EU drug watchdog warns of ‘very rare’ spinal cord inflammation, possibly related 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 and says there was a “reasonable possibility” that they may have caused a back infection in rare cases.
After three days of meetings and discussions, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said Friday it wants 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 one “side effect of unknown frequency” to the vaccine profile.
EMA describes TM as a rare neurological condition characterized by a “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 – and problems with bowel and bladder function.
The recommendation comes after the PRAC reviewed available information on reported cases worldwide and the scientific literature and concluded that “a causal link between these two vaccines and transverse myelitis is at least a reasonable possibility.” However, it said that “the benefit-risk profile of both vaccines remains unchanged.”
The warning is intended for “raise awareness among healthcare professionals and people receiving the vaccines.” Physicians were asked to be vigilant for signs and symptoms of TM, while recipients were urged to “seek immediate medical attention” if they develop the symptoms.
Last month, EMA approved The Janssen plug as a booster for people aged 18 and older, which must be given at least two months after previous vaccinations.
The PRAC also revised the product information for AstraZeneca’s Vaxzevria to reflect that far fewer cases of thrombosis with thrombocytopenia (TTS) – low platelet counts – have been recorded after the second dose of the sample compared to the first.
The use of AstraZeneca’s vaccine, developed by Oxford University, has already been reduced due to “Ultra rare” side effect, which British government statistics last summer estimated at around 14.9 per. million doses of jab. A study published in December blamed a very specific problem with Vaxzevria’s adenovirus vector.
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