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null Coronavirus vaccination programme continues in Finland – Fimea and THL follow the situation

Coronavirus vaccination programme continues in Finland – Fimea and THL follow the situation

12.3.2021

The first reports of suspected cases of thromboembolic events observed after receiving the AstraZeneca coronavirus vaccine came to Fimea 12.3.2021. The reports are short on information, and additional information has been requested. Currently, there is not enough information to draw conclusions of causality between the vaccine and the thromboembolic events. 

Fimea and Finnish Institute for health and welfare (THL) follow the situation in co-operation. THL has started a register-based investigation of the occurrence of thromboembolic events. The incidence of eg. pulmonary and venous thromboembolisms in vaccinated persons is studied by combining data from different registers. For example, appointment data from hospitals, vaccination register data and population information system are being utilised.  For the time being, there is no indication that after vaccination there would be more thromboembolic events than expected.

In the UK more than 11 million doses of the AstraZeneca vaccine have been administered, yet the local medicines agency has not found proof of higher risk of thromboembolism after vaccination. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has started a review of the thromboembolic cases. EMA and Fimea will report on the progress of the review.

THL will continue to investigate the possible connection between the risk of thromboembolic events and coronavirus vaccinations together with Fimea. THL and Fimea recommend that the coronavirus vaccination programme is continued with all coronavirus vaccines having marketing authorisation, including the AstraZeneca vaccine.

If you suspect a thromboembolic event after being vaccinated, contact your healthcare provider. If you want to report an adverse reaction, please provide the patient record of your contact with healthcare, and the batch number of the vaccine. 

Further information

Liisa Näveri, Head of Unit, Fimea

E-mail in form firstname.lastname@fimea.fi

Hanna Nohynek, Head Physician, THL

Petteri Hovi, Senior Researcher, THL

E-mail in form firstname.lastname@thl.fi

Read more:

Submitting a report on an adverse reaction 

Fimea online news 11.3.2021: Astra Zenecan koronarokotteen turvallisuutta selvitetään Euroopan lääkeviraston johdolla (in Finnish)

Fimea website: Coronavirus (COVID-19)