THL temporarily suspends the use of the AstraZeneca COVID-19 vaccine
The Finnish Medicines Agency Fimea has reported two cases of cerebral venous sinus thrombosis (clots in the vessels draining blood from the brain) within 4–10 days of receiving the AstraZeneca COVID-19 vaccine. Both patients had medical risk factors for blood clots, and the analysis of the cases is still incomplete. As a precautionary measure, the Finnish Institute for Health and Welfare (THL) has decided to suspend the use of the AstraZeneca vaccine in Finland until more information on the cases is available and possible causality can be determined. The suspension is effective immediately.
The situation will be assessed during the coming week, and vaccinations with the AstraZeneca vaccine can continue at the earliest on March 29. THL will report on its findings without delay. Vaccinations with other vaccines will continue normally.
The National Advisory Committee on Vaccines (KRAR), appointed by THL, is in favour of limiting the use of the AstraZeneca vaccine as the analysis of the cases is incomplete.
If you have received the AstraZeneca vaccine
The reported coagulation disorders are extremely rare, and no causal link with the vaccine has yet been confirmed.
If you have made a vaccination appointment, wait for the health care authorities to contact you regarding its possible cancellation. You may also cancel your appointment yourself.
If you have already received the AstraZeneca COVID-19 vaccine, be alert for serious reactions that may occur three days after vaccination or later. Seek immediate medical care if you get a severe, worsening headache or multiple, increasing bruises on your skin or mucous membranes.
EMA: benefits of the AstraZeneca vaccine outweigh the risks
In its report released on March 18, the European Medicines Agency (EMA) assesses that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risks of side effects. The vaccine prevents hospitalisation and death from COVID-19. The vaccine is not associated with an increase in the overall risk of blood clots. In addition, there is no evidence of problems related to specific batches of the vaccine.
EMA is further analysing whether the vaccine is associated with very rare blood coagulation disorders involving low levels of blood platelets and an increased risk of blood clots. The two cases recently reported in Finland may be connected to such coagulation disorders. The matter is currently being investigated.
Around 20 million people have received the AstraZeneca vaccine as of March 16, and EMA has reviewed a total of 18 cases of cerebral venous sinus thrombosis and seven cases of blood clots in multiple blood vessels (disseminated intravascular coagulation, DIC). Most of these occurred in people under 55 years of age within two weeks after vaccination. Possible causality with the vaccine is still under investigation.
Additional information
Taneli Puumalainen
Chief Physician
Finnish Institute for Health and Welfare
[email protected]
Hanna Nohynek
Chief Physician
Finnish Institute for Health and Welfare
[email protected]
