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Rare Spinal Cord Condition Flagged as Potential Adverse Effect of COVID-19 Vaccines: EU Drug Regulator

by Mimi Nguyen Ly


The European Union’s drug regulator has indicated that a change to the product information for COVID-19 vaccines from AstraZeneca and Johnson & Johnson has been recommended to include a warning of a rare spinal cord condition called transverse myelitis.

TM is a rare condition that involves inflammation of one or both sides of the spinal cord. Symptoms can include weakness in the limbs, and tingling, numbness, pain or loss of pain sensation, or issues with bladder and bowel function.

The Pharmacovigilance and Risk Assessment Committee (PRAC), the European Medicines Agency’s (EMA) committee that assesses the safety of human medicines, recommended the change on Jan. 14 after concluding that a causal link between the two vaccines and TM is “at least a reasonable possibility.”…


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