Vaccines contain pathogens or their components to create immunity against infections or symptomatic clinical disease. Vaccines trigger the production of antibodies or create cell-mediated immunity.
Vaccines are usually classified into those that contain live attenuated pathogens and those that do not. Live attenuated vaccines include several viral vaccines and the BCG vaccine against tuberculosis. The majority of currently used vaccines do not contain attenuated pathogens. Instead, they contain inactivated (killed) whole pathogens, split pathogens or their surface components, or toxoids (bacterial toxins modified to be safe).
The oldest and best known vaccines are those against whooping cough, diphtheria and tetanus, as they have been used to vaccinate the Finns since the 1940s and '50s. The latest addition is the papillomavirus vaccine that was added to the girls' vaccination programme in 2013.
The vaccines in the National Immunisation Programme protect the population from common or serious communicable diseases. Some vaccines in the programme, such as the hepatitis or BCG vaccines, are targeted only at groups at risk. These groups are at a particular risk of becoming infected due to an underlying disease or exposure. A special group at risk is tourists. They can have themselves vaccinated at their own initiative against many communicable diseases present in their destination.
Traditionally, vaccines are administered by an intramuscular or subcutaneous injection, but there are also vaccines that are administered orally or by a nasal spray. Examples of these include vaccines against cholera, typhoid fever, rotavirus and influenza.
Fimea is responsible for evaluating the applications for a National Marketing Authorisation and granting and controlling the actual marketing authorisations of vaccines. Altogether, there are 110 valid marketing authorisations for vaccines, but only about 50 of them are currently available on the Finnish market. Nowadays, many vaccines are granted a marketing authorisation via the European Medicines Agency's centralised marketing authorisation procedure.
The National Immunisation Programme uses only vaccines that have a marketing authorisation. The efficacy and safety of the vaccines in the immunisation programme is monitored actively at the initiation phase of the programme. The immunisation coverage is monitored at regular intervals through registrysamples.
To obtain a marketing authorisation, the manufacturer must use high-quality manufacturing techniques and be able to specify and monitor the quality of the vaccine in detail. Moreover, the efficacy and safety of the vaccine must be convincingly demonstrated. There are cases, however, where the efficacy cannot be demonstrated directly, for example when a disease is very rare. In these cases the efficacy must be determined indirectly from the reactions of the immune system or a reduction in the number or infections or carriers of the pathogen.
Physicians and nurses will provide information on all vaccines, prescriptions required and associated costs. All vaccines in the National Immunisation Programme are free of charge.
The National Immunisation Programme
The National Immunisation Programme is formulated and monitored by the National Institute for Health and Welfare. Municipalities are responsible for executing the programme.
The conditions for including a vaccine into the national programme are as follows:
- The vaccination reduces a disease significantly from the public health perspective.
- The vaccine is safe for the individual.
- Widespread use of the vaccine is not expected to trigger adverse effects that outweigh the benefits at the level of the general population.
- The required financial investment should be reasonable compared to the health benefit gained.
Report adverse reactions to vaccines
All vaccinations are associated with adverse reactions, the most common of which are local reactions at the injection site (such as redness or a hard lump). The rarest adverse reactions cannot be determined before the vaccine has seen widespread use. This is why any possible adverse reactions to new vaccines are closely monitored. It is also important to submit a record of all suspected adverse reactions to the National Institute for Health and Welfare.
Pursuant to the Communicable Diseases Act, recording suspected adverse reactions is mandatory for health care professionals. Adverse reactions can also be reported by the vaccinated person.