CDC and FDA Recommend Pausing Use of Johnson & Johnson Vaccine Over Blood Clot Concerns

The U.S. Centers for Disease Control and Prevention and the Food and Drug Administration said on Tuesday they are recommending a "pause" in the use of the single-dose Johnson & Johnson COVID-19 vaccine out of an "abundance of caution" while a review of reports of rare, potentially dangerous blood clots is conducted.

In a joint statement on Tuesday, 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 Food and Drug Administration'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," the statement added. "Right now, these adverse events appear to be extremely rare."

Speaking at a virtual news briefing after the announcement, Marks said that symptoms averaged about a week to nine days after vaccination, but not longer than three weeks.

Schuchat and Marks recommended that individuals who had already received the Johnson & Johnson vaccine who experience severe headache, abdominal pain, leg pain or shortness of breath within three weeks of getting the shot contact their health care provider.

Following the recommended pause in vaccination with the Johnson & Johnson vaccine, Jeffrey Zients, the White House coronavirus coordinator, said, "we are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine."

In a statement sent to NPR, Johnson & Johnson said it was "aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine."

"We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public," the company said.

— Scott Neuman, NPR