FDA Limits Use of Johnson & Johnson COVID-19 Vaccine

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:

People over age 18 may still receive the J&J vaccine:

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