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Use of the single-dose Johnson & Johnson Covid vaccine will resume in a few days, but with a warning added to its label about the risk of a rare blood clotting disorder in young women, the Food and Drug said on Friday. Administration.
Concerns about the disorder had led to a pause in vaccine use that had started 10 days earlier.
The FDA has decided not to limit the use of the vaccine based on age or gender, although some European countries have placed such restrictions on a vaccine made by AstraZeneca due to a similar bleeding disorder.
Federal health officials said information about the disorder would also be provided at vaccination sites, and Dr Peter Marks, the FDA’s main vaccine regulator, predicted the injections could be resumed on Saturday morning. .
The company supported adding the warning label and accepted its wording, said Dr. Joanne Waldstreicher, Johnson & Johnson’s chief medical officer. The label notes that “most cases” of a bleeding disorder have occurred in women between the ages of 18 and 49.
The suspension came after authorities learned that six women had developed a serious disorder that led to blood clots in their brains about two weeks after receiving the vaccine. One is dead.
The hiatus was widely seen as a blow to national and global immunization efforts and wiped out an effective vaccine that many states and countries planned to roll out in hard-to-reach places. Unlike vaccines manufactured by Pfizer-BioNTech and Moderna, Johnson & Johnson’s vaccine requires only one injection and is easier to store and distribute because it does not require extremely cold temperatures.
At an advisory group meeting on the issue of blood clotting on Friday, the CDC reported that it had identified a total of 15 cases, including three deaths.
But the risk is considered extremely low – nearly eight million Americans have received the Johnson & Johnson vaccine – and the panel decided that the benefits of the vaccine far outweighed its risks. The group also concluded that not using it would cause more deaths than the bleeding disorder could cause.
The panel voted 10-4 to resume use of the vaccine with the warning label. Some of the panel members who voted ‘no’ wanted a stronger warning about the risk to younger women and the availability of other Covid vaccines that do not appear to pose the same risk.
Lifting the hiatus will allow states to jump-start vaccination efforts among hard-to-reach populations like rural Americans, migrants and the elderly who find it difficult to leave their homes. Their access to the vaccine was hampered by the suspension, which left around 10 million doses on the shelves.
In Wisconsin, officials said they plan to start using their Johnson & Johnson doses as soon as possible.
“We’ve also heard from a number of vaccinators that there are a lot of people who don’t like needles,” said Julie Willems Van Dijk, deputy secretary of the state’s health department. “They just want to get the vaccine that requires them to have a vaccine for two.”
CDC director Dr Rochelle P. Walensky said governors of a number of states have expressed keen interest in resuming the use of projectiles.
“They were wondering why we had taken a break, and they were anxious to get that back, to have an opportunity for a single dose vaccine, for a single possibility,” she said.
About 135.8 million people in the United States have received at least one vaccine against the coronavirus. But daily doses have fallen nearly 13% since last week, from a peak of 3.38 million daily doses on average to around 2.95 million.
It is difficult to say what is driving this decrease. Even before use of the Johnson & Johnson vaccine was discontinued, shipments had plummeted due to a factory error that had ruined millions of doses.
Larry Bergner, the administrator for the 58,000-resident Newton County, Missouri, health department said demand declined before the hiatus. He feared that the federal government’s decision had left more people in his area reluctant to get vaccinated.
“Some tell me they had planned to get the vaccine until J.&J. Was discontinued,” Mr. Bergner said. “Now they’re saying they’re going to wait until they feel sure all the vaccines are safe.”
The county had distributed flyers and made phone calls to businesses, churches and other community groups to spark interest in a vaccination clinic on Wednesday, but only 14 people showed up. It was actually about double what Mr Bergner had expected, he said, even though the health department could have processed around 100 injections.
Dr Walensky said the federal government plans to emphasize the safety of the vaccine to Americans who may be reluctant to take it after the hiatus.
“We need to educate clinicians in an extraordinary way, like we did last week,” she said. “We have already planned to start this on Monday, to public health officials. And then we have to sensitize patients in an extraordinary way, meet people where they are, educate them. “
She said the CDC had spoken to health care providers for young women, including the American College of Obstetricians and Gynecologists. The break and the investigation into the rare bleeding disorder, she added, should give the public confidence in the system used to monitor vaccine safety.
Earlier this week, European Union regulators did not recommend the kind of age restrictions on Johnson & Johnson injections that some countries have placed on the AstraZeneca vaccine. Johnson & Johnson agreed to include a warning about the risks of blood clots, and several European countries have resumed use of the vaccine, just like South Africa.
Until a few hours before the break was recommended by US officials, regulators had scheduled a review of the FDA’s emergency use authorization similar to that made official Friday, with warnings about blood clots.
But senior health officials ruled on April 12 that the government should call for a recess while federal officials and the CDC’s panel of experts investigate a possible link between the clots and the vaccine. They were concerned that a number of cases of the disorder had not been identified and wanted to give those who had just received the vaccine more time to reach the point at which rare clotting usually appears.
“In doing this intensive scientific assessment over the past few days, I think we have become more and more confident about the decision that has been made today,” said Dr. Janet Woodcock, acting commissioner of the FDA, on Friday.
In the CDC panel analysis, women between the ages of 30 and 39 appear to be most at risk, with 11.8 cases per million doses administered. Among women aged 18 to 49, there were seven cases per million doses.
The state of coagulation, which the CDC calls thrombosis with thrombocytopenic syndrome, causes severe blood clots and a tendency to bleed at the same time due to abnormally low levels of platelets, a blood component involved in clotting.
The disorder is “rare but clinically serious,” Dr. Tom Shimabukuro, deputy director of the CDC’s immunization safety office, said at the meeting.
Other potential cases, including some in men, are being investigated. A 25-year-old man who took part in a clinical trial of the vaccine also developed the disorder.
The symptoms closely resemble a rare syndrome that can be caused by heparin, a widely used blood thinner, said Dr. Michael Streiff, a hematologist at Johns Hopkins University. Heparin, typically used to treat blood clots, should not be given to these patients, he said.
Symptoms include severe headache, abdominal pain, leg pain, or shortness of breath. These problems usually do not appear until about six days after vaccination. Once symptoms appear, treatment should begin as soon as possible, as it can get worse quickly, the researchers say.
Dr Marks, the FDA regulator, said the agency recommends blood thinners other than heparin and a blood product called intravenous immunoglobulin, which can help ease the immune response that’s causing the problem.
“It seems to reverse this process,” he said.
Researchers suspect that in these rare cases, the vaccine causes an intense reaction from the patient’s immune system, which produces antibodies that activate platelets, a blood component necessary for clotting. It is not known why this happens in some people, and experts say they have so far been unable to identify the underlying traits or conditions that can make some people vulnerable.
Top U.S. health officials have pointed out that the discovery of the small number of rare disease cases and the suspension of vaccine use shows safeguards are in place to assess risks and educate doctors and hospitals about unusual symptoms. .
“This break was critical to our ability to educate the public,” said Dr. José R. Romero, chair of the expert group of the Advisory Committee on Immunization Practices on Friday.
A poll released this week by Ipsos / Axios found that the hiatus itself had boosted confidence in federal vaccine controllers, with 81% saying the CDC and FDA had acted appropriately. Sentiment was unusually bipartisan, with 87% of Republicans and 91% of Democrats sharing this view.
Measuring the impact of the Johnson & Johnson break is tricky, said Liz Hamel, vice president of public opinion polling and research at the Kaiser Family Foundation. “You don’t know what the trajectory of vaccine uptake would have been without this hiatus,” she said.
The biggest challenge ahead, she noted, will be creating messages of vaccine confidence that resonate with the public. “We don’t know if this increased reluctance among women in particular,” she said.
Benjamin Mueller, Matina Stevis-Gridneff, Julie Bosman, Jan Hoffman, Carl Zimmer and Emily Anthes contributed reporting.
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