The Food and Drug Administration (FDA) updated on Monday its warnings on the J&J/Janssen vaccine to include information about an “increased risk” of 0.00083% of contracting Guillain-Barré syndrome (GBS).
Based on a federal vaccine safety monitoring system, the FDA identified 100 cases of the rare neurological disorder following the injection of 12.5 million doses. Of these, 95 were severe and required hospitalization and it was one reported death.
The news represents a new blow to the J&J/Janssen vaccine, which received emergency use authorization in February but has had a minor role in the U.S. vaccination campaign against COVID-19.
Guillain-Barre syndrome causes the immune system itself to injure nerves, leading to muscle damage and, in rare cases even paralysis and death, but most people recover fully within weeks to a few years.
According to the CDC, most cases following COVID-19 injections have occurred in men 50 years of age or older, with symptoms usually appearing three weeks after vaccination.
Unlike the other two COVID-19 vaccines approved in the United States, Pfizer and Moderna, Johnson & Johnson has run into significant regulatory problems. On April 13, the federal government recommended a pause on it as a precaution.