Important Information regarding Janssen/Johnson & Johnson (J&J) COVID-19 Vaccine

 

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

The NYS COVID-19 Vaccine Team

Categories: Covid ResourcesPublished On: June 15th, 2021Tags: , , ,

Share

Related Posts

  • FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age – December 9, 2022   Dear COVID-19 Vaccination Provider: On December 8, 2022, FDA authorized the bivalent Moderna COVID-19 vaccine for children ages 6 months through 5 years of age and bivalent Pfizer-BioNTech COVID-19 vaccine for children 6 months through 4 […]

  • Yesterday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-bivalent-covid-19-vaccines. CDC’s Director Dr. Rochelle Walensky released a statement and signed a decision memo recommending updated (bivalent) COVID-19 boosters for children five years and older. This expands on CDC's recommendation issued September 1, 2022, for updated COVID-19 boosters of people ages 12 and older.

  • Updated Clinical Guidance For Individuals 6 Months-11 Years Old – June 22, 2022   Dear NYS COVID-19 Vaccine Provider: Effective June 18, 2022, the CDC has recommended that everyone ages 6 months and older in the United States should receive a COVID-19 primary series vaccination for the prevention of COVID-19. This attached provider guidance has […]

  • Updated Guidance for The New York State COVID-19 Vaccination Program for Individuals 12 Years of Age or Older June 13, 2022   Note: This guidance document applies specifically to health care providers offering COVID-19 vaccinations to adolescents and adults ages 12 and older. Guidance specific to COVID-19 vaccination of children ages 5-11 can be found […]