States across the country are temporarily halting the administration of the Johnson & Johnson vaccine after six recipients developed a rare blood clotting disorder.
On Tuesday, the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration announced they are recommending a “pause” in the use of the single-dose shot after six women developed the illness within one to three weeks of vaccination.
Per the New York Times, one woman has died and a second woman in Nebraska has been hospitalized in critical condition.
In a joint statement, the two agencies said they are “reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.”
“In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia),” said Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.”
“Right now, these adverse events appear to be extremely rare,” the statement continued.
Dr. Marks added at a virtual press conference that symptoms averaged about a week to nine days after vaccination, but no longer than three weeks.
Although the agencies framed their announcement as a recommendation, Gov. Mike DeWine of Ohio advised all health providers in his state to temporarily stop giving Johnson & Johnson shots within hours of the notice.
Other states including New York, Connecticut, and Nebraska have followed suit.
Officials also said that the federal government has temporarily halted administration of the vaccines by the U.S. military, providers at federally run sites, and at CVS and Walgreens.
Dr. Janet Woodcock, the acting commissioner of the FDA, said at a press conference Tuesday that the pause is only expected to last “a matter of days,” though it depends on “what we learn in the next few days.”
Scientists with the FDA and CDC will now determine if there are links between the vaccine and the disorder, and whether the FDA should continue to authorize the use of the vaccine for all adults.
The Times reports that the CDC’s outside vaccine advisory committee will meet for an emergency meeting on Wednesday.
Per data from the CDC, nearly 7 million people in the United States have received Johnson & Johnson shots thus far, and about 9 million more doses have been shipped out to the states.