FDA Limits Use of Johnson & Johnson Covid Vaccine
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.
An advisory panel for the Centers for Disease Control and Prevention voted in December 2021 to recommend that American adults receive the Pfizer or Moderna Covid vaccines in place of the Johnson & Johnson vaccine, citing the blood-clot risk for the latter. The FDA and CDC temporarily halted distribution of the Johnson & Johnson vaccine in April 2021 after several reports of blood clots.
The blood clots cited by the FDA on Thursday develop as part of a rare condition called thrombosis with thrombocytopenia syndrome, or TTS. In all, the FDA and CDC have confirmed 60 cases of the syndrome in people who received the Johnson & Johnson vaccine up to March 18, 2022, with nine confirmed fatalities. Patients with TTS first recorded symptoms one to two weeks after receiving the shot.
Close to 17 million Americans have received the Johnson & Johnson vaccine since it was first authorized for emergency use, according to the CDC. Meanwhile, over 76 million Americans have received the Moderna vaccine and 126 million have received Pfizer’s vaccine.
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