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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 may have caused a spinal inflammation.
Following three days of meetings and discussions, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said Friday it wants to include a warning for cases of transverse myelitis (TM) reported following vaccination’ with Vaxzevria and Janssen jabs. It is also adding the condition as an adverse reaction of unknown frequency to the vaccine profile.
The EMA describes TM as a neurological condition characterized by an inflammation of one or both sides of the spinal cord, which can cause weakness in arms or legs, tingling, numbness, pain, or loss of pain sensation, and problems with bowel and bladder function.
The recommendation comes after PRAC reviewed available information on reported cases worldwide and scientific literature, concluding that a causal relationship between these two vaccines and transverse myelitis is at least a reasonable possibility.
The warning is intended to raise awareness among healthcare professionals and people receiving the vaccines. Doctors were told to be on alert for signs and symptoms of TM, while recipients were urged to seek immediate medical attention if they develop the symptoms. It remains unclear as to what can be done to remedy the damage once it has been done.
Last month, EMA approved the Janssen jab as a booster for people 18 and older, to be given at least two months after previous vaccinations.
The use of AstraZeneca’s vaccine, developed with Oxford University, has already been scaled back due to the side effect. A study published in December blamed a very specific issue with Vaxzevria’s adenovirus vector. You can share this story on social media.
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