Expert advisers from the Centers for Disease Control and Prevention will meet on 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’s coronavirus vaccine & Johnson.
The Advisory Committee on Immunization Practices will see new data at the meeting that shows elevated risks of disease in both men and women, federal official says, paving the way for experts to possibly recommend further restrictions on use vaccine.
FDA Tuesday noted that although problems do occur in both men and women, the highest rate was about 1 in 100,000 for women aged 30 to 49.
Among women who were diagnosed with the syndrome, which can impair clotting and cause internal bleeding, about one in seven died, the FDA said. The federal official who described the planning for Thursday’s meeting said the updated figures showed around nine deaths from the disorder.
Thursday’s panel could advise that the vaccine be given only to people who cannot access a different brand or who want it despite the risk, or restrict it to certain groups.
The Washington Post first reported plans for Thursday’s meeting and new federal data.
Johnson & Johnson spokesperson Jake Sargent said the company is sharing reports with regulators of side effects in people who have received the vaccine and “strongly supports awareness of the signs and symptoms of this rare event.”
About 16 million people in the United States received a single injection of the Johnson & Johnson vaccine as primary immunization, compared to 73 million fully immunized with Moderna’s vaccine and 113 million with Pfizer’s vaccine. Of people in the United States who received a booster shot, only 1.5% received that from Johnson & Johnson.
The side effect, known as thrombosis with thrombocytopenia syndrome, can impair clotting and cause internal bleeding. An increased risk for the disease has been linked to the Johnson & Johnson vaccine and AstraZeneca shot, which is not licensed in the United States. It has not been linked to Moderna or Pfizer vaccines.
On Tuesday, the Food and Drug Administration announced it had added a warning vaccine information sheets for patients and providers, indicating that the vaccine should not be given to anyone who has had a bleeding problem after a first dose. The agency said it “continues to find” that the benefits of the vaccine outweigh its risks.
As more cases of bleeding disorders have been brought to trial by federal health authorities in recent months, FDA and CDC officials have grown increasingly alarmed at the numbers that have hit them. been presented by the CDC’s Office of Immunization Safety, which monitors reporting in the Vaccine Adverse Event Reporting System, or VAERS, a decades-old system that relies on self-reported cases by patients and healthcare providers .
Reports on the state of health have become sufficiently disturbing in recent weeks that federal officials have determined they need to call an emergency meeting of CDC advisers.
In April, shortly after Johnson & Johnson’s vaccine administration began in the United States, federal officials briefly recommended stopping use of the vaccine over concerns about the risk of blood clots. At the time, the disease had appeared in six women, all of whom developed the disease one to three weeks after vaccination. One of the women had died. As of May, 28 cases had been confirmed.
FDA update fact sheet for providers said that “the currently available evidence supports a causal relationship” between the disease and the Johnson & Johnson vaccine.
The new data comes amid an increase in virus cases caused by the variant coronavirus Delta and Omicron, the version of the virus that has already become dominant in some countries and is spreading rapidly in the United States.
Several laboratory experiments suggest that a single dose of Johnson & Johnson’s vaccine may offer little defense against infection with Omicron. The company said at the end of last month that he is testing blood samples from clinical trial participants who received his booster injection to see how their vaccine-induced antibodies behave against Omicron.
The coup has largely fallen out of favor in the United States, despite early hopes that its unique format would be easy to roll out in more isolated communities and among those hesitant to receive two doses.
Federal health officials in October authorized booster shots for people who had received a single injection of the Johnson & Johnson vaccine at least two months earlier. They enabled a “mix and match” approach, allowing people to get a second injection of a Pfizer or Moderna vaccine. Of those in the United States who originally received a single injection of Johnson & Johnson and then a second injection, less than 28% received Johnson & Johnson as a booster.
Christina jewett contributed reports.