Human medicines and vaccines are always thoroughly researched and tried before they obtain a marketing authorisation. The purpose of these trials is to ensure that the vaccine is safe but also efficient.
The research proceeds over several steps, and the last ones are the so-called clinical trials where the medicine or vaccine is studied and tried on voluntary subjects. Normally, there are as many as tens of thousands of test subjects – and not only adults in basic good health.
Each trial phase is carefully controlled and monitored. The purpose of this is to ensure that the research done is scientifically reliable, ethically performed and meets all laws.
As is the case with any medicine, the safety and efficacy of the COVID-19 vaccine is finally confirmed only as time goes by, in so-called follow-up research. When a large enough number of people get the vaccine, we also accumulate information on its efficacy and impact on various population groups, such as different age categories or people with a chronic disease etc. With the help of follow-up research, we also may learn more about potentially rare adverse reactions.
In the case of COVID-19 vaccines, the follow-up research is particularly important since the development work was relatively rapid – even though every trial phase was completed.
The safety of vaccines will be followed throughout their lifespan. Follow-up information is accumulated, for example, through adverse reaction notifications, further research and regular safety audits as well as various studies. Having all this information, it is possible to assess the safety and efficacy of the vaccine on a continuous basis.
It is worth remembering that the COVID-19 vaccines can be approved and introduced to use only if they meet all the quality, safety and efficacy requirements set in the EU medicines legislation.
The vaccine development and safety are supervised both in Finland and collectively in the EU area. The European authority is the European Medicines Agency, EMA while the Finnish Medicines Agency, Fimea, is the Finnish authority in charge of controlling vaccines. The collaboration between authorities in various countries and EMA is very active and close.