Europe’s drug regulator said it is reviewing rare blood clots in four people in the United States who received Johnson & Johnson’s COVID-19 vaccine.
Johnson & Johnson (J&J) stated it was aware of the rare reports of blood clots in individuals given its COVID-19 vaccine, and was working with regulators to assess the data and provide relevant information.
One person reportedly died from a clotting disorder reported in J&J’s clinical trial before the FDA’s approval.
The FDA said it was aware of the EMA’s statement and provided the agency with the data that formed the basis of its report.
The European Medicines Agency’s safety committee has also been looking at how AstraZeneca’s COVID-19 vaccine is associated with very rare cases of unusual blood clots and said it was now reviewing reports of capillary leak syndrome in people given AstraZeneca’s vaccine.