Vaccine 27 (2009) 615–618

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Editorial

Ethical issues in immunisation

a r t i c l e i n f o

Keywords:EthicsCompulsory immunisationHerd immunityVaccinationThimerosalMMR

a b s t r a c t

Discussions about current and future immunisation programmes raise novel questions about familiarethical issues. Two sets of ethical issues dominate these discussions. The first is the issue of compulsoryimmunisation: what should be done about parents who fail to immunise their children? The second is:given competing demands on health care budgets, how should principles of justice in access and distri-bution inform vaccination programmes? This paper considers these two issues in the light of traditionalethical principles. With respect to the first, we argue that compulsion is justified only in cases in whichwe know with practical certainty that parental failure to immunise puts their own child or other children

at high risk of severe illness. We also argue that the state should compensate those who suffer vaccine-related injury. With respect to the second, we claim that allocating resources according to health careneed requires establishing priorities between public health programmes such as immunisation and other

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. Introduction

Immunisation ranks as one of the 15 most important advancesn health care in the last century [1]. Immunisation undoubtedlyrevents illness and saves lives [2]. However, immunisation is oftenontroversial, at least to the general public.

. Compulsory immunisation

Parents have a moral responsibility to care for their children asell as possible. This can and should be according to their personaleliefs, unless these put their children at serious risk. Most juris-ictions have legislation designed to protect children from parental

gnorance, neglect and abuse. A frequent ethics approach woulde as follows: The common good requires us to acknowledge androtect a public interest in recognising that parents have the pri-ary responsibility for protecting the health and welfare of their

hildren, but also a public interest in ensuring that the welfare ofhildren is not put at risk through parental ignorance, neglect orbuse. We have to balance these two ‘social goods’, particularlyn circumstances in which they conflict. Both are generally recog-ised by the law. Which should take precedence over the other,

f parents for whatever reason fail to have their children immu-ised?

A fundamental first step is to convince parents that an invasiverocedure, given by health workers to generally healthy children,

s a good idea. Parents need to know that for almost all vaccines

he benefits of routine immunisation vastly outweigh the risks.ut, like fluoride and other medically based interventions given enasse, vaccination programmes are susceptible to conspiracy the-

rists and common perceptions incorrectly blaming vaccines forll manner of ills [3–5]. Vaccines commonly cause minor adverse

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Crown Copyright © 2008 Published by Elsevier Ltd. All rights reserved.

vents, such as local reactions or fever, but devastating harms onlyery rarely [2].

Anti-vaccination movements are almost as old as immunisa-ion itself. Compulsory smallpox vaccination in the USA and Britainn the nineteenth century produced vociferous opposition [4–6].owever, smallpox vaccination then was risky and occasionally

atal [6]. Benjamin Franklin wrote poignantly how he did not vacci-ate one of his sons, who later died from smallpox [7,8]. When theisks of vaccines are high there is a temptation not to immunise,ven if the risks of disease are higher [7].

Inaccurate adverse publicity about some much safer, modernaccines has, in recent decades, lowered immunisation rates sohat disease outbreaks and deaths have occurred. In the 1970s,njustified concern about encephalopathy from pertussis vaccineseduced immunisation rates in the UK, resulting in an estimated000 excess hospital admissions of children with whooping coughnd at least 28 deaths [9]. More recently, unsound data linkingMR vaccine to autism [10] caused immunisation levels to fall

nough to cause a major increase in measles cases [11]. So healthrofessionals have to consider carefully how to handle concernsbout theoretical but unproven risks of vaccines that are unlikely toause significant harm. The principles of risk communication pro-ide a framework. They call for: accepting and involving the public;lanning and evaluating efforts; listening and being responsive toublic concerns; being honest, frank and open; working with cred-

ble sources; meeting the needs of the media; and communicatinglearly and appropriately with the target group [12].

Overly reactive responses to perceived risks, especially if used

o stave off litigation, can be harmful and ethically dubious. Theontroversy over the mercury based preservative thimerosal (orhiomersal), used in vaccines since the 1930s, is an example. In999, the US Food and Drug Administration (FDA) raised concerns

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16 Editorial / Vaccin

bout mercury exposure through vaccines, particularly for pre-erm infants. Although children are exposed to greater levels of

ercury from fish [13,14], the US authorities asked pharmaceuti-al companies to remove thimerosal from vaccines [13]. The basisor the decision was theoretical concerns about possible neurologi-al damage and insufficient safety data [14]. An American Academyf Pediatrics press release stated, “. . .current levels of thimerosalill not hurt children, but reducing those levels will make safe

accines even safer” [14]. Although an understandable attempt toeassure the public, this message may have appeared contradic-ory to many parents, who would question the need to removehimerosal if truly harmless. The decision to remove thimerosal,owever, may have caused harm in itself. About 10% of hospitalsuspended neonatal hepatitis B immunisation because the vac-ine contained thimerosal, resulting in several cases of preventableeonatal acute hepatitis B infection, at least one of which was fatal14,15]. In retrospect, continuing to use thimerosal-containing vac-ines until safety data were obtained would have been advisablend ethical, but the adverse publicity risked alienating the pub-ic against immunisation. Subsequently, the best evidence suggestshat thimerosal is harmless [14].

Parents may fail to immunise their children because of practi-al barriers, such as remoteness, deprivation, lack of knowledge, orecause of parental objection to immunisation. Compulsory immu-isation will be unnecessary if high immunisation rates can bechieved simply by convincing parents and providers of the over-helming benefits and ensuring systems and structures support

imely immunisation. In some instances, even just the inconve-ience to parents of excluding their children from school duringisease outbreaks, as in many states in Australia, may be sufficiento persuade them. Other countries, however, have taken a more dra-onian approach, adopting the view that parents should be obligedo immunise their children in order to protect other children aroundhem. In Belgium recently, parents who failed to immunise theirhildren against polio were given prison sentences that would benacted if the children remained unimmunised [16].

We know in advance that neither persuasion nor the threat ofunishment will work with all parents, even when parents’ failureo immunise their child exposes the child to a risk of contracting aevere illness. This is in part because immunisations are associatedith a remote risk of severe harm to the child who is being immu-ised. A few parents are understandably reluctant to impose thatisk on their child and some feel that vaccines hold more risks thanre acknowledged [4,5].

So the question arises: is it legitimate for the state to compelarents to immunise their children? Comparable constraints on thexercise of parental responsibility are already in place. Many juris-ictions currently compel parents to protect their children fromisk of accident by using seat belts for travel in cars, even thought is known that while seat belts are usually protective, they veryccasionally cause severe harm to children [17]. But only a few juris-ictions, e.g. Croatia, France, Italy, Poland, Slovakia and Taiwan, haveompulsory vaccination, while others such as the USA have laws,ariably enforced, regarding compulsory immunisation for schoolntry [18]. Most countries rely on good systems of vaccine deliv-ry together with incentive schemes and campaigns to maintainommunity demand [18]. It should be noted, however, that in theSA mandates might serve a function other than solely to compelaccination, because they occasionally allow children who wouldtherwise not be able to receive vaccines to receive them. Specifi-

ally, mandates may deliver vaccines to the so-called working poor,ho fall between the cracks of the Vaccine for Children’s program

nd insurance coverage.It is also important to distinguish immunisations, which pro-

ect only the child so immunised, and immunisations, which confer

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hat is now called ‘herd immunity’, because they protect others asell as the child who is directly immunised [19]. A vaccine con-

ers herd immunity if, once a critical proportion of the populationas been immunised, circulation of the organism falls to a pointt which it no longer threatens people who have not been immu-ised [19]. A parent may decide not to vaccinate their child, buto “free ride” on the immunity of others [20], but when too manyndividuals choose this action, herd immunity is lost and epidemicsccur [21]. The extent of herd immunity varies and our knowledge isncomplete. Immunising a child against measles protects that childgainst measles, and once about 95% of all children are immunised,easles stops circulating and outbreaks cease [21]. Immunising a

hild against pertussis protects not only that child, but also protectsewborn babies too young to be immunised [21]. As immunisation

evels fall, the risk of disease rises. If, for example, a measles orolio outbreak occurred, the risk–benefit ratio has changed andompulsory immunisation might become ethically justifiable.

Can a justifiable case be made for compulsion with respect toaccines, which confer little or no herd immunity, such as those foretanus and rabies? This would need to be argued on a case-by-caseasis. For instance, a child bitten by a rabid animal will usually dienless rabies vaccine is administered [2]. If parents refused rabies

mmunisation, compulsion would arguably be justified as a childrotection issue, given the risk of almost certain death without

mmunisation and the availability of a remedy. In such cases, themminence and severity of the risk to the child’s health and thevailability of effective preventative treatment make compulsionegitimate.

Of course, it should go without saying that any society, whichompels childhood immunisations, should also provide no-faultompensation for any children inadvertently harmed by immunisa-ion [22,23]. However, we also believe that no-fault compensations the most ethical approach to vaccine-related injury when peoplere immunised by the state in good faith without compulsion [22].

The recent development of vaccines against human papillo-avirus (HPV), which can cause cervical cancer and much more

arely anal and penile cancers, illustrates some practical and ethicalroblems with vaccination [24–28]. Compulsory HPV immunisa-ion has been advocated by some women in the USA because HPVnfection disproportionately disadvantages women [24]. While

aking HPV immunisation compulsory for girls entering middlechool (and making middle school attendance compulsory) wouldlmost certainly achieve very high levels of HPV immunisation [24],any would argue that the resulting infringement to civil liberty is

oo high a price to pay [25,26]. Enforcement would in practice bextremely difficult, and the inevitable loud opposition from HPVaccine opponent groups could lead to poorer HPV vaccine uptakehan without compulsion [27]. Australia has recently introducedPV vaccination for all schoolgirls aged 10–12 years and hopes tochieve very high coverage through non-compulsory, school-basedrogrammes [28]. If immunising boys against HPV were shown torotect girls, immunising boys would be ethically justifiable.

If there is a case for compulsory immunisation of children withome vaccines that do not confer herd immunity, there seems anven stronger case for compulsory immunisation with vaccines thato confer herd immunity. The justification would be that compul-ory immunisation protects not only the recipient but also otherhildren. But the evidence for herd immunity would need to betrong, the risk of contracting the disease substantial and the dis-ase itself sufficiently harmful to a child to justify the infringement

f parental autonomy. Even then a case can be made for exemptingarents with an ‘in principle’ objection to immunisation [29,30]. If aublic health measure requires only general, rather than absolutelyniversal, participation in order to achieve its purpose, par-nts of children with ‘in principle’ objections (including religious

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Editorial / Vaccin

bjections) could be exempted easily enough. If so, ‘in princi-le’ parental objections to vaccination should be respected, in so

ar as respecting them is consistent with the programme’s publicealth purpose. But if respecting parental objections would seri-usly impede an objectively reasonable public health measure, thenhe parental obligations may be over-ridden for the sake of theommon good.

. Immunisation and the public funding of health care

Justice in the allocation of public funds for health care is a secondajor ethical issue dominating discussion of vaccine programmes.lthough the cost of developing vaccines has increased enormously,accines are still among the most cost-effective of all health inter-entions [1]. Nonetheless, given the financial pressures on all healthare systems, whether public or private, questions arise about theunding of immunisation programmes. These questions are appli-ations of a more general question: according to what principles ofustice should financial resources for health care be allocated?

There is a wide range of answers to this question: Let the freearket allocate resources. Allocate according to social contribution

r social merit. Give to each equally. Prefer young to older people.e believe that the only genuinely just answer is: “Give to each

ccording to health care need.” But in practice this means that indi-idual patients, rival patient groups, and indeed rival public healthrogrammes, will be unwitting competitors for the same healthare dollar [30–32]. Justice and equity, therefore, require the com-unity to make reasoned and reasonable comparisons between

everal interventions all of which meet health care needs. In doingo, the community ought not to diminish the importance of immu-isation programmes, just because benefits lie in the future andre not as predictable as, say, a drug that gives a few extra monthso a dying cancer patient. Public funding for vaccines has beenssessed since 2006 in Australia through the same mechanism usedor other medications, such as anti-cancer drugs, lipid-loweringgents, and anti-depressants. A government-appointed committee,he Pharmaceutical Benefits Advisory Committee (PBAC), adviseshe Minister for Health on the cost-effectiveness, in terms of coster quality adjusted life year (QALY), of new drugs or vaccines, andovernment makes the final decision about funding [33]. Australiaas already publicly funded rotavirus vaccines and HPV vaccineshrough this PBAC mechanism [33].

Decision-making by governments clearly faces ethical chal-enges as costs of new vaccines rise and the pharmaceuticalndustry uses disease support groups to lobby on their behalf.or developing countries, cost is often the paramount issue. Allesource-poor countries use oral polio vaccine (OPV), because theyannot afford inactivated polio vaccines (IPV). The philanthropicnitiative by the Bill and Melinda Gates Foundation to finance theevelopment and delivery of vaccines for developing countriesas already saved over 5 million lives, and has galvanised vaccineanufacturers to develop new vaccines specifically for developing

ountries [34]. Nevertheless, huge inequity persists.Where there exist alternative vaccines with different cost and

afety profiles, considerations additional to justice in the allocationf health care resources will be relevant. For instance, competingemands on the public purse (education, law and order, defence,ublic welfare, other forms of health care) may require that a toler-bly good vaccine is publicly funded rather than a perfect one. Forxample, OPV costs considerably less than IPV, but causes vaccine-

ssociated paralytic poliomyelitis (VAPP) once in every 2.4 millionoses of vaccine [35]. In 2000, the USA elected to change to achedule using solely IPV to prevent approximately 8 cases of VAPPccurring each year and to maintain confidence in public immu-isation programs [36]. In Australia, the cost of changing from IPV

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o OPV, over $100 million per case of VAPP prevented, was felt toe prohibitive and to represent a significant opportunity cost ofoney that could be spent on more effective health care interven-

ions [37]. When the price of IPV fell, the price of OPV rose andhen IPV-containing combination vaccines became available, Aus-

ralia elected to change to IPV. The UK has subsequently made theame decision. This illustrates the tension that can arise when con-iderations of cost-effectiveness compete with considerations ofon-maleficence and with averting possible loss in public confi-ence in immunisation programmes.

Finally new questions about fairness, or equity, will arise in theontext of pandemics. Supply is likely to be limited, even if gov-rnments stockpile vaccines, such as pandemic influenza vaccines.lanning for pandemics includes prioritising who would receive theaccine [38,39].

. Conclusion

Although the great majority of the public agree that the benefitsf vaccines far outweigh the risks and accept the merits of child-ood immunisation, immunisation has always stimulated ethicalebate and new vaccines will inevitably bring new and difficultthical challenges.

Competing interests: All authors declare that they have no com-eting interests.

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David Isaacs a,d,f,∗

Henry Kilham b,f

Julie Leask c,d

Bernadette Tobin e

Department of Infectious Diseases, Children’s Hospital at Westmead,NSW 2145, Australia

b Department of Medicine, Children’s Hospital at Westmead,NSW 2145, Australia

c National Centre for Immunisation Research and Surveillance,Children’s Hospital at Westmead,

NSW 2145, Australiad Discipline of Paediatrics and Child Health, University of Sydney,

Sydney, NSW 2006, Australiae Plunkett Centre for Ethics, St. Vincent’s Hospital, Darlinghurst,

NSW 2027, Australiaf The Centre for Values, Ethics and the Law in Medicine,

The University of Sydney, Australia

∗ Corresponding author at: Departments of Infectious Diseases,Children’s Hospital at Westmead, NSW 2145, Australia.

Tel.: +612 98453414; fax: +612 98453421.

E-mail address: davidi@chw.edu.au (D. Isaacs)

21 May 2008

Available online 19 November 2008