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A panel of advisers to the Centers for Disease Control and Prevention on Friday voted 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 C.D.C. 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 18 and 49 years old.
Federal health officials are expected to respond quickly and formally recommend that states lift the pause.
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 million doses given. There have been 7 cases per 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 C.D.C. 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 F.D.A., 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. Among men and women who are 50 or over, there has been less than one case per million doses.
The clotting disorder is “rare but clinically serious,” Dr. Tom Shimabukuro, the deputy director of the C.D.C.’s immunization safety office, said at the meeting.
Roughly 10 million doses or more of the Johnson & Johnson vaccine, produced at the company’s factory in the Netherlands, are sitting on shelves across the United States and could be deployed immediately.
The vaccine has immense potential benefits for the population. If vaccinations resume for all adults, 26 to 45 cases of the clotting disorder would be expected over the next six months, according to a model presented by Dr. Sara Oliver, a C.D.C. scientist. However, 600 to 1,400 fewer Covid-19 related deaths would be expected over the same time period.
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.
Additional potential cases of the clotting disorder, including some in men, are currently being reviewed. The C.D.C. scientist also mentioned one case that developed in a 25-year-old man who participated in a clinical trial of the vaccine.
Twelve of the 15 women in the confirmed cases developed blood clots in the brain. Many also had clots elsewhere. Initial symptoms, which include headaches, typically begin six or more days after vaccination, Dr. Shimabukuro said. As the disorder develops, it can cause more severe headaches, nausea and vomiting, abdominal pain, weakness on one side of the body, speech difficulties, loss of consciousness and seizures.
Dr. Shimabukuro noted that seven of the women were obese, two had hypothyroidism, two had high blood pressure, and two were using oral contraceptives. It is not yet clear whether any of these factors might increase the risk of developing the clotting disorder after vaccination.
The patients’ symptoms closely resemble a rare syndrome that can be caused by heparin, a widely used blood thinner, Dr. Michael Streiff, a hematologist at Johns Hopkins University, told the panel. Heparin, which might typically be used to treat blood clots, should not be used to treat these patients, he said.
Doctors should consider the rare clotting disorder in patients who present with blood clots and low levels of platelets within three weeks of receiving the Johnson & Johnson vaccine, Dr. Streiff said.
“Recognition that this syndrome exists is helping to improve outcomes,” he said.
The meeting comes as the federal government is also investigating problems at a Baltimore factory that was slated to help satisfy the country’s vaccine demand. Emergent BioSolutions, the plant’s operator, has produced tens of millions of doses of Johnson & Johnson’s vaccine, but they cannot be distributed until regulators certify the plant.
After Emergent had to discard up to 15 million possibly contaminated doses of the vaccine last month, federal regulators conducted an inspection that found a series of problems, including the risk that other batches could have been contaminated.