The federal agency revised the vaccine’s Emergency Use Authorization after an analysis of the risk for thrombosis with thrombocytopenia syndrome (TTS).
Last night, the Food and Drug Administration (FDA) announced it had limited the authorization of the Johnson & Johnson (Janssen) COVID-19 vaccine to people 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to people 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.
This news comes after the federal agency conducted an analysis of 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 1 to 2 weeks following administration of the Janssen COVID-19 vaccine, 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 statement.
Marks said the FDA had been monitoring the occurrence of TTS following administration of the Janssen vaccine and decided to update information from our safety surveillance systems to revise the EUA.
The FDA and Centers for Disease Control and Prevention (CDC) have investigated all suspected cases of TTS reported to VAERS. In an updated analysis of TTS cases following administration of the Janssen COVID-19 vaccine that were reported to VAERS through March 18, 2022, the FDA and CDC confirmed 60 cases, including 9 fatal cases. The FDA has determined 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 same statement.