EU drug regulator finds possible link between Johnson & Johnson Covid vaccine, rare deep-vein blood clotting cases

EU drug regulator finds possible link between Johnson & Johnson Covid vaccine, 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.

ALSO READ: Johnson & Johnson’s Covid-19 jabs to remain shelved as US watchdogs await ‘more information’ on blood-clotting risk


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.

Also Read: Johnson & Johnson agrees to pay $230 million to New York to settle opioid claim

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.

About The Author

Osigweh Lilian Oluchi is a graduate of the University of Lagos where she obtained a B.A (Hons) in English, Masters in Public and International affairs (MPIA). Currently works with 1stnews as a Database Manager / Writer. [email protected]

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