A safety panel of the European drug regulator on Friday recommended adding a rare spinal inflammation called transverse myelitis as a side effect of AstraZeneca’s Covid-19 vaccine as reported by SCMP.
The vaccine
The vaccine has faced several setbacks, including production delays and probes by regulators following rare cases of severe side effects such as blood clots with low platelets, which led to several countries restricting or stopping its use.
The European Medicines Agency’s safety committee also reiterated its recommendation of a similar warning to be included for Johnson & Johnson’s one-shot vaccine.
Benefit-risk profile
Transverse myelitis is characterised by an inflammation of one or both sides of the spinal cord and can cause weakness in the arms or legs, sensory symptoms or problems with bladder or bowel function.
The committee, after reviewing data, concluded that a causal relationship between these two vaccines and transverse myelitis is at least a reasonable possibility. However, it added the benefit-risk profile of both vaccines remains unchanged.
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Source: SCMP