Six of the 7.5 million people shot in Washington.
This step means that one-shot son onson և oh john onson products will remain on the shelf for at least a week.
During an emergency emergency meeting, when federal officials advised that the vaccine be discontinued one day after vaccination, advisers from the Centers for Disease Control and Prevention agreed to convene within 10 days, acknowledging the urgency of deciding on the vaccine. In the United States մի Part of the worldwide strategy to end the epidemic.
The Advisory Committee on Immunization Practice studied in detail six cases of blood clots in women aged 18 to 48 years. Women develop symptoms six to 13 days after vaccination, most often headaches. One of the recipients of the vaccine, a woman from the state of Virginia, died in March, and the other is in critical condition, health officials said. Two have been discharged and three remain in hospital.
Instead of voting on the vaccination campaign on how to resume the proposal, the commission members said they wanted more information on the risks, cause and frequency of rare brain tissue. Once the panel was reassembled, members could then vote to recommend the vaccine to people over the age of 18, continue with a general break, or pause for certain age groups.
“We are very fortunate to have so many other alternatives in the United States to help stop this epidemic. “We have very good, well-proven alternatives where we see no safety signals,” said Helen Cape Talbot, an associate professor of medicine at Vanderbilt University and a member of the committee. “I think it puts us in a slightly different position. We can be much more careful, thoughtful, using the old ‘Do No harm first’ model. »
Beth Bell, a global health expert at the University of Washington who heads the House Coronavirus Vaccines Working Group, said he did not want to vote Wednesday for fear of undermining support for the easier-to-use vaccine.
The Economist-YouGov national survey found that public confidence in son onson և John onson vaccines may be declining. In a matter of days, the proportion of people who thought the vaccine was “more or less unsafe” increased from 26% on Monday to 39% on Tuesday after federal officials offered a break on Monday.
The vaccine has been shown to be a powerful tool for creating immunity in vulnerable communities, such as the home population or the homeless population, who may not be able to return for a second shot. The decision, no doubt, will resonate around the world.
The vaccine was part of the US immunization strategy. Եւ Investigation continues. South Africa has suspended the use of gunfire.
But some health officials say Wednesday’s lack of a proposal is a decision that will have repercussions.
“Prolonging the pause will inevitably lead to the fact that the most vulnerable people in the United States, who were the main candidates for the onson և ons John onson vaccine, will remain vulnerable. “Those at risk will remain at risk; those who benefit immediately from the vaccine will remain unvaccinated indefinitely,” said Nirav Shah, director of the Maine Center for Disease Control and Prevention. “This comes at a time when the United States is still reporting 5,000 deaths across the country in the last seven days.”
A CDC official և Johnson & Johnson CEO described the six cases in great detail to date. All the women were white, and only one was taking hormonal contraceptives, which can cause blood clots, suggesting that this was not the cause of the blood clot.
Tom Shimabukuro, of the CDC Vaccine Safety Team, explained that rare, severe thrombi were particularly alarming because they were accompanied by low blood clotting levels involved in thrombosis, a combination almost unheard of in healthy young people.
“We have a picture where we have a lot of blood clots [blood] “Vessels have low platelets, so it’s a kind of paradox,” Shimabukuro said. “This is unusual. It usually does not happen. “
The combination is also rare in people who have been vaccinated with AstraZeneca և Oxford University. Four of the vaccine recipients were initially treated with heparin, an anticoagulant that is not recommended because the events are very similar to a drug-induced immune response that can worsen blood clots.
Some women have had blood clots in other parts of their bodies, և Shimabukuro said, adding that the agency would launch a wider network in search of thrombosis with low platelet counts.
Aran Marin, chief medical officer at Johnson & Johnson’s Johnson & Johnson division, who developed the vaccine during the company presentation, provided data on two cases of thrombosis in people who received the vaccine in clinical trials, one of whom was 25 years old. – An old man who has symptoms.
“I would like to reiterate that based on current data, Johnson & Johnson believes that the overall benefit-risk profile of the vaccine is positive for the population for which it is authorized,” said Marin.
Blood tissue is similar to that reported by several European countries following the AstraZeneca coronavirus vaccine, which uses a similar technology. Some experts say it is important to understand whether vaccine risks outweigh the benefits to certain groups of people. But they also said that the risk of developing a blood clot after receiving the vaccine was much lower than using a platelet problem caused by a severe coccoid-19 infection or using birth control hormones, such as oral contraceptives.
The immediate practical impact of the proposed shutdown was limited, as the vast majority of the 192 million personnel deployed in the United States were made by Pfizer-BioNTech և Moderna using a different technology.
To date, nearly 1.5 million of the son onsons և John onsons have been given to women between the ages of 18 and 50, says Sarah Oliver, a CDC medical expert and member of the committee’s covid-19 working group. Oliver said that John Onson և son Onson vaccines make up less than 5% of all vaccines.
The Food and Drug Administration (CDC) has said it has decided to discontinue the Johnson & Johnson vaccine because they are concerned about possible harm if doctors do not know how to detect, manage and treat the complication. They want to make sure that medical professionals are aware that vaccine-linked blood clots should not be treated with ordinary heparin, which can deepen blood clots.
Officials also want to encourage reporting from clinicians if there are additional cases that may help identify the syndrome or risk factors.
In many ways, the scenario in the United States echoes what happened in Europe, as rare thrombosis cases began to be recognized in early March among older people, mostly women, who had recently received the AstraZeneca vaccine.
Rare but alarming condensation cases in Europe have forced some countries to discontinue the vaccine altogether, and scientists have begun to study whether clots are linked to vaccines. The potential impact of regulators’ risk tolerance և vaccine suspensions sparked public controversy when countries stopped vaccinating in the middle of the epidemic. Over time, more cases were identified and investigated.
Of the 34 million people vaccinated in Europe, regulators found 169 cases of cerebral hemorrhage and 53 cases of abdominal pain, which raised suspicions.
After weeks of scientific work and meetings, European scientists and regulators concluded that coagulation cases may be related to the vaccine, and decided on a diagnostic test and treatment. As a result, many countries have restricted the use of the AstraZeneca-Oxford vaccine for older adults.
The type of brain blood tissue found in six U.S. cases leads to a condition called cerebral venous sinus thrombosis. The normal level of this blood tissue in the general population is 2 to 14 per million people per year. What stood out for the scientists and doctors was that these thrombi were accompanied by a very low level of platelets, the blood cells involved in blood clotting. That combination of symptoms. At the same time, the risk of bleeding and thrombosis is contraindicated, but occurs in the case of rare immune responses, when the body produces antibodies that bind to platelets, causing them to activate and consume.
A similar syndrome occurs in some patients after exposure to the anticoagulant heparin, which triggers warnings not to use in these patients.
Since the launch of the U.S. Vaccine Program on December 14, the CDC Vaccine Advisory Committee has been monitoring the data on a weekly basis.
Preliminary information on six cases was found in the vaccine monitoring system run by the CDC և FDA. The three-decade-old system, known as the Vaccine Adverse Event Reporting System, or VAERS, is an early warning platform that also collects information on possible side effects or health problems after vaccination. It controls unusual or unexpected patterns that require closer scrutiny. Anyone can report a reaction or injury, including health care providers, patients, and patient representatives, such as caregivers or attorneys.
Son Onson և John Onson’s proposal to stop the action led to quick action. The US military has announced that many states are ending their use of the single-dose vaccine. As of Wednesday, about 7.5 million doses of broad onson և 7. onson vaccines had been injected nationwide. About 16 million doses have been shipped to federal states through federal channels since the beginning of March.
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The Washington Post’s Scott Scott contributed to this report.