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www.fdanews.com/articles/205344-eu-includes-spinal-inflammation-as-a-jj-covid-19-shot-side-effect

EU Includes Spinal Inflammation as a J&J COVID-19 Shot Side Effect

November 15, 2021

The European Medicines Agency (EMA) has recommended including transverse myelitis, a rare form of spinal inflammation, to the list of Johnson & Johnson (J&J) COVID-19 vaccine side effects.

Transverse myelitis previously cropped up as a safety issue during vaccines trials from J&J and AstraZeneca, whose shot also employs adenovirus-based technology. In fact, both drugmakers temporarily paused U.S. late-stage trials in fall 2020 over concerns patients may have contracted the rare neurological condition.

When asked about the EMA’s new recommendation, J&J confirmed to FDAnews that “rare cases of transverse myelitis” have been reported following vaccination and pledged to cooperate with the EMA’s Pharmacovigilance Risk Assessment Committee and other relevant health authorities.

“While the chances of experiencing these conditions are very low, the product information of COVID-19 Vaccine Janssen will be updated to include important information about the signs and symptoms of transverse myelitis,” said the company spokesperson, adding that the drugmaker “strongly” supports raising awareness of rare events so they can be “quickly identified and effectively treated.”

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