The Food and Drug Administration and the Centers for Disease Control will stop using the vaccine at federal sites and urge states to do so as well while they examine the safety issues.
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.”
While the move was framed as a recommendation to health practitioners in the states, the federal government is expected to pause administration of the vaccine at all federally run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same.
Scientists with the F.D.A. and C.D.C. will jointly examine possible links between the vaccine and the disorder and determine whether the F.D.A. should continue to authorize use of the vaccine for all adults or limit the authorization. An emergency meeting of the C.D.C.’s outside advisory committee has been scheduled for Wednesday.
The move could substantially complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy. Regulators in Europe and elsewhere are concerned about a similar issue with another coronavirus vaccine, developed by AstraZeneca and Oxford University researchers. That concern has driven up some resistance to all vaccines, even though the AstraZeneca version has not been authorized for emergency use in the United States.
The vast majority of the nation’s vaccine supply comes from two other manufacturers, Pfizer-BioNTech and Moderna, which together deliver more than 23 million doses a week of their two-shot vaccines. There have been no significant safety concerns about either of those vaccines.
But while shipments of the Johnson & Johnson vaccine have been much more limited, the Biden administration had still been counting on using hundreds of thousands of doses every week. In addition to requiring only a single dose, the vaccine is easier to ship and store than the other two, which must be stored at extremely low temperatures.