EMA provides updates on COVID-19 vaccines safety issues

Vaxzevria and COVID-19 Vaccine Janssen: update on very rare cases of transverse myelitis

The PRAC has recommended a change to the product information for Vaxzevria and COVID-19 Vaccine Janssen to include a warning to raise awareness among healthcare professionals and people receiving the vaccines of very rare cases of transverse myelitis (TM) reported following vaccination. TM has also been added as an adverse reaction of unknown frequency.

TM is a rare neurological condition characterised by an inflammation of one or both sides of the spinal cord. It can cause weakness in the arms or legs, sensory symptoms (such as tingling, numbness, pain or loss of pain sensation) or problems with bladder or bowel function.

The Committee has reviewed available information on globally reported cases, including those in the European database for suspected side effects (EudraVigilance) and data from the scientific literature, with both vaccines². The PRAC has concluded that a causal relationship between these two vaccines and transverse myelitis is at least a reasonable possibility. The benefit-risk profile of both vaccines remains unchanged.

Healthcare professionals should be alert to signs and symptoms of TM, allowing early diagnosis, supportive care and treatment. People receiving either of these vaccines are advised to seek immediate medical attention if they develop symptoms of the condition.

EMA will continue to closely monitor this issue and will communicate further if new information becomes available.

Vaxzevria: fewer cases of thrombosis with thrombocytopenia reported after second dose

The PRAC has recommended updating the product information for Vaxzevria to add more information about the very rare cases of thrombosis with thrombocytopenia (TTS) that occurred following vaccination.

A review of cumulative data has highlighted that the majority of suspected TTS events were reported worldwide after the administration of the first dose. Fewer events have been observed after the second dose. In fact, out of 1,809 thromboembolic events with thrombocytopenia reported worldwide, 1,643 were reported after the first dose and 166 after the second dose.

As per the current product information, the administration of a second dose of Vaxzevria is contraindicated in people who have experienced TTS following vaccination with this vaccine.

² In total, 38 globally reported cases were considered, 25 cases with Vaxzevria and 13 with COVID-19 Vaccine Janssen. Respectively, global exposure to the vaccines was estimated at 1,391 billion doses for Vaxzevria and at 33,584,049 for COVID-19 Vaccine Janssen. These numbers refer to suspected and not adjudicated cases of TM.