COVID-19 Vaccine was authorized for emergency use on February 27, 2021. On April 13, 2021, however, 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 thrombocytopenia syndrome (TTS.
However, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that the US regulator recognizes that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States 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.
Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions.
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.