Developing a new vaccine is a demanding and closely monitored process that takes years. Only a small percentage make it to clinical trials and even fewer end up as finished products. We employ ~110 clinical vaccine research experts at our 10 research clinics across Finland. Each clinic has its own team, including professional study nurses, laboratory nurses and physicians. The team is responsible for conducting the studies following a unique research plan, national and international legislation, and the guidelines for Good Clinical Practice (GCP).
What is vaccine research and how do we work?
We study several vaccines each year, and thousands of Finns participate voluntarily in the studies. In addition to this, we conduct large-scale register studies utilizing the nationwide, comprehensive, and timely health information available in Finland.
Before the studies begin, researchers from pharmaceutical manufacturers, universities, biotechnology companies, and other actors in the medical field gather information on the causes, occurrence, and severity of the disease targeted by the vaccine – and a vaccine is developed to prevent the development of the disease or a complication caused by the disease. The phase before clinical trials (phase 0) takes place in a laboratory. The new vaccine is studied chemically. Cell cultures can be used and the effects of the vaccine assessed on animals. This stage can take several years.
Clinical vaccine research
First studies with human subjects (phase I): The primary purpose is to assess the safety of the vaccine. The trial subjects keep records of any symptoms that may occur after vaccination. The responses of their immune system to the vaccination are monitored. Because the vaccine has not been previously tested on human subjects, only a few (dozens) healthy volunteers typically participate in the trial.
Comprehensive studies within the target group (phase II): The vaccine is given to people that belong to its future target group. This means children may also be involved in this phase. The study determines the dose and schedule that produces the best response and the least amount of side effects. Volunteers are typically divided into two groups in a randomized and blinded manner. One group receives the research vaccine, the other either a placebo or a pre-existing vaccine. Possible side effects and the responses of the immune system are monitored for weeks or months.
Studies of safety and efficacy (phase III): This phase can include up to tens of thousands of volunteers. The trial subjects belong to the target group of the vaccine. They are divided into two groups in the same way as in the previous phase. The vaccination schedule and dose are selected based on the results obtained during the previous phase. The main objective is to demonstrate how well the vaccine can prevent disease by comparing the occurrence of the disease in the research and control groups. In addition, the study monitors the occurrence of possible side effects. Because it can take time for the disease to break out, follow-up takes months or even years.
Large-scale studies of effectiveness (phase IV): Rare side effects cannot be detected until the vaccine is widely administered in the general population. This phase monitors the effects of vaccinations during widespread use and how the disease, preventable with the vaccine, becomes less common after the vaccine administration is initiated. During phase IV, it is possible to utilize Finland’s extensive registers and databases to provide nationwide, comprehensive, and timely health information.
Real-World Evidence studies
FVR also conducts RWE (Real-World Evidence) studies based on the utilization of national health registers. These studies will search for additional data on the effectiveness and potential side effects of vaccines after a commercial license has been obtained. The studies are based on real-world information and help with understanding the effects of vaccines in widespread use. This is particularly important for assessing the feasibility of widespread deployment of vaccines, for example when they are included in the national vaccination program, or for monitoring the effects of vaccines that are already a part of a national vaccination program.
In addition, we carry out studies on the burden of vaccine-preventable diseases that assess the occurrence of diseases in different population groups as well as the complications caused by diseases and how they consume healthcare resources, for example, the length of hospital stays.
Contrary to clinical trials, the trial subjects are not contacted during RWE studies, but the studies may be carried out by obtaining a permit from authorities. Typically, RWE studies concern a very large population, and in some cases, the subject of the study may be the entire population of Finland.
Pragmatic vaccine trials
FVR has strong expertise in conducting phase IV clinical vaccine trials utilizing national health registers. These extensive field studies (so-called pragmatic studies) aim to use the best possible study design, namely a randomized trial method resulting in high-quality research and straightforward interpretation of the results. Extensive clinical vaccine trials are difficult to implement and require close monitoring and a large workforce of professionals. Therefore, they are expensive. However, using national health registers to monitor subjects significantly reduces expenses and makes it possible to conduct extensive studies.
A research group carrying out pragmatic studies transferred to FVR from the Finnish Institute for Health and Welfare (THL). Two extensive pragmatic phase IV field studies have been conducted at THL:
The FINIP vaccine trial was conducted between 2008 and 2018 in collaboration with GSK (GlaxoSmithKline). It remains the largest pneumococcal vaccine trial with child subjects ever conducted and involved more than 47,000 subjects all over Finland. More information on the study can be found HERE >>.
The FinFluHD influenza vaccine trial was conducted between 2018 and 2022 in collaboration with Sanofi Pasteur. It involved more than 33,000 subjects during the 2019–2020 flu season, but due to the COVID-19 pandemic, the study was put on hold and was suspended in the spring of 2022. Publication of the research results is still pending. More information on the study can be found at www.thl.en/finfluhd.
All RWE studies utilize Finland’s national health registers which are nationwide, comprehensive, up-to-date, combinable, and affordable. In particular, the following registry data may be used in studies:
- Up-to-date demographics from the Digital and Population Data Services Agency
- Various registers of the Finnish Institute for Health and Welfare
- Finnish national infectious diseases register
- Care register for health care (Hilmo)
- Register of primary health care outpatient visits (Avohilmo)
- Medical birth register
- Benefit registers of The Social Insurance Institution of Finland (KELA)
- Data from the National Patient Data Repository and Prescription Centre of the Kanta Services
- Causes of death and demographic variables of the population from Statistics Finland
The data of Finnish registers, together with national health insurance, centralized public health care system, good access, skilled staff, and the trust of the population, form a good basis for conducting studies.