On Tuesday morning, U.S. federal health regulators recommended suspending Johnson & Johnson’s Covid-19 vaccine and investigated six reports of blood clots in women aged 18-48 years. ..
As of Monday, 6.8 million people have been vaccinated in the United States and no other serious side effects have been reported.
Experts have not yet determined if the vaccine, if any, is the cause of blood clots. However, the investigation follows action by European regulators to conclude that vaccines produced by AstraZeneca may also be responsible for a very rare coagulopathy.
Public health experts in the United States and Europe emphasize that for most people, the benefits of the Covid vaccine far outweigh the risks.
Last week, some European countries restricted the use of the AstraZeneca-Oxford vaccine to the elderly. This is because rare cases of blood disorders occurred in young people.AstraZeneca vaccine is not licensed in the United States
What does this mean for people who have recently been vaccinated with Johnson & Johnson?
Currently, less than one million J & J vaccinations are under investigation. If the risk of blood clots from the vaccine is real (not yet determined), the risk is very low. The risk of getting Covid-19 in the United States is much higher.
FDA Recommended People who have received Johnson & Johnson vaccine within the last 3 weeks should contact their doctor if they experience severe headache, abdominal pain, leg pain, or shortness of breath. For the first few days after vaccination, you don’t have to worry about mild headaches or flu-like symptoms. These are common harmless side effects caused by the production of a protective immune system against the coronavirus.
What is a pause?
During clinical trials and after widespread use of the vaccine, experts track the medical problems experienced by the vaccinated people. In the event of an unusually large group of cases, regulators may decide to suspend the study or discontinue use of the vaccine for further investigation.
Pauses are common, and investigations usually reveal that medical problems are accidental problems. If the investigation reveals that the vaccine poses a risk, regulators can write new guidance on who should or should not be vaccinated.
In this case, the Food and Drug Administration and the US Centers for Disease Control and Prevention have recommended a suspension, and some states have already paid attention to the advice of the authorities. More and more states are temporarily suspending vaccine use, including New York, Virginia, Ohio, CVS Health, and Walgreens.
At a press conference on Tuesday, federal officials said the government’s review would probably only take a few days. The CDC Panel is expected to discuss this issue at a meeting on Wednesday.
What was the problem that caused the pause?
Six women in the United States who received the Johnson & Johnson vaccine developed a rare disease with blood clots within about two weeks of vaccination. In a condition called dural venous sinus thrombosis, blood clots form in the veins that drain blood from the brain. The results are “stroke-like,” said Dr. Anne Schuchat of the CDC.
Researchers studying very similar disorders in European AstraZeneca recipients say they appear to be caused by a violent response to the vaccine by the immune system. Platelets produce antibodies, which are blood components that help form normal blood clots to repair wounds. In addition to blood clots, abnormal bleeding occurs. European researchers call the disorder identified there “vaccine-induced immune thrombotic thrombocytopenia.”
Dr. Peter Marks of the FDA said the unusual combination of coagulation and bleeding set a warning signal to regulators as a possible safety signal.
So far, researchers have not found a way to predict who will develop the disorder and have not identified the underlying condition that may indicate susceptibility.
What is a blood clot?
A blood clot is a thick, gelatinous blood clot that can interfere with circulation. Blood clots form in response to injuries and can be caused by many illnesses, including cancer, hereditary disorders, certain medications, and prolonged sitting and rest. Covid itself can cause serious coagulation problems. Blood clots that form on the legs can break and move to the lungs or, rarely, to the brain, which can be fatal.
How common are blood clots?
According to the CDC, 300,000 to 600,000 people in the United States develop blood clots in parts of the body, such as lungs and veins in the legs, each year.
Based on that data, the US population has about 1,000 to 2,000 blood clots every day. Currently, millions of people are vaccinated daily, so some of these blood clots occur in people who are accidentally injected, regardless of the vaccine.
In England Regulator saidApproximately 1 in 1,000 people are affected by intravenous blood clots each year.
However, the coagulopathy that vaccinated people are concerned about is much rarer and different from typical blood clots. In addition to coagulation in the brain (cerebral sinus thrombosis, or CVST for short), all patients had significantly lower platelet levels and were more prone to abnormal bleeding.
What does Johnson & Johnson say about the new incident?
Tuesday, Johnson & Johnson Said The company was aware of a very rare disorder involving people with thrombocytopenia and blood clots in a small number of individuals who received the COVID-19 vaccine. “In addition, we have been considering these cases with European health authorities,” the company said in a statement. “We have decided to aggressively delay the deployment of the vaccine in Europe.”
Is this the same issue associated with the European AstraZeneca vaccine?
At a press conference on Tuesday, FDA Dr. Marks said the case was “very, very similar.”
Both Johnson & Johnson and AstraZeneca use adenovirus to bring DNA to human cells and initiate the process of generating immunity to the coronavirus. It is not yet known if the technology will cause problems.
German researchers speculate that DNA from the vaccine can provoke an immune response in some people. However, because this condition is so rare, researchers say patients are likely to have some individual biological properties that predispose them to an immune hyperreactivity.
Last month, European regulators began investigating similar cases of hypoplatelet-related cerebral venous thrombosis. They concluded that this disorder was a very rare side effect of the AstraZeneca vaccine. It’s too early to know if the Johnson & Johnson vaccine is the cause of the same type of rare blood clot.
What are the symptoms of AZ-related coagulopathy?
European regulators say vaccine recipients Number of possible symptomsIncludes swelling of the legs, persistent abdominal pain, severe and persistent headache or blurred vision, and small blood stains under the skin beyond the area where the injection was given.
However, the sequence of symptoms was so vague that almost immediately the UK emergency room surged in patients worried about whether it would fit the explanation.
Nevertheless, German researchers say that such symptoms in vaccinated people must be followed. Antibodies can be detected by blood tests.
Can the disorder be treated?
Doctors in Germany and Norway treat patients with anticoagulants to stop the growth of blood clots and give intravenous immunoglobulin to help eliminate the false antibodies that are causing the problem.
Researchers there and US federal health officials on Tuesday advised not to use the common anticoagulant heparin and instead choose alternative medicine. The reason is that this disorder is very similar to the rare syndrome caused by heparin, which can exacerbate the situation in these patients.
Heparin can cause “extreme harm,” Dr. Marks said.
German researchers emphasize that treatment should be started as soon as possible because the condition can deteriorate rapidly.
Does this risk primarily affect women?
Still do not know. All six cases investigated among people vaccinated with the J & J are related to women. However, the number is so small that it is impossible to draw firm conclusions from it.
In Europe, women initially appeared to be at increased risk of blood clots associated with the AstraZeneca vaccine, but in some cases vaccinated men were involved.
Closer research has shown that in some countries, more women are vaccinated as a whole because they are overrated by healthcare professionals. UK regulators currently say there is no evidence of whether men or women are more likely to be affected by blood clots.
Are rare blood clots associated with the Moderna and Pfizer-BioNTech vaccines?
The FDA has not found similar cases in people vaccinated with Moderna or Pfizer-BioNTech vaccines.
However, lower platelet levels are due to Moderna, Pfizer-BioNTech, and AstraZeneca vaccine. One Florida doctor died From cerebral hemorrhage when his platelet levels could not be restored, and others were hospitalized. U.S. health officials say the cases are under investigation, but the results of those reviews have not been reported and have not yet been shown to be associated with the vaccine.
Benjamin Mueller contributed to the report.
How much do you need to worry about J & J vaccines and blood clots?
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