Pharmacist Madeline Acquilano inoculates a professor with the Johnson & Johnson Covid-19 vaccine at Hartford Hospital in Hartford, Connecticut, on March 3, 2021.
Joseph Precious | AFP | Getty Images
A group for the Centers for Disease Control and Prevention on Wednesday decided to postpone a decision on Johnson & Johnson’s Covid-19 vaccine after six women developed a rare but potentially life-threatening blood clotting disorder. he left a dead and critical condition.
The CDC’s Advisory Committee on Immunization Practices met a day after the Food and Drug Administration called on states to temporarily stop using the J&J vaccine “as a precaution.” The group voted unanimously to meet in a week to decide what the CDC would recommend about the J&J vaccine. The postponement means the break for the J&J vaccine will remain in effect.
The committee debated whether and for how long they wanted to continue the J&J vaccine break, while the CDC investigates the cause of the blood clotting. One committee member recommended a one-month detention for restarting immunizations, while other members recommended a few weeks. Some members asked if they could stop voting until they had more time to digest the data.
One of the options the group considered was whether to limit the use of the vaccine according to age or other risk factors.
The CDC and FDA have advised states to reschedule meetings with the J&J vaccine after six women developed cerebral venous sinus thrombosis or CVST within about two weeks of receiving the shot, U.S. health officials said Tuesday. CVST is a rare form of stroke that occurs when a blood clot forms in the venous sinuses of the brain. Eventually it can leak into the brain tissue and cause bleeding.
“CVST is rare, but clinically serious and can lead to substantial morbidity and mortality,” Dr. Tom Shimabukuro, a CDC official, told the committee. He said CVST cases appear to be three times higher in the J&J vaccine group than among women between the ages of 20 and 50, with similar averages.
Within hours of the FDA warning early Tuesday, more than a dozen states as well as some national pharmacies stopped vaccinations with the J&J vaccine, some replacing scheduled appointments with either the Pfizer vaccine or the modern one.
US health officials said the discontinuation of the vaccine could take only a few days, depending on what they learn from the case investigation. White House chief medical officer Dr. Anthony Fauci said Tuesday that discontinuing the vaccine would give U.S. health authorities time to thoroughly investigate cases and “find common denominators among the women involved.”
A 25-year-old man developed CVST along with a hemorrhage during the clinical trial, which was hospitalized but recovered. All six cases that appeared after the clinical trial were found in white women, Shimabukuro said, noting that the average time to onset of symptoms was eight days. Three were described as obese, one with hyperthyroidism, one with asthma and one with hypertension, he said.
Five of the six patients initially developed headaches, and one had back pain and bruising before other more severe symptoms appeared, he said. One of the women died. Three of the patients remain hospitalized, while two have been discharged, he said.
“These are significant blood clots that cause these problems,” he said.
Dr. Aaran Maree, chief medical officer for the J&J vaccine division, Janssen Pharmaceutical Cos., Told the committee that none of the women are in birth control, which has been theorized as a possible link to blood clotting. All also gave negative results for Covid-19.
One of the two patients who recovered was a 26-year-old woman, who was described as “overweight but active”, did not take any medication and had no history of coagulation disorders.
She was hospitalized with severe headaches a week after receiving the J&J vaccine and was discharged, but returned to the hospital a week later with abdominal pain and a fast heartbeat, he said. Tests showed that he developed thrombocytopenia and CVST.
A 48-year-old woman with an “unusual medical history” was hospitalized after three days of malaise and abdominal pain. She developed severe thrombocytopenia and CVST that progressed with hemorrhagic stroke, despite treatment with thinner blood heparin. She received the J&J vaccine two weeks before the onset of symptoms and remains seriously ill, according to the latest report.
This is a developing story. Please check again for updates.