Wednesday, September 27, 2023

FDA Issues New Fact Sheet Due to Increase Risk of Guillain-Barré Syndrome with Janssen COVID-19 Vaccine

One step closer: Pfizer Inc. and BioNTech SE have applied for a FDA emergency use authorization for their coronavirus vaccine. (WYDaily/ Courtesy of Unsplash)
On July 13, 2021, the FDA has announced that new fact sheets have been issued for providers and patients/caregivers regarding an increased risk of developing Guillain-Barré Syndrome following receiving the Janssen (Johnson & Johnson) single dose COVID-19 vaccine (Courtesy of Unsplash)

NATIONWIDE — On Tuesday, July 13, the U.S. Food and Drug Administration (FDA) announced that it would release new fact sheets regarding the Janssen (Johnson & Johnson) COVID-19 single dose vaccine for physicians to provide.

The new fact sheet includes information gathered that reflects an increased risk of patients who received this single shot vaccine of developing Guillain-Barré Syndrome (GBS).

GBS is noted as a neurological disorder in which the body’s immune system damages nerve cells. The Mayo Clinic states that the first symptoms of GBS usually present as weakness and tingling in a patient’s extremities. As these symptoms continue to progress, in extreme cases, the body could eventually become entirely paralyzed.

The National Institute of Neurological Disorders and Stroke states that, in most cases, those who are diagnosed with GBS eventually recover, though still having some degree of weakness.

The exact cause of GBS is unknown and there is no known cure for the disorder.

In an analysis of the Vaccine Adverse Event Reporting (VAERS) data, 100 preliminary cases out of the 12.5 million doses administered were identified as having developed GBS following the Janssen vaccine. The FDA reports that out of the 100 preliminary cases identified, 95 were considered serious and required hospitalization, with one reported death.

The FDA states that while there is evidence that shows an association between the Janssen vaccine and the heightened risk of developing GBS, it is important to note that there is not enough to establish a causal relationship.

Additionally, it is noted that there has not been identified any correlation between the Moderna and Pfizer-BioNTech two dose COVID-19 vaccines and GBS.

The Centers for Disease Control and Prevention (CDC) is continuing to work with the FDA in vaccine safety surveillance. The FDA also continues to emphasize how data shows that the benefits of receiving a vaccine for COVID-19 outweighs the known and potential risks.

As a result of this risk, the FDA has issued a new Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) which has the added warning regarding GBS. A new fact sheet has also been created to for patients who receive the single-dose vaccine as well as caregivers of patients.

It is important to note that if a patient develops the following symptoms after receiving the vaccine, they should seek immediate medical attention:

  • Difficulty Walking
  • Weakness or tingling sensations
  • Difficulty with facial movements including: speaking, chewing or swallowing
  • Double vision or inability to move eyes
  • Difficultly with bladder control or bowel functioning
  • The worsening of any of these symptoms

According to the FDA, studies have shown that there is an increased risk of developing GBS after receiving certain vaccinations, to include the seasonal influenza and shingles prevention vaccines. Each year in the United States, approximately 3,000-6,000 people are diagnosed with GBS.

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