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Blood clots linked to AstraZeneca shot have 22% mortality charge: research

Blood clots linked to AstraZeneca shot have 22% mortality rate: study

A paramedic prepares doses of the AstraZeneca vaccine for patients at a walk-in COVID-19 clinic at a Buddhist temple in the Smithfield suburb of Sydney on Aug. 4, 2021.

Saeed Khan | AFP | Getty Images

A new study has provided further details on the “rare but devastating” blood clotting complications associated with the Oxford-AstraZeneca Covid-19 vaccine.

In a peer-reviewed article published Wednesday in the New England Journal of Medicine, Massachusetts Medical Society scientists analyzed the first 220 cases of the disease reported in the UK.

The Oxford-AstraZeneca vaccine – now one of the most widely used Covid vaccines in the world – was launched in the UK in January, making it the first country to give the vaccine.

A very small number of people who were vaccinated with the AstraZeneca vaccine have developed blood clots. Described by health officials as “extremely rare”, it is characterized by blood clots accompanied by low platelet counts.

The Massachusetts Medical Society study uses data identified from 294 patients who presented to UK hospitals between March 22nd and June 6th.

All of these patients had received their first dose of the Oxford-AstraZeneca shot and were hospitalized with symptoms between five and 48 days after their vaccination. The average time between vaccination and hospitalization was 14 days, the results showed.

The overall mortality rate for VITT in the study was 22%.

The researchers also found that 41% of patients who presented with VITT were not diagnosed with any underlying health problems. Of those reporting a past or current illness, the study found that no illnesses or medications that were “unexpected in the general population” were prevalent.

“Against the background of a successful vaccination program in the UK, VITT has emerged as a rare but devastating complication,” the study’s authors said in their report. “We found that it often affects young, otherwise healthy vaccine recipients and is associated with high mortality.”

“In our cohort, 85% of the patients were younger than 60 years, although the (Oxford / AstraZeneca) vaccination was predominant in older adults,” the scientists found.

As a precaution, Great Britain has been offering people under 40 an alternative to the Oxford AstraZeneca vaccine since May.

People diagnosed with VITT ranged from 18 to 79 years old, with the mean age being 48, the study showed.

As of July 28, inclusive, an estimated 24.8 million first doses of the Oxford-AstraZeneca Covid vaccine had been administered in the UK, with an estimated 23.6 million second doses received.

On July 28, government figures show that for every million first or unknown doses of the Oxford AstraZeneca shot, 14.9 people developed a rare blood clot with low platelet counts. After a second dose of the vaccine, the number dropped to 1.8 cases per million.

The overall death rate for that period was 18%, the government data showed, with 73 deaths. Six of these occurred after the second dose.

Late last month, AstraZeneca published a study that found the VITT rate was 8.1 per million after the first dose of its vaccine, which dropped to 2.3 per million after a second dose.

According to official information, 411 suspected cases of VITT had been reported in Great Britain by July 28.

Benefits vs. Risks

In a statement Thursday, AstraZeneca said the research published in the New England Journal of Medicine was drawn from “a small sample size.”

“Recent practical evidence from millions of people shows that AstraZeneca’s vaccine has a similar safety profile to other vaccines and that thrombosis with thrombocytopenia is extremely rare and treatable,” said a spokesman.

The spokesman added that the infection with Covid-19 “poses a far greater risk” for rare blood clotting events.

“Vaccines remain the most effective protection against Covid-19 and the best way out of this pandemic,” they said.

Both the UK and EU drug regulators have identified possible links between the Oxford AstraZeneca vaccine and rare blood clots.

In April, the company announced it would comply with government requests in the UK and Europe to update its Covid vaccine labels. However, it stressed that the WHO had said “a causal relationship is considered plausible but not confirmed”.

The UK Joint Vaccination and Immunization Committee has stated time and time again that for the vast majority of people, the benefits of the Oxford-AstraZeneca vaccine continue to outweigh the risks.

Several health authorities, including the WHO, the European Medicines Agency and the International Society on Thrombosis and Hemostasis, agree that the benefits of giving the vaccine outweigh the risks.

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Health

A brand new research hints at a purpose the J.&J. and AstraZeneca vaccines could trigger blood clots in uncommon circumstances.

A new study hints at a reason the J.&J. and AstraZeneca vaccines may cause blood clots in rare cases.

An advisory group from the Centers for Disease Control and Prevention has recommended that the Johnson & Johnson Covid-19 vaccine hiatus be lifted for all adults while also putting up a warning sign about a rare but dangerous blood clot disorder. However, a central mystery remains: how could a vaccine given to nearly eight million people cause the side effect in just a few of them?

There’s no clear answer yet, but Dr. Andreas Greinacher, a researcher at the University Medical Center Greifswald in Germany, leads an attempt to find out. Speaking at a news conference on Tuesday, he said he had an agreement with Johnson & Johnson to study the components of the vaccine to see if it could interfere with normal blood clotting under certain rare conditions.

“We just agreed that we’d like to work together,” he said.

It is possible, said Dr. Greinacher that the Johnson & Johnson vaccine can cause rare side effects through the same process that he suspects is responsible for similar side effects of the AstraZeneca vaccine. The main component of both vaccines are harmless viruses called adenoviruses, which invade human cells and deliver a coronavirus gene that later triggers an immune response.

On Tuesday, Dr. Greinacher and his colleagues published a report on how the AstraZeneca vaccines can trigger the side effect. The study has not yet been published in a scientific journal.

The scientists found that components of the AstraZeneca vaccine can adhere to a protein that releases platelets when blood clots form. These lumps of molecules could be viewed by the body as foreign invaders, the scientists speculated, triggering a cascade of reactions that turn platelets into dangerous clots.

Dr. Paul A. Offit, a vaccines expert at Philadelphia Children’s Hospital who was not involved in the study, found Dr. Greinacher fascinating, but far from the final word. “It throws a lot of opportunities,” he said.

Dr. Offit said it was not clear which of the many factors the researchers looked at could explain the rare blood clots in people vaccinated with AstraZeneca’s doses. “It’s like taking a sip from a fire hose,” he said.

At a press conference on Tuesday, Dr. Greinacher said the research could reveal ways the AstraZeneca vaccine can lower the risk of blood clots or treat the side effects. However, he stressed that the small risk of these side effects was outweighed by the protection that vaccines like AstraZeneca offer against Covid-19.

“Not being vaccinated is far more dangerous than being vaccinated and at risk for this adverse drug reaction,” he said.

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J&J requested Pfizer, Moderna to assist research blood clots however they declined: WSJ

J&J asked Pfizer, Moderna to help study blood clots but they declined: WSJ

A person walks past a sign that reads “The vaccine is our best shot against COVID-19” on the Upper West Side amid the coronavirus pandemic in New York City on March 30, 2021.

Noam Galai | Getty Images

Johnson & Johnson has privately asked Covid-19 vaccine competitors Pfizer and Moderna to participate in a study examining the potential risk of blood clots. The companies refused, however, the Wall Street Journal reported on Friday, citing people familiar with the matter.

Pfizer and Moderna executives said their vaccines were safe and they didn’t see the need to redouble efforts by regulators and companies already addressing the rare blood clot problem, the journal’s report said.

Only AstraZeneca, whose vaccine raised regulatory concerns about blood clots, agreed to join the effort, the Journal said.

CNBC has asked the four companies to comment.

On Tuesday, the Food and Drug Administration and Centers for Disease Control and Prevention advised states to temporarily suspend use of J & J’s vaccine “out of caution” after six women developed a rare but potentially life-threatening bleeding disorder Dead and one left in critical condition.

The women developed a condition known as cerebral venous sinus thrombosis (CVST) within about two weeks of receiving the shot, US health officials told reporters. CVST is a rare form of stroke that occurs when a blood clot forms in the venous sinuses of the brain. It can eventually leak blood into the brain tissue and cause bleeding.

A CDC panel on Wednesday decided to postpone a decision on J & J’s vaccine use while officials investigate the cases.

Read the full Wall Street Journal report here.

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Health

J&J Vaccine and Blood Clots: A Danger, if It Exists, Is Tiny

J&J Vaccine and Blood Clots: A Risk, if It Exists, Is Tiny

On Tuesday morning, U.S. health officials recommended a break in using Johnson & Johnson’s Covid-19 vaccine while examining six reports of blood clots in women ages 18 to 48. One has died, another is in critical condition in the hospital.

As of Monday, 6.8 million people in the United States had received the vaccine with no other serious side effects reported.

Experts are yet to determine to what extent the vaccine may be responsible for the clots. However, the investigation follows action by European regulators who concluded that a vaccine made by AstraZeneca may also be the cause of a similar, extremely rare, coagulation disorder.

US and European public health experts have emphasized that for most people, the benefits of Covid vaccines far outweigh the risks.

Several countries in Europe last week restricted the use of the AstraZeneca-Oxford vaccine to older adults due to the rare occurrence of a blood disorder in younger people. The AstraZeneca vaccine was not approved in the United States.

Fewer than one in a million J&J vaccinations are currently being studied. If there is indeed a risk of blood clots from the vaccine – which has yet to be determined – the risk is extremely small. The risk of contracting Covid-19 in the United States is much higher.

The FDA recommends people who have received the Johnson & Johnson vaccine within the past three weeks to see their doctor if they have severe headache, abdominal pain, leg pain, or difficulty breathing. Doctors who see people with these symptoms, especially if the patients are young women, should ask if they have recently had a Covid shot, said Dr. Anthony Fauci, senior scientific advisor to the Biden administration, at a press conference Tuesday.

People shouldn’t worry about mild headaches and flu-like symptoms for the first few days after vaccination. These are common, harmless side effects caused by the immune system’s defense against the coronavirus.

For people who got the vaccine a month or two ago, the blood clot problem means “nothing,” said Dr. Fauci. The six cases occurred within a “fairly narrow window” of six to 13 days after people got the shot, he said.

During clinical trials and after the widespread use of vaccines, experts track all of the medical problems that arise in people who receive them. If an unusually large number of cases arise, regulators may decide to stop a study or stop using a vaccine for further investigation.

Breaks are frequent, and tests usually show that the medical problems were incidental. If the investigation reveals that a vaccine poses a risk, regulators can write new guidance on who should or should not receive it. The break also gives them time to advise doctors on how to recognize and treat the disease.

If so, the Food and Drug Administration and Centers for Disease Control and Prevention recommend a break States have already followed the advice of the agencies. Companies that are temporarily discontinuing use of the vaccine include CVS Health and Walgreens.

In a press conference Tuesday, federal officials said the government review would likely only take a few days. A CDC panel is expected to discuss the issue at a meeting on Wednesday.

Six women in the United States who received the Johnson & Johnson vaccine developed a rare blood clot disorder within about two weeks of being vaccinated. In people with this condition called cerebral venous sinus thrombosis, clots form in veins that drain blood from the brain. The results are “stroke-like,” said Dr. Anne Schuchat from the CDC.

Researchers studying a very similar disorder in AstraZeneca recipients in Europe say it appears to be caused by an intense immune system response to the vaccine, which makes antibodies that activate platelets, a blood component that helps to form normal blood clots in the Contributes to wound repair. In addition to clots, abnormal bleeding occurs. European researchers have named the disorder identified there as “vaccine-induced immune thrombotic thrombocytopenia”.

Dr. FDA’s Peter Marks said it was the unusual combination of clotting and bleeding that set a red flag for regulators as a possible safety signal.

So far, researchers have failed to find a way to predict who will develop the disorder and have not identified an underlying condition that could indicate a susceptibility.

Updated

April 13, 2021, 5:17 p.m. ET

Dr. Fauci said if scientists could identify a common core trait among the women who developed the blood clots, it could help identify who is at risk and allow regulators to pinpoint categories of people who are not receiving the J&J vaccine should.

A blood clot is a thickened, gelatinous clot of blood that can block blood flow. Clots form in response to injury and can also be caused by many diseases, including cancer and genetic disorders, certain medications, and prolonged sitting or bed rest. Covid itself can cause serious coagulation problems. Clots that form in the legs sometimes break off and travel to the lungs or, rarely, to the brain, where they can be fatal.

In the United States, 300,000 to 600,000 people each year develop blood clots in their lungs, leg veins, or other parts of the body, according to the CDC

Based on this data, approximately 1,000 to 2,000 blood clots occur daily in the US population. With millions of people being vaccinated every day now, some of these clots appear in those who just happened to receive the shots, regardless of the vaccine.

In the UK, about 1 in 1,000 people are affected by a blood clot in a vein each year, according to regulators.

However, the worrying coagulation disorder among vaccine recipients is much rarer and different from typical blood clots. In addition to clotting in the brain – cerebral venous sinus thrombosis for short, or CVST for short – all patients had remarkably low levels of platelets, which made them prone to abnormal bleeding.

On Tuesday, Johnson & Johnson announced that the company was aware of an extremely rare condition involving people with blood clots combined with low platelets in a small number of people who received the vaccine. “In addition, we have examined these cases with the European health authorities,” said the company in its statement. “We made the decision to proactively delay the launch of our vaccine in Europe.”

At the press conference on Tuesday, Dr. Marks from the FDA said the cases are “very, very similar.”

What You Need To Know About The Johnson & Johnson Vaccine Break In The United States

Both Johnson & Johnson and AstraZeneca use adenoviruses to transport DNA into human cells and begin the process of creating immunity to the coronavirus. It is not yet known if this technology is causing the problem.

German researchers have speculated that DNA from the vaccine could trigger the immune response in some people. However, the condition is so rare that researchers say patients likely also have an individual biological trait – which is still unknown – that predisposes them to the immune overreaction.

Last month, European regulators began investigating similar cases of cerebral vein thrombosis related to low platelets. They concluded that the disorder was a very rare side effect of the AstraZeneca vaccine. It’s too early to know if Johnson & Johnson’s vaccine is responsible for the same type of rare blood clot.

European regulators had recommended that recipients of the vaccine seek medical help for a number of possible symptoms, including leg swelling, persistent abdominal pain, severe and persistent headache or blurred vision, and tiny spots of blood under the skin outside of the area where the Injection was given was given.

However, these symptoms were so vague that the UK emergency departments almost immediately saw an increase in patients worried they were as they were described.

Still, German researchers say such symptoms need to be followed up in vaccine recipients. Blood tests can detect the antibodies.

Doctors in Germany and Norway have treated patients with blood-thinning drugs to stop the clot from growing and with intravenous immunoglobulin, which can help clear up the misdirected antibodies that are causing the problem.

The researchers there and the US federal health authorities advised against the use of a conventional blood thinner, heparin, on Tuesday and recommended that alternative drugs be chosen instead. The reason is that the disorder is very similar to a rare syndrome caused by heparin and it is possible that heparin could make the situation worse in these patients.

Heparin could “do a lot of damage,” said Dr. Marks.

German researchers have stressed that treatment should start as soon as possible as the condition can worsen quickly.

We do not know yet. The six cases studied in people who received the J&J vaccine all involved women. However, this number is so small that no clear conclusions can be drawn from it.

When asked on Tuesday whether the use of contraception could be a risk factor, US health officials said they knew no connection.

In Europe, it initially appeared that women were at a higher risk of blood clots associated with the AstraZeneca vaccine, although in some cases men who had received the vaccine were affected.

Upon closer inspection, it was found that in some countries more women overall received the vaccine because they were overrepresented among health workers. UK regulators now say they have no evidence as to whether men or women are more likely to be affected by blood clots.

The FDA did not find any similar cases in people who received the Moderna or Pfizer-BioNTech vaccines.

However, decreased platelet counts have been reported in a few patients who received the Moderna, Pfizer-BioNTech and AstraZeneca vaccines. One recipient, a doctor in Florida, died of a cerebral haemorrhage when his platelet counts failed to restore, and others were hospitalized. US health officials have stated that the cases are being investigated, but they have not reported the results of those reviews and have yet to advise that they are linked to the vaccines.

Benjamin Mueller contributed to the reporting.

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Health

AstraZeneca Vaccine and Blood Clots: What Is Recognized So Far

AstraZeneca Vaccine and Blood Clots: What Is Known So Far

Still, German researchers have said these clots were more common in recipients of the AstraZeneca-Oxford vaccine than in people who had never received the shot.

European regulators had recommended that recipients of the vaccine seek medical help for a number of possible symptoms, including leg swelling, persistent abdominal pain, severe and persistent headache or blurred vision, and tiny spots of blood under the skin outside of the area where the Injection was given was given.

However, these symptoms were so vague that the UK emergency departments almost immediately saw an increase in patients worried they were as they were described. As a result, some emergency physicians have asked for more central guidance on how to deal with what they termed largely unnecessary hospital visits.

German researchers have described special blood tests that can help diagnose the disorder and have suggested treatment with a blood product called intravenous immunoglobulin, which is used to treat various immune disorders.

Drugs called anticoagulants or blood thinners can also be given but are not used frequently – heparin – because the vaccine-related condition is very similar to that rarely seen in people given heparin.

Other vaccines, particularly those given to children for measles, mumps, and rubella, have been linked to transient low levels of platelets, an essential component of blood clotting.

Reduced platelet counts have been reported in a small number of patients who received the Moderna, Pfizer-BioNTech and AstraZeneca vaccines. One recipient, a doctor in Florida, died of a cerebral haemorrhage when his platelet counts failed to restore, and others were hospitalized. US health officials have stated that the cases are being investigated, but they have not reported the results of those reviews and have yet to advise that they are linked to the vaccines.

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Blood Clots Linked to AZ Vaccine Stem From Uncommon Antibody Response

Blood Clots Linked to AZ Vaccine Stem From Rare Antibody Reaction

The antibodies resulted in a condition called thrombotic thrombocytopenia, which caused both clotting and abnormal bleeding. The researchers suggested calling the newly identified version in these patients “vaccine-induced immunothrombotic thrombocytopenia” or VITT.

Scientists have put forward various theories of what triggers the immune response. The AstraZeneca vaccine uses a chimpanzee adenovirus to transport DNA into recipients and trigger an immune response against the coronavirus. Laboratory research has shown that the chimpanzee virus or DNA could be causing the problem. Some researchers have suggested that bleeding from the injection mixed with the vaccine could bring platelets into the crosshairs of the immune system.

Dr. Greinacher called the theories plausible but unproven.

The article described special blood tests that could help diagnose the disorder and differentiate it from other, more common, clotting problems unrelated to the vaccine. The research team suggested treatment with a blood product called intravenous immunoglobulin, which is used to treat various immune disorders. Dr. Greinacher compared the treatment to putting out a fire.

Medicines called anticoagulants or blood thinners can also be given. However, the researchers advised against prescribing a commonly used heparin because the vaccine-induced condition is very similar to a severe reaction that is rarely seen in people given heparin.

The second report from Norway described five patients, one male and four female health workers aged 32 to 54, who had blood clots and bleeding seven to ten days after receiving the AstraZeneca vaccine. Four had severe blood clots in the brain and three died. Severe headache was one of her early symptoms. Like the German patients, they all had high levels of antibodies that could activate blood platelets.

The team from Norway also recommended intravenous immunoglobulin treatment. The researchers said the disorder is rare but “a new phenomenon with devastating effects on otherwise healthy young adults,” and they suggested it might be more common than previous studies with the AstraZeneca vaccine had shown.

On Friday, European regulators also said they were reviewing reports of some blood clot cases that have occurred in people who had received the Johnson and Johnson vaccine. In the United States, federal agencies are investigating reports of another type of unusual blood disorder in which a few dozen people who received either the Pfizer-BioNTech or Moderna vaccines experienced steep decreases in platelet counts.

Benjamin Mueller and Melissa Eddy contributed to this.

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World News

U.Okay. says under-30s ought to get a non-AstraZeneca possibility; E.U. finds a ‘potential hyperlink’ to uncommon clots.

U.K. says under-30s should get a non-AstraZeneca option; E.U. finds a ‘possible link’ to rare clots.

The UK said Wednesday that it would offer alternatives to the AstraZeneca vaccine for adults under 30 as European regulators identified a “possible link” with rare blood clots, a setback for the world’s most widely used vaccine and a blow for the 100+ Described countries relying on it to save lives amid a global surge in coronavirus cases.

The European regulator, the European Medicines Agency, has no longer advised restricting the use of the vaccine in the 27 countries of the European Union, stating that it is up to national authorities to decide who should receive which vaccine.

Until the announcement, the UK had never let up in the use of the vaccine, making it a holdover in Europe, although many countries discovered unusual, sometimes fatal, blood clots in some recipients. However, there is evidence that very few Britons were also affected, forcing the country to reduce the use of a vaccine, which is the backbone of its world’s best immunization program, among younger people.

Concerns about the blood clots have threatened the pace of vaccination well beyond Europe. At least 111 countries of different incomes have administered doses of AstraZeneca’s shot, making it the most powerful weapon of international aid groups in the fight against the death toll in AstraZeneca Countries with a shortage of vaccines.

Both UK and European regulators said it was possible the clots were linked to the vaccine but that more research was needed. The European regulators described the cases as a serious but “very rare” side effect.

According to official information, the European regulatory authorities had received reports of 222 cases of the rare blood clotting problem in Great Britain and the European Economic Area with 30 countries (European Union plus Iceland, Norway and Liechtenstein) by Sunday. They said that about 34 million people in those countries had received the AstraZeneca vaccine and that the coagulation problems occurred at a rate of about 1 in 100,000 recipients. The condition can be treated.

European regulators said they had carried out detailed reviews of 86 cases by March 22, of which 18 were fatal.

The agency reiterated that the general benefits of the vaccine still outweighed the risks, but urged health professionals and recipients of the shot to be careful about symptoms such as shortness of breath, chest pain, or leg swelling.

Many European countries have restricted the use of the vaccine in younger people as some scientists believe they are at greater risk of developing the rare blood clots. You also have a lower risk of developing severe Covid-19, which raises the safety bar for any vaccine given to younger people.

However, the regulator said it had not concluded that age or gender posed a specific risk and would investigate the issue further.

“This case clearly shows one of the challenges posed by large-scale vaccination campaigns,” said Emer Cooke, head of the agency, in a press conference Wednesday. “When millions of people receive these vaccines, very rare events that were not identified during clinical trials can occur.”

“The risk of mortality from Covid is much greater than the risk of mortality from the side effects,” added Ms. Cooke.

No other vaccine has sparked as much controversy as the shot by the British-Swedish company who used the Block Spats on supply cuts, its effectiveness and ultimately on rare but sometimes fatal blood clots that have been reported in some recipients.

These concerns prompted several European countries to first restrict the use of AstraZeneca in older age groups and then suspend it on reports of blood clots, only to reintroduce it last month after the European Medicines Agency issued a preliminary opinion on the vaccine’s benefits outweighing the risks .

Because doctors reported a higher incidence of severe blood clots in younger people, some countries decided to stop giving the shot to anyone under the age of 55.

Europe’s concerns about the vaccine’s side effects are also likely to threaten global vaccination efforts, with much of the developing world relying on the AstraZeneca vaccine to help fight the pandemic. The shot is the cornerstone of Covax, a program designed to make vaccine access more equitable around the world.

The vaccine appeared to trigger an immune response in which antibodies bind to platelets and activate them, German doctors and the European Medicines Agency have said. These platelets, in turn, caused dangerous clots to form in certain parts of the body, including veins that drain blood from the brain, leading in some cases to a rare type of stroke.

Doctors have said why the antibodies develop in these people is not known. Some component of the vaccine or an excessive immune response – or both – could be the cause, they said.

There is no known disease that makes patients more susceptible to this coagulation disorder after vaccination, according to the European regulatory authorities.

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EU medicines regulator finds doable hyperlink between AstraZeneca Covid vaccine and blood clots

EU medicines regulator finds possible link between AstraZeneca Covid vaccine and blood clots

Syringes are filled with Astrazeneca’s vaccine in the pharmacy.

Christopher Neundorf | Image Alliance | Getty Images

LONDON – Europe’s Medicines Agency announced on Wednesday a possible link between the coronavirus vaccine developed by AstraZeneca and Oxford University and rare blood clotting problems in adults who received the shot.

It comes after a review of all currently available evidence in extremely rare cases of unusual blood clots in some vaccinated individuals.

Emer Cooke, executive director of the European Medicines Agency, said in a televised press conference that the regulator’s safety committee “has confirmed that the overall benefits of the AstraZeneca vaccine in preventing Covid-19 outweigh the risks of side effects.”

“A plausible explanation for these rare side events is an immune response to the vaccine that is similar to that seen in heparin-treated patients,” said Cooke, noting that it was heparin-induced thrombocytopenia.

The EMA has commissioned further research to investigate the link between the vaccine and blood clots, and said its safety committee had concluded that unusual blood clots with low platelets should be listed as “very rare” side effects of the shot. It also drew the public’s attention to other possible side effects that are flagged as adverse drug reactions on the product information of the vaccine.

The European Medicines Agency said it was “of great importance” that health professionals and those receiving the Oxford-AstraZeneca vaccine are aware of these risks and look out for possible symptoms, typically in the first two weeks after vaccination occur.

“These include, for example, shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, neurological symptoms such as severe or persistent headaches or blurred vision and skin bruises beyond the injection site,” said Dr. Sabine Straus, chair of EMA’s security committee, said at the same press conference.

AstraZeneca’s shares fell nearly 1% during afternoon trading in London.

The Oxford-AstraZeneca shot has been followed by safety concerns in recent weeks, and several European countries temporarily stopped using the vaccine last month.

The EMA said on March 31 that it had found the shot to be safe and effective, but added that it could not rule out the possibility of a causal link between the vaccine and coagulation events, so the investigation will continue.

The World Health Organization, the UK Medicines Agency and the International Society on Thrombosis and Hemostasis have all stated that the benefits of administering the Oxford-AstraZeneca shot far outweigh the risks.

AstraZeneca previously said that its studies didn’t find a higher risk of blood clots as a result of its vaccine.

Most countries have since resumed the use of the shot, but many have suspended vaccinations for certain age groups.

A senior European Medicines Agency official said Tuesday that there was a clear “link” between the Oxford-AstraZeneca vaccine and very rare blood clots in the brain, although the direct cause was not yet known.

In an interview with the Italian newspaper Il Messaggero published on Tuesday, Marco Cavaleri, chairman of the EMA’s vaccine evaluation team, said: “In my opinion, we can now say that there is a link to the vaccine, but we are still me don’t know what is causing this reaction. “

The EMA then denied in a statement to Agence France-Presse that it had made a connection between the Oxford-AstraZeneca shot and rare blood clots.

UK vaccine study in children paused

The drug and health products regulator, which approved the Oxford-AstraZeneca vaccine for use in the UK, examined the data after a handful of reports – in both the UK and continental Europe – of serious but rare blood clots, some of which were fatal .

A UK study of the Oxford AstraZeneca vaccine in children has already been paused while the drug agency investigated a possible link between the shot and the bleeding disorders, particularly cases of blood clots in veins in the brain known as cerebral venous sinus thrombosis (CVST) as well Thrombocytopenia (low levels of platelets in the blood that help blood to clot).

The UK government noted that as of March 24th inclusive, there were 22 reports of CVST and 8 reports of other low platelet thrombosis events totaling 18.1 million doses of the AstraZeneca vaccine (one shot with two doses). given up to this date.

People are waiting in a vaccination center in Cologne on April 5, 2021.

Marius Becker | Image Alliance | Getty Images

“We need to know more about those affected and understand exactly how the diseases came about while many other questions remain open,” said Adam Finn, professor of pediatrics at Bristol University, UK, ahead of the announcement on Wednesday.

“There are some things that are very clear, however. The first is that these cases are indeed very rare. The second is that the vaccines available and used in the UK are very effective in preventing COVID,” said Finn.

“In short, if you are currently offered a dose of Oxford AstraZeneca vaccine, your chances of staying alive and staying healthy will go up if you take the vaccine and go down if you don’t.”

– CNBC’s Holly Ellyatt contributed to this report.

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Health

WHO probing studies of blood clots in recipients

Pfizer CEO joins World Health Organization at press conference on the coronavirus outbreak

Tedros Adhanom Ghebreyesus, Director General of the World Health Organization (WHO), speaks after Dr. Anthony Fauci, Director of the National Institute for Allergies and Infectious Diseases, during the 148th session of the Executive Board on the Coronavirus Disease (COVID-19) outbreak in Geneva, Switzerland, January 21, 2021.

Christopher Black | WHO | via Reuters

The World Health Organization announced on Friday that it is reviewing recent reports of blood clots in some people who have received the AstraZeneca Covid-19 vaccine, which has led some countries to stop introducing the shooting.

At least nine countries, including Denmark, Norway, Iceland and Thailand, have stopped using the vaccine for safety reasons. By Wednesday, around 5 million people in Europe had received the Oxford-AstraZeneca vaccine. Of this number, 30 so-called thromboembolic events were reported in recipients. These are blood clots that form in blood vessels and block blood flow.

AstraZeneca said in a statement Friday that there is “no evidence” that the vaccine causes an increased risk of developing blood clots.

WHO director-general Tedros Adhanom Ghebreyesus said Friday that the agency’s Global Advisory Committee on Vaccine Safety “is systematically reviewing safety signals and carefully evaluating recent reports on the AstraZeneca vaccine”.

“Once WHO has a full understanding of these events,” he added, “the results and changes to our current recommendations will be communicated to the public immediately.”

Dr. Mariangela Simao, WHO deputy director general for access to medicines and health products, added that the global health agency “is likely to have a statement this next week when investigations are complete”.

“The WHO is very much aligned with the position that we should continue immunization until we have cleared up the causal link,” she said.

Dr. Soumya Swaminathan, WHO’s chief scientist, said it was still unclear whether the vaccine was actually causing the clots. An AstraZeneca spokesperson noted that “the observed number of these types of events in vaccinated people is significantly lower than expected in the general population”.

“The adverse events reported after vaccination must be seen in the context of events that occur naturally in the population,” said Swaminathan. “Just because it’s reported after a vaccination doesn’t mean it’s the vaccination. It could be completely independent.”

The European Medicines Agency, the European Medicines Agency, has stressed that there is no evidence that the AstraZeneca shot caused blood clots and that the benefits of the vaccine “continue to outweigh the risks”.

“Reports of previously received blood clots are no greater than the numbers that would have occurred naturally in the vaccinated population,” said Dr. Phil Bryan, Vaccine Safety Director for the UK Medicines and Health Products Regulatory Agency.

“Public safety will always come first. We will continue to examine this issue carefully, but the evidence available does not confirm the vaccine is the cause. People should still get their COVID-19 vaccine when prompted become.” he added.

– CNBC’s Sam Meredith contributed to this report.

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European Nations Droop Use of AstraZeneca Photographs Over Worries About Blood Clots

European Countries Suspend Use of AstraZeneca Shots Over Worries About Blood Clots

Italy’s suspension of another batch was tied to a man in Sicily who died after receiving his shot. It is unclear whether a blood clot was involved.

The vaccine manufactured by AstraZeneca has been injected into more than 142,000 people in Denmark, which has a population of around six million.

The Danish Health Minister Magnus Heunicke said on Twitter that it was “currently not possible to determine whether there is a connection”. He added: “We acted early, it needs a thorough investigation.”

Denmark had already cut the target for the completion of its vaccination campaign, partly due to delivery delays. The safety break will delay it further.

AstraZeneca’s vaccine was screened for potential safety issues over the past year while being tested in clinical trials. Two vaccinated volunteers in the UK developed neurological symptoms related to transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often caused by viral infections.

These concerns temporarily put the vaccine to a halt around the world, but the investigation ultimately found no evidence to link the symptoms to the vaccine. One of the sick participants was later found to have an undiagnosed case of multiple sclerosis.

Since then, more than 70 countries have approved the vaccine, with the exception of the United States, where regulators are waiting for data from a large clinical trial expected in the next few weeks. A Food and Drug Administration decision to approve AstraZeneca’s vaccine is likely more than a month away.

The largest real world data on the safety of the vaccine comes from the UK, which had given 9.7 million doses in the last month. The UK Medicines Agency, the regulator of medicines and health products, said: “The number and types of suspected adverse reactions reported to date are not uncommon when compared to other types of vaccines routinely used.”

Rebecca Robbins reported from Bellingham, Washington, and Thomas Erdbrink from Amsterdam. Jason Horowitz and Emma Bubola reported from Italy, Benjamin Mueller from London and Denise Grady from New York.