FDA Limits Use of Johnson & Johnson COVID-19 Vaccine Due to Risk of Rare Blood Clots

FDA action was based on an analysis for the risk of thrombosis with thrombocytopenia syndrome, a rare and potentially life-threatening condition that causes blood clots combined with low levels of blood platelets.

The FDA has limited the authorization of the Johnson & Johnson (Janssen) COVID-19 vaccine to administration in individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, as well as those 18 years of age and older who choose the Janssen COVID-19 vaccine because they would not otherwise be vaccinated against COVID-19.

The announcement was based on an analysis for the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare and potentially life-threatening condition that causes blood clots combined with low levels of blood platelets. The onset of symptoms start approximately 1 to 2 weeks following administration of the Janssen vaccine, which the FDA said warrants limiting the authorized use of the vaccine.

“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. 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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.

Marks added that the FDA had been monitoring rates of TTS after administration of the Janssen vaccine and decided to update their safety surveillance systems to revise the vaccine’s emergency use authorization.

“Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine,” Johnson & Johnson said in a statement on the company’s website. “Johnson & Johnson continues to collaborate with health authorities and regulators around the world to ensure healthcare professionals and individuals are warned and fully informed about reports of TTS, enabling correct diagnosis, appropriate treatment, and expedited reporting.

An updated analysis of TTS cases after administration of the Janssen COVID-19 vaccine reported to the Vaccine Adverse Event Reporting System through March 18, 2022, confirmed 60 cases, including 9 fatal cases confirmed by the FDA and CDC. The FDA said that the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered.

“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,” Marks said in the release.