The European Medicines Agency (EMA) has recommended mentioning a rare spinal inflammation called transverse myelitis (TM) as a possible, but very rare side effect of the AstraZeneca vaccine.
The EMA, the European Union’s drug watchdog, is weighing a warning label mandate on AstraZeneca jabs, claiming that research suggests a “reasonable possibility” that the vaccine may have resulted in the spinal condition on rare occasions. It is weighing a similar warning for the Johnson & Johnson vaccine.
According to the EMA, TM is a rare neurological condition, which can cause weakness in arms or legs, numbness, tingling, pain or loss of pain sensation and problems with bowel and bladder function.
It concluded that “a causal relationship between these two vaccines and transverse myelitis is at least a reasonable possibility.” However, it said the “benefit-risk profile of both vaccines remains unchanged.”
The EMA decision comes after AstraZeneca, the vaccine developed by research from the University of Oxford, has faced two years of setbacks in the European Union and the United States. Production delays and lower efficacies than mRNA counterparts, left regulators in the United States, United Kingdom, and Europe hesitant to scale up its delivery.
To make up for waning demand in the industrialized West, AstraZeneca looked overseas, at less wealthy countries otherwise relegated to the bottom of the global vaccine queue. AstraZeneca announced that the vaccine they jointly produced with researchers at the University of Oxford had reached its 2 billionth jab on 15 November 2021.
Image: Mufid Majnun