EU medicines watchdog warns of ‘very rare’ spinal cord inflammation possibly linked to AstraZeneca and J&J vaccines
The European Medicines Agency wants to put warning labels on Covid-19 jabs made by AstraZeneca and Johnson & Johnson, saying there was a ‘reasonable possibility’ they could have caused spinal inflammation on rare occasions.
After three days of meetings and discussions, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said on Friday it wanted to include a warning for “very rare cases of transverse myelitis (TM) reported after vaccination” with Vaxzevria and Janssen jabs. It also adds the condition as “adverse effect of unknown frequency” to the vaccination profile.
The EMA describes TM as a rare neurological condition characterized by “inflammation of one or both sides of the spinal cord”, which can cause weakness in the arms or legs, tingling, numbness, pain – or loss of pain sensation – and problems with bowel and bladder function.
The recommendation comes after the PRAC reviewed available information on reported cases worldwide and the scientific literature, concluding that “A causal relationship between these two vaccines and transverse myelitis is at least a reasonable possibility.” However, he said the “benefit-risk profile of both vaccines remains unchanged.”
The warning is intended to “educate health professionals and vaccinated people”. Doctors were told to be on alert for signs and symptoms of TM, while recipients were told to “seek medical attention immediately” if they developed the symptoms.
Last month, the EMA approved the Janssen jab as a booster for people aged 18 and over, to be given at least two months after previous vaccinations.
The PRAC has also revised the product information for AstraZeneca’s Vaxzevria, to reflect that significantly fewer cases of thrombosis with thrombocytopenia (TTS) – blood clotting with low platelet counts – have been recorded after the second dose. of the vaccine, compared to the first.
Use of AstraZeneca’s vaccine, developed with Oxford University, has already been curtailed due to the “super rare” side effect, which UK government statistics last summer put at around 14.9 per million prick doses. A study published in December implicated a very specific problem with the Vaxzevria adenovirus vector.