Guillain-Barre syndrome (GBS) is an autoimmune disorder that causes muscle weakness leading to paralysis. People should seek medical attention if they notice weakness or tingling in the arms and legs, after receiving a vaccine, the FDA said.

The updated warning label says, “Reports of adverse events following use of the Janssen COVID-19 vaccine under emergency use authorization suggest an increased risk of Guillain-Barre syndrome during the 42 days following vaccination.”

The evidence is insufficient to establish a causal relationship.

Meanwhile, Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, US, said the possibility of a rare infection is likely when millions of people are being vaccinated, according to a CNN report.

Most cases were reported in men, most of them over 50 years. Also, the syndrome starts developing in the body about two weeks after vaccination in most cases.

Johnson & Johnson has clarified that it is discussing the issue with the FDA and other regulators.

“We have been in discussions with the US Food and Drug Administration and other regulators about rare cases of the neurological disorder, Guillain-Barre 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,” said the company in its communique.

The FDA said that 320 million doses of Moderna or Pfizer vaccines have been administered in the US but there has been no reported case of the disorder among the recipients.

Source: Medindia