The Indian Health Service (IHS) has announced that at the recommendation of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), and out of an abundance of caution, IHS has paused all Johnson and Johnson /Janssen vaccine administration. IHS is doing this 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 Johnson & Johnson/Janssen vaccine product.
IHS would like to stress that these events appear to be extremely rare; however, COVID-19 vaccine safety is a top priority for the federal government and IHS is taking all reports of adverse events seriously. FDA and CDC are recommending this pause while they work together to fully understand these events so they can get information out to healthcare providers and vaccine recipients.
IHS has three vaccine safety monitoring systems in place. To date, there have been no reported cases of the rare and severe type of blood clot seen in some individuals who have received the Johnson & Johnson/Janssen vaccine.
This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson/Janssen COVID-19 vaccine makes up approximately 1.5% percent of our recorded shots in arms to date and less than 5% across the entire U.S. IHS does not expect this pause to affect IHS’ goal of fully vaccinating 44 percent of its active adult patients by the end of April.
For more information, visit the FDA YouTube site to hear the FDA and CDC press conference to answer questions about this pause in Johnson & Johnson/Janssen vaccine administration.
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