nibbāna, freedom from suffering) [1,2,89–91]. Major Buddhist sects include Theravada, Mahayana, Vajrayana, and Zen. Buddhism has no central text commonly referred to by each tradition, nor a central author- ity empowered to pronounce on doctrine or ethics. Vaccination is widely accepted in predominantly Buddhist countries. A key precept within Buddhism generally prohibits killing, either humans or animals [1,2,92,93]. Some canonical passages seem to accept meat consumption, whereas certain Mahayana sutras (texts) denounce eating meat [94]. In the modern Buddhist world, attitudes toward vegetarianism vary by location. This review did not identify contemporary Buddhist concerns with trace bovine components of some vaccines. Buddhism does not oppose treatment of an existing illness by use of non-animal derived medicines, because treatment is an act of mercy [95–98]. Antibiotics kill microorganisms, yet antibi- otics are accepted because they help people get closer to reaching Enlightenment. Serious diseases separate the body from the mind. Preventing disease means preventing disharmony within the body. The Nepalese Lama Zöpa Rinpoche describes a prayer of the Heal- ing Buddha, to prevent diseases not yet experienced [99]. He also describes Logyönma (or Loma Gyönma), “a female healing bud- dha in leaf-wearing aspect,” known as an opponent to epidemic diseases [99,100]. The first written account of variolation describes a Buddhist nun (bhikkhuni) practicing around 1022–1063 CE [9]. She ground scabs taken from a person infected with smallpox (variola) into a powder, and then blew it into the nostrils of a non-immune per- son to induce immunity. Continuing this tradition, the 14th Dalai Lama participated in poliovirus immunization programs personally [101]. 3.1.3. Jainism Jainism arose in India between the 9th and 6th centuries BCE, based on the teachings of Nataputta Vardhamana (also called Mahavira), who prescribed a path of non-violence toward all liv- ing beings [2,88,102,103]. Their scriptures are known as the Jaina Sutras. In the practice of ahimsa, expectations are less strict for lay persons than for monastics. Jains recognize a hierarchy of life forms, such that mobile beings are accorded more protection than immobile ones [2]. Jains are vegetarians or vegans [2,102]. They avoid eating root vegetables in general, as cutting the root from a plant kills it, unlike other parts of the plant (e.g., leaves, fruits, seeds). Although Jains acknowledge that plants must be destroyed for the sake of food, they accept such violence only inasmuch as it is indispensable for human survival [2,88,102]. 2 cine 3 t c t n [ b p t w r n n s i 3 c ( J O fi w a H t t a v b p t J n ( a b w s a l [ h m s a p e f v a h h T p o J O t f 014 J.D. Grabenstein / Vac Jains may drink boiled water, cook food, use paper or soap, and ake necessary antibiotics, but perhaps with some regret. When onsidering vaccination, Jains may benefit from an explanation of he seriousness of the diseases to be prevented, to explain the ratio- ale for killing microorganisms in the course of vaccine production 103,104]. Jains agree with Hindus that violence in self-defense can e justified [88,102]. Jains filter water, to remove any small insects that may be resent. Observant Jains drink primarily water that has been fil- ered and boiled. Boiling kills the multitude of tiny beings in the ater, but this is considered preferable to allowing the beings to eproduce in the water and later die, which would result in a greater umber of deaths. As one Jain writer explained: “. . . we should ot cause violence to creatures; but we cannot live without water; o minimizing sins, we should use water. . . . Meaningless use is mproper” [104]. .1.4. Judaism Judaism is based on the relationship between God and the hildren of Israel. Judaism considers itself the religion of Jacob alternately Yisrael or Israel), grandson of Abraham and father of udah [1,2]. Major Western branches or denominations include rthodox, Conservative, Reform, and Reconstructionist. The first ve books (Torah) of the Hebrew Bible date to around 1200 BCE, ith an evolution of ancient Judaism that reached its present form round 450 BCE. The documentary basis of Judaic teaching is the ebrew Bible (Tanakh or Miqra), expounded in later texts such as he Talmud and the Shulchan Aruch [1,2]. Judaism traditionally expects certain actions of its believers o maintain health. Pikuakh nefesh, acting to save one’s own or nother’s life, is a primary value, a positive commandment (mitz- ah aseh) [105–115]. Judaic principles emphasize the community enefits of disease prevention in a manner superior to individual reference, based on scriptures such as Leviticus 19:16 (Table 1C) hat counsel not to stand idly by while a neighbor is in trouble. ewish scholars applied this directive to encourage smallpox vacci- ation in previous eras. Rabbi and physician Mosheh ben Maimon also called Maimonides or Rambam) expounded: “Anyone who is ble to save a life, but fails to do so, violates ‘You shall not stand idly y the blood of your neighbor”’ [105,108,109]. Indeed, in settings here vaccination services were intermittently available, several cholars stated it is permissible to set aside Sabbath restrictions on ctivity to allow vaccination [105,106,109,110,112,113,115]. Simi- arly, there are exemptions from fasting if one is ill. Parental responsibilities are detailed in a number of Jewish texts 105,107,111], based in Proverbs 23:12–13 (Table 1C). The Talmud as long encouraged parents to teach their children to swim, as a eans of preventing drowning in some unknown, but foreseeable cenario. Scholars have taken this as a metaphor for vaccination gainst a future infection [105,107,108]. Maimonides wrote about revention: “One must avoid those things which have a deleterious ffect on the body, and accustom oneself to things which heal and ortify it” [105]. Another metaphor related to community responsibility is ele- ated to the status of a paradigm: the admonition to erect a railing round one’s roof, when it was often used as a porch, to prevent arm to others who may later walk there from an anticipatable azard (Deuteronomy 22:8, Table 1C) [105,106,108,109,111,115]. his paradigm has been applied as a proactive call for communal rotection: vaccinating oneself and one’s family to reduce the risk f transmission of infectious diseases to neighbors and bystanders. Within halacha (Jewish law), the kashrut is the collection of ewish dietary laws, followed more closely by branches such as rthodox than by other branches. Food considered fit for consump- ion is termed “kosher” in English, with most dietary laws derived rom the Books of Leviticus and Deuteronomy (Table 1C). 1 (2013) 2011– 2023 Among these dietary laws are prohibitions on consuming ani- mals considered impure (e.g., pork, shellfish). Products of impure or improperly slaughtered animals are also non-kosher (treif). Ani- mal gelatin, for example, may be avoided as food; nonetheless, kosher gelatin (from cows or fish prepared to be kosher) may be an alternative food. In distinction to dietary laws, Jewish medical issues are judged based on concepts of medical law contained in halachic codes. The propriety of using vaccines or immune globulins within Judaism would be evaluated from a therapeutic or disease-prevention per- spective. Multiple Jewish authorities agree that limitations on medications with porcine components are only an issue with oral administration (for those who observe kosher rules), not prod- ucts given by injection [86,105]. Thus, the teachings to avoid pork products do not apply to injectable medications, in contrast to food- stuffs. Permissibility of oral administration of medications with non- kosher ingredients, if necessary to preserve life, is provided in the Talmud [105]. In the case of oral medications, the transformation (ponim chadashos) of “primary” pork components into processed materials would make them more acceptable. Oral medication con- taining small amounts of material derived from non-kosher animals devoid of its taste could be kosher under some circumstances. According to a principle known as bitul b‘shishim, a small amount of non-kosher food mixed with a much greater quantity of kosher food may be acceptable if the non-kosher item loses its taste or is diluted beyond a 1:60 ratio [116]. Additional conditions (e.g., inten- tion, gentile source) need to be considered before this ruling can be made. Rabbi Abraham Nanzig, writing in London in 1785 in the era of smallpox outbreaks, described the halachic basis for exposing a child to variola virus (variolation) to induce immunity against smallpox: “One who undergoes this treatment while still healthy, God will not consider it a sin. Rather, it is an act of eager religious devotion, and reflects the Commandment to ‘be particularly careful of your well-being”’ (Deuteronomy 4:15, Table 1C) [105,115]. In the 1850s, distinguished Rabbi Yisroel Lipshutz described Edward Jen- ner as a “righteous gentile,” for his efforts in developing smallpox vaccination [105,109]. Jewish communities (often ultraorthodox, those who adhere meticulously to Jewish law and tend to be more isolated from others) in several countries have experienced measles and mumps outbreaks associated with declining vaccination [37,41,43,46,47,52,55,111]. The transnational social networks between such communities have allowed outbreaks to spread from one country to another [37]. Based on this review, contemporary Jewish vaccine decliners are more likely to cite concerns about vac- cine safety than to invoke a specific religious doctrine that has not been considered by acknowledged Jewish scholars. Those scholars have rejected arguments that medical interventions interfere with divine providence [105,106,111]. The orthodox Hasidic Jews who constitute most of the residents of the village of Kiryas Joel in Orange County, New York, volunteered for several pivotal vaccine trials. These included trials for hepatitis A vaccine and mumps vaccine [117–119]. 3.1.5. Christianity Christians are followers of Jesus, whom they consider the Christ (i.e., Messiah, anointed one). Christians believe that Jesus, descended from Abraham through Isaac, is the Son of God proph- esied in the Hebrew Bible [1,2]. Christianity began as a Jewish sect around 30 CE. Today, the largest groups within Christianity are the Roman Catholic Church, the Eastern Orthodox and Oriental Ortho- dox Churches, and the denominations of Protestantism [1,2]. The life and teachings of Jesus are presented in four canonical gospels (“good news”) and other writings appended to the Hebrew cine 3 B b t 3 n o T O C L t s t c v p t w t k ( g 3 c t b 1 a d D d m A a o i i i n p r e o 3 a t S e m i f f r w p h T K d J.D. Grabenstein / Vac ible (Old Testament) in the form of a New Testament. Various ranches of Christianity define separate lists of books of the Bible hat each considers canonical [1,2]. .1.5.1. Multiple Christian denominations. Most Christian denomi- ations have no scriptural or canonical objection to use of vaccines r immune globulins per se, based on this review (Table 1C and D). hese include Roman Catholicism, Eastern Orthodox and Oriental rthodox Churches, Amish, Anglican, Baptist, the Church of Jesus hrist of Latter-day Saints (LDS), Congregational, Episcopalian, utheran, Methodist (including African Methodist Episcopal), Pen- ecostal, Presbyterian, and Seventh-Day Adventist Church. Exceptions appear in following sections. Roman Catholicism and ome other Christian denominations have expressed concern about he aborted fetal origins of the principal formulation of rubella vac- ine and some cell lines used to manufacture certain types of viral accines, discussed in later sections. The second half of Table 1D rovides scriptural passages interpreted by a minority as contrary o vaccination. Within a Christian creation-fall-redemption-restoration frame- ork, immunization advocacy can form a basis for Christian service o humanity. This is consistent with themes of being one’s brother’s eeper (Genesis 4:9, Table 1C), loving your neighbor as yourself James 2:8, Table 1D), and acting kindly to strangers, as did the ood Samaritan (Luke 10:33–35, Table 1D). .1.5.2. Amish and related communities. The Amish, sometimes alled old-order Amish or Amish Mennonites, are a group of Chris- ian fellowships among Mennonite churches. Amish fellowships egan with a schism within a group of Anabaptists in Switzerland in 693 CE. Related groups in Canada and the northern US are known s Hutterites. Immunization is not prohibited by Amish or Hutterite religious octrine, but vaccine acceptance varies from district to district. istricts that typically decline immunization reflect a social tra- ition within these religious communities, related to modernity, ore than a theological objection. Low immunization rates in mish communities have been attributed variously to limited ccess to care, limited disease understanding, higher priority to ther activities, and concerns about vaccine safety, with variabil- ty among various communities [18,120–123]. They tend to define llness in terms of failure to function in a work role, more than n terms of symptoms [19]. Within Amish and related commu- ities, multiple Haemophilus influenzae type b, measles, pertussis, oliomyelitis, rubella, and tetanus cases and outbreaks have been eported [11,18,19,26,50,51,56–58,64,67,70–80,83]. District lead- rs have been more accepting of immunization at times of local utbreaks. .1.5.3. Church of Christ, Scientist. Spiritual healing of disease is central tenet for members of the First Church of Christ, Scien- ist, founded in 1879 CE in Boston by Mary Baker Eddy. Christian cientists frequently decline some or all medical help for dis- ase. Individual believers often forego immunization, and church embers have lobbied governments for religious exemptions from mmunization. Eddy called believers to unmask the devil’s lies, one mani- estation of which is disease. Disease, in this construct, is not undamentally real, but rather something that can be dispelled, to eveal the perfection of God’s creation. “Sickness is part of the error hich Truth casts out” [124]. From this arose the Christian Science rinciple that disease is cured or prevented by prayer that affirms uman perfection as God’s child and denies the reality of disease. his principle is featured in Eddy’s canon, Science and Health with ey to the Scriptures [124]. Christian Science “practitioners” (who o not practice medicine) aid believers in focused prayer. 1 (2013) 2011– 2023 2015 In a 1901 interview with the New York Herald, Eddy said [125]: “At a time of contagious disease, Christian Scientists endeavor to rise in consciousness to the true sense of the omnipotence of Life, Truth, and Love, and this great fact in Christian Science realized will stop a contagion.” Later, she said: “Rather than quarrel over vaccination, I recommend, if the law demand, that an individual submit to this process, that he obey the law, and then appeal to the gospel to save him from bad physical results” [125]. Outbreaks of diphtheria, measles, and poliomyelitis have been reported among followers of Christian Science [16,17,23–25,28,50,66], including repeat measles outbreaks at Principia College and affiliated K-12 schools between 1985 and 1994 [48]. Three measles deaths and hundreds of cases occurred during those outbreaks. The Church has a policy for members to report communicable diseases to health authorities, but members have limited ability to do so. First, their practitioners and nurses are not trained in disease recognition. Second, members are taught that disease is healed by convincing oneself of its unreality. As a result, several outbreaks have been recognized only after many people were infected [28,48]. In such cases, Christian Science parents were more willing to accept immunization after outbreaks were recognized by health authorities. 3.1.5.4. Dutch reformed congregations. Members of certain tra- ditional reformed (bevindelijk gereformeerden) Christian denom- inations in the Netherlands, founded in the 1570s CE, have a tradition of declining immunization that dates back to con- cerns about adverse events after smallpox vaccination from 1823 onward [15,45,59,126]. These communities were the epi- centers of paralytic poliomyelitis, measles, congenital rubella syndrome, and mumps outbreaks between 1971 and 2008 [11,15,34,45,54,58–65,77–80,82,126]. Members of these denominations have familial and cultural ties to associated Christian communities in other countries (e.g., Canada, United States), where immunization rates may also be low. These ties have resulted in international transmission of vaccine- preventable diseases (e.g., measles, poliomyelitis, rubella) with multiple outbreaks in locations otherwise free of circulating disease [11,58,61,64,78–80,82]. The contemporary basis for the objection of some members of these churches includes choosing to forego immunization rather than making a person less dependent on God [15,45,59,126]. For a subset, avoiding interference with divine providence before infec- tion may be paramount; another subset described immunization as a gift from God to be used with gratitude [15,59]. Arguments against immunization have been refuted by other members of the traditional reformed community [15], for example by pointing out that using agricultural practices or raising dikes, to prevent flood- ing, could also be construed as contrary to divine intent, yet are common practices [45]. Recent increases in immunization rates in Dutch communities suggest that objections to immunization may be declining [45]. 3.1.5.5. Jehovah’s Witnesses. The Jehovah’s Witnesses is a Christian denomination tracing its roots to the late 1870s CE. The Watch Tower Bible and Tract Society is its organizing body [127–130]. Since 1945, the Watch Tower Society has instructed its followers to refuse transfusions of whole blood and certain blood components (e.g., red blood cells, white blood cells, platelets, whole plasma), which they consider a violation of God’s law. This interpretation derives from several scriptural passages (Table 1E) [127–138]. Their blood doctrine has undergone multiple changes since 1945, princi- pally in 1978, 2000, and 2004 [139–142]. By abstaining from blood, Witnesses express their faith that only the shed blood of Jesus can redeem them and save their life. In this view, those who respect life as a gift from God do not try to sustain 2 cine 3 l m a t t a M w c h v f b w I d a c t B a t g t 1 T f c 1 n s A n e [ 3 a b a o S i o b i c 3 ( m G I o p t b b a s 016 J.D. Grabenstein / Vac ife by taking in blood, even in an emergency [129,130]. While albu- in, antimicrobial immune globulins, Rho(D) immune globulin, nd coagulation factors VIII and IX have been declared acceptable o believers since 1978 [137,142], Witnesses today are taught that he use of various blood fractions are “not absolutely prohibited” nd are a matter of personal choice [128,129,136–138,143–145]. ore recently permissible products include those derived from hite blood cells (e.g., interferons, interleukins), cryoprecipitate, ryosupernatant, erythropoietin, and preparations derived from emoglobin [129,135,146]. It is unclear what proportion of Jeho- ah’s Witnesses offered such therapeutic products accept them. The Watch Tower Society distributes worksheets and pre- ormatted power-of-attorney advance directives, on which mem- ers can specify which allowable fractions and treatments they ould personally accept, if any [129,131,132,135,136,144,147]. mportant questions have been raised regarding how much free- om and what degree of information about risks, benefits, and lternatives are available to individual Jehovah’s Witnesses when onsidering these documents [128,129,131–135,148–150]. Some Jehovah’s Witnesses dissent from the blood-product doc- rine, including the Associated Jehovah’s Witnesses for Reform on lood [129,135]. They see no Biblical or ethical wrongness with ccepting transfusion of donor blood or with donating blood for ransfusion. This group functions with anonymity, because congre- ations have ostracized or expelled those who ignore or criticize heir doctrine [128,129,134–136]. The Watch Tower Society denounced vaccination from the 920s through the 1940s, citing scriptural passages such as those in able 1E [127–129,138,151,152]. The group banned their members rom vaccination around this time, under penalty of excommuni- ation [138,151]. The Society revised this doctrine in the December 5, 1952, issue of The Watchtower, saying that those passages did ot apply to vaccination [153]. In 1961, the Society took a neutral tand, neither endorsing nor prohibiting vaccination. In the 1990s, wake! magazine began acknowledging the clinical value of vacci- ation. A contemporary Watchtower web page acknowledges the fficacy of vaccination in preventing hepatitis A and hepatitis B 154]. .1.5.6. Churches that rely on faith healing. In addition to discussion bove, several small Christian denominations or churches hold core eliefs that focus on healing through faith alone (Table 1D), with ctive avoidance of medical care (e.g., Faith Tabernacle, Church f the First Born, Faith Assembly, End Time Ministries) [155]. everal vaccine-preventable outbreaks (and associated deaths) nvolved faith healing to the exclusion or neglect of immunization r treatment after infection [27,39,40,50,51,155–157]. These out- reaks involved both adults who choose not to have themselves mmunized and parents who withheld routine vaccines from their hildren. .1.6. Islam Islam professes beliefs articulated by their Holy Book, the Qur’ān the recitation), and through the teachings and example of Muham- ad (570–632 CE). Muhammad, the last messenger of Allāh (the od, in Arabic), descends from Abraham (Ibrahim) through his son shmael [1,2]. The two major Islamic sects are Sunni and Shı̄‘āh. The Qur’ān and tradition forbid consumption of several animals utright (e.g., “the flesh of swine,” Table 1F), while other animals are ermitted (halal) or forbidden (haram) based on conditions of how hey died or were slaughtered. Gelatin made from porcine skin or ones is forbidden as food. Gelatin made from other halal animals, eef or fish for example, is acceptable as food. Opinions or rulings on interpretation of the Qur’ān are issued s fatwas by Islamic scholars (mujtahids), with varying degrees of trictness. But fatwas are not always widely held to be authoritative, 1 (2013) 2011– 2023 in part because of varying degrees of expertise and also because the relationship for each Muslim is directly with God. According to the Qur’ān, a person is not guilty of sin in a situation where the lack of a halal alternative creates an undesired necessity to consume that which is otherwise haram (Qur’ān 2:173). This is the basis for the “law of necessity” in Islamic jurisprudence: “That which is necessary makes the forbidden permissible” in exceptional circumstances (Table 1F). Opposition to immunization programs among selected Mus- lim communities has occurred during poliovirus immunization programs in Nigeria, Pakistan, and Afghanistan [158]. The oppo- sition within northern Nigeria, notably in the state of Kano, was particularly long-lasting and an impediment to the global eradi- cation effort [68,158–163]. Detailed consideration of the Nigerian situation revealed that what was described as ostensibly religious objections and assertions that vaccines spread the HIV virus or were vehicles for sterilization programs masked deeper struggles related to political power, inadequate health services, and a controver- sial clinical trial of an investigational antibiotic [68,159,162]. While the boycott was centered within Islamic social networks, most of the objections raised related to social issues, rather than theo- logical issues. Eventually, the Nigerian government sent religious representatives to South Africa, Indonesia, and India to observe quality-control tests of poliovirus vaccines to be used in their areas and then sourced the vaccine from manufacturers they trusted [68,162]. In contrast, multiple imams and other Islamic leaders issued clear statements and fatwas describing how immunization is con- sistent with Islamic principles [68,69,162]. In the Nigerian case, engagement of the Organization of the Islamic Conference (includ- ing 17 African countries) and the 15th annual conference of the International Fiqh Council (a global forum of Islamic lawyers, scholars and philosophers to address the practice of Islam in con- temporary life) provided assurances to Nigerian leaders [68]. Earlier, in 1995, the Islamic Organization for Medical Sciences, a well-regarded set of 112 jurisprudents and medical experts con- ducted a seminar in Kuwait on “The judicially prohibited and impure substances in foodstuff and drugs” [164]. Participants included the muftis (experts in Islamic law) of Egypt, Tunisia, Oman, and Lebanon, the secretary general of the Islamic Fiqh Academy in Jeddah, and many other accomplished Islamic scholars. Citing the accepted principle of transformation (fundamental change, as from wine to vinegar) within Islam, they concluded that “The Gelatin formed as a result of the transformation of the bones, skin, and tendons of a judicially impure animal is pure, and it is judicially permissible to eat it” (see also Section 3.2.4) [164]. The full docu- ment also addressed issues related to medication capsules, alcohol, pig fat, and porcine insulin. Omar Kasule, professor of Islamic medicine at the Institute of Medicine University of Brunei Darussalam noted that polio immu- nization is obligatory (wajib) when disease risk is high and the vaccine shown to have benefits far outweighing its risks [165,166]. Muslims will be interested in issues of vaccine safety, Professor Kasule explained, because immunization to prevent disease should not lead to side effects of the same magnitude as the disease. He based this judgment on the purpose of the law to protect life, the principle of preventing harm (izalat aldharar), and the principle of the public interest (maslahat al-ummah). He noted that the Qur’ān uses the concept of wiqaya in multiple situations to refer to tak- ing preventive action (e.g., against hell-fire, punishment, greed, bad acts, harm, heat) and concludes that prevention is one of the laws of Allāh, with obvious application to medicine. Muslims may apply additional scrutiny to vaccines required for pilgrims to the annual Hajj in Mecca, when purity takes on extra significance [167–170]. Another guiding principle comes from the prophetic statement of Muhammad: “God has not made cine 3 t [ 3 m t d i a w S o T n r t 3 3 r p t v c m o l f l s [ 3 v t f z v W s b s c s e v T p g c b S o w u d w f J.D. Grabenstein / Vac hings that are unlawful for you to consume to be your medicine” 171]. .1.6.1. Nation of Islam. The Nation of Islam is a US-based move- ent that aims to improve the condition of African-Americans in he US [172]. Its religious practices have some similarities and some ifferences, compared with traditional Islam. In 1997, the min- ster of health of the Nation of Islam advised believers to avoid ll immunizations, based on concern about viral contamination ith pathogens that cause “AIDS, Ebola, Hanta, Chronic Fatigue yndrome, Gulf-War Syndrome, ‘mad cow’ disease, etc.” [173]. No bjective evidence to substantiate these claims has been offered. hat statement was framed as “until further notice,” although it o longer appears on the Nation of Islam website. The basis was ooted in safety and distrust-of-government concerns, rather than heological grounds. .2. Vaccine components and processes .2.1. Bacteria, viruses, cell substrates The Hindu, Buddhist, and Jain religions have long prioritized especting all forms of life, in the form of ahimsa [88]. The Jains in articular extend this respect even to the bacteria or viruses con- ained in a vaccine, as well as the culture-media cells used to grow iruses or produce recombinant proteins. The Google searches identified a posting contending that Jains annot take vaccines because microbes are killed in the process of anufacturing the vaccines. But this would seem to be a misreading f the Jain approach to regretting the loss of microbial (one-sensed) ife, yet taking actions necessary to sustain life (e.g., ingesting life orms along with food, boiling water) [88,103,104]. Mohandas Gandhi observed: “The very fact of his [humanity’s] iving—eating, drinking and moving about—necessarily involves ome himsa, destruction of life, be it ever so minute” (Table 1A) 174]. .2.2. WI-38 and MRC-5 cell lines Unlike bacteria, viruses do not replicate on their own. To make iral vaccines, large numbers of viruses must be grown in cell cul- ures specific to each virus. Some licensed viral vaccines (i.e., some ormulations of hepatitis A, poliovirus, rabies, rubella, and varicella- oster viruses or combination vaccines containing such component iruses) are produced by growing viruses that infect humans in I-38 or MRC-5 cell cultures [175,176]. WI-38 and MRC-5 repre- ent two commonly used lineages of human diploid cell cultures, atches of immature cells with twice as many chromosomes as perm or egg cells. Embryonic diploid cells are valuable in vac- ine manufacture, because each aliquot of these cells can propagate everal dozen times before senescence. Each of these cell lines started with cells harvested from a delib- rately aborted fetus [177,178]. The cell lines are used to grow the iruses, then discarded and not included in vaccine formulations. hese cell lines cannot form a human being. The WI-38 line was developed at the Wistar Institute in Philadel- hia in 1961, with lung cells from a female fetus of 3 months estation aborted in Sweden, whose parents felt they had too many hildren [175,176,179–183]. Similarly, British scientists funded y the Medical Research Council developed the MRC-5 line in eptember 1966 with fetal lung fibroblasts “taken from a 14-week- ld male fetus removed for psychiatric reasons from a 27-year-old oman. . .” [179,184,185]. These cell lines, still in use today, grad- ally replaced primary cultures of monkey, duck, rabbit, chicken, og, or mouse tissue, an approach vulnerable to contamination ith viruses and bacteria [175,176,183]. Vaccine manufacturers have few options for viral culture media, or reasons of microbiology and safety [175,176,179,186–190]. It is 1 (2013) 2011– 2023 2017 not possible to simply replace one cell line with another, because various viruses grow abundantly only in some kinds of cell lines. WI-38 and MRC-5 lines are well described and understood, with experience accumulated via hundreds of millions of vaccinations, important for safety-assessment reasons. The fetal origins of WI-38 and MRC-5 cell lines pose an ethical or moral problem for people who disapprove of abortion. Criti- cally, the two abortions were not conducted for the purpose of harvesting the cells that were transformed into these cell lines [177,178,191–194]. This lack of intention is a key element in break- ing the complicity link that could otherwise make use of the vaccines unacceptable. No additional abortions are needed to sus- tain vaccine manufacture. The cell lines are not the final product, and no human cells are present in the final vaccine formulations. In the late 1990s—early 2000s, teams of ethicists at the National Catholic Bioethics Center and then at the Vatican’s Pontifical Academy for Life and elsewhere considered the virology, epidemi- ology, and theology of the matter in detail [177,178,193–195]. Their considerations included both cooperation with evil and the principle of double effect. In this case, the cooperation related to those involved with the specific abortions in the 1960s. The prin- ciple of double effect applied insofar as using implicated vaccines today could appear to endorse or acquiesce to the acceptability of additional abortions in our current time. These teams concluded that the association between implicated vaccines and abortion was noncomplicit, and that using these vaccines is not contrary to a principled opposition to abortion. These centers reasoned that, because the abortions that enabled the production of these vaccines are in the past and (critically) the abortions were not undertaken with the intent of producing the cell lines, being immunized does not involve any sharing in immoral intention or action of others. In short, they are morally separate actions. In 2008, this position was elevated to the status of official Roman Catholic teaching [196]. The bioethicist teams agreed that use of a vaccine in the present does not involve sharing in the action of those who carried out the abortion in the past [178,193–196]. Further, they found that parents have a moral obligation to provide for the life and health of their children by means of immunization [178,193–196]. The situation with vaccines differs morally from ongoing harvest of fetal tissue for pharmaceutical manufacturing or research, which could be used to justify future abortions [177]. Still, these ethicists concluded that alternate vaccines should be used if available. They also recommended that parents and cli- nicians should speak out against abortion by asking governments and vaccine manufacturers to stop using cell lines that have links to aborted fetuses [193,194]. 3.2.3. Rubella virus strain RA 27/3 In 1964, the Wistar Institute developed the RA 27/3 strain of rubella virus. The rubella virus isolate “was recovered from the explanted [kidney] tissue of a fetus obtained at therapeutic abor- tion from a mother who had been infected with rubella virus” [179,197–199]. The scientific literature of that era indicates that the abortion was not conducted with the motive of isolating the virus, but rather because the mother was infected with rubella virus and risked major birth defects [179,197,198]. After the RA 27/3 strain was isolated, it has been propagated serially in human diploid cells. The RA 27/3 strain produced superior antibody responses and was better tolerated, compared with other rubella vaccine strains available in the 1960s [199,200]. No further abortions are neces- sary to sustain the manufacture of additional batches of rubella RA 27/3-strain vaccine. Use of the RA 27/3 rubella virus strain was also considered by the National Catholic Bioethics Center and the Pontifical Academy for Life. Using the same logic, they reasoned that because the one abortion that yielded the viral isolate was not undertaken with the 2 cine 3 i n a s m c o i p r p 3 i g d t m c a p v e a v w t p p p a n t m d i f ( ( ( p m t e t t c o b s u o a With both HBV and HPV, a person could forego the vaccines, lead a life fully compliant with religious belief, and still be infected. Many 018 J.D. Grabenstein / Vac ntent to retrieve the virus and because no additional abortions are eeded to obtain more virus, being immunized is morally accept- ble and also associated with parental duty [178,193–195]. The ame provisions for preferring alternatives and petitioning govern- ents and manufacturers also apply. Some find it meaningful that rubella vaccination prevents many ases of fetal death and congenital rubella syndrome that would therwise occur if women were infected with rubella virus dur- ng pregnancy. Immunized women exposed to the virus during regnancy are no longer confronted with the question (what some eligions might consider temptation) of whether to terminate their regnancies on that basis. .2.4. Porcine excipients All vaccines require the use of excipients (inactive ingredients) n manufacturing. Some of these products, such as hydrolyzed elatin or trypsin, may have a porcine (pork) origin. Hydrolyzed gelatin is a mixture of peptides and proteins pro- uced by partial hydrolysis of collagen (connecting fibers and issues) typically extracted from skin, bones, or other components, ost often from pigs or cattle. Hydrolyzed refers here to the pro- ess of breaking down collagen molecules into chains of amino cids (polypeptides) by acidic or alkaline treatment, followed by urification [187,201,202]. Gelatin hydrolysates are added to some accine formulations to help stabilize and preserve active ingredi- nts during freeze-drying and storage; hydrolyzed gelatin may also ct as a solvent [187,203,204]. The enzyme trypsin may be used in producing some viral accines, to resuspend cells adhering to the cell-culture dish all during the process of harvesting cells [187,203,205]. Trypsin ypically is removed from the product physically before further rocessing. Like hydrolyzed gelatin, trypsin is often derived from orcine or bovine sources. Some Jews, Muslims, and others have expressed concern about orcine-origin components, derived from faith-based concerns bout consumption of pork in their diet, despite the injectable ature of most vaccines. Injectable medications are not subject o kosher rules [86,105]. Permissibility of oral administration of edications with such ingredients, if necessary to preserve life, is escribed in earlier sections. Scholars of Judaism and Islam have ssued various rulings or waivers that allow use of such vaccines, or several reasons [86,105–114,164,205,206]: 1) the components of concern (e.g., hydrolyzed gelatin) have been sufficiently transformed from original pork origins, 2) the minute quantities per dose administered (e.g., hydrolyzed gelatin, trypsin) invoke exceptions based on dilution, or 3) the vaccine is intended for important medicinal purposes and not a matter of ingestion, to which dietary rules apply. Other important considerations include the necessity of the roduct to save life and the lack of alternatives. Different scholars ay evaluate and weigh these criteria differently. For Muslims, Sharı̄‘ā law includes the principle of transforma- ion (istihaalah) in which unclean products can be made clean by xtensive processing, transforming the original product into some- hing new (e.g., from wine to vinegar). Under certain circumstances, his can make it permissible for observant Muslims to receive vac- ines, even if the vaccines contain porcine excipients. This principle f transformation was invoked by the 1995 conference convened y the Islamic Organization for Medical Sciences [164,206]. The cholars explicitly concluded that transformation of pork prod- cts into gelatin alters them sufficiently to make it permissible for bservant Muslims to receive vaccines containing porcine gelatin nd certain other medicines, including those formulated in gelatin 1 (2013) 2011– 2023 capsules [164]. Even so, alternative products without components of concern may be preferred, if available. In 2003, the European Council of Fatwa and Research issued a fatwa finding the permissibility of using oral poliovirus vaccine pro- duced with porcine-origin trypsin [205]. Their decision centered on lack of similarity between pork and purified trypsin, physical removal during processing, dilution of any residual, necessity, and lack of alternative. 3.2.5. Bovine excipients Bovine serum or albumin may be added to some cell cultures as a source of nutrition (in the form of albumin, amino acids or pep- tides, and growth factors); albumin can act as a protein stabilizer [187,207]. Hydrolyzed gelatin or trypsin (see porcine excipients, above) may alternately derive from a bovine source. This review identified no explicit religious objection to bovine components. 3.2.6. Misunderstandings of vaccine production or content Google searches revealed multiple postings (data not shown), both by members of the public and by those who describe them- selves as health professionals, that misstate the actual contents of vaccines and immune globulins. These searches revealed erroneous assertions that all vaccines are grown in chicken eggs, that vaccines are blood products, or that vaccines are contaminated with alcohol, toxins, or heavy metals. Some sites incorrectly asserted that most vaccines are genetically modified, claiming that such products are forbidden in both Judaism and Christianity based on Leviticus 19:19 and Matthew 15:13 (Table 1C and D). Objections of certain Catholic officials in the Philippines in the mid-1990s that tetanus toxoid immunization for adult women actually contained contraceptives or abortifacients were based on misunderstanding [208–211]. Similar confusion disrupted immu- nization programs in Kenya, México, Nicaragua, and Tanzania [208,210]. Several websites objected to immunization on the basis that God created humans in His own image and that the body is a temple not to be defiled (Table 1D). Interpretations of the first letter of Paul to the Corinthians contrast with Mark’s gospel in this regard. Even so, vaccines are no less pure than various other commonly used medications and are subject to extensive quality-control and audit procedures by the manufacturers and by multiple government reg- ulators [212,213]. 3.2.7. Pathogen route of exposure Many religions traditionally have been proponents of sexual propriety [1,2]. This review identified several objections to hepatitis B immunization or to human papillomavirus (HPV) immunization, centered on the sexual route of exposure that can be associated with the corresponding pathogens. These objections to immuniza- tion were not theologically based per se, but rather arose indirectly as religious beliefs (usually of parents) affected views of accept- able sexual practices or timing. In the case of hepatitis B virus (HBV), sexual activity is only one of many risk factors for infection, including mother-to-child transmission. For HPV, several studies have shown that immunization does not increase or accelerate a woman’s likelihood of sexual behavior [214–217]. The proportion of never-married teenaged females in the US who had been sexually active at least once fell from 51% in 1988 to 43% in 2006–10 [218]. religions have rites that allow for atonement or forgiveness of sins, but the many diseases caused by HBV and HPV (including multi- ple cancers) remain among the most difficult infectious diseases to attempt to cure. J.D. Grabenstein / Vaccine 3 Table 2 Summary of key points from perspectives of selected religions. Jainism, Buddhism, Hinduism (linked via ahimsa) © Respect for all life, favoring nonviolence [1,2,88] © Recognize the need to sustain human life, with regretful acceptance of cooking food, boiling water, using antibiotics and vaccines [1,2,88,96,103,104,174] Judaism © Consider the imperative for Pikuakh nefesh, acting to save one’s own or another’s life [105,106,109,110] © Consider the duty to protect one’s children and one’s neighbors; do not stand idly by [105–109] © Dietary kosher limitations on medications with porcine components apply to oral administration, but not to injection [86,105]. Even so, consider the importance of medicine in preserving life Christianity © Vaccines with remote fetal implications are morally acceptable (with a duty to protect children), unless alternative products are available [177,178,193–196] © Jehovah’s Witnesses may accept certain blood derivatives, including immune globulins, interferons, coagulation factors, erythropoietin, and others [129,135,137,142,146] © Concern that ‘the body is a temple not to be defiled’ contrasts with other Scripture passages (Table 1D) and modern quality-control requirements for vaccines and immune globulins [212,213] Islam © Consider the law to protect life, the principle of preventing harm (izalat aldharar), and the principle of the public interest (maslahat al-ummah) [165,166] © Transforming haram components may generate halal products (e.g., wine to vinegar) [164,206] © Extensive dilution of components of concern may result in minute quantities per dose [164,205,206] © Vaccines are intended for important medicinal purpose, not diet [68,164,205,206] © Vaccines help protect others [68,164–166,205] 4 t o a i m m h t t i r i m p ( n l t a f a a g t t a e cal considerations of clinical issues [4,45,83,86,177,195,211]. When © Consider the law of necessity, whether alternative vaccines are available [86] . Discussion This review is intended to explain pivotal aspects of religious eaching that have been applied for and against the acceptability f vaccines and immune globulins. As various examples described bove show, the scriptural, canonical passages cited here are not nterpreted uniformly by each believer within a faith tradition. The ultiple sects, denominations, and branches within each of the ajor religions demonstrates the multiple ways various passages ave been applied [4,83,86]. This review identified multiple religious doctrines or impera- ives that call for preservation of life, caring for others, and duty o community (e.g., parent to child, neighbors to each other). Even n cases where vaccine components could be objectionable, this eview found several themes favoring vaccine acceptance, includ- ng transformation of components of concern from their starting aterial, extensive dilution of such components, the medical pur- ose of immunization (in contrast to diet), and lack of alternatives see Table 2). This review revealed few canonical bases for declining immu- ization, with Christian Scientists a notable exception. Along these ines, it would seem that the instances of personal objections hat are properly theological in nature (defined here as system- tic and rational exploration of the nature of God) are relatively ew, and that the preponderance might more accurately be defined s philosophical (i.e., a more general consideration of existence nd reason) or simply personal choice [219]. For several religious roups, declination of immunization is more traditional or social han an essential religious precept [25,143]. The bulk of the objec- ions identified in the searches for this review reflected concerns bout vaccine safety, not matters of theology, as did an analysis of xemptions for school-aged children [219]. For Christian Scientists 1 (2013) 2011– 2023 2019 who believe “Man is incapable of sin, sickness, and death” [124], vaccines would be superfluous. One question-and-answer webpage started with this question: “I need to get a religious exemption or medical exemption for my children. We are moving to HI [Hawaii] and these are the only two exemptions they offer. Anyone know how to get around vaccinat- ing my children?” [220]. How can we understand the intent of this writer? Understanding people’s actual motives is important when discussing immunization. Clinicians counseling people reluctant to be immunized may wish to probe for understanding of vaccine contents and provide factual information. From a Netherlands perspective, Ruijs et al. suggest discussing vaccine decision-making processes (e.g., criteria used, consequences), rather than medical information or an author- itarian stance [221]. Collaboration between public-health leaders and (religious) community leaders historically has helped resolve objections and enabled immunization programs to continue. Reli- gious communities are a powerful social force, as shown in this review and in other studies [222,223]. The accumulation of susceptibles within a community creates vulnerability to infection [4,13,32,33,47,211,224]. A community can afford to have a small number of conscientious objectors to immunization. But each unimmunized person adds to the vulnerability of the group. If geographic clusters within a city neigh- borhood, among preschoolers, or within a suburb, a rural town, an island, a parish, or some other focal area are immunized at only 60% or 80% levels, herd protection does not occur and outbreaks can develop. An increasing collection of vulnerable people is like an increasing collection of kindling wood. Introduce a spark and fire can spring forth. One contagious person among a cluster of vul- nerable people can ignite an outbreak involving many, including those unable to respond to vaccination. One of the limitations of this review is that information about beliefs of less populous religions or denominations were not explic- itly sought. On the other hand, the many searches and traces through reference lists frequently led to documents describing other religious traditions or denominations. None of those docu- ments featured a canonical objection to immunization not already described above. But review of the medical literature identified multiple outbreaks of vaccine-preventable diseases among them [27,29,37,39,40,50,51,83]. Outbreaks rooted in personal or philo- sophical beliefs are not referenced here, but are numerous. The outbreak reports cited in this review are likely not an exhaustive list of all religious-centered outbreaks, for several rea- sons: Some publications may not have been identified (especially those not written in English or relevantly coded in PubMed), some publications about outbreaks related to personal-belief exemptions may not have specified a religious basis for those beliefs, and some relevant outbreaks (or individual cases) may not have been pub- lished. One element of acceptability for some believers is whether vac- cines of concern have any alternatives [86,170,177,178,191–195]. Alternatives can be determined by comparing ingredients and culture media described in product prescribing information. Con- trary to several web pages, measles vaccine is not a prophylactic alternative to measles-mumps-rubella (MMR) vaccine, insofar as selecting measles vaccine alone would be a decision to reject pro- tection against mumps and rubella. Manufacturers attentive to global acceptability will endeavor to replace or avoid components of concern whenever possible. If we are to serve our patients’ needs in all their humanity, we should help them gain access to reasoned ethical and theologi- dealing with vaccines, the implications of a personal infectious- disease decision reach beyond the self, to affect neighbors [10,27,31–33,42,56,68,86,106,109,188]. My decision to immunize 2 cine 3 o y 5 s h o i A v c S M S W d M p a E a A f j R 020 J.D. Grabenstein / Vac r not immunize my family members changes the likelihood that ou or your family will contract a contagious disease, and vice versa. . Personal note The coming together of public health and religion is not a colli- ion; rather it involves repeated intersections. We can advance both ealthcare and our own condition by discussing them openly more ften. I remain open to finding and reading doctrinal teachings not dentified in my searches to date. cknowledgements The assistance of numerous religious scholars, believers, and accine experts who critiqued drafts of this review is greatly appre- iated, including: Ibrahim AbuAmmar, Brant Biehn, Joye L. Bramble, hehla Hussain, Chester J. Kitchen, Barbara J. Kuter, Mark Loeb, anal Morsy, Paul A. Offit, Diane C. Peterson, Samir Shaikh, Neel heth, Benoît Soubeyrand, Walter L. Straus, Rita Swan, Deborah L. exler, Charles (Skip) Wolfe, Robert M. Wolfe, and Karie Young- ahl; from the Associated Jehovah’s Witnesses for Reform on Blood, arvin Shilmer; from the Interfaith Center of Greater Philadel- hia, Abby Stamelman Hocky, Rev. Nicole Diroff, Bijan Etermad, nd Suketu Patel; and from The National Catholic Bioethics Center, dward J. Furton and John M. Haas. Any remaining inaccuracies are the responsibility of the author lone. ppendix A. Supplementary data Supplementary data associated with this article can be ound, in the online version, at http://dx.doi.org/10.1016/ .vaccine.2013.02.026. eferences [1] Smith H. The World’s Religions (Plus). 50th anniv. ed. New York: HarperOne; 2009. [2] Noss DS, Grangaard BR. History of the World’s Religions. 12th ed. Upper Saddle Brook, NJ: Pearson Education; 2008. [3] Williams G. Angel of death: the story of smallpox. Houndmills, UK: Palgrave Macmillan; 2010. [4] Feudtner C, Marcuse EK. Ethics and immunization policy: promoting dialogue to sustain consensus. Pediatrics 2001;107(May):1158–64. [5] Swales JD. The Leicester anti-vaccination movement. Lancet 1992;340:1019–21. [6] Blume S. Anti-vaccination movements and their interpretations. Soc Sci Med 2006;62:628–42. 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Am J Epidemiol 2008;168:1389–96. http://omarkasule-04.tripod.com/id1406.html http://www.eimjm.com/Vol2-No2/Vol2-No2-H1.htm http://www.muslimpopulation.com/America/cuba/How Cuba is tapping into the.php http://www.muslimpopulation.com/America/cuba/How Cuba is tapping into the.php http://www.wikipedia.com/ http://www.mosque7.org/minofhealth/declarationofexem.doc http://www.ncbenter.org/vaticanresponse.pdf http://www.ncbenter.org/vaticanresponse.pdf http://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_20081208_dignitas-personae_en.html http://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_20081208_dignitas-personae_en.html http://www.who.int/immunization_standards/vaccine_quality/vmc/en/index.html http://www.who.int/immunization_standards/vaccine_quality/vmc/en/index.html http://islamqa.info/en/ref/97541 http://www.sciencedirect.com/science/article/pii/0968808095901558 http://www.sciencedirect.com/science/article/pii/0968808095901558 http://www.path.org/vaccineresources/files/Combatting_Antivac_Rumors_UNICEF.pdf http://www.path.org/vaccineresources/files/Combatting_Antivac_Rumors_UNICEF.pdf http://www.cdc.gov/nchs/data/series/sr_23/sr23_031.pdf http://www.mothering.com/community/t/402196/what-religions-dont-vaccinate What the World's religions teach, applied to vaccines and immune globulins 1 Background 2 Methods 3 Results 3.1 Populous religious groups 3.1.1 Hinduism 3.1.2 Buddhism 3.1.3 Jainism 3.1.4 Judaism 3.1.5 Christianity 3.1.5.1 Multiple Christian denominations 3.1.5.2 Amish and related communities 3.1.5.3 Church of Christ, Scientist 3.1.5.4 Dutch reformed congregations 3.1.5.5 Jehovah's Witnesses 3.1.5.6 Churches that rely on faith healing 3.1.6 Islam 3.1.6.1 Nation of Islam 3.2 Vaccine components and processes 3.2.1 Bacteria, viruses, cell substrates 3.2.2 WI-38 and MRC-5 cell lines 3.2.3 Rubella virus strain RA 27/3 3.2.4 Porcine excipients 3.2.5 Bovine excipients 3.2.6 Misunderstandings of vaccine production or content 3.2.7 Pathogen route of exposure 4 Discussion 5 Personal note Acknowledgements Appendix A Supplementary data Appendix A Supplementary data