A safety panel at the European health regulator on Friday recommended adding a rare spinal inflammation, called transverse myelitis, as a possible side effect of AstraZeneca’s Covid-19 vaccine.
The vaccine has faced a number of setbacks, including production delays and investigations by regulators after rare cases of serious side effects such as blood clots with low platelet levels, which have led to restrictions on the use of the immunizer in several countries.
The European Medicines Agency (EMA) safety committee also reiterated the recommendation that a similar warning be included for Johnson & Johnson’s one-dose vaccine.
Transverse myelitis is characterized by inflammation of one or both sides of the spinal cord and can cause weakness in the arms or legs, with sensory symptoms or problems with urinary and digestive functions.
The committee, after reviewing the data, concluded that a causal relationship between the two vaccines and transverse myelitis is at least a reasonable possibility. However, he added that the risk-benefit ratio of both vaccines remains unchanged.
AstraZeneca did not immediately respond to a Reuters request for comment.
The regulatory agency did not provide information on how many cases were recorded after vaccination, but transverse myelitis was added as an adverse reaction of unknown frequency to the immunizer information.
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