Introduction

Smallpox was the first infectious disease against which immunisation was successfully practiced. Variolation, the inoculation of smallpox material into the body, was introduced into the UK in the early 18th century by Lady Mary Wortley Montagu. Although effective, this practice was not without considerable hazards since contacts of a varioliated individual might catch virulent and often fatal smallpox. Later that century Edward Jenner famously developed a vaccine derived from cow pox. The technique of administering the vaccine became known as ‘vaccination’ from the Latin for cow, ‘vacca’. In 1979, as a result of widespread vaccination, the World Health Organization declared that smallpox had been eradicated from the world, less than 200 years after Jenner first administered a vaccine (World Health Organization 2005). This is the first and, so far, the only time in history that man has conquered an infectious disease.

At the beginning of the 21st century, children living in the UK are routinely protected with highly effective and safe vaccines against ten potentially damaging infections: diphtheria, tetanus, poliomyelitis, pertussis, Haemophilus influenzae type b (Hib), meningococcal C, pneumococcal, measles, mumps and rubella. Children in specific at-risk groups are offered additional vaccines including hepatitis B, BCG and influenza vaccines. Most industrialised countries have similar programmes, albeit with some variation. In the USA children are offered 12 vaccines routinely in the first 13 months of life. The majority of parents accept these vaccines for their children, with uptake in the UK in excess of 90% for the primary vaccines and the incidence of vaccine-preventable diseases is generally at an all time low. As a result of immunisation, disease rates in the USA have been reduced by 99% and the pro-spects for eliminating other infections are promising, with poliomyelitis the next infection targeted for global elimination (World Health Organization 2004). New vaccines on the horizon and others already in existence, such as vaccines to protect against varicella and human papillomavirus (HPV), are being considered for inclusion in the routine schedule.

Despite this outstanding success, immunisation has always been the subject of controversy and fiercely argued ethical debates. Although a simple, highly effective and safe public health intervention, which has been described as among the top-10 public health achievements of the 20th century (Centers for Disease Control and Prevention 1999), ensuring every child is fully immunised is a challenge for public health practitioners even in an industrialised country. This is, in part, a result of the difficulties of delivering equitable and accessible services to disadvantaged groups. It is ironic that the very success of the programme, which has consigned many diseases to the history books, also means that many parents no longer perceive a need for vaccines and some, often the most advantaged, reject immunisation for a variety of complex reasons. In this chapter, the current recommendations for childhood immunisation in the UK will be described, determinants of immunisation uptake will be reviewed and some ethical considerations for community public health practitioners will be discussed.

UK childhood immunisation programme

In the UK, the Joint Committee on Vaccination and Immunisation (JCVI), an independent expert advisory committee, advises the government on immunisation. Recommendations, once accepted and approved, are funded centrally and vaccines are provided free to recipients (Salisbury 2005). The role of primary health care practitioners is to deliver the programme by advising parents about it and by providing immunisation services, including the administration of vaccines according to the recommended guidelines as laid down in the Department of Health publication, Immunisation against infectious disease (Department of Health (DH) 2006) known as ‘The Green Book’. The web-based version is regularly updated (DH 2007a), with the programme agreed in September 2006, reproduced here in Table 14.1.

Table 14.1 Recommended UK childhood Immunisation schedule – September 2006 (from DH 2006)

Age	Vaccine	Mode of delivery
8 weeks	Diphtheria/tetanus/acellular pertussis/Inactivated polio	One injection
	vaccine/Haemophilus influenzae type b/(DTaP/IPV/Hib), and pneumococcal	One injection
12 weeks	DTaP/Hib/IPV	One injection
	Meningococcal C	One injection
16 weeks	DTaP/Hib/IPV	One injection
	Meningococcal C	One injection
	Pneumococcal	One injection
12 months	Hib/meningococcal C	One injection
13 months	Measles, mumps and rubella (MMR)	One injection
	Pneumococcal	One injection
Preschool	DTaP/IPV or dTaP/IPV (preschool booster)	One injection
	MMR (second dose) (can be give earlier)	One injection
13–18 years	Tetanus/low-dose diphtheria/IPV (Td/IPV) (school leavers’ booster)	One injection

The programme is constantly under review as new vaccines are developed, new formulations or uses for existing vaccines become available and issues about vaccine safety or efficacy emerge as a result of post-marketing surveillance. Patterns of disease may change requiring alterations to the immunisation schedule. Examples of each of these include the withdrawal of MMR vaccines containing the Urabe mumps strain vaccine in 1992, the introduction of a vaccine to protect against meningococcal C infection (Men C) in 1999, the change from the live oral polio vaccine to the inactivated vaccine and from the whole-cell pertussis vaccine to an acellular vaccine in 2004, the discontinuation of the schools-based BCG programme in Autumn 2005, and the introduction of pneumococcal conjugate vaccine and add-ition of boosters of the conjugate vaccines Hib, Men C and pneumococcal in 2006.

Following introduction of the combined measles, mumps and rubella vaccine to the UK in 1988, different products were available for use. Two of these contained the Urabe mumps vaccine strain. Although active surveillance based on paediatricians’ reports suggested this particular mumps strain was associated with a low risk of aseptic meningitis among recipients, a cluster of cases reported from one area suggested a much higher risk. A detailed study was conducted to examine this more closely and results showed a risk of about 1 in 11 000 cases (Miller et al 1993). A decision was made to withdraw this type of MMR vaccine from use in the UK in 1992 and only those containing the Jeryl Lynn strain have been used subsequently.

In 1999 the UK became the first country in the world to introduce a vaccine against Men C infection. The incidence of this infection had been increasing in the UK in the 1990s and the availability of a safe and effective vaccine enabled the introduction of the vaccine into the childhood schedule, as well as a mass vaccination campaign including all individuals up to 18 years of age. This has been a highly successful initiative and other countries have followed suit (Miller et al 2001a).

Although very safe and highly effective, oral polio vaccine (OPV) can occasionally result in vaccine-associated paralytic polio (VAPP) in recipients (at a rate of about 1 in 1 million) or in unimmunised contacts of a recently immunised individual, most commonly as a result of failing to wash hands after changing a nappy. OPV acts not only by protecting the individual recipient, but also by boosting immunity to polio in the community and by preventing transmission of wild virus. This is very important in situations where polio poses a significant threat. However, as polio has become rare worldwide, the threat of importation of cases to the UK is extremely low, and the risk of VAPP is less acceptable. It is on this basis that the policy in the UK changed in Autumn 2004. At the same time, a five component acellular pertussis vaccine became available. This vaccine has an efficacy similar to the traditional whole-cell vaccine and the advantage of causing fewer of the minor febrile reactions and general upset that are often associated with whole-cell pertussis vaccine. This meant that it was possible to introduce a vaccine that gives equivalent protection against five diseases with one injection rather than the previous regimen of one injection containing four vaccines and one orally administered vaccine, but with an improved safety profile (Bedford & Elliman 2004).

The incidence of tuberculosis (TB) has increased in recent years (Health Protection Agency 2005a), but the pattern of disease has changed from that when BCG vaccine was introduced. It is now less prevalent in the indigenous population and, therefore, the value of the universal schools-based programme has declined. A targeted approach is now more appropriate. In Autumn 2005, the schools-based programme ceased and, instead, vaccine is offered to high-risk groups. All babies born in areas where there is a high incidence of TB (greater than 40 per 100 000 population) should be offered BCG. Other high-risk groups include those whose parents or grandparents come from countries where TB is prevalent and those where there is close contact with TB (Department of Health 2005).

The most recent developments in the childhood programme include the introduction of a conjugate vaccine to protect against pneumococcal infection into the infant immunisation schedule. Pneumococcal infection causes the most severe form of bacterial meningitis as well as septicaemia, pneumonia and ear infections (Bedford & Lane 2006). It has been used successfully in the USA since 2001, where not only have the numbers of cases of invasive pneumococcal infection declined, but also herd immunity has led to a decline in cases of disease among the elderly (CDC 2005). In addition to this new vaccine, boosters of Hib, Men C and pneumococcal vaccine were introduced at 12 and 13 months. The need for these boosters became apparent after using conjugate vaccines for some time. It is now established that when given to very young infants, immunity is relatively short-lived and that only two doses of conjugate vaccines are needed in the primary course. To ensure longer-term protection, a booster is required in the second year of life (Southern et al 2006, Trotter et al 2004).

All these examples demonstrate that vaccine policy is constantly developing in response to research, development and changing circumstances. This should be reassuring for those delivering and receiving vaccines, but changes to the schedule can also shake confidence in the immunisation programme, and raise anxiety for parents about the safety and effectiveness of the programme. It is thus vital that health care professionals are well informed about such changes.

Unique nature of immunisation

Wider benefits and ethical issues

Immunisation is unlike almost every other intervention and it is this very fact that creates some of the ethical dilemmas associated with the practice. When adults are given medication for their cardiovascular disease, the prime beneficiary is the recipient. There is, indeed, some benefit to society in that prevention of the complications, such as a myocardial infarction, will save medical costs, but this is very much a secondary consideration. Whether or not someone is treated has little, if any, effect on the health of others. Another important difference is that patients usually seek treatment, whereas immunisation and screening programmes are actually promoted to healthy individuals by health care professionals.

Apart from a few exceptions, if enough people are immunised with an effective vaccine against an infection, the disease may be eradicated or made so uncommon that even unimmunised people have little, if any, risk of catching the disease. This ‘herd immunity’ is essential for protecting those people who cannot be immunised, or who don’t become immune after receiving the vaccine. It also protects individuals who are not immunised because they or their parents have chosen to decline immunisation. Thus, these individuals can benefit from other people’s acceptance of vaccines without themselves taking any of the associated risks, however small. Those who decline vaccination have been termed rather pejoratively, ‘free-riders’, but declining vaccines is not just a personal decision, it can endanger others, including those who have been immunised and who, for a var-iety of reasons, remain unprotected. A potent example of this involved two renal transplant patients aged 8 and 13 years. Both children had received MMR vaccine before transplantation but the second dose was contraindicated as they were then immunocompromised. Local uptake of MMR vaccine was only 61% and thus the children were not protected by herd immunity. These children acquired measles and became very ill with encephalitis, leaving one of them with significant deficits (Kidd et al 2003). However, when parents are considering immunisation, the protection of the community is not always as high a priority as ensuring that their own child is afforded the best protection. In the eyes of a minority of parents, ‘best protection’ involves declining immunisation for their own children.

For an individual, the safest choice is to not to be immunised but to ensure everybody else is. From a public health perspective, this is untenable. To persuade individuals to continue accepting immunisation even when levels of disease are extremely low requires both very safe vaccines and an understanding that the very reason the diseases are uncommon is because of high vaccine rates. A fall in uptake would lead to a resurgence in disease.

Vaccination programmes raise ethical issues regarding respect for parents’ rights, the duties and responsibilities of health care professionals, and the role of government in formulating policies that protect society and promote public health (Alderson et al 1997). It is almost inevitable that conflicts of interest will result. This was highlighted vividly by the experience reported from Australia, when an unvaccinated 2-year-old child, injured by a wood splinter, developed tetanus. The child was successfully treated, but the parents, who objected to immunisation, declined to allow the child to have a course of tetanus vaccine. The clinicians involved not surprisingly found this case fraught with difficulties, feeling their duty to the child was severely compromised, while recognising that the parents had the authority to make this decision. In this situation they were limited to making strong recommendations that the child should be immunised (Goldwater et al 2003).

Organisation of the UK immunisation programme

In the UK, routine childhood vaccines are provided free of charge. Vaccines are purchased by the NHS and distributed by a central supplier who guarantees the maintenance of ideal conditions for the vaccines. Before vaccines can be used, each batch is subjected to independent testing for purity, potency and toxicity at the National Institute for Biological Standards and Control. Vaccines are usually delivered by primary care or in child health clinics. After a child is born, his/her details are entered into a register (usually computerised) maintained by the primary care trust (PCT). Parents are usually advised about the immunisation programme by the health visitor at, or soon after, the first visit when the baby is 10–14 days old. The nature of this advice and parents’ views about it will be explored in more detail later in this chapter.

As with any treatment, informed consent must be obtained before immunisations are given. In many areas parents are asked to sign a consent form before they attend for immunisation, this is merely consent to be included in the programme and does not mean that consent is in place for each future immunisation. Consent should be sought on each immunisation visit. However, it is not necessary for this to be obtained in writing, a signature on a consent form does not constitute conclusive proof that informed consent has been given but is a record of the de-cision and discussions that have occurred (DH 2006). Disputes between parents can exercise health care professionals who worry, in the case of a child brought for immunisation by someone other than the parent, such as a childminder or grandparent, whether they should they proceed with immunisation without written consent from someone with parental responsibility (Watson 2005).

Evidence of consent may be assumed if an authorised person brings a child for immunisation in response either to an invitation, or on a day when immunisation is normally given. Providing that the health care professional follows the consent procedure, and that the person who brings the child is able to consider any further information that may be relevant and agrees to the immunisation, then the procedure should be carried out. There is no requirement for written authorisation from a person with parental responsibility for the procedure to go ahead. Only in the exceptional circumstance where there is evidence of a previous concern or disagreement about any or all of the immunisations by the parent(s), is it necessary to contact the person with parental responsibility before proceeding. In this situation, it is the duty of each health care professional to ensure that all members of the primary health care team are aware of such knowledge and information (Moreton et al 2005).

The practicalities of providing immunisation will not be covered in depth here since these are all well addressed in the ‘Green Book’. The organisation of immunisation services is an important factor in ensuring high uptake, with those practices who adopt a team approach achieving higher uptakes (Peckham et al 1989). An individual in the practice or clinic should have overall responsibility for immunisation issues. This includes arranging appointments, collecting data, supply and storage of vaccines and clinical advice in difficult cases. Patient reminders and recall systems in primary care are also effective in improving immunisation rates (Jacobson and Szilagyi 2005). Innovative use of new technologies can develop such principles even further, with some practices sending text messages to parents’ mobile phones to remind them of an immunisation appointment (personal communication with Dr Sean Bourke). Data collection is particularly import-ant and this includes providing parents with a record of vaccines given. This information should be entered into the appropriate pages of the Personal Child Health Record as well as transferred to the PCT child health system. Feedback of performance uptake figures to immunisation providers reinforces the importance of data collection (Nicoll et al 1989). Professionals within the practice should be aware of who is the lead in the PCT from whom they can seek further advice. The role of the PCT lead is similar to that played previously by the district immunisation co-ordinator (Elliman & Moreton 2000).

Payment for providing immunisation services

Target payments for immunisation for GPs were introduced in 1990. The fees payable depend on the percentage of the target population who receive the vaccines and whether this percentage is above targets set by the government. Currently, 70% uptake is required for the lower payment and 90% for the higher target fee. While the system has changed somewhat under the new GP contact, the principle remains the same.

As will be discussed later, payments to GPs for immunisation can affect the relationship of trust between practitioners and their patients, although in practice the financial reward is relatively small. One GP calculated that in 2002 his six partners were paid 95p each for every immunisation given (Fitzpatrick 2004a).

Who should immunise?

The provision of immunisation has increasingly become a nursing responsibility. This is a development which is to be encouraged. The ‘Green Book’ advises that a doctor may delegate responsibility for immunisation to a nurse as long as he/she is willing to be professionally accountable for this work, has received training and is competent in all aspects of immunisation, including knowledge of the contraindications to specific vaccines and in the recognition and treatment of anaphylaxis. If nurses carry out immunisation in accordance with accepted PCT policy, the Trust will accept responsibility for immunisation by nurses. Similarly, nurses employed by general practitioners should work to agreed protocols (DH 2006).

Determinants of vaccine uptake

High uptake of immunisation depends on a range of inter-related factors. These include the organisation of immunisation services as described above, and know-ledge and attitudes of health care professionals. Among parents, socio-economic factors as well as attitudes and perceptions are the key factors (Nicoll et al 1989, Peckham et al 1989).

The relationship between social factors and vaccine uptake is complex and there are differences in the characteristics of children whose parents accept immunisation, but do not complete the course (partial immunisers) and those whose parents reject immunisation or specific vaccines altogether (non-immunisers) (Samad et al 2006a). This latter group often has strong beliefs and are less likely to consider vaccination to be safe or to be necessary (Samad et al 2006b). Children who commence the immunisation course but do not complete are more likely to come from large families (Li & Taylor 1993), to have younger mothers (Samad et al 2006a) who are lone parents (Sharland et al 1997) and to have been hospitalised (Samad et al 2006a). Among this group are parents who do not object to immunisation, but for whom social or family pressures may mean that they do not get round to completing the course. These two groups, partial and non-immunisers, thus may require different interventions. Services for partial immunisers in particular need to be accessible and flexible. Health care professionals should consider offering opportunistic or domiciliary immunisation and reviewing immunisation status when families attend primary care for other reasons as well as in other health care settings, particularly hospitals. For non-immunisers, the intervention is more likely to be an issue of giving information that is tailored to respond to parents’ questions and concerns, at a level of complexity appropriate to the individual. In practice, this may mean that some parents require a lot of detailed information, including lengthy discussions with different health care professionals as well as written material.

An important factor in determining vaccine uptake is parents’ attitudes to the safety of vaccines and seriousness of diseases (Peckham et al 1989). This will be examined in more detail in the next section.