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Vaccination

FDA Updates Label on Johnson & Johnson's COVID-19 Vaccine to Warn of Rare Neurological Complication

Strategic Insights

— 2 min read

The US Food and Drug Administration (FDA) has updated the label on Johnson & Johnson's (J&J) coronavirus vaccine to warn of a possible increased risk of a rare neurological complication known as Guillain-Barré syndrome (GBS). The update follows reports of 100 preliminary cases of GBS, out of 12.8 million J&J vaccines given, as reported to the US government's Vaccine Adverse Event Reporting System (VAERS). While the FDA has not established a causal relationship between the vaccine and GBS, it has noted an increase in reports of the condition.

Key Takeaways:

  • The FDA has updated the label on J&J's COVID-19 vaccine to warn of a possible increased risk of Guillain-Barré syndrome (GBS), a rare neurological complication.
  • Reports of 100 preliminary cases of GBS have been filed with VAERS, out of 12.8 million J&J vaccines given.
  • The FDA has not established a causal relationship between the vaccine and GBS, but has noted an increase in reports of the condition.
  • Most people with GBS fully recover from the disorder, but it can in rare cases lead to paralysis or death.
  • The CDC and FDA are monitoring cases of the syndrome, and the CDC's Advisory Committee on Immunization Practices will discuss the matter in an upcoming meeting.
  • J&J has confirmed it is discussing the issue with the CDC and FDA.
  • The CDC and FDA emphasize that the risk of severe adverse events after COVID-19 vaccination remains rare, and everyone age 12 years and older is recommended to receive a COVID-19 vaccine.

Statistics:

  • 100 preliminary reports of Guillain-Barré syndrome have been filed with VAERS, out of 12.8 million J&J vaccines given.
  • 95 of the 100 reports of GBS involved people who needed hospitalization, and one person died.
  • Each year in the United States, an estimated 3,000 to 6,000 people develop GBS.
  • The vaccine's label was previously updated to warn about the risk of a rare type of blood clotting complication.
  • 84.6 million Americans have received both doses of Pfizer's vaccine; 62 million are fully vaccinated with Moderna's and 12.7 million with J&J's one-dose regimen.

Sources:

  • CNN: "FDA updates label on Johnson & Johnson's COVID-19 vaccine to warn of rare side effect"
  • FDA: "Johnson & Johnson COVID-19 Vaccine Fact Sheet for Recipients and Caregivers"
  • CDC: "COVID-19 Vaccines: Answering Your Questions"
  • CDC: "Guillain-Barré Syndrome (GBS) after Receipt of the J&J/Janssen COVID-19 Vaccine"

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