An advisory panel to the Centers for Disease Control and Prevention (CDC) said the benefits of COVID-19 vaccines "far outweigh" potential risks amid an ongoing review of reports of a rare nerve disorder in a small fraction of J&J jab recipients. However, given the possible link, a new update will advise patients with a history of Guillain-Barré syndrome to seek mRNA vaccines.
CDC's Dr. Hannah Rosenblum, who presented during the Advisory Committee on Immunization Practices (ACIP) meeting Thursday, said "this assessment demonstrates that the benefits of COVID-19 vaccination far outweigh the potential risks."
Dr. Nicola Klein with the Kaiser Permanente Vaccine Study Center noted eight confirmed cases of GBS following J&J vaccination amid a backdrop of over 345,000 doses administered, per data collected through the Vaccine Safety Datalink. Nearly all confirmed cases occurred within 21 days of vaccination and involved adults aged 18-64. Researchers noted a reporting rate of 8.1 GBS cases per million J&J doses administered, versus 1.1 such cases following mRNA vaccination, compared to approximately 1.6 expected cases of GBS per million doses administered, per data collected through a national surveillance system, VAERS.
The news comes after the FDA on July 12 announced 100 preliminary reports of Guillain-Barré cases against a backdrop of about 12.5 million Johnson & Johnson doses administered. Of the total, 95 cases were serious and involved hospitalization, with one reported death in a 57-year-old man with underlying health issues.
The FDA had revised the vaccine's accompanying fact sheets to reflect an increased risk of the disorder in the 42 days after vaccination. The updated warning advised seeking immediate medical attention upon symptoms post-vaccination like "weakness or tingling sensations (especially in the legs or arms) worsening or spreading to other parts of the body, difficulty walking, difficulty with facial movements including speaking, chewing or swallowing, double vision or inability to move eyes or difficulty with bladder control or bowel function."
Guillain-Barré syndrome (GBS) occurs when a person’s immune system and inflammation damage the nerves, spurring muscle weakness and in some severe cases, paralysis, according to the CDC. It is a rare neurological disorder estimated to affect 3,000 to 6,000 Americans annually, per the FDA.
Triggers for the syndrome include recent respiratory or gastrointestinal infection weeks before symptoms, or other viral infections like the flu and Zika virus. The first symptoms typically involve weakness and tingling in the extremities, according to Mayo Clinic, which notes no known cure and an estimated mortality rate ranging from 4% to 7%. Treatment typically requires hospitalization and involves plasma exchange and antibody infusions to alleviate symptoms and help speed up recovery.
Symptoms can last for several weeks to years, and while most will go on to fully recover, some are left with permanent nerve damage.