Is Joint Clinical Assessment (JCA) appropriate for assessing the broader value of vaccines?
November 21, 2025 | JCA, Market Access, vaccines
By Emily Morton-West
Executive summary
- The current JCA framework has been designed for therapeutic drugs and overlooks vaccines’ preventive nature, societal impact and broader public health value
- Substantial variation across European Union (EU) member states in disease epidemiology, immunization programmes and assessment practices risks misalignment with national strategies
- Without adapting JCA to include assessment of real world data (RWD) and broader benefits, vaccines may be undervalued, leading to delayed access and increased manufacturer burden
Introduction
In January 2030, the JCA process will be expanded to cover all new medicinal products, including vaccines. With vaccine trials typically spanning 3–5 years, manufacturers planning studies today must anticipate the requirements of the future JCA framework. JCA’s current methodology is primarily designed for therapeutic drugs and, while the health technology assessment (HTA) regulation acknowledges future adaptation for vaccines, the extent of these changes remains unclear. Since the COVID-19 pandemic, there has been mounting pressure for HTA to better account for the unique characteristics of vaccines, such as their preventive nature, population-level impact and broader societal value.
The HTA process for vaccines shows greater variation across EU member states than for therapeutic drugs
In most EU member states, vaccines are commonly evaluated by National Immunization Technical Advisory Groups (NITAGs), with some member states also involving traditional HTA bodies. While HTA bodies typically assess pharmaceuticals based on clinical and economic evidence, NITAGs take a broader view, factoring in societal impact, equity and implementation logistics. If this heterogeneity in approach across EU vaccine clinical assessment is not reflected in the JCA process, it is likely that national agencies will still conduct their own clinical assessment. This will increase the burden on manufacturers and may result in delayed access to new vaccines.
High variation in disease epidemiology exists across EU member states for vaccine preventable diseases
The epidemiology of vaccine-preventable diseases varies considerably across EU member states because of factors such as population density, migration patterns, climate and historical immunization coverage. For example, measles outbreaks may be more frequent in countries with lower vaccine uptake, while others may face higher risks from tick-borne encephalitis due to warmer and more humid climates. This heterogeneity complicates the creation of a one-size-fits-all clinical assessment under JCA, as the public health value of a vaccine can differ dramatically depending on local context.
Current immunization programs differ between EU member states
Immunization schedules and delivery models vary widely across the EU. Some countries offer school-based vaccination programmes, while others rely on primary care or public health clinics. These variations reflect national health priorities, infrastructure and historical practices. A harmonized JCA must account for these differences to avoid producing assessments that are misaligned with national immunization strategies. Without this flexibility, JCA risks undermining the relevance and applicability of its conclusions.
JCA process does not consider the wider social benefits of immunization
Currently, the JCA process does not account for the broader value of vaccines, such as their role in reducing disease transmission, preventing antimicrobial resistance and alleviating the burden on carers. By overlooking these indirect benefits, JCA risks undervaluing vaccines that contribute meaningfully to societal wellbeing by underestimating their long-term public health impact.
JCA report will likely need to be updated with RWD on vaccine effectiveness
Given the preventive nature of vaccines and the time required to observe their full impact, RWD play a crucial role in understanding vaccine effectiveness. RWD can provide insights into long-term protection, population-level outcomes and public health impact, elements that are often not fully captured in pre-licensure clinical trials. The JCA process for vaccines should therefore adopt an iterative approach, with regular updates to account for emerging RWD, allowing for a more comprehensive assessment of vaccine value, including duration of protection, effectiveness in diverse populations and contribution to disease elimination.
Conclusion
While JCA offers a structured and collaborative approach to clinical assessment, it is not yet equipped to fully evaluate the unique and far-reaching benefits of vaccines. This may lead to undervaluation of vaccines, delayed market access and reduced incentives for innovation in areas where public health needs are greatest but harder to quantify. If these broader impacts are not recognized in the assessment process, manufacturers may deprioritize development of vaccines that are crucial for public health but less likely to be favourably evaluated under current JCA criteria.
To learn more, get in touch with Emily Morton-West (emily.morton-west@amiculum.biz)
This content was provided by Amiculum
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