Pharmacist Madeline Acquilano vaccinates a teacher with the Johnson & Johnson Covid-19 vaccine at Hartford Hospital in Hartford, Connecticut, on March 3, 2021.
Joseph Prezioso | AFP | Getty Images
A panel of Centers for Disease Control and Prevention decided on Wednesday to postpone a decision on Johnson & Johnson’s Covid-19 vaccine after six women developed a rare but potentially life-threatening blood clotting disorder that included one death and critical condition. left it.
The CDC’s advisory committee on immunization practices met a day after the Food and Drug Administration asked states to temporarily discontinue J & J’s vaccine “out of an abundance of caution.” The panel unanimously voted to meet again in a week’s where they will decide what they will recommend to the CDC about J & J’s vaccine. The postponement means that the interruption of the vaccination of J&J remains in force.
The committee debated whether and for how long they want to continue the pause over the vaccination of J&J while the CDC investigates the cause of the blood clot. One committee member gave a month-long recommendation to start the vaccination again, while others recommended a few weeks. Some members asked if they could no longer vote until they had more time to digest the data.
One of the options the panel considered was to recommend limiting the use of the vaccine based on age or other risk factors.
Dr Grace Lee, a member of the committee, said she was concerned that a vote to suspend the use of the vaccine indefinitely would send the wrong message to the public. She and others added that it may appear as if something is fundamentally wrong with the vaccine.
“It’s not the decision that I think makes the most sense,” she said.
Sandra Fryhofer of the American Medical Association was in favor of a break. She said there is enough stock of Moderna and Pfizer vaccines to continue rapid vaccinations in the US
“I know there are a lot of patients who have not had to be vaccinated yet, 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 said vote to postpone a decision about the use of the vaccine is “equivalent to making a decision.”
An extension of the break will always lead to the fact that the most vulnerable individuals in the United States who were the best candidates for the J&J vaccine will remain vulnerable. “
The CDC and the FDA have advised states to reschedule J&J vaccine appointments after six women developed cerebral venous sinus thrombosis, or CVST, within about two weeks of receiving it, 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 serious, and can result in serious illness and death,” said Dr. Tom Shimabukuro, a CDC official, told the committee. He said the CVST cases were three times larger in the J&J vaccine group than among women aged 20 to 50 years with similar backgrounds.
Within hours of the FDA’s warning early Tuesday, more than a dozen states as well as a number of national pharmacies stopped vaccinations with J & J’s vaccine. Some replace scheduled appointments with the Pfizer or Moderna vaccine.
U.S. health officials said the break in vaccine use would only last a few days, depending on what they learn in their investigation into the cases. White House medical adviser Anthony Fauci said Tuesday that the vaccine discontinuation would give U.S. health regulators time to investigate the matter thoroughly and find a common denominator among the women involved. ‘
A 25-year-old man developed CVST during the clinical examination along with a hemorrhage that was admitted to the hospital but recovered. All six cases that occurred after the clinical trial were found in white women, Shimabukuro said. The median time to onset of symptoms 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 had headaches and one had back pain and bruises before severe other symptoms ensued, he said. One of the women died. Three of the patients are being admitted to hospital while two have been discharged, he said.
“It’s significant blood clots that are causing these problems,” he said.
Dr. Aaran Maree, chief medical officer for J & J’s vaccination division, Janssen Pharmaceutical Cos., Told the committee that none of the women are on birth control, which is considered in theory to be a possible link with the blood clotting. They also all 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’, had no medication and had no history of coagulation disorder.
She was admitted to the hospital a week after receiving the J&J vaccine and was discharged, but returned to the hospital a week later with abdominal pain and rapid heartbeat. Tests showed she developed thrombocytopenia and CVST.
One 48-year-old woman with an “inconspicuous medical history in the past” was admitted to hospital after three days of illness and abdominal pain. She developed severe thrombocytopenia and CVST which progressed with hemorrhagic stroke despite treatment with the blood thinner heparin. She received the J&J vaccine two weeks before the onset of the symptom and remains critically ill, according to the latest report.