The Food and Drug Administration (FDA) has limited the authorized use of the Janssen COVID-19 Vaccine due to the increased risk of thrombosis with thrombocytopenia syndrome (TTS).

The Janssen COVID-19 Vaccine is now authorized for use in individuals 18 years of age and older:

  • For whom other authorized or approved COVID-19 vaccines (Comirnaty, Spikevax) are not accessible or clinically appropriate; and
  • Who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

As of March 18, 2022, there have been 60 confirmed cases of TTS reported to the Vaccine Adverse Event Reporting System (VAERS) following the administration of the Janssen COVID-19 Vaccine; 9 of these cases resulted in death. The reporting rate of TTS and TTS death has been determined to be 3.23 and 0.48 per million doses of vaccine administered, respectively. Among reported cases, symptoms began approximately 1 to 2 weeks after vaccination and have been observed in both males and females, with the highest reporting rate in females 30 to 49 years old.

“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

Examples of individuals who may still receive the Janssen COVID-19 Vaccine include those who experienced an anaphylactic reaction after receipt of an mRNA COVID-19 vaccine or who have personal concerns with receiving mRNA vaccines and would otherwise not get vaccinated. In situations where there is limited access to mRNA COVID-19 vaccines, the Janssen COVID-19 can be administered to people who would otherwise remain unvaccinated.

“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,” added Marks.

A revised fact sheet for the Janssen COVID-19 Vaccine can be found here.

Reference

Coronavirus (COVID-19) Update: FDA limits use of Janssen COVID-19 Vaccine to certain individuals. News release. May 5, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals