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(Reuters) – The European Union’s medicines regulator on Friday identified a possible link between rare cases of blood clotting in the deep veins with Johnson & Johnson’s COVID-19 vaccine and recommended that the disease be listed as a side effect of the vaccine.
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 said that although the chances of meeting these conditions are very low, the product information will be updated accordingly as it continues to work closely with the authorities, including the EMA.
“We strongly support awareness of the signs and symptoms of rare events to ensure that they can be quickly identified and treated effectively,” the company said.
The J&J and AstraZeneca vaccines have previously been associated with a very rare combination of blood clotting and low platelet counts known as thrombosis with thrombocytopenia syndrome (TTS).
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.
(Report by Pushkala Aripaka in Bengaluru and Ludwig Burger in Frankfurt, edited by Maju Samuel and Frances Kerry)
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