Authorities reviewed the data and resumed the rollout of the J&J shot 10 days later, but with a warning added to its label about the risk for a rare blood-clotting disorder. The pause in April was a recommendation by the CDC and FDA “out of an abundance of caution.”Īfter initial reports that six women between the ages of 18 and 48 developed a rare blood clot within one to three weeks of vaccination, health authorities learned of nine additional cases in women and one in a man. Jason Zucker, an infectious disease specialist at NewYork-Presbyterian/Columbia University Irving Medical Center and instructor in medicine at Columbia University Vagelos College of Physicians and Surgeons, shares what you should know about the J&J vaccine, its safety, and what to watch for if you’ve already gotten the J&J shot. “The chance of having this occur is very low,” the FDA said in its fact sheet.ĭr. Nearly 13 million doses of the vaccine have been administered in the United States.
Federal authorities had received about 100 reports of the syndrome in people who had received the J&J shot. In July, the FDA issued a warning that the J&J vaccine could lead to an increased risk of a rare neurological condition known as Guillain–Barré syndrome. For women 50 years and older and men of all ages, this adverse event is even more rare.”
The latest data found that it “occurs in about 7 per 1 million vaccinated women between 18 and 49 years old. However, in April, the Centers for Disease Control (CDC) and FDA recommended a pause in the use of the J&J vaccine after they learned of six women who developed a rare and severe type of blood clot after receiving the shot (thrombosis with thrombocytopenia syndrome, or TTS). The pause lasted for 10 days as authorities reviewed data and evaluated recommendations. The CDC concluded that TTS after the J&J vaccine is rare. The J&J vaccine, the third one authorized in the United States to help protect against COVID-19, is delivered in a single dose and can be stored at refrigerator temperatures for a long period. In February, the Food and Drug Administration (FDA) granted emergency use authorization for a COVID-19 vaccine produced by Janssen Pharmaceuticals, part of the drug company Johnson & Johnson (J&J).
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