15. April 2021 – As announced last week, EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots that occurred in the United States following the use of Janssen’s COVID-19 vaccine. The type of blood clot reported, cerebral venous sinus thrombosis (CVST), occurred in most cases in combination with low levels of blood platelets (thrombocytopenia). EMA is investigating all the cases reported and will decide whether regulatory action is necessary. The Agency is working closely with the US FDA and other international regulators. EMA currently expects to issue a recommendation next week.

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