A European drug regulator is reviewing blood clots among four people in the United States who received the COVID-19 vaccine from Johnson & Johnson, according to a report.
The European Medicines Agency said three serious cases of coagulation and low platelets occurred in the US during the deployment of the J&J vaccine from its Janssen unit and that one person died from a coagulation disorder reported during a clinical trial. The EMA report is the first to mention a blood clot probe associated with the J&J vaccine.
Johnson & Johnson said it was aware of the rare reports of blood clots and was working with regulators.
“Currently, 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 problem and had not found “any causal link to the vaccination.”
About 5 million people in the United States had received the J&J vaccine as of Thursday morning, according to the U.S. Centers for Disease Control and Prevention.
The issue of blood clots in the brain reported by some Europeans who received the AstraZeneca vaccine is also under investigation.