FDA, CDC call for pause on Johnson & Johnson vaccine after clotting

(AP Photo/Themba Hadebe)
(AP Photo/Themba Hadebe) (Copyright 2021 The Associated Press. All rights reserved.)

Federal health agencies on Tuesday called for an immediate pause in use of Johnson & Johnson’s coronavirus vaccine after 6 people in the United States developed a rare disorder involving blood clots within about two weeks of vaccination, officials said.

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, according to a joint statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

The FDA also said the blood clots could not be treated as they typically could. The agency noted, the potential for developing the clots “appear to be extremely rare.”

The 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.

More than 6.8 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.