JOIN USUS to resume J&J Covid-19 vaccinations despite rare clot risk
A panel of advisers to the Centers for Disease Control and Prevention voted Friday to recommend lifting the pause on the Johnson & Johnson Covid-19 vaccine for all adults and adding a label about an exceedingly uncommon, but potentially dangerous, blood clotting disorder.
The vote came after a CDC scientist presented nine new confirmed cases of the disorder, bringing the total to 15. All the cases have been in women, and 13 have been in women between ages 18 and 49.
Federal health officials are expected to respond quickly and formally recommend that states lift the pause. Several states, including Texas, Alabama, Utah and Wisconsin, said they expected to follow that recommendation.
Administration of the vaccine ground to a halt last week after reports emerged of a rare blood clotting disorder in six women who had received the vaccine. The disorder combines blood clots, often in the brain, and a low level of platelets, blood cells that typically promote clotting.
“This pause was essential to our ability to inform the public,” Dr José R. Romero, the chair of the advisory panel, said at the meeting.
The overall risk of developing the clotting disorder is extremely low. Women between 30 and 39 appear to be at greatest risk, with 11.8 cases per 1 million doses given. There have been seven cases per 1 million doses among women between 18 and 49.
Three women have died from the rare clots and seven remain hospitalized, four of whom are in the intensive care unit, a CDC scientist said at Friday’s meeting.
“These cases are not just numbers to any of us, and we take them very seriously,” Dr Joanne Waldstreicher, the chief medical officer of Johnson & Johnson, said at the meeting. “These are people.”
The company supported adding a warning label to the vaccine, and has agreed upon language for a potential label with the FDA, she said. The label she presented notes that “most cases” of the clotting disorder have occurred in women between 18 and 49 years old.
Nearly 8 million doses of the Johnson & Johnson vaccine have now been administered.
The vaccine, which is easy to store and requires just one shot, is also especially well-suited for use in hard-to-reach populations, including people who are homebound, homeless, or incarcerated.