Pre-licensure trials establish vaccine safety and efficacy against predefined endpoints under ideal conditions. After authorisation, vaccine developers often need a different type of evidence: effectiveness in routine care, full vaccine-preventable burden, duration of protection, long-term safety, reduction in healthcare resource utilisation; i.e. outcomes that inform payer and immunisation programme decisions.
Arto Palmu, M.D., Ph.D., University Lecturer in Clinical Epidemiology and Chief Scientific Officer at FVR – Finnish Vaccine Research, sees pragmatic vaccine trials, register-based follow-up and real-world evidence as central tools for closing that gap.
“Pre-licensure trials focus on relative reduction in a highly specific primary outcome. For public health decision-making, absolute reductions in the total disease burden are often more relevant,” says Arto.
A vaccine may have strong safety and efficacy data but still need further evidence for routine use. National immunisation programmes, advisory bodies and payers typically want to understand:
Pre-licensure trials are rarely designed to answer all of these questions. Post-authorisation and pragmatic studies can be built around the evidence needed for policy, payer and programme decisions.
A robust comparative vaccine trial can help estimate how much of a disease burden is vaccine-preventable, also for less specific outcomes. If the vaccinated group has fewer outcomes than the comparison group, the difference can indicate the vaccine-preventable share of the burden. This is how the “vaccine-probe” works.
A pragmatic vaccine trial combines a randomized comparative design with outcomes that reflect routine healthcare. It is useful when the aim is to measure vaccine effectiveness in a broader, less selected population and under real-world conditions.
Combined with register-based follow-up, the same design can support long-term outcome assessment without a separate follow-up infrastructure.
“Register-based follow-up can make long-term outcome assessment affordable and feasible for several years, depending on the endpoint, data availability and study design,” says Arto.
“Finland is a strong environment for register-based vaccine research because the core infrastructure is already in place. The country has national health and population registers, a personal identity code system for individual-level data linkage, a statutory framework for secondary use of health and social data, and centralised data permit processes. For vaccine studies, this can support linked endpoint assessment across multiple data sources,” says Arto.
Finland also has decades of experience in large vaccine effectiveness studies, including research related to meningococcal, Haemophilus influenzae type b, pneumococcal, HPV, influenza and shingles vaccines.
“Another strength is Kanta, Finland’s national patient data repository. Kanta brings together patient record data generated in public and private healthcare,” says Arto.
For sponsors, these assets are highly relevant when the evidence generation is dependent on long-term follow-up, linked outcomes or population-level data.
In spring 2026, a nationwide trial was launched in Finland to evaluate whether the recombinant zoster vaccine reduces the risk of incident dementia. FinDementia is a randomised, placebo-controlled, observer-blind Phase IV pragmatic trial conducted by FVR in collaboration with GSK, the manufacturer of Shingrix®, as well as selected Finnish wellbeing services counties and pharmacy partners. The target enrolment is nearly 35,000 adults aged 76 years or older, with long-term follow-up based on Finnish health registers.
For Arto, FinDementia illustrates a broader evidence pathway. “An observational finding can generate a signal; a pragmatic comparative trial can then test whether the association can be verified in a stronger design. Register-based follow-up makes that assessment feasible at scale."
The case is relevant for both public health and value discussions. If the recombinant zoster vaccine reduces dementia risk, even modestly, the implications could be substantial in ageing societies.
“In pragmatic and register-based vaccine studies, the sponsor may not approach us with a finished protocol. Often, the sponsor comes with an evidence need. FVR can help translate that need into a feasible study design in Finland: from research question and protocol development to implementation, register-based follow-up, reporting and publication,” says Arto.
This is especially useful when the research question is complex, follow-up is long or the outcome needs to inform public health, payer or market access decisions.
For vaccine developers planning post-licensure evidence generation in Europe, Finland and FVR bring together several relevant capabilities:
FVR collaborates with international vaccine developers on pragmatic vaccine trials, observational register-based studies and real-world evidence generation.
Contact FVR to explore whether Finnish register data, long-term follow-up and FVR’s vaccine-specific scientific expertise can support your post-licensure evidence plans.
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