The US Food and Drug Administration (FDA) updated its warnings on the COVID-19 vaccine from Janssen, a subsidiary of Johnson & Johnson (J&J), on Monday to include information about an “increased risk” of contracting the disease Guillain-Barré Syndrome.
Based on a federal monitoring system on vaccine safety, the FDA identified 100 cases of the rare neurological disorder, following the injection of 12.5 million doses. Of these, 95 were serious, and required hospitalization. There was one reported death.
The news represents a further blow to the J&J vaccine, which received authorization for emergency use in February, but plays a minor role in the United States’ vaccination campaign against COVID-19.
Guillain-Barré Syndrome 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 recover.
Cases of this disorder have been observed after the administration of certain vaccines, including those that prevent seasonal flu and shingles.
The J&J vaccine has suffered severe production problems, and a Baltimore plant responsible for its manufacture was closed for three months due to contamination problems.
Likewise, the vaccine was subjected to a safety hiatus in April after an increased risk of a rare form of clotting was identified, mainly in young women.
The suspension was lifted after the danger was determined to be remote, and the benefits far outweighed the risks, but the episode left a lasting drop in demand.