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Tags: Coronavirus | Coronavirus Special | Health Topics | Vaccines | Cold/Flu | covid-19 | fda

FDA Plans Warning on J&J Vaccine for Autoimmune Disorder

boxes of the johnson and johnson covid-19 vaccine
(Timothy D. Easley/Getty Images)

Monday, 12 July 2021 05:43 PM

Johnson & Johnson said 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 wrote Monday in a statement:

"The safety and well-being of the people who use our products is our number one priority.

"We have been in discussions with the U.S. Food and Drug Administration and other regulators about rare cases of the neurological disorder, Guillain-Barré syndrome, that have been reported following vaccination with the Janssen COVID-19 vaccine. The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree.

"Any adverse event report about individuals receiving Johnson & Johnson’s single-shot COVID-19 vaccine, as well as our own assessment of the report, is shared with the U.S. Food and Drug Administration, the European Medicines Agency and other appropriate health authorities. We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated.

"Evidence has demonstrated that Johnson & Johnson's single-shot COVID-19 vaccine offers protection against COVID-19 disease and prevents hospitalization and death, including in countries where viral variants are highly prevalent. A single-shot vaccine that provides this level of protection represents an important tool in the global fight against COVID-19, as we strive to help end this deadly pandemic."

The statement comes after the The Washington Post reported the FDA is expected to announce the new warning of the rare autoimmune disorder.

According to the Post, about 100 preliminary reports of Guillain-Barré syndrome (GBS) have been detected in the United States after vaccination with J&J shot, mostly in men, many of whom were 50 or older. Around 12.8 million people have received the one-dose vaccine in the United States.

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.

The condition has been linked in the past to vaccinations – most notably to a vaccination campaign during a swine flu outbreak in the United States in 1976, and decades later to the vaccine used during the 2009 H1N1 flu pandemic.

© 2021 Thomson/Reuters. All rights reserved.


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Johnson & Johnson said 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.
covid-19, fda, warning, johnson and johnson, guillain-barre syndrome, pandemic
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2021-43-12
Monday, 12 July 2021 05:43 PM
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