Vaccines are among the most powerful and cost-effective tools in public health, yet the question of who should receive which vaccine, at what age, and how many doses continues to divide expert committees across Europe. A new commentary published in The Lancet Regional Health – Europe argues that these differences are not inconsistencies to be ironed out, but the legitimate outcome of evidence-based decision-making rooted firmly in national context. Written by Robin Schaefer, Thomas Harder, Frank Sandmann, and Ole Wichmann, researchers affiliated with the Robert Koch Institute in Germany, the article uses the country’s National Immunisation Technical Advisory Group — the Standing Committee on Vaccination, known by its German acronym STIKO — as a case study to challenge the growing push toward harmonised vaccination recommendations across the European Union.
At the heart of the argument is a distinction between two fundamentally different kinds of evidence. Context-free evidence — data on a vaccine’s safety, efficacy, and effectiveness drawn from randomised controlled trials and observational studies — is largely portable across borders. Context-specific evidence, by contrast, is everything that makes a country unique: the local epidemiology and burden of disease, the potential population-level impact of an intervention, health economic considerations, societal values and preferences, and the practical feasibility of implementing a vaccination programme within a particular health system. The authors contend that while the first category lends itself well to international collaboration and joint assessment, it is the second category that ultimately determines whether, how, and for whom a licensed vaccine is recommended.
The timing of the commentary is significant. In 2021, the European Union adopted a new regulation on Health Technology Assessment (HTA), which came into force in 2025 and requires a joint clinical assessment (JCA) at EU level, beginning with oncology drugs. New vaccines will be required to undergo the JCA starting in 2030. These joint assessment reports will describe the health problem and the safety and clinical efficacy of a health technology, along with the certainty of the underlying evidence. Crucially, however, they will not include the assessment of context-specific aspects such as health economic and health system considerations, which remain a matter of national competence under Article 168 of the Treaty on the Functioning of the EU. In parallel, an updated EU regulation that came into force in 2022 amended the mandate of the European Centre for Disease Prevention and Control (ECDC), allowing it to issue non-binding, evidence-based recommendations, including on immunisation strategies. Both initiatives are designed to support rather than replace national decision-making, but the authors warn that their scope, framing, and integration with existing national processes will critically shape whether they reinforce or constrain country-driven policymaking.
The authors’ argument rests on a detailed account of how STIKO actually works. The committee consists of 16 to 22 members appointed by the German Federal Ministry of Health on the basis of expertise spanning paediatrics, general medicine, immunology, epidemiology, public health, and infectious disease modelling. It is supported by an executive secretariat at the Robert Koch Institute with dedicated in-house capacity in epidemiology, mathematical modelling, and evidence synthesis — a level of institutional support the authors acknowledge is more extensive than that available to many other European NITAGs. To determine its agenda, the committee runs a prioritisation process for evaluating new vaccines and other immunisation products, such as long-acting monoclonal antibodies, informed by horizon scanning of products still in the development pipeline.
For assessing evidence and formulating recommendations, STIKO follows a standard operating procedure built around an Evidence-to-Decision (EtD) framework, broadly aligned with the processes of the World Health Organization’s Strategic Advisory Group of Experts on Immunization and the practices of other European advisory groups. The EtD framework provides a common structure for integrating diverse types of evidence within a single deliberation. Context-free evidence enters primarily through the assessment of vaccine safety, efficacy, and effectiveness, typically via systematic literature reviews graded according to the GRADE approach. Context-specific evidence informs nearly every other domain: the public health relevance of the disease, the balance of benefits and harms at the population level, the feasibility and acceptability of implementation, and ethical and health economic considerations. The framework makes explicit that demonstrating safety and efficacy is a necessary but not sufficient basis for a national recommendation.
The procedural machinery is considerable. Topic-specific working groups composed of STIKO members and carefully vetted external experts prepare draft recommendations and scientific rationales, which are then deliberated and formally voted on by the full committee. A non-public consultation follows with stakeholders including the German federal states, professional societies, and the Federal Joint Committee — the highest decision-making body of the joint self-government of physicians, dentists, hospitals, and health insurance funds, which determines what statutory health insurance covers. The final recommendation is adopted by a further formal vote and published with its full scientific rationale, documenting the evidence considered in each EtD domain and the reasoning that led to the outcome. Notably, in the German system the Federal Joint Committee then has two months to incorporate the vaccine into the national vaccination directive, obliging insurers to cover it — a financing decision that bypasses the health and finance ministries entirely, a feature specific to Germany.
The authors illustrate how identical clinical evidence can yield different conclusions through concrete examples from STIKO’s recent history. In 2025, the committee removed its long-standing recommendation to vaccinate infants against meningococcal serogroup C, citing years of declining incidence that had reduced the disease burden to very low levels, while simultaneously recommending quadrivalent ACWY vaccination for adolescents based on mathematical modelling of different immunisation strategies and a desire to simplify the childhood schedule. In 2024, STIKO recommended long-acting monoclonal antibodies against respiratory syncytial virus for newborns and infants rather than RSV vaccination during pregnancy, a decision driven by the high incidence and burden of RSV disease in Germany, modelling and health economic evaluations favouring the antibody strategy, and implementation concerns about the impact of an additional vaccine on uptake of other vaccines during pregnancy. Earlier decisions followed the same pattern: the 2018 recommendation of herpes zoster vaccination for adults over 60 was shaped by local disease burden, modelling to define the most efficient target population, and a strategy focused on preventing complications and preserving quality of life, while the 2013 rotavirus recommendation rested on the burden of RV-associated hospitalisations and cost-effectiveness analysis in a country where RV deaths are very rare.
These examples underscore the authors’ central claim: differences in national vaccination schedules do not usually arise from disagreements over context-free evidence or divergent interpretations of the science. NITAGs generally only issue recommendations for vaccines already licensed by regulatory authorities such as the European Medicines Agency, which have been demonstrated to be safe and effective. Instead, the differences reflect country-specific considerations — and those considerations can shift a positive clinical assessment into a recommendation for the general population, one limited to risk groups, or no recommendation at all. Health economics alone can flip a decision, because the costs of vaccination programmes, the costs of disease to healthcare systems, utilisation patterns, and budgetary constraints differ fundamentally between countries. Mathematical models, which are often required to estimate population-level effects and cost-effectiveness, depend on strongly country-specific input parameters, limiting the utility of EU-wide models for national decision-making.
The implications for EU policy are pointed. Joint clinical assessments of new vaccines can usefully deliver a robust common synthesis of context-free evidence and reduce duplicated workload across member states, the authors concede. But they offer a narrowly focused view and cannot deliver the country-specific synthesis of local disease burden, health economic context, programmatic feasibility, and societal values that ultimately drives national recommendations. Joint assessments may therefore not automatically lead to quicker vaccine introductions or uniform schedules. Similarly, EU-level vaccination recommendations developed by the ECDC will face inherent limits because they cannot adequately integrate the context-specific considerations of 27 member states. Even the free movement of people within the EU, often cited as a justification for harmonisation, does not stand up to scrutiny in the authors’ view: pre-travel consultations and routine healthcare in destination countries typically allow individuals to receive appropriate advice and catch-up vaccinations, so cross-border mobility supports coordinated infrastructure such as shared surveillance or a European vaccination card, but not identical schedules.
The authors are careful not to dismiss differences as beyond question. They argue that transparency is essential to maintaining trust: STIKO publishes a detailed scientific rationale for every recommendation, documenting the evidence considered and the weighting of context-free and context-specific factors, which enables comparison and mutual learning between advisory groups while contributing to consistent scientific standards despite divergent outcomes. As the number of new vaccines grows and budgets remain constrained, the importance of country-driven processes will only increase — a view echoed by the WHO’s SAGE, which has called for greater country ownership and stronger NITAGs. International collaboration, the authors conclude, is most productive when it supports national processes and builds capacity, and supra-national guidance should leave sufficient flexibility for country contextualisation rather than exerting pressure toward uniformity that the underlying science does not demand.
Subject of Research: National immunisation recommendation-making and the role of country-specific evidence and context, using Germany’s Standing Committee on Vaccination (STIKO) as a case study
Subject of Research: Medicine
Article Title: National immunisation recommendations: why country-specific evidence and context matter
Article References: Schaefer, R., Harder, T., Sandmann, F., & Wichmann, O. (2026). National immunisation recommendations: why country-specific evidence and context matter. The Lancet Regional Health – Europe, 69, Article 101835. https://doi.org/10.1016/j.lanepe.2026.101835
Image Credits: AI Generated
DOI: 10.1016/j.lanepe.2026.101835
Keywords: immunisation recommendations, NITAGs, STIKO, context-specific evidence, joint clinical assessment, health technology assessment, vaccination schedules, European Union, evidence-to-decision framework, health economics, country ownership, vaccine policy
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Phoebe Ingram. (August 30, 2026). Why national immunisation guidelines depend on country-specific evidence and context. Scienmag. https://scienmag.com/why-national-immunisation-guidelines-depend-on-country-specific-evidence-and-context/
Phoebe Ingram. “Why national immunisation guidelines depend on country-specific evidence and context.” Scienmag, 30 August 2026, https://scienmag.com/why-national-immunisation-guidelines-depend-on-country-specific-evidence-and-context/. Accessed 30 August 2026.
Phoebe Ingram. “Why national immunisation guidelines depend on country-specific evidence and context.” Scienmag. August 30, 2026. https://scienmag.com/why-national-immunisation-guidelines-depend-on-country-specific-evidence-and-context/
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