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.