.avif)
Vaccine safety is closely assessed in vaccine trials.
Healthcare professionals monitor the health and symptoms of the person participating in the trial throughout the trial.
Safety may also be assessed more broadly using health registries and databases
An experienced physician is always responsible for vaccine trials and the safety of clients. Based on the monitoring, he or she continuously assesses the symptoms reported by the client or adverse events reported in the registries and determines whether they are possibly related to the vaccination
The goal of vaccine research is to make new, as effective and safe as possible vaccines available that protect the population from serious diseases. The development of new vaccines is typically a process that takes years and involves many stages.
Only a small proportion of the products progress to clinical trials for humans
Before receiving a marketing authorization, the vaccine has been studied in several clinical vaccine trials, in which tens of thousands of volunteers have participated
The study of the safety of the vaccine continues even after the marketing authorization has been granted. At this stage, it is also monitored how the disease prevented by the vaccine becomes less common after vaccinations have started
All drug trials, including vaccine trials, have strict quality and safety requirements. For vaccines, the quality of the research evidence must be particularly strong.
In Finland, trials are supervised by the Finnish Medicines Agency Fimea
All clinical drug and vaccine trials involving humans, as well as medical trials involving humans, require approval from the National Committee for Medical Research Ethics (Tukija)
The trials follow good clinical practice (GCP) and their implementation is monitored regularly by official inspections.
Vaccines may cause mild and transient side effects in some vaccinated individuals, such as redness or itching. These are normal vaccination reactions. FVR staff are available to volunteer subjects throughout the study.
All vaccine trials comply with laws, regulations and EU regulations regarding pharmaceutical trials.
The most important of these are Regulation 536/2014 of the European Parliament and of the Council and Act 983/2021 on Clinical Trials of Pharmaceuticals
Medical research involving humans is governed by the Medical Research Act 488/1999
Register studies are subject to the Act on the Secondary Use of Social and Health Information 552/2019.
Vaccine safety and vaccine-related adverse events are usually the most important issues to be investigated in a study. Information on adverse events occurring during the study is collected in accordance with legislation and the study-specific research protocol.
Participants in vaccine trials are instructed to report all significant health-related events, especially any hospitalizations, according to study-specific guidelines.
Often, potential adverse events are reported through regularly completed electronic diaries.
Information is also collected through regular study office visits and remote contacts.
You can always contact your research clinic if you have any questions about the study, suspect an adverse reaction caused by the vaccine, or have been hospitalized.
If you suspect an adverse event related to the investigational product, please report it to the study staff according to the instructions you received. If you are unsure about reporting or have any questions regarding adverse events, please contact your own study clinic.
If you suddenly become ill, contact the emergency health unit in your area. In urgent emergencies, call the emergency number 112.
If you need to be hospitalized while participating in a vaccine study, we ask that you notify the staff of your vaccine study clinic as soon as possible.
.svg)
Research and participation in research are important public health efforts that promote human health. Research is essential to making new, safer and more effective vaccines available. National vaccination programs in different countries also develop thanks to vaccine trials. By participating in a vaccine trial, you can supplement your own or your child's vaccine protection.
Research and participation in research are important public health efforts that promote human health. Research is essential to making new, safer and more effective vaccines available. National vaccination programs in different countries also develop thanks to vaccine trials. By participating in a vaccine trial, you can supplement your own or your child's vaccine protection.
Research and participation in research are important public health efforts that promote human health. Research is essential to making new, safer and more effective vaccines available. National vaccination programs in different countries also develop thanks to vaccine trials. By participating in a vaccine trial, you can supplement your own or your child's vaccine protection.
Research and participation in research are important public health efforts that promote human health. Research is essential to making new, safer and more effective vaccines available. National vaccination programs in different countries also develop thanks to vaccine trials. By participating in a vaccine trial, you can supplement your own or your child's vaccine protection.
Research and participation in research are important public health efforts that promote human health. Research is essential to making new, safer and more effective vaccines available. National vaccination programs in different countries also develop thanks to vaccine trials. By participating in a vaccine trial, you can supplement your own or your child's vaccine protection.
Research and participation in research are important public health efforts that promote human health. Research is essential to making new, safer and more effective vaccines available. National vaccination programs in different countries also develop thanks to vaccine trials. By participating in a vaccine trial, you can supplement your own or your child's vaccine protection.
Research and participation in research are important public health efforts that promote human health. Research is essential to making new, safer and more effective vaccines available. National vaccination programs in different countries also develop thanks to vaccine trials. By participating in a vaccine trial, you can supplement your own or your child's vaccine protection.
Research and participation in research are important public health efforts that promote human health. Research is essential to making new, safer and more effective vaccines available. National vaccination programs in different countries also develop thanks to vaccine trials. By participating in a vaccine trial, you can supplement your own or your child's vaccine protection.
Research and participation in research are important public health efforts that promote human health. Research is essential to making new, safer and more effective vaccines available. National vaccination programs in different countries also develop thanks to vaccine trials. By participating in a vaccine trial, you can supplement your own or your child's vaccine protection.
Research and participation in research are important public health efforts that promote human health. Research is essential to making new, safer and more effective vaccines available. National vaccination programs in different countries also develop thanks to vaccine trials. By participating in a vaccine trial, you can supplement your own or your child's vaccine protection.
FVR - Finnish Vaccine Research
Peltokatu 26, 33100 Tampere
Business ID 3256659-4
info@fvr.fi
Invoicing instructions
Data protection I About cookies I Self-monitoring plan
Osana-tuki: help@fvr.fi
Copyright 2025 FVR - Finnish Vaccine Research