A European drug regulator safety panel on Friday recommended adding a rare spinal inflammation called transverse myelitis as a side effect of AstraZeneca’s COVID-19 vaccine.
The vaccine has faced several setbacks, including production delays and probing from regulatory bodies after rare cases of serious side effects such as blood clots with low platelets, prompting several countries to restrict or stop its use.
The European Medicines Agency (EMA) safety committee also reiterated its recommendation to include a similar warning for Johnson & Johnson’s single-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, sensory symptoms, or problems with bladder or bowel function.
The committee, after reviewing the data, concluded that a causal relationship between these two vaccines and transverse myelitis is at least a reasonable possibility. However, he added that the benefit-risk profile of both vaccines has not changed.
AstraZeneca did not immediately respond to a Reuters request for comment.
The regulatory agency did not provide information on how many such cases have been reported following administration of the vaccine, but said that transverse myelitis has been added as an adverse reaction of unknown frequency to the product information for the vaccines.
Reports of a serious neurological disease were also the reason for the interruption of early-stage trials of vaccines from AstraZeneca and J&J, which are based on similar technology.
The regulator also recommended updating AstraZeneca’s vaccine product information, regarding rare blood clots occurring after the first dose, to say that fewer such side effects were seen after the second dose.
Among the 1,809 cases of the condition called thrombosis with thrombocytopenia syndrome reported worldwide, it said 1,643 were reported after the first dose and 166 after the second.
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