On May 5, 2022, the U.S. Food and Drug Administration (“FDA”) placed limitations on the authorized use of the COVID-19 vaccine manufactured by Johnson & Johnson and Janssen (“J&J Vaccine”).
FDA now limits the use of the J&J vaccine for individuals 18 years and older:
- when mRNA COVID-19 (Pfizer or Moderna) vaccines are clinically inappropriate;
- when they are without access to other COVID-19 vaccines; or
- when they would not otherwise receive a COVID-19 vaccine
People over age 18 may still receive the J&J vaccine:
- if they had a severe allergic reaction to an mRNA COVID-19 vaccine;
- if they would not get vaccinated because of concerns about mRNA vaccines; or
- if mRNA COVID-19 vaccines are not accessible and they would otherwise not get vaccinated
These limitations apply to the administration of the primary dose of J&J vaccine, booster doses, and additional doses for people who are immunocompromised. The FDA based the decision on its updated analysis and investigation of rare cases of thrombosis with thrombocytopenia syndrome (TTS) associated with J&J vaccine.
FDA Press Release: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals
Updated Fact Sheet for Healthcare Providers Administering Vaccine: https://www.fda.gov/media/146304/download
Updated Fact Sheet for Recipients and Caregivers: https://www.fda.gov/media/146305/download