The European Medicines Agency (EMA), the European Union’s drug regulator, on Friday found a possible link between Johnson & Johnson’s COVID-19 vaccine and rare cases of blood clotting in deep veins.
During a Pharmacovigilance Risk Assessment Committee meeting, the agency said it found a possible link between venous thromboembolism (VTE) and the J&J vaccine.
“VTE is a condition in which a blood clot forms in a deep vein, usually in a leg, arm or groin, and may travel to the lungs causing a blockage of the blood supply, with possible life-threatening consequences,” the agency wrote in its meeting highlights.
It is recommending that the condition be listed as a rare side effect.
The agency also recommends that immune thrombocytopenia (ITP) be listed as a side effect of the J&J vaccine and AstraZeneca’s vaccine.
ITP is a bleeding disorder in which “the immune system mistakenly targets blood cells called platelets that are needed for normal blood clotting,” the agency wrote.
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