EU regulator finds J&J vaccine has ‘possible link’ to blood clots

European Medicines Agency backs use of single-dose COVID-19 shot, saying its overall benefits outweigh risks.

The European Union’s medicines regulator on Tuesday said it had found a “possible link” between Johnson & Johnson’s (J&J) COVID-19 vaccine and the development of rare blood clots in a small number of recipients, but concluded the shot’s overall benefits outweigh any risks associated with its use. The European Medicines Agency (EMA) said its safety committee decided that a warning about unusual blood clots with low blood platelets must be added to the vaccine’s labels, just as the regulator has also required of rival vaccine maker AstraZeneca, whose own jab was found by the agency last month to also have a “possible link” with rare blood clots. The EMA found that all instances of clotting had occurred in adults under 60 years, mostly women, within three weeks of vaccination with J&J’s single-shot vaccine. The agency said these rare blood disorders should be considered as “very rare side effects of the vaccine”.