FDA warns of rare nerve disorder from Johnson & Johnson’s COVID-19 vaccine

JNS: The US Food and Drug Administration (FDA) has warned that there is a risk of rare nerve disorder from Johnson & Johnson’s corona vaccine.

A new warning released by the FDA on Monday stated that the one-dose Johnson & Johnson (Janssen) COVID-19 vaccine could increase people’s risk of developing Guillain-Barré syndrome (GBS), a rare neurological disorder the six weeks after inoculation.

This announcement comes after an analysis of the data from the Vaccine Adverse Event Reporting System (VAERS)—a national early warning system to detect possible safety problems in vaccines licensed in the US—showed that 100 people reportedly developed GBS after receiving the Johnson & Johnson COVID-19 vaccine, reported Health based on an email received by an FDA official.

The FDA also points out that, of the COVID vaccines approved for use in the US, it’s only the Johnson & Johnson vaccine that seems to have a link to an increased risk of GBS and that “no similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines.”

Around 12.8 million people have received J&J’s (Johnson & Johnson) one-dose vaccine in the United States. The FDA said 100 preliminary reports of GBS in the vaccine recipients include 95 severe cases that required hospitalization and one reported death.

GBS is a rare neurological condition in which the body’s immune system attacks the protective coating on nerve fibers. Most cases follow a bacterial or viral infection. Though, almost all people recovered completely from GBS.

Meanwhile, J&J said that it was in discussion with the FDA and other health regulators around the world about the cases of GBS. It said the rate of reported cases of GBS in J&J vaccine recipients exceeds the background rate only by a small degree.

The CDC said it would ask its committee to review the issue with outside vaccine experts at its next meeting.

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