Johnson & Johnson talking with FDA about rare cases of Guillain–Barré syndrome after COVID vaccination

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 its Janssen COVID-19 vaccine.

“The chance of having this occur is very low,” J&J said in a statement

The number of reported cases of Guillain-Barré after use of the vaccine exceeded the number of cases normally expected in the population by a small degree, the company’s statement said.

The statement follows reports in both the New York Times and Washington Post 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.

Most people who suffer from Guillain-Barré recover fully, according to the U.S. Centers for Disease Control and Prevention, but there have been cases of permanent nerve damage.  

J&J vaccine never used in Canada

Health Canada approved J&J’s Janssen vaccine, which requires only one dose, but it has never been used in Canada. There also doesn’t appear to be any confirmed plan to do so.  

Public Services and Procurement Minister Anita Anand recently said the Johnson & Johnson contract remains in place and Canada could draw on supplies from this company at a later date.

But with millions more mRNA shots from Pfizer and Moderna set to arrive in the coming weeks, she said shipments from J&J may not be necessary.

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