Europe – COVID-19 vaccine safety update : Janssen-Cilag International NV

The latest safety data for this vaccine, collected from vaccination campaigns outside the EU/EEA, is presented in this safety update. There are no recommended changes to the product information regarding how to use this vaccine; COVID-19 Vaccine Janssen is effective in preventing COVID-19...

PRAC started an assessment of embolic and thrombotic events (blood clots obstructing blood vessels), following a small number of reported cases of suspected serious, unusual types of thrombosis together with thrombocytopenia (low blood platelets).
Based on the clinical trial data at the time of marketing authorisation, venous thromboembolism was already included in the risk management plan for COVID-19 Vaccine Janssen as a potential, but not confirmed, risk to be monitored and studied.
PRAC requested a review from the marketing authorisation holder. PRAC is also collecting further information to assess whether COVID-19 Vaccine Janssen may cause embolic and thrombotic events and to decide whether the product information should be updated. A causal relationship between these reported events and COVID-19 Vaccine Janssen has so far not been established…
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