https://www.nationalreview.com/news/fda-limits-use-of-johnson-johnson-covid-vaccine/
The Food and Drug Administration limited its emergency authorization of Johnson & Johnson’s Covid vaccine because of the risk of blood clots, the agency said on Thursday.
The risk of “rare and potentially life-threatening blood clots” following use of the vaccine “warrants limiting the authorized use of the vaccine,” the FDA said in a statement.
“The FDA has determined that the reporting rate of [blood clots] is 3.23 per million doses of vaccine administered and the reporting rate of TTS deaths is 0.48 per million doses of vaccine administered,” the agency said.
However, the agency determined that the benefits of the vaccine “outweigh the known and potential risks” for adults who either cannot receive Pfizer or Moderna vaccines or who refuse to take any Covid vaccine except Johnson & Johnson’s. This means that the Johnson & Johnson vaccine is authorized only for individuals who cannot receive an mRNA vaccine or refuse to do so.
“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions,” Dr. Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, said in a statement. Marks added that the FDA “will continue to monitor the safety” of all Covid vaccines authorized in the U.S.