Vaccination Policy

Vaccination Policy in National Immunisation Decisions

Vaccination policy is the set of public decisions that settles whether a vaccine enters a national programme, which groups are offered it and at what ages, and how the doses are paid for, bought and delivered. In health economics it is the point where vaccine evidence meets a fixed budget, because a licensed vaccine only becomes a funded programme once its health gains, including protection passed on to unvaccinated people, are judged worth the care displaced to pay for it. England offers a clear case to study, since regulations link the advice of the Joint Committee on Vaccination and Immunisation (JCVI) to a demonstration of cost-effectiveness and vaccine tenders have been scored on net health benefit. The way protection is measured belongs to vaccine efficacy and vaccine effectiveness, and the welfare case for public action belongs to vaccination externalities.

Advisory committees and the bodies that decide

The WHO guide for standardisation of economic evaluations of immunisation programmes (2019) reports that a rising number of countries have a separate National Immunization Technical Advisory Group (NITAG). It describes these groups as a technical resource that guides national policy makers and programme managers, and it names the JCVI and the United States Advisory Committee on Immunization Practices as examples that use cost-effectiveness evidence and exert great influence on policy.

The JCVI Code of Practice of June 2013 gives the committee's terms of reference as advising UK health departments on immunisations after considering the burden of disease, vaccine safety and efficacy, and the impact and cost-effectiveness of immunisation strategies. It also states that the JCVI is not a policy maker in its own right and has no regulatory function. Government uses its advice to inform, develop and make policy.

In England the Health Protection (Vaccination) Regulations 2009 turn some of this advice into a duty. The Secretary of State must make arrangements to ensure, so far as is reasonably practicable, that a JCVI recommendation is implemented when it concerns new or changed provision under a national vaccination programme, is made by the full committee in response to a question referred by the Secretary of State, rests on an assessment that demonstrates cost-effectiveness, and does not concern travel or occupational health. Advice that a vaccine is clinically appropriate but cannot be shown to be cost effective, for lack of data, does not bind the Secretary of State. Ministers in Scotland and Northern Ireland may choose to accept JCVI advice but are not bound by it.

What a national introduction decision weighs

A licensed vaccine may still not be adopted. The WHO guide groups the issues in WHO's 2014 principles for adding a vaccine to a national programme under the disease and its burden, the vaccine with its safety, cost, affordability, cost-effectiveness and supply, and the capacity of the programme and health system to deliver it over the long term.

The guide is explicit that cost-effectiveness alone is not sufficient for a funding decision, and that ratios need to be read alongside feasibility, budget impact and value-based considerations such as fairness. It treats affordability as whether a new vaccine can be absorbed into an immunisation budget without significantly affecting resources for other public health priorities. In a Dutch example in the guide, a model of infant pneumococcal conjugate vaccination gave EUR 71,250 per QALY against a threshold then taken as EUR 20,000, and the Dutch Health Council decided that the unfavourable cost-effectiveness and the high budget impact stood in the way of introduction at that time.

Ultsch and colleagues, reporting a European expert consensus, describe three ways of turning evidence into a decision. A pure threshold rule is transparent but ignores severity and budget impact, multi-criteria decision analysis is transparent and needs no threshold, and informal judgement can take in issues that are hard to quantify.

Cost-effectiveness rules for vaccines in England

The JCVI Code states that the committee uses the methods and criteria of NICE. A programme counts as cost effective if its health benefits, both the direct benefits to those vaccinated and the indirect benefits to the unvaccinated, are greater than the opportunity cost measured as the health benefits of programmes that may be displaced to fund it. The JCVI page on GOV.UK, last updated 21 August 2026, says that while the Code is being updated the committee will continue to judge a programme cost effective if its benefits exceed its costs when each QALY is valued at GBP 20,000. That figure sits below the range in the NICE manual (PMG36), where a most plausible ICER under GBP 25,000 per QALY gained is normally judged on the estimate itself and one between GBP 25,000 and GBP 35,000 calls for explicit reference to other factors.

The 2013 Code appends the 2012 report of the Working Group on Uncertainty in Vaccine Evaluation and Procurement, which proposed a two-part test. The committee should first agree a most plausible ICER, adjusted by recorded cost and QALY adjustment factors when the modelling misses relevant benefits or costs, and test it against GBP 20,000 per QALY. It should then treat a vaccine as not cost effective if there is more than a 10% likelihood that the ICER exceeds GBP 30,000 per QALY. The group rejected "prevention is better than cure" as a reason for a higher vaccine threshold, since any health benefits or savings from prevention would generally already be in the model. It also asked that the committee see estimates of net health benefit at GBP 20,000 per QALY.

$$NHB = \Delta Q - \frac{\Delta C}{\lambda}$$

where $NHB$ is net health benefit in QALYs, $\Delta Q$ is the incremental QALYs of the programme, $\Delta C$ is its incremental cost to the NHS and $\lambda$ is the value placed on a QALY, the cost at which the NHS is taken to displace one QALY elsewhere, so $\Delta C/\lambda$ is the health forgone to fund the programme. A positive value means population health rises after allowing for displaced care.

Methods were later reviewed by the Cost-Effectiveness Methodology for Immunisation Programmes and Procurements (CEMIPP) group, which reported in July 2016. In June 2019 the Government declined its three main proposals, a GBP 15,000 per QALY threshold, a 1.5% health discounting rate and a change in time horizon, because they risked a more stringent bar for immunisation and a departure from the approach taken for medicines.

Threshold price and the tender for supply

A cost-effectiveness verdict depends on the price assumed. The Code states that the modelling for the JCVI reports cost-effectiveness as a function of vaccine price at different cost per QALY thresholds, and the 2012 report asks for a one-way analysis showing the price at which the adjusted ICER becomes acceptable when the price is uncertain. That price is a threshold price per course.

$$P^{*} = \lambda q - a + s$$

where $P^{*}$ is the highest price per course at which the programme is cost effective, $\lambda$ is the value of a QALY, $q$ is the QALYs gained per course given, including indirect protection, $a$ is the administration and other programme cost per course and $s$ is the NHS treatment cost averted per course. At any tendered price $P$, net health benefit per course equals $(P^{*} - P)/\lambda$.

The 2012 report describes how the Department of Health scored tenders with points intended to maximise expected net health benefit, based on the gap between the cost per course required to be cost effective and the tendered cost per course. A single bidder wins if its score is positive, and in a competitive tender the bid with the largest positive score wins. The report adds that maximising net health benefit can mean buying below the maximum cost-effective price, which then works as a value-based pricing ceiling in procurement.

Worked example with a two-dose adolescent programme

All numbers in this example are illustrative. A two-dose vaccine is proposed for a cohort of 600,000 adolescents, and 80% uptake gives 480,000 courses. The model gives 0.004 discounted QALYs gained per course, including indirect protection, GBP 30 of averted NHS treatment cost per course and GBP 20 of administration cost per course.

1. Threshold price at GBP 20,000 per QALY. The health gain is valued at 20,000 × 0.004 = GBP 80 per course, and 80 minus 20 plus 30 = GBP 90 per course.

2. Threshold price at the NICE values. At GBP 25,000 the price is 100 minus 20 plus 30 = GBP 110 per course, and at GBP 35,000 it is 140 minus 20 plus 30 = GBP 150.

3. The uncertainty test. Suppose the only material uncertainty is in $q$, and its 10th percentile is 0.0025 QALYs per course. At that value the health gain is worth 30,000 × 0.0025 = GBP 75 per course at GBP 30,000 per QALY, and 75 minus 20 plus 30 = GBP 85 is the price at which the ICER reaches GBP 30,000. As a check, the net cost per course is 85 + 20 minus 30 = GBP 75, and 75 / 0.0025 = GBP 30,000 per QALY, so any higher price fails the 10% test. The binding ceiling is therefore GBP 85, below the GBP 90 from the central estimate.

4. Scoring two bids. Supplier A offers GBP 75 and supplier B GBP 85 per course. Net health benefit per course is (90 minus 75) / 20,000 = 0.00075 QALYs for A and (90 minus 85) / 20,000 = 0.00025 QALYs for B. Over 480,000 courses that is 480,000 × 0.00075 = 360 QALYs for A and 480,000 × 0.00025 = 120 QALYs for B. Both bids are at or below the GBP 85 ceiling, with B exactly on the limit, and A wins.

5. First-year budget impact. Gross cost is 480,000 × (75 + 20) = GBP 45.6 million. Averted treatment cost is 480,000 × 30 = GBP 14.4 million over the horizon, and if a fifth of it (GBP 2.88 million) falls in year one, net year-one spending is 45.6 minus 2.88 = GBP 42.72 million.

6. Interpretation. The programme is cost effective at A's price under the GBP 20,000 rule and the 10% test, yet it still needs about GBP 43 million in its first year, the gap between cost-effectiveness and affordability. The per-course QALY gain was held fixed at 80% uptake. With strong herd effects the gain per course changes with coverage, and capturing that needs a dynamic transmission model.

Programme design beyond the yes or no

Once a vaccine is accepted, choices about who is eligible and how doses are delivered each carry their own cost-effectiveness. In a WHO guide illustration, extending coverage through fixed facilities becomes very costly beyond a point, perhaps because the remaining unvaccinated people are dispersed and hard to reach, while adding mobile teams raises coverage at a better incremental ratio.

Equity enters at the same stage. The WHO guide warns that a new vaccine may mainly benefit children already reached by existing programmes, who tend to be richer or more urban than the unvaccinated. Where the unprotected are at equal or greater risk and also disadvantaged, it judges any move towards universal coverage likely to improve equity whether it improves or worsens cost-effectiveness, and it points to extended cost-effectiveness analysis and distributional cost-effectiveness analysis for setting equity beside efficiency. Subsidies, free provision and mandates as responses to under-vaccination rest on the externality argument and are treated under vaccination externalities.

Limits and common misreadings

Most errors in reading vaccination policy come from treating one stage of the decision as the whole of it. The same few misreadings recur in appraisals and in public debate about why a vaccine is or is not offered.

• Licensed means funded. Licensing permits supply. Inclusion in a programme is a separate decision, and the English statutory duty covers only recommendations meeting every condition in the 2009 Regulations.
• Cost effective means affordable. The Dutch pneumococcal decision cited budget impact alongside cost-effectiveness.
• One threshold for all appraisals. The JCVI values a QALY at GBP 20,000 while the NICE manual (PMG36) works with GBP 25,000 to GBP 35,000, so a vaccine and a medicine with the same ICER can receive different verdicts in England.
• Discounting as a technical detail. Ultsch and colleagues report that discount rates and approaches usually have a major impact on vaccine evaluations, and recommend presenting both discounted and undiscounted results.
• Errors are easy to undo. The 2012 report warns that a cost-ineffective vaccine in a stable programme is likely to be difficult or even damaging to withdraw, so the net health loss can last a long time.

Sources

• Department of Health and Social Care. Cost-effectiveness methodology for Immunisation Programmes and Procurements (CEMIPP): the government's decision and summary of consultation responses. London: GOV.UK; 11 June 2019. https://assets.publishing.service.gov.uk/media/5cfe7ae840f0b6095cabfa16/CEMIPP_Consultation_Response_1.pdf
• Joint Committee on Vaccination and Immunisation. Code of Practice June 2013, including Annex 5, Report from the Working Group on Uncertainty in Vaccine Evaluation and Procurement (18 September 2012). https://assets.publishing.service.gov.uk/media/5a7b9b3440f0b62826a04a80/JCVI_Code_of_Practice_revision_2013_-_final.pdf
• Joint Committee on Vaccination and Immunisation. GOV.UK group page, code of practice section. Last updated 21 August 2026. https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation
• National Institute for Health and Care Excellence. NICE technology appraisal and highly specialised technologies guidance: the manual (PMG36). Published 31 January 2022, last updated 13 October 2026. Sections 6.3.4 to 6.3.8. https://www.nice.org.uk/process/pmg36
• The Health Protection (Vaccination) Regulations 2009, SI 2009/38. Regulations 1 and 2. https://www.legislation.gov.uk/uksi/2009/38
• Ultsch B, Damm O, Beutels P, Bilcke J, Brüggenjürgen B, Gerber-Grote A, et al. Methods for health economic evaluation of vaccines and immunization decision frameworks: a consensus framework from a European vaccine economics community. PharmacoEconomics. 2016;34(3):227-244. https://doi.org/10.1007/s40273-015-0335-2
• World Health Organization. WHO guide for standardization of economic evaluations of immunization programmes. 2nd edition (WHO/IVB/19.10). Geneva: WHO; 2019. Sections 1.1, 2.3, 8 and 9. https://iris.who.int/handle/10665/329389