FDA To Attach Warning for Guillain-Barre Syndrome to Johnson & Johnson COVID-19 Vaccine

The risk for developing the rare neurological condition are low following vaccination, with the FDA noting the benefits of vaccination far outweigh the potential risks.

Officials with the FDA are planning to attach a warning for Guillain-Barre syndrome to the Johnson & Johnson COVID-19 vaccine, according to reporting by The New York Times.1

Although researchers have found that the risk of developing the rare neurological condition after vaccination are low, the risk seems to be 3 to 5 times higher among recipients of the vaccine compared to the general population. The new warning follows a temporary safety pause on the vaccine earlier in the year for concerns about rare blood clotting issues.1

A federal monitoring system has helped identify approximately 100 suspected cases of Guillain-Barre syndrome among recipients of the Johnson & Johnson single-shot vaccine, according to the reporting; however, these reports are considered preliminary and most people recover.1

The syndrome occurs when the body’s immune system attacks the nerves, according to the Mayo Clinic. The first symptoms are usually weakness and tingling in the extremities, although this can quickly spread and paralyze the entire body. Severe forms of the syndrome can be a medical emergency and most people require hospitalization.2

The exact cause of the syndrome is unknown, although two-thirds of patients report symptoms of an infection in the 6 weeks preceding their diagnosis. These infections can include respiratory or gastrointestinal infections.2

Treatments can help improve symptoms and reduce the duration of the illness, although there is no known cure. Although most people recover, Guillain-Barre has a mortality rate of 4% to 7% and between 60% and 80% of people are able to walk at 6 months. Lingering effects can include weakness, numbness, or fatigue.2

Reports in the FDA monitoring database show that Guillain-Barre syndrome developed within 3 weeks of vaccination, according to The New York Times. In one case, a 57-year-old man who had suffered both a heart attack and stroke within the past 4 years died after receiving the Johnson & Johnson vaccine and developing Guillain-Barre syndrome.1

The Biden administration is expected to announce the change as early as Tuesday, according to the Times, although officials with the FDA have concluded that the benefits in preventing severe disease or death from COVID-19 still strongly outweigh the risk.1 No link has been found between Guillain-Barre syndrome and other COVID-19 vaccines developed by Moderna or Pfizer and BioNTech.1

REFERENCES

1. LaFraniere S, Weiland N. FDA Will Attach Warning of Rare Nerve Syndrome to Johnson & Johnson Vaccine. New York Times. July 12, 2021. Accessed July 12, 2021. https://www.nytimes.com/2021/07/12/us/fda-warning-johnson-johnson-vaccine-nerve-syndrome.html?action=click&module=Top%20Stories&pgtype=Homepage

2. Mayo Clinic. Guillain-Barre syndrome. April 30, 2021. Accessed July 12, 2021. https://www.mayoclinic.org/diseases-conditions/guillain-barre-syndrome/symptoms-causes/syc-20362793