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null The benefits of the AstraZeneca’s corona vaccine still outweigh the adverse reactions - very rare cases of blood clotting disorders require further review

The benefits of the AstraZeneca’s corona vaccine still outweigh the adverse reactions - very rare cases of blood clotting disorders require further review

18.3.2021

In a press briefing held 18 March 2021 European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) reported the results of the safety review on thromboembolic events on people who have received AstraZeneca’s corona vaccine.

According to PRAC the benefits of the AstraZeneca’s corona vaccine continue to outweigh the adverse reactions. The vaccine is used to combat the spread of the corona pandemic and to prevent the serious form of COVID-19 that lead to hospitalisation and death.

The use of AstraZeneca's vaccine does not involve an increased risk of thromboembolic events (e.g. deep vein thrombosis and pulmonary embolism). Furthermore, no quality deviations related to certain batches of the vaccine have been discovered. 

Link to very rare blood clotting disorders is reviewed

The possible connection between the vaccine and two very rare blood clotting disorders is further reviewed. They involve reduced platelet count and excessive blood clotting.  

By 16 March 2021, nearly 20 million people had been vaccinated with AstraZeneca’s corona vaccine, and there were 18 reported cases of cerebral venous sinus thrombosis (CVST). In addition, seven vaccinated persons have been reported to have disseminated intravascular coagulation (DIC). The adverse reactions mainly occurred in women under 55 years of age within the first two weeks after receiving the vaccine. PRAC will continue to review the matter. EMA and Fimea will report on the progress of the review.

If you have symptoms of cerebral venous sinus thrombosis or DIC after vaccination, such as prolonged, worsening headache or blurred vision, bruising without injury or numerous minor subcutaneous haemorrhages, seek medical help and inform the health care professional about the vaccination.

Finnish institute for health and welfare (THL) will inform about the possible impact of PRAC review on the Finnish vaccination guidelines.

Read more:

EMA press release 18 March 2021: COVID-19 Vaccine AstraZeneca: Benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets


 

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  • Maija Kaukonen, Head of Division, Senior Medical Officer
  • Liisa Näveri, Head of the Pharmacovigilance Unit
  • E-mail address format: firstname.lastname@fimea.fi