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New York Times

“We Were Flying Blind”: Doctor’s explanation of female J & J vaccine-related thrombotic cases

An 18-year-old woman suffered from severe headaches, vomiting, seizures, confusion, weakness, and stroke-like symptoms in one arm earlier this month when a doctor at a Nevada hospital was shocked by a very young person. I was sick. The scan found several large blood clots blocking the veins that drain blood from the brain. This is a condition that can incapacitate or kill the patient. After signing up for The New York Times’ The Morning newsletter, the doctor performed a procedure to aspirate a giant blood clot from her brain, but found that a new blood clot had formed. The patient is one of six women aged 18-48 years who developed a blood clot in the brain within two weeks of receiving the Johnson & Johnson coronavirus vaccine. Due to one death and their catastrophic incident, US health officials recommended suspending vaccine use on Tuesday. Since then, two more cases have been added. One is for men who were vaccinated during the company’s clinical trials, and the other is for women who were vaccinated after general use. As in some original cases, young women in Nevada were first treated with heparin. Heparin is the standard anticoagulant that experts have since learned and can actually exacerbate the rare coagulopathy that affected a small number of people who received Johnson & Johnson. AstraZeneca vaccine in some countries. But until the last few weeks, doctors around the world had little information about the condition, and Nevada doctors weren’t immediately aware of it. Dr. Brian Lipman, an infectious disease specialist who helped care for patients in Nevada at Dignity Health St. Rose Dominican Hospital on Henderson’s Siena campus, said: .. The US decision to stop using the vaccine gives authorities time to learn more about the rare disorders that cause blood clots, assess whether they are related to the vaccine, and inform doctors and patients how to recognize symptoms. Treat the condition that was aimed at. The suspension may last at least until next Friday. Experts from the US Centers for Disease Control and Prevention will review the data this Friday to decide whether to resume use of the vaccine. CDC Director Dr. Rochelle Warrensky and other U.S. Supreme Health officials said on Friday that the current extension of the suspension for more than a week is a reasonable safeguard to assess risk. I asked the people to reassure me. They also emphasized that, overall, the Johnson & Johnson vaccine and other vaccines used in the United States are safe, given that millions of Americans were shot without worry. But even the constant epidemic staggers the world and even temporarily suspends the use of highly effective vaccines that many countries have planned to deploy is a false decision. Public health experts have sent a message that the move will undermine global credibility, even if the vaccine is revived, and a huge number of people who may have been vaccinated by them or their governments I’m afraid to die unnecessarily with COVID-19 because I refused the vaccination. The United States, where Johnson & Johnson provided only about 5% of the COVID vaccine supply, can afford the suspension. There are plenty of other vaccine doses from Moderna and Pfizer-BioNTech to fill the gap. Other countries are not. Also, many countries have stopped or restricted the use of other effective AstraZeneca vaccines. This is also because it is associated with a similar rare coagulopathy. Approximately 7.4 million Americans have been given the Johnson & Johnson vaccine, and so far only eight cases of coagulation problems have been reported, seven of which are women. In Europe, the United Kingdom, and three other countries, 222 cases have been reported, primarily in women under the age of 60, of the 34 million people who received the AstraZeneca vaccine. Due to the large number of cases involving young people, some countries are currently limiting their use to the elderly. In these rare cases, researchers believe that the vaccine causes a violent reaction in the patient’s immune system, releasing large amounts of antibodies that activate platelets, the blood component required for coagulation. Abnormal syndromes occur and widespread coagulation causes low platelet levels in patients and a tendency to bleed at the same time. It is not known why this happens in some people, many of them in young women, and experts have so far identified features or underlying conditions in which they may sensitize some people. Say he couldn’t. Johnson & Johnson said in a statement released Wednesday: Diagnosis by medical professionals, appropriate treatment and prompt reporting. We continue to believe in the positive benefit-risk profile of vaccines. The company also stated in a letter published Friday in the New England Journal of Medicine that no causal link had been established between the vaccine and coagulopathy. For some critics, it makes no sense to interfere with global vaccination campaigns during a pandemic because of some rare cases of disability. However, rare side effects may be acceptable as a price to pay for some drugs and vaccines, especially when they are severe and unpredictable, such as blood clots in the brains of young and healthy people. , Even the rarest ones are difficult to accept. “This is a catastrophic complication,” said Dr. Anthony Fauci, chief medical adviser to the Biden administration’s pandemic, in an interview. He added: “One woman has died, three are in the hospital and one is in the intensive care unit. It’s a small number, but I believe it’s a devastating complexity — I don’t make a decision. Did — I think their rationale, at least from what they told me, was that they wanted to call a short pause to see, warn people. Sometimes this is a bit abdomen. It starts with small symptoms like discomfort, and suddenly they get a stroke. “He also said,” Because of the extent of the illness, there may be more people we are unaware of. I don’t. ” Informing doctors and the general public of symptoms such as severe headache, shortness of breath, leg or abdominal pain may help identify more cases. Another reason for the suspension is to inform the doctor that heparin, the standard treatment for blood clots, should not be given to these patients. “Because heparin can make things worse in this situation.” It is not known if the first heparin given to some patients exacerbated their condition. Experts recommend the use of other anticoagulants that patients urgently need as blood clots continue to grow and new blood clots continue to form. European doctors who treated recipients of AstraZeneca vaccines with similar conditions said it could worsen rapidly. “The real question is how long it will take to decide what they are trying to do,” Forch said of the CDC’s advisory board. “I hope other countries in the world are monitoring this and, like AstraZeneca, J & J will be an important part of the global response.” “Don’t hurry, but in a reasonable amount of time. I hope you make the decision. ” Another of the first six patients with coagulation was a healthy 48-year-old woman who went to the emergency room in Nebraska because she felt sick with abdominal pain for three days. Her case was explained in a letter to the editors of the New England Journal of Medicine, published Wednesday. Her platelet count was low and other blood tests were abnormal. A CT scan found a widespread blood clot in a vein in her abdomen. She began to have a headache, and another scan found a blood clot in her brain. She was given heparin. More blood clots developed and she had a hemorrhagic stroke. Later, doctors learned that she had received the Johnson & Johnson vaccine two weeks ago. They stopped heparin and gave her another anticoagulant, along with intravenous immunoglobulin, which is also the recommended treatment for coagulopathy. Her platelet count increased, but the doctor wrote, “At the time of this report, the patient remained seriously ill.” According to Lippmann, a young woman in Nevada was fighting for her life and had to wear a ventilator. He said he was speaking independently, not on behalf of the hospital. The patient’s family declined the request for an interview. Lippmann had the same problems that happened in Britain and Europe after the team began to fall into place when the team studied her blood samples and the patient received primarily AstraZeneca vaccine. He said he noticed that he seemed to be there. young woman. They switched from heparin to another anticoagulant and began following the guidance provided by a British doctor who treated AstraZeneca’s recipients with similar disorders. Hoping for more information about the condition and possible association with Johnson & Johnson Vaccine, Lippmann called the Food and Drug Administration emergency number. It was a weekend, and he said the respondent told him that no one was available to help him and that the line had to be left open for emergencies. “I thought this was an emergency,” Lippmann said. “She hung me up.” He called back to ask how to reach Janssen, who manufactures Johnson & Johnson vaccines. That information was not available, and he said the respondent also told him that the FDA could not provide advice on caring for the patient. “We will investigate this further so that doctors seeking help from the FDA can get the help they are looking for,” FDA spokesman Stephanie Caccomo said in an email. Lippmann said a pharmacist at his hospital submitted a report to the CDC online in early April, but authorities did not contact him to ask about the case until this week. The agency declined to comment on whether spokesman Kristen Nordland had contacted Lippmann in an email. At a meeting of the CDC Advisory Board on Wednesday, Johnson & Johnson and the agency’s safety expert, Dr. Tom Shimabukuro, released data on young women in Nevada. After the meeting, Nevada officials issued a statement that the meeting was the first to know of an incident in their state — they told the public that the incident had not been reported before. And they weren’t informed of the state to their “federal partners.” At a hospital in Nevada, an intervention radiologist used a device to aspirate blood clots by passing a tube through a blood vessel into the brain of a young woman. Later, more blood clots were formed and he performed the procedure again. But this condition causes more than a blood clot: like others, the patient also had a cerebral hemorrhage. She was transferred to a larger hospital, where she was still on ventilator, Lippmann said. Her prognosis was uncertain, “not just her life, but the life of her entire family,” he added. This article was originally published in The New York Times. © 2021 The New York Times Company