A European drug regulator is reviewing blood clots among four people in the United States who received Johnson & Johnson’s COVID-19 vaccine, according to a report.
The European Medicines Agency said three serious cases of clotting and low platelets occurred in the US during the rollout of J&J’s vaccine from its Janssen unit and that one person died from a clotting disorder reported during a clinical trial. The EMA’s report is the first to mention a probe of blood clots associated with the J&J vaccine.
Johnson & Johnson said it was aware of the rare reports of blood clots and was working with regulators.
“At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine,” the company said in a statement to Reuters.
The Food and Drug Administration said it was aware of the blood clot issue and also had not found “a causal relationship with vaccination.”
Nearly 5 million people in the United States had received J&J’s vaccine as of Thursday morning, according to the US Centers for Disease Control and Prevention.
The issue of blood clots in the brain reported by some in Europe who got the AstraZeneca vaccine is also under probe.