Expert advisers to the Centers for Disease Control and Prevention will meet Thursday to discuss what federal health officials see as a worrying increase in rates of a rare but serious blood clotting disorder linked to Johnson & Johnson’s coronavirus vaccine.
The Advisory Committee on Immunization Practices will see new data at the meeting that shows increased risks of the condition in men and women, according to a federal official, paving the way for the experts to recommend possible new restrictions on vaccine use.
The FDA said Tuesday that while problems have occurred in men and women, the highest rate was in about 1 in 100,000 women ages 30-49.
Of the women diagnosed with the syndrome, which can hinder clotting and cause internal bleeding, about one in seven of them died, the FDA said. The federal official who described the schedule for Thursday’s meeting said updated figures showed about nine deaths from the condition.
Thursday’s panel may recommend that the vaccine be given only to people who don’t have access to another brand or want it despite the risk, or limit it to certain groups.
The Washington Post first reported plans for Thursday’s meeting and new federal data.
Jake Sargent, a spokesperson for Johnson & Johnson, said the company shares reports with regulatory authorities about side effects in people who received the vaccine and “strongly support raising awareness about the signs and symptoms of this rare event.”
About 16 million people in the United States have received a single shot of the Johnson & Johnson vaccine as their primary immunization, compared with 73 million fully immunized with Moderna’s vaccine and 113 million with Pfizer’s. Of people in the United States who have received a booster shot, only 1.5 percent have received Johnson & Johnson’s.
The side effect, known as thrombosis with thrombocytopenia syndrome, can hinder clotting and cause internal bleeding. An increased risk of the condition has been associated with the Johnson & Johnson vaccine and the injection of AstraZeneca, which is not approved in the United States. It is not linked to the Moderna or Pfizer vaccines.
On Tuesday, the Food and Drug Administration announced it has added a warning to the vaccine’s fact sheets for patients and suppliers, stating that the injection should not be given to anyone who has had a clotting problem after a first dose. The agency said it “continues to discover” that the vaccine’s benefits outweigh its risks.
As more cases of the clotting disorder were reviewed by federal health officials in recent months, FDA and CDC officials became increasingly alarmed by the numbers presented to them by the CDC’s Immunization Safety Office, which reports in the Vaccine Adverse Event Reporting System of VAERS checks. , a decades-old system that relies on self-reported cases from patients and caregivers.
Reports about the condition became worrisome enough in recent weeks that federal officials decided they should call an emergency meeting of CDC advisers.
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In April, shortly after the Johnson & Johnson vaccine was administered in the United States, federal officials briefly advised stopping use of the injection due to concerns about the risk of blood clots. At the time, the condition had developed in six women, all of whom developed the disease within one to three weeks of vaccination. One of the women had died. By May, 28 cases had been confirmed.
The updated FDA factsheet for suppliers says “the currently available evidence supports a causal relationship” between the condition and Johnson & Johnson’s vaccine.
The new data comes amid a spate of virus cases, driven by the Delta coronavirus variant and Omicron, the version of the virus that has already become dominant in some countries and is spreading rapidly in the United States.
Several lab experiments suggest that a single dose of Johnson & Johnson’s injection offers little protection against infection with Omicron. The company said late last month it was testing blood samples from clinical trial participants who received the injection as a booster to see how their vaccine-induced antibodies fare against Omicron.
The shot has largely fallen out of favor in the United States, despite early hopes that the one-time format could be easily deployed in more isolated communities and among those timid about receiving two doses.
Federal health officials authorized booster shots in October for people who had received a single shot of the Johnson & Johnson vaccine at least two months earlier. They enabled a “mix and match” approach, allowing people to receive a second shot of a Pfizer or Moderna vaccine. Of the people in the United States who originally received a single Johnson & Johnson shot and then received a second shot, less than 28 percent received Johnson & Johnson as their booster.
Christina Jewett reporting contributed.