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FDA Outlines Reason For J&J Vaccine Halt, Presser @ 1000ET

US

US FDA tweet thread on the suspension of use of the J&J COVID-19 vaccine in the United States:

  • "Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.
  • As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare
  • Treatment of this specific type of blood clot is different from the treatment that might typically be administered. CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.
  • Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.
  • Please join us via YouTube for an audio press conference at 10 a.m. EDT. [1500BST, 1600CET]We will keep the public updated as we learn more. https://www.youtube.com/channel/UC_giJ3xlEL9jUF1Yf...
  • COVID19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously."

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