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FDA, CDC Recommend Pause In Use Of J&J Vaccine Over Rare Blood Clots

Some 6.8 million have received the vaccine in the United States. Six people have experienced the clots, the FDA and CDC said.

Breaking news this morning about the single-dose J&J vaccine, via the New York Times:

WASHINGTON — Federal health agencies on Tuesday called for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the United States developed a rare disorder involving blood clots within about two weeks of vaccination.

All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition.

Nearly seven million people in the United States have received Johnson & Johnson shots so far, and roughly nine million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention.

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the C.D.C., said in a joint statement. “Right now, these adverse events appear to be extremely rare.”

The clotting disorder is called cerebral venous sinus thrombosis, and is extremely rare. Federal officials are concerned doctors may not be trained to look for the rare disorder if recipients of the vaccine develop symptoms.

“Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” the statement said.

Officials will hold a press conference at 10 a.m EST.

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