Jenna F Gritzfeld and Andrew Earnshaw from the JCVI offer invaluable insight into how vital decisions on vaccines are made, both during and outside a pandemic.
The Joint Committee on Vaccination and Immunisation (JCVI) was originally an advisory board for polio immunisation that became the JCVI in 1963. Now a departmental expert committee and statutory body, the role of the JCVI is to advise UK health departments on immunisations after considering the evidence on the burden of disease, on vaccine safety and efficacy, and on the impact and cost-effectiveness of immunisation strategies. The JCVI also considers and identifies factors for the successful and effective implementation of immunisation strategies and identifies important knowledge gaps where further research or surveillance should be considered.
The schedule
The UK’s routine immunisation schedule, last updated in February 2022, begins at eight weeks of age with vaccines against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, hepatitis B, meningococcal group B and rotavirus (UK Health Security Agency (UKHSA), 2022). Further vaccinations to provide protection against a range of infections take place at 10 and 16 weeks, one year, three years, 12 years, 14 years, 65 years, and finally age 70 when the shingles vaccine is offered.
Getting the vaccination schedule right requires a range of experts, including epidemiologists, immunologists, mathematical modellers, health economists, nurses, and paediatricians, as well as at least one lay member. Deciding which vaccines need to be discussed can be the result of requests from the Department of Health and Social Care (DHSC), epidemiological data from UKHSA, or through annual horizon scanning of vaccine developments.
How JCVI advice works
In general, JCVI advice can be separated into three areas:
- Evaluation of a new immunisation programme, or major changes to, or discontinuation of, an existing immunisation programme
- Evaluation of a minor change to an existing programme – this could include a review of the clinical definition of a clinical risk group to whom immunisation is offered or a change in vaccine
- Assessment of an emerging immunisation-related issue or new report on, for example, the coverage of vaccinations, implementation of immunisation programmes, clinical effectiveness of an immunisation programme, or horizon scanning of vaccine developments.
The formulation of advice is based on the appraisal of the best scientific evidence available from a range of sources. Clinical trial data is crucial in evaluating the safety and efficacy of a new vaccine for the immunisation programme. Most recently, clinical trial data was vital in developing advice on the use of the different vaccines for the Covid-19 vaccination programme. Robust surveillance data informs initial decision-making and contributes to continual evaluation of a vaccine programme; it is critical for evaluating how well a vaccine performs during real-world use. UKHSA has prepared weekly surveillance reports during the Covid-19 pandemic. The data in these reports is regularly scrutinised by the JCVI and helps determine next steps in the vaccination programme, such as the decision to offer a spring dose to individuals who are at the highest risk of severe Covid-19.
The process of developing advice is standard, whether it is for the childhood immunisation programme or a vaccine for older adults. In considering the Covid-19 vaccination programme, Covid-19 disproportionately affects those in older age groups, residents in care homes for older adults, and those with certain underlying health conditions. For this reason, these groups were prioritised for vaccination across all of the JCVI’s advice. For younger people, including children, who were not in a clinical risk group, the decisions to offer vaccination were more finely balanced. This was most obvious in children aged five to 11 who, in comparison with the rest of the population/older age groups, were at the lowest risk from Covid-19. The decision to make a non-urgent offer reflected the concern that the Covid-19 pandemic had impacted the national childhood immunisation programme and the JCVI did not want a Covid-19 vaccination programme to displace vaccination against illnesses like measles and meningococcal disease.
Cost Analysis And Modelling Ensures That Funds Used For Vaccination Could Not Be Better Used Elsewhere
Cost-effectiveness analysis and modelling studies are also important parts of the decision-making process. This helps ensure that funds used for vaccination programmes could not be used to provide greater health benefits elsewhere.
The final steps
The NHS Constitution states that patients have the right to receive the vaccinations that the JCVI recommends, where certain criteria, including cost-effectiveness are met. On 1 September 2015 the UK introduced the meningococcal B vaccine into the childhood schedule, the first country in the world to do so. Cost-effectiveness contributed to the decision to offer the vaccine to infants and not adolescents. There was uncertainty around the impact of the vaccine on meningococcal carriage and concern that recommending vaccination in adolescents would result in a net loss of health in the population through displacement of other interventions within the NHS.
When gathering evidence, JCVI may identify important knowledge gaps. In the meningococcal B vaccination programme, there was not enough evidence that the vaccine would prevent carriage in adolescents. If the JCVI needs further data, the committee can request research and analyses, generally through UKHSA or DHSC via the National Immunisation Schedule Evaluation Consortium (NISEC). The requested studies will guide future decision-making by the committee.
Depending on the issue under consideration, once the JCVI has reached a position, the committee may decide to issue an interim statement for a short period of consultation with stakeholders who submitted evidence which informed the committee’s advice. In 2008, the UK human papillomavirus (HPV) vaccination programme was introduced, offering vaccines to girls aged 12 to 13, with a ‘catch-up’ programme offered up to the age of 18. In 2018 this was expanded to include men up to 45 years old who have sex with men and was further expanded in 2019 to include 12- to 13-year-old boys. This programme has been hugely successful: recent evidence showed substantial reductions of 87% and 97% in the incidence of cervical cancer and CIN3, respectively, in young women who were offered the bivalent Cervarix vaccine at age 12 to 13 years (Falcaro et al, 2021). Recent evidence has suggested it may be possible to move to a one-dose schedule for the routine adolescent programme. As this would be a significant change to the programme, the JCVI released an interim statement in February 2022 on a one-dose schedule for the HPV immunisation programme. The goal of the HPV interim statement is to ensure the most appropriate and up-to-date evidence was used in the decision-making process (DHSC, 2022).
Alongside data and cost-effectiveness, it is important to consider how a programme can achieve high coverage. UKHSA carries out surveys in England to understand public knowledge, beliefs and attitudes to immunisation. The responses can be used to better plan the immunisation programme and ensure that high quality, accessible information on immunisations is available to the public.
As JCVI is not a policy-maker, any advice formulated by the committee will be considered by DHSC in the development of policy. JCVI advice forms the basis of updates to the Green Book, which contains the latest information on vaccines and vaccination procedures for vaccine preventable infectious diseases in the UK (UKHSA, 2020).
Maintaining Immunisation Programmes
The most recent major change to the childhood immunisation programme was reducing vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) from a 2+1 to a 1+1 schedule. This was the result of a successful vaccination programme with high uptake which resulted in low levels of disease, both in those vaccinated and in the wider population through herd immunity. The change to a 1+1 schedule will rationalise heath service resources, simplify the vaccine schedule, reduce the needle burden in infants, and allow space in the schedule for new vaccines to be introduced.
The Covid-19 pandemic has been an exceptional time for vaccine decision-making. For the JCVI, the aim of the Covid-19 vaccination programme was to reduce mortality and serious disease and protect the NHS and social care system. Although the Covid-19 pandemic has dominated the last two years, other infectious diseases have not disappeared, and vaccine coverage has been impacted. It is now more important than ever that we maintain our national immunisation programme and prevent a resurgence of infections.
The JCVI will continue to ensure that the vaccines recommended for the immunisation programme are considered safe and effective and that the overall programme is optimised for the UK epidemiological situation. The NHS delivers one of the best immunisation programmes in the world, based on JCVI advice, and the committee is ever grateful for the passion and dedication of immunisation professionals in the UK.
Jenna F Gritzfeld is a senior scientist at the JCVI Scientific Secretariat; Andrew Earnshaw is head of the JCVI Scientific Secretariat.
What’s the MHRA and how does it work with the JCVI?
- The Medicines and Healthcare products Regulatory Agency (MHRA) is the body that regulates medicines, medical devices and blood components for transfusion in the UK
- It has statutory responsibility for undertaking post-authorisation safety monitoring in the UK
- The MHRA shares vaccine safety data with the JCVI. This data contributes to JCVI decisions on immunisation programmes. JCVI continues to review Covid-19 vaccine safety data as it becomes available.
Resources
Routine immunisation schedule, UK Government 2022 bit.ly/UKHSA_immunisation_schedule
National Immunisation Schedule Evaluation Consortium nisec.ac.uk
Immunisation against infectious disease, last updated Nov 2020 bit.ly/Green_Book_immunisation
References:
Department of Health and Social Care. (2022) JCVI interim advice on a one-dose schedule for the routine HPV immunisation programme. See: gov.uk/government/publications/single-dose-of-hpv-vaccine-jcvi-interim-advice/jcvi-interim-advice-on-a-one-dose-schedule-for-the-routine-hpv-immunisation-programme (accessed 5 April 2022).
Falcaro M, Castañon A, Ndlela B et al. (2021) The effects of the national HPV vaccination programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study. The Lancet 398(10316): 2084-92.
National Immunisation Schedule Evaluation Consortium. (2022) Welcome to NISEC. See: www.nisec.ac.uk (accessed 5 April 2022).
UK Government. (2022a) Joint committee on vaccination and immunisation. See: gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation (accessed 5 April 2022).
UK Government. (2022b) The routine immunisation schedule from February 2022. See: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1055877/UKHSA-12155-routine-complete-immunisation-schedule_Feb2022.pdf (accessed 5 April 2022).
UK Health Security Agency. (2020) Immunisation against infectious disease. See: gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book (accessed 5 April 2022).
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