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CMS Issues Statement on J&J Vaccine Pause

This week, CDC and FDA recommended a pause in the use of the Johnson & Johnson (Janssen) COVID-19 vaccine pending an investigation into six reported U.S. cases of a rare and severe type of blood clot in individuals who received the vaccine. COVID-19 vaccine safety is a top priority for the federal government, and CDC takes all reports of health problems following COVID-19 vaccination very seriously.
 
If any residents or staff in your facility develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of receiving the J&J vaccine, please seek medical care, and report the event to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.
 
CDC has notified all federal pharmacy partners about the recommendation to pause the use of the J&J vaccine and is exploring options to minimize any potential interruption in ongoing access to vaccine for long-term care facility (LTCF) residents and staff. Importantly, CDC is not seeing these events with the Pfizer-BioNTech or Moderna COVID-19 vaccines.
 
CMS realizes there may be concern among LTCF staff and residents who have received the J&J vaccine, but it's important to note these adverse events appear to be extremely rare - with six reported cases out of more than 6.8 million doses of J&J vaccine administered in the U.S.. All of the cases occurred among women between the ages of 18 and 48, with symptom onset 6 to 13 days after vaccination.
 
CDC convened an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) yesterday, Wednesday, April 14 to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.

Staff Contact: ngrosso@mehca.org

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