FDA limits use of J&J COVID vaccine due to blood clot risk
The Food and Drug Administration (FDA) announced Thursday that it has limited the use of the Johnson & Johnson coronavirus vaccine to adults for whom other COVID-19 vaccines aren't "accessible or clinically appropriate."
Driving the news: The change in the FDA's recommendation for the J&J shot follows an updated analysis of the vaccine's association with a rare blood clot disorder, per the press release.
- The J&J vaccine will also remain available to adults who elect to receive it and who would otherwise not get vaccinated.
State of play: The FDA said that "after conducting an updated analysis, evaluation and investigation of reported cases" of the blood clot cases, its findings warranted limiting the use of the vaccine.
- However, the FDA determined that the benefits of receiving the J&J vaccine outweigh its potential risks for individuals who cannot receive any of the other shots or who choose to receive the J&J vaccine.
What they're saying: “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," Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the press release.
- "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 big picture: Last year, the FDA temporarily called for an immediate halt to the J&J shot after six women developed the blood clot disorder within two weeks of receiving their vaccines.
- Just over a week later, the pause was lifted after regulators determined that the benefits of the shot outweighed the risk of the rare blood clot disorder.