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

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.

Johnson & Johnson in discussion with FDA regarding COVID-19 vaccine side effectsJohnson & Johnson said on Monday it was in discussions with the US Food and Drug Administration about rare cases of a neurological disorder that have been reported following vaccination with the Janssen COVID-19 vaccine. (Reuters file photo)

Johnson & Johnson said on Monday it was in discussions with the US 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.

First uploaded on: 13-07-2021 at 12:18 IST
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