Real World Evidence (RWE) Studies

FVR conducts Real World Evidence (or register-based studies) that rely on Finland’s national health registers for vaccine research.

Register studies draw on Finland’s national health registers and data resources, which are nationwide, comprehensive, up-to-date and linkable. We use, for example, the following registers: 

Population Register of the Digital and Population Data Services Agency
Registers of the Finnish Institute for Health and Welfare (THL)
National Infectious Diseases Register
Care Register for Health Care (Hilmo)
Primary Health Care Outpatient Care Register (Avohilmo)
National Vaccination Register
Medical Birth Register
Benefit registers of the Social Insurance Institution of Finland (Kela)
Patient Data Repository of the Kanta Services
Prescription Centre register
Registers of Statistics Finland (causes of death and demographic variables)

FVR conducts Real World Evidence (or register-based studies) that rely on Finland’s national health registers for vaccine research. Registry-based studies are conducted to assess, among other factors, the disease burden associated with various illnesses, as well as the effectiveness and potential adverse effects of vaccines following their market authorisation.

These real-world, observational studies provide critical insights into vaccine performance under routine conditions and are particularly valuable when evaluating the inclusion of vaccines in national immunization programs or monitoring the long-term impact of vaccines already implemented in such programs.

We also conduct observational medical studies that require informed consent from participants. In these studies, data collected directly from the participants are used in addition to registry-based information. Furthermore, we carry out pragmatic effectiveness studies to evaluate the burden of infectious diseases, the benefits and risks of vaccines, and their broader public health impact.

Ongoing register-based studies

Register-based study on the paediatric PCV vaccination programme in Finland

Scientific study examining the burden of pneumococcal disease in Finland during the current infant pneumococcal vaccination programme (10-valent pneumococcal conjugate vaccine, PCV10). The study uses data from national health registers.

Register-based study on the disease burden of meningitis

Meningitis is a rare but serious illness caused by various bacteria. This study describes every meningitis case in Finland during 1995–2022, with special attention to diseases caused by Neisseria meningitidis. Invasive meningococcal disease (IMD) can be fatal and may lead to significant physical, psychological, and social sequelae. No comprehensive study on the long-term effects of IMD has previously been conducted in Finland.

Effectiveness and impact of the preschool pertussis booster in Finland – a register-based study

A population-based national register study on pertussis in children under 14 years of age in Finland, 1995–2019. It assesses the effectiveness of the pertussis vaccine given at preschool age in a cohort design, taking previous vaccinations and time since vaccination into account. The impact of the preschool booster is also evaluated by comparing the temporal incidence of pertussis according to whether that dose was included in the vaccination programme or not. Incidence is further analysed by age, period, geographic area, vaccination status and hospitalisation.

Effectiveness of the COVID-19 vaccine against severe disease in risk groups in Finland

Scientific study assessing the effectiveness of the COVID-19 vaccine (Pfizer-BioNTech) against severe disease among people aged 65 years and older, and among people aged 12 years and older who are susceptible to severe COVID-19 because of an underlying condition or medication, in Finland. The study uses data from national health registers.

Register-based studies

Pragmatic field studies

FVR has specialised expertise in phase 4 clinical vaccine trials that make use of national register data. In these large field studies (so-called pragmatic trials) the goal is to employ the optimal design -randomised controlled trials - so that study quality is high and the results are straightforward to interpret. Large clinical vaccine trials are difficult to run, demand meticulous follow-up and significant professional manpower, and are therefore costly.

Using national health registers for participant follow-up, however, greatly reduces expenses and makes even extensive trials feasible. In pragmatic studies, participant recruitment and vaccination procedures are often carried out in collaboration with existing healthcare organizations, following routine clinical practices as closely as possible. This approach enhances the feasibility of the study and improves the generalizability of the findings to real-world settings.

A research team experienced in pragmatic studies transferred to FVR from the Finnish Institute for Health and Welfare (THL). THL has completed two large pragmatic phase 4 field studies:

FinIP vaccine study (2008–2018), conducted in collaboration with GSK (GlaxoSmithKline). It remains the largest pneumococcal vaccine study ever performed in children, involving more than 47 000 participants across Finland.

Additional information: www.finip.fi
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FinFluHD influenza vaccine study (2018–2022), conducted with Sanofi Pasteur. During the 2019–2020 influenza season it enrolled over 33 000 participants, but the coronavirus pandemic led to a pause and termination in spring 2022. Study results can be read here.

Additional information: www.thl.fi/finfluhd

Ongoing medical studies

A cross-sectional study to evaluate pneumococcal nasopharyngeal carriage in children in Finland

This medical study aims to describe the current prevalence of pneumococcal nasopharyngeal carriage and serotype distribution in young children in Finland. Complementary baseline information is collected from health registers for the study subjects.
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