EMA lists rare spinal condition as side effect of AstraZeneca’s COVID-19 shot

(Reuters) – 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 (AZN.L) COVID-19 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 (JNJ.N) 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, 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.

AstraZeneca did not immediately respond to a Reuters request for comment.

The regulatory agency did not provide any information on how many such cases have been reported after the vaccination was given but said transverse myelitis has been added as an adverse reaction of unknown frequency to the vaccines’ product information.

A healthcare worker holds a vial of the AstraZeneca/Oxford University COVID-19 vaccine at the Pentland Medical Practice in Currie, Scotland, Britain, January 7, 2021. REUTERS/Russell Cheyne/Pool

Reports of the serious neurological illness was also at the heart of trial halts in the early stages of development for both AstraZeneca and J&J’s shots, which are based on similar technology.

The regulator also recommended updating the product information for AstraZeneca’s vaccine regarding rare blood clotting with a low platelet count following the first shot, to say fewer such side effects were observed after the second dose.

Among 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.

Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli and Krishna Chandra Eluri

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https://www.reuters.com/business/healthcare-pharmaceuticals/ema-lists-rare-spinal-condition-side-effect-astrazenecas-covid-19-shot-2022-01-14