May 11, 2022

FDA restricts use of Janssen’s Covid-19 vaccine in adults

The United States Food and Drug Administration (FDA) has limit permitted use of Janssen’s Covid-19 vaccine to persons aged 18 and over.

With the update to the US COVID-19 Vaccine Information Sheet, the vaccine is intended for use in individuals for whom no other licensed or approved Covid-19 vaccine is available or clinically appropriate.

It is also indicated for people who choose Janssen’s vaccine because they would not otherwise receive a Covid-19 vaccine.

The latest decision comes after the regulatory agency conducted an updated review and assessment of reported cases and concluded that the risk of thrombosis with thrombocytopenia syndrome (TTS) warrants limited use of the vaccine.

TTS causes rare blood clots as well as reduced blood platelet levels.

Development of such symptoms was reported nearly one to two weeks after administration of Janssen’s Covid-19 vaccine.

Additionally, the FDA noted that the established and potential benefits of the vaccine in preventing Covid-19 outweigh the known and potential risks in adults.

The updated authorization for use of the vaccine and a warning about the risk of TTS have been included in the information sheet for healthcare providers administering the vaccine.

In addition, the information sheet for beneficiaries and carers now reflects the revised authorized use of the injection with data on the risk of blood clot with reduced levels of blood platelets added.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “We closely monitored the Janssen COVID-19 vaccine and the occurrence of TTS after it was administered and used the information provided. updating our safety oversight systems to revise the EUA.

“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 assess new safety information.”

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