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FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) Covid-19 Vaccine Use

  1. FDA and CDC have determined that therecommended pause regarding the use of theJanssen (Johnson & Johnson) COVID-19Vaccine in the U.S. should be lifted and use ofthe vaccine should resume.
  2. The FDA and CDC have confidencethat this vaccine is safe and effectivein preventing COVID-19.
  3. The FDA has determined that theavailable data show that the vaccine’sknown and potential benefitsoutweigh its known and potential risksin individuals 18 years of age andolder.
  4. At this time, the available data suggestthat the chance of TTS (Thrombosis-thrombocytopenia syndrome)occurring is very low, but the FDA andCDC will remain vigilant in continuingto investigate this risk.
  5. Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers AdministeringVaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised.

During the pause, FDA and CDC examined available data to assess therisk of TTS. Also conducted extensive outreach to providers andclinicians to ensure they were made aware of the potential for theseadverse events and could properly manage and recognize these eventsdue to the unique treatment required for TTS. The FDA and CDC willcontinue to closely monitor the safety of COVID-19 vaccines.

This information was obtained from the CDC website that was updated on Friday, April 23,  2021 7:00 p.m. ET

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