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WASHINGTON — The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) on Friday evening lifted its pause of the Johnson & Johnson/Janssen COVID-19 vaccine.

Soon thereafter, the Indian Health Service (IHS) followed suit on Friday at 10 p.m. - EDT and lifted the pause among the Indian health system.

“Indian Health Service facilities will resume administration of the Johnson & Johnson/Janssen COVID-19 vaccine. IHS originally paused administration of the Johnson & Johnson/Janssen COVID-19 vaccine to allow the FDA and CDC to review data involving six reported U.S. cases of a rare and severe type of blood clot in individuals receiving the vaccine,” IHS said in a statement.

IHS has vaccine safety monitoring systems in place. To date, there have been no cases reported through IHS of the rare and severe type of blood clot seen in some individuals who have received the Johnson & Johnson/Janssen COVID-19 vaccine.

The FDA and CDC said in a statement the two agencies have confidence that this vaccine is safe and effective in preventing Covid-19.

The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.

IHS originally paused administration of the Johnson & Johnson/Janssen COVID-19 vaccine to allow the FDA and CDC to review data involving six reported U.S. cases of a rare and severe type of blood clot in individuals receiving the vaccine.

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The Native News Health Desk is made possible by a generous grant from the National Institute for Health Care Management Foundation as well as sponsorship support from RxDestroyer, The Leukemia & Lymphoma Society and the American Dental Association. This grant funding and sponsorship support have no effect on editorial consideration in Native News Online. 
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