Top U.S. health officials on Tuesday called for a break in the use of Johnson & Johnson’s COVID-19 vaccine while reviewing cases of rare blood clots in people receiving the shots.
Officials said they are reviewing six cases of a “rare and severe blood clot type” of more than 6.8 million people in the U.S. who have received the Johnson & Johnson vaccine.
All six cases were in women aged 18 to 48 years.
The Centers for Disease Control and Prevention (CDC) immunization practice advisory committee will meet Wednesday to review cases and the Food and Drug Administration (FDA) will also study them.
“Until this process is completed, we recommend a pause in the use of this vaccine with great caution,” said Peter Marks, FDA chief executive, and Anne Schuchat, CDC chief executive, in a joint statement. “This is important, in part, to ensure that the medical provider community is aware of the potential of these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clots.”
The type of blood clot in question, called cerebral venous sinus thrombosis, requires a different treatment than blood clots usually do. Agencies said they want health care providers to be able to plan for them.
Marks and Schuchat stressed that “these adverse events appear to be extremely rare.”
“The safety of the COVID-19 vaccine is a top priority for the federal government and we take all reports of health problems after the COVID-19 vaccination very seriously,” officials added. “People who have received the J&J vaccine who have severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of vaccination should contact their doctor.” .
The move is sure to cause shock waves through the U.S. vaccination effort and could worsen the vaccine’s hesitation, which was already a problem as some people refused to be inoculated.
However, two more vaccines, from Pfizer and Moderna, have accounted for most of the U.S. supply so far and no serious safety issues have been raised with them.
So far about 7 million Johnson & Johnson shots have been administered in the United States, compared to much higher Pfizer and Moderna figures, at about 98 and 85 million, respectively.
Johnson & Johnson had also been struggling with its manufacture, as problems at a Baltimore plant delayed the distribution of more doses. But there are about 9 million more Johnson & Johnson shots that have been distributed, according to CDC data, which are now under a pause.
“While it’s unfortunate, it’s the right step,” said Ashish Jha, dean of the Brown School of Public Health, he wrote from the pause on Twitter. “The central point of vaccine success is ensuring that people have confidence that it is safe. These events (central venous thrombosis) are VERY rare. 6 out of 7 million. No vaccine (or medicine) is perfect. But the trust is based on having a system that takes adverse events seriously, investigates them, makes decisions based on data ”.
The move brings home in the United States some of the comings and goings that have taken place in Europe over a different vaccine, AstraZeneca, which has been paused in some countries also due to rare blood clots. This vaccine has not yet been approved by the FDA for use in the US
Updated at 7:55 p.m.