FDA limits use of J&J COVID-19 vaccine because of TTS risk

Editor's Note

The Food and Drug Administration (FDA) on May 5 announced that it has limited the authorized use of Johnson & Johnson’s Janssen COVID-19 vaccine to those 18 years of age and older for whom other COVID-19 vaccines are not accessible or clinically appropriate and to those who would otherwise not receive a vaccine.

After conducting an updated analysis and investigation of reported cases of thrombosis with thrombocytopenia syndrome (TTS) approximately 1 to 2 weeks after receiving the vaccine, the FDA determined the risk warranted limiting its authorized use.

As of March 18, 2022, the FDA and Centers for Disease Control and Prevention (CDC) have identified 60 confirmed cases of TTS, including 9 deaths.

The FDA continues to monitor COVID-19 vaccine safety through passive and active surveillance systems in collaboration with the CDC, CMS, Department of Veterans Affairs, and other academic and large nongovernment healthcare data systems.