BREAKING: U.S. Calls For Pause in Johnson & Johnson Covid Vaccine to Study ‘Extremely Rare’ Cases of Blood Clots

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The FDA and CDC have called for a pause in distribution to the Johnson & Johnson/Janssen vaccine while they study data involving a handful of cases of blood clots developing among the roughly 6.8 million American recipients to date.

In a statement jointly released by leaders of the two agencies — Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the CDC — the recommendation for the pause was attributed to six reported U.S. cases of a blood clot called cerebral venous sinus thrombosis, which all occurred among women between the ages of 18 and 48. One woman died and a second woman has been hospitalized in critical condition, officials said.

“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 a pause in the use of this vaccine out of an abundance of caution,” Marks and Schuchat said. They added, “Right now, these adverse events appear to be extremely rare. Covid-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following Covid-19 vaccination very seriously.”

In a release (via The New York Times), Johnson & Johnson said: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.”

The CDC and FDA are scheduled to hold a joint press conference on Tuesday to answer questions about their call for the pause.

This story is breaking.