The U.S. Food and Drug Administration on Thursday announced it has limited the use of Johnson & Johnson's Janssen Pharmaceuticals COVID-19 vaccine over concerns associated with blood clots.
The FDA said the Janssen vaccine is now only authorized for use in adults "for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate" and for adults who "elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine."
The agency determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), which can cause rare but potentially life-threatening blood clots one to two weeks after receiving the J&J vaccine, warrants limiting the shot's authorized use.
FDA official Dr. Peter Marks said, "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. 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."
The Janssen vaccine has faced a series of problems since last year.
The FDA and Centers for Disease Control and Prevention paused the use of J&J's COVID vaccine in April 2021. After an 11-day review, the agencies lifted the pause, saying that the "known and potential benefits... outweigh its known and potential risks."
The FDA added a warning to the Janssen COVID vaccine in July 2021 stating that the shot has been linked to Guillain-Barré syndrome, a serious but rare neurological disorder.
The issue of COVID-19 vaccines has been hotly contested, but federal and state health officials say vaccines and boosters can keep most patients from getting the most serious cases of COVID-19 leading to hospitalization and death while acknowledging the vaccine protections wane over time and do allow for breakthrough infections in many Americans.
Federal officials also acknowledge the COVID-19 vaccines have generated a larger than usual number of adverse reaction reports, including suspected deaths and some heart inflammation, and that concerns have grown about the Johnson & Johnson vaccine and its ties to blood clotting. Federal officials say those concerns aside, they believe serious vaccine reactions are still fairly rare and in most cases, their protections outweigh the risks.