Johnson & Johnson in discussion with FDA regarding COVID-19 vaccine side effects

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Johnson & Johnson in discussion with FDA regarding COVID-19 vaccine side effects
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Johnson & Johnson (JNJ.N) said on Monday it was in discussions with the U.S. Food and Drug Administration about rare cases of a neurological disorder, Guillain-Barré syndrome, that have been reported following vaccination with the Janssen COVID-19 vaccine.

A vial and sryinge are seen in front of a displayed Johnson & Johnson logo in this illustration taken January 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photosaid on Monday it was in discussions with the U.S. Food and Drug Administration about rare cases of a neurological disorder, Guillain-Barré syndrome, that have been reported following vaccination with the Janssen COVID-19 vaccine.

The chance of having Guillain-Barré syndrome occur is very low and the rate of reported cases exceeds the background rate by a small degree, J&J said. The statement follows a Washington Post report on Monday, which said the FDA was expected to announce a new warning on J&J's coronavirus vaccine related to a rare autoimmune disorder.

Guillain-Barré syndrome is a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system, or the network of nerves located outside of the brain and spinal cord.Sign up for our newsletter Subscribe for our daily curated newsletter to receive the latest exclusive Reuters coverage delivered to your inbox.

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