Johnson & Johnson coronavirus vaccine (file photo). Photograph:( Reuters )
The US Food and Drug Administration revised the Johnson & Johnson COVID-19 vaccine's warning labels to include information about a "increased risk" of a rare neurological disease.
The US Food and Drug Administration warned on Monday that the Johnson & Johnson COVID-19 vaccines may increase the risk of Guillain-Barre syndrome, a rare neurological illness, after 100 early instances were identified among the 12.5 million doses given out.
According to a news report published on CNN, 95% of the instances were serious enough to necessitate hospitalisation and one person died, according to the organisation.
Guillain-Barré syndrome is a rare neurological illness in which the immune system targets nerves, resulting in temporary but possibly life-threatening paralysis.
According to the CNN report, Johnson & Johnson said that it was discussing the matter with the US Centers for Disease Control and Prevention and the Food and Drug Administration.
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"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," the company said in a brief statement.
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The majority of people who develop GBS symptoms do so after contracting a respiratory infection, such as the flu or becoming ill with diarrhoea, according to the CDC.
A pathogen linked to eating raw poultry is one of the most common causes.
(With inputs from agencies)