'Increased Risk' Of Rare Nerve Disorder After J&J Covid Vaccine: US

Washington, (UrduPoint / Pakistan Point News - 13th Jul, 2021 ) :The US food and Drug Administration updated its warning labels Monday for the Johnson & Johnson Covid-19 vaccine to include information about an observed "increased risk" of a rare neurological disorder.

The news is a further blow for the shot, which was granted an emergency use authorization in February but has played a minor role in America's immunization campaign.

Based on analysis of a Federal vaccine safety monitoring system, officials have identified 100 preliminary reports of Guillain-Barre Syndrome (GBS) after approximately 12.5 million doses administered, people familiar with the matter said.

Of these reports, 95 of them were serious and required hospitalization. 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.

GBS has also been observed at an increased rate with certain vaccines, including certain seasonal influenza vaccines and a vaccine to prevent shingles.

The J&J vaccine has suffered severe production issues, and a Baltimore plant responsible for its manufacture has been shut for three months based on contamination issues.

The shot was also subject to a safety pause in April after a heightened risk was identified involving a rare form of clotting, mostly in younger women.

The pause was lifted after it was determined that the danger was remote and the benefits still greatly outweighed the risks, but the episode left a lasting drop in demand.