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.” It recommends changing the product information for the COVID-19 shots—AstraZeneca’s Vaxzevria and Johnson & Johnson’s Janssen–to include a warning of “very rare cases of transverse myelitis (TM) reported following vaccination.” TM …
Rare Spinal Cord Condition Flagged as Potential Side Effect of COVID-19 Vaccines: EU Drug Regulator
January 15, 2022
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adverse effectsCCP VirusCOVID-19 vaccineEuropePUBLIC HEALTH INFORMATIONtransverse myelitisVaccines & SafetyWorld
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