The decision to offer COVID-19 vaccinations to children and young people over the age of 12 years has been the subject of some discussion. Although there have long been anti-vaccination movements, often controversies such as this are the result of a misunderstanding of the process of decision-making and the assessment of risk, rather than a reaction to the vaccine itself. To understand why this decision was made, it is necessary to examine what the Joint Committee on Vaccination and Immunisation (JCVI) has said, and how this translates into a recommendation from the Chief Medical Officers, and subsequently a policy decision by the Government.
The JCVI is a statutory body established:
‘To advise UK health departments on immunisations for the prevention of infections and/or disease following due consideration of the evidence on the burden of disease, on vaccine safety and efficacy and on the impact and cost effectiveness of immunisation strategies.’
Joint Committee on Vaccination and Immunisation, 2013
The JCVI (2021) does not make policy itself, but advises those who do have this power, who are the Ministers for Health and Social Care, via the Chief Medical Officers of the four UK countries.
Although it is often said that decisions should ‘follow the evidence’, in practice it is more complex than this seemingly self-evident truth would suggest. Firstly, evidence is often lacking, weak, or nuanced. This is particularly the case with children and young people, as robust research studies are often difficult to do in those under 16 years of age for ethical and practical reasons. Therefore, we often rely on studies conducted with adults to make decisions about children. Using adult data in this way results in a high degree of what is termed ‘indirectness’—that is the participants in the studies (who are adults), differ from those for whom the recommendation is to be made (who are children) (Guyatt et al, 2011).
It is also true that the evidence that may be used to support or refute a recommendation comes in many different forms. There is evidence on the direct benefits of the vaccine in protecting recipients from infection, and the disadvantage of possible side-effects. There are also indirect benefits, such as reduced community transmission, and a possible reduction in school days missed if fewer people are becoming infected. While direct benefits can be demonstrated in randomised studies relatively easily, the indirect benefits are harder to quantify (Gallagher et al, 2021). A further complication is that, unlike most medicines, which are given to people who are ill, vaccinations are in this case being recommended to healthy people. There is therefore often a far lower acceptance of side effects in vaccines than in other medicines.
The criteria used to make recommendations are contained within Evidence to Decision frameworks, such as that by the Grading of Recommendations, Assessment, Development and Evaluation Working Group (GRADE). The framework for health system and public health decisions contains the following items (Moberg et al, 2018):
- Priority of the problem—is the problem a priority?
- Benefits and harms—how substantial are the desirable and undesirable anticipated effects?
- Does the balance between desirable and undesirable effects favour the intervention or the comparison?
- Certainty of the evidence—what is the overall certainty of the evidence of effects?
- Outcome importance—is there important uncertainty about or variability in how much people value the main outcomes?
- Resource use—how large are the resource requirements (costs)?; what is the certainty of the evidence of resource requirements (costs)?; does the cost-effectiveness of the intervention favour the option or the comparison?
- Equity—what would be the impact on health equity?
- Acceptability—is the option acceptable to key stakeholders?
- Feasibility—is the option feasible to implement?
The JCVI noted that the direct benefits in reducing infections are small:
‘Evidence strongly indicates that almost all children and young people are at very low risk from COVID-19.’
Department of Health and Social Care, 2021a
Although vaccination might reduce the rare condition known as paediatric inflammatory multisystem syndrome, which has been associated with COVID-19 infection, and post-acute COVID-19 syndrome (long COVID), there is significant uncertainty about this.
Children who are at particular risk for serious disease are already offered vaccination, and it was recommended that those who are household contacts of persons who are immunosuppressed should be offered the vaccine. This latter recommendation demonstrates an important issue with regards to interventions to reduce infectious diseases, which is that they work both at the individual level (a vaccine stops a person getting COVID-19) and at the population level (if someone does not get COVID-19, they can't transmit it to someone else). In this case, the vaccine is given not to protect the young person themselves, but rather the contact who is immunosuppressed.
There are other considerations in the JCVI statement. Interrupting COVID-19 transmission may reduce the number of school days missed, with consequent improvement in education and general wellbeing, although as more adults are vaccinated the need to miss school may be reduced. Similarly, the benefit of lower community transmission may become less important as more adults and children at risk are vaccinated. Finally, it is noted that there may be a possible impact upon other vaccination programmes if resources are diverted to a broader COVID-19 vaccination programme. Based on this, the JCVI concluded that the margin of benefit was too small to support a universal programme of vaccination of otherwise healthy 12-to-15-year-old children (Public Health England, 2021).
In using this to make a recommendation however, the Chief Medical Officers within the UK used a wider public health perspective to see if that changed the balance of benefits and risks, remembering that the JCVI concluded that the:
‘Benefits from vaccination are marginally greater than the potential known harms.’
The most important of these broader issues was thought to be that of the impact of vaccination on reducing the amount of education that is missed or disrupted. This, it is thought, would have a beneficial impact on education, and also more general wellbeing and mental health. Further, it is noted that the impact of COVID-19 has been greatest in more deprived areas, and so a successful vaccination programme should improve equity (Department of Health and Social Care (DHSC), 2021b).
Taking these factors into account, the final recommendation to extend the offer of universal vaccination with a first dose of Pfizer-BioNTech COVID-19 vaccine to all children and young people aged 12 to 15 was made. If one considers the factors listed previously, the reasons for this become clearer:
- The problem is a priority
- The balance between desirable and undesirable effects favours vaccination, but not strongly unless one includes the effect on education and mental health as well
- It is considered that the resources used, while considerable, are affordable
- That vaccination will increase equity and
- That the programme is feasible.
One area that is still to be tested is that of acceptability to the most important stakeholders, that is the families and young people concerned. The issue of whether or not to recommend a second dose is unresolved, and will be made after more data become available, particularly with regards to the incidence of myocarditis in those vaccinated. This decision demonstrates a relatively cautious and data-driven approach to the vaccination.
For many, the decision whether or not to have the vaccine will be based on opinions that they hear from those whom they trust, although GRADE sees expert opinion as an interpretation of evidence, rather than a form of evidence itself (Schünemann et al, 2013). In other words, it is important to look at the evidence behind any opinion before using it to decide on a course of action. It is also important to remember that this recommendation is made at the group level, and so may not apply to every child. It is crucial to remember the nurse's professional and legal duty of care to each individual child. It is perhaps here that nurses' expertise is most important, in translating the general recommendation into individual action.
The issue of consent is one that sometimes causes some controversy. Although parents generally consent for those aged under 16 years, if a young person has enough intelligence, competence and an understanding of the risks and benefits of the vaccination, they can give consent themselves. This is known as ‘Gillick competence’ (NHS website, 2019). However, it is important that this is not perceived as being forced upon young people and their families. The JCVI has emphasised the importance of providing sufficient information for an informed decision to be made. Although it may be difficult in the context of a pandemic, whatever decision individuals make, this must be respected, taking care not to apply undue pressure or stigmatising those with whom we might disagree (Saxena et al, 2021).
Over time, more information will become available, and the uncertainty will reduce. Until then, it is important to acknowledge where uncertainty exists, and to be clear and honest about the rationale for decisions.
Policy regarding vaccination is likely to change as the pandemic evolves and more evidence becomes available. Crucially, the balance is always between the potential benefits and harms of vaccination to the children and young people themselves, with wider societal benefits being of secondary consideration. For example, the benefits of vaccinating children between the ages of 5 and 11 years in a clinical risk group are now thought to outweigh the harms, the same conclusion has yet to be made for those without a risk factor. A similar decision has been made to give booster doses to older children with particular risk factors (DHSC, 2021c).