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Tipsheet

FDA Makes Announcement About J&J Vaccine

AP Photo/Matt Rourke

The Food and Drug Administration announced Thursday that it is limiting the emergency use authorization of the Johnson & Johnson Covid-19 vaccine to people who either cannot or will not take other vaccines, citing the risk of thrombocytopenia syndrome (TTS).

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“After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine,” FDA said in a statement.

Individuals 18 years of age or older who had a severe reaction to the Pfizer or Moderna Covid-19 vaccines or who do not have access to these shots may still receive the J&J jab. Additionally, people who would otherwise not be inoculated at all if they cannot receive the J&J shot may still get it.

“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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions.”

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