The Finnish Institute for Health and Welfare (THL) has a long history in vaccine research and production. Its studies have been closely tied to public health promotion, infectious disease prevention, and the development of the national vaccination program. THL and its predecessors have participated in internationally significant vaccine studies since the 1950s - starting with the Salk polio vaccine, the A meningococcal vaccine in the 1970s, and the Haemophilus influenzae type b (Hib) vaccine in the 1980s. The latter led to the inclusion of Hib vaccination in Finland’s national program and internationally. THL has also conducted large pneumococcal vaccine studies since the 1980s and influenza studies since the 2000s.
THL’s first predecessor, the State Serum Laboratory, was established in 1915 to support the prevention of communicable and infectious diseases. It produced vaccines and conducted serological research and training. In the 1940s, its name was changed to the State Serum Institute, and its operations expanded to include microbiological and biochemical laboratory research in medicine, as well as production of substances for hospital use.
In 1970, it became the National Public Health Laboratory, serving as a research institute and expert body for health care institutions. In 1982, its responsibilities were expanded to include public health promotion and health monitoring, and it was renamed the National Public Health Institute (KTL). KTL became an internationally significant research body and an essential expert authority in health matters, including infectious disease control and vaccine supply. Until 2004, KTL produced its own whole-cell pertussis-containing diphtheria-tetanus-pertussis (DTP) vaccine. In 2009, the Finnish Institute for Health and Welfare (THL) was formed when KTL merged with the National Research and Development Centre for Welfare and Health (Stakes). THL became an independent government research and expert agency, operating under Finnish law, with the mission to promote people’s well-being, health, and safety through research and expertise.
The clinical vaccine studies carried out by THL in cooperation with vaccine manufacturers now continue within FVR’s RWE (Real World Evidence) Unit. Most of the Tampere-based THL research team transferred to this unit, with its longest-standing member shaving worked on vaccine and vaccine-preventable disease research since the1990s. THL itself still conducts active vaccine research, but no longer in projects funded by vaccine manufacturers. Finland’s long history of large-scale vaccine effectiveness studies was celebrated at a 70th anniversary seminar held on 20 May 2025, during Clinical Trials Day, at THL.
The FVR RWE Unit continues THL’s tradition of conducting public health–oriented, large-scale registry-based and pragmatic vaccine studies, as well as other medical research, using real-world data and existing healthcare infrastructure.
The research team’s first focus area was pneumococcal vaccines. Between 1994 and 2003, it conducted the large Phase 3–4 FinOM study series on the first pneumococcal conjugate vaccine, later registered as Prevenar®. Research topics included otitis media in young children, the immunology of pneumococcal infections, pneumococcal carriage, and links between bacterial and viral infections.
THL also participated in an EU project studying the epidemiology of pneumococcal diseases before the widespread introduction of conjugate vaccines in Europe. As part of this, a10-month pneumococcal carriage surveillance study was carried out in Tampere day-care centers in 2003–2004.Pneumococcal research expanded to investigate the disease burden of pneumococcal pneumonia, as well as the immunogenicity of polysaccharide and experimental conjugate vaccines in older adults in the FinCAP study series (2005–2007).
The largest pneumococcal vaccine study was the Phase 4 FinIP trial (2008–2018), coordinated by the Tampere research group and involving 47,000 children across Finland. This remains the largest pneumococcal vaccine study in children worldwide. Infants were vaccinated with the 10-valent pneumococcal vaccine at child health clinics, and vaccine effectiveness was monitored through national registers. FinIP demonstrated the vaccine’s effectiveness against both severe and milder pneumococcal disease, providing key data to support national vaccination programmes.
More information: www.finip.fi
Another major focus area for the THL research team was influenza vaccines. The H5N1 avian influenza virus posed an international pandemic threat in the early 2000s, and THL participated in an EU project preparing for a pandemic by promoting rapid deployment of an effective low-dose vaccine and monitoring its effects. As part of this work, an avian influenza vaccine was studied in Tampere, for which Finland had secured a procurement slot.
However, the pandemic was unexpectedly caused by the H1N1 swine influenza virus instead. THL commissioned a follow-up study in Tampere covering more than 3,000 participants during the 2009–2011 epidemic seasons, assessing the immunogenicity and effectiveness of the H1N1 vaccine administered during the national vaccination campaign.
From 2015 to 2020, THL participated in two EU research consortia studying influenza vaccine effectiveness in adults and older adults across multiple countries. In 2017, THL launched an ongoing study monitoring the immune responses of healthcare personnel receiving repeated annual influenza vaccinations.
Between 2019 and 2022, the Tampere research group coordinated the large Phase 3/4 FinFluHD study, comparing the high-dose influenza vaccine (Efluelda®) with the standard-dose vaccine in preventing cardiovascular, circulatory, and respiratory diseases in people aged 65 and over. The trial involved more than 33,000 participants in 13 municipalities. Vaccinations were given at health centers, and outcomes were monitored through national registers. The study also developed a method for partially registry-based safety monitoring.
At Tampere University, vaccines have been developed and studied for decades. The Vaccine Research Center was formally established in 2004, but its roots go back to 1979, when the first clinical vaccine studies were conducted at the university. In 2004, the center became a dedicated unit within the university tasked with carrying out scientifically and ethically high-quality clinical vaccine research.
From the very start, its approach and objectives were clear: to develop safer and more effective vaccines for both children and adults, thereby preventing disease and improving quality of life. Initially, the Tampere Vaccine Research Center specialized in children’s vaccines, but gradually expanded its work to include adult vaccines as well. Its strongest expertise was in viral vaccines, especially clinical trials related to rotavirus, influenza, and varicella (chickenpox) vaccines. In the prevention of bacterial diseases, key research areas included pneumococcal and meningococcal vaccines for children.
Between 1998 and 2022, the center conducted more than 150 studies in children and adults. The implementation of these studies and patient visits was carried out by vaccine research clinics and their teams: investigator physicians, research nurses, and laboratory technicians. These teams were located across multiple sites in Finland. This internationally unique clinic network has enabled large nationwide studies and supported multinational vaccine research.
Participation in these studies often allowed people in Finland to benefit from new vaccines even before they received regulatory approval and marketing authorisation, and before their inclusion in the national vaccination program. In addition to clinical vaccine trials, the Vaccine Research Center also conducted academic research projects in collaboration with university research groups. The positive results of both clinical and academic studies have had a significant impact on the development of national vaccination programs in Finland and internationally.
One of the most significant achievements of the Vaccine Research Center was conducting large-scale rotavirus studies in Finland around the turn of the millennium. These studies were instrumental in establishing the center itself. Nearly 30,000 Finnish infants participated in trials that led to a major breakthrough: in 2006, the rotavirus vaccine was approved in the EU and the United States, and three years later it was included in Finland’s national vaccination program.
Before vaccinations began, rotavirus was the most common cause of diarrhea and vomiting in children worldwide.
In Finland, it resulted in hospital care for nearly 2,000 young children each year, and almost every child contracted it before the age of five.
The rotavirus vaccine was introduced into Finland’s national program in 2009. Administered at child health clinics, it has reduced rotavirus-related hospital visits and inpatient stays by over 81%. That translates to thousands of children spared from a painful illness every year, and families whose everyday life is made easier. At the same time, the burden and costs to the healthcare system have dropped significantly.
These positive effects are a strong example of how scientific research can improve children’s health and enhance family well-being.
Every winter, influenza viruses cause severe respiratory infections and large-scale epidemics. Preventing them was a key goal at the Vaccine Research Center, and remains one at FVR - Finnish Vaccine Research. There is still a need for more effective vaccines, especially for vulnerable groups such as young children, older adults, and the elderly.
Studies conducted at the Vaccine Research Center advanced influenza prevention significantly. Research in Finland played a decisive role in the registration of the nasal spray influenza vaccine for children in the United States, and later in the EU (2015). Another important step came in 2019 with the introduction of the quadrivalent influenza vaccine for adults, which provided broader protection against influenza. This vaccine covers four virus strains: two type A and two type B viruses.
However, following the COVID-19 pandemic in 2022, one of the type B influenza viruses disappeared globally, allowing a return to the trivalent influenza vaccine.
The influenza virus is a cunning pathogen because it mutates actively. Even though the World Health Organization (WHO) selects each year the viruses most likely to circulate in the coming season, predictions are not always 100% accurate. This creates ongoing challenges for the vaccine’s effectiveness.
Research continues with the goal of developing influenza vaccines that offer better and longer-lasting protection. Approaches include new manufacturing methods, adding an adjuvant, or increasing the antigen content of the vaccine. A particularly important target is the development of a universal influenza vaccine - one that could protect against mutated or entirely new influenza viruses, helping prepare for future influenza pandemics.
Influenza vaccine research is not just a reaction to changes in the virus, it is an effort to take major steps toward better preparedness against both seasonal flu and global influenza pandemics.
Years of research on the varicella vaccine have left a lasting positive impact on the health of children in Finland and on the Finnish healthcare system. At the Vaccine Research Center, varicella vaccines were studied extensively: from their effectiveness to the possibility of combining them with the MMR (measles, mumps, and rubella) vaccine for children. These studies played a key role in the registration of varicella vaccines (Varivax® and Varilrix®) for pediatric use.
In 2017, Finland made history by becoming the first Nordic country to include the varicella vaccine in its national vaccination program - a decision strongly influenced by research conducted in Finland and its positive results. The benefits of vaccination are now clear. According to a follow-up study conducted by THL in 2023, the number of varicella cases seen in primary healthcare decreased significantly compared to the pre-vaccination period of 2014-2016: by 90% among children under one year old, and by 98% in the age group of 2-8 years. Healthcare visits overall fell by 73%.
The follow-up study shows that Finland’s varicella vaccination program has effectively reduced both the incidence of disease and the burden on healthcare services. Monitoring of vaccination effects will continue, but it is already evident that preventing varicella means children no longer need to suffer from the disease and its complications. Children’s well-being has improved significantly, and families’ everyday lives have become easier, with fewer long absences from daycare and school - not to mention the reduced strain on nationwide healthcare services.
After a varicella (chickenpox) infection, the herpes zoster virus remains dormant in the nervous system. It can later reactivate, causing painful shingles. Around 10–20% of people develop shingles, most often after the age of 60. In addition to preventing varicella in children, preventing shingles in adults was an important goal at the Vaccine Research Center.
Two vaccines have been developed for shingles prevention, one of which (Shingrix®) is still in use. The Vaccine Research Center played an important role in studies leading to its approval. In these studies, the vaccine’s effectiveness in preventing shingles was 97% in people over 50 years old and 90% in those over 70.
A long-term follow-up study (which is still ongoing and involving both FVR and some of the original trial participants) has shown that the vaccine’s protection remains durable. In summer 2025, THL proposed adding the shingles vaccine to the national vaccination program for at-risk groups. The near future will determine when funding for this will be secured.
Extensive research on HPV vaccines was conducted at Tampere University, playing a key role in introducing HPV vaccination in Finland. The HPV vaccine for girls (Cervarix®) was added to the national vaccination program in 2012.
At the Vaccine Research Center, broad studies were carried out on HPV vaccines originally developed for boys (Gardasil4™ and Gardasil9™), with the aim of including boys in the HPV vaccination program as well. This goal was achieved in 2020, when the boys’ HPV vaccine was incorporated into Finland’s national program.
Thanks to these studies, HPV vaccine protection now extends to both sexes, safeguarding girls and boys against diseases caused by human papillomavirus, including genital warts and cancer. HPV vaccines have been shown to be safe and highly effective in preventing infections from the HPV types included in the vaccine.
In addition to directly protecting boys from HPV infections and, in the long term, HPV-related cancers, vaccinating boys has been shown to provide herd immunity, reducing the risk of HPV infection even among unvaccinated girls and women. This is especially important because girls who remain unvaccinated, or whose parents decline vaccination, are often at greater risk of contracting HPV.
RSV is the most common cause of severe lower respiratory tract infections as well as hospitalisation in infants and older adults. The Vaccine Research Center conducted long-term research aimed at protecting young infants from RSV infection. One major focus was studying the use of RSV antibodies in newborns.
Previously, only one monoclonal antibody was available, which was a costly treatment requiring repeated doses, reserved for very high risk children. Research efforts have since led to the approval of two new, easier-to-administer RSV antibodies, both authorised for use in healthy infants under one year old. In 2022, the antibody nirsevimab (Beyfortus®) received marketing authorisation. Earlier studies had shown it prevented about 80% of RSV infections in infants that would otherwise require hospital care.
Based on recommendations from Finland’s Council for Choices in Health Care, nirsevimab has been offered since autumn 2024 to all infants under 3 months old to prevent RSV respiratory infections, as well as to at-risk infants under 12 months. Due to positive experience with nirsevimab, this recommendation has been extended to cover the 2025–2026 RSV season. The Vaccine Research Center also studied another antibody, clesrovimab (Enflonsia®), which showed similar effectiveness to nirsevimab. Enflonsia® was approved in the United States in summer 2025, and its marketing application is currently under review in the EU.
Another important preventive approach, and a major research focus, has been vaccinating pregnant women. Several RSV vaccine studies in expectant mothers have been conducted, with positive results. One such vaccine was approved in 2023; studies found it prevented 70% of severe RSV infections in infants during their first six months of life. RSV is a serious disease for both newborns and older adults. The Vaccine Research Center (and later FVR - Finnish Vaccine Research) has participated in numerous studies aimed at finding ways to prevent it.
Decades of research have paid off: in 2023, the first RSV vaccines for older adults, Arexvy and Abrysvo®, became available, offering protection for people over 60. Additionally, Abrysvo® was approved for use in pregnant women to protect newborns. In 2024, prevention options expanded further when mRESVIA® was approved for adults over 60.
The RSV disease burden in Europe is substantial, increasing hospitalisations and mortality rates especially among the elderly. Preventing RSV infections through vaccination is therefore a major step toward better health and quality of life. In August 2025, THL will begin a broader evaluation of how Finland should prevent RSV epidemics in the future. This assessment will consider not only antibody treatments but also vaccinations for pregnant women, older adults, and people in high-risk groups.
Large-scale studies of antibody treatments and vaccines for these groups have involved thousands of participants in Finland, whose contributions have been essential to making these preventive measures available.
The Vaccine Research Center conducted numerous pneumococcal vaccine studies, playing an important role especially in preventing serious pneumococcal disease in children. Thanks to this research, the pneumococcal vaccine included in Finland’s national vaccination program has also been updated over time.
Vaccination of children against pneumococcal disease began in Finland in 2009, when the vaccine was first introduced into the national program for high-risk groups, and in 2010 for all infants. Since then, cases of meningitis, sepsis, pneumonia, and milder infections such as otitis media caused by pneumococcal bacteria have decreased significantly. Hospitalisations, antibiotic treatments, and associated costs have also dropped.
The reduction in disease has been most notable among vaccinated young children. However, because children play a major role in transmitting the bacteria to other age groups, vaccination has also prevented pneumococcal infections more broadly, significantly reducing disease cases across the entire population. This has been especially important for older adults, for whom pneumococcal disease carries a high mortality risk.
There is still a need to develop more effective and broadly protective pneumococcal vaccines. Over 100 different pneumococcal serotypes are known, distinguished by the structure of the bacterial surface. A vaccine targeting one serotype offers no protection against others. Through a complex manufacturing process, current vaccines can include surface components from as many as 21 serotypes, but protection is not optimal against all included types.
Vaccine development focuses on including the most common disease-causing serotypes, but these can vary by age group and region. It has also been observed that while vaccination reduces cases caused by serotypes in the vaccine, these can be partly replaced by disease cases caused by other serotypes. This is why work toward more broadly protective vaccines continues.
The complexity of manufacturing current pneumococcal vaccines makes them expensive. Developing simpler, more affordable vaccines could enable broader use in low-income countries. Through follow-up studies conducted by FVR, researchers can track which pneumococcal serotypes are circulating, which cause serious disease, and which vaccines are most effective in preventing illness. Preventing pneumococcal disease through vaccination is also important in the global fight against antibiotic resistance. Every winter, influenza viruses cause severe respiratory infections and large-scale epidemics. Preventing them was a key goal at the Vaccine Research Center, and remains one at FVR - Finnish Vaccine Research. There is still a need for more effective vaccines, especially for vulnerable groups such as young children, older adults, and the elderly.
Meningococcal diseases are rare but potentially life-threatening. This makes it essential to prevent them through vaccination. Effective meningococcal vaccines have been under development for a long time, and the Vaccine Research Center has played a significant role in studying them. The research goal has been to make available a safe, broad-spectrum vaccine protecting against the clinically most significant meningococcal serogroups, especially for infants, but also for teenagers and young adults, the age groups in which the disease is most common.
FVR continues meningococcal vaccine research with this same goal.
Currently, there are two main types of meningococcal vaccines on the market:
1. Vaccines that protect against serogroup B meningococci (Bexsero® and Trumenba®)
2. Combination vaccines that protect against serogroups A, C, W, and Y (Nimenrix®, Menveo®, MenQuadfi®)
Only some of these vaccines are suitable for use in infants. In many countries, meningococcal vaccines are part of the national vaccination program and widely used. In Finland, the incidence of meningococcal disease has remained low enough that vaccines are included in the national program only for people in certain medical risk groups. Additionally, the ACWY meningococcal vaccine is offered to conscripts.
The incorporation of THL’s commercial vaccine research operations marked a new phase in Finnish vaccine research.
In 2019, the Chancellor of Justice recommended that THL’s commercial vaccine studies be administratively separated from its official government functions. This recommendation initiated concrete preparations between 2019 and 2021, led by the Ministry of Social Affairs and Health in cooperation with THL and the Tampere University Foundation. The aim was to establish a state-owned special task company to conduct commercial vaccine research independently from official functions and in a way that is internationally competitive.
In December 2021, the Finnish Government reviewed the company’s establishment and board composition, and in January 2022 the company was entered into the Trade Register. Ownership was divided between the state (51%) and the Tampere University Foundation (49%). To achieve majority ownership, the state made a capital investment of €6.7 million.
FVR - Finnish Vaccine Research began full-scale operations on 1 September 2022, when the commercial functions of both THL and Tampere University’s Vaccine Research Center were transferred to the company through a non-cash asset transfer, including staff and assets. Beyond administrative and structural reforms, the founding of the company was above all a long-term, value-driven investment in society and in global health security.