Coronavirus (COVID-19)

The epidemic caused by the novel coronavirus SARS-CoV-2, which began in December 2019 in Wuhan, China, was declared a global pandemic by the World Health Organisation (WHO) in March 2020. SARS-CoV-2 causes an infectious disease called COVID-19.

Testing for COVID-19

COVID-19 tests from several manufacturers are available in Finland. Some of the tests are suitable for both asymptomatic and symptomatic people, while others are only intended for testing those with symptoms. Some of the tests suit professional testing and some home testing.

When purchasing a test, the instructions for use inside the package are not always available. In that case, the customer should ask a salesperson about the suitability of the test. The test manufacturer is responsible for ensuring that the test works correctly and is safe for the purpose specified by the manufacturer.

There are three main types of COVID-19 test technologies:

• tests that detect the virus genome (nucleic acid tests, such as PCR tests)
• tests that detect other components of the virus (so-called antigen tests)
• serological tests, i.e. antibody tests.

COVID-19 test regulation and control

All COVID-19 tests intended for patient diagnostics are so-called in vitro diagnostic (IVD) medical devices regulated by the EU Regulation on Medical Devices and the Finnish Medical Devices Act. Sample collection supplies, such as nasopharyngeal swabs, are also considered to be medical devices. The conformity of medical devices is supervised by Fimea, but the placing on the market of medical devices does not require approval by authorities.

Only medical devices that are in conformity with the requirements may be placed on the market and put into service in Finland and in the EU area. Before a product enters the market, the manufacturer must demonstrate its safety, fitness for purpose and performance. The CE marking indicates conformity with the requirements.

COVID-19 vaccines

Several vaccines have been developed against COVID-19. Like other medicinal products, a vaccine must have a marketing authorisation before it can be introduced to market. When a product is granted a marketing authorisation, an overall assessment is conducted of the product. The benefits of the product must be greater than the known adverse reactions. The safety of a vaccine is evaluated under the same criteria as in the normal marketing authorisation process. Also required is a follow-up safety programme after the vaccine is put on the market. Acceptable adverse drug reactions must always be proportioned to the illness treated with the medicine. In the case of vaccines, it should be remembered that the majority of vaccines are administered to healthy people.

The Finnish Institute for Health and Welfare is responsible for the vaccines used and the vaccination order, and it gives national recommendations concerning risk groups. Vaccinations are organised by municipalities.

More information on the COVID-19 vaccines used in Finland as well as applicable vaccination recommendations can be found on the Finnish Institute for Health and Welfare’s COVID-19 vaccines website in Finnish and Swedish.

Adverse drug reactions of COVID-19 vaccines and reporting them

The safety of vaccines is monitored through EU-level cooperation throughout their lifecycle. After the marketing authorisation phase, safety monitoring and evaluation will continue reflecting the information gathered from the vaccine.

Common known adverse drug reactions of COVID-19 vaccines include fever, chills, headache, fatigue, muscle and joint pain, enlarged and painful lymph nodes, allergic reactions, nausea, vomiting, diarrhoea and reactions at the injection site. Known adverse drug reactions are listed in the package leaflet. Adverse reaction records are used to detect new and unexpected adverse drug reactions. The records are not used to map out the prevalence of adverse drug reactions which can be determined through studies or the relevant information obtained from the health care registers.

Adverse reaction records do not directly indicate that the vaccine has adverse effects. They reflect the reporter’s observations and views. They do not mean that there is an established link between the vaccine and the observed effects.

From the viewpoint of the emergence of safety concerns, the main thing is the reported harm, i.e., the content of records, not their number. If, based on adverse reaction records, a vaccine is suspected of causing safety concerns, its evaluation will be initiated. If a possible causal link to the vaccine is established on the basis of the assessment, measures will be taken to change the terms of the marketing authorisation. COVID-19 vaccines have centralised marketing authorisations issued by the European Commission; consequently, decisions on such marketing authorisation measures are taken at the EU level through European cooperation.

An adverse drug rection of a vaccine and an adverse drug event entitling a person to compensation are not always the same. Information on possible compensation for any adverse reactions of COVID-19 vaccines can be found on the website of the Finnish Mutual Insurance Company for Pharmaceutical Injury Indemnities.

Further information:

Submitting a report on an adverse reaction
Adverse reactions reported on corona vaccines

Read more

Coronavirus (Finnish Institute for Health and Welfare)
COVID-19 vaccines (Finnish Institute for Health and Welfare, in Finnish)
COVID-19 vaccines (European Commission)
Coronavirus disease (COVID-19, EMA)
Coronavirus disease (COVID-19) pandemic (WHO)
Coronavirus – EU response (European Commission)