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FDA Announces Revisions to EUA Fact Sheets for Janssen/Johnson & Johnson Vaccine

LeadingAge NY recently received the below message from the New York State Vaccination Team:

On July 13, 2021, the U.S. Food and Drug Administration (FDA) announced revisions to the Emergency Use Authorization (EUA) fact sheets for the Janssen/Johnson & Johnson (J&J) COVID-19 vaccine to include information regarding an observed increased risk of Guillain-Barre Syndrome (GBS) after administration of the vaccine. Based on an analysis of data from the Vaccine Adverse Event Reporting System (VAERS), there have been 100 preliminary reports nationwide of GBS following vaccination with the Janssen vaccine after approximately 12.5 million doses administered. Although the available evidence suggests an increased risk of GBS after vaccination with J&J vaccine, there is not enough evidence to establish a causal relationship at present. No similar signal has been identified for either the Pfizer or Moderna COVID-19 vaccines.

Updates to the EUA fact sheet for health care providers include a warning about GBS and information regarding the adverse event reports suggesting an increased risk for GBS. The fact sheet for vaccine recipients has been updated to include information about GBS and explains that those who receive the Janssen vaccine should seek medical attention right away if they develop any of the following symptoms:

  • 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.

The updated EUA fact sheets are attached and can be found at the following links:

The FDA Press Release is available at: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-13-2021

Contact: Diane Darbyshire, ddarbyshire@leadingageny.org, 518-867-8828