The FDA says it is limiting emergency use authorization of the Johnson & Johnson Covid-19 vaccine to people 18 and older for whom other vaccines aren't appropriate or accessible and those who opt for J&J because they wouldn't otherwise get vaccinated.
The FDA said in a statement that the change is being made because of the risk of a rare and dangerous clotting condition called thrombosis with thrombocytopenia syndrome after receiving the vaccine."We've been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA," Dr.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in the statement."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. ... Today's action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions."This is a developing story and will be updated.