What are vaccines and what are they used for?
Vaccines are medicinal products used to prevent infectious diseases and the secondary diseases, disabilities and deaths associated with them. Vaccines protect the individual from infectious diseases and thus reduce the spread of pathogens in the population. The individual protection provided by vaccination depends on a number of factors, including the characteristics of the pathogen, the vaccine and the person being vaccinated. Sometimes the vaccinated person may fall ill despite having received the vaccine, but in these cases their symptoms are usually milder.
Thanks to vaccinations, many infectious diseases, as well as the associated secondary diseases and complications, have become rare in Finland or have even disappeared entirely.
How can marketing authorisation be obtained for a vaccine?
As with other medicinal products, there must be research-based evidence of a vaccine’s effectiveness and safety in order for it to obtain a marketing authorisation.
In practice, vaccines are developed first in the laboratory, then with animal testing, and then with phases 1 to 3 of clinical trials using volunteers. During the trials carried out on people in the third stage, the focus is particularly on the effectiveness and safety of the vaccine.
Before granting marketing authorisation, the medicinal authorities assess whether the benefits of the product indicated by the research is significant enough in comparison to the possible harm for the product to be granted marketing authorisation on this basis.
In addition, precise quality standards are required for the vaccine production process, and these are monitored by the medicinal authorities.
Composition of vaccines
Vaccines contain the active substance as well as excipients which are needed for purposes such as obtaining the right composition and ensuring the preservability of the vaccine. In some vaccines, one of the excipients is an adjuvant, which improves the vaccine so that it provides better or longer-lasting protection. Aluminium compounds, for example, are sometimes used as adjuvants. In any particular vaccine dose that contains this adjuvant, the quantity of aluminium is very small. The ingredients of vaccines that have received marketing authorisation are listed in the summary of product characteristics and the package leaflet.
The national vaccination programme
The goal of the national vaccination programme is to protect Finnish citizens as well as possible from diseases that are preventable through vaccination. The national vaccination programme only uses vaccines that have a marketing authorisation, and the vaccinations are voluntary and free of charge. The vaccines within the vaccination programme are funded from the state budget.
The Ministry of Social Affairs and Health is responsible for making decisions on the vaccines of the national vaccination programme. The Finnish Institute for Health and Welfare (THL) develops the national vaccination programme, consults the national vaccines expert group (KRAR), and monitors and assesses the impact of vaccines on the population as a whole. THL also distributes the vaccines of the national vaccination programme to the different municipalities. The municipalities are then responsible for administering these vaccines. Further information can be found on the THL website (www.thl.fi).
Acquiring vaccines that are not part of the national vaccination programme
The national vaccination programme does not include all vaccines. Vaccines can also be purchased with a doctor’s prescription and then obtained from a health centre. Vaccinations can also be obtained from a private health clinic, for example before travelling abroad.
Report to the Finnish Medicines Agency any adverse reactions to vaccines
All vaccinations are associated with some kinds of adverse reactions, the most common of which are local reactions such as redness at the injection site itself. The rarest adverse reactions cannot be determined before the vaccine has seen widespread use in the population.
The safety of vaccines is continually monitored in a comprehensive manner based on information such as reports of adverse effects, and so it is important to report to the Finnish Medicines Agency (Fimea) any suspected adverse effects that are encountered. The primary purpose of the reporting system is to detect adverse effects that are previously unidentified and rare. As such, Fimea would like to receive reports particularly on adverse effects that are not mentioned in the vaccine’s package leaflet. Reports of suspected adverse effects of vaccines are submitted using the form provided by Fimea for reporting adverse effects.