Babies and children aged 0–5 years old

Two qualitative studies were included, each with an associated quantitative paper. One study evaluated the use of the Celebrate and Protect vaccine reminders programme for childhood vaccines, and the other examined the use of a web-based decision aid aimed at parents whose children were eligible for the MMR vaccine.

Young people aged 11–18 years old

Three qualitative studies were included. One mixed-methods study evaluated an e-consent school-based intervention for HPV vaccinations. Two qualitative studies examined the same school-based HPV intervention, which promoted financial incentives for consent form return.

Babies and children aged 0–5 years

The qualitative evidence for the Celebrate and Protect reminders programme was low to very low quality and was from a single study which provided limited information about recruitment methods. The quantitative evidence for vaccine uptake was very low quality, as it was from a non-peer-reviewed report which did not report how many participants were in the control arm or how they were recruited. The limited details on the methods used for recruitment meant that it was not possible to calculate effect sizes and confidence intervals for vaccine uptake, and so the only data that was available was percentage uptake per trial arm. Percentage vaccine uptake was not one of the outcomes stated in the protocol, but the study was included to provide the committee with an indication of the effectiveness of the intervention, with the quality of the outcomes downgraded for risk of bias. This approach was taken with the agreement of the committee.

Qualitative evidence for the use of an MMR web-based decision aid was very low quality and the evidence for vaccine uptake was low quality. Very few parents were included in the semi-structured interviews used in the study, and only two themes were identified with limited evidence to support each theme. The qualitative evidence was from a pilot of the intervention which did not provide information on vaccine uptake, and so the quantitative evidence was instead provided from a study published 3 years after the feasibility study had been completed. The effectiveness data is therefore from a different group to those who provided their views on the intervention; however, the newer study does not report changing the intervention from the format used in the pilot. Finally, this intervention was carried out on a population with high vaccine uptake, with 100% of children being given the vaccine in the intervention arm, and 98% in the control arm. It was therefore difficult to determine the effectiveness of the decision aid, which could potentially show a greater effect in a population with lower vaccine uptake.

Young people aged 11–18 years

For young people aged 11–18, the qualitative evidence for the use of e-consent forms was low to very low quality and the quantitative evidence for vaccine uptake was very low quality. The evidence was from a mixed-methods study of a pilot project designed to evaluate the implementation of the intervention. The quality of qualitative outcomes was downgraded as they were obtained from a single study with limited detail provided to support the themes. While the views on effectiveness of the intervention were directly applicable to the review, the views on implementation were only relevant (rather than highly relevant) as the part of the intervention which allowed nurses to monitor consent form return and update vaccination records was not fully functional during the pilot phase.

Qualitative evidence for the use of incentivised consent forms for the HPV vaccine ranged from very low to moderate quality, and the quantitative outcome was low quality. The effectiveness of this intervention was assessed by the number of consent forms returned, rather than vaccine uptake. Although this is not the stated outcome for this review, the committee discussed whether consent form return was an appropriate outcome that would provide an accurate reflection of changes in vaccine uptake. It was decided that, although vaccine consent forms could be returned with non-consent to the vaccine, it was likely that many of those returned would consent to vaccination. This was supported by an additional outcome in the incentivised consent form study, which reported the proportion of consent forms returned with a positive outcome (consented to vaccination). In the incentivised consent form arm, not only were more consent forms returned, but there was a higher proportion of positive consent forms returned in the intervention arm than in the control arm. In addition, in both arms over 85% of the returned forms gave consent for vaccination. Consent form return was therefore included as a proxy outcome for vaccine uptake, with the quality of the evidence downgraded once for indirectness. It was also highlighted that the evidence for this intervention was from an area of relatively low vaccine uptake. Although there was no evidence for the use of incentives in areas of higher uptake, the committee decided that, given the effectiveness of the intervention, incentives should be recommended to providers in all areas (see below for more details).

As there was limited evidence on this subject, the committee also decided to include a research recommendation to examine the effectiveness and acceptability of school-based incentive schemes. They included both financial and non -financial incentives and specified that the incentives did not have to be aimed at incentivising uptake directly but could be aimed at promoting other behaviours (for example, consent form return) that ultimately result in increased vaccine uptake. (See below for the committee’s discussion about the potential issues raised by the use of financial incentives for vaccine uptake.) The committee discussed whether lower levels of incentive would have been equally effective in Forster 2017; and wondered at what level would the incentive cease to be effective. As a result, the economist carried out a costing exercise to estimate the resource implications of recommending incentives to increase consent form return (see the cost-effectiveness and resource use section below). This involved a range of scenarios and the remaining uncertainty around the level of incentive needed for cost-effectiveness resulted in the committee adding consideration of the levels, as well as types, of incentive that could be effective to the research recommendation. This research recommendation is explained in detail in Appendix K

Qualitative evidence for the use of new methods of obtaining consent (Audrey 2020, Audrey 2021, Fisher 2020a) ranged from very low to moderate quality and the quantitative outcome was very low quality. Both qualitative and quantitative evidence was directly applicable to the review, and while the quantitative evidence did not show an increase in vaccine uptake with the new methods of obtaining consent, the committee thought that the qualitative evidence raised some important issues that are relevant to the current methods used for school-based vaccinations. The new methods of obtaining consent described in the study are similar to those used in current practice and so the committee decided that the qualitative findings were directly relevant and could be applied to the current processes involved in obtaining consent for school-based vaccinations.

People aged 65 years and over and pregnant women

As no evidence was identified for either people aged 65 years and over or pregnant women, the committee could not make recommendations on specific interventions to increase vaccination uptake in either of these groups based on this review. Limited qualitative and quantitative evidence was identified for these groups in the intervention reviews and the main qualitative review on barriers to and facilitators for vaccine uptake. The committee therefore decided to make a research recommendation for each of these populations to identify whether there are any interventions that are both acceptable and effective at increasing vaccine uptake (for the research recommendation for people aged 65 years and over, see Appendix K in the review B on the barriers to and facilitators for vaccine uptake for more details; for pregnant women see Appendix K in the vaccinations for pregnant women review F for more details).

Babies and children aged 0–5 years

For babies and children, the qualitative evidence associated with the Celebrate and Protect intervention indicated that contact with parents soon after the birth of a child can be a problem, and some parents highlighted that they would like more, balanced, information about vaccinations. It was unclear from the quantitative evidence whether the intervention was effective at increasing uptake as the data was reported as % with no indication of variation. The committee agreed that there was insufficient evidence of benefit (increased vaccine uptake) to support recommending this particular intervention. They also noted that the funding for this intervention came from a pharmaceutical company and that this may have affected parents’ responses to the intervention and, as a result, its effectiveness.

When discussing birthday celebration and reminder cards as a method of increasing childhood vaccination uptake, the committee highlighted concerns over a potential scenario where a child has died, and the relevant information has yet to be updated in their GPs system, resulting in a celebration card being sent to the family. Although this could also happen for vaccine reminder letters, the committee thought that receiving a celebration card for a child who has died would be a much worse scenario and would cause unnecessary pain to the bereaved family. The committee noted that they had already recommended using invitations/ reminders for vaccination with information based on the evidence in the reminders and education reviews (evidence reviews C and E respectively) and that these recommendations did not need amending based on the celebrate and protect intervention.

The quantitative evidence for the MMR decision aid had already been considered in the education review (evidence review E) alongside other studies looking at decision aids. The evidence from Shourie 2013 could not differentiate vaccine uptake between people using the MMR decision aid and usual care, but this may be due at least in part to the very high baseline vaccination rate in this study. The committee noted that the main themes identified in the qualitative evidence from this review showed that parents thought the decision aid helped them make informed decisions about vaccination and that that the presentation of information about the benefits and harms of vaccination was useful. The desire to make an informed decision based on information that is perceived to be balanced was also reflected in the main barriers and facilitators review (evidence review B). Based on the evidence in review E, the committee decided against making a specific separate recommendation in favour of using decision aids, however they agreed when they are available on trusted sites, they could potentially be a useful method of helping people make decisions about whether to be vaccinated or have their children vaccinated. This was supported by the qualitative findings with parents highlighting how the decision aid helped with decision making and reduced the need for them to ask further questions before reaching a decision.

Young people aged 11–18 years

One of the main barriers to young people receiving the HPV vaccine in schools relates to difficulties with gaining consent, as is the case when consent forms are not returned. This leads to immunisation providers spending lots of time chasing up non-responders to try to obtain consent. Evidence for the use of incentivised consent forms showed an increase in the number of forms returned when entry into a prize draw was offered. The committee therefore thought that this may be a useful method of increasing the number of forms returned. The committee discussed whether there were potential ethical issues surrounding the offer of financial incentives relating to vaccinations (see evidence review G for more discussion about this issue). However, it was highlighted that the incentive used in the evidence was based on consent form return rather than receiving the vaccination. The committee decided that this was a more acceptable form of intervention as it was promoting decision making about the vaccination, rather than the vaccination itself. However, it was noted that financial incentives may not be appropriate in all settings, such as faith schools, where a prize draw could be considered a form of gambling. The committee therefore decided not to specify what the intervention should be and instead the decision on exactly what incentive is offered can be made at a local level, by people who have an awareness of the particular school, the local community and its beliefs. The committee discussed how other potential incentives could include vouchers or lunch passes, which may be more acceptable in some settings than financial rewards. In addition, they also did not specify the target of the intervention. In the Forster studies (2018 and 2020) the intervention was aimed at students, but other interventions may be better suited to targeting parents and so the committee left this open for the providers to decide. Finally, the recommendation was not limited to areas of low uptake because the committee noted that the use of incentives for consent form uptake could also provide benefits in areas of high uptake by reducing the time needed for the immunisation team to chase up non-responders.

The committee considered whether e-consent forms could remove some of the barriers associated with non-return of paper consent forms. However, the evidence highlighted that while some parents preferred e-consent forms, others may not have access to the technology needed to access and return them online. Given that the evidence could not differentiate between vaccine uptake when e-consent or paper consent forms were used, the committee decided that they could not make a recommendation in favour of a single option. Instead, it thought that schools would be better placed to decide on the best option to suit their local community and decided against making a recommendation based on methods of consent form return, although they noted that e-consent forms are already in use in many areas.

The evidence for both e-consent and incentivised consent form return highlighted the importance of young people being made aware of vaccines and the vaccination process. One of the main themes relating to the HPV vaccine was that young people want to be involved in discussions surrounding the vaccine, such as the benefits and harms associated with vaccination. As this was a common theme in both qualitative studies and had been raised in the main barriers and facilitators review as well, the committee decided it was important to highlight this in a recommendation to try to help parents, carers and young people make an informed choice about vaccination. The committee decided that information about Gillick competence should also be included so that parents and young people are all fully aware of all the options surrounding vaccine consent. An additional recommendation was made, specifically aimed at young people, which highlighted the importance of school-based education. Although the qualitative evidence reported a range of views on the most appropriate method of giving young people information about vaccination, school-based education was commonly stated as one of these options. It was the committee’s experience that this is standard practice in some schools, and they agreed that this was an important way of providing information about vaccinations delivered in school settings to children of appropriate ages and young people. They noted that the information provided could be tailored to their needs and level of understanding as young people would be able to understand more complex information than children.

The committee agreed that consent is a particularly important issue relating to school-based vaccinations because the person giving consent may not be present at the time of the vaccination. In addition, the evidence from studies looking at vaccinations for 11–18 year olds in this review, alongside the evidence from the qualitative review (evidence review B), highlighted that while immunisation teams are well trained to assess Gillick competence, some people do not feel comfortable with the concept of young people being allowed to self-consent for vaccination. This is therefore an issue which needs to be carefully considered.

Although the aim of the recommendation for incentivised consent form return is to increase the number of young people who return their vaccination forms, there will still be times when a young person does not have a signed consent form at the time of a school vaccination session. If a nurse is unable to contact the parents or carers of the young person to ask for their views, then they can instead make an assessment over whether the young person is capable of making the choice about vaccination themselves. The studies on new methods of obtaining consent suggested that this could take place at the time of a routine vaccination session, and the committee agreed that, where possible this would be useful. However, they thought that time constraints would often make this difficult to achieve in practice. Instead, they agreed that Gillick competence assessments and vaccinations for those who are considered competent should be offered at the earliest opportunity, which could either be during a routine vaccination session or during catch-up sessions for young people who have been identified as not up to date with their vaccinations.

An alternative scenario for assessing Gillick competence is when the parent or carer has returned the consent form and has refused vaccination, but the young person has different views to their parents and wishes to be vaccinated. The committee thought that if a young person is assessed as competent then, where possible, they should still be offered vaccination and that this could be assessed as part of the catch-up process. To do otherwise might be discriminatory as the young people who lacked parental consent (or refusal) could be assessed for Gillick competence but the young people whose parents had refused vaccination would be denied this opportunity. However, the committee were aware of the potential issues associated with going against parental wishes. In addition, although the committee thought that offering a Gillick competence assessment is important, their experience was that there are not always clear systems in place to ensure that vaccination teams feel supported when carrying out this assessment. The studies on new methods of obtaining consent included processes that immunisation nurses had to follow to guide their Gillick competence assessments, such as young people being asked if they had discussed vaccination with their family and whether being vaccinated could cause conflict with their parents or carers. The immunisation nurses reported that this helped them to make decisions on a person’s capacity to consent. As a result, the committee agreed that it was important that school aged immunisation providers have a policy on Gillick competence in place and that this should include guidance about what action to take when a young person’s vaccination preference is different from their parents to help to support the decisions of the immunisation teams in the schools. They also included cross references to help ensure that the assessment of Gillick competence is be carried out in line with national guidance, such as that set out in the Green book and by the General Medical Council.

When discussing consent, the committee noted that parental refusal might be limited to specific vaccinations (for example, HPV) and that that there are some settings, such as faith schools, where it may be deemed unacceptable for young people to be vaccinated if this is against the parents’ wishes. This was considered a key issue, as assessing for Gillick competence in this scenario could potentially damage the ability of the immunisation team to access the school for other vaccination campaigns. The committee highlighted a qualitative study (Chantler 2019) which investigated methods of obtaining consent for school vaccinations. The findings of this study reinforced the concerns of some schools about young people being allowed to self-consent to vaccination, and highlighted that, in some cultures, a young person may feel unable to go against the decisions of their parents. It is therefore important that school aged immunisation providers and vaccination teams tailor their approach to Gillick competence assessments based on local populations. This will maximise the number of young people that are vaccinated but also ensure that the actions of vaccination teams do not have any unintended consequences.

Catch up sessions and tailoring immunisation programmes

Catch-up sessions are part of routine practice, and the committee discussed the importance of these to ensure that children and young people are given additional opportunities to be up to date with the routine adolescent vaccination schedule. In addition, they note that catch-up sessions in schools would ensure that children and young people who are not up to date with their vaccinations have other opportunities to be vaccinated. These sessions are currently limited to children and young people who had missed school-aged vaccinations, but they could be expanded to provide opportunities to catch up on earlier preschool vaccinations. At the moment, children and young people have to be directed to their GP to be offered these vaccinations. The committee noted that some children or young people will be unable to attend the school-aged catch-up sessions, for example due to sickness, exclusion or extended leave, so alternative provisions are necessary to ensure that they can be offered their overdue vaccinations. This could involve signposting to GPs or other places where the vaccinations are available. To help with identifying these children and young people, CHIS can provide vaccination histories to providers and the committee made a recommendation for CHIS to do so.

Catchup sessions commonly occur in schools but can be carried out in other settings, such as GP surgeries. The committee noted that very little evidence for catch-up sessions had been identified as part of the evidence reviews for this guideline. One study (Altinoluk-Davis 2020) was identified as part of evidence review D (on improving access to vaccinations). It was carried out in the UK and showed that a nurse led catch up at school resulted in more MMR vaccinations than a reminder to have a catch-up vaccination at a general practice. The committee used this study to provide support for their recommendation for school-based catch-up sessions. However, this study only looked at MMR vaccinations and was a cohort study rather than an RCT, so the results were judged to be of low quality. Some evidence in the qualitative review evaluated the use of a catch-up campaign for young people, based in GP surgeries (see evidence review B). Based on the importance of enabling children and young people who have missed vaccinations to be identified and vaccinated later, the committee agreed that despite the findings of the studies above more research was still needed on this topic. They therefore made a research recommendation to compare the effectiveness and acceptability of school-based and GP-based catch-up campaigns in the UK (see Appendix K). This will help providers establish the most appropriate and acceptable setting or settings for catch-up sessions as these may vary depending on the vaccination.

The committee also discussed the importance of tailoring interventions to increase vaccine uptake to specific communities to increase their effectiveness. They were aware that the WHO has a specific programme called ‘Tailoring Immunisation Programmes’ (TIP) but noted that this approach had not been evaluated to determine whether it was effective as a method of designing and testing interventions to increase routine vaccine. The committee therefore wrote a research recommendation on this topic (see Appendix K for more details).

Consent for non-school-based vaccinations

The committee noted that vaccinations that are given in schools differ from other vaccines, as this is the only scenario where the person giving consent is not the person receiving the vaccine, and they are not with the person receiving the vaccine at the time of vaccination as is the case with parents of young children. Given these differences in the vaccination process, the committee did not think that the evidence for incentivised consent form return could be applied to other vaccination groups, such as babies and children, pregnant women or people who are aged 65 years and over. Instead, it was decided that additional evidence is needed to identify whether incentives are also effective at increasing vaccination uptake in these other groups. This supported the findings of the infrastructure review that more research is needed to determine the most effective methods to increase vaccine uptake for all ages and groups. The committee therefore made a research recommendation aimed at examining whether incentives are also effective at increasing vaccine uptake in these groups (see Appendix K, evidence review G).

Although most of the evidence relating to consent in this review was for young people aged 11–18 years, the committee discussed how issues relating to vaccine consent can also be a barrier to uptake for some groups of adults. This is particularly important for individuals who need support with decision making or who may lack the mental capacity to consent for vaccination and are at risk of not being vaccinated as a result. Although there was no evidence for these other populations, the committee thought it was important to promote equality by ensuring that all people are given the support necessary to make informed decisions on vaccination. An additional recommendation was therefore included which links to the NICE guideline on decision making and mental capacity. This will provide clinicians with guidance on what to consider when discussing consent for non-school-based vaccinations. The committee were also aware that there is a NICE guideline on Advocacy services for adults with health and social care needs that is being developed and is likely to be relevant to this topic when it publishes in 2022.

Future proofing the recommendations

In the evidence reviews we looked for evidence regarding routine vaccinations for people aged 65 and over because this was the age limit for vaccinations for older people on the NHS routine schedule at the time the work was carried out. Since there was limited evidence for this age group, we also included data from relevant studies including people aged 50 and over, where the majority of participants were in our target age group, or the mean age was 65 or over with committee agreement taken on a review-by-review basis. These studies were downgraded for applicability where the committee deemed it appropriate.

According to the Joint Committee on Vaccination and Immunisation minutes from the meeting on 22 June 2021 shingles vaccination eligibility is changing to include people aged 60 and over and this will be introduced in a phased manner down from the current age of 70 years. It is unclear when this change will be initiated or completed. In order to future proof the guideline recommendations we have therefore changed those mentioning people aged 65 and over to refer to older people instead and defined them as follows: adults who are eligible for routine vaccination on the UK schedule, excluding pregnancy-related vaccinations. We also suggest that people consult the green book for information about current age limits and vaccinations for older people. The content of the recommendations has not been changed otherwise as this was not deemed necessary. The majority of recommendations that apply to older people are also more generally applicable and have not been altered because they do not mention groups of people by age. The committee discussions of the evidence have also been retained in their original form, with the addition of the information about the use of the term older people where the relevant recommendations that specifically mentioned people aged 65 and over are discussed.