Europe's health regulator says unusual blood clots should be listed as very rare side effects of the Johnson & Johnson COVID-19 vaccine.
The European Medicines Agency (EMA) says the overall benefits of the vaccine outweigh the risks.
In a statement, the EMA says it took into consideration all the data currently available - with eight reports of serious cases of unusual blood clots in the US, one of whom died.
All cases were in people under 60 years of age within three weeks after vaccination, the majority of which were women.
EMA’s safety committee (#PRAC) recommends adding ‘very rare cases of unusual blood clots with low blood platelets’ to the list of side effects for Janssen #vaccine.
Overall benefit-risk remains positive.
— EU Medicines Agency (@EMA_News) April 20, 2021
But it adds that specific risk factors have not been confirmed.
The EMA's safety committee says a warning about unusual blood clots with low blood platelets "should be added to the product information".
It also says these events should be listed as very rare side effects of the vaccine.
As of April 13th, over seven million people had received the one-shot jab in US.
Earlier this month, the company delayed the rollout of its vaccine in Europe after US authorities recommended pausing the rollout there.