(Reuters) (Reuters) – A safety panel of the European drug regulator on Friday recommended adding a rare spinal inflammation known as transverse myelitis as an adverse result of the COVID-19 vaccine by AstraZeneca.
The vaccine has had to overcome a variety of difficulties, including delays in production and inquiries by regulators in response to rare cases of serious adverse reactions, like blood clots caused by low platelets, which resulted in several countries restricting or stopping its use.
The European Medicines Agency’s safety panel also recommended the same warning to be included for Johnson & Johnson’s one-shot vaccine.
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 and sensory symptoms, as well as problems with bladder or bowel function.
The committee, after reviewing data it concluded that a causal connection between these two vaccines and transverse myelitis is an improbable possibility.
However the benefit-risk profile of both vaccines was unchanged.
AstraZeneca did not immediately respond to a Reuters request for comment.
Although the regulatory agency didn’t give any details on the number of cases recorded after vaccination, they did say that transverse myelitis was added to the product’s information as an adverse reaction with an unknown frequency.
Reports of a severe neurological disease were also an element of the trial halts in the early stages of development for J&J’s shots as well as AstraZeneca’s shots. Both are based upon similar technology.
The regulator also suggested changing the product’s information for AstraZeneca’s vaccination regarding rare blood clotting and a low platelet count following the first shot. This would say that fewer side effects were reported after the second dose.
Of the 1,809 cases of thrombosis with thrombocytopenia syndrome reported worldwide 1 643 cases were reported after the first dose and 166 after the second.
