The Medical Letter on Drugs and Therapeutics
In Brief: Guillain-Barré Syndrome with the Johnson & Johnson COVID-19 Vaccine
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Med Lett Drugs Ther. 2021 Aug 9;63(1630):121
Principal Faculty
  • Mark Abramowicz, M.D., President: no disclosure or potential conflict of interest to report
  • Jean-Marie Pflomm, Pharm.D., Editor in Chief: no disclosure or potential conflict of interest to report
  • Brinda M. Shah, Pharm.D., Consulting Editor: no disclosure or potential conflict of interest to report
Additional Contributor(s)
  • Michael Viscusi, Pharm.D., Associate Editor: no disclosure or potential conflict of interest to report
Upon completion of this activity, the participant will be able to:
  1. Discuss the new warning about Guillain-Barré syndrome that was added to the Fact Sheet of the Johnson & Johnson COVID-19 vaccine.
 Select a term to see related articles  COVID-19   drug safety   vaccines 

On July 12, 2021, the FDA added a warning to the Fact Sheet for the Johnson & Johnson (Janssen) adenovirus-based COVID-19 vaccine about an increased risk of Guillain-Barré syndrome (GBS) following administration of the product.1

The warning is based on 100 cases of GBS that were reported to the Vaccine Adverse Events Reporting System (VAERS) following administration of the Johnson & Johnson vaccine. Most of the cases occurred within 42 days of vaccination; 95 of the 100 persons who developed GBS required hospitalization, and 1 died. About 12.5 million doses of the Johnson & Johnson vaccine had been administered at the time the warning was issued.2,3

According to the CDC, 3000-6000 cases of GBS are reported annually in the US. In many cases, GBS occurs following a viral or bacterial infection, including COVID-19.4 The syndrome has been reported following administration of other vaccines, including the Oxford-AstraZeneca adenovirus-based COVID-19 vaccine (not authorized for use in the US).5

Recipients of the Johnson & Johnson vaccine who develop weakness or tingling in the legs or arms that worsens or spreads or who have difficulty with walking, facial or ocular movement, bladder control, or bowel function should seek immediate medical attention. The Pfizer-BioNTech and Moderna mRNA-based COVID-19 vaccines have not been associated with GBS to date.2

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