The Finnish Medicines Agency Fimea has received the first report of an adverse reaction to the coronavirus vaccine since Finland began rolling out its vaccination programme on 27 December.
The agency’s Chief Physician Maija Kaukonen confirmed that the report had been received, but said she cannot disclose any further details due to patient confidentiality.
Kaukonen added however that reports of allergic or adverse reactions are likely to increase as the vaccination programme progresses, and the agency will provide additional information as it becomes available.
"When there are at least five such reports, we will put information on our website about the type of reactions that have occurred," Kaukonen said.
Since the programme began, vaccinations have been given to healthcare staff in Finland’s five largest hospital districts of Helsinki, Turku, Tampere, Kuopio and Oulu.
THL: Reporting of reactions is encouraged
Hanna Nohynek, a vaccinologist and senior physician with the Finnish Institute for Health and Welfare (THL), told Yle that reports of an adverse reaction to a new vaccine are not surprising, especially in the early stages of a roll out.
"The reporting threshold is much lower for new vaccinations and it is encouraged," Nohynek said, adding that the report can be made by the vaccinated person, their close relative or a healthcare professional.
Nohynek noted that authorities assess the benefits and drawbacks of each vaccine before it is authorised and distributed, and that monitoring continues after distribution has begun.
Both THL and Fimea constantly monitor adverse reactions to vaccines and report them on their websites.
Reaction rate currently higher for coronavirus vaccine
The number of allergic reactions worldwide to the coronavirus vaccine is currently occurring at a rate of about one in 100,000 people. Usually, the rate of adverse reactions to vaccinations is about one per one million.
"Time will tell whether this rate will continue or whether it will settle closer to one per one million. At the moment, these allergic reactions have become somewhat more pronounced than in other vaccines," Nohynek said, adding that she still urges everyone in Finland to take the vaccine as it provides protection against the virus.
"The benefits of the vaccine far outweigh the side effects. Vaccinations should not be abandoned because of concerns over adverse reactions," Nohynek said.
By Saturday 2 January, almost 5,000 people in Finland have been vaccinated from the first batch of about 10,000 vaccines which Finnish health authorities received just after Christmas.
Last Wednesday, about 40,000 more doses arrived in Finland, with vaccinations set to continue next week.
Mild side effects are common, severe symptoms are rare
Once a vaccine has been authorised, a summary of its product characteristics is published on the European Medicines Agency (EMA) website. In the case of the Pfizer BioNTech Comirnaty coronavirus vaccine, this included information on potential side effects.
Typical side effects may include swelling or pain at the point of injection, tiredness, fever or headache, as well as muscular or joint pain. The incidence of fever has so far been found to be higher after the second dose of the Pfizer-BioNTech vaccine.
THL’s vaccinologist Nohynek said that all vaccines can have side effects, but they are usually mild and short-lived.
"Most side effects of vaccines are mild and temporary, such as redness or swelling at the point of injection. Sometimes a vaccination can also be followed by a short-term fever as well as limb pain and headaches that can be treated with antipyretics and NSAIDs [nonsteroidal anti-inflammatory drug]," Nohynek said.
THL has compiled further information about the coronavirus vaccine on its website.
THL: Pregnant women can be vaccinated
According to THL, the general guideline regarding vaccines is that a vaccination should be postponed if the patient has a severe febrile illness or an acute infection.
Similarly, the vaccine should be used with caution in individuals receiving anticoagulant therapy or with thrombocytopenia or other coagulation disorders such as haemophilia. These people may experience bleeding or bruising after an intramuscular injection.
There is currently very limited information on the use of the vaccine on pregnant women in Finland. However, preliminary studies did not indicate any direct or indirect harmful effects with respect to pregnancy, embryonic or fetal development, or postnatal development.
According to THL, the coronavirus vaccine currently being distributed in Finland does not protect everyone, just like any other vaccination cannot offer full coverage. However, the vaccine's effectiveness against lab-confirmed coronavirus is excellent, at more than 90 percent effective, THL said.
The agency also warned that caution should still be exercised, as studies show that patients who receive the vaccine are not fully protected until seven days after receiving the second dose of the vaccine.