Janssen's COVID-19 vaccine under EU review over blood clots
Europe's medicines watchdog said on Friday it was reviewing reports of rare blood clots in four people who received the COVID-19 vaccine developed by Janssen, the pharmaceutical arm of Johnson & Johnson, Trend reports citing Xinhua.
In a statement, the European Medicines Agency (EMA) said its safety committee had started a review to assess reports of thromboembolic events, which occurred through the formation of blood clots and resulted in the obstruction of a vessel in people who received the Janssen jab.
Of the four serious cases of "unusual blood clots with low blood platelets," three occurred in the United States, which had started the vaccine's rollout, while the fourth occurred during a clinical trial. One person died as a result.
The EMA said that it was not yet clear if there was a link between the vaccine and the reported conditions, and that its safety committee would decide if regulatory action, such as label changes, was needed.
The single-dose Janssen vaccine is currently only administered in the U.S. under an emergency use authorization. The jab was authorized in the European Union (EU) in March, but the rollout has not started yet in any EU member state.