US health officials call for pause on Johnson & Johnson vaccine over rare blood clots

Top U.S. health officials on Tuesday called for a pause in the use of the Johnson & Johnson COVID-19 vaccine while they review rare cases of blood clots in people receiving the shots.

The officials said they are reviewing six cases of a "rare and severe type of blood clot" out of more than 6.8 million people in the U.S. who have received the Johnson & Johnson vaccine.

All six cases were in women between ages 18 and 48.

The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices will meet on Wednesday to review the cases, and the Food and Drug Administration (FDA) will look into them as well.

"Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution," said Peter Marks, a top FDA official, and Anne Schuchat, a top CDC official, in a joint statement. "This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot."

The type of blood clot in question, called cerebral venous sinus thrombosis (CVST), requires different treatment than blood clots usually do. The agencies said they want health providers to be able to plan for them.

Marks and Schuchat stressed that "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," the officials added. "People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider."

The move is sure to send shockwaves through the U.S. vaccination effort and could worsen vaccine hesitancy, which was already a problem as some people refused to be inoculated.

Still, two other unaffected vaccines, from Pfizer and Moderna, have made up the bulk of U.S. supply so far, and no serious safety issues have been raised with them.

About 7 million Johnson & Johnson shots have been administered in the U.S. so far, compared to much higher numbers for Pfizer and Moderna, about 98 million and 85 million, respectively.

Johnson & Johnson had also been struggling with its manufacturing, as problems at a Baltimore plant delayed the distribution of more doses. Still, there are about 9 million more Johnson & Johnson shots that have been distributed, according to CDC data, that are now subject to a pause.

"While unfortunate, it's the right step," Ashish Jha, dean of the Brown School of Public Health, wrote of the pause on Twitter. "Central to vaccination success is ensuring people have confidence they are safe. These events (central venous thrombosis) are VERY rare. 6 out of 7 million. No vaccine (or drug) is perfect. But confidence is built on having a system that takes adverse events seriously, investigates them, makes data-driven decisions."

The move brings home to the U.S. some of a back-and-forth that has played out in Europe over a different vaccine, from AstraZeneca, that has been subject to a pause in some countries due to rare blood clots as well. That vaccine has not yet been approved by the FDA for use in the U.S.

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