Medical assistant floater Charlene Batas will administer a one-time dose of the Johnson & Johnson COVID-19 vaccine to a woman at a clinic targeting immigrant community members in Los Angeles, California, on March 25, 2021.
Mario Tama | Getty images
A panel from Centers for Disease Control and Prevention decided on Wednesday to delay a decision on Johnson & Johnson’s Covid-19 vaccine after six women developed a rare, but potentially life-threatening, blood clotting disorder that left a dead and critical condition.
The CDC’s Advisory Committee on Immunization Practices met a day after the Food and Drug Administration asked states to temporarily stop using J & J’s vaccine “out of an abundance of caution.” The panel voted unanimously to reconvene within a week, where it will decide what it will recommend to the CDC about J & J’s vaccine.
The committee has debated whether and for how long they wanted to continue the J & J vaccine hiatus while the CDC is investigating the cause of the blood clotting. One committee member recommended waiting a month before resuming immunizations, while other members recommended a few weeks. Some members asked if they could wait to vote until they had more time to process the data.
One of the options the panel considered was whether it would recommend restricting the use of the vaccine based on age or other risk factors.
The CDC and FDA advised states to reschedule J&J vaccine appointments after six women developed cerebral sinus vein thrombosis, or CVST, within about two weeks of receiving the injection, U.S. health officials told reporters Tuesday. CVST is a rare type of stroke that occurs when a blood clot forms in the venous sinuses of the brain. It can eventually leak blood into the brain tissue and cause bleeding.
“CVST is rare, but clinically serious, and can lead to significant morbidity and mortality,” said Dr. Tom Shimabukuro, a CDC official, to the committee. He said CVST cases were found to be three times greater in the J&J vaccine group than in women 20 to 50 years old from similar backgrounds.
Within hours of the FDA’s warning early on Tuesday, more than a dozen states and some national pharmacies discontinued J & J’s vaccinations, some replacing scheduled appointments with the Pfizer or Moderna vaccine.
US health officials had said the pause in vaccine use could be just a few days, depending on what they learn from their investigation of the cases. Dr. Anthony Fauci, chief medical adviser to the White House, said on Tuesday that the pause in vaccine use would give US health authorities the time they need to thoroughly investigate the cases and “find some common denominators among the women who attend. were involved”.
A 25-year-old man developed CVST along with bleeding during the clinical trial who was hospitalized but recovered. All six cases that occurred after the clinical trial were found in white women, Shimabukuro said, noting that the median time to symptom onset was eight days. Three were described as obese, one had hyperthyroidism, one had asthma, and one had hypertension, he said.
Five of the six patients initially developed a headache, and one had back pain and bruising before more serious other symptoms appeared, he said. One of the women has died. Three of the patients remain in the hospital, while two have been discharged, he said.
“These are significant blood clots that cause these problems,” he said.
Dr. Aaran Maree, chief medical officer of J & J’s vaccine division Janssen Pharmaceutical Cos., Told the committee that none of the women received birth control, which was believed to be a possible link to blood clotting. They also all tested negative for Covid-19.
One of the two patients who recovered was a 26-year-old woman described as “overweight but active,” who was on no medication and had no history of coagulation disorder.
She was hospitalized with a severe headache a week after receiving the J&J vaccine and was discharged, but returned to the hospital a week later with abdominal pain and a rapid heart rate, he said. Tests showed that she developed thrombocytopenia and CVST.
A 48-year-old woman with an “unremarkable past medical history” was hospitalized after three days of malaise and abdominal pain. She developed severe thrombocytopenia and CVST that worsened with hemorrhagic stroke despite treatment with the blood thinner heparin. She received the J&J vaccine two weeks before symptoms started and she remains seriously ill, according to the latest report.
This is a story in progress. Please check again for updates.