EMA Recommends Adding Transverse Myelitis Risk to AstraZeneca and Janssen COVID-19 Vaccine Product Information

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Recently, the European Medicines Agency (EMA) published the minutes of the January 10-13, 2022 meeting of its Pharmacovigilance Risk Assessment Committee (PRAC) on its official website. According to the minutes, the PRAC recommended adding rare cases of transverse myelitis (TM) to the product information of two COVID-19 vaccines (AstraZeneca's Vaxzevria and Johnson & Johnson’s COVID-19 Vaccine Janssen) to increase awareness among healthcare professionals and the public about the rare TM cases that may occur after vaccination with these two vaccines. TM has also been added as an adverse reaction with an unknown frequency.

TM is a rare neurological disorder characterized by inflammation of one or both sides of the spinal cord, which may lead to weakness in the arms or legs, sensory symptoms (such as tingling, numbness, pain, or loss of pain sensation), or bladder or bowel dysfunction.

PRAC Reviewed the Existing Information of the Above Two COVID-19 Vaccines from Global Reported Cases, Including Cases from the European Adverse Drug Reaction Database (EudraVigilance) and Data from Scientific Literature. PRAC Concluded That There Is at Least a Reasonable Possibility of a Causal Relationship Between These Two COVID-19 Vaccines and TM. The Benefit-Risk Profile of the Two Vaccines Remains Unchanged.

PRAC Points Out That Healthcare Professionals Should Be Alert to the Symptoms and Signs of TM for Early Diagnosis, Supportive Care, and Treatment. PRAC Recommends That Individuals Who Have Received These Two Vaccines Seek Immediate Medical Attention If Symptoms Occur. EMA Will Continue to Closely Monitor This Issue and Provide Further Communication When New Information Becomes Available.

In addition, the PRAC also noted that a small number of thrombosis with thrombocytopenia syndrome (TTS) cases have been reported after receiving the second dose of AstraZeneca's COVID-19 vaccine Vaxzevria. The PRAC recommends updating the product information for Vaxzevria to include more details about the extremely rare TTS cases following vaccination.

Review of cumulative data highlights that the majority of suspected TTS events reported globally occurred after the first dose. Fewer TTS events were observed after the second dose. In fact, out of 1,809 reported thromboembolic events with thrombocytopenia globally, 1,643 occurred after the first dose and 166 after the second dose.

Based on the current product information, individuals who developed TTS after receiving the first dose of Vaxzevria should not be administered a second dose of Vaxzevria.

Reference Source: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022 Share