Frequently asked questions (COVID-19)
How many cases of adverse reactions to COVID-19 vaccines have been reported in Finland?
Finnish Medicines Agency Fimea has a webpage that provides information on the adverse reaction reports submitted for corona vaccines. The page is updated several times a week with the number of submitted reports, and a more detailed weekly report is published on Wednesday in Finnish and in Swedish.
Why did the development of a coronavirus vaccine happen so quickly compared with normal vaccine development?
There have been international efforts of many kinds to speed up research and development work on a coronavirus vaccine. For example, companies were given economic incentives. Some of the vaccines under development are based on new technologies that have not been used before. Members of the international science community have openly shared information with each other. Information about research into the previous SARS and MERS coronavirus epidemics, and on vaccine development has also been utilised in the development of the coronavirus vaccine.
An accelerated evaluation by the European Medicines Authority allows faster approval a sales permit. Under normal conditions, all information on sales applications must be delivered at the beginning of the evaluation process, but in an expedited evaluation research data is evaluated as it becomes ready.
There are several phases in developing vaccines.
Read more in the journal Duodecim (9 April 2020): Koronavirusrokotekehitys on kilpajuoksua ajan kanssa
Is the vaccine safe, even though it has been developed so quickly?
The safety of the vaccine is evaluated under the same criteria as in the normal process for a sale permit. At least one extensive phase-3 study with the vaccine is required, with up to tens of thousands of people participating. The studies have often also included people other than working-age adults in reasonably good health.
Safety requires a sufficient number of people to be vaccinated and enough follow-up time so that rarer side-effects, or those which emerge after a delay, might be noticed. Also required is a follow-up safety programme after the vaccine is put on the market.
How is the safety of the vaccine monitored?
The safety of vaccines is followed through their entire life cycle as a cooperative effort on the EU level. After the sales permit phase, the monitoring and evaluation of safety continue in light of information from the vaccine. Safety evaluations are made with the help of reports on side effects, studies, periodic safety surveys, and register-based reports. If necessary, measures are taken to promote the safe use of the vaccine.
How are corona tests regulated and monitored?
All coronavirus tests intended for patient diagnostics are considered to be so-called vitro diagnostic (IVD) medical devices, governed by the Finnish Medical Devices Act. The sample collection devices, such as nasopharyngeal swabs are also considered to be medical devices. The regulatory compliance of medical devices is monitored by the Finnish Medicines Agency Fimea.
Only medical devices that comply with legal requirements are allowed on the Finnish and the EU market. 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. However, the legislation does not specify detailed performance requirements and therefore there are no specific requirements for SARS-CoV-2 tests, for example for their sensitivity.
Depending on the risk category, introducing certain medical devices on the market requires an assessment by an external inspection body, also known as a notified body. Coronavirus tests for professional use do not require an assessment by a notified body, so these tests may be placed on the market under the current legislation with the manufacturer’s own declaration of conformity. In such cases, the manufacturer puts a CE marking on the test to self-declare that the product compliant with the applicable requirements. Nevertheless, at-home test kits are always considered high-risk products and are subject to assessment by a notified body prior to being placed on the market.
Medical devices are not subject to a prior inspection or a marketing authorisation process like pharmaceuticals, but are monitored by authorities after being placed on the market.
On the other hand, the actual coronavirus testing process from sample collection to test result analysis, requires a clinical microbiology licence pursuant to Infectious Diseases Act 1227/2016. The licence is applied for from a Regional State Administrative Agency, while the Finnish Institute for Health and Welfare acts as an expert on the licences. Laboratories carrying out the tests may only use compliant test kits, and the test methods chosen by the laboratory will also be assessed in more detail when the lab applies for the licence. As a result, the suitability of the coronavirus tests used in Finnish health care has been carefully assessed, and the tests carried out by laboratories can be relied on.
However, it should be kept in mind that even the best laboratory tests are not 100% accurate, and many factors in sample collection can have an effect the result. Furthermore, testing is not a substitute for maintaining a safety distance, staying at home when ill or after travelling in high-risk areas and other recommended measures.
What do the corona tests investigate?
There are three main types of 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
The first two types of tests are suitable for the direct diagnosis of a SARS-CoV-2/ COVID-19 infection in a patient.
For early diagnosis of COVID-19 patients, the recommended tests are still the ones based on the detection of the SARS-CoV-2 virus genome, such as PCR. Therefore, Finnish health care uses primarily PCR tests. The sample used for PCR tests is typically a nasopharyngeal sample, but the use of sample types, like saliva, has been investigated.
PCR tests are mainly carried out in a laboratory, but there are also some point-of-care PCR tests available on the market. Antigen and antibody tests are available as both laboratory and point-of-care versions. The tests might differ from each other in some respects, such as in the time and equipment required to perform the test, the quantity of samples that can be analysed in one go and the complexity of performing the test.
Antigen tests detect virus antigens, which are viral components other than the genome (RNA or DNA depending on the virus). The usefulness of these tests depends greatly on the sensitivity of the test, which may vary considerably from one test type to another. The sample for antigen tests is primarily collected from the respiratory tract (usually a nasopharyngeal sample). Great expectations have been placed on antigen tests, since they are cheaper and faster to perform than PCR tests. In Finland, too, antigen tests have now been introduced in certain situations, but they cannot replace PCR tests yet.
The third group, the so-called antibody tests, or serological tests, serve as an indirect indication of a contact with the virus in the past. They detect antibodies generated by the body against the virus, but not the virus itself. Antibody tests are usually performed on a blood sample. According to various estimates, the antibodies reach a detectable level in the patient’s blood one to two weeks after the infection, meaning that the test may give a false negative result in the early stage of an infection. Furthermore, antibody tests do not give a reliable indication of the elimination of the virus from the body at the end of the disease. Thus, antibody tests are better suited for preliminary assessment of viral exposure and potential immunity at the individual or population level.
Where are corona tests performed? Are there any reliable at-home tests on the market?
At-home tests (tests intended for self-testing) are typically products like pregnancy tests sold in shops and pharmacies. When performing an at-home test, the patient collects the sample, runs the actual test and interprets the results by themselves without an involvement of a health care professional. At-home tests must be specifically proven safe and functional for use by a layperson. They must be easy to perform, and reading and interpreting the results must also be simple. So far, there are no at-home tests proven to be safe and functional for SARS-CoV-2 / COVID-19 testing on the market in Finland and Europe.
It is important to make a distinction between an actual at-home test and an at-home sample collection.
In at-home sample collection, the patient collects the sample independently, but delivers it to a laboratory for further processing and analysis by professionals. The laboratory has a quality management system that applies to all aspects of its operations, and the test results and their interpretation is always confirmed by a professional. At-home sample collection has been tested in many countries in Europe and elsewhere. Although it has many potential benefits, the challenge in at-home sample collection for coronavirus diagnostics is to obtain a sample that is sufficiently representative and of good enough quality so that the test result is reliable.
Point-of-care testing refers to tests performed by a health care professional outside laboratory conditions. For the time being, however, the majority of SARS-CoV-2 tests are carried out centrally in a laboratory.
The term ‘rapid test’ is used fairly extensively and can refer to very different types of tests and equipment. In most cases, a rapid test refers to non-automated strip test kits, like the pregnancy tests sold in pharmacies, which may be at-home tests or point-of-care tests. However, sometimes a rapid test can also refer to a test method that is quicker than regular methods and is performed as a point-of-care test or in a laboratory.
How are respirator masks (face masks) controlled? What authority can I contact for more information about their use and manufacture?
Finnish Safety and Chemicals Agency (Tukes)
Respirator masks intended for consumer use
Regulation on personal protective equipment (EU) 2016/425
Finnish Safety and Chemicals Agency (Tukes)
Face masks intended for consumer use
Consumer Safety Act 920/2011 and Government Decree on information to be supplied in respect of consumer products and services 613/2004
General consumer goods are not CE marked.
If the product does not meet the requirements of personal protective equipment (PPE), it is not allowed to give consumers a false impression that the product is a PPE. If face masks or similar products are marketed to consumers as respirator masks, they must meet the requirements of PPEs.
The Ministry of Social Affairs and Health, Department for Work and Gender Equality
Respiratory systems intended for professional use
Regulation on personal protective equipment (EU) 2016/425
These products are subject to EU type-examination. Requirements were reduced on 31 March 2020.
Finnish Medicines Agency (Fimea)
Surgical face masks intended for health care professionals
Medical Device Regulation (EU) 2017/745 or directive 93/42/EEC
The products must be CE marked. Product information must include the name and address of the responsible manufacturer. If the manufacturer is located outside Europe, also the name and address of the authorised representative in Europe must be included.
The Finnish Institute of Occupational Health (FIOH)
Expert support for respirator masks and face masks intended for both professional use and consumer use.
The Finnish Institute of Occupational Health is an expert and researcher of respirator masks, not an authority. FIOH previously conducted testing and certification of PPEs but the testing and certification functions were sold to SGS Fimko in the autumn of 2019.
How should pharmacy personnel protect themselves against infections? And how are the customers protected against infections in a pharmacy?
With regard to protecting the pharmacy personnel and the customers, It is essential to consider the following in the pharmacy premises:
- Is it possible to re-arrange customer routes and waiting areas to maintain maximum distance between the customers and between the customers and the personnel? Are customers given clear instructions on these practices?
- Is it possible to arrange a separate pick-up point (another door or service point, etc.,) for online orders and deliveries of pharmaceuticals to health care units?
- Is it possible to install plexiglass screens in the service points to protect against direct droplet infection?
- Have materials handled by several customers (toys for children, plastic folders, shopping baskets, etc.) been removed from use?
- Is it possible to avoid contact with payment equipment and the Kela card (e.g. the customers scan the Kela card themselves, use of contactless payment, etc.)?
- Are effective measures in place to ensure general hygiene (effective and regular hand washing, protective gloves to be replaced when necessary, use of hand sanitiser, intensive cleaning of premises and goods)?
With regard to PPEs, it should be noted that a light face mask is not sufficient on its own to prevent virus infections. They are intended to protect patients from possible respiratory droplet infection caused by the health care personnel. light face masks do not prevent virus infections (in Finnish)
Products used to protect the user from viruses and hazardous substances in the surrounding environment are referred to as personal protective equipment (PPE). They are used in health care settings during therapeutic procedures and cleaning to prevent patients with COVID-19 from infecting others. Similar PPEs are also used in several industrial sectors, e.g. in in pharmaceutical manufacturing.
More information about protection and cleaning can be found in the guidelines for employees, workers and workplaces collected by FIOH.
General information for citizens on the protection against the coronavirus can be found on the website of the Finnish National Institute for Health and Welfare (THL).
Does antimalarial medication help against the coronavirus and are they safe?
The effectiveness and safety of hydroxychloroquine and chloroquine, which are used to treat malaria and rheumatoid arthritis, in the treatment or prevention of the coronavirus has not been studied in extensive and well-designed controlled studies. Chloroquine and hydroxychloroquine have been found effective against various viruses in cell models, including the SARS-CoV-2 virus that causes COVID-19.
After the start of the COVID-19 epidemic, several countries have started clinical patient studies regarding the treatment and prevention of clinical pictures of varying severity caused by the SARS-CoV-2 coronavirus, using various doses and treatment periods.
WHO is also starting an extensive international study that will study the effectiveness of chloroquine derivatives in the treatment of COVID-19, as well as other promising therapeutic drugs. Even though research evidence is still very scattered and uncertain, the use of these drugs is already included in the clinical guidelines of some countries. On the other hand, there has been alarming information in the media about self-medication attempts with medicinal product containing chloroquine, some of which have been fatal.
Chloroquine derivatives have known adverse effects, and even a very small overdose can lead to severe adverse effects. That is why the uncontrolled use of these combinations must be avoided.
Fimea is cooperating with other national and international authority networks as well as pharmaceutical and health care operators to make chloroquine derivatives and other medicinal products that could potentially be used in the treatment of COVID-19 available, if their controlled use is sufficiently backed by the increasing body of scientific data.
In addition, Fimea encourages research communities to participate, if possible, in the international clinical drug trials on the treatment of COVID-19 that are about to start, and has committed to the rapid assessment of related trial notifications.
What clinical drug or vaccine trials or are ongoing to treat/prevent COVID-19?
(Updated on 8 April 2020)
The first clinical drug trial on the treatment of COVID-19, REMAP-CAP (trial ID 2015-002340-14), is about to start in Finland. It is a multi-national trial with more than 50 research communities around the world.
The Finnish arm of the trial will compare two approved immune response modulators (Anakinra®, interleukin-1 receptor antagonist, and Rebif ®, interferon beta-1a) to standard treatment in the treatment of pneumonia caused by COVID-19 among patients who require intensive care.
Ongoing clinical drug trials on COVID-19 in Europe are public, and they have been listed here: Clinical trials for COVID-19.
Ongoing clinical drug trials on COVID-19 elsewhere in the world can be found in the ClinicalTrials.gov portal.
The lists are continuously updated. Fimea has committed to prioritising the assessment of drug and vaccine trials on COVID-19.
Do light face masks protect against a virus infection?
No. A light face mask is not sufficient on its own to prevent virus infections. They are intended to protect patients from possible respiratory droplet infection caused by the health care personnel. Read more: Light face masks do not prevent virus infections (in Finnish).
Do anti-inflammatory drugs worsen COVID-19?
At the moment, there is no convincing scientific evidence of an association between ibuprofen and worsening of COVID-19 infection, and discontinuation of ibuprofen can't be recommended on this ground. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is currently evaluating safety information on the use of ibuprofen and ketoprofen in severe infections. The assessment was started in the summer of 2019, based on a study conducted by the French National Agency for Medicines and Health Products Safety (ANSM). Read more: Anti-inflammatory drugs and COVID-19 (in Finnish)
Do antihypertensive drugs (e.g. ACE inhibitors or AT-II receptor blockers) worsen COVID-19?
ACE inhibitors and AT-II receptor blockers are commonly used for the treatment of hypertension (high blood pressure) and heart failure. It has been said, that these medicines could expose the user to more severe forms of the coronavirus infection. This topic is discussed because the COVID-19 virus attaches to the target molecule of these medicinal products, angiotensin-converting enzyme 2 (ACE2). There are no scientific proof on the effect of antihypertensive drugs on the susceptibility to or progress of COVID-19 virus infection.
Antihypertensive drugs are safe to use, and there is no scientific evidence that they would increase the adverse effects related to a virus infection.
There are risks related to self-discontinuation of cardiac, antihypertensive and antidiabetic medication without physician's approval. The physician in charge of the case is responsible for the medication of each patient, and possible changes in the medication should be agreed with the physician.
EMA's press release (10 June 2020)
EMA’s press release (27 March 2020)
Are reliable coronavirus home tests available?
According to Fimea, rapid tests to detect coronavirus infection at home have been marketed to consumers, for example online. However, Fimea is not aware of a reliable home test so far.
Read more (in finnish): Luotettavia kotitestejä koronaviruksen testaamiseen ei toistaiseksi ole saatavilla
Should I stock up on medication?
Excessive stockpiling of medicines at home ‘just in case’ is not recommended even in the special situation caused by the coronavirus; for prescription medicines, follow the Kela guidelines for the duration of the coronavirus pandemic. If a large quantity of drugs is stored at home, there is a risk that they will expire if they are not needed.
Read more: Fimea advises against overstocking medicine
Has the coronavirus epidemic affected the availability of drugs?
Based on the information supplied by pharmaceutical companies, there are no severe issues related to the availability of medicines due to the coronavirus epidemic. Finnish health care and pharmaceutical operators are constantly working in close cooperation to prevent shortages so as to avoid problems even if the situation is prolonged.
Marketing authorisation holders are responsible for the availability of the medicinal products. They must ensure that the supply chains are flexible enough to prevent disruptions of supply. Supply chain management can include, for example, keeping extra storage or alternative acquisition of products and materials. Marketing authorisation holders must notify Fimea well in advance of any shortages of supply.
Together with pharmaceutical manufacturers and importers, Fimea is constantly evaluating the impact of the COVID-19 epidemic on the production, supply chains and stocks. Fimea has also provided pharmacies with instructions for customer service situations and advised them to always check the latest information from official sources.
The authorities are actively monitoring the situation in collaboration with other operators in the sector. Information about the situation is also regularly updated between European pharmacovigilance authorities.
How has Finland prepared for shortages?
Fimea is actively monitoring the situation. Finnish health care operators are working in close collaboration, and information about the situation is also regularly updated between European pharmacovigilance authorities.
Together with pharmaceutical manufacturers and importers, Fimea is constantly evaluating the impact of the novel coronavirus on the availability of drugs, supply chains and stocks.
In Finland, the availability of medicinal products is also ensured by maintaining obligatory reserve supplies. This obligation concerns pharmaceutical plants, importers of medicinal products, health care units and the Finnish National Institute for Health and Welfare (THL).
Does the coronavirus epidemic in China or India affect the availability of medicines?
China and India play a role in the global manufacture of raw materials, semi-finished products and active ingredients of medicinal products but medicines are also manufactured elsewhere. Fimea has required pharmaceutical operators to secure their supply chains and to prepare by mapping alternative means of acquisition, when necessary.
Setting up a new production plant or transferring a production process to a new plant requires a lot of effort and time and it might not even be possible in some cases, unless the situation has been prepared for and alternative places of production are available.