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The European Medicines Agency also recommended that immune thrombocytopenia (ITP), a bleeding disorder caused by the body mistakenly attacking platelets, be added as an adverse reaction with unknown frequency to the product information of the drug. J&J vaccine and AstraZeneca vaccine.
J&J did not immediately respond to a request for comment.
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Both products are based on harmless vector viruses that instruct human cells to make a protein that prepares the immune system against future coronavirus infections.
The EMA said the new life-threatening coagulation disease known as venous thromboembolism (VTE) to be included on the J&J product label is distinct from TTS.
VTE usually begins with a clot forming in a vein in a leg, arm, or groin, which then travels to the lungs and blocks the blood supply there.
Regardless of the use of the vaccine, VTE is most often caused by injury or lack of movement in bedridden patients. Birth control pills and a number of chronic diseases are also considered risk factors.
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