For vaccine developers, pandemic preparedness only matters if it helps turn an R&D question into a study that can start quickly. In practice, this means active research sites, usable epidemiological data, adaptable study protocols and experienced teams that know how vaccine studies are run.
“The real question is what needs to be in place before an outbreak begins,” says Marissa Gripenberg, Senior R&D Specialist at FVR – Finnish Vaccine Research. “If the essentials are already prepared, study teams can move from the development question to execution much faster.”
Marissa is an epidemiologist specialised in infectious diseases, vaccine development and immunisation. Before joining FVR, she worked in Big Pharma at Sanofi and GSK, and has international field experience from Médecins Sans Frontières and the World Health Organization. At FVR, her work includes R&D partnerships, infectious disease programmes and EU-led pandemic preparedness initiatives.
A key lesson from COVID-19 is that it is not simply speed that matters. It is that speed depends on capabilities that are already working when a clinical vaccine programme begins.
“You need the science, the funding, the regulatory interaction, the infrastructure and the data flows to support fast decision-making,” Marissa says.
For sponsors, the questions become practical very quickly: where could the trials run, which populations can be reached, which endpoints are realistic and what data will help interpret the results?
The first feasibility question is whether the right capacity is already in place in the populations and settings where the study is needed. That means experienced study teams, defined safety follow-up, access to relevant cohorts, reliable data flows and familiarity with clinical vaccine trial protocols. Marissa describes this as “ever-warm” research capacity. Such a network remains active between outbreaks so it can respond immediately when new vaccine programmes begin.
“In a pandemic, you do not want to start by building the network,” she says. “You want to know which organisations can conduct clinical vaccine research, which teams are experienced and how studies can be initiated quickly. This shortens the distance between a development question and an executable study.”
Because FVR runs clinical vaccine studies continuously, sponsors are not starting with a cold network. The teams, processes and quality systems are already in use, supported by practical experience across populations and disease areas.
Prepared protocol frameworks are useful only if they help make the decisions that come next: objectives, endpoints, target populations, safety follow-up, laboratory methods, data collection and routes for scientific or regulatory questions.
The framework also has to move with the evidence. Disease incidence, eligible populations, recruitment assumptions and endpoint feasibility can all change during a vaccine development programme.
“You need protocols that are prepared, but also flexible,” Marissa says. “If the situation changes, the study design needs to be able to adapt while remaining scientifically credible.”
Epidemiology helps underpin country selection, site selection, cohort definition, endpoint strategy and the timing of study activation.
“In Finland, we have strong national data systems and good visibility into disease occurrence, vaccination status and healthcare use,” Marissa says. “That type of data can help target research to the populations and areas where it is most relevant.”
Finland’s data environment can support several parts of that chain. Real-time disease occurrence data can inform where a study is most feasible. Vaccination data can support cohort definition and interpretation. Healthcare utilisation and hospitalisation data can help assess disease burden and outcomes. Registry-based follow-up can support post-authorisation evidence generation and longer-term safety monitoring.
The value increases when these data can be interpreted alongside broader, cross-border evidence. Comparable, usable data helps connect country-level feasibility with multi-country evidence generation. “This is where we still need to improve worldwide,” says Marissa.
FVR participates in European pandemic preparedness work through the EU-funded BEREADY NOW initiative, which is developing Europe’s research ecosystem and an “ever-warm” network of clinical research sites. Within the initiative, FVR contributes practical day-to-day clinical vaccine study experience to that work: planning studies, working with clinical sites, engaging participants, managing study conduct and connecting research questions with Finnish health data capabilities.
For international sponsors, Finland offers a unique combination that is difficult to recreate quickly: experienced vaccine research professionals, high public trust, digital healthcare systems, comprehensive national health registries and a stable clinical research environment. FVR’s network of eight clinics adds active research infrastructure for faster study start-up.
Public health organisations, academic networks, funders and regulators all shape pandemic preparedness. Marissa argues that vaccine manufacturers also need to be involved early, while assumptions about feasibility, data needs and study design are still being formed.
“Pharma needs to be at the table when pandemic preparedness is being discussed,” she says. “Not only to understand what is being planned, but to bring in the perspective of what is feasible, what can be done and what the practical constraints are.”
Early industry input matters because it keeps preparedness planning close to the realities of study design, evidence generation and execution. The point is not alignment for its own sake. This supports earlier decisions on endpoints, target populations, safety monitoring, data requirements, regulatory strategy and the trade-offs that determine whether a study can start on time.
For vaccine developers, outbreak-to-evidence readiness comes down to the elements that make execution possible: active research networks, adaptable protocol frameworks, regulatory dialogue models, laboratory capacity, validated methods, real-time surveillance, harmonised data systems, cross-border data mechanisms and partnerships that already work in practice.
Preparedness also means keeping an eye on emerging and less commercially prioritised pathogens that could become relevant for future vaccine development. “You cannot develop a vaccine for a pandemic that does not yet exist,” Marissa says. “But you can prepare the technologies and platforms, networks, protocols, data systems and partnerships that make faster development possible when they are needed.”
FVR supports international vaccine developers with feasibility assessment, clinical vaccine studies, real-world evidence generation and European partnership work in infectious diseases and pandemic preparedness.
If you are assessing study feasibility in Finland or looking for an experienced vaccine research partner in Europe, contact FVR to discuss how its network, data environment and study capabilities could support your next programme.
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