US FDA updates warning label for Johnson & Johnson’s COVID-19 vaccine about rare neurological disorder

The US Food and Drug Administration updated its warning labels on Monday (Jul 12) for the Johnson & Johnson (J&J) COVID-19 vaccine to include information about an observed “increased risk” of a rare neurological disorder called Guillain-Barre Syndrome (GBS).

The news is a further blow for the company, which was granted an emergency use authorisation for its shot in February but has played a minor role in America’s coronavirus immunisation campaign.

Based on analysis of a federal vaccine safety monitoring system, officials have identified 100 preliminary reports of GBS after about 12.5 million doses administered, people familiar with the matter said.

Of these reports, 95 of them were serious and required hospitalisation. There was one reported death.

GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness or, in the most severe cases, paralysis.

It affects an estimated 3,000 to 6,000 people each year in the United States, and most go on to recover.