COVID-19 Vaccine AstraZeneca® – conclusion of EMA review of usage safety in reference to the thromboembolic events following vaccination

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its preliminary review of a signal of thromboembolic events in people vaccinated with COVID-19 Vaccine AstraZeneca® as of yesterday 18 March 2021. The EMA concluded that the benefits of the vaccine in combating the, still widespread, threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risks. Although the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, including rare cases of Cerebral Venous Sinus Thrombosis (CVST). These are rare reports, with 18 cases of CVST and 7 cases of Disseminated Intravascular Coagulation (DIC) assessed as part of the EMA review. Approximately 20 million people in the UK and EEA had received the vaccine as of March 16 2021.Given the vaccine’s proven efficacy in preventing hospitalisation and death from COVID-19, the PRAC concluded that the benefits of COVID-19 Vaccine AstraZeneca® outweighs the extremely small likelihood of developing DIC or CVST. However, given the findings, healthcare professionals and vaccine recipients should be aware of the remote possibility of developing such syndromes. Recipients should be advised to seek immediate medical attention should they develop symptoms as outlined below and should inform healthcare professionals of their recent vaccination.  While further analysis is ongoing, the product information for the vaccine will be updated to include more information on these risks.
For the current time there is no evidence of a problem related to specific batches of the vaccine.

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