A panel of the Centers for Disease Control and Prevention decided on Wednesday to postpone a decision on Johnson & Johnson’s Covid-19 vaccine while investigating cases of six women developing a rare but potentially life-threatening bleeding disorder, where one person is dead and one is critical condition.
The CDC’s Advisory Committee on Immunization Practices met the day after the Food and Drug Administration requested states to temporarily “cease” use of J & J’s vaccine “out of caution.” The panel unanimously voted to meet in a week’s time to decide what to recommend to the CDC about J & J’s vaccine.
The postponement means the pause for J & J’s vaccine will remain in place.
The committee debated whether and how long they wanted to continue the hiatus on J & J’s vaccine while the CDC investigates the cause of the clotting. One committee member recommended a month-long hiatus from resuming vaccinations, while other members recommended a few weeks. Some members asked if they could hold the vote on hold until they had more time to process the data.
One of the options the panel considered was whether to recommend restricting vaccine use based on age or other risk factors.
Dr. Grace Lee, a member of the committee, said she feared a vote to suspend the use of the vaccine indefinitely would send the wrong message to the public. She and others added it might appear that something is fundamentally wrong with the vaccine.
“This is not the decision that I think makes the most sense,” she said.
Sandra Fryhofer of the American Medical Association advocated taking a break. She said there are enough supplies of Moderna and Pfizer vaccines to keep the rapid vaccinations going in the US
“I know there are a lot of patients who couldn’t be vaccinated and need to be vaccinated, but we want to make sure these vaccines are safe,” she said.
Dr. Nirav Shah, the director of the CDC in Maine, said the committee’s vote to postpone a decision on how to use the vaccine was “equivalent to a decision”.
“Any extension of the hiatus will invariably result in the most vulnerable people in the US, who were prime candidates for the J&J vaccine, remaining at risk. The most at risk will remain at risk.”
The CDC and FDA advised states to postpone appointments for J&J vaccines after six women developed cerebral sinus thrombosis (CVST) within about two weeks of receiving the shot, U.S. health officials told reporters Tuesday. CVST is a rare form 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 severe and can lead to significant morbidity and mortality,” said Dr. Tom Shimabukuro, a CDC official, told the committee. He said CVST cases in the J&J vaccine group appeared to be three times higher than in women aged 20 to 50 with similar backgrounds.
Within hours of the FDA’s warning early Tuesday, more than a dozen states, as well as a few national pharmacies, suspended vaccinations with J & J’s vaccine, with some replacing scheduled appointments with either the Pfizer or Moderna vaccine.
U.S. health officials had said the break in using the vaccine could only be a few days, depending on what they learned when investigating the cases. The Chief Medical Officer of the White House, Dr. Anthony Fauci said Tuesday the hiatus in vaccine use would give US health officials the time they need to thoroughly investigate the cases and “find some common ground among the women involved”.
A 25-year-old male developed CVST along with bleeding during the clinical study. He was hospitalized but recovered. All six cases that appeared after the clinical trial were found in white women, Shimabukuro said, noting that the median time to symptoms was eight days. Three were described as obese, one had hyperthyroidism, one had asthma, and one had high blood pressure, he said.
Five of the six patients developed headaches initially and one had back pain and bruising before developing more serious other symptoms, he said. One of the women died. Three of the patients are staying in the hospital while two have been discharged, he said.
“These are significant blood clots that are causing these problems,” he said.
Dr. Aaran Maree, chief physician of the vaccines division at J&J, Janssen Pharmaceutical Cos., Told the committee that none of the women were on birth control, which has been suggested as a possible association with blood clotting. They all also tested negative for Covid-19.
One of the two patients who recovered was a 26-year-old woman who was described as “overweight but active”, who was not on medication, and had no history of bleeding disorders.
She was hospitalized and discharged with a severe headache a week after receiving the J&J vaccine, but returned to the hospital a week later with abdominal pain and a fast heart rate, he said. Tests showed that she developed thrombocytopenia or low platelet levels and CVST.
A 48-year-old woman with an “unremarkable medical history” was admitted to the hospital after three days with malaise and abdominal pain. She developed severe thrombocytopenia and CVST which, despite treatment with the blood-thinning heparin, progressed to a hemorrhagic stroke. She received the J&J vaccine two weeks before symptoms began and is still critically ill, according to the latest report.