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FDA Plans to Warn J&J Vaccine Can Increase Guillain-Barre Risk

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People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barre syndrome, a rare neurologic disorder where the body's own immune system attacks the nerves, the US Food and Drug Administration (FDA) is expected to announce according to multiple media reports.

The FDA is expected to add the new warning to the labeling for the vaccine, while still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the delta variant and serious COVID-19 outcomes.

More than 100 cases of Guillain-Barre reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.

Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention (CDC) statement . The CDC also revealed that most cases occur about 2 weeks following immunization.

Guillain-Barre syndrome often causes muscle weakness and sometimes, temporary paralysis. Most people who develop the syndrome recover.

However, a 57-year-old man was not so lucky, The New York Times reported Monday. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barre.

The new warning comes in the wake of a number of setbacks for the company's COVID-19 vaccine. On April 13 the FDA and CDC both recommended a 10 day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.

The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.

The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as Tuesday, the Times reports.