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“Use of the Janssen COVID-19 Vaccine should be resumed in the United States. ”

The CDC & FDA in a joint statement issued Friday, ending the 10-day recommended pause on use of the Johnson & Johnson (Jansen) one-dose COVID vaccine following a thorough safety review.

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    On April 13, the CDC and FDA announced it was recommending a pause on use of the J&J vaccine due to reports of thrombosis-thrombocytopenia syndrome (TTS). The CDC describes TTS as a “rare, but clinically serious and potentially life-threatening adverse event.”

    • TTS is not just blood clotting – it’s blood clotting WITH a condition of low platelets, which can potentially cause severe internal bleeding.

    • According to the CDC, out of the 6.8 million administered J&J vaccine doses administered, 15 cases of TTS were reported among women ages 18 to 64, resulting in three deaths.

      • American Society of Hematology President Martin S. Tallman, MD provided a big picture perspective in response to the lifting of the pause, noting that “COVID-19 infection carries a much higher risk of blood clots — 147,000 in 1 million hospitalized COVID-19 patients experience clots, compared to roughly two in 1 million individuals who received the J&J vaccine.”
    • During the safety review, the FDA and CDC worked to assess the risk of TTS and concluded “the vaccine is safe and effective in preventing COVID-19.” Additionally, the FDA “determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.

    • In response to recent reports of fewer numbers of people getting vaccinated and vaccine hesitancy, White House chief medical adviser Dr. Anthony Fauci said the J&J pause actually shows how thorough the federal gov’t agencies are being. “The CDC and the FDA are the gold standard for both safety and the evaluation of efficacy, I think in the long run what we’re going to see - and we’ll probably see it soon - is that people will realize that we take safety very seriously,” he said.