Johnson & Johnson vaccine approved for use in US

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The CDC and FDA announced Sunday, April 25, that Johnson & Johnson’s Janssen (J&J or Janssen) COVID-19 vaccine use may resume in the United States after a temporary pause. The Utah Department of Health, as well as the state health departments of Idaho and of Nevada, have followed the national direction and lifted their statewide pauses of the vaccine.

The U.S. COVID-19 vaccine program prioritizes safety, which involves reporting of any adverse events and rapid intervention and investigation. These protocols protect people from harm and inform the public about vaccine benefits and potential risks. This escalation was put into play for the J&J vaccine. Experts say the rare and treatable condition of thrombosis with thrombocytopenia syndrome (TTS), which involves blood clots with low platelets, is slightly elevated in adult women younger than 50 in the first three weeks of receiving the J&J vaccine.

Per CDC and FDA guidance, the J&J vaccine’s benefits outweigh its known and potential risks. Women 18 to 50 years old should be aware of the associated risk of TTS and follow CDC guidance and answers to common questions.

Tamara Sheffield, MD, Intermountain’s medical director for community health and prevention, says, “The pause was the right thing to do to educate vaccine recipients to seek medical attention should they experience symptoms, and to provide information to clinicians on how to appropriately diagnose and treat this rare side effect. The CDC concluded the vast benefits of vaccinating the population, including women 18 to 50, against COVID and its short- and long-term complications using the J&J vaccine, far outweigh the potential risks of this rare and treatable side effect. Waiting to vaccinate or deciding not to vaccinate puts these women at their greatest risk.”

Physicians, APPs, and clinical caregivers should follow Intermountain’s clinical guidance for recognizing, consulting for treatment, and reporting TTS.

Intermountain will be resuming use of the J&J vaccine in our COVID-19 vaccine clinics in the coming days.

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