Updated EUA Fact Sheets Note Risk of Guillain-Barré
after J&J COVID-19 Vaccination
- Use the updated Janssen/J&J COVID-19 EUA fact sheet for patients.
- Report cases of Guillain-Barre Syndrome (GBS) occurring within 42 days of COVID-19 vaccination to VAERS and to the Health District (telephone 425-339-3503, fax 425-339-8706).
Background (courtesy of the Washington State Department of Health)
“The US Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) fact sheets on the Johnson & Johnson (Janssen) COVID-19 vaccine on July 8 to add a warning about the possible increased risk of a rare neurological complication known as Guillain-Barré syndrome within 42 days of receiving this vaccine. Guillain-Barré syndrome is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis. The FDA lists the chance of getting this syndrome as “very rare.” [SHD addenda: 1. Janssen vaccine use has been limited in Snohomish County (~30K doses total) and we are not aware of any local GBS cases associated with COVID-19 vaccination. 2. The Annals of Neurology (Allen) report cited below estimated a risk of 5.8 cases per million first doses of the analogous Astra-Zeneca adenovirus vector vaccine in use there.]
At this time, there has been no change in vaccine recommendations from the Centers for Disease Control and Prevention (CDC) or Western States Scientific Safety Review Workgroup. Following the lead of these groups, Washington state continues to recommend all three COVID-19 vaccines with no preference between them.
This is an evolving situation and we expect to hear more from the FDA and the CDC. We will update you if anything changes with our recommendation. We expect the Advisory Committee on Immunization Practices (ACIP) to review the data on this rare occurrence at their next meeting July 22. Given the increasing COVID-19 variant infections and higher risk for spread of the virus, continued vaccination is critical to prevent increased spread of disease.
If a patient refuses the Johnson & Johnson vaccine, offer them either Moderna or Pfizer COVID-19 vaccine. It is important to continue protecting people against COVID-19. People who have previously had Guillain-Barré syndrome may receive any of the COVID-19 vaccines. [SHD addendum: …after discussing the matter with their health care provider.]
Please discard any existing Johnson & Johnson EUA fact sheets you may have printed. When vaccinating patients with Johnson & Johnson, make sure you give them the most updated EUA fact sheet for recipients, which includes a description of what symptoms they should watch for. If a patient calls you with any of the following symptoms within 42 days of receiving this vaccine, please advise them to seek medical attention right away:
- Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body
- Difficulty walking
- Difficulty with facial movements, including speaking, chewing, or swallowing
- Double vision or inability to move eyes
- Difficulty with bladder control or bowel function
- Updated EUA Fact Sheet for Providers (FDA)”
- Allen CM, et al. Guillain-Barre Syndrome Variant Occurring after Sars-CoV-2 Vaccination. Ann Neurol 2021;00:1-4.
- Maramattom BV, et al. Guillain-Barre Syndrome following ChAdOx1-S/nCoV-19 Vaccine. Ann Neurol 2021; 00:1-3.