The Food and Drug Administration (FDA) has limited the authorized use of the Janssen COVID-19 vaccine to individuals 18 years of age and older over the risk of rare blood clots.
The move limits the vaccine to individuals 18 and older for whom other other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, as well as those 18 and older who would otherwise not receive a COVID-19 vaccine. Johnson & Johnson's COVID-19 vaccine, approved last year, is administered via one shot, while other vaccine available in the U.S. are administered through two doses, plus booster shots.
The move comes after the Centers for Disease Control and Prevention (CDC) recommended a pause of the vaccine out of an abundance of caution last year. The agency reversed course later and lifted that recommendation after reviewing data to assess the risk of rare, but life-threatening blood clots associated with the vaccine. The pause came after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine.
The FDA has conducted an updated analysis, evaluation and investigation of reported cases and decided to limit the use of the J&J-owned vaccine, citing 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 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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “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. …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.”
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."