Johnson & Johnson in discussion with FDA regarding COVID-19 vaccine side effects
FILE PHOTO: A vial and sryinge are seen in front of a displayed Johnson & Johnson logo in this illustration taken January 11, 2021. REUTERS
Johnson & Johnson 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.
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.
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