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# FDA Limits Use of Janssen Vaccine Due to Clot Risk
- URL: https://www.fdaweb.com/fda-limits-use-of-janssen-vaccine-due-to-clot-risk/
- Published: 2022-05-05T12:00:00.000Z
- Updated: 2026-09-14T17:43:22.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151757

FDA 5/5 limited the emergency use authorization (EUA) of Janssen’s (Johnson & Johnson) Covid-19 vaccine to individuals 18 years of age and older for whom other Covid-19 vaccines are not accessible or clinically inappropriate, citing its risk of thrombosis with thrombocytopenia syndrome. It is also indicated for use in individuals 18 years of age and older who elect to receive it because they would otherwise not receive a Covid-19 vaccine.  

An [agency release](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals?ref=fdaweb.com) says that “after conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine.”

“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions,” CBER director **Peter Marks** is quoted in the release as saying. “We’ve been closely monitoring the Janssen Covid-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”

FDA says the vaccine’s [Fact Sheet for Healthcare Providers Administering Vaccine ](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjA1MDUuNTc0ODQ2MTEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L21lZGlhLzE0NjMwNC9kb3dubG9hZD91dG1fY2FtcGFpZ249Q29yb25hdmlydXMrJTI4Q09WSUQtMTklMjkrVXBkYXRlJTNBK0ZEQStMaW1pdHMrVXNlK29mK0phbnNzZW4rQ09WSUQtMSZ1dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkifQ.Pi1Mx6vGxIkcIeP8JJKEhi-keb8WyXVK%5F8Q%5FYP38tWs/s/1256267564/br/130890302129-l?ref=fdaweb.com) now reflects the revised EUA indication and includes a “warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS. Additionally, information on the revision to the authorized use of the vaccine and updated information on this risk of blood clots with low levels of blood platelets has been added to the [Fact Sheet for Recipients and Caregivers](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjA1MDUuNTc0ODQ2MTEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L21lZGlhLzE0NjMwNS9kb3dubG9hZD91dG1fY2FtcGFpZ249Q29yb25hdmlydXMrJTI4Q09WSUQtMTklMjkrVXBkYXRlJTNBK0ZEQStMaW1pdHMrVXNlK29mK0phbnNzZW4rQ09WSUQtMSZ1dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkifQ.tiiqkh3-t6EpVb-VVitE-YWtbAb8ODtZJWQ5-w2d3Ac/s/1256267564/br/130890302129-l?ref=fdaweb.com).”