Add blood clot risk to J&J jab product info, says EMA

20 April 2021

At its meeting on Tuesday, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) decided that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen.

The PRAC also concluded that these events should be listed as very rare side effects of the vaccine.

"The overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects"The committee took into account what it said was all currently available evidence including eight reports from the USA of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome, out of more than seven million Americans that have so far received Janssen’s vaccine.

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