The New York Times
‘We were Flying Blind’: A doctor’s report of a woman’s J & J vaccine-related blood clot case
An 18-year-old woman was hit earlier this month with severe headaches, vomiting, seizures, confusion and weakness in one arm. These are symptoms that shocked the regions of doctors in a hospital in Nevada to see someone so young. Scans have found that several large blood clots are blocking veins from the brain, a condition that can deactivate or kill a patient. Sign up for The Morning Newsletter of the New York Times Doctors performed a procedure to suck large blood clots from her brain, only to find that new ones had formed. The patient is one of six women aged 18 to 48 years who received blood clots within two weeks of receiving the Johnson & Johnson coronavirus vaccine. One died, and their devastating cases led U.S. health officials to recommend Tuesday that the vaccine be discontinued. Two more cases have since been added: one involving a man who was vaccinated during the company’s clinical trials, and one with a woman who received the vaccine after it was approved for general use. As in several of the original cases, the young woman in Nevada was initially treated with heparin, a standard blood thinner that experts have since learned could exacerbate the rare clotting disorder that had small numbers of people taking the Johnson & Johnson or AstraZeneca vaccines in several countries. But until the last few weeks, doctors around the world had little information about the condition, and the doctors in Nevada did not immediately acknowledge it. “We have flown blind based on reports from Europe and the hematological society in the UK,” said Dr. Brian Lipman, an infectious disease specialist who helped treat the Nevada patient at Dignity Health St. Rose Dominican Hospital, Siena Campus, in Henderson. . The US decision to suspend the use of the vaccine was intended to give officials time to learn more about the rare disorder that causes the blood clots, to determine if it is related to the vaccine and to doctors and patients. inform on how to recognize symptoms and treat the condition. The break may last until at least next Friday, when expert advisers from the Centers for Disease Control and Prevention plan to meet to review the data and decide whether to start using the vaccine again. Dr. Rochelle Walensky, the director of the CDC, and other top U.S. health officials on Friday tried to reassure the public that the break, which now lasts more than a week, is a reasonable guarantee to determine the risk. They also stressed that the Johnson & Johnson vaccine and the other vaccines used in the United States are generally safe, given how many millions of Americans have received their concerns. But because the world has been stunned by a relentless epidemic, it is even a ridiculous decision to stop using an extremely effective vaccine that many countries have planned to stop temporarily. Public health experts fear that the move sends a message that will erode confidence worldwide, even if the vaccine is reintroduced and that large numbers of people who could be immunized will die unnecessarily from COVID-19 because they or their governments have the vaccine of the company rejected. The United States, where Johnson and Johnson provided only about 5% of the COVID vaccine supply, can afford the suspension: there are many other vaccine doses from Moderna and Pfizer-BioNTech to fill the gap. Other countries do not. And many countries have also stopped or restricted the use of another effective vaccine, made by AstraZeneca, because it has also been linked to a similar rare clotting disorder. About 7.4 million Americans have received the Johnson & Johnson vaccine, and so far only eight cases of the clotting problem have been reported, seven of which in women. In Europe, Britain and three other countries, 222 cases were reported, mostly in women under 60 – out of 34 million people who received the AstraZeneca vaccine. Several countries have now restricted its use to older adults because in so many cases there were younger people. Researchers suspect that in these rare cases, the vaccine causes an intense reaction by the patient’s immune system, which eliminates antibodies that activate platelets, a blood component needed to clot. There is an unusual syndrome, with extensive clotting that leaves the patient with low platelet levels and at the same time tends to bleed. Why it occurs in some people, many of whom are younger women, is not known, and experts believe that so far they have not been able to identify the characteristics or underlying conditions that may make some people susceptible. In a statement issued on Wednesday, Johnson & Johnson said: “The safety and well-being of people using our products is our top priority, and we support the awareness of the signs and symptoms of this extremely rare event in order to “We believe in the positive benefit-risk profile of our vaccine.” The company also said in a letter published in The New England Journal of Medicine on Friday that no Causal link between the vaccine and the coagulation disorder has not been established. can be tolerated as the price we have to pay for some drugs or vaccines, it is difficult to accept even the rarest if it is serious g and are unpredictable – like blood clots in the brain, especially in young, healthy people. “It’s a devastating complication,” said Dr. Anthony Fauci, the chief medical adviser for the pandemic in the Biden government, said in an interview. He added: ‘One woman was killed, three in hospital and one in intensive care. Although the numbers are small, it’s a devastating complication, so I believe – I did not make the decision – I believe that their rationale, at least from what they told me, is that they wanted to call a quick break to to see, to warn people. Sometimes it starts with minor symptoms, like a little discomfort in the abdomen, and then they suddenly get a stroke. “He also said, ‘Maybe there are a lot more people we don’t see because of the spectrum of the disease.’ Informing your doctors and the public about the symptoms – severe headaches, shortness of breath, leg or abdominal pain – can help identify more cases. Another reason for the break, Fauci said, is to let doctors know that the drug heparin, a standard treatment for blood clots, should not be given to these patients because heparin can make things worse in these circumstances. It is not known whether the heparin given by some of the patients initially worsened their condition. Experts recommend the use of other blood thinners, which patients urgently need because their blood clots continue to grow, and new ones continue to form. Doctors in Europe who treated recipients of the AstraZeneca vaccine who had a similar condition said it could worsen quickly. “The real issue is how long it will take before they decide what they are going to do,” Fauci said of the CDC’s advisory panel. “The rest of the world is watching it, and J&J will hopefully be an important part of the global response, just like AstraZeneca.” He added: “You do not want to be in a hurry with them, but I hope they decide within a reasonable time.” Another of the first six patients with the clotting condition was a healthy 48-year-old woman who went to an emergency in Nebraska because she felt bad with abdominal pain for three days. Her case was described in a letter to the editor of The New England Journal of Medicine published on Wednesday. Her platelet count was low and other blood tests were also abnormal. A CT scan found extensive blood clots in veins in her abdomen. She started getting headaches, and another scan found blood clots in her brain. She was given heparin. More blood clots developed, and she had a hemorrhage. Doctors then learned that she had received the Johnson & Johnson vaccine two weeks earlier. They stop the heparin and give her another blood thinner, along with intravenous immunoglobulin, a treatment that is also recommended for the clotting disorder. Her platelet count increased, but doctors wrote: “The patient remained critically ill at the time of this report.” The young woman in Nevada fought for her life and had to be placed on a fan, according to Lipman. He said he speaks independently and not as a representative of the hospital. The patient’s family rejected a request for an interview. Lipman said the pieces began to fall into place while the team studied her blood samples, and they realized she seemed to have the same problem as they know it occurred in Britain and Europe after patients received the AstraZeneca vaccine, mostly in young women. They switched from heparin to another blood thinner, starting with the guidance of doctors in Britain who treated AstraZeneca recipients with a similar disorder. Hoping for more information on the condition and any possible connection to the Johnson & Johnson vaccine, Lipman called an emergency number at the Food and Drug Administration. It was a weekend, and he said the person who answered told him that no one was available to help and that the line should be kept open for emergencies. “I thought it was an emergency,” Lipman said. “She was sitting next to me.” He calls back to ask how to reach Janssen, who makes the Johnson & Johnson vaccine. The information was not available, and he said the person who responded also told him that the FDA could not provide advice on patient care. An FDA spokeswoman Stephanie Caccomo said in an email: “We will investigate further to ensure that doctors who ask the FDA for help receive the help they seek.” Lipman said the pharmacist in his hospital submitted a report to the CDC in early April, but that the agency had not contacted him so far this week to ask about the matter. The agency declined to comment on whether it communicated with Lipman, a spokeswoman Kristen Nordlund said in an email. At a meeting of a CDC advisory panel Wednesday, Johnson & Johnson and Dr. Tom Shimabukuro, an agency security expert, both presented information about the young woman in Nevada. After the meeting, Nevada officials issued a statement saying the meeting was the first time they had heard of a case in their state – they had previously told the public that no cases had been reported – and they asked. federal partners’ why the state was informed. At the hospital in Nevada, an invasive radiologist passed a tube through the blood vessels and through the young woman’s brain, using a device to suck out the blood clots. Later, blood clots formed, and he performed the procedure again. But the condition causes more than blood clots: the patient, like others, also had a brain hemorrhage. She was transferred to a larger hospital, where she is still in a ventilator, Lipman said. Her prognosis is uncertain, he said, adding: “Her life, not just her life, her whole family’s life, has changed.” This article originally appeared in The New York Times. © 2021 The New York Times Company