The US Food and Drug Administration (FDA) has limited the permitted use of the Janssen Covid-19 vaccine for people 18 years of age and older.
With the update of the COVID-19 vaccine data sheet in the United States, the vaccine is intended for use in humans for whom no or clinically appropriate Covid-19 vaccines are available.
It is also indicated for people who choose the Janssen vaccine because they would not otherwise receive the Covid-19 vaccine.
The latest move comes after the regulatory agency conducted an updated assessment and assessment of reported cases and concluded that the risk of thrombosis with thrombocytopenia syndrome (TTS) requires limited use of the vaccine.
TTS causes rare blood clots along with decreased platelet levels in the blood.
The development of such symptoms has been reported nearly one to two weeks after administration of the Janssen Covid-19 vaccine.
In addition, the FDA noted that the identified and potential benefits of the vaccine to prevent Covid-19 outweigh the known and potential risks in adults.
The updated vaccine authorization and the TTS risk statement were included in the information sheet for vaccine healthcare providers.
In addition, the fact sheet for recipients and carers already reflects a revised authorized use of the injection with data on the risk of blood clots with added reduced platelet levels in the blood.
Peter Marx, director of the FDA’s Center for Biological Research and Evaluation, said: “We closely monitored the Janssen COVID-19 vaccine and the emergence of TTS after its use, and used updated information from our safety monitoring systems to review the EUA.
“The agency will continue to monitor the safety of Janssen Covid-19 and all other vaccines and, as was the case during the pandemic, will thoroughly evaluate the new safety information.