EU drug regulator finds possible link between J&J Covid vaccine and rare deep-vein blood clotting cases
The European Medicines Agency (EMA) has announced a possible link between the Johnson & Johnson (J&J) Covid vaccine and rare cases of blood clotting in deep veins, recommending it be listed as a potential side effect to the jab.
After a meeting of its Pharmacovigilance Risk Assessment Committee (PRAC), the drug regulator said on Friday that venous thromboembolism, a potentially life-threatening blood clotting condition, should be added to the J&J vaccine’s product label as a rare possible side effect. The illness causes a clot to form in the vein of a leg, arm, or the groin, which can then travel to the lungs and cut off the blood supply.
Alongside the blood clotting concern, the EMA warned that immune thrombocytopenia, a disorder that causes the body to mistakenly attack its own blood platelets, should be added to the drug’s potential side effects. It also recommended adding it as a possible adverse reaction to AstraZeneca’s Covid vaccine.
This is not the first time that J&J has been advised to add a blood clotting risk as a potential side effect, with the PRAC previously highlighting the potential link between the company’s vaccine and cerebral venous sinus thrombosis, as well as splanchnic vein thrombosis – clots that target the brain and the abdomen respectively.
The EMA did not announce any change to its previous risk assessment of the J&J vaccine, which stated that the positives outweigh the potential risks, giving European nations the green light to use the jab.
Responding to the EMA’s updates on Friday, J&J said that it would update its product information accordingly, while noting that the chances of such conditions are very low.
Alongside the blood clotting concern, the EMA warned that immune thrombocytopenia, a disorder that causes the body to mistakenly attack its own blood platelets, should be added to the drug’s potential side effects. It also recommended adding it as a possible adverse reaction to AstraZeneca’s Covid vaccine.
This is not the first time that J&J has been advised to add a blood clotting risk as a potential side effect, with the PRAC previously highlighting the potential link between the company’s vaccine and cerebral venous sinus thrombosis, as well as splanchnic vein thrombosis – clots that target the brain and the abdomen respectively.
The EMA did not announce any change to its previous risk assessment of the J&J vaccine, which stated that the positives outweigh the potential risks, giving European nations the green light to use the jab.
Responding to the EMA’s updates on Friday, J&J said that it would update its product information accordingly, while noting that the chances of such conditions are very low.
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