The Food and Drug Administration (FDA) has announced that it is limiting use of Johnson & Johnson’s COVID-19 vaccine over concerns of rare side effects including blood clots.
The FDA announced on Thursday that it was restricting authorized use of the vaccine, which is produced by the Johnson & Johnson-owned company Janssen Pharmaceuticals, to adults age 18 and over who would not otherwise become vaccinated against COVID. The agency said that the risk of the vaccine causing thrombosis with thrombocytopenia syndrome (TTS), a rare but potentially fatal blood clotting condition, “warrants” limiting its use.
“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,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement published by the FDA. “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,” he added. “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.”
The FDA announced Thursday that it is limiting the use of Johnson & Johnson’s COVID-19 vaccine due to risk of thrombosis. A vial of the Janssen COVID-19 Vaccine is shown in this photo taken at a clinic in Los Angeles, California, on December 15, 2021.
FREDERIC J. BROWN/AFP/Getty
An updated FDA fact sheet for the vaccine notes that approximately 15 percent of TTS cases associated with the vaccine have been fatal. However, the risk of developing the condition or dying from it remains low, occurring at a rate of 3.23 cases and 0.48 deaths per 1 million doses administered,…