The US Food and Drug Administration (FDA) has limited the authorised use of Janssen’s COVID-19 vaccine.
It means that it will only be available to individuals of 18 years or older for whom other authorised or approved COVID-19 vaccines are not accessible or clinically appropriate, and to similarly aged individuals who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive one.
The decision follows updated analysis, evaluation and an investigation of reported cases. During this process the FDA determined that the risk of thrombosis with thrombocytopenia syndrome (TTS) – a syndrome of potentially life-threatening blood clots – developing one to two weeks after administration of the Janssen COVID-19 vaccine warrants a limitation.
The FDA has also decided that the known benefits of the vaccine for the prevention of COVID-19 clearly outweigh the potential risks for individuals 18 years of age and older, in cases where other vaccines are unavailable.
“We recognise that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the US 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,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. 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,” he added.
The Janssen COVID-19 vaccine was authorised for emergency use in February 2021. During the following April, the FDA and the Centers for Disease Control and Prevention (CDC) announced a recommended pause in administration of the vaccine to investigate six reported cases of TTS and to help ensure that healthcare providers were made aware of the potential for the condition emerging.